79C3C34C52B45572883A05D425EB0F82

Scientific and Ethical Approaches for Observational Exposure Studies

https://nepis.epa.gov/Exe/ZyPDF.cgi/P10012LY.PDF?Dockey=P10012LY.PDF

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Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsprisoners10
PoliticalIllegal Activitycrime1
PoliticalIllegal Activityillegal2
PoliticalIndigenousindigenous3
PoliticalIndigenousnative1
Politicalcriminalcriminal1
Politicaldisplaceddisplaced1
Politicalnomadnomads1
Politicalpolitical affiliationparty35
Politicalpolitical affiliationpolitical4
Politicalvulnerablevulnerable91
Politicalvulnerablevulnerability14
HealthCognitive Impairmentcognitive2
HealthCognitive Impairmentimpaired2
HealthComatosecomatose3
HealthDrug Usagedrug10
HealthDrug Usageinfluence19
HealthDrug Usagesubstance12
HealthDrug Usageusage1
HealthHealthy Peoplevolunteers1
HealthMentally Disableddisabled5
HealthMentally Disabledmentally5
HealthMentally Incapacitatedincapable2
HealthMotherhood/Familyfamily11
HealthPhysically Disabledillness2
HealthPhysically Disabledphysically3
HealthPregnantpregnant28
HealthTerminally Illterminally3
Healthillill4
Healthpatients in emergency situationsemergencies1
Healthvisual impairmentblind1
SocialAccess to Social Goodsnecessities2
SocialAccess to Social Goodsaccess28
SocialAgeage19
SocialChildchild38
SocialChildchildren207
SocialElderlyelderly5
SocialEthnicityethnic3
SocialEthnicityethnicity3
SocialFetus/Neonatefetus5
SocialFetus/Neonatefetuses16
SocialFetus/Neonateneonates4
SocialHomeless Personshomeless1
SocialIncarceratedrestricted2
SocialInfantinfant1
SocialLaboratory Staffresearch staff13
SocialLinguistic Proficiencylanguage40
SocialLiteracyliteracy4
SocialMarital Statussingle4
SocialMothersmothers2
SocialOccupationjob1
SocialOccupationoccupation2
SocialPolice Officerofficer1
SocialPolice Officerpolice2
SocialPresence of Coercioncoerced1
SocialProperty Ownershiphome39
SocialProperty Ownershiphomeowner1
SocialRacial Minorityminority3
SocialRacial Minorityrace4
SocialRacial Minorityracial2
SocialReligionbelief1
SocialReligionreligious2
SocialSoldierarmed forces0
SocialSoldiermilitary2
SocialStudentstudent2
SocialThreat of Stigmathreat3
SocialThreat of Stigmastigmatization1
SocialThreat of Stigmastigmatized2
SocialThreat of Violenceviolence1
SocialTrade Union Membershipunion1
SocialUnemploymentunemployed1
SocialVictim of Abuseabuse10
SocialWomenwomen38
SocialYouth/Minorsminor1
SocialYouth/Minorsyouth1
Socialeducationeducation16
Socialeducationeducational8
Socialembryoembryo1
Socialemployeesemployees8
Socialgendergender2
Socialparentsparent7
Socialparentsparents33
Socialphilosophical differences/differences of opinionopinion2
Socialphilosophical differences/differences of opinionphilosophy2
EconomicEconomic/Povertypoor10
EconomicEconomic/Povertylow-income1
EconomicEconomic/Povertysocial status1
General/OtherDependentdependent5
General/OtherDiminished Autonomydiminished3
General/OtherImpaired Autonomyautonomy12
General/OtherIncapacitatedincapacitated1
General/OtherIncapacitatedincapacity3
General/OtherManipulablemanipulated1
General/OtherNatural Hazardshazard23
General/OtherPublic Emergencyemergency4
General/OtherRelationship to Authorityauthority13
General/OtherUndue Influenceundue influence12
General/Otherbelmontbelmont25
General/Othercioms guidelinescioms77
General/Othercommon rule45XcfrX465
General/Othercommon rulecommonXrule24
General/Othercultural differenceculturally3
General/Otherdeclaration of helsinkihelsinki1
General/Otherparticipants in a control groupcontrol group1
General/Otherparticipants in a control groupplacebo2

Political / Criminal Convictions

Searching for indicator prisoners:

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p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
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p.000033: www.bioethics.gov/reports/past_commissions/nbac_human_part.pdf (Accessed September 3, 2007).
p.000033: may be important in conducting observational human exposure studies involving those groups, especially
p.000033: children and pregnant women. The discussions about the ethical issues are based largely on EPA’s human subjects
p.000033: regulations and on the recommendations from the Council for International Organizations of
p.000033: Medical Sciences document, International Ethical Guidelines for Biomedical Research Involving Human
p.000033: Subjects (CIOMS, 2002).
p.000033:
p.000033: 3.1 Identification of Vulnerable Groups
p.000033: In the United States, human subjects regulations (45 CFR 46 and 40 CFR 26) do not formally define
p.000033: vulnerable populations. Instead, the Common Rule gives examples of potentially vulnerable groups (see Text Box 3-1).
p.000033: In addition, HHS extends added human subjects protections to pregnant women, human fetuses,
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
...

p.000035: (Council for International Organizations of Medical Sciences, 2002)
p.000035:
p.000035: • Junior or subordinate members of a hierarchical group; examples include employees, students, members of the armed
p.000035: forces, police, and others who work for, or closely with re- searchers; they may have expectations of preferential
p.000035: treatment if they agree to participate or fear of disapproval or retaliation if they refuse to participate in a study.
p.000035:
p.000035: Common Rule: Examples of vulnerable groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: EPA extends stringent protections to these groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035: HHS extends additional protections to these groups
p.000035: (45 CFR 46)
p.000035:
p.000035: Additional vulnerable groups in NIH training materials
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
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p.000038: subjects rule is completely consistent with the HHS rule in adding additional protections for pregnant women and
p.000038: fetuses involved in observational research (40 CFR
p.000038: 26.304 and 45 CFR 46.204). These additional protections (specified in 45 CFR 46.204 subparagraphs a
p.000038: through j) reflect the CIOMS recommendations by requiring: availability of data from previously conducted
p.000038: studies to assess the risk to pregnant women and fetuses; scientific necessity for inclusion of pregnant women and
p.000038: fetuses (i.e., providing benefit to the woman or fetus, or producing important, but otherwise unobtainable,
p.000038: biomedical knowledge); that risk is reduced to the least possible level for achieving the objectives of
p.000038: the research; and other protections.
p.000038:
p.000038: 3.6 Other Potentially Vulnerable Groups
p.000038: HHS specifies additional protections for prisoners as a potentially vulnerable group in Subpart C of 45 CFR
p.000038: 26. Additional requirements for other vulnerable groups in research studies are not specifically defined in either
p.000038: EPA’s or HHS’ human subjects rules. Nonetheless, other groups (as discussed in Section 3.1) may be considered to be
p.000038: vulnerable and, as such, may warrant additional consideration and protection as required in the Common Rule. For
p.000038: these other potentially vulnerable groups, such as employees, students, handicapped persons, mentally disabled
p.000038: persons, and economically or educationally disadvantaged persons, nursing home residents or otherwise
p.000038: incapacitated elderly, etc., the Common Rule requires researchers and IRBs to fully evaluate the
p.000038: protocols to ensure that the safety and welfare of the groups will be protected. As discussed in Section 3.1,
p.000038: It also should be noted that, although Federal regulations define vulnerability in terms of the ability
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p.000054: or affiliated with the research study, to be available for translations.
p.000054:
p.000054: 5.1.3 Voluntary Participation
p.000054: The third pillar of informed consent is voluntary participation. The Belmont Report emphasizes that
p.000054: participants “should understand clearly the range of risk and the voluntary nature of participation” [emphasis
p.000054: added]. The ethical principles of respect for persons and their autonomous decisions morally obligate
p.000054: the researcher to ensure that an individual’s decision to participate in a human research study is truly
p.000054: voluntary and uncoerced (Emanuel et al., 2000). A number of study characteristics may affect whether the
p.000054: participant’s actions are truly voluntary.
p.000054: • Access to study-dependent benefits or care that would otherwise not normally be received may impair
p.000054: voluntariness.
p.000054: • Voluntary participation also may be compromised when there is an existing relationship between the
p.000054: researcher and participants, such as employer and employee or teacher and student.
p.000054: • Restricted voluntariness may be an intrinsic part of belonging to certain vulnerable groups,
p.000054: including children, prisoners, handicapped persons, mentally disabled persons, and economically or
p.000054: educationally disadvantaged persons, or members of the military, for example. When research participants come from such
p.000054: groups, additional protections to insure voluntariness in the context of the research may be required
p.000054: (see also 40 CFR 26, Subparts B, C, and D).
p.000054: • Payments as incentives may have undue influence and are discussed below.
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: • Whether payments will lead to a coerced decision to participate often is difficult to determine without
p.000055: input from people from similar socioeconomic backgrounds as the participants (p. 111, NRC & IOM, 2005).
p.000055: Researchers should work with community representatives to develop a consent process that will be
p.000055: maximally effective in providing information, ensuring and documenting comprehension, and ensuring
p.000055: that participation is voluntary (also see Section 6).
p.000055: Researchers should remember that obtaining informed consent should be “an on-going, interactive
p.000055: dialogue . . . involving the disclosure and exchange of relevant information” (IOM, 2002): it is not
p.000055: simply having a consent form signed. The process is most effective when the researcher spends time with
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p.000058: payments. They also recommend that the policies disclose any recompense in a full and open
p.000058: process,22 while not overemphasizing any recompense.
p.000058: Although the NRC & IOM Committee on Ethical Issues in Housing-Related Health Hazard Research Involving
p.000058: Children and the IOM Committee on Clinical Research Involving Children both concluded that it is appropriate to
p.000058: reimburse expenses or compensate for time or inconvenience, neither committee endorsed incentive
p.000058: payments to parents. In Europe, too, incentive payments to induce parents to allow their children to
p.000058: 5.2.3 Payments When Children or Other
p.000058: Vulnerable Populations Are Involved
p.000058:
p.000058: It is essential that special care be taken with regard to payments when members of vulnerable populations are
p.000058: included in research studies. Vulnerable populations may include children and adolescents, those with
p.000058: cognitive impairments because of medical conditions or age, economically disadvantaged persons, and prisoners. These
p.000058: populations often are not capable of making autonomous, fully informed decisions regarding risks and
p.000058: benefits, or they may be particularly vulnerable to undue influence resulting from the offer of a payment for
p.000058: research participation. In addition, payments made directly to parents or guardians could alter
p.000058: judgment regarding the best interests of minor or incompetent persons in their care.
p.000058: The ethical concern is that too high a payment may “undermine free and informed consent by leading parents
p.000058: to expose their children to unacceptable risks” (NRC & IOM, 2005). The NRC & IOM committee recognized
p.000058: that some commentators argued that children should never be paid, and that parents ought not to be paid to
p.000058: enroll their children in research. Yet, on balance, the committee felt that “reimbursement for expenses and some
p.000058: modest payment for time spent in research
p.000058: 21 The IOM Recommendation 6.2 states, “In addition to offering small gifts or payments to parents and children as
...

p.000060: participants and provide information on grievance procedures and research-related injuries. These questions
p.000060: could be addressed to the IRB, an ombudsman, an ethics committee, or other knowledgeable
p.000060: administrative body. Consent documents are expected to have at least two names with appropriate
p.000060: telephone contact information⎯one that can provide information regarding the research and
p.000060: another that can provide information regarding their rights as research participants. Grievance
p.000060: procedures should be structured so that grievances reach the approving IRBs and sponsoring
p.000060: organizations.
p.000060:
p.000060: 5.3.1 Ombudsman
p.000060: An ombudsman is a neutral independent advocate for research participants (and their families or guardians, where
p.000060: applicable). Institutions and IRBs may recommend or require the use of an ombudsman in
p.000060: certain types of research studies, particularly those seeking to study vulnerable populations.
p.000060: Ombudsmen can fill several roles as participant advocates. They may be an independent source of information
p.000060: regarding the study. They may be present during the informed consent process to ensure that risks, benefits,
p.000060: and study requirements are communicated correctly and understood by potential participants
p.000060: or their guardians. An ombudsman may be used in studies involving prisoners or military personnel to
p.000060: ensure that there is no coercion to participate. And the ombudsman may
p.000060:
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: communicate problems or grievances raised by research participants to the IRB and sponsoring organization.
p.000061:
p.000061: 5.3.2 Community Advisory Board
p.000061: CABs can help ensure that participant rights are considered and addressed during the study design and can
p.000061: play an important role in monitoring the research process. Community members may choose to seek
p.000061: information about the study from the advisory panel, as an independent entity, before deciding whether to enroll.
p.000061: Representatives from such advisory boards can be included in the research team that designs the study (see
p.000061: Section 2.3). The role of CABs is more fully discussed in Section 6.
p.000061:
p.000061: 5.4 Creating a Supportive Environment for Research and Interaction
p.000061: It is recommended that researchers and institutions strive to create a supportive environment for research
p.000061: and interaction with research participants and communities. At the personal level,
p.000061: this means researchers building trust with individuals and treating them with respect. Following the IOM
p.000061: recommendations about the informed consent process⎯that it “should be an on-going, interactive dialogue between
p.000061: research staff and research participants involving the disclosure and exchange of relevant information,
...

p.000061: Director’s Council of Public Representatives (COPR) (NIH, 2005). Although the advice from this workshop was
p.000061: developed in the context of NIH-supported clinical research, many of the recommendations are applicable to
p.000061: observational human exposure studies and human subject research in general. A summary
p.000061: of
p.000061: recommendations from the report for enhancing public trust is provided in Appendix D. The recommendations are
p.000061: focused on the following areas.
p.000061: • Building trust through community partnerships
p.000061: • Building relationships with patients (participants) (True partnerships with patients may not be possible,
p.000061: but bidirectional relationships must be enhanced.)
p.000061: • Building partnerships with community providers
p.000061: • Building trust in scientists
p.000061: • Building trust in the (EPA) and scientific research.
p.000061:
p.000061: 5.5 Recruitment Strategies
p.000061: Many strategies are used to select and recruit people into research studies requiring human participation. The IRB is
p.000061: responsible for reviewing the selection process to ensure that it is, above all, equitable. The requirement for
p.000061: IRB review is stated in 40 CFR 26.111(a)3.
p.000061: Selection of subjects is equitable. In making this assessment, the IRB should take into account the
p.000061: purposes of the research and the setting in which the research will be conducted and should be particularly cognizant
p.000061: of the special problems of research involving vulnerable populations, such as children, prisoners,
p.000061: pregnant women, mentally disabled persons, or economically or educationally disadvantaged
p.000061: persons.
p.000061: The IRB guidebook is an excellent resource for consideration of concerns and elements for equitable
p.000061: participant selection (U.S. HHS, 1993). It states that “Defining the appropriate group of subjects
p.000061: for a research project involves a variety of factors⎯ requirements of scientific design,
p.000061: susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness.” The IRB
p.000061: guidebook raises a number of points to consider in the process for selection of human participants (see Text Box
p.000061: 5-5).
p.000061: Various participant recruitment strategies may be used depending on the type of research being performed and the
p.000061: population of interest. This section addresses the strategies and approaches for identifying and contacting people and
p.000061: subsequent recruitment into a research study. Sampling design approaches and issues, such as statistical
p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
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p.000117: Source. The origin of an agent for the purposes of an exposure assessment
p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
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p.000118: United States Environmental Protection Agency
p.000118:
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p.000118:
p.000118: Office of Research and Development (810R) Washington, DC 20460
p.000118:
p.000118: Official Business Penalty for Private Use
p.000118: $300
p.000118: PRESORTED STANDARD POSTAGE & FEES PAID EPA
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Political / Illegal Activity

Searching for indicator crime:

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p.000045: researchers may decide to use materials prepared by other organizations that have expertise regarding
p.000045: a particular hazard.
p.000045: Another important element of planning for field data collection and training of research staff is on hazards and
p.000045: situations that the field staff may encounter during their field work. Although the previous discussion highlights the
p.000045: need to be prepared to report potentially negligent or illegal behaviors, these same behaviors may place the
p.000045: research staff in imminent danger during the conduct of their work in residences and communities. The research team
p.000045: should develop a plan for identifying potential situations, hazards, and dangers that may place the
p.000045: research team at risk of imminent harm. This should generally involve working with
p.000045: community representatives to identify the hazards and situations that may be of concern. For example, a
p.000045: researcher’s observation of illegal drugs in a study residence may place the researcher in potential
p.000045: danger. Similarly, if studies are conducted in areas with high crime rates, researchers need to be aware of
p.000045: the potential dangers and have a plan for addressing them. In some cases, situations may arise
p.000045: because of to inadvertent actions. For example, if an area has a high rate of daytime break- ins, the presence
p.000045: of researchers in the area may trigger calls to local authorities when the researchers, who are
p.000045: strangers, are observed in the neighborhood. Feedback from the community representatives should be solicited when
p.000045: developing a plan for responding to situations such as these. Comprehensive training should be developed for
p.000045: research field staff to assist them in identifying potentially dangerous situations and in responding to
p.000045: such situations.
p.000045:
p.000045: 4.4 Third-Party Issues
p.000045: Third-party issues can arise in observational human exposure studies in two ways. First, the study may collect
p.000045: limited information about or related to individuals other than the study participants. Second,
p.000045: study activities may affect or involve people or organizations other than the study participants.
p.000045: Examples of activities that may involve or affect third parties in observational human exposure studies
p.000045: could include, but are not limited to the following types.
p.000045: • Asking the participant about demographic, occupational, smoking, or product use information for
p.000045: other household members
p.000045: • Collecting residential environmental samples in multiperson households
p.000045:
p.000045:
p.000046: 46
p.000046:
...

Searching for indicator illegal:

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p.000045: (2) conditions of neglect that may adversely impact study participants or third parties,
p.000045: (3) environmental hazards and situations that may be associated with imminent harm (e.g., combustible
p.000045: materials near an open flame, unsecured firearms accessible to very young children),
p.000045: (4) policies and procedures for reporting or intervention by members of the research team, and
p.000045: (5) local and state reporting requirements.
p.000045: It is advisable that this training be developed in consultation with community representatives who can
p.000045: provide input on potential hazards and situations that may be encountered in the study community,
p.000045: local norms and attitudes about potential interventions and reporting, and local agencies available to assist on
p.000045: these types of issues. It is also especially important to consider
p.000045: staff experience and training in hazard communication. Consistency in communication is very important, and
p.000045: researchers may decide to use materials prepared by other organizations that have expertise regarding
p.000045: a particular hazard.
p.000045: Another important element of planning for field data collection and training of research staff is on hazards and
p.000045: situations that the field staff may encounter during their field work. Although the previous discussion highlights the
p.000045: need to be prepared to report potentially negligent or illegal behaviors, these same behaviors may place the
p.000045: research staff in imminent danger during the conduct of their work in residences and communities. The research team
p.000045: should develop a plan for identifying potential situations, hazards, and dangers that may place the
p.000045: research team at risk of imminent harm. This should generally involve working with
p.000045: community representatives to identify the hazards and situations that may be of concern. For example, a
p.000045: researcher’s observation of illegal drugs in a study residence may place the researcher in potential
p.000045: danger. Similarly, if studies are conducted in areas with high crime rates, researchers need to be aware of
p.000045: the potential dangers and have a plan for addressing them. In some cases, situations may arise
p.000045: because of to inadvertent actions. For example, if an area has a high rate of daytime break- ins, the presence
p.000045: of researchers in the area may trigger calls to local authorities when the researchers, who are
p.000045: strangers, are observed in the neighborhood. Feedback from the community representatives should be solicited when
p.000045: developing a plan for responding to situations such as these. Comprehensive training should be developed for
p.000045: research field staff to assist them in identifying potentially dangerous situations and in responding to
p.000045: such situations.
p.000045:
p.000045: 4.4 Third-Party Issues
p.000045: Third-party issues can arise in observational human exposure studies in two ways. First, the study may collect
p.000045: limited information about or related to individuals other than the study participants. Second,
p.000045: study activities may affect or involve people or organizations other than the study participants.
p.000045: Examples of activities that may involve or affect third parties in observational human exposure studies
p.000045: could include, but are not limited to the following types.
...

Political / Indigenous

Searching for indicator indigenous:

(return to top)
p.000077: public health: The role of action-oriented partnerships. J Public Health Manag Pract 7(2):21-32.
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: U.S. EPA, Office of Environmental Justice Resources:
p.000078: Executive Office of the President. (1997). Environmental Justice: Guidance under the National Environmental Policy Act.
p.000078: Council on Environmental Quality, pp. 7-17).
p.000078: Available: http://epa.gov/compliance/resources/policies/ej/ej_guidance
p.000078: _nepa_ceq1297.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2006). Future mechanisms to enhance stakeholder involvement
p.000078: and engagement to address environmental justice: A letter report. Available:
p.000078: http://epa.gov/compliance/resources/publications/ej/nejac/st akeholder-involv-9-27-06.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2004). Environmental justices and federal facilities:
p.000078: Recommendations for improving stakeholder relations between federal facilities and environmental justice communities.
p.000078: Waste and Facility Siting Subcommittee, Federal Facilities Working Group. Available:
p.000078: http://www.epa.gov/compliance/resources/publications/ej/n ejac/ffwg-final-rpt-102504.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2004). Meaningful involvement and fair treatment by tribal
p.000078: environmental regulatory programs. Indigenous Peoples Subcommittee. Available:
p.000078: http://epa.gov/compliance/resources/publications/ej/nejac/ip s-final-report.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2000). Guide on consultation and collaboration with Indian
p.000078: tribal governments and the public participation of indigenous groups and tribal members in environmental decision
p.000078: making. Indigenous Peoples Subcommittee.
p.000078: Available: http://www.lm.doe.gov/env_justice/pdf/ips_consultation_gu ide.pdf
p.000078: NEJAC (National Environmental Justice Advisory Council) (2000). NEJAC May 200 Meeting Report. Environmental Justice and
p.000078: Community-Based Health Model Discussion. Available: http://epa.gov/compliance/resources/publications/ej/nejac/co
p.000078: mmunity-based-health-recom-report.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2000). The model plan for public participation. The Public
p.000078: Participation and Accountability Subcommittee. EPA­ 300/K-00-001. Available:
p.000078: http://epa.gov/compliance/resources/publications/ej/nejac/m odel-public-part-plan.pdf
p.000078:
p.000078: U.S. EPA (U.S. Environmental Protection Agency). (2008). The Environmental Justice Strategic Enforcement Assessment
p.000078: Tool (EJSEAT). Available: http://www.epa.gov/compliance/resources/policies/ej/ej­ seat.html
p.000078:
p.000078: U.S. EPA (U.S. Environmental Protection Agency). (2006). Environmental Justice Collaborative Problem-Solving
p.000078: Cooperative Agreement Program FACT SHEET. Office of Environmental Justice. Available:
p.000078: http://www.epa.gov/compliance/resources/publications/ej/fa ctsheets/fact-sheet-ej-cps-grants-6-13-06.pdf
p.000078:
...

Searching for indicator native:

(return to top)
p.000070: which the individual is acting (ERG, 2007).
p.000070:
p.000070: 6.2.2 Identifying Who Represents the Community
p.000070: To sufficiently represent the community, an individual has to have not only the right to speak for the
p.000070: community’s interests (a right afforded by legitimate membership in the group) but also should be able
p.000070: to describe those interests on behalf of the community. Identifying those who represent the community is
p.000070: not simply a matter of identifying the most vocal activists because those individuals do not necessarily
p.000070: represent the interests of the entire community. In fact, several individuals may be necessary to adequately
p.000070: represent the diversity of viewpoints within a community; in such cases, a CAB may be appropriate (ERG, 2007).
p.000070: One of the researcher’s first steps should be asking the potential participants from the community who they see
p.000070: as a
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: legitimate representative (i.e., someone who can speak for them). Corburn cites an example of a locale
p.000071: in Brooklyn, NY, that contained individuals with widely different backgrounds. It was impossible to
p.000071: identify appropriate spokespeople, or even to define the nature of the community, without talking with
p.000071: community members (Corburn, 2007).
p.000071: The NRC & IOM (2005) Report also discusses the issue of who can represent the identified community. Some
p.000071: communities may have a formal governmental structure and a recognized political authority (e.g.,
p.000071: Native American tribes). Other communities may have clearly identifiable leaders (e.g., religious communities),
p.000071: whereas still other communities have no formal leadership structure at all. Whether there is a
p.000071: legitimate political authority or some other hierarchal leadership structure, the goal is to seek community input
p.000071: as to who best represents the interests of the community with regard to the proposed research project,
p.000071: rather than selecting those who are favorable to the research project. The NRC & IOM report cautions against
p.000071: the ethically questionable practice of seeking out population spokespeople and research participants
p.000071: whose positive response to a research plan can be predicted in advance and refers the reader to an article on this
p.000071: topic by Juengst (2000).
p.000071: With multiple sources of leadership and authority in many communities, careful consideration should be given
p.000071: to what aspect of the community a particular person will represent, and what efforts may be needed to ensure
p.000071: that the entire range of views in a community are obtained. Researchers should consider reaching out to multiple
p.000071: organizations such as churches, social service agencies, community-based organizations, and tenant and
p.000071: other community advocacy groups.
p.000071:
p.000071: 6.2.3 Building Relationships and Trust
p.000071: A key first step in developing trust is to establish a relationship with the community before the study. Trust must be
...

Political / criminal

Searching for indicator criminal:

(return to top)
p.000042: • Restricting access to identifying information to only those requiring access
p.000042: • Assigning codes to participants, data, and samples rather than using identifiers
p.000042: • Physically separating identifying information and linkage files from other study information
p.000042: • Securing identifying information in locked files with limited access
p.000042: • Restricting identifying information from computers that are networked with other computers or electronic systems
p.000042: • Restricting identifying information from computers that are not kept in secure locations with limited access
p.000042: • Training research staff members on human subject protection and on information security procedures
p.000042:
p.000042:
p.000042: Another step that can help protect confidentiality is to obtain a Certificate of Confidentiality. Certificates of
p.000042: Confidentiality are issued by NIH (2002) to protect identifiable research information from forced disclosure.
p.000042: They allow the investigator and others who have access to research records to refuse to disclose identifying
p.000042: information on research participants in any civil, criminal, administrative, legislative, or other
p.000042: proceeding, whether at the Federal, State, or local level. Certificates of Confidentiality may be granted for studies
p.000042: collecting information that, if disclosed, could have adverse consequences for subjects or damage
p.000042: their financial standing, employability, insurability, or reputation. By protecting researchers and
p.000042: institutions from being
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043: compelled to disclose information that would identify research subjects, Certificates of Confidentiality
p.000043: help achieve the research objectives and promote participation in studies by assuring
p.000043: confidentiality and privacy to participants. Any research project that collects sensitive, personally identifiable
p.000043: information and that has been approved by an IRB is eligible for a certificate. Identifying information is broadly
p.000043: defined as any item or combination of items in the research data that could lead directly or indirectly to the
p.000043: identification of a research subject.
p.000043: Federal funding is not a prerequisite for a certificate. A Certificate of Confidentiality does not
p.000043: diminish, however, the investigator’s need to protect the personally identifiable information as
p.000043: described above.
p.000043:
p.000043: 4.2.2 Confidentiality of Participation
p.000043: In some types of research, the knowledge that a person is participating in a particular research study
...

Political / displaced

Searching for indicator displaced:

(return to top)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
p.000035: instructs the IRB to consider the “purposes of the research and the setting in which the research will
p.000035: be conducted.” CIOMS goes further and recommends that “Special justification is required for inviting
p.000035: vulnerable individuals to serve as research subjects” (CIOMS, 2002).12
p.000035: Although Federal regulations define vulnerability in terms
p.000035: of the person’s ability to protect their own
p.000035:
p.000035: interests or particular sensitivity to risks because of physical condition, the lay public may perceive a
...

Political / nomad

Searching for indicator nomads:

(return to top)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
p.000035: instructs the IRB to consider the “purposes of the research and the setting in which the research will
p.000035: be conducted.” CIOMS goes further and recommends that “Special justification is required for inviting
p.000035: vulnerable individuals to serve as research subjects” (CIOMS, 2002).12
p.000035: Although Federal regulations define vulnerability in terms
p.000035: of the person’s ability to protect their own
p.000035:
p.000035: interests or particular sensitivity to risks because of physical condition, the lay public may perceive a
...

Political / political affiliation

Searching for indicator party:

(return to top)
p.000035: 35
p.000035: 3.1. Identification of Vulnerable Groups
p.000035: 35
p.000035: vii
p.000035:
p.000035: 3.2. Justification for Involving Vulnerable Persons in Observational Research 36
p.000035: 3.3. Minimal Risk and Vulnerable Groups
p.000037: 37
p.000037: 3.4. Research Involving Children
p.000037: 37
p.000037: 3.5. Women as Research Subjects
p.000038: 38
p.000038: 3.6. Other Potentially Vulnerable Groups
p.000039: 39
p.000039: 4. Privacy, Confidentiality, and Other Concerns Related to Observational
p.000039: Human Exposure Studies
p.000041: 41
p.000041: 4.1. Privacy Issues
p.000041: 41
p.000041: 4.2. Confidentiality
p.000042: 42
p.000042: 4.2.1. Confidentiality of Information
p.000043: 43
p.000043: 4.2.2. Confidentiality of Participation
p.000044: 44
p.000044: 4.3. Collateral Observations
p.000044: 44
p.000044: 4.3.1. Potential Nonstudy Hazards in the Residence 44
p.000044: 4.3.2. Collateral Observations with Mandated Reporting Requirements 45
p.000044: 4.3.3. Hazard Communication
p.000045: 45
p.000045: 4.3.4. Planning and Staff Training
p.000046: 46
p.000046: 4.4. Third-Party Issues
p.000046: 46
p.000046: 4.4.1. Determining Whether a Third Party Is a Human Subject 47
p.000046: 4.4.2. Informing Third Parties of Research Activities 47
p.000046: 4.4.3. Research Results and Third Parties
p.000047: 47
p.000047: 4.5. Data and Safety Monitoring and Oversight
p.000048: 48
p.000048: 5. Creating an Appropriate Relationship Between the Participant and Researcher 51
p.000048: 5.1. Informed Consent
p.000052: 52
p.000052: 5.1.1. Information
p.000052: 52
p.000052: 5.1.2. Comprehension
p.000054: 54
p.000054: 5.1.3. Voluntary Participation
p.000055: 55
p.000055: 5.2. Payments to Research Participants
p.000056: 56
p.000056: 5.2.1. Types and Amounts of Payments Offered in Research Studies 56
p.000056: 5.2.2. Regulations and Guidance Regarding Payment to Research Participants 58
p.000056: 5.2.3. Payments When Children or Other Vulnerable Populations Are Involved 59
p.000056: 5.2.4. Payments in Observational Human Exposure Studies 61
p.000056: 5.3. Research Rights and Grievance Procedures
p.000061: 61
p.000061: 5.3.1. Ombudsman
p.000061: 61
p.000061: 5.3.2. Community Advisory Board
p.000062: 62
p.000062: 5.4. Creating a Supportive Environment for Research and Interaction 62
p.000062: 5.5. Recruitment Strategies
p.000062: 62
p.000062: 5.6. Retention Strategies
p.000063: 63
p.000063: 5.7. Ensuring Recruitment or Retention Methods Will Not Lead to Unacceptable Risk 64
...

p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
p.000003: range of risks associated with participation and the voluntary nature of participation, and provides
p.000003: essential protections to the participant. Recent observations by various national and international review
p.000003: committees on the appropriate level of payment to research participants are presented. This is a
p.000003: complex ethical issue, balancing the issue of fairness against the possibility of undue influence
p.000003: and the loss of free consent. Other topics include participant recruitment, retention strategies, research
p.000003: rights, and grievance procedures.
...

p.000008: D. These sections apply to all research either conducted or funded by EPA and are, therefore, directly applicable to
p.000008: NERL’s observational human exposure studies.4 Subpart B prohibits EPA from conducting or supporting research
p.000008: that involves intentional exposure of “a pregnant woman (and, thereby, her fetus), a nursing woman,
p.000008: or a child.” NERL researchers conducting (or funding) observational human exposure studies must comply
p.000008: with all of these regulatory requirements, including seeking review and approval by an IRB and by the
p.000008: Agency’s Human Subjects Research Review Official (HSRRO) before beginning any human subjects research.
p.000008: EPA’s human subjects rules also define a variety of fundamental terms⎯from “human subject” to “research” to
p.000008: “intentional exposure” to “observational research.” Understanding these regulatory definitions is vital for
p.000008: NERL researchers to comply with the regulatory requirements.5
p.000008: To more effectively ensure the protection of human subjects, NERL scientists and managers need to
p.000008: understand the ethical principles and issues that prompted the development of the
p.000008: regulatory requirements in the first place and to be knowledgeable
p.000008:
p.000008:
p.000008: 4 Subparts K, L, M, O, P, and Q of 40 CFR 26 set basic ethical requirements that have to be met if human subjects data
p.000008: from a person or group external to EPA and not funded by EPA (a third party) are to be used by EPA in specified
p.000008: rulemaking actions. These subparts do not apply to NERL researchers and will not be discussed further in this
p.000008: document.
p.000008: 5 The Glossary (Appendix F) lists definitions for a number of important terms; definitions that come from the
p.000008: regulatory language are identified with their specific CFR citation.
p.000008: about the most recent thinking and guidance on protection of human subjects.
p.000008: The Belmont Report (U.S. DHEW, 1979) is a foundational document in the development of the ethics of human
p.000008: subjects research in the United States. Because of the adverse publicity and political embarrassment arising
p.000008: from the unethical treatment of African- American men in the Tuskegee Syphilis Study, Congress passed
p.000008: the National Research Act of 1974, which called on the Department of Health, Education, and Welfare (DHEW) to
p.000008: codify its rules on human subjects research and established the National Commission for the Protection of
p.000008: Human Subjects of Biomedical and Behavioral Research. The commission was charged with identifying the
p.000008: basic ethical principles that should underlie human subjects research. The commission published the
...

p.000009: unaffiliated with the research
p.000009: Provision of information to subjects about the purpose of the research and its procedures, potential risks, benefits,
p.000009: and alternatives, so that the individual understands this information and can make a voluntary decision whether to
p.000009: enroll and continue to participate
p.000009: Respect for subjects by
p.000009: • permitting withdrawal from the research,
p.000009: • protecting privacy through confidentiality,
p.000009: • informing subjects of newly discovered risks or benefits,
p.000009: • informing subjects of results of the research, and
p.000009: • maintaining welfare of subjects.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Collectively, these documents have reaffirmed the basic ethical principles asserted in the Belmont Report
p.000010: and have attempted, in some cases, to expand scientific and ethical reasoning and understanding to define
p.000010: approaches for dealing with additional elements of human subjects research. These additional
p.000010: elements, which often have been identified because of specific incidents or case studies, include issues
p.000010: such as those described below.
p.000010: • Payment to participants⎯How much is adequate and fair, without being an undue inducement?
p.000010: • Non-study hazards⎯What is the researcher’s responsibility to identify hazards in the home that are
p.000010: not part of the study?
p.000010: • Third-party issues⎯Are there people other than the participant who may be impacted during the study and by the
p.000010: study results? If so, what needs to be done to protect their interests and to respect them as persons?
p.000010: • Community involvement⎯How should the community be involved in the design
p.000010: and implementation of studies?
p.000010: These documents, together with EPA’s regulatory requirements for the protection of human subjects, serve as
p.000010: important references for the subsequent sections of this document (see Table 1-4).
p.000010:
p.000010: 1.3 Purpose of This Document
p.000010: This document is meant to serve as a resource of current scientific and ethical information for
p.000010: NERL researchers as they develop and conduct observational human exposure studies. The increased
p.000010: scrutiny of research studies involving human participants makes it imperative that researchers ensure that
p.000010: their research protocols for protection of human subjects in observational human exposure studies
p.000010: incorporate the most up-to-date ethical approaches. Protocols for protecting study participants in
p.000010: research studies have been developed by experts in both academia and various Federal agencies and adopted
p.000010: by the research community because they ensure that observational research meets the highest
p.000010: ethical and scientific standards. However, because ethical and scientific approaches for human
...

p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000012: 12
p.000012:
p.000012: address all of the relevant issues for their particular study to ensure that the specific elements of
p.000012: the study will safeguard and protect the human research subjects.
p.000012: In addition to being an information resource for NERL researchers, this document provides useful
p.000012: information for contractors and grantees funded by NERL to consider during the design and implementation of
p.000012: their exposure science research. Although not its intended audience, this document also may prove to be useful
p.000012: to other researchers, within and outside of EPA, who are involved in observational human exposure
p.000012: studies.
p.000012:
p.000012: 1.4 Process for Developing the Document
p.000012: This document was written by exposure science researchers in EPA’s NERL, with substantial input from experts
p.000012: within and outside of the Agency. Information relevant to the process and the document has been routinely
p.000012: posted on the EPA Web site at http://www.epa.gov/nerl/sots.
p.000012: NERL staff began this work by hosting a series of stakeholder meetings in the summer of 2006 to seek
...

p.000012: discussed in several sections. Appendixes include additional descriptions of NERL observational human
p.000012: exposure studies, details about the process for developing this document, a list of acronyms and abbreviations,
p.000012: a glossary, and other supplemental information. The main body of the document includes the following
p.000012: sections.
p.000012: • Introduction, Purpose, and Scope (Section 1) lays out the background for observational human exposure studies,
p.000012: the scope of the document, and some of the important scientific and ethical issues that are critical to human
p.000012: subjects and observational research.
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: • Study Conceptualization and Planning (Section 2) establishes that ethical concerns are to be incorporated in
p.000013: the scientific effort from the very beginning and includes ethical issues such as justifying the study
p.000013: because of its social and scientific merit and ensuring scientific validity and independent review.
p.000013: • Protection of Vulnerable Groups (Section 3) discusses some of the special protections afforded to vulnerable groups
p.000013: by EPA’s human subjects rules and the ethical issues of involving such groups in observational research.
p.000013: • Ensuring Privacy and Confidentiality (Section 4) lays out the ethical issues and the regulatory requirements,
p.000013: including observations of nonstudy hazards and the recently discussed issues of third-party involvement or
p.000013: concerns.
p.000013: • The Relationship Between the Participant and the Researcher (Section 5) builds on the ethical principles of
p.000013: respect for persons and beneficence to discuss the issues around recruitment, informed consent,
p.000013: payment, and the researcher’s need to support the welfare of the participants.
p.000013: • Community and Stakeholder Relationships (Section 6) begins with the principles of fairness, justice, and
p.000013: equity and of respect for persons to develop approaches to demonstrate respect for culture
p.000013: and to empower the participants’ community to endure, including the need to build trust in the community and
p.000013: with stakeholders through open and honest communications and legitimate power sharing.
p.000013: • Strategies for Effective Communication (Section 7) builds on the presumption of an ongoing, interactive
p.000013: dialogue and exchange of ideas between researchers and the participants, community, and stakeholders and focuses
p.000013: on steps that the researcher needs to take for effective communications. The section discusses communication
p.000013: strategies, implementation plans, communication tools, reporting of results, and approaches for
p.000013: effective communications, two-way communications between the researchers, participants, community, and other
p.000013: stakeholders.
p.000013:
p.000013: References
p.000013: Beauchamp TL, Childress, JF (2001). Principles of Biomedical Ethics: Fifth Edition. New York, NY: Oxford University
p.000013: Press.
p.000013:
...

p.000031: – the monitoring and oversight team can ensure that participants are free to withdraw from the
p.000031: research at any time; are fully informed about the technical study results; understand any new
p.000031: information about relevant risks and benefits; and that the privacy and confidentiality of
p.000031: the subjects is properly protected. Through these efforts, the monitoring and oversight team will ensure that
p.000031: the welfare of the research subjects remains a focus of the study effort.
p.000031:
p.000031: Text Box 2-7. Examples of Issues That May Cause a Study To Be Stopped Early
p.000031: • Participant recruiting and enrollment⎯low response rates, disproportionate enrollment of select groups, problems
p.000031: associated with advertising, inadequate selection criteria
p.000031: • Informed consent⎯difficulties with the process and materials, poor comprehension
p.000031: • Participation⎯poor response to questionnaires, poor compliance with researcher requests in data collection
p.000031: activities
p.000031: • Burden⎯higher than predicted
p.000031: • Changes in participant behaviors⎯potential changes because of participation in the study
p.000031: • Grievances⎯participant issues
p.000031: • Retention⎯high dropout rates
p.000031: • Community issues⎯poor interactions, lack of support
p.000031: • Third-party issues⎯problems with landlords, spouses, or others
p.000031: • Collateral observations⎯identification of nonstudy hazards, difficulty reporting
p.000031: • Unanticipated results⎯high contaminant concentrations measured, unexpected results
p.000031: • New data indicating that participation in the study (or observations measured in the study) represent a risk to
p.000031: participants or others
p.000031:
p.000031:
p.000031:
p.000031: References
p.000031: Castelloe, JM (2000). Sample size computations and power analysis with the SAS system. Paper 265-25 in Proceedings of
p.000031: the 25th Annual SAS Users Group International Conference. Cary, NC: SAS Institute, Inc. Available:
p.000031: http://support.sas.com/rnd/app/papers/powersamplesize.pdf [accessed 16 April 2008].
p.000031:
p.000031: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of
p.000031: Human Subjects. U.S. Code of Federal Regulations. Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/
p.000031: 40cfr26_06.html [accessed 12 June 2007].
p.000031:
p.000031: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000031: Biomedical Research Involving Human Subjects.
p.000031: Geneva, Switzerland: CIOMS. Available at http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000031:
p.000031: Coggon D, Rose G, Barker DJP (1997). Epidemiology for the Uninitiated, Fourth Edition. London: BMJ Publishing Group
...

p.000040: setting” (p. 64, NRC & IOM, 2005). The legal precept of freedom from unreasonable search and
p.000040: seizure and the historic and deeply rooted principle that “a man’s home is his castle” contribute to a belief in the
p.000040: “sanctity of the home” (see the discussion on pp. 62-66, NRC & IOM, 2005).
p.000040: The joint NRC and IOM report Ethical Considerations for Research on Housing-Related Health
p.000040: Hazards Involving Children discusses the ethical issues associated with entering a participant’s home to conduct
p.000040: research and explores the researchers’ responsibilities that derive from conducting research in people’s homes
p.000040: (NRC & IOM, 2005). These housing-related discussions are particularly relevant to observational human
p.000040: exposure studies, which often include environmental and
p.000040: biological measurements in people’s homes or personal locations. Many of the topics identified in that report are
p.000040: discussed in this section (Text Box 4-1).
p.000040:
p.000040:
p.000040: Text Box 4-1. Topics in Section 4
p.000040: Privacy Issues Confidentiality
p.000040: Confidentiality of Information Confidentiality of Participation
p.000040: Collateral Observations
p.000040: Potential Nonstudy Hazards in the Residence Collateral Observations with Mandated Reporting
p.000040: Requirements
p.000040: Hazard Communication Planning and Staff Training
p.000040: Third-Party Issues
p.000040: Determining Whether a Third Party is a Human Subject Informing Third Parties of Research Activities Research Results
p.000040: and Third Parties
p.000040: Data and Safety Monitoring and Oversight
p.000040:
p.000040:
p.000040:
p.000040: 4.1 Privacy Issues
p.000040: Privacy refers to an expectation that a person is free from intrusion into personal matters and is free from the
p.000040: presence or view of others. The Institutional Review Board Guidebook defines privacy as “control over the
p.000040: extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with
p.000040: others” (U.S. HHS, 1993). Beauchamp and Childress find that the right to privacy is based on the principle of
p.000040: respect for autonomy. “We often respect persons by respecting their autonomous wishes not to be observed, touched, or
p.000040: intruded upon…. A loss of privacy occurs if others use any of several forms of access, including intervening in zones
p.000040: of secrecy, anonymity, seclusion, or solitude” (pp. 295-296, Beauchamp and Childress, 2001).
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041: Although research participants may agree to allow researchers to enter their home or other zone of personal space
p.000041: to conduct their research measurements, they have not abrogated their right to privacy. “When individuals
p.000041: voluntarily grant others some form of access to themselves, their act is an exercise of the
p.000041: right to privacy, not a waiver of that right” (p. 297, Beauchamp and Childress, 2001). Researchers should remember
...

p.000045: should develop a plan for identifying potential situations, hazards, and dangers that may place the
p.000045: research team at risk of imminent harm. This should generally involve working with
p.000045: community representatives to identify the hazards and situations that may be of concern. For example, a
p.000045: researcher’s observation of illegal drugs in a study residence may place the researcher in potential
p.000045: danger. Similarly, if studies are conducted in areas with high crime rates, researchers need to be aware of
p.000045: the potential dangers and have a plan for addressing them. In some cases, situations may arise
p.000045: because of to inadvertent actions. For example, if an area has a high rate of daytime break- ins, the presence
p.000045: of researchers in the area may trigger calls to local authorities when the researchers, who are
p.000045: strangers, are observed in the neighborhood. Feedback from the community representatives should be solicited when
p.000045: developing a plan for responding to situations such as these. Comprehensive training should be developed for
p.000045: research field staff to assist them in identifying potentially dangerous situations and in responding to
p.000045: such situations.
p.000045:
p.000045: 4.4 Third-Party Issues
p.000045: Third-party issues can arise in observational human exposure studies in two ways. First, the study may collect
p.000045: limited information about or related to individuals other than the study participants. Second,
p.000045: study activities may affect or involve people or organizations other than the study participants.
p.000045: Examples of activities that may involve or affect third parties in observational human exposure studies
p.000045: could include, but are not limited to the following types.
p.000045: • Asking the participant about demographic, occupational, smoking, or product use information for
p.000045: other household members
p.000045: • Collecting residential environmental samples in multiperson households
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: • Collecting environmental samples in common areas of multifamily housing units
p.000046: • Collecting personal or environmental samples in a day care, school, health care, or occupational setting
p.000046: • Measuring chemical occurrences or concentrations that may be of interest or import to other
p.000046: household members or to the community
p.000046: • Collecting activity or dietary information about a community
p.000046: It is important for researchers and research staff to understand whether and to what extent the research
p.000046: involves or affects third parties, and how third-party involvement might affect the study participants. Several
p.000046: examples of possible third-parties are listed in Text Box 4-5. Study planning; IRB review; and communication
p.000046: before, during, and after the study should take third- party issues into account.
p.000046:
p.000046: Text Box 4-5. Possible Third-Parties in Exposure Studies
p.000046: • Household members not enrolled in the study
p.000046: • Relatives
p.000046: • Care givers for children or elders
p.000046: • School staff
p.000046: • Employers
p.000046: • Other members of the community
p.000046: • Building managers or facility operators
p.000046: • Landlords
p.000046:
p.000046:
p.000046:
p.000046: 4.4.1 Determining Whether a Third Party Is a Human Subject
p.000046: It is up to the IRB to determine whether a third party is a human subject afforded human
p.000046: subject protections under the Common Rule. A third party would meet the Common Rule definition of
p.000046: a human subject [40 CFR 26.102(f)] if individually identifiable private information about them is collected
p.000046: (CFR, 2006). When this occurs, the informed consent of the third party must be obtained, or, if certain criteria are
p.000046: met, the IRB may determine that informed consent may be waived. It can be difficult to determine whether information
p.000046: about a third party is both individually identifiable and private. Discussions of this issue and
p.000046: recommendations for determining whether third-party information is identifiable and private have been
p.000046: submitted to the HHS Office of Human Research Protections by NIH (2001) and by the National Human
p.000046: Research Protections Advisory Committee (NHRPAC, 2002).
p.000046: Whether or not a third party is determined to be a human subject, the researcher should treat
p.000046: research
p.000046: information about a third party as confidential.
p.000046:
p.000046: 4.4.2 Informing Third Parties of Research Activities
p.000046: Obtaining permission from or informing third parties of certain types of activities may be needed in some
p.000046: observational human exposure studies. For example, household members living with a study participant need to
p.000046: be informed about home study visits and residential sample collection activities. Study activities that
p.000046: occur outside of the participant’s home or yard may require informing or gaining permission from third
p.000046: parties. A study may include collection of environmental samples (i.e., ambient air, dust, soil) from outdoor
p.000046: common areas of multifamily housing where the study participant lives. Issues regarding privacy, permission, and
p.000046: payments for third parties in housing-related studies have been discussed in the NRC & IOM (2005) report.
p.000046: Observational human exposure studies also may include cases when study participants are asked
p.000046: to collect personal samples (i.e., wearing a personal air monitor) over a time period that includes time
p.000046: they spend in a school, day care, or workplace. Such monitoring might require informing or
p.000046: gaining permission from an organization’s staff or an employer. In each case, the researcher and IRB have to
p.000046: consider whether obtaining permission from or informing a third party is appropriate and, if so, to define the
p.000046: procedures for doing so. The researcher and IRB have to also consider the potential impact of third-party
p.000046: knowledge of research activities on confidentiality and risk for the study participant and have to ensure that it is
p.000046: clearly and fully explained in the informed consent process.
p.000046:
p.000046: 4.4.3 Research Results and Third Parties
p.000046: Prior to initiating a research study, researchers should consider whether research results may
p.000046: be provided to third parties. In some studies, there may be reasons to inform household members living with a
p.000046: study participant about specific residential measurement results. In community research studies, aggregated or
p.000046: summary research results may provide a benefit to the community. In this case, it would be beneficial to seek
p.000046: out the advice of community representatives regarding results reporting prior to the study. Researchers
p.000046: also should determine whether there are State or local reporting requirements for some types of
p.000046: measurement results above specified action levels (i.e., blood-lead levels, heavy metal concentration in soil).
p.000046: It is important that the researcher and IRB ensure that confidentiality and privacy of study
p.000046: participants are carefully
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: considered in any case where reporting study results to third parties is contemplated or may be required. Ideally,
p.000047: the informed consent process would make clear whether, under what conditions, and how research results might be
p.000047: provided to third parties.
p.000047:
p.000047: 4.5 Data and Safety Monitoring and Oversight
...

p.000048: Emanuel, EJ, Wendler D, Grady C (2000). What makes clinical research ethical? JAMA 283(20): 2701-2711.
p.000048:
p.000048: NCI (National Cancer Institute) (2001). Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials
p.000048: Funded by the National Cancer Institute. Available: http://www3.cancer.gov/rrp/dsm_ess.html [accessed April 2007].
p.000048:
p.000048: NEI (National Eye Institute) (2001). National Eye Institute Guidelines for Data Monitoring and Oversight of
p.000048: Observational Studies. Available: http://www.nei.nih.gov/funding/datastudies.asp [accessed April 2007].
p.000048:
p.000048: NHLBI (National Heart Lung and Blood Institute) (2007). Monitoring Boards for Data and Safety (Interim Policy). Policy
p.000048: effective date: 14 May 2007. Available: http://public.nhlbi.nih.gov/ocr/home/GetPolicy.aspx?id=8 [accessed September
p.000048: 2007].
p.000048:
p.000048: NHRPAC (National Human Research Protections Advisory Committee) (2002). Clarification of the status of third parties
p.000048: when referenced by human subjects in research. Available: http://www.hhs.gov/ohrp/nhrpac/documents/third.pdf [accessed
p.000048: April 2007].
p.000048:
p.000048: NIH (National Institutes of Health) (2002). Extramural Projects - Application Instructions (03/15/2002) - Detailed
p.000048: Application Instructions for Certificate of Confidentiality Involving Extramural Research Projects. Certificates of
p.000048: Confidentiality. Available: http://grants.nih.gov/grants/policy/coc/index.htm. [accessed April 2007]
p.000048:
p.000048: NIH (National Institutes of Health) (2001). Protection of third party information in research: Recommendations of the
p.000048: National Institutes of Health to the Office for Human Research Protections. Available:
p.000048: http://bioethics.od.nih.gov/nih_third_party_rec.html [accessed March 2007].
p.000048:
p.000048: NIH (National Institutes of Health) (1998). NIH Guide: NIH Policy for Data and Safety Monitoring. Available:
p.000048: http://grants.nih.gov/grants/guide/notice-files/not98­ 084.html [accessed April 2007].
p.000048:
p.000048: NRC & IOM (National Research Council and Institute of Medicine) (2005). Ethical Considerations for Research on
p.000048: Housing-Related Health Hazards Involving Children.
p.000048: Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=11450 [accessed
p.000048: June 2007].
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: U.S. FDA (U.S. Food and Drug Administration) (2001). Draft Guidance for Clinical Trial Sponsors on the Establishment of
p.000049: Clinical Trial Data Monitoring Committees. U.S. Department of Health and Human Services, Food and Drug Administration,
p.000049: Rockville, MD. Available: http://www.fda.gov/cber/gdlns/clindatmon.pdf. [accessed April 2007].
p.000049: U.S. HHS (U.S. Department of Health and Human Services) (1993). Protecting Human Research Subjects: Institutional
p.000049: Review Board Guidebook. Office for Human Research Protections. Available: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
p.000049: [accessed June 2007].
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
...

p.000057: regulations do discuss providing additional safeguards for subjects vulnerable to coercion or undue
p.000057: influence [40 CFR 26.111(b)]. The NIH IRB guidebook advises IRBs to determine whether the rewards offered for
p.000057: participation in research constitute undue influence (U.S. HHS, 1993). According to the IRB guidebook undue
p.000057: inducement might blind prospective subjects to risks, impair their ability to exercise proper judgment, or may
p.000057: cause people to lie or to withhold information that would make them ineligible to enroll or continue
p.000057: participation.
p.000057: The U.S. Food and Drug Administration (FDA) has provided guidance for investigators and IRBs for clinical research
p.000057: studies (FDA, 1998). The guidance states that “payment to research subjects for participation in studies is not
p.000057: considered a benefit, it is a recruitment incentive.” FDA expects payments to accrue as the study progresses and not
p.000057: to be contingent on completing the study, although a “small proportion as an incentive for
p.000057: completion of the study is acceptable.” The guidance is concerned with the issue of coercion or undue influence, and
p.000057: it recognizes the IRB as the responsible party for deciding what is or is not acceptable.
p.000057: The U.S. Office of Management and Budget (OMB) develops standards and guidelines for statistical surveys performed by
p.000057: the Federal government. Under Guideline 2.3.2, OMB states that, while incentives are not typically used in Federal
p.000057: surveys, agencies may consider use of respondent incentives if they believe incentives would be necessary
p.000057: to use for a particular survey to achieve data of sufficient quality for their intended use (OMB,
p.000057: 2006a). OMB requires that agencies provide a justification for giving incentives to respondents.
p.000057: Some
p.000057: of the factors cited by OMB to be addressed include those particularly relevant to observational
p.000057: human exposure studies, including unusual reporting burdens (keeping data logs for extended periods,
p.000057: coordinating study team visits, participating in a medical examination, etc.), complex study designs (such as
p.000057: studies requiring ongoing participation of respondents), and past experience, especially when there is
p.000057: evidence of attrition or poor response rates (OMB, 2006b). Although OMB primarily considers incentives with
p.000057: regard to survey response rates and data quality, researchers need to consider payments to
p.000057: participants, including participation incentives, in the broader context discussed in this section.
p.000057: CIOMS also provides guidance and commentary on this issue in the International Ethical Guidelines for Biomedical
p.000057: Research Involving Human Subjects (2002). Guideline 7 and the associated commentary emphasize that payments to
...

p.000072: boundaries of privacy (crucial when designing sampling strategies) of different groups (Israel et al., 2005b, Chapter
p.000072: 11).
p.000072: Vega (1992) provides a thorough discussion of the theoretical and pragmatic implications of
p.000072: cultural diversity for community research and explains that researchers should interact with
p.000072: communities using methods that promote understanding and demonstrate sensitivity and competence in
p.000072: working with diverse
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: cultures (e.g., with respect to class, gender, ethnicity, race, age, and sexual orientation). To aid in this
p.000073: process, researchers should include sufficient time in their project timeline to interact and dialogue with the
p.000073: community before the study begins to understand the cultural issues that may affect the research. Researchers and the
p.000073: results of their work are expected to promote a strengthening of the community; however, it should be recognized
p.000073: that, given the heterogeneity and the diverse views within a community, the study findings potentially may
p.000073: conflict with the desires of the community or may promote feelings of anger or distrust among members
p.000073: of the community with each other. Enlisting the services of a third-party evaluator/mediator may be
p.000073: useful for sustaining positive relations between all research participants and the community at
p.000073: large.
p.000073: The Research Triangle Park Particulate Matter Panel Study (Williams et al., 2003), a NERL investigation of PM
p.000073: and related pollutants involving African-Americans in North Carolina, demonstrated an effective strategy for using
p.000073: communication to address cultural differences between the community and research personnel. Before beginning
p.000073: the research, the study design included time and a budget for building collaborations with
p.000073: organizations having close ties with the African- American community to establish trust between
p.000073: the community and research team. Using input from the community partner organizations, the
p.000073: researchers developed a systematic communication plan to establish rapport with the community and to guide
p.000073: interaction between study participants and the key study personnel. A well-designed and culturally sensitive
p.000073: communication plan was integral to the success of the study. Eighty percent of the original participants
p.000073: completed the four- season study (Williams et al., 2003).
p.000073:
p.000073: 6.2.6 Honesty, Power Relationships, and Partnerships
p.000073: The NRC & IOM report (NRC & IOM, 2005) describes a relational paradigm that acknowledges that research
p.000073: is part of a broader societal context, with the conduct of research often mirroring a system in which
...

p.000081: communications will be developed with each group, and the timing of the communications. It is likely
p.000081: that most studies will involve the individuals, community groups and stakeholders shown in Text
p.000081: Box 7-3.
p.000081:
p.000082: 82
p.000082:
p.000082:
p.000082: Text Box 7-3. Individuals and Groups Involved in Communications
p.000082: • Principal investigator—the researcher with ultimate responsibility for the study
p.000082: • Research team
p.000082: • Study participants
p.000082: • Third parties associated with study participants (e.g., spouse, children, landlords)
p.000082: • Community representatives
p.000082: • Community members
p.000082: • Governments (local, State, and Federal)
p.000082: • Study institution management
p.000082: • Study sponsors or funding organization
p.000082: • Organizations with interest in the participants, the community, or the research question
p.000082: • Stakeholders that may be impacted by the results of the study
p.000082: • The scientific community
p.000082: • Media
p.000082: • The general public
p.000082:
p.000082: The study participants are a key group involved in communications during a study and are easily identified.
p.000082: Similarly, it is generally not difficult to identify the third parties associated with the study participants,
p.000082: because these groups must be identified when considering ethical issues in the study and when developing the
p.000082: human subjects research protocol. Research teams should ensure that the communication strategy includes the
p.000082: strategy and approach for third-party communications.
p.000082: As discussed in Section 6, it is critical that community representatives are identified early in
p.000082: the scoping and planning phase of the study. It is important that researchers are informed about the community
p.000082: in which they will conduct the study and understand the unique characteristics and culture of the community and
p.000082: the potential study participants to develop effective bidirectional communications. When
p.000082: possible, researchers should identify other research organizations who have worked in the community and attempt
p.000082: to gather information from them on the nature of the community, who represents the community, and what
p.000082: communication strategies have been used previously in the community. Understanding how the community
p.000082: defines itself or thinks of itself is critical to establishing effective communications.
p.000082: Identification of all relevant stakeholder groups may be more difficult. As defined in Section 6, the term
p.000082: stakeholder is used here to identify a person or group who has a valid interest in an activity or
p.000082: decision, but who does not speak directly for the community or the participants. There may be many
p.000082: organizations who consider themselves as stakeholders that represent the
p.000082: interests of the community, the participants, or the research problem. For example, there are many
p.000082: nonprofit organizations that advocate for the protection of children’s health. When conducting an
...

p.000097: would not meet the authors’ intentions regarding “observational human exposure studies” as they are defined
p.000097: in this document. An intervention study, such as described in these two examples, does not involve
p.000097: observing people’s exposures in their everyday environments, as they go about their normal activities. In
p.000097: an intervention study, either the participant’s environment (cleaning of the household surfaces) or their
p.000097: behavior (wearing a particle mask) has been manipulated by the researcher. Secondly, the objective of these
p.000097: studies is not to understand exposures in everyday environments but would use changes in exposure
p.000097: to test the effectiveness of an intervention strategy. Such a study is not addressed in this document.
p.000097: Observational human exposure studies, as used by the authors of this document, generally meet the
p.000097: regulatory definition of observational research. But, not all studies meeting the CFR definition of
p.000097: observational research would be considered by the authors to be observational human exposure studies.
p.000097:
p.000097: Examples of NERL Observational Human Exposure Studies
p.000097: NERL and its predecessor organizations have
p.000097: conducted observational human exposure studies since 1980. Table A-1 lists many of those that NERL has
p.000097: conducted, supported, or participated in since 1980. The table gives the name of the study, dates, sample
p.000097: size, then type of study, a brief explanation of the research, and NERL’s role therein. The table represents a
p.000097: variety of first-party or second-party research efforts. In many cases, NERL staff would design,
p.000097: oversee, and, if possible, participate directly in the study (first-party), but often contractor
p.000097: support would be needed to accomplish the field sampling or some of the sample analysis. In other
p.000097: cases, NERL researchers would solicit proposals for exposure research to be conducted to address specific
p.000097: exposure issues and then would fund researchers in academia or at nonprofit institutions to design and
p.000097: conduct the research (second-party research). In a few cases, grants might already be in place with research
p.000097: institutions, and NERL simply would augment the pre-existing funding to expand the exposure component
p.000097: (second-party). Some other cases involve research efforts initiated by other Federal agencies with which NERL
p.000097: would collaborate and participate in directly (first-party).
p.000097: An examination of the entries in the table shows that most of the agents being studied were chemicals, often
p.000097: air pollutants or pesticides. A few of the entries indicate that other agents, for example, molds and fungi or other
p.000097: microbes, were the subject of the study. The largest number of the studies involved small numbers
p.000097: of participants and often were designed to determine whether or not a method for collecting
p.000097: exposure-related data or samples was feasible or burdensome. Most of the smaller studies used convenience samples.
p.000097: Studies, like DEARS, CTEPP, NHEXAS, and TEAM, which
p.000097: involved large numbers of participants, employed randomized or probability-based approaches
p.000097: for selecting participants.
p.000097: Table A-2 shows the types of samples that often have been collected in NERL’s observational human
p.000097: exposure studies. Some of the samples, like air concentrations or surface wipes, allow NERL staff
p.000097: to determine the concentration of the studied chemicals in the environmental media with which the participants
p.000097: may come into contact. Other items, like time activity diaries or videotaping children to measure the amount of
p.000097: hand-to-mouth activity, allow NERL researchers to understand how people may come into contact with the agent
p.000097: and to estimate the duration or frequency of a potential exposure. Still other measures, like personal
p.000097: samplers or biological samples, represent an attempt to determine a time-integrated measure of exposure. NERL
p.000097:
p.000097:
p.000098: 98
p.000098:
...

Searching for indicator political:

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p.000008: “intentional exposure” to “observational research.” Understanding these regulatory definitions is vital for
p.000008: NERL researchers to comply with the regulatory requirements.5
p.000008: To more effectively ensure the protection of human subjects, NERL scientists and managers need to
p.000008: understand the ethical principles and issues that prompted the development of the
p.000008: regulatory requirements in the first place and to be knowledgeable
p.000008:
p.000008:
p.000008: 4 Subparts K, L, M, O, P, and Q of 40 CFR 26 set basic ethical requirements that have to be met if human subjects data
p.000008: from a person or group external to EPA and not funded by EPA (a third party) are to be used by EPA in specified
p.000008: rulemaking actions. These subparts do not apply to NERL researchers and will not be discussed further in this
p.000008: document.
p.000008: 5 The Glossary (Appendix F) lists definitions for a number of important terms; definitions that come from the
p.000008: regulatory language are identified with their specific CFR citation.
p.000008: about the most recent thinking and guidance on protection of human subjects.
p.000008: The Belmont Report (U.S. DHEW, 1979) is a foundational document in the development of the ethics of human
p.000008: subjects research in the United States. Because of the adverse publicity and political embarrassment arising
p.000008: from the unethical treatment of African- American men in the Tuskegee Syphilis Study, Congress passed
p.000008: the National Research Act of 1974, which called on the Department of Health, Education, and Welfare (DHEW) to
p.000008: codify its rules on human subjects research and established the National Commission for the Protection of
p.000008: Human Subjects of Biomedical and Behavioral Research. The commission was charged with identifying the
p.000008: basic ethical principles that should underlie human subjects research. The commission published the
p.000008: Belmont Report in 1979. This report established three basic principles: (1) respect for
p.000008: persons; (2) beneficence; and (3) justice, which have become the cornerstones for regulations involving
p.000008: human subjects (see Table 1-2).
p.000008: In 1981, the Department of Health and Human Services (HHS) issued regulations based on the Belmont Report. Ten
p.000008: years later, the core HHS regulations (Subpart A) were adopted by almost all of the Federal
p.000008: departments and agencies that conducted or sponsored human subjects research as the “Common Rule.”
p.000008: Since 1991, ethical thought and regulatory processes for the protection of human subjects have continued to
...

p.000067: consultation and review, membership on community advisory boards, and involvement in a community-based
p.000067: participatory research process” if that is used (p. 83, NRC & IOM, 2005). In addition, IRBs may
p.000067: seek additional community representation on the IRB panel.
p.000067: The Centers for Disease Control and Prevention (CDC) recommends nine governing principles for
p.000067: “outsiders.” To help alleviate these potential issues, researchers should ensure an equitable
p.000067: distribution of paid research work among different communities within the larger community as to not promote a
p.000067: perceived bias among community members. Additionally, when possible, researchers should make efforts
p.000067: to provide payments to community members employed as research staff through community partner
p.000067: organizations to prevent conflict of interest issues. Refer to Section 5 for further discussion on
p.000067: remuneration of community members as research participants.
p.000067:
p.000067:
p.000067: Text Box 6-2. Community Engagement Principles for Researchers
p.000067: (From CDC, 1997)
p.000067: Requirement Explanation
p.000067:
p.000067: Clarity Clear communication of the study objectives, research goals, and the populations or
p.000067: communities of interest.
p.000067:
p.000067: engaging communities in health-related research (see Text Box 6-2). Health research is a “privileged and
p.000067: empowered activity in that the researchers have special
p.000067: Knowledge of the Community
p.000067: Familiarity with the economic conditions, political structures, demographics, history, past research experiences, and
p.000067: research perceptions of the community.
p.000067:
p.000067: access to resources and sensitive information about people and, through the analysis and presentation
p.000067: of findings, are able to influence the way people think and have considerable influence on decisions regarding
p.000067: the allocation of resources” (CDC, 1997). Regardless of the approach utilized to involve the community in research,
p.000067: whether the process employs community-based participatory research (CBPR) or another community
p.000067: engagement method, researchers should guide their interactions with community members using these
p.000067: underlying principles to promote the aforementioned ethical principles of respect of persons, fairness, and
p.000067: beneficence.
p.000067: One form of community involvement is to include qualified members of the community on the research staff.
p.000067: Section 2 advocates community representatives as part of the research team. Paid research staff members from
p.000067: the community could serve as valuable consultants for protocol development and research design, including how to
p.000067: collect the data, how to recruit and retain participants, and how to interpret and disseminate the
p.000067: results. However, including paid research staff from the community may introduce a conflict of interest among
...

p.000070: and the community members overlap in particular individuals, it is important to distinguish the role in
p.000070: which the individual is acting (ERG, 2007).
p.000070:
p.000070: 6.2.2 Identifying Who Represents the Community
p.000070: To sufficiently represent the community, an individual has to have not only the right to speak for the
p.000070: community’s interests (a right afforded by legitimate membership in the group) but also should be able
p.000070: to describe those interests on behalf of the community. Identifying those who represent the community is
p.000070: not simply a matter of identifying the most vocal activists because those individuals do not necessarily
p.000070: represent the interests of the entire community. In fact, several individuals may be necessary to adequately
p.000070: represent the diversity of viewpoints within a community; in such cases, a CAB may be appropriate (ERG, 2007).
p.000070: One of the researcher’s first steps should be asking the potential participants from the community who they see
p.000070: as a
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: legitimate representative (i.e., someone who can speak for them). Corburn cites an example of a locale
p.000071: in Brooklyn, NY, that contained individuals with widely different backgrounds. It was impossible to
p.000071: identify appropriate spokespeople, or even to define the nature of the community, without talking with
p.000071: community members (Corburn, 2007).
p.000071: The NRC & IOM (2005) Report also discusses the issue of who can represent the identified community. Some
p.000071: communities may have a formal governmental structure and a recognized political authority (e.g.,
p.000071: Native American tribes). Other communities may have clearly identifiable leaders (e.g., religious communities),
p.000071: whereas still other communities have no formal leadership structure at all. Whether there is a
p.000071: legitimate political authority or some other hierarchal leadership structure, the goal is to seek community input
p.000071: as to who best represents the interests of the community with regard to the proposed research project,
p.000071: rather than selecting those who are favorable to the research project. The NRC & IOM report cautions against
p.000071: the ethically questionable practice of seeking out population spokespeople and research participants
p.000071: whose positive response to a research plan can be predicted in advance and refers the reader to an article on this
p.000071: topic by Juengst (2000).
p.000071: With multiple sources of leadership and authority in many communities, careful consideration should be given
p.000071: to what aspect of the community a particular person will represent, and what efforts may be needed to ensure
p.000071: that the entire range of views in a community are obtained. Researchers should consider reaching out to multiple
p.000071: organizations such as churches, social service agencies, community-based organizations, and tenant and
p.000071: other community advocacy groups.
p.000071:
p.000071: 6.2.3 Building Relationships and Trust
p.000071: A key first step in developing trust is to establish a relationship with the community before the study. Trust must be
p.000071: built; it cannot be assumed. This relationship involves not only listening to community input but
p.000071: actually taking it into consideration (ERG, 2007). A long history of research with no direct benefits and
p.000071: no feedback of results to the community, however, has contributed to a general mistrust of
...

Political / vulnerable

Searching for indicator vulnerable:

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p.000001: As EPA employees, NERL scientists face both regulatory and moral obligations to ensure the protection of the
p.000001: human subjects participating in observational research. The regulatory requirements are set forth in
p.000001: EPA’s human subjects regulations (40 CFR 26). NERL scientists are resolved to meet both the “letter” of the law as set
p.000001: forth in the regulations and also the “spirit” that derives from the most up-to-date thinking and consensus on
p.000001: these sensitive issues. This document provides information on regulatory requirements and the state of
p.000001: the science for a number of issues associated with observational human exposure studies to help NERL scientists meet
p.000001: their goal of conducting these studies based on the most up-to-date and sound science and the highest ethical
p.000001: standards.
p.000001: To gather information for the scientific and ethical approaches for observational human exposure studies,
p.000001: NERL convened an expert panel workshop on November 28 and 29, 2006, to discuss the state of the science. The 11-member
p.000001: panel discussed their ideas for the content of this document and the state of the science for various elements
p.000001: of observational human exposure studies. The panel agreed that the document planned by EPA should
p.000001: include the following six major topic areas:
p.000001: (1) identifying elements to be considered in study conceptualization,
p.000001: (2) ensuring protection of vulnerable groups,
p.000001: (3) addressing privacy and other concerns related to observational human exposure studies,
p.000001: (4) creating an appropriate relationship between the participant and investigator,
p.000001:
p.000001:
p.000001: iv
p.000001:
p.000001: (5) building and maintaining appropriate community and stakeholder relationships, and
p.000001: (6) designing and implementing strategies for effective communication.
p.000001: The structure and content of the current document follow the recommendations of the Expert Panel. These
p.000001: recommendations include pragmatic steps that NERL scientists can undertake during the development and
p.000001: implementation of observational human exposure studies.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: v
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Acknowledgments
p.000001:
p.000001:
p.000001: This document was developed through the joint efforts of many U.S. Environmental Protection Agency (EPA)
p.000001: staff. Roy Fortmann, Larry Cupitt, Kent W. Thomas, and Peter Egeghy, researchers in the National Exposure
p.000001: Research Laboratory, were primary authors of the document. Linda Sheldon provided input to the
p.000001: development of the document and contributed through discussions with the authors on issues associated with
...

p.000019: 2.2. Ensuring Scientific Validity of the Research Study 20
p.000019: 2.2.1. Study Design
p.000020: 20
p.000020: 2.2.2. Feasibility
p.000021: 21
p.000021: 2.2.3. Sample Size Determination
p.000022: 22
p.000022: 2.2.4. Representativeness of the Sample
p.000022: 22
p.000022: 2.2.5. Information Collection Rule
p.000023: 23
p.000023: 2.2.6. Quality Assurance Project Plan
p.000024: 24
p.000024: 2.2.7. The Study Design Document
p.000024: 24
p.000024: 2.3. Ethical Issues in Ensuring Fair Subject Selection
p.000024: 24
p.000024: 2.4. Ensuring a Favorable Risk-Benefit Ratio
p.000025: 25
p.000025: 2.4.1. Designing in Benefits for the Participants
p.000025: 25
p.000025: 2.4.2. Assessing Benefits and Risks of Study Participation 25
p.000025: 2.5. Independent Scientific and Ethical Review
p.000026: 26
p.000026: 2.5.1. Scientific Peer Review
p.000027: 27
p.000027: 2.5.2. Conflicts of Interest
p.000027: 27
p.000027: 2.5.3. Develop the Human Subjects Protocol for Institutional Review Board Review 28
p.000027: 2.5.4. Ethical Review
p.000029: 29
p.000029: 2.5.5. Internal U.S. EPA Review of Scientific and Ethical Issues 29
p.000029: 2.6. Informed Consent
p.000029: 29
p.000029: 2.7. Ensuring That Participant Behaviors Are Not Changed Adversely Because of
p.000029: Being in the Study
p.000030: 30
p.000030: 2.8. Criteria and Standards for Monitoring Scientific and Ethical Issues 30
p.000030: 3. Ensuring Protection of Vulnerable Groups
p.000035: 35
p.000035: 3.1. Identification of Vulnerable Groups
p.000035: 35
p.000035: vii
p.000035:
p.000035: 3.2. Justification for Involving Vulnerable Persons in Observational Research 36
p.000035: 3.3. Minimal Risk and Vulnerable Groups
p.000037: 37
p.000037: 3.4. Research Involving Children
p.000037: 37
p.000037: 3.5. Women as Research Subjects
p.000038: 38
p.000038: 3.6. Other Potentially Vulnerable Groups
p.000039: 39
p.000039: 4. Privacy, Confidentiality, and Other Concerns Related to Observational
p.000039: Human Exposure Studies
p.000041: 41
p.000041: 4.1. Privacy Issues
p.000041: 41
p.000041: 4.2. Confidentiality
p.000042: 42
p.000042: 4.2.1. Confidentiality of Information
p.000043: 43
p.000043: 4.2.2. Confidentiality of Participation
p.000044: 44
p.000044: 4.3. Collateral Observations
p.000044: 44
p.000044: 4.3.1. Potential Nonstudy Hazards in the Residence 44
p.000044: 4.3.2. Collateral Observations with Mandated Reporting Requirements 45
p.000044: 4.3.3. Hazard Communication
p.000045: 45
p.000045: 4.3.4. Planning and Staff Training
p.000046: 46
p.000046: 4.4. Third-Party Issues
p.000046: 46
p.000046: 4.4.1. Determining Whether a Third Party Is a Human Subject 47
p.000046: 4.4.2. Informing Third Parties of Research Activities 47
p.000046: 4.4.3. Research Results and Third Parties
p.000047: 47
p.000047: 4.5. Data and Safety Monitoring and Oversight
p.000048: 48
p.000048: 5. Creating an Appropriate Relationship Between the Participant and Researcher 51
p.000048: 5.1. Informed Consent
p.000052: 52
p.000052: 5.1.1. Information
p.000052: 52
p.000052: 5.1.2. Comprehension
p.000054: 54
p.000054: 5.1.3. Voluntary Participation
p.000055: 55
p.000055: 5.2. Payments to Research Participants
p.000056: 56
p.000056: 5.2.1. Types and Amounts of Payments Offered in Research Studies 56
p.000056: 5.2.2. Regulations and Guidance Regarding Payment to Research Participants 58
p.000056: 5.2.3. Payments When Children or Other Vulnerable Populations Are Involved 59
p.000056: 5.2.4. Payments in Observational Human Exposure Studies 61
p.000056: 5.3. Research Rights and Grievance Procedures
p.000061: 61
p.000061: 5.3.1. Ombudsman
p.000061: 61
p.000061: 5.3.2. Community Advisory Board
p.000062: 62
p.000062: 5.4. Creating a Supportive Environment for Research and Interaction 62
p.000062: 5.5. Recruitment Strategies
p.000062: 62
p.000062: 5.6. Retention Strategies
p.000063: 63
p.000063: 5.7. Ensuring Recruitment or Retention Methods Will Not Lead to Unacceptable Risk 64
p.000063: 6. Building and Maintaining Appropriate Community and Stakeholder Relationships 67
p.000063: 6.1. Approaches to Community Involvement
p.000068: 68
p.000068: 6.2. Issues in Community Involvement
p.000071: 71
p.000071: 6.2.1. Defining “Community”
p.000071: 71
p.000071: 6.2.2. Identifying Who Represents the Community 71
p.000071: 6.2.3. Building Relationships and Trust
p.000072: 72
p.000072: 6.2.4. Importance of Language and Communications with the Community 73
p.000072: 6.2.5. Recognizing and Addressing Cultural Differences 73
p.000072: 6.2.6. Honesty, Power Relationships, and Partnerships 74
p.000072: 6.2.7. Building a Lasting Infrastructure
p.000074: 74
p.000074: 6.3. Community Involvement in Observational Human Exposure Studies 75
...

p.000117: the protection of the human subjects participating in their observational research. The
p.000117: regulatory requirements are set forth in EPA’s human subjects regulations (40 CFR 26). The moral
p.000117: obligations derive from the ethical principles of biomedical ethics. NERL scientists and managers are
p.000117: resolved to meet both the “letter” of the law as set forth in the regulations and also the “spirit” that
p.000117: derives from the most up-to-date thinking and consensus on these sensitive issues.
p.000117: This document provides information on regulatory requirements and ethical issues to consider when
p.000117: performing human subjects research. Knowledge about these requirements and issues will help NERL scientists meet
p.000117: their goal of conducting observational human exposure studies based on the most up-to-date and sound science
p.000117: and the highest ethical scientific standards.
p.000117: The ethical and moral issues associated with human subjects research has long been the subject of a great deal
p.000117: of thought and discussion, both in the United States and abroad. Issues in biomedical ethics continue to be
p.000117: discussed and debated in today’s headlines. Spurred by the atrocities of World War II concentration camps and by
p.000117: the disclosure of unethical treatment of undereducated African-American men and
p.000117: other vulnerable groups by medical staff in the United States, the U.S. and world communities were prompted
p.000117: to establish ethical principles for medical and scientific experiments that involve people as
p.000117: participants. In the United States, the Belmont Report (U.S. DHEW, 1979) is the foundational document in the
p.000117: development of the
p.000117:
p.000117:
p.000001: 1
p.000001:
p.000001: ethics of human subjects research. This report lays out the fundamental ethical principles behind research
p.000001: that involves humans as research subjects. These three basic principles, (1) respect for persons, (2) beneficence,
p.000001: and
p.000001: (3) justice, have become the cornerstones for regulations involving human subjects. Ethicists have expanded on
p.000001: those principles since 1979, translating them into ethical requirements that any human subjects research must be both
p.000001: ethically acceptable and scientifically sound.1 EPA’s Science Advisory Board has affirmed, “Bad
p.000001: science is always unethical” (U.S. EPA, 2000).
p.000001: In an effort to ensure that NERL’s observational human exposure studies are founded on the ethical
p.000001: principles of respect for persons, beneficence and nonmaleficence, and justice and adhering to the
p.000001: principle that bad science is always unethical, scientists and managers from NERL have assembled this
p.000001: document as a resource and reference for NERL exposure scientists. These same scientists and managers have sought
...

p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
...

p.000009: additional emphasis on the welfare of the subjects.
p.000009: More recently, there has been increased scrutiny and discussions of the ethics of research involving human
p.000009: participants,6 and a number of respected institutions have
p.000009:
p.000009:
p.000009: 6 The term “human participants” often is used in this document. It denotes the importance of the study participant
p.000009: being actively engaged in a partnership with the researchers to address the objectives and goals of the study. The term
p.000009: should be considered to be synonymous with the term “human subject” as used in the Common Rule and in documents used to
p.000009: describe regulatory requirements for studies involving human subjects.
p.000009: Social or scientific value
p.000009:
p.000009: Scientific validity
p.000009:
p.000009:
p.000009: Fair subject selection
p.000009:
p.000009:
p.000009: Favorable risk- benefit ratio
p.000009:
p.000009:
p.000009: Independent review
p.000009:
p.000009:
p.000009:
p.000009: Informed consent
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Respect for potential and enrolled subjects
p.000009: that will improve health and well-being or increase knowledge
p.000009: Use of accepted scientific principles and methods, including statistical techniques, to produce reliable and valid data
p.000009: Selection of subjects so that stigmatized and vulnerable individuals are not targeted for risky research, and the rich
p.000009: and socially powerful are not favored for potentially beneficial research
p.000009: Minimization of risks; enhancement of potential benefits and risks to the subject are proportionate to the benefits to
p.000009: the subject and to society
p.000009: Review of the design of the research trial, its proposed subject population, and risk-benefit ratio by individuals
p.000009: unaffiliated with the research
p.000009: Provision of information to subjects about the purpose of the research and its procedures, potential risks, benefits,
p.000009: and alternatives, so that the individual understands this information and can make a voluntary decision whether to
p.000009: enroll and continue to participate
p.000009: Respect for subjects by
p.000009: • permitting withdrawal from the research,
p.000009: • protecting privacy through confidentiality,
p.000009: • informing subjects of newly discovered risks or benefits,
p.000009: • informing subjects of results of the research, and
p.000009: • maintaining welfare of subjects.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Collectively, these documents have reaffirmed the basic ethical principles asserted in the Belmont Report
p.000010: and have attempted, in some cases, to expand scientific and ethical reasoning and understanding to define
p.000010: approaches for dealing with additional elements of human subjects research. These additional
p.000010: elements, which often have been identified because of specific incidents or case studies, include issues
p.000010: such as those described below.
...

p.000012: This document was written by exposure science researchers in EPA’s NERL, with substantial input from experts
p.000012: within and outside of the Agency. Information relevant to the process and the document has been routinely
p.000012: posted on the EPA Web site at http://www.epa.gov/nerl/sots.
p.000012: NERL staff began this work by hosting a series of stakeholder meetings in the summer of 2006 to seek
p.000012: input on the content and format of the document. In November 2006, NERL convened an expert panel to
p.000012: provide its advice and guidance about the scope and content of this document. The Expert Panel consisted of
p.000012: 11 nationally recognized authorities in diverse fields: exposure science, environmental health,
p.000012: bioethics, epidemiology law, community-based research, research in minority communities, public health,
p.000012: toxicology, pediatrics, children’s environmental health, etc. Details about the Expert Panel and the workshop can
p.000012: be found in Appendix B. The summary report from the Expert Panel may be accessed
p.000012: online at http://www.epa.gov/nerl/sots/workshop-report.pdf.
p.000012: The structure and content of the current report follow the recommendations of the Expert
p.000012: Panel. Specifically, the Expert Panel recommended that this document should include the following six major
p.000012: topic areas:
p.000012: (1) elements to be considered in study conceptualization,
p.000012: (2) ensuring protection of vulnerable groups,
p.000012: (3) addressing privacy and other concerns related to observational human exposure studies,
p.000012: (4) creating an appropriate relationship between the participant and investigator,
p.000012: (5) building and maintaining appropriate community and stakeholder relationships, and
p.000012: (6) designing and implementing strategies for effective communication.
p.000012: These recommendations include pragmatic steps that NERL scientists can undertake during the development and
p.000012: implementation of observational human exposure studies. Note that each step may require consideration and
p.000012: application of multiple ethical and scientific principles, and the same ethical principle may
p.000012: be fundamental to several of the topic areas. As a result, the same ethical principle may be discussed in
p.000012: several sections throughout this document.
p.000012: Using the advice of the Expert Panel, an internal review draft of the document was written. Based on the
p.000012: comments from internal EPA reviewers, the internal review draft was revised, and an external review draft
p.000012: was prepared. The external review draft was submitted for peer review by EPA’s Human Subjects Review
p.000012: Board (HSRB), a Federal advisory committee consisting of a panel of experts chartered to review and advise the Agency
p.000012: on the scientific and ethical underpinnings of human subjects research efforts. The external review draft
p.000012: also was announced in the Federal Register and made available for public review and comment. The document
p.000012: subsequently was revised in response to comments from the HSRB and from the public in
...

p.000012: The document is organized along the lines that the Expert Panel recommended. It has seven sections, an
p.000012: introduction followed by a section addressing each of the major topic areas. The content of each section also
p.000012: is based on recommendations from the Expert Panel Workshop. Because the authors concluded that
p.000012: the discussion for each topic area needed to be complete in and of itself (i.e., capable of standing
p.000012: independently without having to reference other sections), there may be some issues or topics that are
p.000012: discussed in several sections. Appendixes include additional descriptions of NERL observational human
p.000012: exposure studies, details about the process for developing this document, a list of acronyms and abbreviations,
p.000012: a glossary, and other supplemental information. The main body of the document includes the following
p.000012: sections.
p.000012: • Introduction, Purpose, and Scope (Section 1) lays out the background for observational human exposure studies,
p.000012: the scope of the document, and some of the important scientific and ethical issues that are critical to human
p.000012: subjects and observational research.
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: • Study Conceptualization and Planning (Section 2) establishes that ethical concerns are to be incorporated in
p.000013: the scientific effort from the very beginning and includes ethical issues such as justifying the study
p.000013: because of its social and scientific merit and ensuring scientific validity and independent review.
p.000013: • Protection of Vulnerable Groups (Section 3) discusses some of the special protections afforded to vulnerable groups
p.000013: by EPA’s human subjects rules and the ethical issues of involving such groups in observational research.
p.000013: • Ensuring Privacy and Confidentiality (Section 4) lays out the ethical issues and the regulatory requirements,
p.000013: including observations of nonstudy hazards and the recently discussed issues of third-party involvement or
p.000013: concerns.
p.000013: • The Relationship Between the Participant and the Researcher (Section 5) builds on the ethical principles of
p.000013: respect for persons and beneficence to discuss the issues around recruitment, informed consent,
p.000013: payment, and the researcher’s need to support the welfare of the participants.
p.000013: • Community and Stakeholder Relationships (Section 6) begins with the principles of fairness, justice, and
p.000013: equity and of respect for persons to develop approaches to demonstrate respect for culture
p.000013: and to empower the participants’ community to endure, including the need to build trust in the community and
p.000013: with stakeholders through open and honest communications and legitimate power sharing.
p.000013: • Strategies for Effective Communication (Section 7) builds on the presumption of an ongoing, interactive
p.000013: dialogue and exchange of ideas between researchers and the participants, community, and stakeholders and focuses
p.000013: on steps that the researcher needs to take for effective communications. The section discusses communication
...

p.000015: (HSRRO). The HSRRO, located in the EPA Office of the Science Advisor, ensures that Agency studies comply with
p.000015: the Common Rule and all directives of 40 CFR 26 providing guidance and principles to govern Federal agency
p.000015: sponsored human subject research.. Only after HSRRO approval can any research actually begin. As the NERL study
p.000015: is implemented, project data and concerns of the participants will be monitored on a continuing basis and
p.000015: compared with previously established standards and
p.000015:
p.000015:
p.000017: 17
p.000017:
p.000017:
p.000017: Table 2.1. Seven Requirements for Determining Whether a Research Trial is Ethical
p.000017: From Emanuel, Wendler, and Grady (2000)
p.000017: Requirement Explanation
p.000017: Topics in this Section
p.000017:
p.000017:
p.000017: Social or scientific value
p.000017:
p.000017: Evaluation of a treatment, intervention, or theory that will improve health and well-being or increase knowledge
p.000017:
p.000017: Defining the study problem Justifying the study Identifying a research team
p.000017:
p.000017:
p.000017: Scientific validity
p.000017:
p.000017: Use of accepted scientific principles and methods, including statistical techniques, to produce reliable and valid data
p.000017:
p.000017: Study design Feasibility
p.000017: Sample size determination Representativeness of the sample Information collection rule
p.000017: Quality assurance Study design document
p.000017:
p.000017:
p.000017: Fair subject selection
p.000017:
p.000017: Selection of subjects so that stigmatized and vulnerable individuals are not targeted for risky research, and the rich
p.000017: and socially powerful are not favored for potentially beneficial research
p.000017:
p.000017: Ethical issues in fair subject selection
p.000017:
p.000017:
p.000017: Favorable risk- benefit ratio
p.000017:
p.000017: Minimization of risks; enhancement of potential benefits and risks to the subject are proportionate to the benefits to
p.000017: the subject and to society
p.000017:
p.000017: Designing in benefits for participants
p.000017: Assessing benefits and risks of study participation
p.000017:
p.000017:
p.000017: Independent review
p.000017:
p.000017: Review of the design of the research trial, its proposed subject population, and risk-benefit ratio by individuals
p.000017: unaffiliated with the research
p.000017:
p.000017: Scientific peer review Conflicts of interest
p.000017: Developing the protocol for ethical review Ethical review
p.000017: EPA review of scientific and ethical issues
p.000017:
p.000017:
p.000017: Informed consent
p.000017:
p.000017: Provision of information to subjects about the purpose of the research, its procedures, potential risks, benefits, and
p.000017: alternatives, so that the individual understands this information and can make a voluntary decision whether to enroll
p.000017: and continue to participate
p.000017:
p.000017: Informed consent
p.000017: Ensuring that participant behaviors are not adversely changed
p.000017:
p.000017:
p.000017: Respect for potential and enrolled subjects
p.000017:
p.000017: Respect for subjects by
p.000017: • permitting withdrawal from the research,
...

p.000023: scientific and ethical standards. The research team can meet regularly to specifically evaluate the plan. It
p.000023: should be noted that a study design is not the same as an implementation plan. The latter includes an even
p.000023: greater level of detail describing how the study will be performed and includes protocols and
p.000023: operating procedures. Text Box 2-4 lists a number of elements that may be appropriate to include in a study design.
p.000023:
p.000023: 2.3 Ethical Issues in Ensuring Fair Subject Selection
p.000023: One of the ethical principles of human subjects research is that selection of participants should be fair. In
p.000023: Section 2.2.4, the discussion centers on understanding what population or cohort the participants in a research
p.000023: study represents, and how such a selection may be influenced by the research questions and
p.000023: study objectives. That consideration actually represents the first component of ensuring that subject selection is
p.000023: fair. That is, the scientific goals of the study should be the primary basis for determining what groups or
p.000023: individuals should be recruited and enrolled in a study. Participants should not be recruited either because of
p.000023: privilege or because of vulnerability or their inability to look out for their own interests properly.
p.000023: Similarly, groups or individuals should not be excluded peremptorily without consideration of the risks and
p.000023: benefits to them as individuals. Section 3 of this document discusses protection of
p.000023: vulnerable groups and concludes that NERL researchers should include vulnerable groups in observational
p.000023: human exposure studies only if their participation is critical to the success and applicability of the
p.000023: research. Even then, EPA and NERL researchers will have to meet stringent standards for protecting the rights and
p.000023: safety of the vulnerable participants. “The essence of
p.000023:
p.000023:
p.000023: Text Box 2-4. Elements That May Be Included in a Study Design
p.000023: • Introduction and background, including the purpose and scope of the study
p.000023: • The desired outputs and outcomes of the study, including the objectives and the hypotheses to be tested
p.000023: • A brief description or overview of the study
p.000023: • The technical approach and conceptual model that accounts for
p.000023: – sources of the chemicals being studied;
p.000023: – potential routes and pathways of exposure;
p.000023: – factors that may impact exposure and other relevant stressors;
p.000023: – selection and characteristics of the study participants; eligibility criteria; and recruitment, retention, and
p.000023: payment approaches;
p.000023: – justification for sample size, the methodology for selecting participants, and the sampling methods;
p.000023: – characteristics of the community in which the study will be performed;
p.000023: – environmental conditions, factors, or end points to be measured, including sampling and analysis approaches and
p.000023: methods (with description of expected performance);
p.000023: – survey design and questionnaires and other survey instruments, as applicable (with description of prior use and
p.000023: validation in similar studies);
p.000023: – pilot studies that may be undertaken;
p.000023: – quality assurance project plan and quality control;
p.000023: – timeframe for the study;
p.000023: – exposure scenarios to be considered;
p.000023: – burden of the study on the participants;
p.000023: – resources available; and
p.000023: – feasibility
p.000023: • Discussion of alternative study designs and approaches considered and reasons for rejecting other approaches and
p.000023: selecting the one proposed
p.000023: • An analysis plan that considers
p.000023: – Information and data needs, including data storage, security, access, and release;
p.000023: – nature of the measurement data (e.g., variability, quality assurance);
p.000023: – how the collected data will be used, and how the proposed analyses will address objectives of the study; and
p.000023: – hypotheses to be tested and statistical power and sample size required to test the hypotheses
p.000023: • Resources required or available
p.000023: • Project organization and management, including team members and roles and responsibilities
p.000023: • Schedule
p.000023:
p.000023: fairness in human subjects research is that scientific goals, considered in dynamic interaction with
p.000023: the potential for and distribution of risks and benefits, should guide the selection of subjects.”
p.000023: (Emmanuel et al, 2000). On the other hand, as discussed in Section 3, many study problems specifically
p.000023: address exposures of vulnerable groups to chemicals and other stressors. Researchers should not avoid
p.000023: research studies that will,
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: of necessity, include vulnerable groups to address the study hypotheses or objectives simply to avoid the more
p.000024: stringent requirements for working with these groups.
p.000024:
p.000024: 2.4 Ensuring a Favorable Risk-Benefit Ratio
p.000024: 2.4.1 Designing in Benefits for the Participants
p.000024: Study designs vary depending on the objectives of the study, existing knowledge on the research question, and
p.000024: the hazard being studied (NRC & IOM, 2005). Recent ethical discussions about study designs in human subjects
p.000024: research (cf., Recommendation 7.1, p. 143, NRC & IOM [2005] and Emanuel et al. [2000]) support the development
p.000024: of innovative study designs to maximize the benefit9 to the study participants, as well as to
p.000024: the community and the greater society beyond. Observational human exposure studies generally collect data that
p.000024: contribute to generalizable knowledge that will benefit the community and society as a whole, but they often do not
p.000024: provide obvious direct benefit to study participants. Therefore, it is important to include elements
p.000024: in the study design that can offer benefits to the participants wherever possible. This is not always
p.000024: straightforward, but one way that participants, as well as communities, can benefit from these studies is
p.000024: by incorporating strong educational components into the conduct of the research. For example, brochures, videos,
p.000024: and other materials that educate study participants on safety around the home or on how to reduce their
...

p.000027: identifies a number of topics that should be considered in development of the human subjects research protocol.
p.000027: In addition, the authors’ experience leads them to suggest that three additional topics beyond those from
p.000027: the CIOMS (2002) document also may need to be considered in a human subjects protocol: (1) approaches to
p.000027: minimize changes in participant behavior because of participation in the study (see Section 2.3.4);
p.000027: (2) approaches to minimize therapeutic misconception (see Section 5.4.1); and (3) actions to involve
p.000027: the community in a community-based participatory research
p.000027:
p.000027: Text Box 2-5. Potential Topics in a Human Subjects Research Protocol
p.000027: 1. Title
p.000027: 2. Summary in lay language
p.000027: 3. Justification for the study
p.000027: 4. Ethical issues and proposed resolution
p.000027: 5. Summary of previous research
p.000027: 6. Affirmation of Belmont Principles and 40 CFR 26 compliance
p.000027: 7. Previous history or use of the protocol
p.000027: 8. Information on the location and demographics of research
p.000027: 9. Information on funding organization, researcher partners, and collaborators
p.000027: 10. Names, qualifications, and experience of investigators
p.000027: 11. Objectives, hypotheses, assumptions, and variables
p.000027: 12. Study design
p.000027: 13. Sample size and power and statistical analysis plan
p.000027: 14. Criteria and justification for subject selection
p.000027: 15. Justification for use of vulnerable groups, if any
p.000027: 16. Process of recruitment
p.000027: 17. Actions to involve the community in a community-based participatory research program
p.000027: 18. Description and explanation of any and all interventions
p.000027: 19. Measurements or data to be collected
p.000027: 20. Any clinical or other tests
p.000027: 21. Rules or criteria for removing subjects or terminating the study
p.000027: 22. Adverse events and unanticipated problems⎯reporting and responses
p.000027: 23. Potential benefits to subjects or others
p.000027: 24. Expected benefits of the research to the population
p.000027: 25. Informed consent process and responsibilities
p.000027: 26. Protections for the consent/assent of vulnerable participants
p.000027: 27. Efforts to minimize “therapeutic misconception”
p.000027: 28. Approaches to minimize changes in participant behavior
p.000027: 29. Payments
p.000027: 30. Plans for informing subjects about items that could affect subjects’ willingness to continue in the study
p.000027: 31. Plans to inform subjects about the results of the study
p.000027: 32. Privacy and confidentiality
p.000027: 33. Security of personal information and when, how, and by whom private information can be revealed
p.000027: 34. All foreseen uses of personal data or biological materials
p.000027: 35. Procedures for data and safety monitoring and oversight of the study and the criteria for identifying, reporting,
p.000027: and responding to adverse events, including ethical breaches, environmental measures in excess of reporting standards,
p.000027: and collateral observations, and criteria for prematurely terminating the study if necessary
p.000027: 36. A list of the references cited in the protocol
p.000027: 37. The source and amount of funding
p.000027: 38. Protocols for dealing with financial or other conflicts of interest
p.000027: 39. Schedule
p.000027: 40. Arrangements with sponsors regarding publication rights and procedures
p.000027: 41. Reasons for not publishing the study findings
p.000027: 42. Procedures for preventing falsification of data
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: (CBPR) effort, as appropriate (see Section 6, especially Section 6.10).
p.000028:
p.000028: 2.5.4 Ethical Review
p.000028: In the United States, ethical reviews of studies involving human subjects are performed by IRBs.
p.000028: The Common Rule specifies requirements (40 CFR 26.107 –
...

p.000032: [accessed June 2007].
p.000032: U.S. EPA (U.S. Environmental Protection Agency) (2000). Comments on the use of data from the testing of human subjects:
p.000032: A report by the Science Advisory Board and the FIFRA Scientific Advisory Panel. Environmental Protection Agency,
p.000032: Science Advisory Board. EPA-SAB-EC-00-017. Available: http://www.epa.gov/scipoly/sap/meetings/1999/november/e c0017.pdf
p.000032: [accessed 16 April 2008].
p.000032:
p.000032: U.S. HHS (U.S. Department of Health and Human Services) (1993). Protecting Human Research Subjects: Institutional
p.000032: Review Board Guidebook. Office for Human Research Protections. Available: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
p.000032: [accessed 12 June 2007].
p.000032:
p.000032: Van Belle G, Fisher L (2004). Biostatistics: A Methodology for the Health Sciences (2nd Edition) Hoboken, NJ: John
p.000032: Wiley & Sons.
p.000032:
p.000032: Wackerly DD, Mendenhall W, Scheaffer RL (2001). Mathematical Statistics with Applications (6th Edition). Pacific Grove,
p.000032: CA: Duxbury Press.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: SECTION 3
p.000033: Ensuring Protection of Vulnerable Groups
p.000033:
p.000033:
p.000033:
p.000033: Concern for the protection of vulnerable groups is fundamental to modern ethical thought and guidelines.
p.000033: The Belmont Report was “meant to provide broad principles that could be used to generate specific
p.000033: rules and regulations in response to [U.S.] research scandals such as Tuskegee and Willowbrook.11 It
p.000033: focuses on informed consent, favorable risk-benefit ratio, and the need to ensure that vulnerable
p.000033: populations are not targeted for risky research” [emphasis added] (Emanuel et al., 2000).
p.000033: The Common Rule requires IRBs to assure that “additional safeguards have been included in the study to protect
p.000033: the rights and welfare of these [vulnerable] subjects” [at 40 CFR 26.111(b) in CFR, 2006a]. If an
p.000033: observational human exposure study includes vulnerable research participants, it is essential that the investigators be
p.000033: cognizant of the special issues and requirements of research involving vulnerable populations. Researchers
p.000033: have to justify the involvement of vulnerable populations in the research study and
p.000033: include the appropriate safeguards for protection of their safety and welfare. The Common Rule protections are
p.000033: discussed further in the IRB guidebook (U.S. HHS, 1993). EPA regulations include not only the general
p.000033: protections for vulnerable populations found in the Common Rule (Subpart A) but also define
p.000033: additional protections for children and for pregnant or nursing women (and their fetus or nursing child)
p.000033: in Subparts B, C, and D (CFR, 2006a).
p.000033: The section begins by identifying or defining vulnerable groups and then discusses ethical issues that
p.000033:
p.000033:
p.000033: 11 For more information about these and other research scandals, see Ethical and Policy Issues in Research Involving
p.000033: Human Participants, Vol. I, Report and Recommendations of the National Bioethics Advisory Commission, Bethesda, MD,
p.000033: August, 2001. See p. 153 for information about the Willowbrook State School experiments. The report is available at
p.000033: www.bioethics.gov/reports/past_commissions/nbac_human_part.pdf (Accessed September 3, 2007).
p.000033: may be important in conducting observational human exposure studies involving those groups, especially
p.000033: children and pregnant women. The discussions about the ethical issues are based largely on EPA’s human subjects
p.000033: regulations and on the recommendations from the Council for International Organizations of
p.000033: Medical Sciences document, International Ethical Guidelines for Biomedical Research Involving Human
p.000033: Subjects (CIOMS, 2002).
p.000033:
p.000033: 3.1 Identification of Vulnerable Groups
p.000033: In the United States, human subjects regulations (45 CFR 46 and 40 CFR 26) do not formally define
p.000033: vulnerable populations. Instead, the Common Rule gives examples of potentially vulnerable groups (see Text Box 3-1).
p.000033: In addition, HHS extends added human subjects protections to pregnant women, human fetuses,
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
p.000035: interests, ethically perceptive researchers will plan and implement special provisions for the protection of the
p.000035: rights and welfare of the vulnerable persons.
p.000035:
p.000035: Text Box 3-1. Potentially Vulnerable Groups Identified in U.S. Regulations
p.000035:
p.000035: Text Box 3-2. Potentially Vulnerable Groups Identified in International Guidance
p.000035: (Council for International Organizations of Medical Sciences, 2002)
p.000035:
p.000035: • Junior or subordinate members of a hierarchical group; examples include employees, students, members of the armed
p.000035: forces, police, and others who work for, or closely with re- searchers; they may have expectations of preferential
p.000035: treatment if they agree to participate or fear of disapproval or retaliation if they refuse to participate in a study.
p.000035:
p.000035: Common Rule: Examples of vulnerable groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: EPA extends stringent protections to these groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035: HHS extends additional protections to these groups
p.000035: (45 CFR 46)
p.000035:
p.000035: Additional vulnerable groups in NIH training materials
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
p.000035: instructs the IRB to consider the “purposes of the research and the setting in which the research will
p.000035: be conducted.” CIOMS goes further and recommends that “Special justification is required for inviting
p.000035: vulnerable individuals to serve as research subjects” (CIOMS, 2002).12
p.000035: Although Federal regulations define vulnerability in terms
p.000035: of the person’s ability to protect their own
p.000035:
p.000035: interests or particular sensitivity to risks because of physical condition, the lay public may perceive a
p.000035: broader definition of vulnerability as it relates to education, economics, social status, and other factors. As
p.000035: shown in Text Boxes 3-1 and 3-2 and described above, the concept of vulnerability is broader than that
p.000035: presented in the Common Rule. It is not adequate to simply check the list in Text Box 3-1 to identify if a potentially
p.000035: vulnerable group is included in an observational study. The researchers should assess the potential
p.000035: vulnerability of a study population within the study by evaluating the characteristics (e.g., socioeconomic
p.000035: status) of the study population within the context of the study by considering the various design elements of the
p.000035: study, as discussed in Section 2.
p.000035: 12 In the commentary on Guideline 13 in CIOMS (2002), the committee states that the central problem presented by plans
p.000035: to involve vulnerable persons as research subjects is that such plans may entail an inequitable distribution of the
p.000035: burdens and benefits of research participation. Classes of individuals conventionally considered vulnerable are those
p.000035: with limited capacity or freedom to consent or to decline to consent. They are the subject of specific guidelines in
p.000035: the CIOMS document (Guidelines 14 and 15) and include children, and persons who, because of mental or behavioral
p.000035: disorders, are incapable of giving informed consent. Ethical justification of their involvement usually requires that
p.000035: • the research could not be carried out equally well with less vulnerable subjects;
p.000035: • the research is intended to obtain knowledge that will lead to improved diagnosis, prevention, or treatment of
p.000035: diseases or other health problems characteristic of, or unique to, the vulnerable class—either the actual subjects or
p.000035: other similarly situated members of the vulnerable class;
p.000035: • research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily be
p.000035: assured reasonable access to any diagnostic, preventive, or therapeutic products that will become available as a
p.000035: consequence of the research;
p.000035: • the risks attached to interventions or procedures that do not hold out the prospect of direct health-related
p.000035: benefit will not exceed those associated
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: CIOMS recommendations, although written to address biomedical research, also generally are
p.000036: applicable to observational human exposure studies. The authors of this document consider the CIOMS
p.000036: requirement that the research could not be carried out equally well with less vulnerable subjects
p.000036: to be particularly important. EPA and NERL researchers should include vulnerable groups in
p.000036: observational human exposure studies only if their participation is critical to the success and
p.000036: applicability of the research. Even then, EPA and NERL researchers will have to meet stringent standards for
p.000036: protecting the rights and safety of the vulnerable participants. For example, EPA regulations
p.000036: governing observational research with children are even more stringent than the CIOMS guideline.
p.000036: If such research does not hold out the prospect of direct benefit to the child, no increase whatsoever over
p.000036: minimal risk is permitted.
p.000036: However, many observational human exposure studies are developed specifically to study the exposures of
p.000036: selected vulnerable groups to chemicals and other environmental stressors in everyday environments. So,
p.000036: researchers should be prepared to address the issues associated with vulnerable groups in
p.000036: observational research. Furthermore, as discussed in Section 3.4, there has been increased concern in recent years that
p.000036: exclusion of vulnerable groups from research studies is not ethical. Failure to conduct research with vulnerable groups
p.000036: may deprive them of the benefits of research. NIH, for example, has a policy (NIH, 1998) with a
p.000036: goal of increasing participation of children in research.
p.000036:
p.000036: 3.3 Minimal Risk and Vulnerable Groups
p.000036: EPA has codified protections for children, pregnant or nursing women, and fetuses in Subparts B, C, and D of the EPA
p.000036: human subjects rule (40 CFR 26). Subpart B strictly prohibits research involving intentional exposure of children
p.000036: or pregnant or nursing women (and, therefore, exposure of her fetus).
p.000036: EPA’s regulations do allow for observational research involving fetuses and pregnant women (40 CFR 26
p.000036: Subpart C) or children (40 CFR 26 Subpart D) but with additional protections in place and with
p.000036: strict limitations on research that presents more than minimal
p.000036: risk (CFR, 2006a).13 When considering vulnerable groups, The Institutional Review Board Guidebook (U.S. HHS,
p.000036: 1993) states that “IRBs should therefore determine whether the proposed subject population would be more sensitive or
p.000036: vulnerable to the risks posed by the research as a result of their general condition or disabilities. If so, the
p.000036: procedures would constitute more than minimal risk for those subjects.”
p.000036: When conducting observational human exposure studies, it is recommended that researchers consult these
p.000036: regulations and guidebooks. NERL researchers also will need to ensure that all of the requirements in Subparts B, C,
p.000036: and D of the EPA Human Subjects Rule are met.
p.000036:
p.000036: 3.4 Research Involving Children
p.000036: Children long have been recognized as a vulnerable group in research studies. EPA and HHS both extend special
p.000036: protections to children (CFR, 2006a,b). There are many books, reports, and research manuscripts that
p.000036: specifically address issues associated with research involving children (e.g., NRC & IOM, 2005; IOM,
p.000036: 2004; Kodish, 2005; NRC, 2003; AAP, 2003).
p.000036: CIOMS has drafted guidelines for including children in biomedical research (Guideline 14, CIOMS, 2002). The
p.000036: guidelines require an investigator to provide the assurances shown in Text Box 3-3 before undertaking
p.000036: research involving children.
p.000036:
p.000036: Text Box 3-3. Assurances Required by CIOMS Before Research Involving Children May Begin
p.000036: • the research might not equally well be carried out with adults;
p.000036: • the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000036: • a parent or legal representative of each child has given permission;
p.000036: • the agreement (assent) of each child has been obtained to the extent of the child’s capabilities; and
...

p.000036: encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: some cases, are higher) from those of adults. Children are behaviorally and physiologically different
p.000037: from adults. Their interaction with their environment, through activities such as playing on floors, mouthing of
p.000037: hands and objects, and handling of food, may increase contact with contaminated surfaces. Children
p.000037: have proportionately higher breathing rates, relative surface area, and food intake requirements
p.000037: that also may increase exposure. Differences in absorption, metabolism, storage, and excretion
p.000037: may result in higher biologically effective doses to target tissues. Immature organ systems may be more
p.000037: susceptible to toxicological challenges. Windows of vulnerability, when specific toxicants may permanently
p.000037: alter the function of an organ system, are thought to exist at various stages of development. Because
p.000037: the factors influencing children’s exposures to chemicals are not characterized well (Cohen Hubal et
p.000037: al., 2000), it is sometimes important that observational human exposure studies involve children.
p.000037: Because children are so vulnerable, there long has been concern about including them in research studies,
p.000037: and biomedical research often excluded children. However, in recent years, there has been concern
p.000037: that excluding children from research is not ethical. NIH’s Policy and Guidelines on the Inclusion of
p.000037: Children as Participants in Research Involving Human Subjects (NIH, 1998) has a goal of increasing
p.000037: participation of children in research. The policy of NIH is that children must be included in all human
p.000037: subjects research conducted or supported by NIH, unless there are scientific and ethical reasons
p.000037: not to include them. Proposals or applications to NIH for research have to present an acceptable
p.000037: justification if children will be excluded from a research study. Of course, as discussed above, if the research
p.000037: topic is irrelevant to children, the CIOMS guidelines would recommend that they be excluded from the
p.000037: research.
p.000037: Observational human exposure studies conducted by NERL are not expected to involve greater than minimal risk. It
p.000037: will be the responsibility of the NERL researchers to present adequate information for the IRB to
...

p.000037: role of the family goes far beyond their involvement in the informed consent process. In observational
p.000037: human exposure studies, even when children are the participants, the parents or guardian play
p.000037: a key role in the collection of data and information during the study. For studies with very young children,
p.000037: family members supply all of the information relevant to the child. NERL researchers need to ensure that both
p.000037: the child and the parents or guardians and other caregivers are informed fully and are willing
p.000037: participants. Without their willing participation, the research cannot be successful.
p.000037:
p.000037: 3.5 Women as Research Subjects
p.000037: Women are routinely included as research participants in observational human exposure studies.
p.000037: However, pregnant women and their fetuses are vulnerable groups and require special protections.
p.000037: EPA’s human subjects rule prohibits intentional dosing studies and provides additional controls for
p.000037: observational research (40 CFR 26, Subparts B and C).
p.000037: CIOMS (2002) includes two guidelines for biomedical research involving women as research
p.000037: subjects. The first of these, number 16, states that women should not be excluded from
p.000037: biomedical research because of the potential for becoming pregnant during a study. The document continues, “A
p.000037: general policy of excluding from such clinical trials women biologically capable of becoming pregnant is
p.000037: unjust in that it deprives women as a class of persons of the benefits of new knowledge derived from the
p.000037: trials.” The second relevant CIOMS guideline, number 17, asserts that, if involved in a research study,
p.000037: pregnant women should be fully informed, and included only if the
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: research benefits pregnant women and is thoroughly supported by reliable evidence in animal studies.
...

p.000038: behind the guidelines generally may be applicable to observational human exposure studies. EPA’s human
p.000038: subjects rule is completely consistent with the HHS rule in adding additional protections for pregnant women and
p.000038: fetuses involved in observational research (40 CFR
p.000038: 26.304 and 45 CFR 46.204). These additional protections (specified in 45 CFR 46.204 subparagraphs a
p.000038: through j) reflect the CIOMS recommendations by requiring: availability of data from previously conducted
p.000038: studies to assess the risk to pregnant women and fetuses; scientific necessity for inclusion of pregnant women and
p.000038: fetuses (i.e., providing benefit to the woman or fetus, or producing important, but otherwise unobtainable,
p.000038: biomedical knowledge); that risk is reduced to the least possible level for achieving the objectives of
p.000038: the research; and other protections.
p.000038:
p.000038: 3.6 Other Potentially Vulnerable Groups
p.000038: HHS specifies additional protections for prisoners as a potentially vulnerable group in Subpart C of 45 CFR
p.000038: 26. Additional requirements for other vulnerable groups in research studies are not specifically defined in either
p.000038: EPA’s or HHS’ human subjects rules. Nonetheless, other groups (as discussed in Section 3.1) may be considered to be
p.000038: vulnerable and, as such, may warrant additional consideration and protection as required in the Common Rule. For
p.000038: these other potentially vulnerable groups, such as employees, students, handicapped persons, mentally disabled
p.000038: persons, and economically or educationally disadvantaged persons, nursing home residents or otherwise
p.000038: incapacitated elderly, etc., the Common Rule requires researchers and IRBs to fully evaluate the
p.000038: protocols to ensure that the safety and welfare of the groups will be protected. As discussed in Section 3.1,
p.000038: It also should be noted that, although Federal regulations define vulnerability in terms of the ability
p.000038: to protect one’s own interests, the lay public may perceive a broader definition of vulnerability as
p.000038: it relates to education, economics, social status, and other factors. The researcher should evaluate
p.000038: vulnerability in this broader context to ensure that adequate safeguards are included for potentially
p.000038: vulnerable populations that do not meet the definition of the Federal regulations.
p.000038: References
p.000038: AAP (American Academy of Pediatrics) (2003). Pediatric Environmental Health. (2nd Edition). Elk Grove Village, IL:
p.000038: American Academy of Pediatrics.
p.000038:
p.000038: CFR (Code of Federal Regulations) (2006a). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000038: Subjects. U.S. Code of Federal Regulations.
p.000038: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr26_06. html [accessed 12 June 2007].
p.000038:
p.000038: CFR (Code of Federal Regulations) (2006b). 45 CFR Subtitle A Department of Health and Human Services Part 46 Protection
p.000038: of Human Subjects. U.S. Code of Federal Regulations. Available:
p.000038: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr46_06.ht ml [accessed 13 June 2007].
p.000038:
p.000038: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000038: Biomedical Research Involving Human Subjects.
p.000038: Geneva, Switzerland: CIOMS. Available at http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000038:
p.000038: Cohen Hubal EA, Sheldon LS, Burke JM, McCurdy TR, Berry MR, Rigas ML, Zartarian VG, Freeman NCG (2000).
...

p.000047:
p.000047: 4.5 Data and Safety Monitoring and Oversight
p.000047: The Common Rule requires for IRB approval that, “When appropriate, the research plan makes adequate
p.000047: provision for monitoring the data collected to ensure the safety of subjects.” [40 CFR 26.111(a)(6)].
p.000047: Data and safety monitoring plans (DSMPs) are developed and applied in all clinical trial
p.000047: research studies. Clinical trials are prospective studies designed to answer specific questions about the effects or
p.000047: impact of particular biomedical or behavioral interventions. The DSMPs are used to insure the safety of
p.000047: participants, the validity of data, and appropriate termination of studies for which significant risks
p.000047: or benefits have been uncovered or when it appears that the trial cannot be concluded successfully
p.000047: (NIH, 1998; NCI, 2001; U.S. FDA, 2001). Depending on the study scope and potential risks and benefits, a
p.000047: data safety monitoring board (DSMB) may be created to assess procedures for data and safety monitoring
p.000047: and to independently assess safety and outcomes on an ongoing basis during the study.
p.000047: Formal independent monitoring boards or committees, like DSMBs, have not seen widespread use in
p.000047: observational human exposure studies, although much of the information included in DSMPs often has been
p.000047: captured in the research protocols. Researchers and IRBs may, however, consider using monitoring and oversight boards
p.000047: to help assure participant safety and research integrity in observational human exposure studies,
p.000047: particularly in complex longitudinal studies and in studies that include vulnerable subjects.
p.000047: At least two NIH institutes have developed guidelines for monitoring and oversight in
p.000047: the observational research that they sponsor.
p.000047: (1) The National Heart, Lung, and Blood Institute (NHLBI) has developed an interim policy on the
p.000047: creation and role of observational study monitoring boards (OSMBs) for observational research
p.000047: sponsored by that institute (NHLBI, 2007). OSMBs may be established for large or complex studies on a case-by-case
p.000047: basis. The role of the OSMB is “to help assure the integrity of the study by closely monitoring data
p.000047: acquisition for comprehensiveness, accuracy, and timeliness; and monitoring other concerns such as
p.000047: participant confidentiality.”
p.000047: (2) The National Eye Institute (NEI) has developed guidelines for data monitoring and oversight
p.000047: committees (DMOCs) for observational research (NEI, 2001). The role of the DMOC is to “assist the NEI and the
p.000047: study investigators in protecting the interests of study participants and in preserving the integrity and
p.000047: credibility of the study.”
p.000047: When appropriate, formal procedures for routine monitoring of scientific and ethical issues will need to be
p.000047: incorporated into observational research and approved by the IRB to ensure participant safety and the integrity of
p.000047: the research. Even though most observational human exposure studies are considered low-risk, there is often a need to
p.000047: determine whether appropriate threshold values for biological or environmental levels of chemicals exist or can be
...

p.000054: protections. Researchers should make plans for trained staff or trained community members, associated
p.000054: or affiliated with the research study, to be available for translations.
p.000054:
p.000054: 5.1.3 Voluntary Participation
p.000054: The third pillar of informed consent is voluntary participation. The Belmont Report emphasizes that
p.000054: participants “should understand clearly the range of risk and the voluntary nature of participation” [emphasis
p.000054: added]. The ethical principles of respect for persons and their autonomous decisions morally obligate
p.000054: the researcher to ensure that an individual’s decision to participate in a human research study is truly
p.000054: voluntary and uncoerced (Emanuel et al., 2000). A number of study characteristics may affect whether the
p.000054: participant’s actions are truly voluntary.
p.000054: • Access to study-dependent benefits or care that would otherwise not normally be received may impair
p.000054: voluntariness.
p.000054: • Voluntary participation also may be compromised when there is an existing relationship between the
p.000054: researcher and participants, such as employer and employee or teacher and student.
p.000054: • Restricted voluntariness may be an intrinsic part of belonging to certain vulnerable groups,
p.000054: including children, prisoners, handicapped persons, mentally disabled persons, and economically or
p.000054: educationally disadvantaged persons, or members of the military, for example. When research participants come from such
p.000054: groups, additional protections to insure voluntariness in the context of the research may be required
p.000054: (see also 40 CFR 26, Subparts B, C, and D).
p.000054: • Payments as incentives may have undue influence and are discussed below.
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: • Whether payments will lead to a coerced decision to participate often is difficult to determine without
p.000055: input from people from similar socioeconomic backgrounds as the participants (p. 111, NRC & IOM, 2005).
p.000055: Researchers should work with community representatives to develop a consent process that will be
p.000055: maximally effective in providing information, ensuring and documenting comprehension, and ensuring
p.000055: that participation is voluntary (also see Section 6).
p.000055: Researchers should remember that obtaining informed consent should be “an on-going, interactive
p.000055: dialogue . . . involving the disclosure and exchange of relevant information” (IOM, 2002): it is not
p.000055: simply having a consent form signed. The process is most effective when the researcher spends time with
p.000055: potential participants to discuss the study and to answer questions.
p.000055:
p.000055: 5.2 Payments to Research Participants
p.000055: The decision whether to pay research participants, including the appropriate level of payment,20 is
p.000055: a complex ethical issue. Monetary or nonmonetary payments are not ethical if they constitute an
p.000055: undue inducement for participants to assume research risks that they would not otherwise accept. On the other
p.000055: hand, it may be ethically appropriate to offer reasonable payments in some research studies. Indeed,
p.000055: payment of human subjects for their participation in scientific research is a common practice in the United
p.000055: States, with a history of well over 100 years (Grady, 2005). The difficulty for researchers and IRBs is that
p.000055: there is often little clear and uniform guidance for determining what constitutes “undue inducement”
p.000055: or “reasonable” payment for any particular research study, population, and level of risk. Additional
p.000055: considerations regarding payment to participants arise when working with vulnerable populations, including
p.000055: children.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 20 There are many terms that may be found in the literature to describe both monetary and nonmonetary payments, like
p.000055: payment, remuneration, compensation, recompense, incentive, inducement, reimbursement, and reward. Each of these words
p.000055: has its own definition, and each word also may carry specific connotations. In general, these terms refer to money or
p.000055: other items that “are often given to acknowledge the time and inconvenience of participating in research or to
p.000055: reimburse participants for any costs they incur. The term compensation is often used in the context of compensation for
p.000055: research-related injuries” (p. 112, NRC & IOM, 2005). The authors have chosen to use “payment” as the general term for
p.000055: monetary and nonmonetary items provided to research subjects for their participation in the research. They may
p.000055: occasionally refer to compensation for research-related injuries, but the text should make it clear when they do.
p.000055: 5.2.1 Types and Amounts of Payments Offered in Research Studies
p.000055: Payments have been offered in a wide variety of research studies, ranging from clinical trials
p.000055: to behavioral and social research to observational human exposure studies. Payments can take various
p.000055: forms, including monetary payments (e.g., cash, gift certificates, reimbursement for expenses),
p.000055: nonmonetary payments (e.g., gifts, valuable information), or nothing at all (e.g., for a sense of
p.000055: altruism). Grady (2005) has described payment for the participation of research subjects as serving
...

p.000056: of discomfort and burden, costs to participants, and population characteristics. However, large
p.000056: differences in payment levels have been found even in multisite studies in which the same protocol is
p.000056: administered across all sites.
p.000056: Grady et al. (2005) performed a survey of practices for paying research participants in the United States in
p.000056: Phase 1 to 4 clinical trials and physiologic, behavioral, and other types of research. Across 467
p.000056: studies of varying complexity that included payments, the median
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: payment was $155 (mean $266, range $5 to $2,000). The basis for dollar amounts was infrequently described, with
p.000057: 19% of the payments based on time, and 12% based on the procedures. In a model of payment factors,
p.000057: studies with some prospect of therapeutic benefit, studies having at least one invasive procedure, and studies with
p.000057: greater numbers of clinic visits were significantly associated with higher dollar amounts. About 9.5%
p.000057: of the studies offered completion bonuses, and a similar percentage offered escalating payments for
p.000057: followup study visits.
p.000057:
p.000057: 5.2.2 Regulations and Guidance Regarding Payment to Research Participants
p.000057: There is little specific guidance regarding payments in Federal human research regulations. The Common Rule and
p.000057: additional human subjects protections do not directly address payments to research participants, but the
p.000057: regulations do discuss providing additional safeguards for subjects vulnerable to coercion or undue
p.000057: influence [40 CFR 26.111(b)]. The NIH IRB guidebook advises IRBs to determine whether the rewards offered for
p.000057: participation in research constitute undue influence (U.S. HHS, 1993). According to the IRB guidebook undue
p.000057: inducement might blind prospective subjects to risks, impair their ability to exercise proper judgment, or may
p.000057: cause people to lie or to withhold information that would make them ineligible to enroll or continue
p.000057: participation.
p.000057: The U.S. Food and Drug Administration (FDA) has provided guidance for investigators and IRBs for clinical research
p.000057: studies (FDA, 1998). The guidance states that “payment to research subjects for participation in studies is not
p.000057: considered a benefit, it is a recruitment incentive.” FDA expects payments to accrue as the study progresses and not
p.000057: to be contingent on completing the study, although a “small proportion as an incentive for
p.000057: completion of the study is acceptable.” The guidance is concerned with the issue of coercion or undue influence, and
p.000057: it recognizes the IRB as the responsible party for deciding what is or is not acceptable.
p.000057: The U.S. Office of Management and Budget (OMB) develops standards and guidelines for statistical surveys performed by
...

p.000058: for reasonable expenses that are necessary for research participation. The specifics may vary, but
p.000058: examples of reasonable expenses are costs of transportation to the research site, parking, lodging, meals,
p.000058: and babysitting. Other payments are never appropriate in pediatric research, for example, paying parents
p.000058: for the use of their child in research” (pp. 225-6, IOM, 2004).21
p.000058: The IOM committee recommends establishing policies on acceptable and unacceptable types of
p.000058: payments. They also recommend that the policies disclose any recompense in a full and open
p.000058: process,22 while not overemphasizing any recompense.
p.000058: Although the NRC & IOM Committee on Ethical Issues in Housing-Related Health Hazard Research Involving
p.000058: Children and the IOM Committee on Clinical Research Involving Children both concluded that it is appropriate to
p.000058: reimburse expenses or compensate for time or inconvenience, neither committee endorsed incentive
p.000058: payments to parents. In Europe, too, incentive payments to induce parents to allow their children to
p.000058: 5.2.3 Payments When Children or Other
p.000058: Vulnerable Populations Are Involved
p.000058:
p.000058: It is essential that special care be taken with regard to payments when members of vulnerable populations are
p.000058: included in research studies. Vulnerable populations may include children and adolescents, those with
p.000058: cognitive impairments because of medical conditions or age, economically disadvantaged persons, and prisoners. These
p.000058: populations often are not capable of making autonomous, fully informed decisions regarding risks and
p.000058: benefits, or they may be particularly vulnerable to undue influence resulting from the offer of a payment for
p.000058: research participation. In addition, payments made directly to parents or guardians could alter
p.000058: judgment regarding the best interests of minor or incompetent persons in their care.
p.000058: The ethical concern is that too high a payment may “undermine free and informed consent by leading parents
p.000058: to expose their children to unacceptable risks” (NRC & IOM, 2005). The NRC & IOM committee recognized
p.000058: that some commentators argued that children should never be paid, and that parents ought not to be paid to
p.000058: enroll their children in research. Yet, on balance, the committee felt that “reimbursement for expenses and some
p.000058: modest payment for time spent in research
p.000058: 21 The IOM Recommendation 6.2 states, “In addition to offering small gifts or payments to parents and children as
p.000058: gestures of appreciation, investigators may also—if they minimize the potential for undue influence—act ethically to
p.000058: reduce certain barriers to research participation when they
...

p.000060: subject” [40 CFR 26.116(a)(7)].
p.000060: Information about the research often best can be answered by the researcher. However, it may benefit
p.000060: researchers and participants if information about the research can be obtained from or confirmed by a trusted
p.000060: independent person or organization. Participants also need to know how they can contact
p.000060: someone, independent from the researcher, who can answer questions concerning the rights of research
p.000060: participants and provide information on grievance procedures and research-related injuries. These questions
p.000060: could be addressed to the IRB, an ombudsman, an ethics committee, or other knowledgeable
p.000060: administrative body. Consent documents are expected to have at least two names with appropriate
p.000060: telephone contact information⎯one that can provide information regarding the research and
p.000060: another that can provide information regarding their rights as research participants. Grievance
p.000060: procedures should be structured so that grievances reach the approving IRBs and sponsoring
p.000060: organizations.
p.000060:
p.000060: 5.3.1 Ombudsman
p.000060: An ombudsman is a neutral independent advocate for research participants (and their families or guardians, where
p.000060: applicable). Institutions and IRBs may recommend or require the use of an ombudsman in
p.000060: certain types of research studies, particularly those seeking to study vulnerable populations.
p.000060: Ombudsmen can fill several roles as participant advocates. They may be an independent source of information
p.000060: regarding the study. They may be present during the informed consent process to ensure that risks, benefits,
p.000060: and study requirements are communicated correctly and understood by potential participants
p.000060: or their guardians. An ombudsman may be used in studies involving prisoners or military personnel to
p.000060: ensure that there is no coercion to participate. And the ombudsman may
p.000060:
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: communicate problems or grievances raised by research participants to the IRB and sponsoring organization.
p.000061:
p.000061: 5.3.2 Community Advisory Board
p.000061: CABs can help ensure that participant rights are considered and addressed during the study design and can
p.000061: play an important role in monitoring the research process. Community members may choose to seek
p.000061: information about the study from the advisory panel, as an independent entity, before deciding whether to enroll.
p.000061: Representatives from such advisory boards can be included in the research team that designs the study (see
p.000061: Section 2.3). The role of CABs is more fully discussed in Section 6.
p.000061:
p.000061: 5.4 Creating a Supportive Environment for Research and Interaction
p.000061: It is recommended that researchers and institutions strive to create a supportive environment for research
...

p.000061: the Report and Recommendations on Public Trust in Clinical Research for the NIH Director from the
p.000061: Director’s Council of Public Representatives (COPR) (NIH, 2005). Although the advice from this workshop was
p.000061: developed in the context of NIH-supported clinical research, many of the recommendations are applicable to
p.000061: observational human exposure studies and human subject research in general. A summary
p.000061: of
p.000061: recommendations from the report for enhancing public trust is provided in Appendix D. The recommendations are
p.000061: focused on the following areas.
p.000061: • Building trust through community partnerships
p.000061: • Building relationships with patients (participants) (True partnerships with patients may not be possible,
p.000061: but bidirectional relationships must be enhanced.)
p.000061: • Building partnerships with community providers
p.000061: • Building trust in scientists
p.000061: • Building trust in the (EPA) and scientific research.
p.000061:
p.000061: 5.5 Recruitment Strategies
p.000061: Many strategies are used to select and recruit people into research studies requiring human participation. The IRB is
p.000061: responsible for reviewing the selection process to ensure that it is, above all, equitable. The requirement for
p.000061: IRB review is stated in 40 CFR 26.111(a)3.
p.000061: Selection of subjects is equitable. In making this assessment, the IRB should take into account the
p.000061: purposes of the research and the setting in which the research will be conducted and should be particularly cognizant
p.000061: of the special problems of research involving vulnerable populations, such as children, prisoners,
p.000061: pregnant women, mentally disabled persons, or economically or educationally disadvantaged
p.000061: persons.
p.000061: The IRB guidebook is an excellent resource for consideration of concerns and elements for equitable
p.000061: participant selection (U.S. HHS, 1993). It states that “Defining the appropriate group of subjects
p.000061: for a research project involves a variety of factors⎯ requirements of scientific design,
p.000061: susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness.” The IRB
p.000061: guidebook raises a number of points to consider in the process for selection of human participants (see Text Box
p.000061: 5-5).
p.000061: Various participant recruitment strategies may be used depending on the type of research being performed and the
p.000061: population of interest. This section addresses the strategies and approaches for identifying and contacting people and
p.000061: subsequent recruitment into a research study. Sampling design approaches and issues, such as statistical
p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062: Text Box 5-5. IRB Guidebook Issues on Identifying Subjects
p.000062: 1. Who will bear the burden? Who will reap the benefits?
p.000062: 2. Is there a disproportionate burden on any single group?
p.000062: 3. Is the proposed subject population required or justified?
p.000062: 4. Are there susceptible groups of people who should be excluded from the research?
p.000062: 5. Are anticipated benefits distributed fairly? Do others have a greater need to receive any of the anticipated
p.000062: benefits?
p.000062: 6. Are the research burdens distributed fairly?
p.000062: 7. Will any special physiological, psychological, or social characteristics of the subject group pose special risks
p.000062: for them?
p.000062: 8. Would it be possible to conduct the study with other, less vulnerable subjects?
p.000062: 9. Has the selection process overprotected potential subjects who are considered vulnerable (e.g., children,
p.000062: cognitively impaired, economically or educationally disadvantaged persons, patients of researchers, seriously ill
p.000062: persons), so that they are denied opportunities to participate in research?
p.000062: 10. If the subjects are susceptible to pressures, are there mechanisms to reduce the pressures or minimize their
p.000062: impact?
p.000062:
p.000062:
p.000062: Some of the common approaches for identifying and making initial contact with potential participants include, but are
p.000062: not limited to
p.000062: • direct telephone or in-person contact with a person selected through a statistical sampling process
p.000062: to obtain a representative sample of the population being studied;
p.000062: • use of print or other media advertisements, often used to recruit people in a community with specific
p.000062: characteristics;
p.000062: • advertisement or word-of-mouth contacts through community groups, civic organizations, or other types of
p.000062: organizations; and
p.000062: • recruitment at physicians’ offices, hospitals, and clinics or at churches, schools, or other
p.000062: social institutions, either in person or through the use of advertisements or study brochures.
p.000062: CABs can be consulted regarding proposed approaches for recruitment in community-based
p.000062: research. All procedures and materials for participant recruitment are reviewed and approved by the IRB prior to
p.000062: implementation. Some of the materials prepared for recruitment might include the following.
...

p.000089: exposure either are not available or difficult to measure or interpret. In these cases, measurements in
p.000089: environmental media may be the best exposure metric. Whatever metric is chosen, it is important that the
p.000089: chemical analyses can be performed relatively quickly to reduce such exposures as quickly as possible.
p.000089: The second, and more difficult, step in developing the reporting protocol is to determine the
p.000089: level of concern that triggers reporting of the concentration to the study participant. For some environmental
p.000089: media, such as drinking water, EPA (2007) has established maximum contaminant levels that can be used as
p.000089: triggers for reporting. For example, if the researcher measures a level of arsenic in drinking water above
p.000089: 0.010 mg/L, he or she would be expected to report the level to the study participant. For other environmental media,
p.000089: such as air, there are few applicable standards. The National Ambient Air Quality Standards might be
p.000089: used for the criteria pollutants. Guidelines for occupational exposures, such as threshold limit
p.000089: values (TLVs) and biological exposure indices (BEIs) published by the
p.000089:
p.000089:
p.000090: 90
p.000090:
p.000090: American Conference of Governmental Industrial Hygienists (ACGIH, 2008) also may be used. TLVs are not
p.000090: standards; ACGIH formulates a conclusion on the level of exposure that the typical worker can experience without
p.000090: adverse health effects. Many people would argue that the TLVs are not conservative enough for the average
p.000090: population, particularly not for vulnerable lifestages (e.g., children, the elderly) and TLVs are only for
p.000090: exposure by inhalation. WHO (2005) also publishes air quality guidelines. These types of guidelines can be used to
p.000090: advise study participants if their exposures are high relative to the guidelines. Reporting levels should
p.000090: be conservative, but not so low that reporting the level to the participant causes unwarranted concern and
p.000090: stress. For other environmental media measured in observational human exposure studies, such
p.000090: as house dust or surface wipes, the measurement results cannot be used easily to estimate exposures, and they
p.000090: are a poor metric if used alone.
p.000090: An alternative approach to comparison of measurement results against available guidelines and
p.000090: standards is the comparison of measurements in biological fluids to measurement data available from the
p.000090: National Health and Nutrition Examination Survey (NHANES). For example, results of measurements of
p.000090: chemicals or their metabolites in urine or blood can be compared to different percentiles (e.g., the
p.000090: 95th) reported in the NHANES national reports (CDC, 2005). This type of comparison shows that the participant’s
p.000090: measurements are at the high end of the distribution of the NHANES data, suggesting that action may need to be
p.000090: taken to mitigate exposures. However, researchers need to be judicious in the selection of the exposure
p.000090: metric. Biomarkers in blood and biomarkers in urine can be very different exposure metrics and may represent
...

p.000108: observational human exposure studies. The authors recognize that this document may also prove to be
p.000108: useful to others involved in exposure science research, but the document is not meant to represent an
p.000108: official Agency “guidance document” and should not be used that way. This document does not provide solutions to
p.000108: the scientific and ethical issues that will undoubtedly arise as such studies are undertaken: no document could
p.000108: provide all of the answers in advance or develop a comprehensive checklist for all such studies.
p.000108: Rather, this document attempts to identify the types of issues that will need to be considered and addressed as NERL
p.000108: researchers plan and implement observational human exposure studies. The researchers will need to work with others
p.000108: – the study team, IRB members, EPA Human Subjects Research Review Official (HSRRO), the participants
p.000108: and their community, and other stakeholders – to identify and address all of the relevant
p.000108: issues for their particular study in order to ensure that the specific elements of the study will
p.000108: safeguard and protect the human research subjects.
p.000108: Charge to the Human Studies Review Board
p.000108: The draft document on Scientific and Ethical Approaches for Observational Exposure Studies consists of
p.000108: the following seven sections:
p.000108: 1. Introduction
p.000108: 2. Elements to be Considered in Study Conceptualization and Planning
p.000108: 3. Ensuring Protection of Vulnerable Groups
p.000108: 4. Privacy, Confidentiality, and Other Concerns Related to Observational Human Exposure Measurement Studies
p.000108: 5. Creating an Appropriate Relationship Between Participant and Investigator
p.000108: 6. Building and Maintaining Appropriate Community and Stakeholder Relationships
p.000108: 7. Designing and Implementing Strategies for Effective Communication
p.000108:
p.000108: The Human Studies Review Board is asked to address the following questions for each section of the draft
p.000108: document:
p.000108: 1. One of the goals of the document is identify the major scientific and ethical areas and issues that researchers
p.000108: should address in the design and implementation of observational human exposure measurement studies, with the emphasis
p.000108: on the areas requiring ethical considerations. Does each section identify the major areas and issues where ethical
p.000108: considerations should be addressed?
p.000108: 2. The document is intended to serve as a reference and resource of information that researchers can use in the design
p.000108: and implementation of observational exposure studies. For each section, are there additional sources of information
p.000108: that should be considered for inclusion?
p.000108: 3. Is the information presented accurately and clearly in each section?
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Appendix C
p.000109: Recommended Content of a Human Subjects Protocol
p.000109:
p.000109:
p.000109:
...

p.000109: (6) A statement that the principles of the Belmont Report and requirements specified in 40 CFR 26 will
p.000109: be implemented
p.000109: (7) An account of previous submissions of the protocol for ethical review and their outcomes
p.000109: (8) A brief description of the sites where the research is to be conducted, including information about the
p.000109: adequacy of facilities for the safe and appropriate conduct of the research, and relevant demographic and
p.000109: epidemiological information about the population to be studied
p.000109: (9) The names and addresses of the funding organization, research partners, and collaborators
p.000109: (10) The names, addresses, institutional affiliations, qualifications, and experience of the
p.000109: principal investigator and other investigators
p.000109: (11) The objectives of the study, its hypotheses or research questions, its assumptions, and
p.000109: its variables
p.000109: (12) A detailed description of the design of the study
p.000109: (13) The number of research subjects needed to achieve the study objective, and how this was determined
p.000109: statistically
p.000109: (14) The criteria for inclusion or exclusion of potential subjects and justification for the exclusion of
p.000109: any groups on the basis of age, sex, social or economic factors, or other reasons
p.000109: (15) The justification for involving as research subjects any persons with limited capacity to consent or
p.000109: members of vulnerable social groups and a description of special measures to minimize risks and
p.000109: discomfort to such subjects
p.000109: (16) The process of recruitment (e.g., advertisements) and the steps to be taken to protect privacy and
p.000109: confidentiality during recruitment
p.000109: (17) A description and explanation of any and all interventions
p.000109: (18) The measurements to be performed in the study, including environmental and biological sample
p.000109: collection, and other data and information that will be collected
p.000109: (19) If applicable, clinical and other tests involving the study participants that are to be carried out
p.000109: (20) The rules or criteria according to which subjects may be removed from the study or the study may be
p.000109: terminated
p.000109: (21) The methods of recording and reporting adverse events or reactions, and provisions for dealing with
p.000109: complications
p.000109: (22) The potential benefits of the research to subjects and to others
p.000109: (23) The expected benefits of the research to the population, including new knowledge that the study
p.000109: might generate
p.000109:
p.000109:
p.000109:
p.000111: 111
p.000111:
p.000111: (24) The means proposed to obtain individual informed consent and the procedure planned to communicate information to
p.000111: prospective subjects, including the name and position of the person responsible for obtaining consent
p.000111: (25) When a prospective subject is not capable of informed consent, satisfactory assurance
...

p.000117: exposure of a human subject [40 CFR 26.302]
p.000117: Privacy. Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or
p.000117: intellectually) with others
p.000117: Research. A systematic investigation, including research development, testing, and evaluation, designed to develop or
p.000117: contribute to generalizable knowledge
p.000117: Research involving intentional exposure of a human subject. A study of a substance in which the exposure to the
p.000117: substance experienced by a human subject participating in the study would not have occurred but for the human subject’s
p.000117: participation in the study [40 CFR 26.202(b)]
p.000117: Respect for persons. A fundamental ethical value that is the basis of much of modern bioethical thought and
p.000117: regulation. The concept incorporates at least two fundamental ethical considerations, namely (1) respect for autonomy,
p.000117: which requires that those who are capable of deliberation about their personal choices should be treated with respect
p.000117: for their capacity for self- determination; and (2) protection of persons with impaired or diminished autonomy, which
p.000117: requires that those who are dependent or vulnerable be afforded security against harm or abuse.
p.000117: Source. The origin of an agent for the purposes of an exposure assessment
p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
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p.000118: United States Environmental Protection Agency
p.000118:
p.000118:
p.000118:
p.000118: Office of Research and Development (810R) Washington, DC 20460
p.000118:
p.000118: Official Business Penalty for Private Use
p.000118: $300
p.000118: PRESORTED STANDARD POSTAGE & FEES PAID EPA
...

Searching for indicator vulnerability:

(return to top)
p.002000: ethically acceptable: (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4)
p.002000: favorable risk-benefit ratio, (5) independent review, (6) informed consent, and
p.002000: (7) respect for potential and enrolled subjects.
p.002000:
p.002000:
p.002001: 2001
p.002001:
p.002001: Principles of Biomedical Ethics:(Fifth Edition (Beauchamp and Childress, 2001)
p.002001:
p.002001: A classic text in biomedical ethics. Core chapters discuss respect for autonomy, nonmaleficence, beneficence, and
p.002001: justice. The chapter on professional-patient relationships discusses issues important to privacy, confidentiality, and
p.002001: protection of subjects. The fifth edition is an update that reflects developments in philosophical analysis, as well as
p.002001: developments in science and medicine.
p.002001:
p.002001:
p.002002: 2002
p.002002:
p.002002: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002)
p.002002:
p.002002: Developed by the Council for International Organizations of Medical Sciences particularly for use in developing
p.002002: countries, the guidelines relate mainly to ethical justification and scientific validity of research; ethical review;
p.002002: informed consent; vulnerability of individuals, groups, communities, and populations; women as research subjects;
p.002002: equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury;
p.002002: strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health care
p.002002: services.
p.002002:
p.002002:
p.002003: 2003
p.002003:
p.002003: Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC, 2003)
p.002003:
p.002003: This NRC publication targets policymakers, research administrators, research sponsors, IRB members, and investigators.
p.002003: It examines three key ethical issues: (1) obtaining informed, voluntary consent from prospective participants; (2)
p.002003: guaranteeing the confidentiality of information collected from participants, which is a particularly challenging
p.002003: problem in social sciences research; and
p.002003: (3) using appropriate review procedures for minimal-risk research.
p.002003:
p.002003:
p.002005: 2005
p.002005:
p.002005: Ethical Considerations for Research on Housing- Related Health Hazards Involving Children, (NRC & IOM, 2005)
p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
...

p.002000: ethically acceptable: (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4)
p.002000: favorable risk-benefit ratio, (5) independent review, (6) informed consent, and
p.002000: (7) respect for potential and enrolled subjects.
p.002000:
p.002000:
p.002001: 2001
p.002001:
p.002001: Principles of Biomedical Ethics:(Fifth Edition (Beauchamp and Childress, 2001)
p.002001:
p.002001: A classic text in biomedical ethics. Core chapters discuss respect for autonomy, nonmaleficence, beneficence, and
p.002001: justice. The chapter on professional-patient relationships discusses issues important to privacy, confidentiality, and
p.002001: protection of subjects. The fifth edition is an update that reflects developments in philosophical analysis, as well as
p.002001: developments in science and medicine.
p.002001:
p.002001:
p.002002: 2002
p.002002:
p.002002: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002)
p.002002:
p.002002: Developed by the Council for International Organizations of Medical Sciences particularly for use in developing
p.002002: countries, the guidelines relate mainly to ethical justification and scientific validity of research; ethical review;
p.002002: informed consent; vulnerability of individuals, groups, communities, and populations; women as research subjects;
p.002002: equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury;
p.002002: strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health care
p.002002: services.
p.002002:
p.002002:
p.002003: 2003
p.002003:
p.002003: Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC, 2003)
p.002003:
p.002003: This NRC publication targets policymakers, research administrators, research sponsors, IRB members, and investigators.
p.002003: It examines three key ethical issues: (1) obtaining informed, voluntary consent from prospective participants; (2)
p.002003: guaranteeing the confidentiality of information collected from participants, which is a particularly challenging
p.002003: problem in social sciences research; and
p.002003: (3) using appropriate review procedures for minimal-risk research.
p.002003:
p.002003:
p.002005: 2005
p.002005:
p.002005: Ethical Considerations for Research on Housing- Related Health Hazards Involving Children, (NRC & IOM, 2005)
p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
...

p.000023: programs and QAPPs is outside of the scope of this document. There are many good references on the topic,
p.000023: including the EPA Web site, www.epa.gov/quality/.
p.000023:
p.000023: 2.2.7 The Study Design Document
p.000023: The study design document should contain sufficient detail to allow independent review and assessment of the scientific
p.000023: soundness of the study and the approaches that will be followed to ensure that the study meets the highest
p.000023: scientific and ethical standards. The research team can meet regularly to specifically evaluate the plan. It
p.000023: should be noted that a study design is not the same as an implementation plan. The latter includes an even
p.000023: greater level of detail describing how the study will be performed and includes protocols and
p.000023: operating procedures. Text Box 2-4 lists a number of elements that may be appropriate to include in a study design.
p.000023:
p.000023: 2.3 Ethical Issues in Ensuring Fair Subject Selection
p.000023: One of the ethical principles of human subjects research is that selection of participants should be fair. In
p.000023: Section 2.2.4, the discussion centers on understanding what population or cohort the participants in a research
p.000023: study represents, and how such a selection may be influenced by the research questions and
p.000023: study objectives. That consideration actually represents the first component of ensuring that subject selection is
p.000023: fair. That is, the scientific goals of the study should be the primary basis for determining what groups or
p.000023: individuals should be recruited and enrolled in a study. Participants should not be recruited either because of
p.000023: privilege or because of vulnerability or their inability to look out for their own interests properly.
p.000023: Similarly, groups or individuals should not be excluded peremptorily without consideration of the risks and
p.000023: benefits to them as individuals. Section 3 of this document discusses protection of
p.000023: vulnerable groups and concludes that NERL researchers should include vulnerable groups in observational
p.000023: human exposure studies only if their participation is critical to the success and applicability of the
p.000023: research. Even then, EPA and NERL researchers will have to meet stringent standards for protecting the rights and
p.000023: safety of the vulnerable participants. “The essence of
p.000023:
p.000023:
p.000023: Text Box 2-4. Elements That May Be Included in a Study Design
p.000023: • Introduction and background, including the purpose and scope of the study
p.000023: • The desired outputs and outcomes of the study, including the objectives and the hypotheses to be tested
p.000023: • A brief description or overview of the study
p.000023: • The technical approach and conceptual model that accounts for
p.000023: – sources of the chemicals being studied;
p.000023: – potential routes and pathways of exposure;
p.000023: – factors that may impact exposure and other relevant stressors;
p.000023: – selection and characteristics of the study participants; eligibility criteria; and recruitment, retention, and
p.000023: payment approaches;
...

p.000027: 34. All foreseen uses of personal data or biological materials
p.000027: 35. Procedures for data and safety monitoring and oversight of the study and the criteria for identifying, reporting,
p.000027: and responding to adverse events, including ethical breaches, environmental measures in excess of reporting standards,
p.000027: and collateral observations, and criteria for prematurely terminating the study if necessary
p.000027: 36. A list of the references cited in the protocol
p.000027: 37. The source and amount of funding
p.000027: 38. Protocols for dealing with financial or other conflicts of interest
p.000027: 39. Schedule
p.000027: 40. Arrangements with sponsors regarding publication rights and procedures
p.000027: 41. Reasons for not publishing the study findings
p.000027: 42. Procedures for preventing falsification of data
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: (CBPR) effort, as appropriate (see Section 6, especially Section 6.10).
p.000028:
p.000028: 2.5.4 Ethical Review
p.000028: In the United States, ethical reviews of studies involving human subjects are performed by IRBs.
p.000028: The Common Rule specifies requirements (40 CFR 26.107 –
p.000028: 115) for IRB membership, IRB functions and operations, IRB review of research, and other details related to IRB review
p.000028: and approval of research. Emanuel states that “the independent ethical review of [human subjects
p.000028: research] should involve individuals with training in science, statistics, ethics, and law, as well as
p.000028: reflective citizens who understand social values, priorities, and the vulnerability and concerns of
p.000028: potential subjects” (Emanuel et al., 2000). It is beyond the scope of this document to include
p.000028: detailed discussions on IRB membership, operations, processes, etc. The reader is referred to the Common
p.000028: Rule, as well as a number of other available references (e.g., OHRP, 2007; CFR, 2006; U.S. HHS,
p.000028: 1993; NRC, 2003).
p.000028: It is essential that research with human subjects be carried out or strictly supervised by suitably
p.000028: trained, qualified, and experienced investigators. For all research subject to the Common Rule, these qualified
p.000028: researchers are expected to prepare a human subjects research protocol (as in Section 2.5) and to submit
p.000028: the protocol to be ethically and scientifically appraised by one or more suitably constituted IRBs,
p.000028: independent of the investigators.
p.000028: There are a number of other issues associated with IRBs that may impact researchers
p.000028: conducting observational human exposure studies. As an example, there has been concern about the transparency of
p.000028: IRBs. Questions have been raised about what information the IRB should make available to the public
p.000028: regarding membership on the IRB for review of individual projects, the discussions held with the
p.000028: researchers, the IRB’s concerns about the research protocol, the researchers’ response, etc.
p.000028: Should this information be documented in files that the researchers can make available to the
p.000028: participants, community, stakeholders, and the public? At the present time, there is no clear approach as
...

p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
p.000035: interests, ethically perceptive researchers will plan and implement special provisions for the protection of the
p.000035: rights and welfare of the vulnerable persons.
p.000035:
p.000035: Text Box 3-1. Potentially Vulnerable Groups Identified in U.S. Regulations
p.000035:
...

p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
p.000035: instructs the IRB to consider the “purposes of the research and the setting in which the research will
p.000035: be conducted.” CIOMS goes further and recommends that “Special justification is required for inviting
p.000035: vulnerable individuals to serve as research subjects” (CIOMS, 2002).12
p.000035: Although Federal regulations define vulnerability in terms
p.000035: of the person’s ability to protect their own
p.000035:
p.000035: interests or particular sensitivity to risks because of physical condition, the lay public may perceive a
p.000035: broader definition of vulnerability as it relates to education, economics, social status, and other factors. As
p.000035: shown in Text Boxes 3-1 and 3-2 and described above, the concept of vulnerability is broader than that
p.000035: presented in the Common Rule. It is not adequate to simply check the list in Text Box 3-1 to identify if a potentially
p.000035: vulnerable group is included in an observational study. The researchers should assess the potential
p.000035: vulnerability of a study population within the study by evaluating the characteristics (e.g., socioeconomic
p.000035: status) of the study population within the context of the study by considering the various design elements of the
p.000035: study, as discussed in Section 2.
p.000035: 12 In the commentary on Guideline 13 in CIOMS (2002), the committee states that the central problem presented by plans
p.000035: to involve vulnerable persons as research subjects is that such plans may entail an inequitable distribution of the
p.000035: burdens and benefits of research participation. Classes of individuals conventionally considered vulnerable are those
p.000035: with limited capacity or freedom to consent or to decline to consent. They are the subject of specific guidelines in
p.000035: the CIOMS document (Guidelines 14 and 15) and include children, and persons who, because of mental or behavioral
p.000035: disorders, are incapable of giving informed consent. Ethical justification of their involvement usually requires that
p.000035: • the research could not be carried out equally well with less vulnerable subjects;
...

p.000036: • when the prospective subjects are either incompetent or otherwise substantially unable to give informed consent,
p.000036: their agreement will be supplemented by the permission of their legal guardians or other appropriate representatives.
p.000036:
p.000036:
p.000036: 13 Minimal risk is defined at 40 CFR 26.102(i) and again at 40 CFR 26.402(g). It “means that the probability and
p.000036: magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily
p.000036: encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: some cases, are higher) from those of adults. Children are behaviorally and physiologically different
p.000037: from adults. Their interaction with their environment, through activities such as playing on floors, mouthing of
p.000037: hands and objects, and handling of food, may increase contact with contaminated surfaces. Children
p.000037: have proportionately higher breathing rates, relative surface area, and food intake requirements
p.000037: that also may increase exposure. Differences in absorption, metabolism, storage, and excretion
p.000037: may result in higher biologically effective doses to target tissues. Immature organ systems may be more
p.000037: susceptible to toxicological challenges. Windows of vulnerability, when specific toxicants may permanently
p.000037: alter the function of an organ system, are thought to exist at various stages of development. Because
p.000037: the factors influencing children’s exposures to chemicals are not characterized well (Cohen Hubal et
p.000037: al., 2000), it is sometimes important that observational human exposure studies involve children.
p.000037: Because children are so vulnerable, there long has been concern about including them in research studies,
p.000037: and biomedical research often excluded children. However, in recent years, there has been concern
p.000037: that excluding children from research is not ethical. NIH’s Policy and Guidelines on the Inclusion of
p.000037: Children as Participants in Research Involving Human Subjects (NIH, 1998) has a goal of increasing
p.000037: participation of children in research. The policy of NIH is that children must be included in all human
p.000037: subjects research conducted or supported by NIH, unless there are scientific and ethical reasons
p.000037: not to include them. Proposals or applications to NIH for research have to present an acceptable
...

p.000038: 26. Additional requirements for other vulnerable groups in research studies are not specifically defined in either
p.000038: EPA’s or HHS’ human subjects rules. Nonetheless, other groups (as discussed in Section 3.1) may be considered to be
p.000038: vulnerable and, as such, may warrant additional consideration and protection as required in the Common Rule. For
p.000038: these other potentially vulnerable groups, such as employees, students, handicapped persons, mentally disabled
p.000038: persons, and economically or educationally disadvantaged persons, nursing home residents or otherwise
p.000038: incapacitated elderly, etc., the Common Rule requires researchers and IRBs to fully evaluate the
p.000038: protocols to ensure that the safety and welfare of the groups will be protected. As discussed in Section 3.1,
p.000038: It also should be noted that, although Federal regulations define vulnerability in terms of the ability
p.000038: to protect one’s own interests, the lay public may perceive a broader definition of vulnerability as
p.000038: it relates to education, economics, social status, and other factors. The researcher should evaluate
p.000038: vulnerability in this broader context to ensure that adequate safeguards are included for potentially
p.000038: vulnerable populations that do not meet the definition of the Federal regulations.
p.000038: References
p.000038: AAP (American Academy of Pediatrics) (2003). Pediatric Environmental Health. (2nd Edition). Elk Grove Village, IL:
p.000038: American Academy of Pediatrics.
p.000038:
p.000038: CFR (Code of Federal Regulations) (2006a). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000038: Subjects. U.S. Code of Federal Regulations.
p.000038: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr26_06. html [accessed 12 June 2007].
p.000038:
p.000038: CFR (Code of Federal Regulations) (2006b). 45 CFR Subtitle A Department of Health and Human Services Part 46 Protection
p.000038: of Human Subjects. U.S. Code of Federal Regulations. Available:
p.000038: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr46_06.ht ml [accessed 13 June 2007].
p.000038:
p.000038: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000038: Biomedical Research Involving Human Subjects.
p.000038: Geneva, Switzerland: CIOMS. Available at http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000038:
...

p.000117: participation in the study [40 CFR 26.202(b)]
p.000117: Respect for persons. A fundamental ethical value that is the basis of much of modern bioethical thought and
p.000117: regulation. The concept incorporates at least two fundamental ethical considerations, namely (1) respect for autonomy,
p.000117: which requires that those who are capable of deliberation about their personal choices should be treated with respect
p.000117: for their capacity for self- determination; and (2) protection of persons with impaired or diminished autonomy, which
p.000117: requires that those who are dependent or vulnerable be afforded security against harm or abuse.
p.000117: Source. The origin of an agent for the purposes of an exposure assessment
p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
p.000117:
p.000117:
p.000118: 118
p.000118:
...

Health / Cognitive Impairment

Searching for indicator cognitive:

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p.000058: The IOM committee recommends establishing policies on acceptable and unacceptable types of
p.000058: payments. They also recommend that the policies disclose any recompense in a full and open
p.000058: process,22 while not overemphasizing any recompense.
p.000058: Although the NRC & IOM Committee on Ethical Issues in Housing-Related Health Hazard Research Involving
p.000058: Children and the IOM Committee on Clinical Research Involving Children both concluded that it is appropriate to
p.000058: reimburse expenses or compensate for time or inconvenience, neither committee endorsed incentive
p.000058: payments to parents. In Europe, too, incentive payments to induce parents to allow their children to
p.000058: 5.2.3 Payments When Children or Other
p.000058: Vulnerable Populations Are Involved
p.000058:
p.000058: It is essential that special care be taken with regard to payments when members of vulnerable populations are
p.000058: included in research studies. Vulnerable populations may include children and adolescents, those with
p.000058: cognitive impairments because of medical conditions or age, economically disadvantaged persons, and prisoners. These
p.000058: populations often are not capable of making autonomous, fully informed decisions regarding risks and
p.000058: benefits, or they may be particularly vulnerable to undue influence resulting from the offer of a payment for
p.000058: research participation. In addition, payments made directly to parents or guardians could alter
p.000058: judgment regarding the best interests of minor or incompetent persons in their care.
p.000058: The ethical concern is that too high a payment may “undermine free and informed consent by leading parents
p.000058: to expose their children to unacceptable risks” (NRC & IOM, 2005). The NRC & IOM committee recognized
p.000058: that some commentators argued that children should never be paid, and that parents ought not to be paid to
p.000058: enroll their children in research. Yet, on balance, the committee felt that “reimbursement for expenses and some
p.000058: modest payment for time spent in research
...

p.000084: communications with the public. That memorandum stated, “By using plain language, we send a
p.000084: clear message about what the Government is doing, what it requires and what services it offers. Plain language
p.000084: saves the Government and the private sector time, effort, and money.” Plain language is reader friendly and designed to
p.000084: increase the participant’s understanding of the communication material. It serves as a means by which lay
p.000084: audiences can access and understand scientific information. Researchers desiring to use plain language in
p.000084: their verbal and written communications with communities must decide on key messages to include and
p.000084: delete unnecessary descriptive, bureaucratic, or jargon-filled language. Researchers should use words that
p.000084: commonly are understood, rather than difficult abstract terms and concepts. A friendly,
p.000084: conversational tone is used to engage the lay audience, rather than a formal, scholarly tone that
p.000084: distances the community. Stableford and Mettger (2007) argue that proficiency in creating appropriate plain
p.000084: language materials is an acquired skill that requires knowledge and experience. “It is both an art and
p.000084: a science, requiring the ability to simultaneously think about the cognitive, emotional, and visual appeal of the
p.000084: piece as well as applying research- based strategies to ensure a truly easy-to-read and understand print
p.000084: material.”
p.000084: The Department of Health and Human Services (HHS) has developed a Web site that specifically
p.000084: address the issues related to “plain language” (see
p.000084: http://www.health.gov/communication/literacy/plainlang uage/PlainLanguage.htm). The site includes a list of
p.000084: references and other helpful resources.
p.000084: To maintain community engagement through the
p.000084: research process, it is critical that communications are at the appropriate level, and that materials are written at a
p.000084: reading level that is appropriate to the audience. For the nonscientist, many IRBs and other groups target
p.000084: materials to be used with participants and communities at a reading level no higher than the 8th grade to
p.000084: improve the likelihood of comprehension. In some communities, however, other factors, like primary languages other than
p.000084: English, educational disadvantages, etc., may require communications materials to be written in
p.000084: alternate languages and at different reading levels. The issue is comprehension, as was discussed in
p.000084: Section 5.1.2. Empirical testing of communication methods and content is essential to ensure
p.000084: comprehension (Health Canada, 2006).
p.000084: Researchers also should recognize that in this information age, dissemination of
...

Searching for indicator impaired:

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p.000061: subsequent recruitment into a research study. Sampling design approaches and issues, such as statistical
p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062: Text Box 5-5. IRB Guidebook Issues on Identifying Subjects
p.000062: 1. Who will bear the burden? Who will reap the benefits?
p.000062: 2. Is there a disproportionate burden on any single group?
p.000062: 3. Is the proposed subject population required or justified?
p.000062: 4. Are there susceptible groups of people who should be excluded from the research?
p.000062: 5. Are anticipated benefits distributed fairly? Do others have a greater need to receive any of the anticipated
p.000062: benefits?
p.000062: 6. Are the research burdens distributed fairly?
p.000062: 7. Will any special physiological, psychological, or social characteristics of the subject group pose special risks
p.000062: for them?
p.000062: 8. Would it be possible to conduct the study with other, less vulnerable subjects?
p.000062: 9. Has the selection process overprotected potential subjects who are considered vulnerable (e.g., children,
p.000062: cognitively impaired, economically or educationally disadvantaged persons, patients of researchers, seriously ill
p.000062: persons), so that they are denied opportunities to participate in research?
p.000062: 10. If the subjects are susceptible to pressures, are there mechanisms to reduce the pressures or minimize their
p.000062: impact?
p.000062:
p.000062:
p.000062: Some of the common approaches for identifying and making initial contact with potential participants include, but are
p.000062: not limited to
p.000062: • direct telephone or in-person contact with a person selected through a statistical sampling process
p.000062: to obtain a representative sample of the population being studied;
p.000062: • use of print or other media advertisements, often used to recruit people in a community with specific
p.000062: characteristics;
p.000062: • advertisement or word-of-mouth contacts through community groups, civic organizations, or other types of
p.000062: organizations; and
p.000062: • recruitment at physicians’ offices, hospitals, and clinics or at churches, schools, or other
p.000062: social institutions, either in person or through the use of advertisements or study brochures.
p.000062: CABs can be consulted regarding proposed approaches for recruitment in community-based
p.000062: research. All procedures and materials for participant recruitment are reviewed and approved by the IRB prior to
p.000062: implementation. Some of the materials prepared for recruitment might include the following.
p.000062: • Recruitment scripts⎯prepared scripts used for in- person or telephone study information and recruitment
p.000062: contacts
p.000062: • Printed materials⎯brochures, flyers, newspaper advertisements, letters, and information articles
...

p.000117: in the study. The studies involve interaction with study participants but do not involve intervention or manipulation
p.000117: of the factors being studied, and there is no attempt by the researcher to affect the outcome.
p.000117: Observational research. Any human research that does not meet the definition of research involving intentional
p.000117: exposure of a human subject [40 CFR 26.302]
p.000117: Privacy. Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or
p.000117: intellectually) with others
p.000117: Research. A systematic investigation, including research development, testing, and evaluation, designed to develop or
p.000117: contribute to generalizable knowledge
p.000117: Research involving intentional exposure of a human subject. A study of a substance in which the exposure to the
p.000117: substance experienced by a human subject participating in the study would not have occurred but for the human subject’s
p.000117: participation in the study [40 CFR 26.202(b)]
p.000117: Respect for persons. A fundamental ethical value that is the basis of much of modern bioethical thought and
p.000117: regulation. The concept incorporates at least two fundamental ethical considerations, namely (1) respect for autonomy,
p.000117: which requires that those who are capable of deliberation about their personal choices should be treated with respect
p.000117: for their capacity for self- determination; and (2) protection of persons with impaired or diminished autonomy, which
p.000117: requires that those who are dependent or vulnerable be afforded security against harm or abuse.
p.000117: Source. The origin of an agent for the purposes of an exposure assessment
p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
...

Health / Comatose

Searching for indicator comatose:

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p.000033: In addition, HHS extends added human subjects protections to pregnant women, human fetuses,
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
p.000035: interests, ethically perceptive researchers will plan and implement special provisions for the protection of the
...

p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
p.000035: instructs the IRB to consider the “purposes of the research and the setting in which the research will
...

p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
p.000117:
p.000117:
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p.000118:
p.000118:
p.000118:
p.000118: United States Environmental Protection Agency
p.000118:
p.000118:
p.000118:
p.000118: Office of Research and Development (810R) Washington, DC 20460
p.000118:
p.000118: Official Business Penalty for Private Use
p.000118: $300
p.000118: PRESORTED STANDARD POSTAGE & FEES PAID EPA
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000019: scientific integrity of the research, including developing the conceptual model8 for the effort and
p.000019: devising a reliable sampling and analysis plan. Stakeholder input is critical to assuring that the generalizable
p.000019: research information from the study actually will be applicable for addressing the study problem. Community
p.000019: input is particularly important during the planning stage because the community representatives
p.000019: can provide valuable information about the community members (the future study cohort), the cultures of
p.000019: the community, community values, community concerns, feasibility of working in the community, information
p.000019: needed to develop the technical approach, and information on important factors like pollutant sources and
p.000019: other stressors in the community. (Additional considerations for communicating and
p.000019: working with both the participants and the community in which they live are the topics of Sections 5 through 7 of
p.000019: this document.)
p.000019: In developing the study design and the human subjects protocol, the research team often will have
p.000019: to deal with a variety of complex issues, including how to maximize benefits for participants, the community, and
p.000019: the stakeholders, and how to ensure the integrity, generalizability, and representativeness of the study.
p.000019:
p.000019: 2.2.1 Study Design
p.000019: In epidemiology, the concept of study design has been structured to include (1) experimental studies, like drug
p.000019: trials, where the variables are isolated and controlled (See discussion on experimental studies in
p.000019: Appendix A.) and (2) observational studies where the variables are not controlled intentionally, but are simply
p.000019:
p.000019:
p.000019: 8 A conceptual framework or model is often an effective approach to describe the relationship between the predicted
p.000019: exposures of the population and the population stressors, laying out the predicted pathways and routes of exposure
p.000019: (e.g., see Cohen Hubal et al., 2000). A conceptual model often is illustrated by a block diagram that represents the
p.000019: major scientific processes and interactions. The model is often very useful in developing an analysis plan that
p.000019: describes the hypotheses or objectives of the study, identifies the data needed to address the objectives, and
p.000019: specifies the analyses that will be done to test the hypotheses or address the objectives.
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: observed along with the outcome or response measures. Clearly, the NERL human exposure observational studies
p.000020: (see Table A-1) fall into the latter category. Such studies may be cross-sectional studies (where a subset of the
p.000020: population is observed at the same time); cohort studies (which measure the same variables and response measures
p.000020: in a group of people repeatedly over time); case control studies (where the observed population is
p.000020: separated into two groups based on the outcome or response measure [the case group and the control group], and
p.000020: exposure variables between the two groups are analyzed for differences); or studies that combine
p.000020: approaches. The research may collect data from the participants once (e.g., in a large-scale,
p.000020: randomized design to collect a representative sample of the population, like many of the National Human
p.000020: Exposure Assessment Survey [NHEXAS] studies); over a few days (e.g., NERL’s Particulate Matter [PM]
p.000020: panel studies); from a cohort in different seasons or years (e.g., NERL’s Detroit Exposure Aerosol Research
p.000020: Study [DEARS]; the NHEXAS study in Maryland); or a series of cross-sectional studies repeated one after another with a
p.000020: different group of participants each time. (This latter case often is necessitated to minimize time and expenses
p.000020: associated with being in the field and because of limitations of sampling equipment or field
p.000020: technicians to assist in the collection of the data.)
p.000020: Although much of the literature on study design involves experimental studies (like drug trials), there is much
p.000020: that can be learned about the design of observational studies in epidemiology,
p.000020: including understanding their strengths and weaknesses. Web sites, like “Epidemiology for the Uninitiated” (Coggin
p.000020: et al., 1997, available at www.bmj.com/epidem/epid.html), provide useful basic information on important topics
p.000020: for observational studies and their design.
p.000020: The specific details of the study design and the sampling approach to be used will depend very much on the
p.000020: objectives to be achieved in the study. Based on the objectives, a good study design must first clearly state
p.000020: the research question (or hypothesis to be tested) and must also define in advance what outcome or
p.000020: response measure will be used to test the question or hypothesis. Study designs that are vague or which propose
p.000020: to test some outcome measures against a variety of potential factors do not represent sound science.
p.000020: Statistically, a correlation is likely to be found between an outcome and some factor if enough factors are
p.000020: tested—whether there is an actual biological or physical relationship or not. This highlights the importance of
p.000020: statistics as an integral part of the study design process. Including individuals
p.000020: with appropriate statistical knowledge and experience on the research team from its very beginning is critical to a
p.000020: scientifically sound study design. (See, for example, Dallal, 2001, “Some Aspects of Study Design” in The
p.000020: Little Handbook of Statistical Practice at www.StatisticalPractice.com, and at
p.000020: www.tufts.edu/~gda llal/LHSP.HTM).
...

p.000048: 2007].
p.000048:
p.000048: NHRPAC (National Human Research Protections Advisory Committee) (2002). Clarification of the status of third parties
p.000048: when referenced by human subjects in research. Available: http://www.hhs.gov/ohrp/nhrpac/documents/third.pdf [accessed
p.000048: April 2007].
p.000048:
p.000048: NIH (National Institutes of Health) (2002). Extramural Projects - Application Instructions (03/15/2002) - Detailed
p.000048: Application Instructions for Certificate of Confidentiality Involving Extramural Research Projects. Certificates of
p.000048: Confidentiality. Available: http://grants.nih.gov/grants/policy/coc/index.htm. [accessed April 2007]
p.000048:
p.000048: NIH (National Institutes of Health) (2001). Protection of third party information in research: Recommendations of the
p.000048: National Institutes of Health to the Office for Human Research Protections. Available:
p.000048: http://bioethics.od.nih.gov/nih_third_party_rec.html [accessed March 2007].
p.000048:
p.000048: NIH (National Institutes of Health) (1998). NIH Guide: NIH Policy for Data and Safety Monitoring. Available:
p.000048: http://grants.nih.gov/grants/guide/notice-files/not98­ 084.html [accessed April 2007].
p.000048:
p.000048: NRC & IOM (National Research Council and Institute of Medicine) (2005). Ethical Considerations for Research on
p.000048: Housing-Related Health Hazards Involving Children.
p.000048: Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=11450 [accessed
p.000048: June 2007].
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: U.S. FDA (U.S. Food and Drug Administration) (2001). Draft Guidance for Clinical Trial Sponsors on the Establishment of
p.000049: Clinical Trial Data Monitoring Committees. U.S. Department of Health and Human Services, Food and Drug Administration,
p.000049: Rockville, MD. Available: http://www.fda.gov/cber/gdlns/clindatmon.pdf. [accessed April 2007].
p.000049: U.S. HHS (U.S. Department of Health and Human Services) (1993). Protecting Human Research Subjects: Institutional
p.000049: Review Board Guidebook. Office for Human Research Protections. Available: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
p.000049: [accessed June 2007].
p.000049:
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p.000050: SECTION 5
p.000050: Creating an Appropriate Relationship Between the Participant and Researcher
p.000050:
p.000050:
p.000050:
p.000050: In observational human exposure studies, the researcher and the participant routinely interact
p.000050: with each other, often in the participant’s home or other private setting and often repeatedly over a
p.000050: number of days. The nature and setting of the interactions mean that exposure researchers should give special
p.000050: consideration to the many scientific and ethical issues that shape the relationship between participants and
p.000050: the researchers. In these studies, it is recommended that a strong relationship, built on
...

p.000057: studies with some prospect of therapeutic benefit, studies having at least one invasive procedure, and studies with
p.000057: greater numbers of clinic visits were significantly associated with higher dollar amounts. About 9.5%
p.000057: of the studies offered completion bonuses, and a similar percentage offered escalating payments for
p.000057: followup study visits.
p.000057:
p.000057: 5.2.2 Regulations and Guidance Regarding Payment to Research Participants
p.000057: There is little specific guidance regarding payments in Federal human research regulations. The Common Rule and
p.000057: additional human subjects protections do not directly address payments to research participants, but the
p.000057: regulations do discuss providing additional safeguards for subjects vulnerable to coercion or undue
p.000057: influence [40 CFR 26.111(b)]. The NIH IRB guidebook advises IRBs to determine whether the rewards offered for
p.000057: participation in research constitute undue influence (U.S. HHS, 1993). According to the IRB guidebook undue
p.000057: inducement might blind prospective subjects to risks, impair their ability to exercise proper judgment, or may
p.000057: cause people to lie or to withhold information that would make them ineligible to enroll or continue
p.000057: participation.
p.000057: The U.S. Food and Drug Administration (FDA) has provided guidance for investigators and IRBs for clinical research
p.000057: studies (FDA, 1998). The guidance states that “payment to research subjects for participation in studies is not
p.000057: considered a benefit, it is a recruitment incentive.” FDA expects payments to accrue as the study progresses and not
p.000057: to be contingent on completing the study, although a “small proportion as an incentive for
p.000057: completion of the study is acceptable.” The guidance is concerned with the issue of coercion or undue influence, and
p.000057: it recognizes the IRB as the responsible party for deciding what is or is not acceptable.
p.000057: The U.S. Office of Management and Budget (OMB) develops standards and guidelines for statistical surveys performed by
p.000057: the Federal government. Under Guideline 2.3.2, OMB states that, while incentives are not typically used in Federal
p.000057: surveys, agencies may consider use of respondent incentives if they believe incentives would be necessary
p.000057: to use for a particular survey to achieve data of sufficient quality for their intended use (OMB,
p.000057: 2006a). OMB requires that agencies provide a justification for giving incentives to respondents.
p.000057: Some
p.000057: of the factors cited by OMB to be addressed include those particularly relevant to observational
p.000057: human exposure studies, including unusual reporting burdens (keeping data logs for extended periods,
p.000057: coordinating study team visits, participating in a medical examination, etc.), complex study designs (such as
...

p.000064: June 2007].
p.000064:
p.000064: OMB (Office of Management and Budget). (2006a). Standards and Guidelines for Statistical Surveys. Section 2.3, Data
p.000064: Collection Methodology. http://www.whitehouse.gov/omb/inforeg/statpolicy/standard s_stat_surveys.pdf
p.000064:
p.000064: OMB (Office of Management and Budget). (2006b). Questions and Answers When Designing Surveys for Information
p.000064: Collection. Office of Information and Regulatory Affairs. January, 2006.
p.000064: http://www.whitehouse.gov/omb/inforeg/pmc_survey_guidanc e_2006.pdf
p.000064:
p.000064: Paasche-Orlow MK, Taylor HA, Brancati FL (2003). Readability standards for informed-consent forms as compared with
p.000064: actual readability. N Engl J Med 348(8):721­ 6.
p.000064:
p.000064: Russell ML, Moralejo DG, Burgess ED. (2000). Paying research subjects: participants' perspectives. J Med Ethics
p.000064: 26(2):126-30.
p.000064:
p.000064: U.S. DHEW (U.S. Department of Health, Education, and Welfare) (1979). The Belmont Report: Ethical Principles and
p.000064: Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: National Commission for the Protection
p.000064: of Human Subjects of Biomedical and Behavioral Research. Available: http://ohsr.od.nih.gov/guidelines/belmont.html
p.000064: [accessed June 2007].
p.000064:
p.000064: U.S. FDA (U.S. Food and Drug Administration) (1998). Information Sheets: Guidance for Institutional Review Boards and
p.000064: Clinical Investigators 1998 Update. U.S. Food and Drug Administration, Washington, DC. Available:
p.000064: http://www.fda.gov/oc/ohrt/irbs/toc4.html [accessed May 2007].
p.000064:
p.000064: U.S. HHS (U.S. Department of Health and Human Services) (1993). Protecting Human Research Subjects: Institutional
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065: Review Board Guidebook. Office for Human Research Protections. Available: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
p.000065: [accessed 12 June 2007].
p.000065:
p.000065: VanderWalde A (2005). Undue inducement: the only objection to payment? Am J Bioethics 5(5):25-27.
p.000065: Weise KL, Smith ML, Maschke KJ, Copeland L (2002). National practices regarding payment to research subjects for
p.000065: participating in pediatric research. Pediatrics 110(3):577-582.
p.000065:
p.000065: Wendler D, Rackoff JE, Emanuel EJ, Grady C (2002). The ethics of paying for children’s participation in research. J
p.000065: Pediatr 141(2):166-171.
p.000065:
p.000065:
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p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: SECTION 6
p.000066: Building and Maintaining Appropriate Community and Stakeholder Relationships
p.000066:
p.000066:
p.000066:
...

p.000077: Children. Washington, DC. Available: http://cfpub2.epa.gov/ncea/cfm/recordisplay.cfm?deid=22521.
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2005). Guidance on Selecting Age Groups for Monitoring and Assessing
p.000077: Childhood Exposures to Environmental Contaminants. Risk Assessment Forum, Washington, D.C. EPA/630/P-03/003F.
p.000077: Available: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=146583.
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2006). Considerations for Developing Alternative Health Risk
p.000077: Assessment Approaches for Addressing Multiple Chemicals, Exposures, and Effects. External Review Draft. 71 FR 16306.
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2006). Paper on Tribal Issues Related to Tribal Traditional Lifeways,
p.000077: Risk Assessment, and Health and Well Being: Documenting What We’ve Heard. The National EPA-Tribal Science Council.
p.000077: Available: http://epa.gov/osp/tribes/tribal/TribalIssues.pdf.
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2006). EPA’s Public Involvement Policy. Available:
p.000077: http://www.epa.gov/publicinvolvement/policy2003/index.htm.
p.000077:
p.000077: U.S. Food and Drug Administration (FDA). Exception from informed consent requirements for emergency research. 21 CFR §
p.000077: 50.24
p.000077:
p.000077: University of Kansas Community Tool Box. Available: http://ctb.ku.edu/en/tablecontents/.
p.000077:
p.000077: University of Washington Community-Campus Partners for Health, Available: http://depts.washington.edu/ccph/index.html.
p.000077:
p.000077: Veazie MA, Teufel-Shone NI, Silverman G, Connolly A, Warne S, King B, et al. (2001). Building community capacity in
p.000077: public health: The role of action-oriented partnerships. J Public Health Manag Pract 7(2):21-32.
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: U.S. EPA, Office of Environmental Justice Resources:
p.000078: Executive Office of the President. (1997). Environmental Justice: Guidance under the National Environmental Policy Act.
p.000078: Council on Environmental Quality, pp. 7-17).
p.000078: Available: http://epa.gov/compliance/resources/policies/ej/ej_guidance
p.000078: _nepa_ceq1297.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2006). Future mechanisms to enhance stakeholder involvement
p.000078: and engagement to address environmental justice: A letter report. Available:
p.000078: http://epa.gov/compliance/resources/publications/ej/nejac/st akeholder-involv-9-27-06.pdf
p.000078:
p.000078: NEJAC (National Environmental Justice Advisory Council) (2004). Environmental justices and federal facilities:
...

p.000093: environmental or biological samples and information for the purpose of quantifying the contact between the
p.000093: participant and the agent being studied. Observational human exposure studies are inherently the process
p.000093: of watching people in context—in their natural environment, doing routine activities—and collecting
p.000093: the
p.000093:
p.000093:
p.000095: 95
p.000095:
p.000095: samples and relevant information from them and from their surroundings to measure and calculate
p.000095: the exposures that occurred in the same context.
p.000095: Scientific Study Design: From a scientific study design perspective, an observational study of the sort
p.000095: being considered in this document is one where the researcher does not control the variables but,
p.000095: rather, observes both the variable and the outcome and tries to infer the relationship between the variable
p.000095: and the outcome. This contrasts with a controlled study where the researcher isolates and controls
p.000095: one or more variables in a systematic way to assess the impact of changes in the variables on an
p.000095: outcome measure. Consider the intervention study examples cited in the section on regulatory
p.000095: distinctions below (cleaning a house to reduce exposure in the residence and wearing a particle mask to reduce
p.000095: exposure to smoke from forest fires). In those cases, participants would be assigned either to receive the
p.000095: intervention (treatment) or not (the control group). The outcomes (exposures) would be measured and compared
p.000095: between the two groups to assess the effectiveness of the intervention. Similarly, drug trials would randomly
p.000095: assign participants to receive either a test medication or a placebo. The medical outcome (e.g., pain
p.000095: relief, blood pressure, cholesterol levels in blood) would then be measured for all participants,
p.000095: and the outcomes compared between the treated group (getting the test medication) and the control
p.000095: group (receiving the placebo).
p.000095: Controlled studies are often desirable in science because, when properly designed, they provide
p.000095: unambiguous estimates of the impact of unique variables on the outcome (even if the impact of one variable could
p.000095: normally be overwhelmed by other factors) and eliminate the need for alternate explanations of
p.000095: the experimental results (because other factors are held constant). However, controlled studies are
p.000095: not always possible. They may be unethical (e.g., to “treat” a group of women with abortions to test if there
p.000095: is a linkage between having had an abortion and breast cancer), impractical (e.g., to follow a cohort large
p.000095: enough to yield statistically significant results in a test of rare side effects to a medication), or just
p.000095: impossible to accomplish (e.g., to measure nutritional levels of a population in the middle of a war zone).
p.000095: As a consequence, much medical research is observational in the scientific sense being considered
p.000095: here. Public health data represent observations of health outcomes, but the factors that may have led
...

p.000113: ACGIH American Conference of Governmental Industrial Hygienists AHS Agricultural Health
p.000113: Study
p.000113: ATSDR Agency for Toxic Substances and Disease Registry BEI biological exposure index
p.000113: CAB community advisory board
p.000113: CBPR community-based participatory research CDC Centers for Disease Control and
p.000113: Prevention CFR Code of Federal Regulations
p.000113: CIOMS Council for International Organizations of Medical Sciences
p.000113: COPR National Institutes of Health Director’s Council of Public Representatives CPSC
p.000113: Consumer Product Safety Commission
p.000113: CTEPP Children’s Total Exposure to Persistent Pesticides and Other Persistent Organic Pollutants
p.000113: DEARS Detroit Exposure and Aerosol Research Study DHEW U.S. Department of Health, Education,
p.000113: and Welfare DMOC data monitoring and oversight committee
p.000113: DNA deoxyribonucleic acid
p.000113: DSMB data safety monitoring board DSMP data and safety monitoring plan
p.000113: EHCRB environmental health and community review board EPA U.S. Environmental Protection
p.000113: Agency
p.000113: ERG Eastern Research Group
p.000113: FCN Federal Communicators Network
p.000113: FDA Food and Drug Administration
p.000113: HHS U.S. Department of Health and Human Services HSRB Human Studies Review Board
p.000113: HSRRO Human Subjects Research Review Official
p.000113: HUD U.S. Department of Housing and Urban Development ICR information collection
p.000113: request
p.000113: IOM Institute of Medicine
p.000113: IRB institutional review board
p.000113: NAS National Academy of Sciences
p.000113: NBAC National Bioethics Advisory Commission NCI National Cancer Institute
p.000113: NCS National Children’s Study
p.000113: NEI National Eye Institute
p.000113: NEJAC National Environmental Justice Advisory Council NERL National Exposure Research
p.000113: Laboratory
p.000113:
p.000113:
p.000115: 115
p.000115:
p.000115: NGO Nongovernmental organization
p.000115: NHANES National Health and Nutrition Examination Survey NHAPS National Human Activity Pattern
p.000115: Study
p.000115: NHEXAS The National Human Exposure Assessment Survey NHLBI National Heart, Lung, and Blood
p.000115: Institute
p.000115: NHRPAC National Human Research Protections Advisory Committee NIH National Institutes of
p.000115: Health
p.000115: NRC National Research Council
p.000115: OHRP Office for Human Research Protections OMB Office of Management and Budget OSMB
p.000115: observational study monitoring board PM particulate matter
p.000115: Q&As questions and answers
p.000115: QAPP quality assurance project plan
...

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p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
p.000003: range of risks associated with participation and the voluntary nature of participation, and provides
p.000003: essential protections to the participant. Recent observations by various national and international review
p.000003: committees on the appropriate level of payment to research participants are presented. This is a
p.000003: complex ethical issue, balancing the issue of fairness against the possibility of undue influence
p.000003: and the loss of free consent. Other topics include participant recruitment, retention strategies, research
p.000003: rights, and grievance procedures.
p.000003: Section 6. Building and maintaining appropriate community and stakeholder relationships: Involving
p.000003: the community in the research effort to improve the research both scientifically and ethically.
p.000003: Various approaches are discussed related to issues such as defining the community, identifying who
p.000003: represents the community, recognizing and addressing cultural differences, and the importance of language,
p.000003: power relationships, and partnerships.
p.000003: Section 7. Designing and implementing strategies for effective communication: Ongoing, interactive
p.000003: dialogue among researchers, participants, the community, stakeholders, and the public to
p.000003: establish effective communications and to foster a relationship of trust. To facilitate information dissemination
p.000003: to participants, communities, and stakeholders, this section of the document describes communication
p.000003: strategies, implementation plans, communication groups, timetables, communication materials, and other
p.000003: tools available to researchers.
p.000003: This document does not and, indeed, could not provide solutions to all scientific and ethical issues that may
p.000003: arise as observational human exposure studies are undertaken. No document could identify and address all
p.000003: potential issues in advance, nor is it possible to develop a comprehensive checklist for all such studies.
...

p.000007: (2) that proposed research be reviewed by an independent oversight group referred to
p.000007: as an institutional review board (IRB) and approved only if risks to subjects have been minimized, and
p.000007: risks are reasonable in relation to anticipated benefits, if any, to the subjects and to the importance of the
p.000007: knowledge that may realistically be expected to result.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: Table 1-1. Examples of the Impact of Observational Human Exposure Studies on Pollution Levels and Regulatory Actions
p.000008: Pollutant Observational Study Result
p.000008: Impact/Action/Result
p.000008:
p.000008: Particulate Matter (PM)
p.000008: Observational panel studies demonstrated the appropriateness of ambient measurement of fine particles as a surrogate
p.000008: for a population’s longitudinal exposure to fine PM.
p.000008: Resolved questions in NAS review of PM science and provided a “generally consistent finding that ambient particle
p.000008: concentrations are a key determinant of the longitudinal variation in personal exposure.” (NRC, 2004). These results
p.000008: have been instrumental in support of the National Ambient Air Quality Standard for PM (U.S. EPA, 1999).
p.000008:
p.000008:
p.000008: Volatile Organic Compounds (VOCs)
p.000008:
p.000008: EPA's Total Exposure Assessment Methodology (TEAM) studies found levels of about a dozen common organic pollutants to
p.000008: be 2- to 5-times higher inside homes than outside. Use of products containing organic chemicals may result in very high
p.000008: and persistent pollutant levels.
p.000008:
p.000008: EPA, States, and the Consumer Product Safety Commission worked together to influence manufacturers to voluntarily
p.000008: reduce emissions of toxic chemicals from consumer products, building materials, and furnishings, and to develop
p.000008: mitigation strategies and educational materials to teach people how to reduce their contact with chemicals indoors. As
p.000008: a result, contact with toxic chemicals indoors has been reduced (see www.cpsc.gov/CPSCPUB/PUBS/450.html).
p.000008:
p.000008:
p.000008: Formaldehyde
p.000008:
p.000008: Studies found elevated formaldehyde levels indoors and helped identify indoor sources.
p.000008:
p.000008: EPA worked with HUD, CPSC, and other agencies to limit formaldehyde in building or consumer products and to educate the
p.000008: public on how to reduce exposures (see www. epa.gov/iaq/formalde.html).
p.000008:
p.000008:
p.000008: EPA has adopted additional protections for children and pregnant or nursing mothers in Subparts B through
p.000008: D. These sections apply to all research either conducted or funded by EPA and are, therefore, directly applicable to
p.000008: NERL’s observational human exposure studies.4 Subpart B prohibits EPA from conducting or supporting research
p.000008: that involves intentional exposure of “a pregnant woman (and, thereby, her fetus), a nursing woman,
p.000008: or a child.” NERL researchers conducting (or funding) observational human exposure studies must comply
p.000008: with all of these regulatory requirements, including seeking review and approval by an IRB and by the
...

p.000029: productivity studies from 1927 to 1932. Similarly, some changes in participant behaviors may change the
p.000029: observations, measurements, and conclusions from observational human exposure studies. For
p.000029: example, participants may do more cleaning in their home because they do not want the researchers to think they are
p.000029: poor housekeepers; this could affect the measurement of environmental concentrations in the home. In a
p.000029: study of chemicals from consumer products, participants may think that because the researchers are
p.000029: studying the products, the products must be harmful. Therefore, study participants may elect not to use the products
p.000029: during the study in the same manner as they would normally. Alternatively, prospective participants may
p.000029: choose to use more of the household product to qualify for the
p.000029: study. As a result, the participant’s exposure to the chemicals could be either more or less than “normal.”
p.000029: Any change in a participant’s behavior that is related to the research question being addressed in the study
p.000029: may impact the study results. Researchers should try to anticipate how a study may impact participant behaviors and
p.000029: ensure that the study design and implementation protocols do not cause changes in behavior that may cause
p.000029: harm to a participant during a study. A number of study elements with the potential to influence
p.000029: participants’ behavior are listed in Text Box 2-6.
p.000029:
p.000029: Text Box 2-6. Study Elements That Could Affect People’s Behavior
p.000029: • Eligibility criteria
p.000029: • Recruiting approach and materials
p.000029: • Enrollment approach
p.000029: • Payments
p.000029: • Retention strategy
p.000029: • Types of measurements made and data collected
p.000029: • Protocols for data collection
p.000029: • Protocols for visits to homes
p.000029: • Interactions with participants
p.000029: • Communications
p.000029:
p.000029:
p.000029: It is very difficult to predict in advance how these elements may be interpreted and acted on by
p.000029: the participants. Researchers may learn from the experiences of others, including the “lessons learned” from
p.000029: experts and their publications. They may wish to engage the community representatives (see Section 6) in a
p.000029: thorough discussion of the issue. Community-based focus groups or pilot studies also may demonstrate how the
p.000029: various elements of the study may have an unintended impact. Additionally, researchers can be very careful
p.000029: in the informed consent process (see Section 5.1), to ensure that participants not only know, but that they
p.000029: understand the facts of the study (Gilbert, 2006), and that they comprehend that the goal is to observe and
p.000029: measure the participant’s exposures during their normal, everyday activities.
p.000029:
p.000029: 2.8 Criteria and Standards for Monitoring Scientific and Ethical Issues
p.000029: Ethical requirements do not end when the participants sign the consent form and agree
...

p.000037: justification if children will be excluded from a research study. Of course, as discussed above, if the research
p.000037: topic is irrelevant to children, the CIOMS guidelines would recommend that they be excluded from the
p.000037: research.
p.000037: Observational human exposure studies conducted by NERL are not expected to involve greater than minimal risk. It
p.000037: will be the responsibility of the NERL researchers to present adequate information for the IRB to
p.000037: demonstrate that the research does not involve greater than minimal risk. Researchers designing observational
p.000037: research studies should carefully evaluate the risks and benefits specific to their study and the
p.000037: participants involved. In developing the study design and human subjects protocols, researchers need to
p.000037: ensure that the protocols ensure the protection of the rights and welfare of the participant children, and that
p.000037: risks and harm are minimized. The perception of risks and benefits, both by
p.000037: the individual and by the family or community, may influence the risk-benefit determination. It may prove
p.000037: useful for the research team to consult with other experienced researchers who have conducted
p.000037: similar studies and with members of the IRB to ensure that the information included in the human subjects
p.000037: research protocol is adequate for the IRB’s review.
p.000037: It is recommended that researchers consider all of the potential issues associated with involvement
p.000037: of children in their studies in developing the study design and research protocols, including the role of the
p.000037: family. EPA’s human subjects rule for observational research not involving greater than minimal risk to
p.000037: children (40 CFR 26.404) (i.e., the kinds of observational human exposure studies that NERL exposure research
p.000037: is likely to entail) focuses on obtaining assent of the children and permission of their parents or guardians. But the
p.000037: role of the family goes far beyond their involvement in the informed consent process. In observational
p.000037: human exposure studies, even when children are the participants, the parents or guardian play
...

p.000050: the document.
p.000050: This relationship should be established on the ethical values of respect for the participant’s autonomy and
p.000050: respect for their welfare. Emanuel and his co-authors find that these two ethical values translate into
p.000050: specific responsibilities for an ethical researcher in regard to informed consent and respect for potential and
p.000050: enrolled subjects (Emanuel et al., 2000). They describe the ethical principles for these responsible actions thusly,
p.000050: “Respect for potential and enrolled subjects is justified by multiple principles including beneficence,
p.000050: nonmaleficence, and respect for persons. Permitting subjects to withdraw and providing them additional information
p.000050: learned from the research are key aspects of respecting subject autonomy. Protecting confidentiality and monitoring
p.000050: well-being are motivated by respect for persons, beneficence, and nonmaleficence.” Section 4 already has
p.000050: described some of the particular concerns regarding privacy, confidentiality, and other issues
p.000050: related to observational human exposure studies. This section further describes elements of the relationship
p.000050: between researchers and participants that are important to consider and address during design and
p.000050: implementation of a study.
p.000050: Of course, the relationship between the researchers
p.000050: and the individual participants does not exist in isolation. The researcher-participant relationship may influence
p.000050: and be influenced by the relationship with the community in which the participant lives.
p.000050: Good, two- way communications are critical for the development and nourishment of an appropriate
p.000050: researcher-participant relationship. Although those two topics are the subject of the next sections of this document,
p.000050: elements from those topics unavoidably will color the discussions in this section as well.
p.000050: Researcher training is a key component for conducting research that incorporates human
p.000050: subject protections and fosters appropriate researcher-participant relationships. Most organizations require basic
p.000050: human subjects training on the essential elements for processes and procedures for research with human subjects. More
p.000050: in-depth training will improve researcher understanding in areas of the informed consent process, observational
p.000050: techniques, community-based research, and other topic areas. Such training will benefit principal
p.000050: investigators throughout the research study from the design stage through communication of research results.
p.000050: Training is also important for staff that will work directly or indirectly with research participants
p.000050: or their samples and data. This document can be used as both a training tool for researchers as well as a
p.000050: resource for designing training courses. There are a number of sources of training on human
p.000050: subjects protection. The Collaborative Institutional Training Initiative (CITI,
...

p.000051: Ethics Review Boards should ensure that the focus of both the informed consent process and the consent forms is on
p.000051: informing and protecting participants, not the research institution.
p.000051: (2) Strengthen Process of Parental Permission and Children’s Assent if Children Are Involved in Research (NRC & IOM,
p.000051: 2005)
p.000051: The process begins with a community-based discussion and concludes with an assurance that individual parents understand
p.000051: the essential elements of the research.
p.000051: Educate parents on issues critical to informed decision making and assess their degree of understanding.
p.000051: Use informational materials in the form that is most appropriate to convey information to potential participants.
p.000051: Consult with community representatives to ensure that information is complete, clear, and understandable, and that any
p.000051: payment will not be exploitive.
p.000051: Expand the perspective about what information about risks and benefits is needed to make an informed choice.
p.000051: Ethically, it is critical to assure that participants and parents understand the crucial features of the research
p.000051: effort.
p.000051: (3) Informed Consent Is a Decision To Participate by an Informed, Competent Individual Without Undue Coercion,
p.000051: Influence, or Intimidation (CIOMS, 2002)
p.000051: Informed consent is a process that takes time and resources.
p.000051: It is not a ritual recitation of text from a form but informative communication in language that suits the individual’s
p.000051: level of understanding.
p.000051: Consent is ethically obtained, considering language and cultural issues, and is documented.
p.000051: Material changes in conditions or procedures require that informed consent be renewed.
p.000051: Consent should explain how samples will be used in current research, and, if applicable, how samples may be used in
p.000051: future research.
p.000051:
p.000051:
p.000051:
p.000051: 5.1.1 Information
p.000051: Some items that researchers should keep in mind as they provide information to the study participants are
p.000051: summarized below. These items may be based on regulatory requirements or currently may
p.000051: be recommendations as ethical “best practices.”
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052:
p.000052: Text Box 5-2. Common Rule Requirements:
p.000052: Elements of Informed Consent
p.000052: (1) An explanation of the purposes of the research
p.000052: (2) The expected duration of the subject's participation
...

p.000055: 2000; VanderWalde, 2005; Weise et al., 2002; Wendler et al., 2002). A number of specific issues or
p.000055: concerns regarding participant payments have been identified. Many researchers and ethicists argue that it
p.000055: is often appropriate to provide reasonable payment and have done so for many years. In the view of an NRC expert
p.000055: panel, the principles of “justice, fairness, and gratitude support payment to those who bear the burdens
p.000055: of research on behalf of society” (NRC, 2004).
p.000055: Direct reimbursement may be made to participants for out-of-pocket expenses for costs directly associated
p.000055: with participation in a study. These might include transportation costs, parking fees, or child
p.000055: care costs. When payment for time and burden is provided, it is often in the form of monetary
p.000055: payments. Different approaches may be considered for determining reasonable amounts for payment,
p.000055: including a set payment for each visit, a small daily payment, payment at the prevailing minimum hourly
p.000055: wage, or payment at some other hourly rate appropriate for the community⎯perhaps a
p.000055: prevailing rate for unskilled labor (Emanuel, 2004). Incentives to encourage enrollment are
p.000055: sometimes used when participants will receive little or no direct benefit from the research and can take
p.000055: the form of monetary or non-monetary payments. Incentives are kept modest so as not to impart undue
p.000055: influence. Researchers need to consider the possible effects of incentive payments on the potential
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056:
p.000056: Text Box 5-3. Payments for Participation of Research Subjects
p.000056: (based on Grady, 2005)
p.000056: Payment Serves As Amount Determined By Potential Advantages
p.000056: Potential Disadvantages
p.000056:
p.000056: Incentive Supply and demand; market rates
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: Compensation Standardized “wage” for time and effort, suggested to be commensurate with wages for
p.000056: unskilled, but essential jobs; additional payment for extra burdens such as endurance of uncomfortable procedures
p.000056: (a) More rapid recruitment
p.000056: (b) Completion bonuses encourage subject retention and high completion rate
p.000056: (c) Possibility of profit for participants
p.000056: (d) Little or no financial sacrifice by subject
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: (a) Recognizes contributions of participants
p.000056: (b) Uniform payment across studies
p.000056: (c) Equal pay for equal work
p.000056: (d) Less risk of undue inducement
p.000056: (a) Undue inducement possibly resulting in incomplete assessment of risks and benefits by subject; subject concealing
p.000056: information to ensure enrollment and retention
p.000056: (b) Competition between studies; better funded studies more likely to meet recruitment goals
p.000056: (c) Different levels of payment at different locations for multicenter research because of supply and demand
p.000056: (a) May have little impact on recruitment
...

p.000056: differences in payment levels have been found even in multisite studies in which the same protocol is
p.000056: administered across all sites.
p.000056: Grady et al. (2005) performed a survey of practices for paying research participants in the United States in
p.000056: Phase 1 to 4 clinical trials and physiologic, behavioral, and other types of research. Across 467
p.000056: studies of varying complexity that included payments, the median
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: payment was $155 (mean $266, range $5 to $2,000). The basis for dollar amounts was infrequently described, with
p.000057: 19% of the payments based on time, and 12% based on the procedures. In a model of payment factors,
p.000057: studies with some prospect of therapeutic benefit, studies having at least one invasive procedure, and studies with
p.000057: greater numbers of clinic visits were significantly associated with higher dollar amounts. About 9.5%
p.000057: of the studies offered completion bonuses, and a similar percentage offered escalating payments for
p.000057: followup study visits.
p.000057:
p.000057: 5.2.2 Regulations and Guidance Regarding Payment to Research Participants
p.000057: There is little specific guidance regarding payments in Federal human research regulations. The Common Rule and
p.000057: additional human subjects protections do not directly address payments to research participants, but the
p.000057: regulations do discuss providing additional safeguards for subjects vulnerable to coercion or undue
p.000057: influence [40 CFR 26.111(b)]. The NIH IRB guidebook advises IRBs to determine whether the rewards offered for
p.000057: participation in research constitute undue influence (U.S. HHS, 1993). According to the IRB guidebook undue
p.000057: inducement might blind prospective subjects to risks, impair their ability to exercise proper judgment, or may
p.000057: cause people to lie or to withhold information that would make them ineligible to enroll or continue
p.000057: participation.
p.000057: The U.S. Food and Drug Administration (FDA) has provided guidance for investigators and IRBs for clinical research
p.000057: studies (FDA, 1998). The guidance states that “payment to research subjects for participation in studies is not
p.000057: considered a benefit, it is a recruitment incentive.” FDA expects payments to accrue as the study progresses and not
p.000057: to be contingent on completing the study, although a “small proportion as an incentive for
p.000057: completion of the study is acceptable.” The guidance is concerned with the issue of coercion or undue influence, and
p.000057: it recognizes the IRB as the responsible party for deciding what is or is not acceptable.
p.000057: The U.S. Office of Management and Budget (OMB) develops standards and guidelines for statistical surveys performed by
p.000057: the Federal government. Under Guideline 2.3.2, OMB states that, while incentives are not typically used in Federal
p.000057: surveys, agencies may consider use of respondent incentives if they believe incentives would be necessary
p.000057: to use for a particular survey to achieve data of sufficient quality for their intended use (OMB,
...

p.000060: duplicate diet samples; collection of environmental samples inside and outside the home; completing
p.000060: questionnaires, food diaries, and time- activity diaries; and providing urine, blood, saliva, or hair
p.000060: samples. Monetary payments often have been included in these studies, with the level of payment
p.000060: related to the number of study days or visits or the specific kinds of environmental and biological
p.000060: samples and information that are collected or provided. Payment for direct participant costs has been included
p.000060: in some studies, such as a reasonable payment for providing researchers with duplicate diet samples.
p.000060: NERL scientists should review the commentary and recommendations in the literature before devising a
p.000060: payment program as part of a research protocol, especially the two recent National Academies of Science
p.000060: documents, Ethical Issues in Housing-Related Health Hazard Research Involving Children (NRC and IOM, 2005)
p.000060: and Ethical Conduct of Clinical Research Involving Children (IOM, 2004). They should seek
p.000060: guidance from EPA’s HSRRO to determine EPA’s latest policies and guidance in this regard. Input also should be sought
p.000060: from community representatives to ensure that any payment is adequate to compensate for expenses and reward
p.000060: participation, but that the payment is not so high as to constitute undue influence or coercion in the
p.000060: community. If the study includes several followup visits over a long term, NERL researchers should ensure that payment
p.000060: is made incrementally as the NRC & IOM committee suggested. NERL scientists also should adopt the IOM
p.000060: Recommendations 6.1 and 6.2, including ensuring that any payment should be for appropriate purposes
p.000060: and age-appropriate, and that the process should be open and fully disclosed, while not overly
p.000060: emphasizing payments during the recruiting or informed consent phases. The final decisions about the ethics of
p.000060: payments rest with the IRB, which will review, modify as needed, and approve the research protocol, and with the EPA
p.000060: HSRRO, who has final authority to approve, modify, or disapprove all of NERL’s human subjects research
p.000060: efforts.
p.000060: 5.3 Research Rights and Grievance Procedures
p.000060: Protecting the research rights of participants and providing independent access to information regarding
p.000060: those rights and to grievance procedures is an important element in developing and maintaining appropriate
p.000060: participant-investigator relationships. As part of the informed consent process, the Common Rule
p.000060: requires “An explanation of whom to contact for answers to pertinent questions about the research and
...

p.000062: Some of the common strategies for maintaining high retention rates in longitudinal studies are listed in Text
p.000062: Box 5-6.
p.000062:
p.000062: Text Box 5-6. Common Strategies for Maintaining High Retention Rates in Longitudinal Studies
p.000062: • Developing and maintaining a strong study identity
p.000062: • Building participant trust
p.000062: • Communicating regularly with participants
p.000062: • Providing feedback that is of use to participants
p.000062: • Maintaining confidentiality
p.000062: • Incorporating active participant tracking mechanisms
p.000062: • Maintaining reasonable levels of burden
p.000062: • Providing periodic tokens of appreciation
p.000062: • Providing reasonable levels of payment at each time point, sometimes including escalating payments or a higher
p.000062: final payment for completion of all study activities
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: It is important that strategies that use payments to encourage retention should be carefully
p.000063: scrutinized against the possibility that they will result in undue influence or diminish voluntary
p.000063: participation. Payments that cover expenses and for time and burden at each visit have to be reasonable, and
p.000063: researchers and IRBs should consider whether the cumulative level of payments over time or the use of escalating
p.000063: payments or final bonus payments might present undue influence on decisionmaking regarding
p.000063: participation. Participants have to feel capable of withdrawing from participation at any time, and escalating
p.000063: payments or completion bonuses can impact decisions to withdraw. Withholding all payment until all study
p.000063: visits are completed or making payment contingent on completing all activities is not an acceptable practice in
p.000063: most longitudinal studies because it can diminish the capacity for voluntary participation. (See the
p.000063: discussion about payment issues in long-term studies in Section 5.2.3.)
p.000063: People are more likely to continue active participation in longitudinal studies when they
p.000063: believe that the research is important, and that they are making a valuable contribution, are receiving regular
p.000063: feedback, and are treated with courtesy and respect by researchers. Observational human exposure studies
p.000063: sometimes involve substantial burdens of time and effort. Over long periods, this level of burden can reduce retention.
p.000063: It may be necessary to develop novel methods that reduce participant time and effort or to focus the study
p.000063: design so that fewer study procedures are implemented at any time point. Because the time needed to analyze
p.000063: samples, verify results, and perform data analyses can be long, it may be difficult to provide timely
p.000063: feedback to participants in observational human exposure studies. Researchers might consider including
p.000063: simple measures that can provide immediate and useful information of value to participants to
p.000063: encourage continued participation. Effective use of these strategies will reduce the need for
...

p.000067: “outsiders.” To help alleviate these potential issues, researchers should ensure an equitable
p.000067: distribution of paid research work among different communities within the larger community as to not promote a
p.000067: perceived bias among community members. Additionally, when possible, researchers should make efforts
p.000067: to provide payments to community members employed as research staff through community partner
p.000067: organizations to prevent conflict of interest issues. Refer to Section 5 for further discussion on
p.000067: remuneration of community members as research participants.
p.000067:
p.000067:
p.000067: Text Box 6-2. Community Engagement Principles for Researchers
p.000067: (From CDC, 1997)
p.000067: Requirement Explanation
p.000067:
p.000067: Clarity Clear communication of the study objectives, research goals, and the populations or
p.000067: communities of interest.
p.000067:
p.000067: engaging communities in health-related research (see Text Box 6-2). Health research is a “privileged and
p.000067: empowered activity in that the researchers have special
p.000067: Knowledge of the Community
p.000067: Familiarity with the economic conditions, political structures, demographics, history, past research experiences, and
p.000067: research perceptions of the community.
p.000067:
p.000067: access to resources and sensitive information about people and, through the analysis and presentation
p.000067: of findings, are able to influence the way people think and have considerable influence on decisions regarding
p.000067: the allocation of resources” (CDC, 1997). Regardless of the approach utilized to involve the community in research,
p.000067: whether the process employs community-based participatory research (CBPR) or another community
p.000067: engagement method, researchers should guide their interactions with community members using these
p.000067: underlying principles to promote the aforementioned ethical principles of respect of persons, fairness, and
p.000067: beneficence.
p.000067: One form of community involvement is to include qualified members of the community on the research staff.
p.000067: Section 2 advocates community representatives as part of the research team. Paid research staff members from
p.000067: the community could serve as valuable consultants for protocol development and research design, including how to
p.000067: collect the data, how to recruit and retain participants, and how to interpret and disseminate the
p.000067: results. However, including paid research staff from the community may introduce a conflict of interest among
p.000067: community members: community representatives may feel a greater allegiance to the researchers providing the payment
p.000067: and be less inclined to uphold the interests of the community. In addition, the community may come to view
p.000067: the paid research staff from the community as
p.000067: Visibility Travel to the community, interact with formal
p.000067: and informal leadership, and establish relationships to build trust.
p.000067:
p.000067: Acceptance Acknowledge, without judging, the assets and deficits of the community.
p.000067:
...

p.000069: governmental agencies, and academia. The CAAA partnership credits community involvement as active research
p.000069: partners in the research process with the success of the project to acquire “more relevant exposure data for
p.000069: the study of children in urban neighborhoods” and to provide “immediate knowledge and understanding of the outcomes
p.000069: and results of the combined environmental health analysis to the communities” (Keeler et al., 2002). There are,
p.000069: however, several drawbacks to utilizing CBPR methods that researchers should consider before developing a
p.000069: CBPR project. CBPR is time consuming (develop partnership, establish and agree on research aims and
p.000069: objectives, disseminate results to the community using appropriate methods, and review
p.000069: manuscripts and presentations) and not conducive to situations where rapid decisions are necessary given a
p.000069: tight timeline. Weighing the research need versus the community’s desire for an intervention is the
p.000069: greatest source of tension in conducting CBPR (Israel et al.,
p.000069: 2005b).
p.000069: One additional opportunity for community input may involve participation on an IRB. IRBs are required by the
p.000069: Common Rule to have members who are sensitive to “community attitudes” [40 CFR 26.107(a)]. How they meet this
p.000069: obligation is totally at their discretion, and NERL researchers have no influence. There have been a number of
p.000069: recent articles in the literature about IRBs that have envisioned a need for more regulatory reform
p.000069: (Ledford, 2007). Ideally, the IRB should take into account the views of the community. Quinn
p.000069: (2004) argues for extending protections now reserved for individuals to groups (populations and
p.000069: communities) through CABs. Her argument is that there are “ethical issues related to research with
p.000069: communities that are distinctly different from the ethical issues related to research with individuals.”
p.000069: CAB members have to be educated on human subjects’ protections, should represent their communities
p.000069: honestly, and need to be willing to interact with researchers on complex research issues.
p.000069: Gilbert (2006) goes even further. He suggests supplementing or even replacing traditional IRBs with
p.000069: environmental health and community review boards (EHCRBs). He argues that traditional IRBs
p.000069: are inadequate for the review of community-based research because they were developed to address issues related to
p.000069: individuals involved in research projects, not communities. He proposes EHCRBs that combine
p.000069: the fundamental and ethical concept of traditional IRBs with an expanded ethical construct of dignity,
p.000069: veracity, sustainability, and justice, with added emphasis on community. He envisions that an
p.000069: EHCRB would function as an IRB with the requirements and responsibilities for review for the
...

p.000070: ethnic and racial stereotypes, and lack of organization. Many of the affected farmworkers originated outside the
p.000070: United States from several different Spanish-speaking countries and possessed contradicting viewpoints
p.000070: on research and the utility of community organization. Moreover, the community organization tailored
p.000070: for this farmworker demographic did not include enough members to adequately populate the
p.000070: study. The researchers utilized multiple approaches, including community forums, community advisory
p.000070: councils, and public presentations, to identify a diverse, yet viable, community within the broader
p.000070: farmworker population.
p.000070: Through this process of using multiple participatory strategies to define the community, a
p.000070: sense of community was nurtured among the farmworkers collectively (O’Fallon and Dearry, 2002).
p.000070: Understanding and describing a community (CDC, 1997) involves exploring factors related to
p.000070: • people (including socioeconomics and demographics, health status, and cultural and ethnic characteristics),
p.000070: • location (geographic boundaries),
p.000070: • commonalities (including shared values, interests, and motivating forces), and
p.000070: • power relationships (including formal and informal lines of authority and influence, stakeholder relationships, and
p.000070: resource flows).
p.000070: It is important to distinguish between stakeholders and the community, but both should be engaged at some point
p.000070: in the course of a study. Stakeholders are groups or organizations that may affect, be affected by, or perceive
p.000070: themselves to be affected by a decision or activity. Stakeholders may have a direct or indirect interest in the
p.000070: “matter” of interest. They may include individuals; environmental, social, or community
p.000070: nongovernment organizations (NGOs); government entities; businesses; and industry. Stakeholders include
p.000070: business, industry, and various levels of government. A critical difference between the community and
p.000070: stakeholders is that the community has a right to speak for its own interests, but stakeholders cannot
p.000070: represent or speak for the community. Although relationships with stakeholders can, at times, be
p.000070: confrontational, stakeholders often provide useful information and expertise. When stakeholders
p.000070: and the community members overlap in particular individuals, it is important to distinguish the role in
p.000070: which the individual is acting (ERG, 2007).
p.000070:
p.000070: 6.2.2 Identifying Who Represents the Community
p.000070: To sufficiently represent the community, an individual has to have not only the right to speak for the
p.000070: community’s interests (a right afforded by legitimate membership in the group) but also should be able
p.000070: to describe those interests on behalf of the community. Identifying those who represent the community is
p.000070: not simply a matter of identifying the most vocal activists because those individuals do not necessarily
...

p.000071: trust with all partners, and the establishment of the agreement helps reduce misunderstandings.
p.000071: Contracts or memorandums of understanding that outline the roles and expectations of the researcher and the
p.000071: community are discussed in both Minkler and Wallerstein (2003) and Israel et al. (2005b). An example
p.000071: outlining expectations in a partnership with tribal communities is presented in Appendix E of Minkler and
p.000071: Wallerstein (2003), whereas an example discussing access to data and authorship issues is presented
p.000071: in Appendix I of Israel et al. (2005b). An example of a memorandum of understanding between the
p.000071: University of Michigan School of Public Health, Detroiter’s Working for Environmental Justice, the Detroit
p.000071: Hispanic
p.000071:
p.000071:
p.000071:
p.000071: 23 For a more detailed description of each of the suggestions for enhancing trust, please see Chapter 3 of Israel et
p.000071: al. (2005).
p.000071:
p.000072: 72
p.000072:
p.000072: Development Corporation, and the Warren Conner Development Coalition for a study investigating asthma is
p.000072: available at http://depts.washington.edu/ccph/pdf_files
p.000072: /MOU10.pdf.
p.000072: Work within communities involves a considerable investment of researchers’ and residents’ time. It should be an
p.000072: ongoing, interactive exchange of information and ideas between the researchers and the community members,
p.000072: where voices are both heard and honored. Trust is fostered when all interested parties feel that they have
p.000072: influence, and that their input contributes to the community effort. The collaborations should be
p.000072: inclusive of the entire community, including those members with incompatible interests and perceptions. If
p.000072: participation, influence, and benefits are limited only to some of the partners, then distrust is likely, and
p.000072: the potential benefits of community involvement may be lost. Being inclusive can create some
p.000072: organizing challenges, but the benefit of effective community involvement “has the potential to
p.000072: lead to greater understanding of community perspectives of the risk and benefits of research, improve informed
p.000072: consent, increase study enrollment, enhance data validity and quality, and build trust for research” (NRC & IOM, 2005).
p.000072:
p.000072: 6.2.4 Importance of Language and Communications with the Community
p.000072: Even when all partners and community members are speaking the same language, some terms are not
p.000072: necessarily understood by all. Communications with participants should be reviewed by all partners to ensure
p.000072: that the language used will be appropriate for all participants. At times, one method to
p.000072: communicate research findings will not fit all community members and partners. Even among the partners,
p.000072: understanding each other’s meanings is essential, so that all partners can move forward with a common
p.000072: understanding (Israel et al., 2005b).
p.000072: Furthermore, Minkler and Wallerstein (2003) note that “research must be produced, interpreted, and
p.000072: disseminated to community members in clear, useful, and respectful language.” Researchers, and especially
...

p.000073: communication plan was integral to the success of the study. Eighty percent of the original participants
p.000073: completed the four- season study (Williams et al., 2003).
p.000073:
p.000073: 6.2.6 Honesty, Power Relationships, and Partnerships
p.000073: The NRC & IOM report (NRC & IOM, 2005) describes a relational paradigm that acknowledges that research
p.000073: is part of a broader societal context, with the conduct of research often mirroring a system in which
p.000073: power is unequally and perhaps unfairly distributed. The trust and mutual commitment required from
p.000073: the researchers and the community are subject to the overall power relations in society.24 The Expert Panel convened to
p.000073: discuss the content of this document recognized that
p.000073:
p.000073:
p.000073: 24 A discussion of the evolution of theories on power relations, including the contribution of feminism,
p.000073: poststructuralism, and postcolonialism, can be found in Minker and Wallerstein (2003, Chapter 2).
p.000073: the researchers have a variety of forms of power that needed to be understood and acted on ethically
p.000073: (ERG, 2007). One form of power is resources, both funds and access to resources and decisionmakers. Other forms of
p.000073: power may be more subtle, including expertise, which can intimidate or limit a participant’s choices.
p.000073: Peer pressure, fear of intimidation, expectations of benefits from the research, and power to
p.000073: stigmatize the community all, whether real or perceived, can influence the relationship between the
p.000073: researcher and the community. Many forms of power may be tipped toward the researcher, but the community often
p.000073: has power in the form of knowledge about the community that can impact the quality of the research effort. An ethical
p.000073: balance of power can lead to benefits for all partners (ERG, 2007).
p.000073: In describing principles in Methods in Community- Based Participatory Research for Health, Israel et al.
p.000073: (2005b) describe CBPR as facilitating “a collaborative, equitable partnership in all phases of research,
p.000073: involving an empowering and power-sharing process that attends to social inequalities.” One way to address the
p.000073: inequities is to ensure that the roles and responsibilities are mutually acceptable to all parties.
p.000073: Researchers involved in CBPR should recognize and address the inequalities, thereby promoting trust, mutual
p.000073: respect, open communication, information sharing, collaborative decisionmaking, and resource sharing.
p.000073: It is important that researchers recognize that partnerships with the community are ongoing processes that
p.000073: need to be monitored and maintained. As a study progresses, the dynamics of the partnership may change as roles
p.000073: and responsibilities for the partners change. All partners need to be willing to make the investment of time
p.000073: and resources necessary to maintain an effective partnership.
p.000073:
p.000073: 6.2.7 Building a Lasting Infrastructure
p.000073: Infrastructure is anything that builds the capacity of the community by providing its members with skills and
...

p.000095: is a linkage between having had an abortion and breast cancer), impractical (e.g., to follow a cohort large
p.000095: enough to yield statistically significant results in a test of rare side effects to a medication), or just
p.000095: impossible to accomplish (e.g., to measure nutritional levels of a population in the middle of a war zone).
p.000095: As a consequence, much medical research is observational in the scientific sense being considered
p.000095: here. Public health data represent observations of health outcomes, but the factors that may have led
p.000095: to or influenced those outcomes are not under the control of any researcher. Observational techniques long
p.000095: have been
p.000095: used in medical studies to infer information about the impacts of certain factors on health
p.000095: outcomes. Commonly used techniques include cohort studies, case- control studies, cross-sectional studies, case
p.000095: reports, case series, and descriptive studies (NEAC, 2006; Vandenbroucke et al., 2007).
p.000095: Observational human exposure studies as used in this document are considered to be observational from a
p.000095: scientific study design perspective because the variables leading to exposure are not controlled by the researchers.
p.000095: Most of the observational human exposure studies conducted by NERL to date have been cross-sectional
p.000095: studies (sometimes repeated several times). While a particular variable may not be controlled by
p.000095: the researcher, the study design (e.g., selection of the population to be studied, location of the
p.000095: research, data selection to exclude confounding factors) can sometimes influence the range of values over which a
p.000095: variable may be observed. For example, NERL’s observational human exposure studies to understand exposure to PM
p.000095: (see www.epa.gov/heasd/sources/projects_completed/pm_pa nel_studies.htm and www.epa.gov/heasd/sources/project
p.000095: s/a3a_understanding_airshed_sources.htm) have traditionally excluded homes with smokers from the
p.000095: study population to avoid cigarette smoke as a confounding factor in the studies.
p.000095: Observational Studies in Market Research, Ethnography, and the Common Vernacular:
p.000095: Observational market research can involve covert observation, overt observation, or
p.000095: researcher participation. Covert observation is said to have a “key advantage” that “the respondent or consumer is
p.000095: unaware that they are being observed, allowing their behavior to be observed naturally”
p.000095: (see http://www.asiamarketresearch.com/glossary/observatio nal-research.htm). This means that the
p.000095: subject’s behavior will be natural and uncontaminated by the researcher’s presence. On the other hand, covert
p.000095: observation may be construed to be deceitful and ethically questionable. Overt observations involve
p.000095: sampling surveys, polls, interviews, focus groups, etc. Validity of the data obtained this way may
p.000095: be shaded by people’s natural tendency to behave or respond ideally when they know they are being watched.
p.000095: Motorists routinely slow down when they think they are being observed by the police. Finally, the researcher may
p.000095: participate in the activity being observed. Ethnography is a long-term investigation of a group
...

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p.000006: and Childress, 2001). Ethical obligations have to be carefully considered as they relate to the
p.000006: scientific elements of these studies. Therefore, it is important that researchers recognize and understand these
p.000006: obligations and use the most up-to-date scientific and ethical approaches in the design and
p.000006: implementation of observational human exposure studies.
p.000006:
p.000006: 1.1 Observational Human Exposure Studies As we are using the term in this document, “observational
p.000006: human exposure studies” are studies that involve the collection of environmental samples, data, and
p.000006: information from study participants in their everyday environments as they go about their normal
p.000006: activities. These are studies where the NERL researchers do not intentionally try to control the study variables or
p.000006: outcomes, but instead merely observe both the variables and the outcomes. They involve neither the deliberate
p.000006: exposure of participants nor the control of environmental conditions in a way that impacts the
p.000006: participants’ naturally occurring exposures. This scientifically based definition needs to be distinguished
p.000006: at the outset from the broader regulatory term “observational” so that the scope and limits of this
p.000006: document are clear. EPA Regulation 40 CFR 26 (Protection of Human Subjects) at Subpart B, first, defines
p.000006: research involving intentional exposure of a human subject as “a study of a substance in which the exposure to the
p.000006: substance experienced by a human subject participating in the study would not have occurred but for the human subject’s
p.000006: participation in the study” [40 CFR 26.202(a)]. It then goes on at Subpart C to define observational research as “any
p.000006: human research that does not meet the definition of research involving intentional exposure of a human
p.000006: subject” (40 CFR
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: 26.302). By defining “observational” so broadly, a regulatory category is created that encompasses a range
p.000007: of study types whose only common feature is that they do not entail “intentional exposure” as defined in the
p.000007: regulations. Moreover, some of these “observational” study types do not involve the study of exposures at all but
p.000007: rather “observe” other sorts of phenomena. The observational human exposure studies with which we are concerned
p.000007: here, on the other hand, are exposure studies, but they represent a narrower group of studies as defined scientifically
p.000007: at the beginning of this paragraph. Although they would generally be expected to fall within the
p.000007: regulatory category of “observational research”, they are not synonymous with it. (For a more thorough
p.000007: discussion of the scientific and regulatory meanings of observational and exposure, with examples, please
p.000007: see Appendix A.)
p.000007: Observational human exposure studies are performed for many different purposes. They have been used
p.000007: extensively in the fields of social behavioral, economic, biological, medical, epidemiological, and
p.000007: exposure research to collect information that relates one or more variables (e.g., exposure to a chemical) to
...

p.000096: definition of an observational study, because the variable being studied, exposure to some agent, is not controlled by
p.000096: the NERL scientists. The observations are not covert, and they may or may not be noninvasive (e.g.,
p.000096: sometimes blood samples may be collected).
p.000096: Because NERL’s observational human exposure studies meet the definition of human subjects research as set forth
p.000096: in the Common Rule, there is also a regulatory requirement to meet the ethical and scientific standards set forth in
p.000096: EPA’s human subjects regulations and in Agency rules. The research protocol must be evaluated and approved
p.000096: by an IRB and by EPA’s Human Studies Research Review Official (HSRRO) before any human subjects research effort
p.000096: can take place. But, even more compelling to NERL managers and scientists is the fact that NERL cannot
p.000096: conduct observational human exposure studies without the participation of willing individuals. Indeed,
p.000096: without the research participants, NERL’s human exposure research would be nothing. This intimate
p.000096: involvement of research subjects in NERL’s research imposes moral and ethical obligations to deal with
p.000096: participants respectfully and to ensure their safety, protection, and well-being.
p.000096: Regulatory Distinction Between Intentional Exposure and Observational Research
p.000096: Intentional Exposure: The CFR states, “Research involving intentional exposure of a human subject
p.000096: means a study of a substance in which the exposure to the substance experienced by a human
p.000096: subject participating in the study would not have occurred but for the human subject’s participation in
p.000096: the study” [40 CFR 26.202(a)]. This definition sets forth two requirements regarding an
p.000096: intentional exposure: (1) the exposure has to be to a substance that is being studied, and (2) at least one
p.000096: aspect of the exposure to the substance being studied has to be attributable to the subject’s
p.000096: participation in the study.
p.000096: The first requirement means the objective of the study must be to understand the impact or exposure of
p.000096: the substance being studied. In observational human exposure studies, like those that NERL conducts, the
p.000096: research protocol may require the use of isopropyl alcohol or some other chemical to collect a
p.000096: personal sample (e.g., to sterilize the puncture site immediately prior to collection of a personal sample of
p.000096: blood drawn by a trained phlebotomist). Indeed, it would be both unethical and bad medical practice not
p.000096: to sterilize the puncture site before drawing blood. But this requirement does not constitute intentional
p.000096: exposure because the research is not the study of isopropyl alcohol but of some other agent. Incidental
p.000096: exposures to chemicals like isopropyl alcohol still must be considered from a safety perspective, pass both scientific
p.000096: and ethical review, and be approved by the IRB, but such incidental exposures do not constitute intentional
p.000096: exposure.
p.000096: The second requirement is that the exposure as experienced by the subject “would not have occurred but for the
p.000096: human subject’s participation in the study.” The two primary ways in which intentional exposure studies commonly meet
p.000096: this definition are by the direct introduction of the study substance into the research environment
p.000096: under the control of the research protocol or by scripting the participants’ activities in such a way that their
p.000096: contact with the study substance is determined by the research. Although either would be sufficient to meet
p.000096: the regulatory definition, many, if not most, intentional exposure studies attempt to control both.
p.000096: Because “exposure is quantified as the concentration of the agent in the medium in contact integrated over the
p.000096: time duration of that contact,” intentional exposure studies are usually more scientifically robust if both
p.000096: the concentration of the agent and the duration of the exposure are controlled by the research.
p.000096:
p.000096:
p.000096:
p.000097: 97
p.000097:
p.000097: Observational Research: In the language of the Code of Federal Regulations, “observational research means
p.000097: any human research that does not meet the definition of research involving intentional exposure of a
p.000097: human subject” (40 CFR 26.302).
p.000097: By this definition, observational research encompasses all human research that does not meet the
p.000097: definition of intentional exposure. As a consequence, it is a broad regulatory category that includes a variety of
p.000097: research domains, including human research that does not involve the study of exposures at all. This regulatory
p.000097: definition of observational is sufficiently broad, moreover, that it encompasses study types that
p.000097: this document is not intended to address. For example, it may be possible to design an intervention study that
p.000097: does not bring about or script in any way the participants’ exposure to a substance, but rather reduces or
p.000097: mitigates it. (Consider a study to test whether professional cleaning of the carpets, floors, walls, and
p.000097: other surfaces in a home might lead to a lower exposure to a residential contaminant or a study to determine if wearing
p.000097: a particle mask would reduce an individual’s exposure to smoke from forest fires.) Such a study
p.000097: might meet the regulatory definition of observational research (Note: The final decision in regard to whether
p.000097: any EPA study meets the definition of observational research resides with the Agency’s HSRRO), but it
p.000097: would not meet the authors’ intentions regarding “observational human exposure studies” as they are defined
p.000097: in this document. An intervention study, such as described in these two examples, does not involve
p.000097: observing people’s exposures in their everyday environments, as they go about their normal activities. In
p.000097: an intervention study, either the participant’s environment (cleaning of the household surfaces) or their
p.000097: behavior (wearing a particle mask) has been manipulated by the researcher. Secondly, the objective of these
p.000097: studies is not to understand exposures in everyday environments but would use changes in exposure
p.000097: to test the effectiveness of an intervention strategy. Such a study is not addressed in this document.
p.000097: Observational human exposure studies, as used by the authors of this document, generally meet the
p.000097: regulatory definition of observational research. But, not all studies meeting the CFR definition of
...

p.000117: Minimal risk. The probability and magnitude of harm or discomfort anticipated in the research are not greater in and
p.000117: of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000117: psychological examinations or tests [40 CFR 26.102(i)].
p.000117: Nonmaleficence. The proscription of deliberate infliction of harm on persons
p.000117: Observational human exposure study. Studies that involve collection of human exposure data (including environmental,
p.000117: biological, survey, activity, and various other forms of data) under real-world field conditions during normal
p.000117: participant day-to-day activities, with no additional exposures to the chemical being studied because of participation
p.000117: in the study. The studies involve interaction with study participants but do not involve intervention or manipulation
p.000117: of the factors being studied, and there is no attempt by the researcher to affect the outcome.
p.000117: Observational research. Any human research that does not meet the definition of research involving intentional
p.000117: exposure of a human subject [40 CFR 26.302]
p.000117: Privacy. Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or
p.000117: intellectually) with others
p.000117: Research. A systematic investigation, including research development, testing, and evaluation, designed to develop or
p.000117: contribute to generalizable knowledge
p.000117: Research involving intentional exposure of a human subject. A study of a substance in which the exposure to the
p.000117: substance experienced by a human subject participating in the study would not have occurred but for the human subject’s
p.000117: participation in the study [40 CFR 26.202(b)]
p.000117: Respect for persons. A fundamental ethical value that is the basis of much of modern bioethical thought and
p.000117: regulation. The concept incorporates at least two fundamental ethical considerations, namely (1) respect for autonomy,
p.000117: which requires that those who are capable of deliberation about their personal choices should be treated with respect
p.000117: for their capacity for self- determination; and (2) protection of persons with impaired or diminished autonomy, which
p.000117: requires that those who are dependent or vulnerable be afforded security against harm or abuse.
p.000117: Source. The origin of an agent for the purposes of an exposure assessment
p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
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p.000104: eaten by participant and analyzed for pesticides, metals, etc. Includes drinking water samples as part of diet or other
p.000104: beverages consumed.
p.000104: Handled food Finger foods like cheese or luncheon meets that have been prepared and processed
p.000104: identically to foods children might eat to evaluate how much pollution may be removed from surfaces and ingested with
p.000104: the food.
p.000104: Human Activity Data
p.000104: Time-activity diaries Recall diaries to account for all times and activities in a day. Information
p.000104: includes location and activities.
p.000104: Activity loggers Device used to assess the nature of a person’s activities. Portable
p.000104: nephelometers have been used to keep up with people’s activities by showing when they were near PM sources.
p.000104: Accelerometers to measure level of activity of children at play. GIS and inertial devices to try to measure locations
p.000104: as a function of time of day.
p.000104: Questionnaires Query participants about things like daily activities for themselves or their
p.000104: children; housing characteristics; participant characteristics, including occupation, diet, smoking habits, hobbies,
p.000104: etc.; and recent use of pesticides or other consumer products.
p.000104: Videotaping Use videos to measure frequency and duration of mouthing activities in children.
p.000104: Household inventories Inventory consumer products in house. Use items to ask about usage frequency and
p.000104: history.
p.000104: Researcher observations Information about open doors and windows (air exchange), heating and cooking sources,
p.000104: pets, and other activities that may lead to potential exposures may be observed.
p.000104: Personal or Biological Samples
p.000104: Urine Urinary excretion of pollutants and their contaminants give important
p.000104: information about the nature of prior exposures and their magnitude.
p.000104: Personal air monitors Individual wears samplers on his/her person while going about normal activities to
p.000104: measure pollutants in breathing zone of individual.
p.000104: Hand wipes Hand wipes remove contaminants from skin surface. Analyze for pesticides, metals,
p.000104: organic chemicals, and use values to estimate dermal exposure and hand-to-mouth ingestion of pollutants.
p.000104: Dermal surrogates Participant may wear cotton garments or socks as a collector. Clothing is analyzed
p.000104: for pesticides, metals, organic chemicals, etc. Measured contaminant quantities are used to estimate potential for
p.000104: dermal exposure.
p.000104: Saliva samples Test for antibodies to infectious agents, suggesting prior exposure and infection
p.000104: by microbial agent. Blood Some epidemiological studies that NERL scientists have
p.000104: collaborated on have collected blood samples.
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: Appendix B
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Health / Healthy People

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p.000103: matter, and air toxics. The study conducted
p.000103: (TACS) methods. identified microenvironmental
p.000103: factors affecting penetration of pollutants into homes and reduction of exposures to pollutants for asthmatic children
p.000103: (0-5 years of age).
p.000103:
p.000103: Pilot Study To Evaluate Data Collection Methods for Young Children’s and Household Activities
p.000103: Detroit Exposure and Aerosol Research Study (DEARS)
p.000103:
p.000103:
p.000103:
p.000103: Accelerometer Pilot Study
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Pilot Study of Waterborne Infections
p.002004: 2004
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004: 2004-2007
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004: 2004
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002005: 2005
p.002005: 3 Homes
p.002005:
p.002005:
p.002005:
p.002005:
p.002005:
p.002005:
p.000150: 150
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.001296: 1296
p.001296: Convenience, pilot study to test methodology
p.001296:
p.001296:
p.001296:
p.001296:
p.001296: Randomized household selection with qualification criteria; longitudinal
p.001296:
p.001296: Convenience, pilot study to test methodology
p.001296:
p.001296:
p.001296:
p.001296:
p.001296: Convenience, all volunteers from community using public water supply
p.001296: Pilot aggregate exposure study of three homes to assess burden of alternative exposure sample collection methods.
p.001296:
p.001296:
p.001296:
p.001296:
p.001296:
p.001296: Recruitment from seven distinct neighborhoods in Detroit required strong community relations and partnership with State
p.001296: and local organizations. This study monitored for air pollutants at the personal level and evaluates how well centrally
p.001296: located (ambient) monitors represent exposure at the residential and personal level. Sampling is for 5 days duration in
p.001296: summer and again in winter.
p.001296: Nine children <24 months old and their primary caregivers participated in this study to (a) determine if very young
p.001296: children will wear an accelerometer for relatively long periods of time and comply with the protocol for its use, (b)
p.001296: evaluate how well a caregiver can estimate the activity level of his/her infant or toddler when completing an
p.001296: exposure-oriented time-activity diary, and (c) compare accelerometer count output with caregiver-provided estimates of
p.001296: children's activity level.
p.001296: Measure antibodies in people’s saliva for antibodies to Cryptosporidium, Noroviruses, Rotaviruses, Helicobacter pylori,
p.001296: and Toxoplasma gondii before and after installation of an ultraviolet treatment system for a public water supply. Also
p.001296: served as test of methodology for detecting people’s prior exposure to infectious agents.
p.001296: NERL designed, contractor conducted
p.001296:
p.001296:
p.001296:
p.001296:
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p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
p.000003: range of risks associated with participation and the voluntary nature of participation, and provides
p.000003: essential protections to the participant. Recent observations by various national and international review
p.000003: committees on the appropriate level of payment to research participants are presented. This is a
...

p.000035: forces, police, and others who work for, or closely with re- searchers; they may have expectations of preferential
p.000035: treatment if they agree to participate or fear of disapproval or retaliation if they refuse to participate in a study.
p.000035:
p.000035: Common Rule: Examples of vulnerable groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: EPA extends stringent protections to these groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035: HHS extends additional protections to these groups
p.000035: (45 CFR 46)
p.000035:
p.000035: Additional vulnerable groups in NIH training materials
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
...

p.000038: fetuses (i.e., providing benefit to the woman or fetus, or producing important, but otherwise unobtainable,
p.000038: biomedical knowledge); that risk is reduced to the least possible level for achieving the objectives of
p.000038: the research; and other protections.
p.000038:
p.000038: 3.6 Other Potentially Vulnerable Groups
p.000038: HHS specifies additional protections for prisoners as a potentially vulnerable group in Subpart C of 45 CFR
p.000038: 26. Additional requirements for other vulnerable groups in research studies are not specifically defined in either
p.000038: EPA’s or HHS’ human subjects rules. Nonetheless, other groups (as discussed in Section 3.1) may be considered to be
p.000038: vulnerable and, as such, may warrant additional consideration and protection as required in the Common Rule. For
p.000038: these other potentially vulnerable groups, such as employees, students, handicapped persons, mentally disabled
p.000038: persons, and economically or educationally disadvantaged persons, nursing home residents or otherwise
p.000038: incapacitated elderly, etc., the Common Rule requires researchers and IRBs to fully evaluate the
p.000038: protocols to ensure that the safety and welfare of the groups will be protected. As discussed in Section 3.1,
p.000038: It also should be noted that, although Federal regulations define vulnerability in terms of the ability
p.000038: to protect one’s own interests, the lay public may perceive a broader definition of vulnerability as
p.000038: it relates to education, economics, social status, and other factors. The researcher should evaluate
p.000038: vulnerability in this broader context to ensure that adequate safeguards are included for potentially
p.000038: vulnerable populations that do not meet the definition of the Federal regulations.
p.000038: References
p.000038: AAP (American Academy of Pediatrics) (2003). Pediatric Environmental Health. (2nd Edition). Elk Grove Village, IL:
p.000038: American Academy of Pediatrics.
p.000038:
...

p.000054: participants “should understand clearly the range of risk and the voluntary nature of participation” [emphasis
p.000054: added]. The ethical principles of respect for persons and their autonomous decisions morally obligate
p.000054: the researcher to ensure that an individual’s decision to participate in a human research study is truly
p.000054: voluntary and uncoerced (Emanuel et al., 2000). A number of study characteristics may affect whether the
p.000054: participant’s actions are truly voluntary.
p.000054: • Access to study-dependent benefits or care that would otherwise not normally be received may impair
p.000054: voluntariness.
p.000054: • Voluntary participation also may be compromised when there is an existing relationship between the
p.000054: researcher and participants, such as employer and employee or teacher and student.
p.000054: • Restricted voluntariness may be an intrinsic part of belonging to certain vulnerable groups,
p.000054: including children, prisoners, handicapped persons, mentally disabled persons, and economically or
p.000054: educationally disadvantaged persons, or members of the military, for example. When research participants come from such
p.000054: groups, additional protections to insure voluntariness in the context of the research may be required
p.000054: (see also 40 CFR 26, Subparts B, C, and D).
p.000054: • Payments as incentives may have undue influence and are discussed below.
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: • Whether payments will lead to a coerced decision to participate often is difficult to determine without
p.000055: input from people from similar socioeconomic backgrounds as the participants (p. 111, NRC & IOM, 2005).
p.000055: Researchers should work with community representatives to develop a consent process that will be
p.000055: maximally effective in providing information, ensuring and documenting comprehension, and ensuring
p.000055: that participation is voluntary (also see Section 6).
p.000055: Researchers should remember that obtaining informed consent should be “an on-going, interactive
p.000055: dialogue . . . involving the disclosure and exchange of relevant information” (IOM, 2002): it is not
p.000055: simply having a consent form signed. The process is most effective when the researcher spends time with
p.000055: potential participants to discuss the study and to answer questions.
p.000055:
p.000055: 5.2 Payments to Research Participants
...

p.000061: of
p.000061: recommendations from the report for enhancing public trust is provided in Appendix D. The recommendations are
p.000061: focused on the following areas.
p.000061: • Building trust through community partnerships
p.000061: • Building relationships with patients (participants) (True partnerships with patients may not be possible,
p.000061: but bidirectional relationships must be enhanced.)
p.000061: • Building partnerships with community providers
p.000061: • Building trust in scientists
p.000061: • Building trust in the (EPA) and scientific research.
p.000061:
p.000061: 5.5 Recruitment Strategies
p.000061: Many strategies are used to select and recruit people into research studies requiring human participation. The IRB is
p.000061: responsible for reviewing the selection process to ensure that it is, above all, equitable. The requirement for
p.000061: IRB review is stated in 40 CFR 26.111(a)3.
p.000061: Selection of subjects is equitable. In making this assessment, the IRB should take into account the
p.000061: purposes of the research and the setting in which the research will be conducted and should be particularly cognizant
p.000061: of the special problems of research involving vulnerable populations, such as children, prisoners,
p.000061: pregnant women, mentally disabled persons, or economically or educationally disadvantaged
p.000061: persons.
p.000061: The IRB guidebook is an excellent resource for consideration of concerns and elements for equitable
p.000061: participant selection (U.S. HHS, 1993). It states that “Defining the appropriate group of subjects
p.000061: for a research project involves a variety of factors⎯ requirements of scientific design,
p.000061: susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness.” The IRB
p.000061: guidebook raises a number of points to consider in the process for selection of human participants (see Text Box
p.000061: 5-5).
p.000061: Various participant recruitment strategies may be used depending on the type of research being performed and the
p.000061: population of interest. This section addresses the strategies and approaches for identifying and contacting people and
p.000061: subsequent recruitment into a research study. Sampling design approaches and issues, such as statistical
p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062: Text Box 5-5. IRB Guidebook Issues on Identifying Subjects
p.000062: 1. Who will bear the burden? Who will reap the benefits?
p.000062: 2. Is there a disproportionate burden on any single group?
...

Searching for indicator mentally:

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p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
p.000003: range of risks associated with participation and the voluntary nature of participation, and provides
p.000003: essential protections to the participant. Recent observations by various national and international review
...

p.000035: (Council for International Organizations of Medical Sciences, 2002)
p.000035:
p.000035: • Junior or subordinate members of a hierarchical group; examples include employees, students, members of the armed
p.000035: forces, police, and others who work for, or closely with re- searchers; they may have expectations of preferential
p.000035: treatment if they agree to participate or fear of disapproval or retaliation if they refuse to participate in a study.
p.000035:
p.000035: Common Rule: Examples of vulnerable groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: EPA extends stringent protections to these groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035: HHS extends additional protections to these groups
p.000035: (45 CFR 46)
p.000035:
p.000035: Additional vulnerable groups in NIH training materials
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
...

p.000038: fetuses (i.e., providing benefit to the woman or fetus, or producing important, but otherwise unobtainable,
p.000038: biomedical knowledge); that risk is reduced to the least possible level for achieving the objectives of
p.000038: the research; and other protections.
p.000038:
p.000038: 3.6 Other Potentially Vulnerable Groups
p.000038: HHS specifies additional protections for prisoners as a potentially vulnerable group in Subpart C of 45 CFR
p.000038: 26. Additional requirements for other vulnerable groups in research studies are not specifically defined in either
p.000038: EPA’s or HHS’ human subjects rules. Nonetheless, other groups (as discussed in Section 3.1) may be considered to be
p.000038: vulnerable and, as such, may warrant additional consideration and protection as required in the Common Rule. For
p.000038: these other potentially vulnerable groups, such as employees, students, handicapped persons, mentally disabled
p.000038: persons, and economically or educationally disadvantaged persons, nursing home residents or otherwise
p.000038: incapacitated elderly, etc., the Common Rule requires researchers and IRBs to fully evaluate the
p.000038: protocols to ensure that the safety and welfare of the groups will be protected. As discussed in Section 3.1,
p.000038: It also should be noted that, although Federal regulations define vulnerability in terms of the ability
p.000038: to protect one’s own interests, the lay public may perceive a broader definition of vulnerability as
p.000038: it relates to education, economics, social status, and other factors. The researcher should evaluate
p.000038: vulnerability in this broader context to ensure that adequate safeguards are included for potentially
p.000038: vulnerable populations that do not meet the definition of the Federal regulations.
p.000038: References
p.000038: AAP (American Academy of Pediatrics) (2003). Pediatric Environmental Health. (2nd Edition). Elk Grove Village, IL:
p.000038: American Academy of Pediatrics.
p.000038:
...

p.000054:
p.000054: 5.1.3 Voluntary Participation
p.000054: The third pillar of informed consent is voluntary participation. The Belmont Report emphasizes that
p.000054: participants “should understand clearly the range of risk and the voluntary nature of participation” [emphasis
p.000054: added]. The ethical principles of respect for persons and their autonomous decisions morally obligate
p.000054: the researcher to ensure that an individual’s decision to participate in a human research study is truly
p.000054: voluntary and uncoerced (Emanuel et al., 2000). A number of study characteristics may affect whether the
p.000054: participant’s actions are truly voluntary.
p.000054: • Access to study-dependent benefits or care that would otherwise not normally be received may impair
p.000054: voluntariness.
p.000054: • Voluntary participation also may be compromised when there is an existing relationship between the
p.000054: researcher and participants, such as employer and employee or teacher and student.
p.000054: • Restricted voluntariness may be an intrinsic part of belonging to certain vulnerable groups,
p.000054: including children, prisoners, handicapped persons, mentally disabled persons, and economically or
p.000054: educationally disadvantaged persons, or members of the military, for example. When research participants come from such
p.000054: groups, additional protections to insure voluntariness in the context of the research may be required
p.000054: (see also 40 CFR 26, Subparts B, C, and D).
p.000054: • Payments as incentives may have undue influence and are discussed below.
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: • Whether payments will lead to a coerced decision to participate often is difficult to determine without
p.000055: input from people from similar socioeconomic backgrounds as the participants (p. 111, NRC & IOM, 2005).
p.000055: Researchers should work with community representatives to develop a consent process that will be
p.000055: maximally effective in providing information, ensuring and documenting comprehension, and ensuring
p.000055: that participation is voluntary (also see Section 6).
p.000055: Researchers should remember that obtaining informed consent should be “an on-going, interactive
p.000055: dialogue . . . involving the disclosure and exchange of relevant information” (IOM, 2002): it is not
p.000055: simply having a consent form signed. The process is most effective when the researcher spends time with
...

p.000061: developed in the context of NIH-supported clinical research, many of the recommendations are applicable to
p.000061: observational human exposure studies and human subject research in general. A summary
p.000061: of
p.000061: recommendations from the report for enhancing public trust is provided in Appendix D. The recommendations are
p.000061: focused on the following areas.
p.000061: • Building trust through community partnerships
p.000061: • Building relationships with patients (participants) (True partnerships with patients may not be possible,
p.000061: but bidirectional relationships must be enhanced.)
p.000061: • Building partnerships with community providers
p.000061: • Building trust in scientists
p.000061: • Building trust in the (EPA) and scientific research.
p.000061:
p.000061: 5.5 Recruitment Strategies
p.000061: Many strategies are used to select and recruit people into research studies requiring human participation. The IRB is
p.000061: responsible for reviewing the selection process to ensure that it is, above all, equitable. The requirement for
p.000061: IRB review is stated in 40 CFR 26.111(a)3.
p.000061: Selection of subjects is equitable. In making this assessment, the IRB should take into account the
p.000061: purposes of the research and the setting in which the research will be conducted and should be particularly cognizant
p.000061: of the special problems of research involving vulnerable populations, such as children, prisoners,
p.000061: pregnant women, mentally disabled persons, or economically or educationally disadvantaged
p.000061: persons.
p.000061: The IRB guidebook is an excellent resource for consideration of concerns and elements for equitable
p.000061: participant selection (U.S. HHS, 1993). It states that “Defining the appropriate group of subjects
p.000061: for a research project involves a variety of factors⎯ requirements of scientific design,
p.000061: susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness.” The IRB
p.000061: guidebook raises a number of points to consider in the process for selection of human participants (see Text Box
p.000061: 5-5).
p.000061: Various participant recruitment strategies may be used depending on the type of research being performed and the
p.000061: population of interest. This section addresses the strategies and approaches for identifying and contacting people and
p.000061: subsequent recruitment into a research study. Sampling design approaches and issues, such as statistical
p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062: Text Box 5-5. IRB Guidebook Issues on Identifying Subjects
p.000062: 1. Who will bear the burden? Who will reap the benefits?
...

Health / Mentally Incapacitated

Searching for indicator incapable:

(return to top)
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
p.000035: interests, ethically perceptive researchers will plan and implement special provisions for the protection of the
p.000035: rights and welfare of the vulnerable persons.
p.000035:
p.000035: Text Box 3-1. Potentially Vulnerable Groups Identified in U.S. Regulations
p.000035:
p.000035: Text Box 3-2. Potentially Vulnerable Groups Identified in International Guidance
...

p.000035: presented in the Common Rule. It is not adequate to simply check the list in Text Box 3-1 to identify if a potentially
p.000035: vulnerable group is included in an observational study. The researchers should assess the potential
p.000035: vulnerability of a study population within the study by evaluating the characteristics (e.g., socioeconomic
p.000035: status) of the study population within the context of the study by considering the various design elements of the
p.000035: study, as discussed in Section 2.
p.000035: 12 In the commentary on Guideline 13 in CIOMS (2002), the committee states that the central problem presented by plans
p.000035: to involve vulnerable persons as research subjects is that such plans may entail an inequitable distribution of the
p.000035: burdens and benefits of research participation. Classes of individuals conventionally considered vulnerable are those
p.000035: with limited capacity or freedom to consent or to decline to consent. They are the subject of specific guidelines in
p.000035: the CIOMS document (Guidelines 14 and 15) and include children, and persons who, because of mental or behavioral
p.000035: disorders, are incapable of giving informed consent. Ethical justification of their involvement usually requires that
p.000035: • the research could not be carried out equally well with less vulnerable subjects;
p.000035: • the research is intended to obtain knowledge that will lead to improved diagnosis, prevention, or treatment of
p.000035: diseases or other health problems characteristic of, or unique to, the vulnerable class—either the actual subjects or
p.000035: other similarly situated members of the vulnerable class;
p.000035: • research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily be
p.000035: assured reasonable access to any diagnostic, preventive, or therapeutic products that will become available as a
p.000035: consequence of the research;
p.000035: • the risks attached to interventions or procedures that do not hold out the prospect of direct health-related
p.000035: benefit will not exceed those associated
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: CIOMS recommendations, although written to address biomedical research, also generally are
p.000036: applicable to observational human exposure studies. The authors of this document consider the CIOMS
p.000036: requirement that the research could not be carried out equally well with less vulnerable subjects
...

Health / Motherhood/Family

Searching for indicator family:

(return to top)
p.000026: study design.
p.000026: For research conducted or sponsored by NERL, human subjects research efforts will undergo both a
p.000026: scientific review and an ethical review. The director of
p.000026: the division conducting or funding the observational research is the manager with the primary
p.000026: responsibility for ensuring that the scientific and the ethical reviews are conducted, and that the review
p.000026: comments are properly addressed. The study design will be reviewed for scientific quality by
p.000026: independent and knowledgeable reviewers. Depending on the scope of the study, the appropriate NERL
p.000026: associate director or the NERL laboratory director will make the final determination about (1) the
p.000026: process for selecting scientific peer reviewers (including the range of disciplines to be
p.000026: included), (2) the nature and scope of the review process (e.g., charge to the reviewers and scope of the
p.000026: review; letter reviews, convening a peer panel, or both; the size and nature of the panel review; etc.),
p.000026: and (3) the adequacy of the responses to the scientific review.
p.000026:
p.000026: 2.5.2 Conflicts of Interest
p.000026: It is recommended that potential conflicts of interest among researchers or study participants be identified at all
p.000026: stages of study planning and implementation, but particularly early in the study during the planning stage. There
p.000026: can be many sources of potential conflicts of interest, including sources of project funding, pressures
p.000026: to publish, consulting arrangements of the investigators, employment of investigators’ family members with
p.000026: affected parties, participation in affected advocacy groups, collaborations or relationships with
p.000026: experts on the IRB or other independent review committees, institutional conflicts for any contractors
p.000026: who may be involved, or a wide range of other situations.
p.000026: Any situations that constitute actual conflicts of interest and all potential or apparent conflicts of interest
p.000026: must be reported to the IRB for their review and resolution. The CIOMS (2002) guidelines for
p.000026: research protocols involving human subjects specify that all sponsors of the research be identified,
p.000026: and that the protocol include actions to disclose and address potential conflicts of interest. Concerns about
p.000026: conflicts of interest also need to be identified and discussed with the researchers, community, and
p.000026: other stakeholders to make a determination of the existence of conflicts, and how they should be avoided or
p.000026: handled.
p.000026: Even if actual conflicts of interest do not exist, researchers should recognize that there can be perceived
p.000026: conflicts of interest that can be just as damaging as real conflicts of interest. Perceptions by
p.000026: participants, community members and representatives, stakeholder groups, and the public may be substantially
p.000026: different from the reality of the situation. This is especially likely to occur when external sources, such as
p.000026: industry, are
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: involved in funding research. Even though researchers may develop agreements with funding organizations that
...

p.000037: not to include them. Proposals or applications to NIH for research have to present an acceptable
p.000037: justification if children will be excluded from a research study. Of course, as discussed above, if the research
p.000037: topic is irrelevant to children, the CIOMS guidelines would recommend that they be excluded from the
p.000037: research.
p.000037: Observational human exposure studies conducted by NERL are not expected to involve greater than minimal risk. It
p.000037: will be the responsibility of the NERL researchers to present adequate information for the IRB to
p.000037: demonstrate that the research does not involve greater than minimal risk. Researchers designing observational
p.000037: research studies should carefully evaluate the risks and benefits specific to their study and the
p.000037: participants involved. In developing the study design and human subjects protocols, researchers need to
p.000037: ensure that the protocols ensure the protection of the rights and welfare of the participant children, and that
p.000037: risks and harm are minimized. The perception of risks and benefits, both by
p.000037: the individual and by the family or community, may influence the risk-benefit determination. It may prove
p.000037: useful for the research team to consult with other experienced researchers who have conducted
p.000037: similar studies and with members of the IRB to ensure that the information included in the human subjects
p.000037: research protocol is adequate for the IRB’s review.
p.000037: It is recommended that researchers consider all of the potential issues associated with involvement
p.000037: of children in their studies in developing the study design and research protocols, including the role of the
p.000037: family. EPA’s human subjects rule for observational research not involving greater than minimal risk to
p.000037: children (40 CFR 26.404) (i.e., the kinds of observational human exposure studies that NERL exposure research
p.000037: is likely to entail) focuses on obtaining assent of the children and permission of their parents or guardians. But the
p.000037: role of the family goes far beyond their involvement in the informed consent process. In observational
p.000037: human exposure studies, even when children are the participants, the parents or guardian play
p.000037: a key role in the collection of data and information during the study. For studies with very young children,
p.000037: family members supply all of the information relevant to the child. NERL researchers need to ensure that both
p.000037: the child and the parents or guardians and other caregivers are informed fully and are willing
p.000037: participants. Without their willing participation, the research cannot be successful.
p.000037:
p.000037: 3.5 Women as Research Subjects
p.000037: Women are routinely included as research participants in observational human exposure studies.
p.000037: However, pregnant women and their fetuses are vulnerable groups and require special protections.
p.000037: EPA’s human subjects rule prohibits intentional dosing studies and provides additional controls for
p.000037: observational research (40 CFR 26, Subparts B and C).
p.000037: CIOMS (2002) includes two guidelines for biomedical research involving women as research
p.000037: subjects. The first of these, number 16, states that women should not be excluded from
p.000037: biomedical research because of the potential for becoming pregnant during a study. The document continues, “A
...

p.000041: sensitive to and respectful of the host’s customs and values” (p. 65, NRC & IOM, 2005).
p.000041: By their very nature, observational human exposure studies encroach on the privacy of a research participant. Entry in
p.000041: a participant’s home (or other personal zones) does represent a loss of privacy, but researchers should be
p.000041: careful to ensure that their presence does not become a violation of the individual’s right to privacy. The
p.000041: relationship between the researcher and the participant may be complicated, and there may be conflicts between
p.000041: the researcher’s role and their ethical obligations (NRC & IOM, 2005). In entering a participant’s
p.000041: personal space, it may be difficult, or impossible, to avoid making observations unrelated to the research question,
p.000041: thereby further intruding on the participant’s personal privacy. Indeed, there may be ethical and legal
p.000041: obligations for the researchers to respond to those observations. Beauchamp and Childress suggest that “policies
p.000041: carefully specify the conditions of access that will and will not count as a loss of privacy or a violation of
p.000041: the right to privacy. The policy should accurately define the zones that are considered private and
p.000041: not to be invaded, and should also identify interests that legitimately may be balanced against privacy
p.000041: interests” (Beauchamp and Childress, 2001).
p.000041: Observational human exposure studies also may infringe on the privacy of other individuals, for example,
p.000041: other members of the participant’s family or household. Researchers should strive to minimize the intrusion and loss
p.000041: of privacy and to show respect for the privacy of study participants and third parties at all times (see Text
p.000041: Box 4-2 for a list of relevant privacy issues). It is incumbent on the researcher to recognize privacy issues
p.000041: in the design and implementation of the research study. The NRC & IOM report suggests that researchers
p.000041: anticipate the ethical issues that arise from conducting research in a person’s home, and that they take steps
p.000041: to correct them (1) by thinking through the issues as part of the study design; (2) by discussing the issues during the
p.000041: informed consent process; and (3) by ensuring that the frontline staff that enter a
p.000041: participant’s home “understand their role as members of the research team, how that role differs from the role of
p.000041: neighbor or friend, and how they should respond when they make observations that are not part
p.000041: of the protocol” (p. 66, NRC & IOM, 2005).
p.000041:
p.000041: Text Box 4-2. Privacy Issues
p.000041: • Researchers should develop an anticipatory plan for how to deal with privacy issues during the study. The plan
p.000041: should include a list of potential observations that could be of concern and a plan for how they will be handled.
p.000041: • The plan needs to address both the legal and ethical obligations of the researcher in response to situations where
p.000041: privacy is compromised.
p.000041: • Privacy issues will vary depending on the culture of the population being studied. What one individual or group
...

p.000043: identification of a research subject.
p.000043: Federal funding is not a prerequisite for a certificate. A Certificate of Confidentiality does not
p.000043: diminish, however, the investigator’s need to protect the personally identifiable information as
p.000043: described above.
p.000043:
p.000043: 4.2.2 Confidentiality of Participation
p.000043: In some types of research, the knowledge that a person is participating in a particular research study
p.000043: could, potentially, put the participant at risk for harm or distress. This topic is discussed in The
p.000043: Institutional Review Board Guidebook, with special emphasis on behavioral and social research that deals
p.000043: with sensitive topics (U.S. HHS, 1993). The guidebook describes the need for additional safeguards to
p.000043: protect and prevent disclosure of the identity of participants, including the use of Certificates of
p.000043: Confidentiality for sensitive matters.
p.000043: Observational human exposure studies often pose particular challenges with regard to limiting
p.000043: dissemination of the knowledge of an individual’s participation in the study. Visiting the
p.000043: research participant’s residence to collect samples or to make observations will necessitate informing
p.000043: other family members or occupants about the visit and study procedures. Research participants may be
p.000043: asked to wear personal monitors over time periods ranging from a day to a week or more. Wearing these devices
p.000043: in public places, schools, or workplaces may identify them as a study participant or generate questions
p.000043: regarding the activity. Field staff visits to the participant’s home or setting up outdoor sample collection
p.000043: devices around the home also might disclose their participation. And, in some cases, third parties outside of
p.000043: the home have to be asked for permission or be informed that monitoring activities are taking place.
p.000043: Researchers and IRBs should consider whether knowledge of an individual’s participation by others might
p.000043: create potential for harm or distress in an observational human exposure study. Such risks might
p.000043: be limited to possible discomfort in attracting unwanted
p.000043: attention; this may be particularly true for adolescents. However, in some cases, the potential risks
p.000043: could be greater, for example, in cases where participation could provoke an adverse reaction from a
p.000043: landlord or employer. Oftentimes study protocols can be structured to minimize these potential risks. Through the
p.000043: informed consent process, prospective participants should be made aware of the limits of the researcher’s ability to
...

p.000058: to expose their children to unacceptable risks” (NRC & IOM, 2005). The NRC & IOM committee recognized
p.000058: that some commentators argued that children should never be paid, and that parents ought not to be paid to
p.000058: enroll their children in research. Yet, on balance, the committee felt that “reimbursement for expenses and some
p.000058: modest payment for time spent in research
p.000058: 21 The IOM Recommendation 6.2 states, “In addition to offering small gifts or payments to parents and children as
p.000058: gestures of appreciation, investigators may also—if they minimize the potential for undue influence—act ethically to
p.000058: reduce certain barriers to research participation when they
p.000058: • reimburse reasonable expenses directly related to a child’s participation in research
p.000058: • provide reasonable, age-appropriate compensation for children based on the time involved in research that does not
p.000058: offer the prospect of direct benefit, and
p.000058: • offer evening or weekend hours, on-site child care, and other reasonable accommodations for parental work and
p.000058: family commitments.”
p.000058: 22 In recommending an open process, the IOM committee chose to reject the
p.000058: arguments from the American Academy of Pediatrics that “any token payment to children for participating in research
p.000058: should not be discussed with them until after research is completed for fear of unduly influencing their decisions
p.000058: (AAP, 2003)…. On balance, the committee agrees that it is best to mention token or other payments during the permission
p.000058: and assent processes” (p. 215, IOM, 2004).
p.000058: The IOM Recommendation 6.1 states, “Institutional review boards, research institutions, and sponsors of research that
p.000058: includes children and adolescents should adopt explicit written policies on acceptable and unacceptable types and
p.000058: amounts of payments related to research participation. These policies should specify that investigators
p.000058: • Disclose the amount, the recipient, the timing, and the purpose (e.g., an expense reimbursement or a token of
p.000058: appreciation to a child) of any payments as part of the process of seeking parents’ permission, and, as appropriate,
p.000058: children’s assent to research participation;
p.000058: • Avoid emphasis on payments or descriptions of payments as benefits of participating in research during the
p.000058: permission or assent procedures; and
p.000058: • Obtain institutional review board approval for the disclosure of information about payments in advertisements and
p.000058: in permission and assent forms and procedures.”
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: participate in research are unacceptable. The European Union requires that clinical trials on minors
p.000059: be undertaken only if “no incentives or financial inducements are given except compensation”
p.000059: (European Parliament, 2001).
p.000059: Payment for participation of children in research also is discussed in the literature. Diekema
p.000059: (2005) emphasizes the need to ensure that payments do not distort parental decisionmaking and do not tempt
p.000059: parents to consider other issues than the welfare of their child. Similarly, Menikoff (2005) suggested that
p.000059: there need to be relatively robust protections in place to ensure that families do not change their behaviors
p.000059: to participate in a study. He suggested that these may include determining payment as a percentage of a family’s
p.000059: income and developing criteria for documenting that behaviors have not changed to be eligible for participation in a
p.000059: study. He suggested that, for a study of pesticides, potential study participants provide documentation (such as
p.000059: receipts) that they routinely have been using a commercial pesticide service. This may be difficult
p.000059: for potential participants to do if they do not save receipts, and it would exclude all potential
p.000059: participants who purchase products and apply pesticides themselves. This likely would affect the study
p.000059: objectives and generalizability of the data collected. A survey of investigators (Iltis et al., 2006) found that
p.000059: payments were made in 52% of the pediatric research studies surveyed, and that payment practices varied,
p.000059: as did the reasons for decisions regarding payments. They found a range of payment values separated
p.000059: across cash, gifts, items, vouchers, and other categories. A survey of IRBs (Weise et al., 2002) found that payment
p.000059: for participation in research was allowed by 66% of responding institutions, but that many IRBs did not have
p.000059: specific policies, and that there was considerable variability regarding the basis for decisions on
p.000059: payments in studies with children. The types of payments included money, certificates, and bonds with large
p.000059: ranges in the amounts of payments for approved pediatric research. This research shows a lack of consistency and
p.000059: the need for guidance and institutional policies that describe acceptable and unacceptable
...

p.000178: questionnaires, were administered to each selected subject and household, respectively, and meteorological and air
p.000178: exchange rate data were recorded for each monitored home.
p.000178: This survey collected 24-hour activity diaries and other questionnaire data from participants from 48 states. It was
p.000178: conducted as a next-day telephone recall interview.
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000100: 100
p.000100:
p.000100: Table A-1. (Continued)
p.000100: Study Date Size Type Brief Description
p.000100: NERL Role
p.000100: Agricultural 1993- 84 applicators AHS survey A large-scale, long-term ongoing study of
p.000100: Iowa and North Collaboration with Health Study present; and a subset is a
p.000100: Carolina pesticide applicators and farm families. This other agencies; (AHS)
p.000100: PES 1999- of family longitudinal collaborative effort involving the National Cancer Institute
p.000100: NERL led a
p.000100: 2003 members in study of (NCI), the National Institute of Environmental Health Sciences
p.000100: contractor-
p.000100: PES pesticide (NIEHS), the National Institute for Occupational Safety and
p.000100: conducted applicators in Health (NIOSH), and the U.S. Environmental Protection substudy called two
p.000100: states. Agency (EPA) examines how lifestyle habits, genetic factors, the Pesticide PES, led by and
p.000100: agricultural exposures contribute to the risk of disease Exposure Study.
p.000100: NERL, was a using questionnaire survey data from 89,658 participants. This
p.000100: cross- is the largest, most comprehensive study of agricultural health sectional ever conducted
p.000100: in the United States. The interagency exposure study. assessment study (Pesticide Exposure Study (PES)),
p.000100: led by
p.000100: NERL, was performed to assess exposures and exposure
p.000100: classification procedures used in the epidemiological study.
p.000100: The National 1995-1998 See specifics A Federal interagency research effort
p.000100: coordinated by EPA and EPA oversaw Human in entries
p.000100: consisting of four demonstration studies using probability- general design for Exposure
p.000100: below. based sampling designs conducted in partnership
p.000100: with other the research, then Assessment
p.000100: Federal agencies (CDC, FDA, and NIST), universities, and solicited, evaluated
...

p.000111: that permission will be obtained from a duly authorized person, or, in the case of a child who is sufficiently mature
p.000111: to understand the implications of informed consent but has not reached the legal age of consent,
p.000111: that knowing agreement, or assent, will be obtained, as well as the permission of a parent, or a legal guardian
p.000111: or other duly authorized representative.
p.000111: (26) An account of any economic or other compensation or incentives to prospective subjects to participate, such as
p.000111: offers of cash payments, gifts, or free services or facilities, and of any financial
p.000111: obligations assumed by the subjects, such as payment for medical services
p.000111: (27) The plans and procedures and the persons responsible for communicating to
p.000111: subjects information arising from the study (on harm or benefit, for example) or from other research on the same
p.000111: topic that could affect subjects’ willingness to continue in the study
p.000111: (28) The plans to inform subjects about the results of the study
p.000111: (29) The provisions for protecting the confidentiality of personal data and respecting the privacy of subjects,
p.000111: including the precautions that are in place to prevent disclosure of the results of a
p.000111: subject’s genetic tests to immediate family relatives without the consent of the subject
p.000111: (30) Information about how the code, if any, for the subjects’ identity is established; where it will be
p.000111: kept; and when, how, and by whom it can be broken in the event of an emergency
p.000111: (31) Any foreseen further uses of personal data or biological materials
p.000111: (32) A description of the plans for statistical analysis of the study, including plans for interim analyses, if
p.000111: any, and criteria for prematurely terminating the study if necessary
p.000111: (33) A list of the references cited in the protocol
p.000111: (34) The source and amount of funding of the research, including the organization that is sponsoring the research
p.000111: and a detailed account of the sponsor’s financial commitments to the research institution,
p.000111: the investigators, the research subjects, and, when relevant, the community
p.000111: (35) The arrangements for dealing with financial or other conflicts of interest that might affect
p.000111: the judgment of investigators or other research personnel, including informing the institutional
p.000111: conflict-of-interest committee of such conflicts of interest; the communication by that committee of the
p.000111: pertinent details of the information to the ethical review committee; and the transmission by that committee to
p.000111: the research subjects of the parts of the information that it decides should be passed on to them
p.000111: (36) The time schedule for completion of the study
p.000111: (37) Particularly in the case of an industrial sponsor, a contract stipulating who possesses the
...

Health / Physically Disabled

Searching for indicator illness:

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p.000088: information on risk communication. Readers of this document should refer to her manuscript to determine
p.000088: which approach may be applicable to their particular study.
p.000088: During longitudinal studies with repeated measurements over months, seasons, or years, it
p.000088: is important that researchers commit to providing interim and ongoing results to participants and the community
p.000088: as the study proceeds. It is important to maintain the researcher-participant relationship throughout
p.000088: the study. This can be facilitated by keeping study participants informed of the study progress and of the
p.000088: interim results
p.000088: Researchers also should recognize that there may be potential risks to the study participants, third parties, or the
p.000088: community because of results generated from a study (refer to Text Box 7-7). Therefore, providing
p.000088: information to communities has to be done thoughtfully and with appropriate preparation. Processes should be
p.000088: developed that provide participants with the option to receive, or decline, study results. Researchers
p.000088: should work with community groups to determine how study results should be disseminated to the community
p.000088: and what communications strategies should be used.
p.000088:
p.000088: Text Box 7-7. Potential Harms of Sharing Research Results with Participants
p.000088: (Fernandez, Kodish, and Weijer, 2003)
p.000088: • Incorrect or harmful decisions based on uncertain or unreliable results
p.000088: • Causing distress for those participants who did not benefit from the research
p.000088: • Rekindling old memories and emotions, especially in the setting of serious illness
p.000088: • Emotional distress among community members
p.000088: • Possible discrimination in obtaining employment or insurance for a participant identified by the research to be at
p.000088: high risk of developing complications
p.000088: • Financial costs to participants and to researchers
p.000088:
p.000088: There are a variety of methods for providing study results to participants and the community. Fact
p.000088: sheets can be used to describe the study and provide general study findings to the community and
p.000088: stakeholders.
p.000088:
p.000088:
p.000089: 89
p.000089:
p.000089: Individualized fact sheets can be used to disseminate results to the individual participants. Meetings
p.000089: with study participants have been used to disseminate study information. Community meetings also can be
p.000089: used to provide updates on study progress and general results.
p.000089: Examples of the processes and the materials used for dissemination of information are included in case studies
p.000089: described by Israel et al. (2005) and others conducting CBPR studies.
p.000089: Overall study results generally are disseminated in peer-reviewed journal manuscripts and study reports. The
p.000089: availability of results published in manuscripts and reports has been greatly enhanced by posting them on
p.000089: Internet Web sites. For example, all EPA reports are now available electronically via EPA’s National Service
p.000089: Center for Environmental Publications Web site (http://www.epa.gov/ncepihom/).
p.000089:
p.000089: 7.8 Reporting Unanticipated Results or Observations
...

p.000009: Performed in the Raleigh, NC, area in homes with children 1 to 3 years old. Homeowners reported either professional or
p.000009: self applications of diazinon. Goals of the study were to evaluate methods to measure excess dietary exposures
p.000009: resulting from food-handling activities by young children during eating and to assess whether the Children’s Dietary
p.000009: Intake Model (CDIM) accurately represents total dietary exposures of children. Study resulted in refinements of model
p.000009: parameters for transfer and activity.
p.000009: Observational measurement study of exposure to chlorpyrifos among children 2-5 years of age in urban New Jersey homes
p.000009: following crack and crevice treatment by a professional applicator. Study investigated decay of pesticide levels over
p.000009: time, transfer of pesticide from microenvironmental media to child, and factors that affect transfer. Dermal transfer
p.000009: evaluated with surface wipes, hand wipes, dermal wipes, cotton garments, and videotaping.
p.000009: Physicians at Case-Western Reserve treating children with idiopathic pulmonary hemorrhage evaluated the nature of the
p.000009: fungus found in homes of the afflicted and control children to determine if Stachybotrys was a potential factor in the
p.000009: illness. Three of the 8 cases, and none of the controls, had Stachybotrys strains that potentially were implicated.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: The largest children’s exposure study undertaken to date. It examines aggregate exposures of children 18 months to 5
p.000009: years to pollutants commonly found in everyday environments. The major objectives were to quantify children’s aggregate
p.000009: exposures, apportion exposure pathways, and identify important exposure media. Participants were recruited from 12
p.000009: urban and rural counties in North Carolina and Ohio using a random digit dialing method. Monitoring was performed at
p.000009: both daycare centers and homes. Samples collected include food, beverages, indoor air, outdoor air, hand wipes, dust,
p.000009: soil, transferable residues, floor and surface wipes, and urine. The samples were analyzed for more than 40 pollutants,
p.000009: including insecticides, phthalate esters, phenols, polychlorinated biphenyls, and PAHs.
p.000009: Scientists monitored air pollutants inside and outside vehicles of healthy highway patrol officers in North Carolina
p.000009: while troopers were on patrol for 9-hour shifts and examined cardiovascular effects. The findings indicated that people
p.000009: driving in motor vehicles are exposed to PM2.5 and other pollutants generated from motor vehicles, and that these
p.000009: exposures appear to cause cardiovascular changes.
p.000009:
p.000009:
p.000102: 102
p.000102: with contractor support; funded and collaborated on others with Harvard School of Public Health, University. of
p.000102: Washington, and NYU.
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: NERL designed, contractor conducted
p.000102:
...

Searching for indicator physically:

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p.000040: research and explores the researchers’ responsibilities that derive from conducting research in people’s homes
p.000040: (NRC & IOM, 2005). These housing-related discussions are particularly relevant to observational human
p.000040: exposure studies, which often include environmental and
p.000040: biological measurements in people’s homes or personal locations. Many of the topics identified in that report are
p.000040: discussed in this section (Text Box 4-1).
p.000040:
p.000040:
p.000040: Text Box 4-1. Topics in Section 4
p.000040: Privacy Issues Confidentiality
p.000040: Confidentiality of Information Confidentiality of Participation
p.000040: Collateral Observations
p.000040: Potential Nonstudy Hazards in the Residence Collateral Observations with Mandated Reporting
p.000040: Requirements
p.000040: Hazard Communication Planning and Staff Training
p.000040: Third-Party Issues
p.000040: Determining Whether a Third Party is a Human Subject Informing Third Parties of Research Activities Research Results
p.000040: and Third Parties
p.000040: Data and Safety Monitoring and Oversight
p.000040:
p.000040:
p.000040:
p.000040: 4.1 Privacy Issues
p.000040: Privacy refers to an expectation that a person is free from intrusion into personal matters and is free from the
p.000040: presence or view of others. The Institutional Review Board Guidebook defines privacy as “control over the
p.000040: extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with
p.000040: others” (U.S. HHS, 1993). Beauchamp and Childress find that the right to privacy is based on the principle of
p.000040: respect for autonomy. “We often respect persons by respecting their autonomous wishes not to be observed, touched, or
p.000040: intruded upon…. A loss of privacy occurs if others use any of several forms of access, including intervening in zones
p.000040: of secrecy, anonymity, seclusion, or solitude” (pp. 295-296, Beauchamp and Childress, 2001).
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041: Although research participants may agree to allow researchers to enter their home or other zone of personal space
p.000041: to conduct their research measurements, they have not abrogated their right to privacy. “When individuals
p.000041: voluntarily grant others some form of access to themselves, their act is an exercise of the
p.000041: right to privacy, not a waiver of that right” (p. 297, Beauchamp and Childress, 2001). Researchers should remember
p.000041: that they are guests in the homes for a specific purpose. “When people visit a home, there are social
p.000041: expectations about what is acceptable behavior. People who are invited into a home are expected to be
p.000041: sensitive to and respectful of the host’s customs and values” (p. 65, NRC & IOM, 2005).
...

p.000042: to maintain confidentiality should be anticipated and disclosed to prospective subjects.”
p.000042: to identify an individual. Precise geographic location information may be sufficient to pinpoint a
p.000042: residence. Researchers may use several strategies to reduce the likelihood of indirect identification when
p.000042: study results are reported (see, also, Text Box 4-3).
p.000042: • Redact from publications, reports, or public data sets information that might be used to indirectly identify a
p.000042: research participant.
p.000042: • Generalize exact information; for example, replace birth date with age or year of birth or classify age as
p.000042: part of a range.
p.000042: • Aggregate information across individuals; for example, only report data in cells of sufficient size
p.000042: to make individual linkages unlikely.
p.000042: • Reduce the specificity of geographic coordinate information to a level that a specific residence or other
p.000042: location can not be identified.
p.000042:
p.000042: Text Box 4-3. Approaches for Protecting Personally Identifiable Information
p.000042: • Developing procedures for safeguarding information prior to collecting the information
p.000042: • Ensuring that data or samples are anonymous by not collecting or by destroying identifying information or linkages
p.000042: • Restricting access to identifying information to only those requiring access
p.000042: • Assigning codes to participants, data, and samples rather than using identifiers
p.000042: • Physically separating identifying information and linkage files from other study information
p.000042: • Securing identifying information in locked files with limited access
p.000042: • Restricting identifying information from computers that are networked with other computers or electronic systems
p.000042: • Restricting identifying information from computers that are not kept in secure locations with limited access
p.000042: • Training research staff members on human subject protection and on information security procedures
p.000042:
p.000042:
p.000042: Another step that can help protect confidentiality is to obtain a Certificate of Confidentiality. Certificates of
p.000042: Confidentiality are issued by NIH (2002) to protect identifiable research information from forced disclosure.
p.000042: They allow the investigator and others who have access to research records to refuse to disclose identifying
p.000042: information on research participants in any civil, criminal, administrative, legislative, or other
p.000042: proceeding, whether at the Federal, State, or local level. Certificates of Confidentiality may be granted for studies
p.000042: collecting information that, if disclosed, could have adverse consequences for subjects or damage
p.000042: their financial standing, employability, insurability, or reputation. By protecting researchers and
p.000042: institutions from being
p.000042:
p.000042:
...

p.000117: research involving human subjects, the principle refers primarily to distributive justice, which requires the equitable
p.000117: distribution of both the burdens and the benefits of participation in research. Differences in distribution of burdens
p.000117: and benefits are justifiable only if they are based on morally relevant distinctions among persons.
p.000117: Minimal risk. The probability and magnitude of harm or discomfort anticipated in the research are not greater in and
p.000117: of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000117: psychological examinations or tests [40 CFR 26.102(i)].
p.000117: Nonmaleficence. The proscription of deliberate infliction of harm on persons
p.000117: Observational human exposure study. Studies that involve collection of human exposure data (including environmental,
p.000117: biological, survey, activity, and various other forms of data) under real-world field conditions during normal
p.000117: participant day-to-day activities, with no additional exposures to the chemical being studied because of participation
p.000117: in the study. The studies involve interaction with study participants but do not involve intervention or manipulation
p.000117: of the factors being studied, and there is no attempt by the researcher to affect the outcome.
p.000117: Observational research. Any human research that does not meet the definition of research involving intentional
p.000117: exposure of a human subject [40 CFR 26.302]
p.000117: Privacy. Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or
p.000117: intellectually) with others
p.000117: Research. A systematic investigation, including research development, testing, and evaluation, designed to develop or
p.000117: contribute to generalizable knowledge
p.000117: Research involving intentional exposure of a human subject. A study of a substance in which the exposure to the
p.000117: substance experienced by a human subject participating in the study would not have occurred but for the human subject’s
p.000117: participation in the study [40 CFR 26.202(b)]
p.000117: Respect for persons. A fundamental ethical value that is the basis of much of modern bioethical thought and
p.000117: regulation. The concept incorporates at least two fundamental ethical considerations, namely (1) respect for autonomy,
p.000117: which requires that those who are capable of deliberation about their personal choices should be treated with respect
p.000117: for their capacity for self- determination; and (2) protection of persons with impaired or diminished autonomy, which
p.000117: requires that those who are dependent or vulnerable be afforded security against harm or abuse.
p.000117: Source. The origin of an agent for the purposes of an exposure assessment
...

Health / Pregnant

Searching for indicator pregnant:

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p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
p.002005: potential ethical concerns, such as issues involving adequacy of informed consent, parents' perception of risk, duties
p.002005: of researchers to child subjects and their parents, the role of IRBs, and the authority of parents to provide
p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
p.000003: range of risks associated with participation and the voluntary nature of participation, and provides
...

p.000008: Resolved questions in NAS review of PM science and provided a “generally consistent finding that ambient particle
p.000008: concentrations are a key determinant of the longitudinal variation in personal exposure.” (NRC, 2004). These results
p.000008: have been instrumental in support of the National Ambient Air Quality Standard for PM (U.S. EPA, 1999).
p.000008:
p.000008:
p.000008: Volatile Organic Compounds (VOCs)
p.000008:
p.000008: EPA's Total Exposure Assessment Methodology (TEAM) studies found levels of about a dozen common organic pollutants to
p.000008: be 2- to 5-times higher inside homes than outside. Use of products containing organic chemicals may result in very high
p.000008: and persistent pollutant levels.
p.000008:
p.000008: EPA, States, and the Consumer Product Safety Commission worked together to influence manufacturers to voluntarily
p.000008: reduce emissions of toxic chemicals from consumer products, building materials, and furnishings, and to develop
p.000008: mitigation strategies and educational materials to teach people how to reduce their contact with chemicals indoors. As
p.000008: a result, contact with toxic chemicals indoors has been reduced (see www.cpsc.gov/CPSCPUB/PUBS/450.html).
p.000008:
p.000008:
p.000008: Formaldehyde
p.000008:
p.000008: Studies found elevated formaldehyde levels indoors and helped identify indoor sources.
p.000008:
p.000008: EPA worked with HUD, CPSC, and other agencies to limit formaldehyde in building or consumer products and to educate the
p.000008: public on how to reduce exposures (see www. epa.gov/iaq/formalde.html).
p.000008:
p.000008:
p.000008: EPA has adopted additional protections for children and pregnant or nursing mothers in Subparts B through
p.000008: D. These sections apply to all research either conducted or funded by EPA and are, therefore, directly applicable to
p.000008: NERL’s observational human exposure studies.4 Subpart B prohibits EPA from conducting or supporting research
p.000008: that involves intentional exposure of “a pregnant woman (and, thereby, her fetus), a nursing woman,
p.000008: or a child.” NERL researchers conducting (or funding) observational human exposure studies must comply
p.000008: with all of these regulatory requirements, including seeking review and approval by an IRB and by the
p.000008: Agency’s Human Subjects Research Review Official (HSRRO) before beginning any human subjects research.
p.000008: EPA’s human subjects rules also define a variety of fundamental terms⎯from “human subject” to “research” to
p.000008: “intentional exposure” to “observational research.” Understanding these regulatory definitions is vital for
p.000008: NERL researchers to comply with the regulatory requirements.5
p.000008: To more effectively ensure the protection of human subjects, NERL scientists and managers need to
p.000008: understand the ethical principles and issues that prompted the development of the
p.000008: regulatory requirements in the first place and to be knowledgeable
p.000008:
p.000008:
p.000008: 4 Subparts K, L, M, O, P, and Q of 40 CFR 26 set basic ethical requirements that have to be met if human subjects data
p.000008: from a person or group external to EPA and not funded by EPA (a third party) are to be used by EPA in specified
p.000008: rulemaking actions. These subparts do not apply to NERL researchers and will not be discussed further in this
p.000008: document.
p.000008: 5 The Glossary (Appendix F) lists definitions for a number of important terms; definitions that come from the
...

p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
p.002005: potential ethical concerns, such as issues involving adequacy of informed consent, parents' perception of risk, duties
p.002005: of researchers to child subjects and their parents, the role of IRBs, and the authority of parents to provide
p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000012: 12
p.000012:
p.000012: address all of the relevant issues for their particular study to ensure that the specific elements of
p.000012: the study will safeguard and protect the human research subjects.
p.000012: In addition to being an information resource for NERL researchers, this document provides useful
p.000012: information for contractors and grantees funded by NERL to consider during the design and implementation of
p.000012: their exposure science research. Although not its intended audience, this document also may prove to be useful
p.000012: to other researchers, within and outside of EPA, who are involved in observational human exposure
p.000012: studies.
p.000012:
p.000012: 1.4 Process for Developing the Document
...

p.000033: populations are not targeted for risky research” [emphasis added] (Emanuel et al., 2000).
p.000033: The Common Rule requires IRBs to assure that “additional safeguards have been included in the study to protect
p.000033: the rights and welfare of these [vulnerable] subjects” [at 40 CFR 26.111(b) in CFR, 2006a]. If an
p.000033: observational human exposure study includes vulnerable research participants, it is essential that the investigators be
p.000033: cognizant of the special issues and requirements of research involving vulnerable populations. Researchers
p.000033: have to justify the involvement of vulnerable populations in the research study and
p.000033: include the appropriate safeguards for protection of their safety and welfare. The Common Rule protections are
p.000033: discussed further in the IRB guidebook (U.S. HHS, 1993). EPA regulations include not only the general
p.000033: protections for vulnerable populations found in the Common Rule (Subpart A) but also define
p.000033: additional protections for children and for pregnant or nursing women (and their fetus or nursing child)
p.000033: in Subparts B, C, and D (CFR, 2006a).
p.000033: The section begins by identifying or defining vulnerable groups and then discusses ethical issues that
p.000033:
p.000033:
p.000033: 11 For more information about these and other research scandals, see Ethical and Policy Issues in Research Involving
p.000033: Human Participants, Vol. I, Report and Recommendations of the National Bioethics Advisory Commission, Bethesda, MD,
p.000033: August, 2001. See p. 153 for information about the Willowbrook State School experiments. The report is available at
p.000033: www.bioethics.gov/reports/past_commissions/nbac_human_part.pdf (Accessed September 3, 2007).
p.000033: may be important in conducting observational human exposure studies involving those groups, especially
p.000033: children and pregnant women. The discussions about the ethical issues are based largely on EPA’s human subjects
p.000033: regulations and on the recommendations from the Council for International Organizations of
p.000033: Medical Sciences document, International Ethical Guidelines for Biomedical Research Involving Human
p.000033: Subjects (CIOMS, 2002).
p.000033:
p.000033: 3.1 Identification of Vulnerable Groups
p.000033: In the United States, human subjects regulations (45 CFR 46 and 40 CFR 26) do not formally define
p.000033: vulnerable populations. Instead, the Common Rule gives examples of potentially vulnerable groups (see Text Box 3-1).
p.000033: In addition, HHS extends added human subjects protections to pregnant women, human fetuses,
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
...

p.000035: rights and welfare of the vulnerable persons.
p.000035:
p.000035: Text Box 3-1. Potentially Vulnerable Groups Identified in U.S. Regulations
p.000035:
p.000035: Text Box 3-2. Potentially Vulnerable Groups Identified in International Guidance
p.000035: (Council for International Organizations of Medical Sciences, 2002)
p.000035:
p.000035: • Junior or subordinate members of a hierarchical group; examples include employees, students, members of the armed
p.000035: forces, police, and others who work for, or closely with re- searchers; they may have expectations of preferential
p.000035: treatment if they agree to participate or fear of disapproval or retaliation if they refuse to participate in a study.
p.000035:
p.000035: Common Rule: Examples of vulnerable groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: EPA extends stringent protections to these groups
p.000035: (40 CFR 26)
p.000035:
p.000035:
p.000035: HHS extends additional protections to these groups
p.000035: (45 CFR 46)
p.000035:
p.000035: Additional vulnerable groups in NIH training materials
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
...

p.000036: If such research does not hold out the prospect of direct benefit to the child, no increase whatsoever over
p.000036: minimal risk is permitted.
p.000036: However, many observational human exposure studies are developed specifically to study the exposures of
p.000036: selected vulnerable groups to chemicals and other environmental stressors in everyday environments. So,
p.000036: researchers should be prepared to address the issues associated with vulnerable groups in
p.000036: observational research. Furthermore, as discussed in Section 3.4, there has been increased concern in recent years that
p.000036: exclusion of vulnerable groups from research studies is not ethical. Failure to conduct research with vulnerable groups
p.000036: may deprive them of the benefits of research. NIH, for example, has a policy (NIH, 1998) with a
p.000036: goal of increasing participation of children in research.
p.000036:
p.000036: 3.3 Minimal Risk and Vulnerable Groups
p.000036: EPA has codified protections for children, pregnant or nursing women, and fetuses in Subparts B, C, and D of the EPA
p.000036: human subjects rule (40 CFR 26). Subpart B strictly prohibits research involving intentional exposure of children
p.000036: or pregnant or nursing women (and, therefore, exposure of her fetus).
p.000036: EPA’s regulations do allow for observational research involving fetuses and pregnant women (40 CFR 26
p.000036: Subpart C) or children (40 CFR 26 Subpart D) but with additional protections in place and with
p.000036: strict limitations on research that presents more than minimal
p.000036: risk (CFR, 2006a).13 When considering vulnerable groups, The Institutional Review Board Guidebook (U.S. HHS,
p.000036: 1993) states that “IRBs should therefore determine whether the proposed subject population would be more sensitive or
p.000036: vulnerable to the risks posed by the research as a result of their general condition or disabilities. If so, the
p.000036: procedures would constitute more than minimal risk for those subjects.”
p.000036: When conducting observational human exposure studies, it is recommended that researchers consult these
p.000036: regulations and guidebooks. NERL researchers also will need to ensure that all of the requirements in Subparts B, C,
p.000036: and D of the EPA Human Subjects Rule are met.
p.000036:
p.000036: 3.4 Research Involving Children
p.000036: Children long have been recognized as a vulnerable group in research studies. EPA and HHS both extend special
p.000036: protections to children (CFR, 2006a,b). There are many books, reports, and research manuscripts that
...

p.000037: is likely to entail) focuses on obtaining assent of the children and permission of their parents or guardians. But the
p.000037: role of the family goes far beyond their involvement in the informed consent process. In observational
p.000037: human exposure studies, even when children are the participants, the parents or guardian play
p.000037: a key role in the collection of data and information during the study. For studies with very young children,
p.000037: family members supply all of the information relevant to the child. NERL researchers need to ensure that both
p.000037: the child and the parents or guardians and other caregivers are informed fully and are willing
p.000037: participants. Without their willing participation, the research cannot be successful.
p.000037:
p.000037: 3.5 Women as Research Subjects
p.000037: Women are routinely included as research participants in observational human exposure studies.
p.000037: However, pregnant women and their fetuses are vulnerable groups and require special protections.
p.000037: EPA’s human subjects rule prohibits intentional dosing studies and provides additional controls for
p.000037: observational research (40 CFR 26, Subparts B and C).
p.000037: CIOMS (2002) includes two guidelines for biomedical research involving women as research
p.000037: subjects. The first of these, number 16, states that women should not be excluded from
p.000037: biomedical research because of the potential for becoming pregnant during a study. The document continues, “A
p.000037: general policy of excluding from such clinical trials women biologically capable of becoming pregnant is
p.000037: unjust in that it deprives women as a class of persons of the benefits of new knowledge derived from the
p.000037: trials.” The second relevant CIOMS guideline, number 17, asserts that, if involved in a research study,
p.000037: pregnant women should be fully informed, and included only if the
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: research benefits pregnant women and is thoroughly supported by reliable evidence in animal studies.
p.000038: Although the CIOMS guideline specifically addresses biomedical research, the ethical concepts
p.000038: behind the guidelines generally may be applicable to observational human exposure studies. EPA’s human
p.000038: subjects rule is completely consistent with the HHS rule in adding additional protections for pregnant women and
p.000038: fetuses involved in observational research (40 CFR
p.000038: 26.304 and 45 CFR 46.204). These additional protections (specified in 45 CFR 46.204 subparagraphs a
p.000038: through j) reflect the CIOMS recommendations by requiring: availability of data from previously conducted
p.000038: studies to assess the risk to pregnant women and fetuses; scientific necessity for inclusion of pregnant women and
p.000038: fetuses (i.e., providing benefit to the woman or fetus, or producing important, but otherwise unobtainable,
p.000038: biomedical knowledge); that risk is reduced to the least possible level for achieving the objectives of
p.000038: the research; and other protections.
p.000038:
p.000038: 3.6 Other Potentially Vulnerable Groups
p.000038: HHS specifies additional protections for prisoners as a potentially vulnerable group in Subpart C of 45 CFR
p.000038: 26. Additional requirements for other vulnerable groups in research studies are not specifically defined in either
p.000038: EPA’s or HHS’ human subjects rules. Nonetheless, other groups (as discussed in Section 3.1) may be considered to be
p.000038: vulnerable and, as such, may warrant additional consideration and protection as required in the Common Rule. For
p.000038: these other potentially vulnerable groups, such as employees, students, handicapped persons, mentally disabled
...

p.000051: be recommendations as ethical “best practices.”
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052:
p.000052: Text Box 5-2. Common Rule Requirements:
p.000052: Elements of Informed Consent
p.000052: (1) An explanation of the purposes of the research
p.000052: (2) The expected duration of the subject's participation
p.000052: (3) A description of the procedures to be followed and identification of any experimental procedures
p.000052: (4) A description of any reasonably foreseeable risks or discomforts to the subject
p.000052: (5) A description of any reasonably expected benefits to the subject or others
p.000052: (6) A disclosure of appropriate alternative procedures that might be advantageous to the subject
p.000052: (7) A description of the extent that confidentiality will be maintained
p.000052: (8) For research involving more than minimal risk, an explanation about whether compensation or medical treatments
p.000052: are available if injury occurs
p.000052: (9) An explanation of whom to contact with questions about the research or to report a research-related injury
p.000052: (10) A statement that participation is voluntary, refusal to participate will involve no penalty, and the subject may
p.000052: discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
p.000052: (11*) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or
p.000052: fetus, if the subject is or may become pregnant) that are currently unforeseeable
p.000052: (12*) Anticipated circumstances under which the subject's participation may be terminated by the investigator without
p.000052: regard to the subject's consent
p.000052: (13*) Any additional costs to the subject that may result from participation in the research
p.000052: (14*) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
p.000052: participation by the subject
p.000052: (15*) A statement that significant new findings developed during the course of the research that may relate to the
p.000052: subject's willingness to continue participation will be provided to the subject.
p.000052: (16*) The approximate number of subjects in the study
p.000052: * Included if appropriate [40 CFR 26.116(b)]
p.000052:
p.000052:
p.000052:
p.000052: • The information “shall be in language understandable to the subject” (40 CFR 26.116). This may require forms
p.000052: to be written and administered in different languages during a study. For example, the National
p.000052: Children’s Study (NCS) plans to produce all consent materials in English and Spanish, with other
p.000052: translations made available as needed (NCS, 2007).
p.000052: Participants often find discussions with research staff more useful than written consent forms (p. 103, NRC & IOM,
p.000052: 2005). NCS plans to pilot test an interactive, computer-based audio/video consent tool and to compare it
...

p.000061: Director’s Council of Public Representatives (COPR) (NIH, 2005). Although the advice from this workshop was
p.000061: developed in the context of NIH-supported clinical research, many of the recommendations are applicable to
p.000061: observational human exposure studies and human subject research in general. A summary
p.000061: of
p.000061: recommendations from the report for enhancing public trust is provided in Appendix D. The recommendations are
p.000061: focused on the following areas.
p.000061: • Building trust through community partnerships
p.000061: • Building relationships with patients (participants) (True partnerships with patients may not be possible,
p.000061: but bidirectional relationships must be enhanced.)
p.000061: • Building partnerships with community providers
p.000061: • Building trust in scientists
p.000061: • Building trust in the (EPA) and scientific research.
p.000061:
p.000061: 5.5 Recruitment Strategies
p.000061: Many strategies are used to select and recruit people into research studies requiring human participation. The IRB is
p.000061: responsible for reviewing the selection process to ensure that it is, above all, equitable. The requirement for
p.000061: IRB review is stated in 40 CFR 26.111(a)3.
p.000061: Selection of subjects is equitable. In making this assessment, the IRB should take into account the
p.000061: purposes of the research and the setting in which the research will be conducted and should be particularly cognizant
p.000061: of the special problems of research involving vulnerable populations, such as children, prisoners,
p.000061: pregnant women, mentally disabled persons, or economically or educationally disadvantaged
p.000061: persons.
p.000061: The IRB guidebook is an excellent resource for consideration of concerns and elements for equitable
p.000061: participant selection (U.S. HHS, 1993). It states that “Defining the appropriate group of subjects
p.000061: for a research project involves a variety of factors⎯ requirements of scientific design,
p.000061: susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness.” The IRB
p.000061: guidebook raises a number of points to consider in the process for selection of human participants (see Text Box
p.000061: 5-5).
p.000061: Various participant recruitment strategies may be used depending on the type of research being performed and the
p.000061: population of interest. This section addresses the strategies and approaches for identifying and contacting people and
p.000061: subsequent recruitment into a research study. Sampling design approaches and issues, such as statistical
p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062: Text Box 5-5. IRB Guidebook Issues on Identifying Subjects
...

p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
p.000117:
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p.000118: United States Environmental Protection Agency
p.000118:
p.000118:
p.000118:
p.000118: Office of Research and Development (810R) Washington, DC 20460
p.000118:
p.000118: Official Business Penalty for Private Use
p.000118: $300
p.000118: PRESORTED STANDARD POSTAGE & FEES PAID EPA
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Health / Terminally Ill

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p.000033: vulnerable populations. Instead, the Common Rule gives examples of potentially vulnerable groups (see Text Box 3-1).
p.000033: In addition, HHS extends added human subjects protections to pregnant women, human fetuses,
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
...

p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
...

p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
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p.000118: Office of Research and Development (810R) Washington, DC 20460
p.000118:
p.000118: Official Business Penalty for Private Use
p.000118: $300
p.000118: PRESORTED STANDARD POSTAGE & FEES PAID EPA
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Health / ill

Searching for indicator ill:

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p.000033: In addition, HHS extends added human subjects protections to pregnant women, human fetuses,
p.000033: neonates, prisoners, and children as vulnerable groups (45 CFR 46, Subparts B, C, and D, see CFR,
p.000033: 2006b). Analogous but somewhat more stringent protections for children, pregnant or nursing women, and fetuses
p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
p.000035: interests, ethically perceptive researchers will plan and implement special provisions for the protection of the
...

p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates)
p.000035: • Prisoners
p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
...

p.000061: issues regarding representative and nonrandom sampling designs, oversampling of subpopulations, and environmental
p.000061: justice considerations are part of the study design process described in Section 2 and are critical
p.000061: for deciding which recruitment approaches will be used.
p.000061:
p.000061:
p.000061:
p.000061:
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p.000062:
p.000062:
p.000062: Text Box 5-5. IRB Guidebook Issues on Identifying Subjects
p.000062: 1. Who will bear the burden? Who will reap the benefits?
p.000062: 2. Is there a disproportionate burden on any single group?
p.000062: 3. Is the proposed subject population required or justified?
p.000062: 4. Are there susceptible groups of people who should be excluded from the research?
p.000062: 5. Are anticipated benefits distributed fairly? Do others have a greater need to receive any of the anticipated
p.000062: benefits?
p.000062: 6. Are the research burdens distributed fairly?
p.000062: 7. Will any special physiological, psychological, or social characteristics of the subject group pose special risks
p.000062: for them?
p.000062: 8. Would it be possible to conduct the study with other, less vulnerable subjects?
p.000062: 9. Has the selection process overprotected potential subjects who are considered vulnerable (e.g., children,
p.000062: cognitively impaired, economically or educationally disadvantaged persons, patients of researchers, seriously ill
p.000062: persons), so that they are denied opportunities to participate in research?
p.000062: 10. If the subjects are susceptible to pressures, are there mechanisms to reduce the pressures or minimize their
p.000062: impact?
p.000062:
p.000062:
p.000062: Some of the common approaches for identifying and making initial contact with potential participants include, but are
p.000062: not limited to
p.000062: • direct telephone or in-person contact with a person selected through a statistical sampling process
p.000062: to obtain a representative sample of the population being studied;
p.000062: • use of print or other media advertisements, often used to recruit people in a community with specific
p.000062: characteristics;
p.000062: • advertisement or word-of-mouth contacts through community groups, civic organizations, or other types of
p.000062: organizations; and
p.000062: • recruitment at physicians’ offices, hospitals, and clinics or at churches, schools, or other
p.000062: social institutions, either in person or through the use of advertisements or study brochures.
p.000062: CABs can be consulted regarding proposed approaches for recruitment in community-based
p.000062: research. All procedures and materials for participant recruitment are reviewed and approved by the IRB prior to
p.000062: implementation. Some of the materials prepared for recruitment might include the following.
p.000062: • Recruitment scripts⎯prepared scripts used for in- person or telephone study information and recruitment
p.000062: contacts
p.000062: • Printed materials⎯brochures, flyers, newspaper advertisements, letters, and information articles
p.000062: • Audio/visual materials⎯radio and television scripts, video segments, public service announcements
...

p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
p.000117:
p.000117:
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p.000118: United States Environmental Protection Agency
p.000118:
p.000118:
p.000118:
p.000118: Office of Research and Development (810R) Washington, DC 20460
p.000118:
p.000118: Official Business Penalty for Private Use
p.000118: $300
p.000118: PRESORTED STANDARD POSTAGE & FEES PAID EPA
...

Health / patients in emergency situations

Searching for indicator emergencies:

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p.000091:
p.000091: ATSDR (Agency for Toxic Substances and Disease Registry) (2007). A Primer on Health Risk Communication Principles
p.000091: and Practices [online publication]. Available: http://www.atsdr.cdc.gov/risk/riskprimer/ [accessed 12 June 2007].
p.000091:
p.000091: CDC (Centers for Disease Control and Prevention) (2005). Third National Report on Human Exposure to Environmental
p.000091: Chemicals. National Center for Environmental Health, Atlanta, GA, NCEH Pub. No. 05­ 0570. Available:
p.000091: http://www.cdc.gov/exposurereport/pdf/thirdreport.pdf [accessed 12 June 2007].
p.000091:
p.000091: Covello V, Allen F (1988). Seven Cardinal Rules of Risk Communication. OPA-87-020. U.S. Environmental Protection
p.000091: Agency, Office of Policy Analysis, Washington, DC. Distributed by the Pennsylvania Dept. of Environmental Resources.
p.000091: Available: http://www.epa.gov/stakeholders/pdf/risk.pdf [accessed 12
p.000091: June 2007].
p.000091:
p.000091: Covello VT, McCallum DB, Pavlova M (eds) (1989). Effective Risk Communication: the role and responsibility of
p.000091: Government and Non-Government Organizations. New York. NY: Plenum Press.
p.000091:
p.000091: Covello V, Minamyer S, Clayton K (2007). Effective risk and crisis communication during water security emergencies
p.000091: summary report of EPA sponsored message mapping.
p.000091: EPA/600/R-07/027. National Homeland Security Research Center, Office of Research and Development, U.S. Environmental
p.000091: Protection Agency, Washington, DC. Available: http://www.epa.gov/nhsrc/pubs/reportCrisisCom040207.pdf
p.000091:
p.000091: FCN (Federal Communicators Network) (2001). Communicators Guide For Federal, State, Regional, and Local Communicators
p.000091: by the Federal Communicators Network. Available: http://www.publicforuminstitute.org/activities/2002/fcn/co mmguid.pdf
p.000091: [accessed 12 June 2007].
p.000091:
p.000091: Fenske RA, Kissel JC, Lu C, Kalman DA, Simcox NJ, Allen EH, Keifer MC (2000) Biologically based pesticide dose
p.000091: estimates for children in an agricultural community.
p.000091: Environ Health Persp 108(6):515-20.
p.000091:
p.000091: Fernandez CV, Kodish E, Weijer C (2003). Informing study participants of research results: an ethical imperative. IRB
p.000091: 25(3):12-19.
p.000091:
p.000091: Health Canada (2006). The Strategic Risk Communications Framework. Available: http://www.riskcommunications.gc.ca
p.000091: [accessed 18
p.000091: September 2007].
p.000091:
p.000091: IOM (Institute of Medicine) (2002). Responsible Research: A Systems Approach to Protecting Research Participants.
p.000091: Daniel D. Federman, Kathi E. Hanna, and Laura Lyman
p.000091:
p.000091:
p.000092: 92
p.000092:
p.000092: Rodriguez (eds). Washington, DC: The National Academies Press.
p.000092:
p.000092: Israel BA, Eng E, Schulz AJ, Parker EA (eds) (2005). Methods in Community-Based Participatory Research for Health. San
p.000092: Francisco, CA: Jossey-Bass.
p.000092:
...

Health / visual impairment

Searching for indicator blind:

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p.000056: studies of varying complexity that included payments, the median
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: payment was $155 (mean $266, range $5 to $2,000). The basis for dollar amounts was infrequently described, with
p.000057: 19% of the payments based on time, and 12% based on the procedures. In a model of payment factors,
p.000057: studies with some prospect of therapeutic benefit, studies having at least one invasive procedure, and studies with
p.000057: greater numbers of clinic visits were significantly associated with higher dollar amounts. About 9.5%
p.000057: of the studies offered completion bonuses, and a similar percentage offered escalating payments for
p.000057: followup study visits.
p.000057:
p.000057: 5.2.2 Regulations and Guidance Regarding Payment to Research Participants
p.000057: There is little specific guidance regarding payments in Federal human research regulations. The Common Rule and
p.000057: additional human subjects protections do not directly address payments to research participants, but the
p.000057: regulations do discuss providing additional safeguards for subjects vulnerable to coercion or undue
p.000057: influence [40 CFR 26.111(b)]. The NIH IRB guidebook advises IRBs to determine whether the rewards offered for
p.000057: participation in research constitute undue influence (U.S. HHS, 1993). According to the IRB guidebook undue
p.000057: inducement might blind prospective subjects to risks, impair their ability to exercise proper judgment, or may
p.000057: cause people to lie or to withhold information that would make them ineligible to enroll or continue
p.000057: participation.
p.000057: The U.S. Food and Drug Administration (FDA) has provided guidance for investigators and IRBs for clinical research
p.000057: studies (FDA, 1998). The guidance states that “payment to research subjects for participation in studies is not
p.000057: considered a benefit, it is a recruitment incentive.” FDA expects payments to accrue as the study progresses and not
p.000057: to be contingent on completing the study, although a “small proportion as an incentive for
p.000057: completion of the study is acceptable.” The guidance is concerned with the issue of coercion or undue influence, and
p.000057: it recognizes the IRB as the responsible party for deciding what is or is not acceptable.
p.000057: The U.S. Office of Management and Budget (OMB) develops standards and guidelines for statistical surveys performed by
p.000057: the Federal government. Under Guideline 2.3.2, OMB states that, while incentives are not typically used in Federal
p.000057: surveys, agencies may consider use of respondent incentives if they believe incentives would be necessary
p.000057: to use for a particular survey to achieve data of sufficient quality for their intended use (OMB,
p.000057: 2006a). OMB requires that agencies provide a justification for giving incentives to respondents.
p.000057: Some
...

Social / Access to Social Goods

Searching for indicator necessities:

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p.000033: are specified in Subparts B, C, and D of the EPA Rule (40 CFR 26). The regulations do not preclude other groups from
p.000033: being considered vulnerable, however, and the National Institutes of Health (NIH), in its Human
p.000033: Participant Protections Education for Research Teams online tutorial (NIH, 2002), lists students or employees and
p.000033: terminally ill or comatose patients as potentially vulnerable groups.
p.000033: CIOMS defines vulnerable persons as those who are relatively (or absolutely) incapable of protecting their own
p.000033: interests. Vulnerability here refers to a substantial incapacity to protect one’s own interests owing to such
p.000033: impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care
p.000033: or other expensive necessities, or being a junior or subordinate member of a hierarchical group. Vulnerable persons
p.000033: may have insufficient power, intelligence, resources, strength, or needed attributes to protect their
p.000033:
p.000033:
p.000035: 35
p.000035:
p.000035: own interests (CIOMS, 2002) (see Text Box 3-2). Because of their incapacity to protect their own
p.000035: interests, ethically perceptive researchers will plan and implement special provisions for the protection of the
p.000035: rights and welfare of the vulnerable persons.
p.000035:
p.000035: Text Box 3-1. Potentially Vulnerable Groups Identified in U.S. Regulations
p.000035:
p.000035: Text Box 3-2. Potentially Vulnerable Groups Identified in International Guidance
p.000035: (Council for International Organizations of Medical Sciences, 2002)
p.000035:
p.000035: • Junior or subordinate members of a hierarchical group; examples include employees, students, members of the armed
p.000035: forces, police, and others who work for, or closely with re- searchers; they may have expectations of preferential
p.000035: treatment if they agree to participate or fear of disapproval or retaliation if they refuse to participate in a study.
p.000035:
...

p.000117: which requires that those who are capable of deliberation about their personal choices should be treated with respect
p.000117: for their capacity for self- determination; and (2) protection of persons with impaired or diminished autonomy, which
p.000117: requires that those who are dependent or vulnerable be afforded security against harm or abuse.
p.000117: Source. The origin of an agent for the purposes of an exposure assessment
p.000117: Stakeholder. A person or group who has a valid interest in an activity, who can affect or is affected by the activity,
p.000117: and who stands to gain or lose depending on the decisions implemented
p.000117: Stressor. Any entity, stimulus, or condition that can modulate normal functions of the organism or induce an adverse
p.000117: response (e.g., agent, lack of food, drought)
p.000117: Vulnerability. A substantial incapacity to protect one’s own interests owing to such impediments as lack of capability
p.000117: to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being
p.000117: a junior or subordinate member of a hierarchical group. Accordingly, special provision must be made for the protection
p.000117: of the rights and welfare of vulnerable persons.
p.000117: Vulnerable groups. Populations extended additional human subjects protections, such as children, individuals with
p.000117: questionable capacity to consent, prisoners, fetuses and pregnant women, the terminally ill, students and employees,
p.000117: and comatose patients, etc.
p.000117:
p.000117:
p.000117:
p.000118: 118
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p.000118:
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p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
...

Searching for indicator access:

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p.000003: tools available to researchers.
p.000003: This document does not and, indeed, could not provide solutions to all scientific and ethical issues that may
p.000003: arise as observational human exposure studies are undertaken. No document could identify and address all
p.000003: potential issues in advance, nor is it possible to develop a comprehensive checklist for all such studies.
p.000003: Rather, this document attempts to present and discuss the types of ethical and scientific issues that will need
p.000003: to be considered and addressed as NERL researchers plan and implement observational human exposure studies. The
p.000003: researchers will need to work with others ― the study team, IRB members, EPA’s HSRRO, the participants
p.000003: and their community, and other stakeholders ― to identify and address all of the relevant issues
p.000003: for any particular study. The authors are confident that this document will be helpful to NERL scientists
p.000003: in their endeavors to assure that all of NERL’s observational human exposure studies will respect,
p.000003: safeguard, and protect the participants in that research.
p.000003:
p.000003: References
p.000003: Beauchamp TL, Childress, JF (2001). Principles of Biomedical Ethics: Fifth Edition. New York, NY: Oxford University
p.000003: Press.
p.000003:
p.000003: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000003: Subjects. U.S. Code of Federal Regulations.
p.000003: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr26_06. html [accessed 12 June 2007].
p.000003:
p.000003: CIOMS (The Council for International Organizations of Medical Sciences) (2008). International Ethical Guidelines for
p.000003: Epidemiological Studies. World Health Organization. Geneva, Switzerland. Available:
p.000003: http://www.cioms.ch/080221feb_2008.pdf [accessed 25
p.000003: April 2008].
p.000003:
p.000003: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000003: Biomedical Research Involving Human Subjects. World Health Organization. Geneva, Switzerland. Available:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000004:
p.000004: Emanuel EJ, Wendler D, Grady C (2000). What Makes Clinical Research Ethical? JAMA 20:2701-2711.
p.000004:
p.000004: ERG (Eastern Research Group) (2007). Report on the Workshop to Discuss State-of-the-Science Approaches for
p.000004: Observational Exposure Measurement Studies. Held in Durham, North Carolina on November 28-29, 2006. Final Report:
p.000004: January 25, 2007. (PB2007-108905).
p.000004:
p.000004: NRC (National Research Council) (2003) Protecting Participants and Facilitating Social and Behavioral Sciences
p.000004: Research. Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=10638
p.000004: [accessed 12 June 2007].
p.000004:
p.000004: NRC & IOM (National Research Council and Institute of Medicine) (2005). Ethical Considerations for Research on
...

p.000007: objectives, designs, and results of these studies.
p.000007: NERL researchers have conducted and relied on observational human exposure studies for more than three
p.000007: decades. Examples of studies conducted or funded by NERL are listed in Appendix A, Table A-1. Common goals in those
p.000007: studies included those that follow.
p.000007: • Identify which chemicals or other stressors that people are exposed to during their normal activities in the
p.000007: environments that they occupy.
p.000007: • Measure the concentrations of the chemicals to which people are exposed.
p.000007: • Identify the most important routes and pathways of exposure.
p.000007: • Identify the factors that impact people’s exposures (i.e., determine the when, why, how, and how much
p.000007: that people are exposed to chemicals in the environment).
p.000007: These studies involve many different types of data collection efforts and typically include
p.000007: observations,
p.000007: measurements, and information on the following items.
p.000007: • Chemical concentrations in environmental media (air, water, soil, floor dust, and dust on surfaces)
p.000007: • Chemical concentrations in the diet (food and beverages).
p.000007: • Biomonitoring (measurements of biomarkers of exposure in urine, blood, and saliva)
p.000007: • Time, location, and activity information
p.000007: • Information on personal activities, product use, diet, occupation, and other factors that may
p.000007: impact exposure
p.000007: • Information on the characteristics of the environments that study participants occupy (homes, schools,
p.000007: offices, public access buildings, etc.)
p.000007: The information obtained in observational human exposure studies is used to better understand people’s
p.000007: contact with chemicals in the environment and to improve exposure assessments and risk assessments.
p.000007: This information is also essential for developing risk mitigation strategies and for developing
p.000007: educational materials and programs for reducing exposures and risks to chemicals or other stressors in the
p.000007: environment (see Table 1-1).
p.000007:
p.000007: 1.2 Ethical Issues in Observational Human Exposure Studies
p.000007: By definition, observational human exposure studies involve human subjects. Whenever their research
p.000007: involves human subjects, EPA researchers are required to ensure the protection of the study participants
p.000007: by complying with the Agency’s human subjects rules as set forth in 40 CFR 26.
p.000007: The Common Rule (Subpart A of the rules) represents basic regulatory actions (common to more than
p.000007: a dozen Federal departments or agencies) that are intended to ensure the protection of all human subjects. The
p.000007: central requirements of the Common Rule are twofold:
p.000007: (1) that people who participate as subjects in covered research are selected equitably and give
...

p.000013: • Community and Stakeholder Relationships (Section 6) begins with the principles of fairness, justice, and
p.000013: equity and of respect for persons to develop approaches to demonstrate respect for culture
p.000013: and to empower the participants’ community to endure, including the need to build trust in the community and
p.000013: with stakeholders through open and honest communications and legitimate power sharing.
p.000013: • Strategies for Effective Communication (Section 7) builds on the presumption of an ongoing, interactive
p.000013: dialogue and exchange of ideas between researchers and the participants, community, and stakeholders and focuses
p.000013: on steps that the researcher needs to take for effective communications. The section discusses communication
p.000013: strategies, implementation plans, communication tools, reporting of results, and approaches for
p.000013: effective communications, two-way communications between the researchers, participants, community, and other
p.000013: stakeholders.
p.000013:
p.000013: References
p.000013: Beauchamp TL, Childress, JF (2001). Principles of Biomedical Ethics: Fifth Edition. New York, NY: Oxford University
p.000013: Press.
p.000013:
p.000013: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000013: Subjects. U.S. Code of Federal Regulations.
p.000013: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr26_06
p.000013: .html [accessed 12 June 2007].
p.000013:
p.000013: CIOMS (The Council for International Organizations of Medical Sciences) (2008). International Ethical Guidelines for
p.000013: Epidemiological Studies. Geneva, Switzerland: CIOMS. Available: http://www.cioms.ch/080221feb_2008.pdf [accessed 25
p.000013: April 2008].
p.000013:
p.000013: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000013: Biomedical Research Involving Human Subjects.
p.000013: Geneva, Switzerland: CIOMS. Available: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000013:
p.000013: Emanuel EJ, Wendler D, Grady C (2000). What Makes Clinical Research Ethical? JAMA 283(20): 2701-2711.
p.000013:
p.000013: NEAC (National Ethics Advisory Committee) (2006). Ethical Guidelines for Observational Studies: Observational research
p.000013: audits and related activities. Wellington, New Zealand: Ministry of Health. Available:
p.000013: http://www.neac.health.govt.nz/moh.nsf/indexcm/neac­ resources-publications-ethicalguidelines.
p.000013:
p.000013: NRC (National Research Council) (2004) Research Priorities for Airborne Particulate Matter: IV. Continuing Research
p.000013: Progress. Washington, DC: The National Academies Press. Available: http://books.nap.edu/openbook.php?record_id=10957
p.000013: [accessed 16 August 2007].
p.000013:
...

p.000022: from which the participants were selected. Pilot studies performed to evaluate a method or to estimate
p.000022: the likely range of exposure concentrations often have employed either purposeful sampling, where
p.000022: the researchers use information on the relevant characteristics of the population to select those
p.000022: participants who will exhibit a wide range of activity levels or potential exposure concentrations, or
p.000022: convenience sampling, where the researchers select the most accessible members of a population
p.000022: NERL’s observational human exposure studies also have routinely collected information about the
p.000022: participants’ activities by using questionnaires and surveys. Survey design is both a science and an
p.000022: art because the design of surveys is based on statistics and science, but designing a good and effective questionnaire
p.000022: is often an art that requires understanding the individuals being surveyed. Text Box 2-3 identifies some of the
p.000022: areas of art involved in designing an effective questionnaire.
p.000022: Understanding the process for selecting participants and the statistical-scientific requirements of
p.000022: questionnaire design are both components of survey sampling and design. A variety of references can provide
p.000022: the researcher with information about the issues in survey sampling and
p.000022: design. (See http://home.ubalt.edu/ntsbarsh/Business-stat/stat­ data/Surveys.htm and
p.000022: www.statpac.com/surveys/, for example.) But the research team must include or have access to the appropriate
p.000022: survey statistics expertise as it plans the research study.
p.000022:
p.000022: Text Box 2-3. Questionnaire Considerations
p.000022: • Questions should be simple and in a language the individual can understand.
p.000022: • Questions should be unambiguous.
p.000022: • Questions should be relevant to the study.
p.000022: • Questions should not be too personal.
p.000022: • The questionnaire should be as short as possible.
p.000022: • The questions should not be leading (e.g., internally suggestive of the answer).
p.000022: • Questions should follow a logical order.
p.000022:
p.000022:
p.000022:
p.000022: 2.2.5 Information Collection Rule
p.000022: As Federal employees, NERL researchers also must be aware of Information Collection Rule requirements. The
p.000022: Paperwork Reduction Act stipulates that every Federal agency must obtain approval from OMB before collecting
p.000022: the same or similar information from 10 or more members of the public. An Information Collection Request (ICR)
p.000022: is required if the same or similar information is being collected from 10 or more non- Federal
p.000022: respondents within a 12-month period, even if the information collection is voluntary. Generally, any
p.000022: survey, questionnaire, monitoring, reporting, or recordkeeping requirement imposed on
p.000022: non-Federal respondents by EPA will require an ICR. Information collections associated with all cooperative
p.000022: agreements funded by the EPA require an ICR. When an ICR is required, it must be approved by OMB
p.000022: before the collection begins, regardless of whether the collection of information is mandatory, voluntary,
...

p.000023: • Introduction and background, including the purpose and scope of the study
p.000023: • The desired outputs and outcomes of the study, including the objectives and the hypotheses to be tested
p.000023: • A brief description or overview of the study
p.000023: • The technical approach and conceptual model that accounts for
p.000023: – sources of the chemicals being studied;
p.000023: – potential routes and pathways of exposure;
p.000023: – factors that may impact exposure and other relevant stressors;
p.000023: – selection and characteristics of the study participants; eligibility criteria; and recruitment, retention, and
p.000023: payment approaches;
p.000023: – justification for sample size, the methodology for selecting participants, and the sampling methods;
p.000023: – characteristics of the community in which the study will be performed;
p.000023: – environmental conditions, factors, or end points to be measured, including sampling and analysis approaches and
p.000023: methods (with description of expected performance);
p.000023: – survey design and questionnaires and other survey instruments, as applicable (with description of prior use and
p.000023: validation in similar studies);
p.000023: – pilot studies that may be undertaken;
p.000023: – quality assurance project plan and quality control;
p.000023: – timeframe for the study;
p.000023: – exposure scenarios to be considered;
p.000023: – burden of the study on the participants;
p.000023: – resources available; and
p.000023: – feasibility
p.000023: • Discussion of alternative study designs and approaches considered and reasons for rejecting other approaches and
p.000023: selecting the one proposed
p.000023: • An analysis plan that considers
p.000023: – Information and data needs, including data storage, security, access, and release;
p.000023: – nature of the measurement data (e.g., variability, quality assurance);
p.000023: – how the collected data will be used, and how the proposed analyses will address objectives of the study; and
p.000023: – hypotheses to be tested and statistical power and sample size required to test the hypotheses
p.000023: • Resources required or available
p.000023: • Project organization and management, including team members and roles and responsibilities
p.000023: • Schedule
p.000023:
p.000023: fairness in human subjects research is that scientific goals, considered in dynamic interaction with
p.000023: the potential for and distribution of risks and benefits, should guide the selection of subjects.”
p.000023: (Emmanuel et al, 2000). On the other hand, as discussed in Section 3, many study problems specifically
p.000023: address exposures of vulnerable groups to chemicals and other stressors. Researchers should not avoid
p.000023: research studies that will,
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: of necessity, include vulnerable groups to address the study hypotheses or objectives simply to avoid the more
p.000024: stringent requirements for working with these groups.
p.000024:
p.000024: 2.4 Ensuring a Favorable Risk-Benefit Ratio
p.000024: 2.4.1 Designing in Benefits for the Participants
p.000024: Study designs vary depending on the objectives of the study, existing knowledge on the research question, and
p.000024: the hazard being studied (NRC & IOM, 2005). Recent ethical discussions about study designs in human subjects
...

p.000031: • Participation⎯poor response to questionnaires, poor compliance with researcher requests in data collection
p.000031: activities
p.000031: • Burden⎯higher than predicted
p.000031: • Changes in participant behaviors⎯potential changes because of participation in the study
p.000031: • Grievances⎯participant issues
p.000031: • Retention⎯high dropout rates
p.000031: • Community issues⎯poor interactions, lack of support
p.000031: • Third-party issues⎯problems with landlords, spouses, or others
p.000031: • Collateral observations⎯identification of nonstudy hazards, difficulty reporting
p.000031: • Unanticipated results⎯high contaminant concentrations measured, unexpected results
p.000031: • New data indicating that participation in the study (or observations measured in the study) represent a risk to
p.000031: participants or others
p.000031:
p.000031:
p.000031:
p.000031: References
p.000031: Castelloe, JM (2000). Sample size computations and power analysis with the SAS system. Paper 265-25 in Proceedings of
p.000031: the 25th Annual SAS Users Group International Conference. Cary, NC: SAS Institute, Inc. Available:
p.000031: http://support.sas.com/rnd/app/papers/powersamplesize.pdf [accessed 16 April 2008].
p.000031:
p.000031: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of
p.000031: Human Subjects. U.S. Code of Federal Regulations. Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/
p.000031: 40cfr26_06.html [accessed 12 June 2007].
p.000031:
p.000031: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000031: Biomedical Research Involving Human Subjects.
p.000031: Geneva, Switzerland: CIOMS. Available at http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000031:
p.000031: Coggon D, Rose G, Barker DJP (1997). Epidemiology for the Uninitiated, Fourth Edition. London: BMJ Publishing Group
p.000031: Ltd. Available at http://www.bmj.com/epidem/epid.html [accessed 29
p.000031: January 2008].
p.000031:
p.000031: Cohen Hubal EA, Sheldon LS, Zufall, MJ, Burke JM, Thomas KW (2000). The challenge of assessing children’s residential
p.000031: exposure to pesticides. Journal of Exposure Analysis and Environmental Epidemiology 10(6 part 2): 638-649.
p.000031:
p.000031: Dallal, GE (2001). Some aspects of study design. In The Little Handbook of Statistical Practice at
p.000031: www.StatisticalPractice.com, and at http://www.tufts.edu/~gdallal/STUDY.HTM [accessed 29
p.000031: January 2008]
p.000031: Emanuel EJ, Wendler D, Grady C (2000). What Makes Clinical Research Ethical? JAMA 283(20): 2701-2711.
p.000031:
p.000031: Gilbert, SG (2006). Supplementing the traditional institutional review board with an environmental health and community
p.000031: review board. Environmental Health Perspectives 114(10): 1626-1629.
p.000031:
p.000031: Kraemer HC, Thiemann S (1987). How Many Subjects? Statistical Power Analysis in Research. Newbury Park, CA: Sage
p.000031: Publications.
p.000031:
...

p.000035: burdens and benefits of research participation. Classes of individuals conventionally considered vulnerable are those
p.000035: with limited capacity or freedom to consent or to decline to consent. They are the subject of specific guidelines in
p.000035: the CIOMS document (Guidelines 14 and 15) and include children, and persons who, because of mental or behavioral
p.000035: disorders, are incapable of giving informed consent. Ethical justification of their involvement usually requires that
p.000035: • the research could not be carried out equally well with less vulnerable subjects;
p.000035: • the research is intended to obtain knowledge that will lead to improved diagnosis, prevention, or treatment of
p.000035: diseases or other health problems characteristic of, or unique to, the vulnerable class—either the actual subjects or
p.000035: other similarly situated members of the vulnerable class;
p.000035: • research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily be
p.000035: assured reasonable access to any diagnostic, preventive, or therapeutic products that will become available as a
p.000035: consequence of the research;
p.000035: • the risks attached to interventions or procedures that do not hold out the prospect of direct health-related
p.000035: benefit will not exceed those associated
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: CIOMS recommendations, although written to address biomedical research, also generally are
p.000036: applicable to observational human exposure studies. The authors of this document consider the CIOMS
p.000036: requirement that the research could not be carried out equally well with less vulnerable subjects
p.000036: to be particularly important. EPA and NERL researchers should include vulnerable groups in
p.000036: observational human exposure studies only if their participation is critical to the success and
p.000036: applicability of the research. Even then, EPA and NERL researchers will have to meet stringent standards for
p.000036: protecting the rights and safety of the vulnerable participants. For example, EPA regulations
p.000036: governing observational research with children are even more stringent than the CIOMS guideline.
p.000036: If such research does not hold out the prospect of direct benefit to the child, no increase whatsoever over
...

p.000038: protocols to ensure that the safety and welfare of the groups will be protected. As discussed in Section 3.1,
p.000038: It also should be noted that, although Federal regulations define vulnerability in terms of the ability
p.000038: to protect one’s own interests, the lay public may perceive a broader definition of vulnerability as
p.000038: it relates to education, economics, social status, and other factors. The researcher should evaluate
p.000038: vulnerability in this broader context to ensure that adequate safeguards are included for potentially
p.000038: vulnerable populations that do not meet the definition of the Federal regulations.
p.000038: References
p.000038: AAP (American Academy of Pediatrics) (2003). Pediatric Environmental Health. (2nd Edition). Elk Grove Village, IL:
p.000038: American Academy of Pediatrics.
p.000038:
p.000038: CFR (Code of Federal Regulations) (2006a). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000038: Subjects. U.S. Code of Federal Regulations.
p.000038: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr26_06. html [accessed 12 June 2007].
p.000038:
p.000038: CFR (Code of Federal Regulations) (2006b). 45 CFR Subtitle A Department of Health and Human Services Part 46 Protection
p.000038: of Human Subjects. U.S. Code of Federal Regulations. Available:
p.000038: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr46_06.ht ml [accessed 13 June 2007].
p.000038:
p.000038: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000038: Biomedical Research Involving Human Subjects.
p.000038: Geneva, Switzerland: CIOMS. Available at http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000038:
p.000038: Cohen Hubal EA, Sheldon LS, Burke JM, McCurdy TR, Berry MR, Rigas ML, Zartarian VG, Freeman NCG (2000).
p.000038: Children’s exposure assessment: a review of factors influencing children’s exposure, and the data available to
p.000038: characterize and assess that exposure. Environ Health Perspect 108(6): 475-486.
p.000038:
p.000038: Emanuel EJ, Wendler D, Grady C (2000). What makes clinical research ethical? JAMA 283(20): 2701-2711.
p.000038:
p.000038: IOM (Institute of Medicine) (2004). Ethical Conduct of Clinical Research Involving Children. Washington, DC: The
p.000038: National Academies Press. Available: http://www.nap.edu/catalog.php?record_id=10958 [accessed 16 April 2008].
p.000038:
p.000038: Kodish E (Ed.) (2005). Ethics and Research with Children: A Case-Based Approach. New York: Oxford University Press.
p.000038:
p.000038: NBAC (National Bioethics Advisory Commission) (2001). Ethical and Policy Issues in Research Involving Human
p.000038: Participants, Volume I: Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, MD:
...

p.000040: biological measurements in people’s homes or personal locations. Many of the topics identified in that report are
p.000040: discussed in this section (Text Box 4-1).
p.000040:
p.000040:
p.000040: Text Box 4-1. Topics in Section 4
p.000040: Privacy Issues Confidentiality
p.000040: Confidentiality of Information Confidentiality of Participation
p.000040: Collateral Observations
p.000040: Potential Nonstudy Hazards in the Residence Collateral Observations with Mandated Reporting
p.000040: Requirements
p.000040: Hazard Communication Planning and Staff Training
p.000040: Third-Party Issues
p.000040: Determining Whether a Third Party is a Human Subject Informing Third Parties of Research Activities Research Results
p.000040: and Third Parties
p.000040: Data and Safety Monitoring and Oversight
p.000040:
p.000040:
p.000040:
p.000040: 4.1 Privacy Issues
p.000040: Privacy refers to an expectation that a person is free from intrusion into personal matters and is free from the
p.000040: presence or view of others. The Institutional Review Board Guidebook defines privacy as “control over the
p.000040: extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with
p.000040: others” (U.S. HHS, 1993). Beauchamp and Childress find that the right to privacy is based on the principle of
p.000040: respect for autonomy. “We often respect persons by respecting their autonomous wishes not to be observed, touched, or
p.000040: intruded upon…. A loss of privacy occurs if others use any of several forms of access, including intervening in zones
p.000040: of secrecy, anonymity, seclusion, or solitude” (pp. 295-296, Beauchamp and Childress, 2001).
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041: Although research participants may agree to allow researchers to enter their home or other zone of personal space
p.000041: to conduct their research measurements, they have not abrogated their right to privacy. “When individuals
p.000041: voluntarily grant others some form of access to themselves, their act is an exercise of the
p.000041: right to privacy, not a waiver of that right” (p. 297, Beauchamp and Childress, 2001). Researchers should remember
p.000041: that they are guests in the homes for a specific purpose. “When people visit a home, there are social
p.000041: expectations about what is acceptable behavior. People who are invited into a home are expected to be
p.000041: sensitive to and respectful of the host’s customs and values” (p. 65, NRC & IOM, 2005).
p.000041: By their very nature, observational human exposure studies encroach on the privacy of a research participant. Entry in
p.000041: a participant’s home (or other personal zones) does represent a loss of privacy, but researchers should be
p.000041: careful to ensure that their presence does not become a violation of the individual’s right to privacy. The
p.000041: relationship between the researcher and the participant may be complicated, and there may be conflicts between
p.000041: the researcher’s role and their ethical obligations (NRC & IOM, 2005). In entering a participant’s
p.000041: personal space, it may be difficult, or impossible, to avoid making observations unrelated to the research question,
p.000041: thereby further intruding on the participant’s personal privacy. Indeed, there may be ethical and legal
p.000041: obligations for the researchers to respond to those observations. Beauchamp and Childress suggest that “policies
p.000041: carefully specify the conditions of access that will and will not count as a loss of privacy or a violation of
p.000041: the right to privacy. The policy should accurately define the zones that are considered private and
p.000041: not to be invaded, and should also identify interests that legitimately may be balanced against privacy
p.000041: interests” (Beauchamp and Childress, 2001).
p.000041: Observational human exposure studies also may infringe on the privacy of other individuals, for example,
p.000041: other members of the participant’s family or household. Researchers should strive to minimize the intrusion and loss
p.000041: of privacy and to show respect for the privacy of study participants and third parties at all times (see Text
p.000041: Box 4-2 for a list of relevant privacy issues). It is incumbent on the researcher to recognize privacy issues
p.000041: in the design and implementation of the research study. The NRC & IOM report suggests that researchers
p.000041: anticipate the ethical issues that arise from conducting research in a person’s home, and that they take steps
p.000041: to correct them (1) by thinking through the issues as part of the study design; (2) by discussing the issues during the
p.000041: informed consent process; and (3) by ensuring that the frontline staff that enter a
p.000041: participant’s home “understand their role as members of the research team, how that role differs from the role of
p.000041: neighbor or friend, and how they should respond when they make observations that are not part
p.000041: of the protocol” (p. 66, NRC & IOM, 2005).
p.000041:
...

p.000042: communicable diseases or evidence of child abuse or neglect. These and similar limits to the ability
p.000042: to maintain confidentiality should be anticipated and disclosed to prospective subjects.”
p.000042: to identify an individual. Precise geographic location information may be sufficient to pinpoint a
p.000042: residence. Researchers may use several strategies to reduce the likelihood of indirect identification when
p.000042: study results are reported (see, also, Text Box 4-3).
p.000042: • Redact from publications, reports, or public data sets information that might be used to indirectly identify a
p.000042: research participant.
p.000042: • Generalize exact information; for example, replace birth date with age or year of birth or classify age as
p.000042: part of a range.
p.000042: • Aggregate information across individuals; for example, only report data in cells of sufficient size
p.000042: to make individual linkages unlikely.
p.000042: • Reduce the specificity of geographic coordinate information to a level that a specific residence or other
p.000042: location can not be identified.
p.000042:
p.000042: Text Box 4-3. Approaches for Protecting Personally Identifiable Information
p.000042: • Developing procedures for safeguarding information prior to collecting the information
p.000042: • Ensuring that data or samples are anonymous by not collecting or by destroying identifying information or linkages
p.000042: • Restricting access to identifying information to only those requiring access
p.000042: • Assigning codes to participants, data, and samples rather than using identifiers
p.000042: • Physically separating identifying information and linkage files from other study information
p.000042: • Securing identifying information in locked files with limited access
p.000042: • Restricting identifying information from computers that are networked with other computers or electronic systems
p.000042: • Restricting identifying information from computers that are not kept in secure locations with limited access
p.000042: • Training research staff members on human subject protection and on information security procedures
p.000042:
p.000042:
p.000042: Another step that can help protect confidentiality is to obtain a Certificate of Confidentiality. Certificates of
p.000042: Confidentiality are issued by NIH (2002) to protect identifiable research information from forced disclosure.
p.000042: They allow the investigator and others who have access to research records to refuse to disclose identifying
p.000042: information on research participants in any civil, criminal, administrative, legislative, or other
p.000042: proceeding, whether at the Federal, State, or local level. Certificates of Confidentiality may be granted for studies
p.000042: collecting information that, if disclosed, could have adverse consequences for subjects or damage
p.000042: their financial standing, employability, insurability, or reputation. By protecting researchers and
p.000042: institutions from being
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043: compelled to disclose information that would identify research subjects, Certificates of Confidentiality
p.000043: help achieve the research objectives and promote participation in studies by assuring
p.000043: confidentiality and privacy to participants. Any research project that collects sensitive, personally identifiable
p.000043: information and that has been approved by an IRB is eligible for a certificate. Identifying information is broadly
p.000043: defined as any item or combination of items in the research data that could lead directly or indirectly to the
p.000043: identification of a research subject.
p.000043: Federal funding is not a prerequisite for a certificate. A Certificate of Confidentiality does not
p.000043: diminish, however, the investigator’s need to protect the personally identifiable information as
p.000043: described above.
p.000043:
p.000043: 4.2.2 Confidentiality of Participation
p.000043: In some types of research, the knowledge that a person is participating in a particular research study
...

p.000048: human requirements for adherence to the research protocol and compliance with ethical standards and with EPA’s
p.000048: human subjects rules
p.000048: • Ensuring that measurements and samples are collected as planned, and that data are reported on a timely basis
p.000048: • Evaluating whether the observed measurements exceed the pre-established threshold values and, if so,
p.000048: ensuring that reporting procedures and plans to respond to the potential risks are completed on a
p.000048: timely basis
p.000048: • Ensuring that quality assurance plans that define procedures for assessing and ensuring study
p.000048: protocol compliance are being met
p.000048: • Ensuring data quality targets are met through independent internal or external auditing
p.000048: requirements
p.000048: • Taking all warranted oversight actions to ensure the safety of the participants and the integrity of the
p.000048: study, including terminating the research study if appropriate
p.000048:
p.000048: References
p.000048: AAP (American Academy of Pediatrics Committee on Environmental Health) (2003). Pediatric Environmental Health. (2nd
p.000048: Edition). Elk Grove Village, IL: American Academy of Pediatrics.
p.000048:
p.000048: Beauchamp TL, Childress JF (2001). Principles of Biomedical Ethics. (5th Edition). New York, NY: Oxford University
p.000048: Press.
p.000048:
p.000048: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I⎯Environmental Protection Agency Part 26 Protection of Human
p.000048: Subjects. U.S. Code of Federal Regulations.
p.000048: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr26_06. html [accessed August 2007].
p.000048:
p.000048: CIOMS (Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000048: Biomedical Research Involving Human Subjects. World Health Organization. Geneva, Switzerland. Available:
p.000048: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed June 2007].
p.000048: Emanuel, EJ, Wendler D, Grady C (2000). What makes clinical research ethical? JAMA 283(20): 2701-2711.
p.000048:
p.000048: NCI (National Cancer Institute) (2001). Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials
p.000048: Funded by the National Cancer Institute. Available: http://www3.cancer.gov/rrp/dsm_ess.html [accessed April 2007].
p.000048:
p.000048: NEI (National Eye Institute) (2001). National Eye Institute Guidelines for Data Monitoring and Oversight of
p.000048: Observational Studies. Available: http://www.nei.nih.gov/funding/datastudies.asp [accessed April 2007].
p.000048:
p.000048: NHLBI (National Heart Lung and Blood Institute) (2007). Monitoring Boards for Data and Safety (Interim Policy). Policy
p.000048: effective date: 14 May 2007. Available: http://public.nhlbi.nih.gov/ocr/home/GetPolicy.aspx?id=8 [accessed September
p.000048: 2007].
p.000048:
p.000048: NHRPAC (National Human Research Protections Advisory Committee) (2002). Clarification of the status of third parties
p.000048: when referenced by human subjects in research. Available: http://www.hhs.gov/ohrp/nhrpac/documents/third.pdf [accessed
p.000048: April 2007].
p.000048:
p.000048: NIH (National Institutes of Health) (2002). Extramural Projects - Application Instructions (03/15/2002) - Detailed
...

p.000054: will involve (NCS, 2007).
p.000054: • Development of written materials with appropriate languages and comprehension levels is only part of the
p.000054: communication challenge. In communities where languages other than English are spoken, it will be
p.000054: important that the research team be able to communicate orally with participants, often in ad hoc
p.000054: situations. Research protocols should address how translations will be accomplished. The use of
p.000054: untrained persons such as co-workers usually will not meet requirements for full understanding of human subject
p.000054: protections. Researchers should make plans for trained staff or trained community members, associated
p.000054: or affiliated with the research study, to be available for translations.
p.000054:
p.000054: 5.1.3 Voluntary Participation
p.000054: The third pillar of informed consent is voluntary participation. The Belmont Report emphasizes that
p.000054: participants “should understand clearly the range of risk and the voluntary nature of participation” [emphasis
p.000054: added]. The ethical principles of respect for persons and their autonomous decisions morally obligate
p.000054: the researcher to ensure that an individual’s decision to participate in a human research study is truly
p.000054: voluntary and uncoerced (Emanuel et al., 2000). A number of study characteristics may affect whether the
p.000054: participant’s actions are truly voluntary.
p.000054: • Access to study-dependent benefits or care that would otherwise not normally be received may impair
p.000054: voluntariness.
p.000054: • Voluntary participation also may be compromised when there is an existing relationship between the
p.000054: researcher and participants, such as employer and employee or teacher and student.
p.000054: • Restricted voluntariness may be an intrinsic part of belonging to certain vulnerable groups,
p.000054: including children, prisoners, handicapped persons, mentally disabled persons, and economically or
p.000054: educationally disadvantaged persons, or members of the military, for example. When research participants come from such
p.000054: groups, additional protections to insure voluntariness in the context of the research may be required
p.000054: (see also 40 CFR 26, Subparts B, C, and D).
p.000054: • Payments as incentives may have undue influence and are discussed below.
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: • Whether payments will lead to a coerced decision to participate often is difficult to determine without
p.000055: input from people from similar socioeconomic backgrounds as the participants (p. 111, NRC & IOM, 2005).
...

p.000060: guidance from EPA’s HSRRO to determine EPA’s latest policies and guidance in this regard. Input also should be sought
p.000060: from community representatives to ensure that any payment is adequate to compensate for expenses and reward
p.000060: participation, but that the payment is not so high as to constitute undue influence or coercion in the
p.000060: community. If the study includes several followup visits over a long term, NERL researchers should ensure that payment
p.000060: is made incrementally as the NRC & IOM committee suggested. NERL scientists also should adopt the IOM
p.000060: Recommendations 6.1 and 6.2, including ensuring that any payment should be for appropriate purposes
p.000060: and age-appropriate, and that the process should be open and fully disclosed, while not overly
p.000060: emphasizing payments during the recruiting or informed consent phases. The final decisions about the ethics of
p.000060: payments rest with the IRB, which will review, modify as needed, and approve the research protocol, and with the EPA
p.000060: HSRRO, who has final authority to approve, modify, or disapprove all of NERL’s human subjects research
p.000060: efforts.
p.000060: 5.3 Research Rights and Grievance Procedures
p.000060: Protecting the research rights of participants and providing independent access to information regarding
p.000060: those rights and to grievance procedures is an important element in developing and maintaining appropriate
p.000060: participant-investigator relationships. As part of the informed consent process, the Common Rule
p.000060: requires “An explanation of whom to contact for answers to pertinent questions about the research and
p.000060: human subjects’ rights, and whom to contact in the event of a research-related injury to the
p.000060: subject” [40 CFR 26.116(a)(7)].
p.000060: Information about the research often best can be answered by the researcher. However, it may benefit
p.000060: researchers and participants if information about the research can be obtained from or confirmed by a trusted
p.000060: independent person or organization. Participants also need to know how they can contact
p.000060: someone, independent from the researcher, who can answer questions concerning the rights of research
p.000060: participants and provide information on grievance procedures and research-related injuries. These questions
p.000060: could be addressed to the IRB, an ombudsman, an ethics committee, or other knowledgeable
p.000060: administrative body. Consent documents are expected to have at least two names with appropriate
p.000060: telephone contact information⎯one that can provide information regarding the research and
p.000060: another that can provide information regarding their rights as research participants. Grievance
...

p.000063: would not normally perform. Not only would this bias the study results but may lead to higher than
p.000063: normal levels of exposure. Alternatively, the act of studying one set of conditions or activities in an observational
p.000063: human exposure study could lead participants to assume that those conditions or activities involve substantial
p.000063: risk. In response, they subsequently may change their activities in ways that could lead to possibly higher
p.000063: risks. The potential for such unintentional outcomes is difficult for researchers to gauge but requires
p.000063: researcher caution in how information and results are conveyed. However, if the informed consent process is
p.000063: truly “an on-going, interactive dialogue . . . involving the disclosure and exchange of relevant
p.000063: information,” then such misunderstandings should be minimized.
p.000063:
p.000063: References
p.000063: AAP (American Academy of Pediatrics Committee on Environmental Health) (2003). Pediatric and Environmental Health. (2nd
p.000063: Edition). Elk Grove Village, IL: American Academy of Pediatrics.
p.000063:
p.000063: Ackerman TF (1989). An ethical framework for the practice of paying research subjects. IRB 11(4):1-4.
p.000063:
p.000063: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000063: Subjects. U.S. Code of Federal Regulations.
p.000063: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/ 40cfr26_06.html [accessed 12 June 2007].
p.000063:
p.000063: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000063: Biomedical Research Involving Human Subjects. World Health Organization. Geneva, Switzerland. Available:
p.000063: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000063:
p.000063: Diekema DS (2005) “Payments for Participation of Children in Research.” Chapter in: Kodish, E, Editor. Ethics and
p.000063: Research with Children: A Case-Based Approach. New York, NY: Oxford University Press. 143-160.
p.000063:
p.000063: Dickert N, Emanuel E, Grady C (2002). Paying research subjects: an analysis of current policies. Ann Intern Med
p.000063: 136(5):368-373.
p.000063:
p.000063: Emanuel EJ (2004). Ending concerns about undue inducement. J Law Med Ethics 32(1):100-105.
p.000063:
p.000063: Emanuel, EJ, Wendler D, Grady C (2000). What makes clinical research ethical? JAMA 283(20): 2701-2711.
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064: Erlen JA, Sauder RJ, Mellors MP (1999). Incentives in research: ethical issues. Orthop Nurs 18(2):84-87.
p.000064:
p.000064: European Parliament (2001). On the approximation of the laws, regulations, and administrative provisions of the Member
p.000064: States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products
...

p.000067: seek additional community representation on the IRB panel.
p.000067: The Centers for Disease Control and Prevention (CDC) recommends nine governing principles for
p.000067: “outsiders.” To help alleviate these potential issues, researchers should ensure an equitable
p.000067: distribution of paid research work among different communities within the larger community as to not promote a
p.000067: perceived bias among community members. Additionally, when possible, researchers should make efforts
p.000067: to provide payments to community members employed as research staff through community partner
p.000067: organizations to prevent conflict of interest issues. Refer to Section 5 for further discussion on
p.000067: remuneration of community members as research participants.
p.000067:
p.000067:
p.000067: Text Box 6-2. Community Engagement Principles for Researchers
p.000067: (From CDC, 1997)
p.000067: Requirement Explanation
p.000067:
p.000067: Clarity Clear communication of the study objectives, research goals, and the populations or
p.000067: communities of interest.
p.000067:
p.000067: engaging communities in health-related research (see Text Box 6-2). Health research is a “privileged and
p.000067: empowered activity in that the researchers have special
p.000067: Knowledge of the Community
p.000067: Familiarity with the economic conditions, political structures, demographics, history, past research experiences, and
p.000067: research perceptions of the community.
p.000067:
p.000067: access to resources and sensitive information about people and, through the analysis and presentation
p.000067: of findings, are able to influence the way people think and have considerable influence on decisions regarding
p.000067: the allocation of resources” (CDC, 1997). Regardless of the approach utilized to involve the community in research,
p.000067: whether the process employs community-based participatory research (CBPR) or another community
p.000067: engagement method, researchers should guide their interactions with community members using these
p.000067: underlying principles to promote the aforementioned ethical principles of respect of persons, fairness, and
p.000067: beneficence.
p.000067: One form of community involvement is to include qualified members of the community on the research staff.
p.000067: Section 2 advocates community representatives as part of the research team. Paid research staff members from
p.000067: the community could serve as valuable consultants for protocol development and research design, including how to
p.000067: collect the data, how to recruit and retain participants, and how to interpret and disseminate the
p.000067: results. However, including paid research staff from the community may introduce a conflict of interest among
p.000067: community members: community representatives may feel a greater allegiance to the researchers providing the payment
p.000067: and be less inclined to uphold the interests of the community. In addition, the community may come to view
...

p.000071: recommend attending to each other’s interests and needs by participating in activities beyond the
p.000071: specific work of the partnership.23 A history of prior positive working relationships is also beneficial
p.000071: (Israel et al., 1998).
p.000071: Trust cannot be separated from respect. Potential participants need to see researchers fostering respect for
p.000071: community members and leaders to gain trust. For example, meeting with key community leaders
p.000071: and groups in their surroundings helps to build trust for a true partnership. Such meetings provide
p.000071: organizers of engagement activities with more information about the community, its concerns, and factors
p.000071: that will facilitate and constrain participation. Once a successful rapport is established, the meetings
p.000071: and exchanges with community members can become an ongoing and substantive partnership (ERG, 2007).
p.000071: One mechanism for helping to build trust may be a contract with the community. A community contract outlines the
p.000071: roles and expectations of both the researcher and the community. Living up to these agreements builds
p.000071: trust with all partners, and the establishment of the agreement helps reduce misunderstandings.
p.000071: Contracts or memorandums of understanding that outline the roles and expectations of the researcher and the
p.000071: community are discussed in both Minkler and Wallerstein (2003) and Israel et al. (2005b). An example
p.000071: outlining expectations in a partnership with tribal communities is presented in Appendix E of Minkler and
p.000071: Wallerstein (2003), whereas an example discussing access to data and authorship issues is presented
p.000071: in Appendix I of Israel et al. (2005b). An example of a memorandum of understanding between the
p.000071: University of Michigan School of Public Health, Detroiter’s Working for Environmental Justice, the Detroit
p.000071: Hispanic
p.000071:
p.000071:
p.000071:
p.000071: 23 For a more detailed description of each of the suggestions for enhancing trust, please see Chapter 3 of Israel et
p.000071: al. (2005).
p.000071:
p.000072: 72
p.000072:
p.000072: Development Corporation, and the Warren Conner Development Coalition for a study investigating asthma is
p.000072: available at http://depts.washington.edu/ccph/pdf_files
p.000072: /MOU10.pdf.
p.000072: Work within communities involves a considerable investment of researchers’ and residents’ time. It should be an
p.000072: ongoing, interactive exchange of information and ideas between the researchers and the community members,
p.000072: where voices are both heard and honored. Trust is fostered when all interested parties feel that they have
p.000072: influence, and that their input contributes to the community effort. The collaborations should be
p.000072: inclusive of the entire community, including those members with incompatible interests and perceptions. If
p.000072: participation, influence, and benefits are limited only to some of the partners, then distrust is likely, and
p.000072: the potential benefits of community involvement may be lost. Being inclusive can create some
p.000072: organizing challenges, but the benefit of effective community involvement “has the potential to
...

p.000073: organizations having close ties with the African- American community to establish trust between
p.000073: the community and research team. Using input from the community partner organizations, the
p.000073: researchers developed a systematic communication plan to establish rapport with the community and to guide
p.000073: interaction between study participants and the key study personnel. A well-designed and culturally sensitive
p.000073: communication plan was integral to the success of the study. Eighty percent of the original participants
p.000073: completed the four- season study (Williams et al., 2003).
p.000073:
p.000073: 6.2.6 Honesty, Power Relationships, and Partnerships
p.000073: The NRC & IOM report (NRC & IOM, 2005) describes a relational paradigm that acknowledges that research
p.000073: is part of a broader societal context, with the conduct of research often mirroring a system in which
p.000073: power is unequally and perhaps unfairly distributed. The trust and mutual commitment required from
p.000073: the researchers and the community are subject to the overall power relations in society.24 The Expert Panel convened to
p.000073: discuss the content of this document recognized that
p.000073:
p.000073:
p.000073: 24 A discussion of the evolution of theories on power relations, including the contribution of feminism,
p.000073: poststructuralism, and postcolonialism, can be found in Minker and Wallerstein (2003, Chapter 2).
p.000073: the researchers have a variety of forms of power that needed to be understood and acted on ethically
p.000073: (ERG, 2007). One form of power is resources, both funds and access to resources and decisionmakers. Other forms of
p.000073: power may be more subtle, including expertise, which can intimidate or limit a participant’s choices.
p.000073: Peer pressure, fear of intimidation, expectations of benefits from the research, and power to
p.000073: stigmatize the community all, whether real or perceived, can influence the relationship between the
p.000073: researcher and the community. Many forms of power may be tipped toward the researcher, but the community often
p.000073: has power in the form of knowledge about the community that can impact the quality of the research effort. An ethical
p.000073: balance of power can lead to benefits for all partners (ERG, 2007).
p.000073: In describing principles in Methods in Community- Based Participatory Research for Health, Israel et al.
p.000073: (2005b) describe CBPR as facilitating “a collaborative, equitable partnership in all phases of research,
p.000073: involving an empowering and power-sharing process that attends to social inequalities.” One way to address the
p.000073: inequities is to ensure that the roles and responsibilities are mutually acceptable to all parties.
p.000073: Researchers involved in CBPR should recognize and address the inequalities, thereby promoting trust, mutual
p.000073: respect, open communication, information sharing, collaborative decisionmaking, and resource sharing.
p.000073: It is important that researchers recognize that partnerships with the community are ongoing processes that
p.000073: need to be monitored and maintained. As a study progresses, the dynamics of the partnership may change as roles
p.000073: and responsibilities for the partners change. All partners need to be willing to make the investment of time
...

p.000084: the media to maintain or increase interest in the study.
p.000084:
p.000084: 7.4 Communicating at Different Levels
p.000084: The diversity of interested people and groups often means that communications materials should be
p.000084: developed at different levels of scientific literacy. In any case, the materials should all be written in
p.000084: “plain language” that is honest and straightforward. Stableford and Mettger (2007) state that “plain language
p.000084: embodies clear communication.” Many researchers mistakenly believe that the term means just using simple words,
p.000084: or worse, ‘‘dumbing things down.’’ It actually refers to communications that engage and are accessible to
p.000084: the intended audience.
p.000084: A 1998 Presidential memorandum required that “plain language” be used in all governmental
p.000084: communications with the public. That memorandum stated, “By using plain language, we send a
p.000084: clear message about what the Government is doing, what it requires and what services it offers. Plain language
p.000084: saves the Government and the private sector time, effort, and money.” Plain language is reader friendly and designed to
p.000084: increase the participant’s understanding of the communication material. It serves as a means by which lay
p.000084: audiences can access and understand scientific information. Researchers desiring to use plain language in
p.000084: their verbal and written communications with communities must decide on key messages to include and
p.000084: delete unnecessary descriptive, bureaucratic, or jargon-filled language. Researchers should use words that
p.000084: commonly are understood, rather than difficult abstract terms and concepts. A friendly,
p.000084: conversational tone is used to engage the lay audience, rather than a formal, scholarly tone that
p.000084: distances the community. Stableford and Mettger (2007) argue that proficiency in creating appropriate plain
p.000084: language materials is an acquired skill that requires knowledge and experience. “It is both an art and
p.000084: a science, requiring the ability to simultaneously think about the cognitive, emotional, and visual appeal of the
p.000084: piece as well as applying research- based strategies to ensure a truly easy-to-read and understand print
p.000084: material.”
p.000084: The Department of Health and Human Services (HHS) has developed a Web site that specifically
p.000084: address the issues related to “plain language” (see
p.000084: http://www.health.gov/communication/literacy/plainlang uage/PlainLanguage.htm). The site includes a list of
p.000084: references and other helpful resources.
p.000084: To maintain community engagement through the
...

p.000085: regardless of the type of material, whether it is a direct mailing, a Web site, a news release, or a set of questions
p.000085: and answers (Q&As) used to respond to media or stakeholder inquiries. In developing the communication
p.000085: materials, the research staff should seek the assistance, advice, and input of people in their
p.000085: organization and community groups with experience in developing such materials. With all of these
p.000085: materials, the researchers should be concerned with how the materials could be misinterpreted, and whether
p.000085: there could be a perception that the study would not meet the highest scientific and ethical standards. In this age
p.000085: of rapid communications and increased accessibility to information, it is essential that communication materials
p.000085: are well developed, accurate, and understandable to all audiences that may read them.
p.000085: Research study Web sites are especially useful for communicating information about observational human
p.000085: exposure studies. Web sites should be developed early in
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: the study to disseminate information to stakeholders and the community. Additionally, the sites can be set up with
p.000086: participant-only pages to provide more detailed information to study participants, including information
p.000086: on study protocols that require participant assistance (e.g., protocols for collecting urine
p.000086: samples, time/activity log entries). However, researchers need to ensure that Internet access is available to their
p.000086: intended audience and be prepared to provide alternative communication tools for those without such
p.000086: access.
p.000086: The plan for disseminating information from the study should be developed in the early design phases of the
p.000086: study and should be included in the study design document. Sufficient resources, both time and funding,
p.000086: need to be budgeted for this activity.
p.000086:
p.000086: 7.6 Informing the Study Participants and Communities
p.000086: Effective communications require that all parties, researchers and participants alike, involved in the
p.000086: communication understand the content and context of the information being exchanged. “When researchers
p.000086: discuss a planned study with community representatives, understand their concerns and needs, and respond to
p.000086: them, protocols can be strengthened both scientifically and ethically” (p. xii, NRC & IOM,
p.000086: 2005). Comprehension is one of the key pillars of informed consent, and it means that participants
p.000086: understand the key elements of the research. The most effective way to improve comprehension is by talking
p.000086: one-on-one with study participants.
p.000086: To accomplish that, the researchers need to make a commitment to communicating with both the study
p.000086: participants and the community to inform them of the study and provide training as appropriate. This can
p.000086: require a substantial investment of time and resources, but it is critical to the success of the study.
p.000086: Working with study participants to inform them about the study and the scientific basis of the study will have
p.000086: many benefits. The more educated the participant is about the purpose of the study and the activities to be
...

p.000097: involved large numbers of participants, employed randomized or probability-based approaches
p.000097: for selecting participants.
p.000097: Table A-2 shows the types of samples that often have been collected in NERL’s observational human
p.000097: exposure studies. Some of the samples, like air concentrations or surface wipes, allow NERL staff
p.000097: to determine the concentration of the studied chemicals in the environmental media with which the participants
p.000097: may come into contact. Other items, like time activity diaries or videotaping children to measure the amount of
p.000097: hand-to-mouth activity, allow NERL researchers to understand how people may come into contact with the agent
p.000097: and to estimate the duration or frequency of a potential exposure. Still other measures, like personal
p.000097: samplers or biological samples, represent an attempt to determine a time-integrated measure of exposure. NERL
p.000097:
p.000097:
p.000098: 98
p.000098:
p.000098: staff put all of this information together to estimate an individual participant’s exposure,
p.000098: either through relatively direct measures of exposure or through algorithms that combine the
p.000098: media concentrations measurements and the activity data.
p.000098:
p.000098: References
p.000098: CFR (Code of Federal Regulations) (2006). 40 CFR Chapter I Environmental Protection Agency Part 26 Protection of Human
p.000098: Subjects. U.S. Code of Federal Regulations.
p.000098: Available: http://www.access.gpo.gov/nara/cfr/waisidx_06/ 40cfr26_06.html [accessed 12 June 2007].
p.000098:
p.000098: NEAC (National Ethics Advisory Committee) (2006). Ethical Guidelines for Observational Studies: Observational research
p.000098: audits and related activities. Wellington, New
p.000098: Zealand: Ministry of Health. Available: http://www.neac.health.govt.nz/moh.nsf/indexcm/neac­
p.000098: resources-publications-ethicalguidelines.
p.000098:
p.000098: U.S. EPA (U.S. Environmental Protection Agency) (1992), Guidelines for Exposure Assessment. Environmental Protection
p.000098: Agency, Risk Assessment Forum, EPA/600/Z­ 92/001. Available: http://www.epa.gov/nceawww1/raf/pdfs/exposure.pdf
p.000098: [accessed 1 May 2008].
p.000098:
p.000098: Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, et al. (2007). Strengthening the Report of Observation
p.000098: Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Medicine 4(10): e297.
p.000098: doi:10.1371/journal.pmed.0040297.
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000099: 99
p.000099:
p.000099: Table A-1. Examples of Observational Human Exposure Studies Conducted or Funded by NERL or Its Predecessor
p.000099: Organizations
...

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p.000035: • Handicapped persons
p.000035: • Mentally disabled persons
p.000035: • Economically disadvantaged persons
p.000035: • Educationally disadvantaged persons
p.000035:
p.000035: • Children
p.000035: • Pregnant women (and their fetuses)
p.000035: • Nursing women (and their neonates
p.000035:
p.000035: • Children
p.000035: • Pregnant women and fetuses
p.000035: • Nursing women and neonates
p.000035: • Prisoners
p.000035: • The terminally ill
p.000035: • Students and employees
p.000035: • Comatose patients
p.000035: • Elderly persons, who may acquire attributes that define them as vulnerable with advancing age.
p.000035: • Residents of nursing homes.
p.000035: • People receiving welfare benefits or social assistance.
p.000035: • People with low or no incomes (poor and unemployed).
p.000035: • Homeless persons.
p.000035: • Nomads.
p.000035: • Refugees or displaced persons.
p.000035: • Some ethnic and racial minority groups.
p.000035: • People with incurable diseases (in clinical studies).
p.000035: • The politically powerless.
p.000035: • Members of communities unfamiliar with modern medical concepts (applies to clinical studies)
p.000035:
p.000035:
p.000035: 3.2 Justification for Involving Vulnerable Persons in Observational Research
p.000035: The Common Rule requires IRBs to ensure that the selection of subjects is equitable [40 CFR 26.111(a)(3)] and
p.000035: instructs the IRB to consider the “purposes of the research and the setting in which the research will
p.000035: be conducted.” CIOMS goes further and recommends that “Special justification is required for inviting
p.000035: vulnerable individuals to serve as research subjects” (CIOMS, 2002).12
...

p.000042: epidemiologists and obtain such information, they need to be cognizant of the relevant ethical issues and of the CIOMS
p.000042: guidelines.
p.000042: 15 Guideline 18 states, “The investigator must establish secure safeguards of
p.000042: the confidentiality of subjects’ research data. Subjects should be told the limits, legal or other, to the
p.000042: investigators’ ability to safeguard confidentiality and the possible consequences of breaches of confidentiality.”
p.000042: Additional CIOMS commentary on the confidentiality guideline states, “Prospective subjects should be informed of limits
p.000042: to the ability of researchers to ensure strict confidentiality and of the foreseeable adverse social consequences of
p.000042: breaches of confidentiality. Some jurisdictions require the reporting to appropriate agencies of, for instance, certain
p.000042: communicable diseases or evidence of child abuse or neglect. These and similar limits to the ability
p.000042: to maintain confidentiality should be anticipated and disclosed to prospective subjects.”
p.000042: to identify an individual. Precise geographic location information may be sufficient to pinpoint a
p.000042: residence. Researchers may use several strategies to reduce the likelihood of indirect identification when
p.000042: study results are reported (see, also, Text Box 4-3).
p.000042: • Redact from publications, reports, or public data sets information that might be used to indirectly identify a
p.000042: research participant.
p.000042: • Generalize exact information; for example, replace birth date with age or year of birth or classify age as
p.000042: part of a range.
p.000042: • Aggregate information across individuals; for example, only report data in cells of sufficient size
p.000042: to make individual linkages unlikely.
p.000042: • Reduce the specificity of geographic coordinate information to a level that a specific residence or other
p.000042: location can not be identified.
p.000042:
p.000042: Text Box 4-3. Approaches for Protecting Personally Identifiable Information
p.000042: • Developing procedures for safeguarding information prior to collecting the information
p.000042: • Ensuring that data or samples are anonymous by not collecting or by destroying identifying information or linkages
p.000042: • Restricting access to identifying information to only those requiring access
p.000042: • Assigning codes to participants, data, and samples rather than using identifiers
p.000042: • Physically separating identifying information and linkage files from other study information
p.000042: • Securing identifying information in locked files with limited access
p.000042: • Restricting identifying information from computers that are networked with other computers or electronic systems
p.000042: • Restricting identifying information from computers that are not kept in secure locations with limited access
p.000042: • Training research staff members on human subject protection and on information security procedures
p.000042:
p.000042:
...

p.000058: payments. They also recommend that the policies disclose any recompense in a full and open
p.000058: process,22 while not overemphasizing any recompense.
p.000058: Although the NRC & IOM Committee on Ethical Issues in Housing-Related Health Hazard Research Involving
p.000058: Children and the IOM Committee on Clinical Research Involving Children both concluded that it is appropriate to
p.000058: reimburse expenses or compensate for time or inconvenience, neither committee endorsed incentive
p.000058: payments to parents. In Europe, too, incentive payments to induce parents to allow their children to
p.000058: 5.2.3 Payments When Children or Other
p.000058: Vulnerable Populations Are Involved
p.000058:
p.000058: It is essential that special care be taken with regard to payments when members of vulnerable populations are
p.000058: included in research studies. Vulnerable populations may include children and adolescents, those with
p.000058: cognitive impairments because of medical conditions or age, economically disadvantaged persons, and prisoners. These
p.000058: populations often are not capable of making autonomous, fully informed decisions regarding risks and
p.000058: benefits, or they may be particularly vulnerable to undue influence resulting from the offer of a payment for
p.000058: research participation. In addition, payments made directly to parents or guardians could alter
p.000058: judgment regarding the best interests of minor or incompetent persons in their care.
p.000058: The ethical concern is that too high a payment may “undermine free and informed consent by leading parents
p.000058: to expose their children to unacceptable risks” (NRC & IOM, 2005). The NRC & IOM committee recognized
p.000058: that some commentators argued that children should never be paid, and that parents ought not to be paid to
p.000058: enroll their children in research. Yet, on balance, the committee felt that “reimbursement for expenses and some
p.000058: modest payment for time spent in research
p.000058: 21 The IOM Recommendation 6.2 states, “In addition to offering small gifts or payments to parents and children as
p.000058: gestures of appreciation, investigators may also—if they minimize the potential for undue influence—act ethically to
p.000058: reduce certain barriers to research participation when they
p.000058: • reimburse reasonable expenses directly related to a child’s participation in research
p.000058: • provide reasonable, age-appropriate compensation for children based on the time involved in research that does not
p.000058: offer the prospect of direct benefit, and
p.000058: • offer evening or weekend hours, on-site child care, and other reasonable accommodations for parental work and
p.000058: family commitments.”
p.000058: 22 In recommending an open process, the IOM committee chose to reject the
p.000058: arguments from the American Academy of Pediatrics that “any token payment to children for participating in research
p.000058: should not be discussed with them until after research is completed for fear of unduly influencing their decisions
p.000058: (AAP, 2003)…. On balance, the committee agrees that it is best to mention token or other payments during the permission
p.000058: and assent processes” (p. 215, IOM, 2004).
p.000058: The IOM Recommendation 6.1 states, “Institutional review boards, research institutions, and sponsors of research that
p.000058: includes children and adolescents should adopt explicit written policies on acceptable and unacceptable types and
p.000058: amounts of payments related to research participation. These policies should specify that investigators
p.000058: • Disclose the amount, the recipient, the timing, and the purpose (e.g., an expense reimbursement or a token of
p.000058: appreciation to a child) of any payments as part of the process of seeking parents’ permission, and, as appropriate,
p.000058: children’s assent to research participation;
...

p.000060: samples and information that are collected or provided. Payment for direct participant costs has been included
p.000060: in some studies, such as a reasonable payment for providing researchers with duplicate diet samples.
p.000060: NERL scientists should review the commentary and recommendations in the literature before devising a
p.000060: payment program as part of a research protocol, especially the two recent National Academies of Science
p.000060: documents, Ethical Issues in Housing-Related Health Hazard Research Involving Children (NRC and IOM, 2005)
p.000060: and Ethical Conduct of Clinical Research Involving Children (IOM, 2004). They should seek
p.000060: guidance from EPA’s HSRRO to determine EPA’s latest policies and guidance in this regard. Input also should be sought
p.000060: from community representatives to ensure that any payment is adequate to compensate for expenses and reward
p.000060: participation, but that the payment is not so high as to constitute undue influence or coercion in the
p.000060: community. If the study includes several followup visits over a long term, NERL researchers should ensure that payment
p.000060: is made incrementally as the NRC & IOM committee suggested. NERL scientists also should adopt the IOM
p.000060: Recommendations 6.1 and 6.2, including ensuring that any payment should be for appropriate purposes
p.000060: and age-appropriate, and that the process should be open and fully disclosed, while not overly
p.000060: emphasizing payments during the recruiting or informed consent phases. The final decisions about the ethics of
p.000060: payments rest with the IRB, which will review, modify as needed, and approve the research protocol, and with the EPA
p.000060: HSRRO, who has final authority to approve, modify, or disapprove all of NERL’s human subjects research
p.000060: efforts.
p.000060: 5.3 Research Rights and Grievance Procedures
p.000060: Protecting the research rights of participants and providing independent access to information regarding
p.000060: those rights and to grievance procedures is an important element in developing and maintaining appropriate
p.000060: participant-investigator relationships. As part of the informed consent process, the Common Rule
p.000060: requires “An explanation of whom to contact for answers to pertinent questions about the research and
p.000060: human subjects’ rights, and whom to contact in the event of a research-related injury to the
p.000060: subject” [40 CFR 26.116(a)(7)].
p.000060: Information about the research often best can be answered by the researcher. However, it may benefit
p.000060: researchers and participants if information about the research can be obtained from or confirmed by a trusted
p.000060: independent person or organization. Participants also need to know how they can contact
...

p.000069:
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: 6.2 Issues in Community Involvement
p.000070: There are a number of issues that need to be addressed in any efforts to ensure
p.000070: community involvement. The Expert Panel that was convened to advise NERL about scientific and ethical
p.000070: issues in observational human exposure studies discussed a number of challenges (ERG, 2007). The topics
p.000070: that the expert panel identified as issues are discussed below.
p.000070:
p.000070: 6.2.1 Defining “Community”
p.000070: “Community” refers to a group of people united by a shared attribute, and the attributes can be wide-ranging, such as
p.000070: geography, culture, social characteristics, values, interests, traditions, or experiences (ERG, 2007).
p.000070: Community can be defined broadly (as a system of interrelated groups operating to meet the needs of its
p.000070: members) or more narrowly (as the population from which study participants are selected). For observational
p.000070: field studies, the Expert Panel from the workshop suggested the narrow definition. A narrow
p.000070: definition allows social and cultural factors to be included but excludes government agencies, industry, and
p.000070: others who do not necessarily represent the interests of the participants (ERG, 2007).
p.000070: Central to the definition of a community is a sense of “who is included and who is excluded from
p.000070: membership” (NRC & IOM, 2005). A person may be a member of a community by choice, as with voluntary
p.000070: associations, or by virtue of their innate personal characteristics, such as age, gender, race, or
p.000070: ethnicity (NRC & IOM, 2005). As a result, individuals may belong to multiple communities at any one time. When
p.000070: initiating community engagement efforts, one should be aware of these complex associations in deciding which
p.000070: individuals to work with in the targeted community.
p.000070: Quandt et al. (2001) discuss a CBPR research project, Preventing Agricultural Chemical Exposure in
p.000070: North Carolina Farmworkers, where the process of defining a community was complicated by language,
p.000070: ethnic and racial stereotypes, and lack of organization. Many of the affected farmworkers originated outside the
p.000070: United States from several different Spanish-speaking countries and possessed contradicting viewpoints
p.000070: on research and the utility of community organization. Moreover, the community organization tailored
p.000070: for this farmworker demographic did not include enough members to adequately populate the
p.000070: study. The researchers utilized multiple approaches, including community forums, community advisory
p.000070: councils, and public presentations, to identify a diverse, yet viable, community within the broader
p.000070: farmworker population.
p.000070: Through this process of using multiple participatory strategies to define the community, a
...

p.000072: Building and maintaining appropriate community and stakeholder relationships requires acknowledgment of the
p.000072: diversity within communities with regard to many factors, including, but not limited to, race/ethnicity,
p.000072: religious beliefs, heritage, and lifestyles. Different groups in the study area may have different
p.000072: cultural norms and practices. The researchers should take these issues into consideration as they work in the
p.000072: community. Community partners can help researchers design the study to be attentive to the increasing
p.000072: heterogeneity of community groups (Minkler and Wallerstein, 2003, Chapter 4) and to the different
p.000072: boundaries of privacy (crucial when designing sampling strategies) of different groups (Israel et al., 2005b, Chapter
p.000072: 11).
p.000072: Vega (1992) provides a thorough discussion of the theoretical and pragmatic implications of
p.000072: cultural diversity for community research and explains that researchers should interact with
p.000072: communities using methods that promote understanding and demonstrate sensitivity and competence in
p.000072: working with diverse
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: cultures (e.g., with respect to class, gender, ethnicity, race, age, and sexual orientation). To aid in this
p.000073: process, researchers should include sufficient time in their project timeline to interact and dialogue with the
p.000073: community before the study begins to understand the cultural issues that may affect the research. Researchers and the
p.000073: results of their work are expected to promote a strengthening of the community; however, it should be recognized
p.000073: that, given the heterogeneity and the diverse views within a community, the study findings potentially may
p.000073: conflict with the desires of the community or may promote feelings of anger or distrust among members
p.000073: of the community with each other. Enlisting the services of a third-party evaluator/mediator may be
p.000073: useful for sustaining positive relations between all research participants and the community at
p.000073: large.
p.000073: The Research Triangle Park Particulate Matter Panel Study (Williams et al., 2003), a NERL investigation of PM
p.000073: and related pollutants involving African-Americans in North Carolina, demonstrated an effective strategy for using
p.000073: communication to address cultural differences between the community and research personnel. Before beginning
p.000073: the research, the study design included time and a budget for building collaborations with
p.000073: organizations having close ties with the African- American community to establish trust between
p.000073: the community and research team. Using input from the community partner organizations, the
...

p.000077: Participación de La Communidad. U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response.
p.000077: Washington, DC. EPA 540-K­ 99-005, OWSER 9200.2-26K, PB99-963230. Available:
p.000077: http://www.epa.gov/superfund/community/today/pdfs/risk­ fs-0203.pdf
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2001). Improved Science-Based Environmental Stakeholder Processes: A
p.000077: Commentary by the EPA Science Advisory
p.000077: Board. EPA-SAB-EC-COM-01-006. EPA Science Advisory Board. Washington, DC. Available:
p.000077: http://yosemite.epa.gov/sab/sabproduct.nsf/CEE3F362F1A1 344E8525718E004EA078/$File/eecm01006_report_appna­ e.pdf
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2003). Framework for Cumulative Risk Assessment. Washington, DC:
p.000077: United States Environmental Protection Agency. EPA/600/P-02/001F. Available:
p.000077: http://cfpub2.epa.gov/ncea/cfm/recordisplay.cfm?deid=54944 .
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2003). Framework for Assessing Risks of Environmental Exposure to
p.000077: Children. Washington, DC. Available: http://cfpub2.epa.gov/ncea/cfm/recordisplay.cfm?deid=22521.
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2005). Guidance on Selecting Age Groups for Monitoring and Assessing
p.000077: Childhood Exposures to Environmental Contaminants. Risk Assessment Forum, Washington, D.C. EPA/630/P-03/003F.
p.000077: Available: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=146583.
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2006). Considerations for Developing Alternative Health Risk
p.000077: Assessment Approaches for Addressing Multiple Chemicals, Exposures, and Effects. External Review Draft. 71 FR 16306.
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2006). Paper on Tribal Issues Related to Tribal Traditional Lifeways,
p.000077: Risk Assessment, and Health and Well Being: Documenting What We’ve Heard. The National EPA-Tribal Science Council.
p.000077: Available: http://epa.gov/osp/tribes/tribal/TribalIssues.pdf.
p.000077:
p.000077: U.S. EPA (U.S. Environmental Protection Agency) (2006). EPA’s Public Involvement Policy. Available:
p.000077: http://www.epa.gov/publicinvolvement/policy2003/index.htm.
p.000077:
p.000077: U.S. Food and Drug Administration (FDA). Exception from informed consent requirements for emergency research. 21 CFR §
p.000077: 50.24
p.000077:
p.000077: University of Kansas Community Tool Box. Available: http://ctb.ku.edu/en/tablecontents/.
p.000077:
...

p.000084: piece as well as applying research- based strategies to ensure a truly easy-to-read and understand print
p.000084: material.”
p.000084: The Department of Health and Human Services (HHS) has developed a Web site that specifically
p.000084: address the issues related to “plain language” (see
p.000084: http://www.health.gov/communication/literacy/plainlang uage/PlainLanguage.htm). The site includes a list of
p.000084: references and other helpful resources.
p.000084: To maintain community engagement through the
p.000084: research process, it is critical that communications are at the appropriate level, and that materials are written at a
p.000084: reading level that is appropriate to the audience. For the nonscientist, many IRBs and other groups target
p.000084: materials to be used with participants and communities at a reading level no higher than the 8th grade to
p.000084: improve the likelihood of comprehension. In some communities, however, other factors, like primary languages other than
p.000084: English, educational disadvantages, etc., may require communications materials to be written in
p.000084: alternate languages and at different reading levels. The issue is comprehension, as was discussed in
p.000084: Section 5.1.2. Empirical testing of communication methods and content is essential to ensure
p.000084: comprehension (Health Canada, 2006).
p.000084: Researchers also should recognize that in this information age, dissemination of
p.000084: informational materials may be rapid and widespread. Therefore, even documents intended for scientific peers may
p.000084: benefit by including summary information in an executive summary or preface that a lay reader can
p.000084: understand.
p.000084:
p.000084: 7.5 Communications Materials
p.000084: Researchers need to communicate clearly with the many groups listed in Section 7.2 to develop their
p.000084: relationship with the participants in the study, to develop their partnership with the community, to gain
p.000084: support from stakeholders, and to inform the public. To achieve the multiple purposes of communications
p.000084: during a research study and to communicate with many diverse groups, a variety of communications materials may
p.000084: need to be developed. Different materials have different purposes and different types of
p.000084: information to be communicated. Because of diversity in interested individuals and groups with
p.000084: respect to education, cultures, information needs, etc., the format and content of communication materials
p.000084: likely will need to be diverse. Text Box 7-4 list activities and materials that may be helpful in
p.000084: facilitating communications.
p.000084: By definition, communication is an exchange of information. This has to be the primary goal of
p.000084: communication activities. The accuracy and completeness of the information transferred is
p.000084: important. There are many different ways to communicate, the effectiveness of which varies substantially.
...

p.000085: accurate and complete information that is less likely to be misinterpreted by anyone who might
p.000085: pick up the brochure. Brochures and flyers that are used to announce a study or are used as recruiting tools
p.000085: should be carefully written in plain language to ensure that there is not a perception of activities that are
p.000085: unethical. For example, if flyers announcing a study state that study participants will be compensated, the flyer
p.000085: needs to ensure that the compensation is not the focus of the flyer, and that the payment does not appear to
p.000085: be excessive and coercive (see Section 5.2). Flyers announcing a study generally do not include the dollar
p.000085: amounts of payment.
p.000085: Researchers need to have similar concerns about all of the communication materials that are developed,
p.000085: regardless of the type of material, whether it is a direct mailing, a Web site, a news release, or a set of questions
p.000085: and answers (Q&As) used to respond to media or stakeholder inquiries. In developing the communication
p.000085: materials, the research staff should seek the assistance, advice, and input of people in their
p.000085: organization and community groups with experience in developing such materials. With all of these
p.000085: materials, the researchers should be concerned with how the materials could be misinterpreted, and whether
p.000085: there could be a perception that the study would not meet the highest scientific and ethical standards. In this age
p.000085: of rapid communications and increased accessibility to information, it is essential that communication materials
p.000085: are well developed, accurate, and understandable to all audiences that may read them.
p.000085: Research study Web sites are especially useful for communicating information about observational human
p.000085: exposure studies. Web sites should be developed early in
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: the study to disseminate information to stakeholders and the community. Additionally, the sites can be set up with
p.000086: participant-only pages to provide more detailed information to study participants, including information
p.000086: on study protocols that require participant assistance (e.g., protocols for collecting urine
p.000086: samples, time/activity log entries). However, researchers need to ensure that Internet access is available to their
p.000086: intended audience and be prepared to provide alternative communication tools for those without such
p.000086: access.
p.000086: The plan for disseminating information from the study should be developed in the early design phases of the
p.000086: study and should be included in the study design document. Sufficient resources, both time and funding,
p.000086: need to be budgeted for this activity.
p.000086:
p.000086: 7.6 Informing the Study Participants and Communities
p.000086: Effective communications require that all parties, researchers and participants alike, involved in the
p.000086: communication understand the content and context of the information being exchanged. “When researchers
...

p.000178: North Carolina, and North Dakota in three phases.
p.000178: A separate VOC TEAM study was carried out in Baltimore, MD: Baltimore lacks the petroleum and chemical manufacturing
p.000178: plants present in most of the previous TEAM study sites and is more representative of many U.S. cities. Focused studies
p.000178: were also conducted in New Jersey and Los Angeles to further explore the sources and factors contributing to personal
p.000178: VOC exposures identified in the earlier TEAM studies.
p.000178: First attempt to develop a methodology for measuring the potential exposure of the general population to common
p.000178: household pesticides using probability-based sampling; questionnaire data collection; and personal monitoring of air,
p.000178: drinking water, food, and dermal contact. Conducted in Jacksonville, FL, and Springfield and Chicopee, MA, to capture
p.000178: high- and low-pesticide-use areas, respectively.
p.000178: A 9-home pilot study was conducted to evaluate monitoring methods in the field that may be used to assess the potential
p.000178: exposures of children aged 6 months to 5 years to pesticides found in the home environment. Newly developed methods
p.000178: were tested for measuring pesticide residues in indoor air, carpet dust, outdoor soil, and on children's hands.
p.000178: Information also was collected on household characteristics, pesticides used and stored at the residence, and
p.000178: children's activities.
p.000178: A study of nonsmokers age 10 years and older in Riverside, CA, in which indoor, outdoor, and personal monitoring of
p.000178: integrated particle mass over 12-hour day and night periods was conducted for PM10 and PM2.5. Polycyclic aromatic
p.000178: hydrocarbon and phthalate measurements were collected indoors and outdoors at a subset of 125 homes. A separate
p.000178: monitoring site provided ongoing 12-hour measurements of ambient particles throughout the study (48 days). Reference
p.000178: PM10 and dichotomous samplers were used at this site in addition to personal and stationary monitors identical to those
p.000178: used for participant monitoring. Nighttime and daytime recall time-activity questionnaires, as well as household
p.000178: questionnaires, were administered to each selected subject and household, respectively, and meteorological and air
p.000178: exchange rate data were recorded for each monitored home.
p.000178: This survey collected 24-hour activity diaries and other questionnaire data from participants from 48 states. It was
p.000178: conducted as a next-day telephone recall interview.
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: EPA designed and run, contractor conducted
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000100: 100
p.000100:
...

p.000257:
p.000257:
p.000257:
p.000257:
p.000257:
p.000257:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Convenience
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Convenience, multiday pilot study to test methodology
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Case control study
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Randomized, cross- sectional
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Convenience, longitudinal
p.000009: National Exposure Research Laboratory (NERL). A primary goal was to determine the relationships between personal
p.000009: exposures to particles and associated gases relative to stationary outdoor monitor concentrations in high-risk
p.000009: subpopulations and to identify human activity patterns that might contribute to personal exposure. The investigators
p.000009: varied study locations, monitoring seasons, and study populations.
p.000009: Susceptible subpopulations of interest included chronic obstructive pulmonary disease (COPD) patients, individuals with
p.000009: cardiovascular disease, the elderly, asthmatics, and African Americans with hypertension. Panels of healthy individuals
p.000009: also were included. Because the elderly is the subpopulation most sensitive to health effects associated with PM
p.000009: exposures, the majority of subjects were over age 65.
p.000009: Performed in the Raleigh, NC, area in homes with children 1 to 3 years old. Homeowners reported either professional or
p.000009: self applications of diazinon. Goals of the study were to evaluate methods to measure excess dietary exposures
p.000009: resulting from food-handling activities by young children during eating and to assess whether the Children’s Dietary
p.000009: Intake Model (CDIM) accurately represents total dietary exposures of children. Study resulted in refinements of model
p.000009: parameters for transfer and activity.
p.000009: Observational measurement study of exposure to chlorpyrifos among children 2-5 years of age in urban New Jersey homes
p.000009: following crack and crevice treatment by a professional applicator. Study investigated decay of pesticide levels over
p.000009: time, transfer of pesticide from microenvironmental media to child, and factors that affect transfer. Dermal transfer
p.000009: evaluated with surface wipes, hand wipes, dermal wipes, cotton garments, and videotaping.
p.000009: Physicians at Case-Western Reserve treating children with idiopathic pulmonary hemorrhage evaluated the nature of the
p.000009: fungus found in homes of the afflicted and control children to determine if Stachybotrys was a potential factor in the
p.000009: illness. Three of the 8 cases, and none of the controls, had Stachybotrys strains that potentially were implicated.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: The largest children’s exposure study undertaken to date. It examines aggregate exposures of children 18 months to 5
p.000009: years to pollutants commonly found in everyday environments. The major objectives were to quantify children’s aggregate
p.000009: exposures, apportion exposure pathways, and identify important exposure media. Participants were recruited from 12
p.000009: urban and rural counties in North Carolina and Ohio using a random digit dialing method. Monitoring was performed at
p.000009: both daycare centers and homes. Samples collected include food, beverages, indoor air, outdoor air, hand wipes, dust,
...

p.000021: duplicate diet, cotton garment samples, and urine samples. A time- activity diary of the children’s activities was
p.000021: included.
p.000021: Work with Veteran’s Administration hospital staff. Cases of Legionnaires Disease were evaluated for potential for
p.000021: exposure from residential drinking water taps. In about 24% of the tested cases, homes were found to have Legionella
p.000021: bacteria in water taps at home, compared to their absence in other cases and in controls
p.000021: Incidental pesticide exposure measurement study of farmworkers’ children ages 5 to 35 mo. Purpose is the evaluation of
p.000021: methods for aggregate exposure measurements and the evaluation of pathways of exposure and important factors that
p.000021: affect exposure. Measurements include pesticide distributions in microenvironments where children spend time, transfer
p.000021: of pesticides from microenvironmental media to child, and factors that affect transfer.
p.000021:
p.000021:
p.000021:
p.000021: Study identified daycare centers with previously established contracts for routine monthly pesticide applications and
p.000021: conducted screening sampling in each to evaluate the distributions of transferable pesticide residues on floor surfaces
p.000021: where children spend time. One daycare was selected for intensive measurements, and children from different age groups
p.000021: volunteered to wear full-body cotton suits for short time periods while their activities were videotaped.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000103: 103
p.000103: of molds/fungi and helped with lead and pesticide measurements.
p.000103:
p.000103:
p.000103: EPA conducted with contractor support
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Multiagency effort; NERL was a participant and led the 9-home exposure component.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: NERL funded IAG with VA to conduct study.
p.000103:
p.000103:
p.000103:
p.000103: EPA grant to UC Berkeley; NERL augmented the existing research effort.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: NERL designed, contractor conducted
p.000103:
p.000103: Table A-1. (Continued)
p.000103: Study Date Size Type Brief Description
p.000103: NERL Role
p.000103: Tampa 2002 9 Residences Convenience Pilot study on methods for measuring personal,
p.000103: indoor NERL designed, Asthmatic sample,
p.000103: pilot residential, outdoor residential, and ambient combustion- contractor
p.000103: Children's Study study to test related products, particulate
p.000103: matter, and air toxics. The study conducted
p.000103: (TACS) methods. identified microenvironmental
p.000103: factors affecting penetration of pollutants into homes and reduction of exposures to pollutants for asthmatic children
p.000103: (0-5 years of age).
p.000103:
p.000103: Pilot Study To Evaluate Data Collection Methods for Young Children’s and Household Activities
p.000103: Detroit Exposure and Aerosol Research Study (DEARS)
p.000103:
p.000103:
p.000103:
p.000103: Accelerometer Pilot Study
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Pilot Study of Waterborne Infections
p.002004: 2004
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004: 2004-2007
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004: 2004
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002004:
p.002005: 2005
p.002005: 3 Homes
p.002005:
p.002005:
p.002005:
p.002005:
p.002005:
p.002005:
p.000150: 150
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.001296: 1296
p.001296: Convenience, pilot study to test methodology
p.001296:
p.001296:
p.001296:
p.001296:
p.001296: Randomized household selection with qualification criteria; longitudinal
p.001296:
p.001296: Convenience, pilot study to test methodology
p.001296:
p.001296:
p.001296:
p.001296:
p.001296: Convenience, all volunteers from community using public water supply
p.001296: Pilot aggregate exposure study of three homes to assess burden of alternative exposure sample collection methods.
p.001296:
p.001296:
p.001296:
p.001296:
p.001296:
p.001296: Recruitment from seven distinct neighborhoods in Detroit required strong community relations and partnership with State
p.001296: and local organizations. This study monitored for air pollutants at the personal level and evaluates how well centrally
...

p.000109: (4) The investigators’ views of the ethical issues and considerations raised by the study and,
p.000109: if appropriate, how it is proposed to deal with them
p.000109: (5) A summary of previous studies on the research problem, including unpublished studies known to the
p.000109: investigators, and information on previously published research on the topic
p.000109: (6) A statement that the principles of the Belmont Report and requirements specified in 40 CFR 26 will
p.000109: be implemented
p.000109: (7) An account of previous submissions of the protocol for ethical review and their outcomes
p.000109: (8) A brief description of the sites where the research is to be conducted, including information about the
p.000109: adequacy of facilities for the safe and appropriate conduct of the research, and relevant demographic and
p.000109: epidemiological information about the population to be studied
p.000109: (9) The names and addresses of the funding organization, research partners, and collaborators
p.000109: (10) The names, addresses, institutional affiliations, qualifications, and experience of the
p.000109: principal investigator and other investigators
p.000109: (11) The objectives of the study, its hypotheses or research questions, its assumptions, and
p.000109: its variables
p.000109: (12) A detailed description of the design of the study
p.000109: (13) The number of research subjects needed to achieve the study objective, and how this was determined
p.000109: statistically
p.000109: (14) The criteria for inclusion or exclusion of potential subjects and justification for the exclusion of
p.000109: any groups on the basis of age, sex, social or economic factors, or other reasons
p.000109: (15) The justification for involving as research subjects any persons with limited capacity to consent or
p.000109: members of vulnerable social groups and a description of special measures to minimize risks and
p.000109: discomfort to such subjects
p.000109: (16) The process of recruitment (e.g., advertisements) and the steps to be taken to protect privacy and
p.000109: confidentiality during recruitment
p.000109: (17) A description and explanation of any and all interventions
p.000109: (18) The measurements to be performed in the study, including environmental and biological sample
p.000109: collection, and other data and information that will be collected
p.000109: (19) If applicable, clinical and other tests involving the study participants that are to be carried out
p.000109: (20) The rules or criteria according to which subjects may be removed from the study or the study may be
p.000109: terminated
p.000109: (21) The methods of recording and reporting adverse events or reactions, and provisions for dealing with
p.000109: complications
p.000109: (22) The potential benefits of the research to subjects and to others
p.000109: (23) The expected benefits of the research to the population, including new knowledge that the study
p.000109: might generate
p.000109:
p.000109:
p.000109:
p.000111: 111
p.000111:
p.000111: (24) The means proposed to obtain individual informed consent and the procedure planned to communicate information to
p.000111: prospective subjects, including the name and position of the person responsible for obtaining consent
p.000111: (25) When a prospective subject is not capable of informed consent, satisfactory assurance
p.000111: that permission will be obtained from a duly authorized person, or, in the case of a child who is sufficiently mature
p.000111: to understand the implications of informed consent but has not reached the legal age of consent,
p.000111: that knowing agreement, or assent, will be obtained, as well as the permission of a parent, or a legal guardian
p.000111: or other duly authorized representative.
p.000111: (26) An account of any economic or other compensation or incentives to prospective subjects to participate, such as
p.000111: offers of cash payments, gifts, or free services or facilities, and of any financial
p.000111: obligations assumed by the subjects, such as payment for medical services
p.000111: (27) The plans and procedures and the persons responsible for communicating to
p.000111: subjects information arising from the study (on harm or benefit, for example) or from other research on the same
p.000111: topic that could affect subjects’ willingness to continue in the study
p.000111: (28) The plans to inform subjects about the results of the study
p.000111: (29) The provisions for protecting the confidentiality of personal data and respecting the privacy of subjects,
p.000111: including the precautions that are in place to prevent disclosure of the results of a
p.000111: subject’s genetic tests to immediate family relatives without the consent of the subject
p.000111: (30) Information about how the code, if any, for the subjects’ identity is established; where it will be
p.000111: kept; and when, how, and by whom it can be broken in the event of an emergency
p.000111: (31) Any foreseen further uses of personal data or biological materials
...

p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116: Appendix F
p.000116: Glossary
p.000116:
p.000116:
p.000116:
p.000116: Agent. A chemical, mineralogical, biological, or physical entity that may cause deleterious effects in an organism
p.000116: after the organism is exposed to it [EPA/600/Z-92/001, May 1992].
p.000116: Assent. A child’s affirmative agreement to participate in research. Mere failure to object should not, absent
p.000116: affirmative agreement, be construed as assent [45 CFR 46.402(d)].
p.000116: Autonomy. The capability and capacity to govern oneself.
p.000116: Beneficence. The ethical obligation to maximize benefits and to minimize harms. This principle gives rise to norms
p.000116: requiring that the risks of research be reasonable in light of the expected benefits, that the research design be
p.000116: sound, and that the investigators be competent both to conduct the research and to safeguard the welfare of the
p.000116: research subjects. Beneficence further proscribes the deliberate infliction of harm on persons; this aspect of
p.000116: beneficence is sometimes expressed as a separate principle, nonmaleficence (do no harm).
p.000116: Child. A person who has not attained the age of 18 years [40 CFR 26.202(a)]
p.000116: Collateral observations. Potentially unsafe hazards, conditions, or situations unrelated to the research study that
p.000116: are observed by the research staff
p.000116: Common Rule. The Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects.” It was
p.000116: adopted by more than a dozen Federal departments or agencies in 1991, with EPA adapting it in Title 40 CFR Part 26
p.000116: Subpart A.
p.000116: Community-based participatory research (CBPR). Collaborative research with a community in which the community is
p.000116: involved in all phases of the research.
p.000116: A fundamental concept is that the research aims to combine knowledge with action and to achieve social
p.000116: change to improve health outcomes and eliminate health disparities.
p.000116: Confidentiality. The keeping safe or not redisclosing by one of the parties in a confidential relationship information
p.000116: that originally was disclosed in the confidential relationship
p.000116: Environmental justice. The fair treatment and meaningful involvement of all people regardless of race, color, national
p.000116: origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations,
p.000116: and policies
p.000116: Exposure. Contact of a chemical, physical, or biological agent with the outer boundary of an organism (e.g., a
p.000116: person). Exposure is quantified as the concentration of the agent in the medium in contact integrated over the time
...

Social / Child

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p.002002: services.
p.002002:
p.002002:
p.002003: 2003
p.002003:
p.002003: Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC, 2003)
p.002003:
p.002003: This NRC publication targets policymakers, research administrators, research sponsors, IRB members, and investigators.
p.002003: It examines three key ethical issues: (1) obtaining informed, voluntary consent from prospective participants; (2)
p.002003: guaranteeing the confidentiality of information collected from participants, which is a particularly challenging
p.002003: problem in social sciences research; and
p.002003: (3) using appropriate review procedures for minimal-risk research.
p.002003:
p.002003:
p.002005: 2005
p.002005:
p.002005: Ethical Considerations for Research on Housing- Related Health Hazards Involving Children, (NRC & IOM, 2005)
p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
p.002005: potential ethical concerns, such as issues involving adequacy of informed consent, parents' perception of risk, duties
p.002005: of researchers to child subjects and their parents, the role of IRBs, and the authority of parents to provide
p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
...

p.000008:
p.000008: EPA, States, and the Consumer Product Safety Commission worked together to influence manufacturers to voluntarily
p.000008: reduce emissions of toxic chemicals from consumer products, building materials, and furnishings, and to develop
p.000008: mitigation strategies and educational materials to teach people how to reduce their contact with chemicals indoors. As
p.000008: a result, contact with toxic chemicals indoors has been reduced (see www.cpsc.gov/CPSCPUB/PUBS/450.html).
p.000008:
p.000008:
p.000008: Formaldehyde
p.000008:
p.000008: Studies found elevated formaldehyde levels indoors and helped identify indoor sources.
p.000008:
p.000008: EPA worked with HUD, CPSC, and other agencies to limit formaldehyde in building or consumer products and to educate the
p.000008: public on how to reduce exposures (see www. epa.gov/iaq/formalde.html).
p.000008:
p.000008:
p.000008: EPA has adopted additional protections for children and pregnant or nursing mothers in Subparts B through
p.000008: D. These sections apply to all research either conducted or funded by EPA and are, therefore, directly applicable to
p.000008: NERL’s observational human exposure studies.4 Subpart B prohibits EPA from conducting or supporting research
p.000008: that involves intentional exposure of “a pregnant woman (and, thereby, her fetus), a nursing woman,
p.000008: or a child.” NERL researchers conducting (or funding) observational human exposure studies must comply
p.000008: with all of these regulatory requirements, including seeking review and approval by an IRB and by the
p.000008: Agency’s Human Subjects Research Review Official (HSRRO) before beginning any human subjects research.
p.000008: EPA’s human subjects rules also define a variety of fundamental terms⎯from “human subject” to “research” to
p.000008: “intentional exposure” to “observational research.” Understanding these regulatory definitions is vital for
p.000008: NERL researchers to comply with the regulatory requirements.5
p.000008: To more effectively ensure the protection of human subjects, NERL scientists and managers need to
p.000008: understand the ethical principles and issues that prompted the development of the
p.000008: regulatory requirements in the first place and to be knowledgeable
p.000008:
p.000008:
p.000008: 4 Subparts K, L, M, O, P, and Q of 40 CFR 26 set basic ethical requirements that have to be met if human subjects data
p.000008: from a person or group external to EPA and not funded by EPA (a third party) are to be used by EPA in specified
p.000008: rulemaking actions. These subparts do not apply to NERL researchers and will not be discussed further in this
p.000008: document.
p.000008: 5 The Glossary (Appendix F) lists definitions for a number of important terms; definitions that come from the
p.000008: regulatory language are identified with their specific CFR citation.
p.000008: about the most recent thinking and guidance on protection of human subjects.
...

p.002002: services.
p.002002:
p.002002:
p.002003: 2003
p.002003:
p.002003: Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC, 2003)
p.002003:
p.002003: This NRC publication targets policymakers, research administrators, research sponsors, IRB members, and investigators.
p.002003: It examines three key ethical issues: (1) obtaining informed, voluntary consent from prospective participants; (2)
p.002003: guaranteeing the confidentiality of information collected from participants, which is a particularly challenging
p.002003: problem in social sciences research; and
p.002003: (3) using appropriate review procedures for minimal-risk research.
p.002003:
p.002003:
p.002005: 2005
p.002005:
p.002005: Ethical Considerations for Research on Housing- Related Health Hazards Involving Children, (NRC & IOM, 2005)
p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
p.002005: potential ethical concerns, such as issues involving adequacy of informed consent, parents' perception of risk, duties
p.002005: of researchers to child subjects and their parents, the role of IRBs, and the authority of parents to provide
p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
...

p.000024: whether or not the children were involved in a research study. As a consequence, the study still
p.000024: would meet the regulatory criteria for minimal risk as long as the research itself introduced no risks over
p.000024: and above those minimal risks
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: experienced by normal children living in safe healthy environments.
p.000025: However, the existence of greater than minimal background risks that are not introduced by the research,
p.000025: nonetheless, raises additional ethical considerations. The joint NRC & IOM Committee on Research on Housing- Related
p.000025: Health Hazards Involving Children discussed the ethical arguments that arise when scientists conduct research that
p.000025: observes children in poor-quality housing. They point out that a researcher’s first duty of beneficence
p.000025: under the Common Rule requires that the risks of the research actions be proportionate to
p.000025: [“reasonable in relation to”; 40 CFR 26.111(a)(2)] the benefits of the research, and that the risks be
p.000025: minimized. They acknowledge, however, that some have argued that the “best interests of the child” also obligates
p.000025: researchers to “rescue” children from harm and to provide better living conditions. They conclude that,
p.000025: properly applied, the ethical principle of beneficence does indeed direct researchers who observe serious harms
p.000025: to child subjects to take steps to try to prevent the harms. However, they also argue that the researcher’s duty does
p.000025: not extend to “personally and directly prevent harm by removing the child from the harmful environment” (p.
p.000025: 60, NRC & IOM, 2005). They conclude instead that “it is unrealistic and unfair to hold individual research
p.000025: investigators responsible for ameliorating the social circumstances that they study” and that “a nuanced
p.000025: balancing of the benefits and risks of research” is an ethically sound approach that is firmly established in
p.000025: Federal regulations (p. 60, NRC & IOM, 2005). Balancing the ethical obligation to mitigate risks or
p.000025: harms observed during research with the reasonable limits on an investigator’s moral responsibility for
p.000025: the social circumstances surrounding the research will be the subject of later sections of this
p.000025: document, particularly Section 4.3.1.
p.000025: Assessing the risks and benefits of the research study can be very difficult for the researchers, especially
p.000025: because the researchers and the community or participants may perceive the risks and benefits
p.000025: quite differently. (See the discussion in NRC & IOM [2005], for example.) To understand the
p.000025: community’s perspective better, the researcher may find it helpful to discuss the assessment of risks
p.000025: and benefits with members of the research team, community representatives, and relevant
p.000025: stakeholders. The research team should consider the use of a community advisory board (CAB) to provide
p.000025: input to the assessment of the risks and benefits of the study. The group could include individuals who are
p.000025: representative of the population to be studied, community representatives, exposure
...

p.000033: the rights and welfare of these [vulnerable] subjects” [at 40 CFR 26.111(b) in CFR, 2006a]. If an
p.000033: observational human exposure study includes vulnerable research participants, it is essential that the investigators be
p.000033: cognizant of the special issues and requirements of research involving vulnerable populations. Researchers
p.000033: have to justify the involvement of vulnerable populations in the research study and
p.000033: include the appropriate safeguards for protection of their safety and welfare. The Common Rule protections are
p.000033: discussed further in the IRB guidebook (U.S. HHS, 1993). EPA regulations include not only the general
p.000033: protections for vulnerable populations found in the Common Rule (Subpart A) but also define
p.000033: additional protections for children and for pregnant or nursing women (and their fetus or nursing child)
p.000033: in Subparts B, C, and D (CFR, 2006a).
p.000033: The section begins by identifying or defining vulnerable groups and then discusses ethical issues that
p.000033:
p.000033:
p.000033: 11 For more information about these and other research scandals, see Ethical and Policy Issues in Research Involving
p.000033: Human Participants, Vol. I, Report and Recommendations of the National Bioethics Advisory Commission, Bethesda, MD,
p.000033: August, 2001. See p. 153 for information about the Willowbrook State School experiments. The report is available at
p.000033: www.bioethics.gov/reports/past_commissions/nbac_human_part.pdf (Accessed September 3, 2007).
p.000033: may be important in conducting observational human exposure studies involving those groups, especially
p.000033: children and pregnant women. The discussions about the ethical issues are based largely on EPA’s human subjects
p.000033: regulations and on the recommendations from the Council for International Organizations of
p.000033: Medical Sciences document, International Ethical Guidelines for Biomedical Research Involving Human
p.000033: Subjects (CIOMS, 2002).
p.000033:
p.000033: 3.1 Identification of Vulnerable Groups
p.000033: In the United States, human subjects regulations (45 CFR 46 and 40 CFR 26) do not formally define
...

p.000035: consequence of the research;
p.000035: • the risks attached to interventions or procedures that do not hold out the prospect of direct health-related
p.000035: benefit will not exceed those associated
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: CIOMS recommendations, although written to address biomedical research, also generally are
p.000036: applicable to observational human exposure studies. The authors of this document consider the CIOMS
p.000036: requirement that the research could not be carried out equally well with less vulnerable subjects
p.000036: to be particularly important. EPA and NERL researchers should include vulnerable groups in
p.000036: observational human exposure studies only if their participation is critical to the success and
p.000036: applicability of the research. Even then, EPA and NERL researchers will have to meet stringent standards for
p.000036: protecting the rights and safety of the vulnerable participants. For example, EPA regulations
p.000036: governing observational research with children are even more stringent than the CIOMS guideline.
p.000036: If such research does not hold out the prospect of direct benefit to the child, no increase whatsoever over
p.000036: minimal risk is permitted.
p.000036: However, many observational human exposure studies are developed specifically to study the exposures of
p.000036: selected vulnerable groups to chemicals and other environmental stressors in everyday environments. So,
p.000036: researchers should be prepared to address the issues associated with vulnerable groups in
p.000036: observational research. Furthermore, as discussed in Section 3.4, there has been increased concern in recent years that
p.000036: exclusion of vulnerable groups from research studies is not ethical. Failure to conduct research with vulnerable groups
p.000036: may deprive them of the benefits of research. NIH, for example, has a policy (NIH, 1998) with a
p.000036: goal of increasing participation of children in research.
p.000036:
p.000036: 3.3 Minimal Risk and Vulnerable Groups
p.000036: EPA has codified protections for children, pregnant or nursing women, and fetuses in Subparts B, C, and D of the EPA
...

p.000036: protections to children (CFR, 2006a,b). There are many books, reports, and research manuscripts that
p.000036: specifically address issues associated with research involving children (e.g., NRC & IOM, 2005; IOM,
p.000036: 2004; Kodish, 2005; NRC, 2003; AAP, 2003).
p.000036: CIOMS has drafted guidelines for including children in biomedical research (Guideline 14, CIOMS, 2002). The
p.000036: guidelines require an investigator to provide the assurances shown in Text Box 3-3 before undertaking
p.000036: research involving children.
p.000036:
p.000036: Text Box 3-3. Assurances Required by CIOMS Before Research Involving Children May Begin
p.000036: • the research might not equally well be carried out with adults;
p.000036: • the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000036: • a parent or legal representative of each child has given permission;
p.000036: • the agreement (assent) of each child has been obtained to the extent of the child’s capabilities; and
p.000036: • a child’s refusal to participate or continue in the research will be respected.
p.000036:
p.000036:
p.000036: The participation of children in some observational human exposure studies is critical to
p.000036: characterizing children’s exposures to chemicals in the environment. It is well recognized that children are not
p.000036: “little adults,”
p.000036: and that their
p.000036: exposures to chemicals differ (and, in
p.000036:
p.000036:
p.000036: with routine medical or psychological examination of such persons unless an ethical review committee authorizes a
p.000036: slight increase over this level of risk (Guideline 9); and,
p.000036: • when the prospective subjects are either incompetent or otherwise substantially unable to give informed consent,
p.000036: their agreement will be supplemented by the permission of their legal guardians or other appropriate representatives.
p.000036:
p.000036:
p.000036: 13 Minimal risk is defined at 40 CFR 26.102(i) and again at 40 CFR 26.402(g). It “means that the probability and
p.000036: magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily
p.000036: encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
p.000036:
p.000036:
p.000037: 37
p.000037:
...

p.000037: family. EPA’s human subjects rule for observational research not involving greater than minimal risk to
p.000037: children (40 CFR 26.404) (i.e., the kinds of observational human exposure studies that NERL exposure research
p.000037: is likely to entail) focuses on obtaining assent of the children and permission of their parents or guardians. But the
p.000037: role of the family goes far beyond their involvement in the informed consent process. In observational
p.000037: human exposure studies, even when children are the participants, the parents or guardian play
p.000037: a key role in the collection of data and information during the study. For studies with very young children,
p.000037: family members supply all of the information relevant to the child. NERL researchers need to ensure that both
p.000037: the child and the parents or guardians and other caregivers are informed fully and are willing
p.000037: participants. Without their willing participation, the research cannot be successful.
p.000037:
p.000037: 3.5 Women as Research Subjects
p.000037: Women are routinely included as research participants in observational human exposure studies.
p.000037: However, pregnant women and their fetuses are vulnerable groups and require special protections.
p.000037: EPA’s human subjects rule prohibits intentional dosing studies and provides additional controls for
p.000037: observational research (40 CFR 26, Subparts B and C).
p.000037: CIOMS (2002) includes two guidelines for biomedical research involving women as research
p.000037: subjects. The first of these, number 16, states that women should not be excluded from
p.000037: biomedical research because of the potential for becoming pregnant during a study. The document continues, “A
p.000037: general policy of excluding from such clinical trials women biologically capable of becoming pregnant is
...

p.000042: may sometimes lead to the indirect identification of the individual. Certain combinations of
p.000042: demographic information, for example, may make it relatively simple
p.000042:
p.000042:
p.000042: 14 Beauchamp and Childress (2001) discuss when one may be ethically justified in infringing on an individual’s privacy
p.000042: and confidentiality⎯for example, because of risks to others evidenced by biomarkers of infectious disease. They also
p.000042: discuss similar ethical issues that may arise in regard to genetic data. CIOMS (2002) Guideline 18 provides suggestions
p.000042: for safeguarding or disclosing genetic information. If exposure scientists collaborate with medical researchers or
p.000042: epidemiologists and obtain such information, they need to be cognizant of the relevant ethical issues and of the CIOMS
p.000042: guidelines.
p.000042: 15 Guideline 18 states, “The investigator must establish secure safeguards of
p.000042: the confidentiality of subjects’ research data. Subjects should be told the limits, legal or other, to the
p.000042: investigators’ ability to safeguard confidentiality and the possible consequences of breaches of confidentiality.”
p.000042: Additional CIOMS commentary on the confidentiality guideline states, “Prospective subjects should be informed of limits
p.000042: to the ability of researchers to ensure strict confidentiality and of the foreseeable adverse social consequences of
p.000042: breaches of confidentiality. Some jurisdictions require the reporting to appropriate agencies of, for instance, certain
p.000042: communicable diseases or evidence of child abuse or neglect. These and similar limits to the ability
p.000042: to maintain confidentiality should be anticipated and disclosed to prospective subjects.”
p.000042: to identify an individual. Precise geographic location information may be sufficient to pinpoint a
p.000042: residence. Researchers may use several strategies to reduce the likelihood of indirect identification when
p.000042: study results are reported (see, also, Text Box 4-3).
p.000042: • Redact from publications, reports, or public data sets information that might be used to indirectly identify a
p.000042: research participant.
p.000042: • Generalize exact information; for example, replace birth date with age or year of birth or classify age as
p.000042: part of a range.
p.000042: • Aggregate information across individuals; for example, only report data in cells of sufficient size
p.000042: to make individual linkages unlikely.
p.000042: • Reduce the specificity of geographic coordinate information to a level that a specific residence or other
p.000042: location can not be identified.
p.000042:
p.000042: Text Box 4-3. Approaches for Protecting Personally Identifiable Information
p.000042: • Developing procedures for safeguarding information prior to collecting the information
p.000042: • Ensuring that data or samples are anonymous by not collecting or by destroying identifying information or linkages
p.000042: • Restricting access to identifying information to only those requiring access
...

p.000043: the home have to be asked for permission or be informed that monitoring activities are taking place.
p.000043: Researchers and IRBs should consider whether knowledge of an individual’s participation by others might
p.000043: create potential for harm or distress in an observational human exposure study. Such risks might
p.000043: be limited to possible discomfort in attracting unwanted
p.000043: attention; this may be particularly true for adolescents. However, in some cases, the potential risks
p.000043: could be greater, for example, in cases where participation could provoke an adverse reaction from a
p.000043: landlord or employer. Oftentimes study protocols can be structured to minimize these potential risks. Through the
p.000043: informed consent process, prospective participants should be made aware of the limits of the researcher’s ability to
p.000043: protect knowledge of their participation in the study and of the possible risks of disclosure.
p.000043:
p.000043: 4.3 Collateral Observations
p.000043: In the course of conducting an observational human exposure study, research staff may observe potentially unsafe
p.000043: conditions or situations that are unrelated to the research study. Such “collateral observations” may
p.000043: involve physical hazards in the study participant’s residential environment or evidence of situations,
p.000043: such as child abuse, that have to be reported to proper authorities. In preparing for the
p.000043: research study, it is recommended that researchers carefully plan for possible collateral observations,
p.000043: including their identification, staff training, and hazard communication and reporting. This may be a major
p.000043: element in the data and safety monitoring and oversight for the study. The informed consent process
p.000043: should reflect procedures used to manage collateral observations. Potential participants should be
p.000043: informed of situations in which confidentiality might be breached, such as statutory requirements for reporting
p.000043: abuse or imminent harm to self or others.
p.000043:
p.000043: 4.3.1 Potential Nonstudy Hazards in the Residence
p.000043: Research staff conducting observational human exposure studies often will spend time in and around
p.000043: study participant residences. In the course of visiting a residence or conducting study-related
p.000043: observations, research staff may observe potential hazards unrelated to the research being performed (see Text Box
p.000043: 4-4). Some hazards may be associated with the potential for physical injury, whereas others may be related to
p.000043: exposure to chemical or biological agents. Some situations may be potential hazards only for young children,
...

p.000043: potential hazards in advance, develop responses to the risks, and submit the proposed plans to the IRB
p.000043: for review to ensure that they are appropriate “in the context of the research and the affected community.” The NRC
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: & IOM also advise that field staff should be trained in how to assess and respond to
p.000044: such risks (Recommendations 7.3 and 7.4, NRC & IOM, 2005). For other behaviors and risks that
p.000044: have not been specifically identified in advance, procedures should be included in the data and safety monitoring
p.000044: and oversight provisions of the study design and research protocol to address these issues. The fundamental
p.000044: ethical principle of beneficence would motivate researchers who observe serious harms to take steps to try to prevent
p.000044: those harms, even for observations that are not directly related to the study. The steps that they may take can
p.000044: range from immediate action to prevent an imminent and serious danger to statutory reporting of
p.000044: observations (see Section 4.3.2) to reporting the observation to the data and safety monitoring and oversight
p.000044: authority for advice on how to respond (see Section 4.5). (The reader is also referred to pages 59-61 and 134-144 of
p.000044: the NRC & IOM [2005] report for a more thorough discussion of researchers’ responsibilities in such
p.000044: cases.)
p.000044:
p.000044: Text Box 4-4. Potential Hazards that Might Be Encountered in a Residential Environment
p.000044: • Unsecured firearm
p.000044: • Uncovered electrical outlets
p.000044: • Unprotected stairways
p.000044: • Missing child-protective cabinet latches
p.000044: • Lack of window guards
p.000044: • Missing or inoperable smoke alarm
p.000044: • Housing code violations
p.000044: • Chipping or flaking paint—potential for lead exposure in older homes
p.000044: • Malfunctioning or unvented combustion appliances—potential for carbon monoxide exposure
p.000044: • Unsecured poisons or other dangerous products
p.000044: • Excessive mold growth
p.000044:
p.000044:
p.000044: 4.3.2 Collateral Observations with Mandated Reporting Requirements
p.000044: Some collateral observations may have statutory requirements for reporting to designated authorities.
p.000044: Examples of such observations include
p.000044: • observed child or elder abuse or evidence of such abuse or neglect,
p.000044: • statements or actions of intent to harm self or others, and
p.000044: • certain communicable diseases.
p.000044: Because different reporting statutes pertain in different states, it is necessary for researchers to
p.000044: learn and understand the applicable reporting requirements for the study location. In the case of abuse, it is
p.000044: also
p.000044: important to understand what actions or situations are considered abusive in a particular state. Although direct
p.000044: physical harm or violence might be obvious to a research staff member, there are other conditions of neglect that
p.000044: might be more difficult to recognize or to know when to report.
p.000044: Study participants should be made aware of statutory requirements for reporting collateral observations as part of the
p.000044: informed consent process. Researchers should include the reporting requirements in the informed
p.000044: consent form (discussed in Section 5) and should ensure that the study participant fully comprehends this
p.000044: information and the impact on their privacy and confidentiality.
p.000044:
p.000044: 4.3.3 Hazard Communication
...

p.000045: understand and effectively implement the action, and whether unintended adverse consequences might
p.000045: result from taking an action. In some cases, it may be reasonable to refer the participant to another
p.000045: organization that can provide expert advice or assistance.
p.000045:
p.000045: 4.3.4 Planning and Staff Training
p.000045: As part of the study planning process and protocol development, it is important that researchers
p.000045: be cognizant of the kinds of collateral observations that might occur in the implementation of the study
p.000045: protocol and to develop plans as to how such observations would be handled. Researchers may choose to
p.000045: include a systematic approach in hazard identification, such as using a home-hazard checklist that becomes an
p.000045: ancillary part of the study protocol. Alternatively, collateral observations could be handled on a
p.000045: case-by-case basis.
p.000045: Staff experience and training is a critical consideration for managing collateral observations. Staff
p.000045: members that visit study participant residences may not have expertise or experience in identifying many of the
p.000045: potential hazards without adequate training. All staff involved in a study, particularly those responsible
p.000045: for field data collection, should be trained on identification and reporting of collateral observations. This
p.000045: training should be study specific and likely will include, but not be limited to
p.000045: (1) identification of actions (e.g., child abuse) that have (state-specific) statutory reporting requirements,
p.000045: (2) conditions of neglect that may adversely impact study participants or third parties,
p.000045: (3) environmental hazards and situations that may be associated with imminent harm (e.g., combustible
p.000045: materials near an open flame, unsecured firearms accessible to very young children),
p.000045: (4) policies and procedures for reporting or intervention by members of the research team, and
p.000045: (5) local and state reporting requirements.
p.000045: It is advisable that this training be developed in consultation with community representatives who can
p.000045: provide input on potential hazards and situations that may be encountered in the study community,
p.000045: local norms and attitudes about potential interventions and reporting, and local agencies available to assist on
p.000045: these types of issues. It is also especially important to consider
p.000045: staff experience and training in hazard communication. Consistency in communication is very important, and
p.000045: researchers may decide to use materials prepared by other organizations that have expertise regarding
p.000045: a particular hazard.
p.000045: Another important element of planning for field data collection and training of research staff is on hazards and
p.000045: situations that the field staff may encounter during their field work. Although the previous discussion highlights the
...

p.000052: (accessed September 12, 2007).
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: participants and, if so, how and when (p. 101, NRC & IOM, 2005).
p.000053: • For studies involving children as participants, it generally is regarded as desirable that the
p.000053: informed consent process should involve both parents (assuming that there are two competent
p.000053: parents available), and that the consent of both parents be obtained, if possible. The IRB may decide
p.000053: that the permission of one parent is sufficient, but only when certain risk-benefit conditions are met.18
p.000053: • For studies involving children as participants, it is desirable for those children with sufficient capacity
p.000053: to be involved in the consent process. Moreover, it is generally accepted that the child’s assent be obtained
p.000053: whenever this is developmentally possible and otherwise appropriate. Under both the EPA Rule and the HHS
p.000053: Rule, the IRB is responsible for determining that adequate provisions have been made for soliciting the assent of the
p.000053: children when, in the judgment of the IRB, the children are capable of providing assent. Assent, however, may
p.000053: be waived in those restricted circumstances in which consent may be waived under the Common Rule. Those
p.000053: circumstances and the required IRB documentation are described in the Common Rule at 40 CFR 26.116(d).
p.000053: • The consent form should clearly state that participation is voluntary and that study
p.000053: participants may “discontinue participation at any time without any penalty or loss of benefits to which the
p.000053: subject is otherwise entitled” [40 CFR 26.116(a)(8)]. If a subject chooses to withdraw from a study, the
p.000053: consequences of their decision and the process for orderly withdrawal should be clearly
p.000053: explained [40 CFR 26.116(b)(4)].
p.000053: • The consent form should address any foreseeable potential future use of samples and data (CIOMS, 2002).
p.000053: For example, effects of environmental exposures on gene expression are potentially very important.
p.000053: Therefore, biologic specimens for DNA analysis may be obtained from participants in future studies. But, it
p.000053: is recognized that human genomic data are private, intimate, and sensitive, and they create
p.000053:
p.000053:
p.000053: 18 See the EPA Rule at 40 CFR 26.406(b) for observational research with children and the HHS Rule at 45 CFR 46.408(b)
p.000053: for all research with children. Under the EPA Rule, greater than minimal risk observational research with children that
p.000053: does not hold out the prospect of direct benefit to the child is not permitted under any circumstances. Under the HHS
p.000053: Rule, greater than minimal risk research involving children without the prospect of direct benefit is permitted in very
p.000053: limited circumstances, but the consent of both parents is required in those cases (unless one parent is deceased,
p.000053: unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and
p.000053: custody of the child).
p.000053: special concerns about the potential for discrimination, stigmatization, and impact on
p.000053: future employment or insurance. The informed consent process needs to explain what the plans may be
p.000053: for such specimens and recognize the rights of the subjects to decide about any such future use,
p.000053: including having the material destroyed. The informed consent process needs to explicitly discuss
p.000053: obtaining permission from participants on behalf of themselves and their child to obtain specimens for
p.000053: genetic analysis.
p.000053:
p.000053: 5.1.2 Comprehension
p.000053: Research participants frequently fail to understand the research protocols in which they agree to participate (NRC
p.000053: & IOM, 2005). In considering the ethical issues raised by the Grimes v. Kennedy Krieger case, the NRC & IOM
p.000053: committee “realized that the crucial issue regarding consent was not what information was
p.000053: contained in the consent forms, but rather what the parents understood about the study and the hazards
p.000053: present in the home before and after the study” (p. 19, NRC & IOM, 2005). The committee laments that “IRBs
p.000053: place their attention on consent forms rather than on the process of providing and discussing information” (p.
p.000053: 103, NRC & IOM, 2005). The IOM recommends that “the informed consent process should be an on-going,
p.000053: interactive dialogue between research staff and research participants involving the disclosure and exchange of
p.000053: relevant information, discussion of that information, and assessment of the individual’s understanding of
p.000053: the discussion” (Recommendation 4.1, IOM, 2002). These comments emphasize how important true two-way
p.000053: communication is to comprehension, the second pillar in the informed consent process.
...

p.000055: nonmonetary payments (e.g., gifts, valuable information), or nothing at all (e.g., for a sense of
p.000055: altruism). Grady (2005) has described payment for the participation of research subjects as serving
p.000055: from one to four purposes: (1) an incentive, (2) compensation, (3) reimbursement, or
p.000055: (4) reward. Text Box 5-3 describes the roles that payments may serve, together with potential advantages
p.000055: and disadvantages or ethical concerns. The text comes mostly from Grady (2005) but builds also on the NRC & IOM
p.000055: document and other writings. (A number of authors have addressed issues associated with payments,
p.000055: including Ackerman, 1989; Dickert et al., 2002; Emanuel 2004; Erlen et al., 1999; Fry et al.,
p.000055: 2005; Grady, 2005; Grady et al., 2005; Iltis et al., 2006; IOM, 2004; NRC & IOM, 2005; Russell et al.,
p.000055: 2000; VanderWalde, 2005; Weise et al., 2002; Wendler et al., 2002). A number of specific issues or
p.000055: concerns regarding participant payments have been identified. Many researchers and ethicists argue that it
p.000055: is often appropriate to provide reasonable payment and have done so for many years. In the view of an NRC expert
p.000055: panel, the principles of “justice, fairness, and gratitude support payment to those who bear the burdens
p.000055: of research on behalf of society” (NRC, 2004).
p.000055: Direct reimbursement may be made to participants for out-of-pocket expenses for costs directly associated
p.000055: with participation in a study. These might include transportation costs, parking fees, or child
p.000055: care costs. When payment for time and burden is provided, it is often in the form of monetary
p.000055: payments. Different approaches may be considered for determining reasonable amounts for payment,
p.000055: including a set payment for each visit, a small daily payment, payment at the prevailing minimum hourly
p.000055: wage, or payment at some other hourly rate appropriate for the community⎯perhaps a
p.000055: prevailing rate for unskilled labor (Emanuel, 2004). Incentives to encourage enrollment are
p.000055: sometimes used when participants will receive little or no direct benefit from the research and can take
p.000055: the form of monetary or non-monetary payments. Incentives are kept modest so as not to impart undue
p.000055: influence. Researchers need to consider the possible effects of incentive payments on the potential
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056:
p.000056: Text Box 5-3. Payments for Participation of Research Subjects
p.000056: (based on Grady, 2005)
p.000056: Payment Serves As Amount Determined By Potential Advantages
p.000056: Potential Disadvantages
p.000056:
p.000056: Incentive Supply and demand; market rates
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: Compensation Standardized “wage” for time and effort, suggested to be commensurate with wages for
p.000056: unskilled, but essential jobs; additional payment for extra burdens such as endurance of uncomfortable procedures
p.000056: (a) More rapid recruitment
p.000056: (b) Completion bonuses encourage subject retention and high completion rate
...

p.000056: (b) Uniform payment across studies
p.000056: (c) Equal pay for equal work
p.000056: (d) Less risk of undue inducement
p.000056: (a) Undue inducement possibly resulting in incomplete assessment of risks and benefits by subject; subject concealing
p.000056: information to ensure enrollment and retention
p.000056: (b) Competition between studies; better funded studies more likely to meet recruitment goals
p.000056: (c) Different levels of payment at different locations for multicenter research because of supply and demand
p.000056: (a) May have little impact on recruitment
p.000056: (b) Might undercompensate some subjects in relation to regular wage and preferentially attract others
p.000056:
p.000056:
p.000056: Provide “wage” for time and effort; base level of payment on some small fraction of participant’s or the community’s
p.000056: income, or on an appropriate hourly rate for the location, or on community-input about the appropriate level of payment
p.000056: (a) Recognizes contributions of participants
p.000056: (b) Decreases potential that payment would be undue inducement in some communities or locations and insufficient in
p.000056: others
p.000056: (c) Provides equivalent payment for participation across communities and locations (markets)
p.000056: (d) Less risk of undue inducement across study
p.000056: (a) Different levels of payment at different locations in multicenter research or in different communities
p.000056: (b) Unequal pay for equal work may violate one’s sense of justice
p.000056:
p.000056:
p.000056: Reimbursement Actual out-of-pocket cost to
p.000056: participant related to participation, such as parking, transportation, child care, cost of food samples, etc.
p.000056: (a) Lowers barriers to participation
p.000056: (b) Reduces burden and impact of research on participants
p.000056: (a) Few disadvantages
p.000056: (b) Possible differences in costs experienced by different participants
p.000056:
p.000056:
p.000056: Reward Token of appreciation at end of study
p.000056: (a) Expresses gratitude for contribution made
p.000056: (b) Not market dependent
p.000056: (c) Avoids undue inducement
p.000056: (a) Probably no impact on recruitment
p.000056: (b) No basis for consistency
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: for differential recruitment that could result in bias in the study sample.
p.000056: Determining appropriate level of payments or incentives for participants in a research study is
p.000056: complex. “No bright line distinguishes proper and reasonable payments to parents and children
p.000056: from payments that are inappropriate” (p. 214, IOM, 2004). The ethical issue is at what level might a
p.000056: payment change from being an incentive (an encouragement) to participate and become an inducement (the
p.000056: cause or reason) for participation. Many research organizations and IRBs do not have written policies or
p.000056: guidelines
p.000056:
p.000056: regarding the determination of reasonable payment. Decisions often are made based on the level
p.000056: of discomfort and burden, costs to participants, and population characteristics. However, large
...

p.000058: participation in studies
p.000058: • The offer of payments may with low risk but no or few cause guardians or parents to
p.000058: direct benefits
p.000058: not act in the best interests of • It is the just and fair thing incompetent persons or children to do
p.000058: for those who bear in their care. burdens of research on
p.000058: • Persons in different behalf of society. circumstances may view the
p.000058: same amount of payment quite differently.
p.000058: • Payments may alter the composition of the study sample and potentially could compromise study integrity.
p.000058: activities is thus justified on the grounds of fairness” (p. 112, NRC & IOM, 2005).
p.000058: Similarly, the IOM Committee on Clinical Research Involving Children found that “certain types of
p.000058: payments to parents or adolescents are usually if not always acceptable, for example, reimbursement
p.000058: for reasonable expenses that are necessary for research participation. The specifics may vary, but
p.000058: examples of reasonable expenses are costs of transportation to the research site, parking, lodging, meals,
p.000058: and babysitting. Other payments are never appropriate in pediatric research, for example, paying parents
p.000058: for the use of their child in research” (pp. 225-6, IOM, 2004).21
p.000058: The IOM committee recommends establishing policies on acceptable and unacceptable types of
p.000058: payments. They also recommend that the policies disclose any recompense in a full and open
p.000058: process,22 while not overemphasizing any recompense.
p.000058: Although the NRC & IOM Committee on Ethical Issues in Housing-Related Health Hazard Research Involving
p.000058: Children and the IOM Committee on Clinical Research Involving Children both concluded that it is appropriate to
p.000058: reimburse expenses or compensate for time or inconvenience, neither committee endorsed incentive
p.000058: payments to parents. In Europe, too, incentive payments to induce parents to allow their children to
p.000058: 5.2.3 Payments When Children or Other
p.000058: Vulnerable Populations Are Involved
p.000058:
p.000058: It is essential that special care be taken with regard to payments when members of vulnerable populations are
...

p.000058: judgment regarding the best interests of minor or incompetent persons in their care.
p.000058: The ethical concern is that too high a payment may “undermine free and informed consent by leading parents
p.000058: to expose their children to unacceptable risks” (NRC & IOM, 2005). The NRC & IOM committee recognized
p.000058: that some commentators argued that children should never be paid, and that parents ought not to be paid to
p.000058: enroll their children in research. Yet, on balance, the committee felt that “reimbursement for expenses and some
p.000058: modest payment for time spent in research
p.000058: 21 The IOM Recommendation 6.2 states, “In addition to offering small gifts or payments to parents and children as
p.000058: gestures of appreciation, investigators may also—if they minimize the potential for undue influence—act ethically to
p.000058: reduce certain barriers to research participation when they
p.000058: • reimburse reasonable expenses directly related to a child’s participation in research
p.000058: • provide reasonable, age-appropriate compensation for children based on the time involved in research that does not
p.000058: offer the prospect of direct benefit, and
p.000058: • offer evening or weekend hours, on-site child care, and other reasonable accommodations for parental work and
p.000058: family commitments.”
p.000058: 22 In recommending an open process, the IOM committee chose to reject the
p.000058: arguments from the American Academy of Pediatrics that “any token payment to children for participating in research
p.000058: should not be discussed with them until after research is completed for fear of unduly influencing their decisions
p.000058: (AAP, 2003)…. On balance, the committee agrees that it is best to mention token or other payments during the permission
p.000058: and assent processes” (p. 215, IOM, 2004).
p.000058: The IOM Recommendation 6.1 states, “Institutional review boards, research institutions, and sponsors of research that
p.000058: includes children and adolescents should adopt explicit written policies on acceptable and unacceptable types and
p.000058: amounts of payments related to research participation. These policies should specify that investigators
p.000058: • Disclose the amount, the recipient, the timing, and the purpose (e.g., an expense reimbursement or a token of
p.000058: appreciation to a child) of any payments as part of the process of seeking parents’ permission, and, as appropriate,
p.000058: children’s assent to research participation;
p.000058: • Avoid emphasis on payments or descriptions of payments as benefits of participating in research during the
p.000058: permission or assent procedures; and
p.000058: • Obtain institutional review board approval for the disclosure of information about payments in advertisements and
p.000058: in permission and assent forms and procedures.”
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: participate in research are unacceptable. The European Union requires that clinical trials on minors
p.000059: be undertaken only if “no incentives or financial inducements are given except compensation”
p.000059: (European Parliament, 2001).
p.000059: Payment for participation of children in research also is discussed in the literature. Diekema
p.000059: (2005) emphasizes the need to ensure that payments do not distort parental decisionmaking and do not tempt
p.000059: parents to consider other issues than the welfare of their child. Similarly, Menikoff (2005) suggested that
p.000059: there need to be relatively robust protections in place to ensure that families do not change their behaviors
p.000059: to participate in a study. He suggested that these may include determining payment as a percentage of a family’s
p.000059: income and developing criteria for documenting that behaviors have not changed to be eligible for participation in a
p.000059: study. He suggested that, for a study of pesticides, potential study participants provide documentation (such as
p.000059: receipts) that they routinely have been using a commercial pesticide service. This may be difficult
p.000059: for potential participants to do if they do not save receipts, and it would exclude all potential
p.000059: participants who purchase products and apply pesticides themselves. This likely would affect the study
p.000059: objectives and generalizability of the data collected. A survey of investigators (Iltis et al., 2006) found that
p.000059: payments were made in 52% of the pediatric research studies surveyed, and that payment practices varied,
p.000059: as did the reasons for decisions regarding payments. They found a range of payment values separated
p.000059: across cash, gifts, items, vouchers, and other categories. A survey of IRBs (Weise et al., 2002) found that payment
p.000059: for participation in research was allowed by 66% of responding institutions, but that many IRBs did not have
p.000059: specific policies, and that there was considerable variability regarding the basis for decisions on
...

p.000091: credibility is determined by the public’s perceptions of the researchers’ knowledge and expertise, openness
p.000091: and honesty, and concern and care (Peters et al., 1997). These factors are important to consider in
p.000091: developing the information and approach that will be used to respond to criticism.
p.000091: There is a large volume of information available on “crisis communication” that the reader can use to
p.000091: develop a plan for anticipating and responding to criticism (e.g., FCN, 2001; ATSDR, 2007; U.S.
p.000091: HHS,
p.000091: 2002). The key is to be proactive and have a plan before any criticism is raised.
p.000091:
p.000091: 7.10 Responding to the Media, Public Inquiries, and Other Stakeholders
p.000091: Like crisis communications, the communication plan should include detailed plans for how to interact with the
p.000091: stakeholders, the media, and the public. Standard approaches have been developed for
p.000091: effective communications (e.g., the Federal Communicators Network's Communicators Guide [FCN, 2001]) with
p.000091: the media and will not be included in this document. A proactive plan, open and transparent
p.000091: communications, and easily to comprehend information will ensure effective communications with
p.000091: stakeholders and the public.
p.000091:
p.000091: References
p.000091: American Conference of Governmental Industrial Hygienists (ACGIH) (2008). TLV/BEI Resources. Available:
p.000091: http://www.acgih.org/tlv/.
p.000091:
p.000091: Alderson P (1995). Will you help us with our research? Arch Dis Child 72(6):541-42.
p.000091:
p.000091: Anderson B, Hall B (1995). Parents’ perceptions of decision making for children. J Law Med Ethics 23(1):15-9.
p.000091:
p.000091: ATSDR (Agency for Toxic Substances and Disease Registry) (2007). A Primer on Health Risk Communication Principles
p.000091: and Practices [online publication]. Available: http://www.atsdr.cdc.gov/risk/riskprimer/ [accessed 12 June 2007].
p.000091:
p.000091: CDC (Centers for Disease Control and Prevention) (2005). Third National Report on Human Exposure to Environmental
p.000091: Chemicals. National Center for Environmental Health, Atlanta, GA, NCEH Pub. No. 05­ 0570. Available:
p.000091: http://www.cdc.gov/exposurereport/pdf/thirdreport.pdf [accessed 12 June 2007].
p.000091:
p.000091: Covello V, Allen F (1988). Seven Cardinal Rules of Risk Communication. OPA-87-020. U.S. Environmental Protection
p.000091: Agency, Office of Policy Analysis, Washington, DC. Distributed by the Pennsylvania Dept. of Environmental Resources.
p.000091: Available: http://www.epa.gov/stakeholders/pdf/risk.pdf [accessed 12
p.000091: June 2007].
p.000091:
p.000091: Covello VT, McCallum DB, Pavlova M (eds) (1989). Effective Risk Communication: the role and responsibility of
p.000091: Government and Non-Government Organizations. New York. NY: Plenum Press.
p.000091:
...

p.000009: also were included. Because the elderly is the subpopulation most sensitive to health effects associated with PM
p.000009: exposures, the majority of subjects were over age 65.
p.000009: Performed in the Raleigh, NC, area in homes with children 1 to 3 years old. Homeowners reported either professional or
p.000009: self applications of diazinon. Goals of the study were to evaluate methods to measure excess dietary exposures
p.000009: resulting from food-handling activities by young children during eating and to assess whether the Children’s Dietary
p.000009: Intake Model (CDIM) accurately represents total dietary exposures of children. Study resulted in refinements of model
p.000009: parameters for transfer and activity.
p.000009: Observational measurement study of exposure to chlorpyrifos among children 2-5 years of age in urban New Jersey homes
p.000009: following crack and crevice treatment by a professional applicator. Study investigated decay of pesticide levels over
p.000009: time, transfer of pesticide from microenvironmental media to child, and factors that affect transfer. Dermal transfer
p.000009: evaluated with surface wipes, hand wipes, dermal wipes, cotton garments, and videotaping.
p.000009: Physicians at Case-Western Reserve treating children with idiopathic pulmonary hemorrhage evaluated the nature of the
p.000009: fungus found in homes of the afflicted and control children to determine if Stachybotrys was a potential factor in the
p.000009: illness. Three of the 8 cases, and none of the controls, had Stachybotrys strains that potentially were implicated.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: The largest children’s exposure study undertaken to date. It examines aggregate exposures of children 18 months to 5
p.000009: years to pollutants commonly found in everyday environments. The major objectives were to quantify children’s aggregate
p.000009: exposures, apportion exposure pathways, and identify important exposure media. Participants were recruited from 12
p.000009: urban and rural counties in North Carolina and Ohio using a random digit dialing method. Monitoring was performed at
p.000009: both daycare centers and homes. Samples collected include food, beverages, indoor air, outdoor air, hand wipes, dust,
p.000009: soil, transferable residues, floor and surface wipes, and urine. The samples were analyzed for more than 40 pollutants,
p.000009: including insecticides, phthalate esters, phenols, polychlorinated biphenyls, and PAHs.
p.000009: Scientists monitored air pollutants inside and outside vehicles of healthy highway patrol officers in North Carolina
p.000009: while troopers were on patrol for 9-hour shifts and examined cardiovascular effects. The findings indicated that people
p.000009: driving in motor vehicles are exposed to PM2.5 and other pollutants generated from motor vehicles, and that these
p.000009: exposures appear to cause cardiovascular changes.
p.000009:
p.000009:
p.000102: 102
p.000102: with contractor support; funded and collaborated on others with Harvard School of Public Health, University. of
p.000102: Washington, and NYU.
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: NERL designed, contractor conducted
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: NERL funded the Environmental and Occupational Health Sciences Institute (EOHSI).
p.000102:
p.000102:
p.000102:
p.000102: NERL staff collaborated with Case-Western Reserve University by conducting lab analysis for Stachybotrys.
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: NERL designed, contractor conducted
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: EPA designed and conducted with contractor support
p.000102:
p.000102: Table A-1. (Continued)
p.000102: Study Date Size Type Brief Description
p.000102: NERL Role
p.000102: First National 2001 168 Child care Probability- A collaborative study with the Department
p.000102: of Housing and HUD and CPSC Environmental centers based
p.000102: Urban Development (HUD) and the Consumer Product Safety study. NERL Health Survey of
p.000102: selection on Commission (CPSC) of pesticide use and young children’s collaborated
p.000102: and
p.000102: Child Care national scale (less than 6 years old)
p.000102: potential exposure to pesticides and conducted analysis
p.000102:
p.000102: Centers (CCC)
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: A Pilot Study Examining Translocation Pathways Following a Granular Application of Diazinon to Residential Lawns (PET)
p.000102: Biological and Environmental Monitoring for Organo- phosphate and Pyrethroid Pesticide Exposures in Children Living in
p.000102: Jacksonville, FL (JAX)
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Exposure Assessment for Community- Acquired Legionnaires Disease
p.000102: Center for the Health Assessment of Mothers and Children of Salinas Quantitative Exposure Assessment Study (CHAMACOS)
p.000102: Feasibility of Macroactivity Approach To Assess Dermal Exposure (Daycare)
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.002001: 2001
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001: 2001
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001:
p.002001: 2001
p.002001:
p.002001:
p.002001:
p.002001:
p.002002: 2002
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002: 2002
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002: 6 Households
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002:
p.002002: 9 Households in NERL exposure component
p.002002:
...

p.000021: collected urine samples for CDC from 200 children visiting six public health clinics in Jacksonville, and collected
p.000021: environmental screening samples at approximately 25% of these children’s homes. A detailed aggregate exposure
p.000021: assessment at 9 homes was overseen by NERL and involved collection of surface wipes, transferable residues, air,
p.000021: duplicate diet, cotton garment samples, and urine samples. A time- activity diary of the children’s activities was
p.000021: included.
p.000021: Work with Veteran’s Administration hospital staff. Cases of Legionnaires Disease were evaluated for potential for
p.000021: exposure from residential drinking water taps. In about 24% of the tested cases, homes were found to have Legionella
p.000021: bacteria in water taps at home, compared to their absence in other cases and in controls
p.000021: Incidental pesticide exposure measurement study of farmworkers’ children ages 5 to 35 mo. Purpose is the evaluation of
p.000021: methods for aggregate exposure measurements and the evaluation of pathways of exposure and important factors that
p.000021: affect exposure. Measurements include pesticide distributions in microenvironments where children spend time, transfer
p.000021: of pesticides from microenvironmental media to child, and factors that affect transfer.
p.000021:
p.000021:
p.000021:
p.000021: Study identified daycare centers with previously established contracts for routine monthly pesticide applications and
p.000021: conducted screening sampling in each to evaluate the distributions of transferable pesticide residues on floor surfaces
p.000021: where children spend time. One daycare was selected for intensive measurements, and children from different age groups
p.000021: volunteered to wear full-body cotton suits for short time periods while their activities were videotaped.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000103: 103
p.000103: of molds/fungi and helped with lead and pesticide measurements.
p.000103:
p.000103:
p.000103: EPA conducted with contractor support
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Multiagency effort; NERL was a participant and led the 9-home exposure component.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: NERL funded IAG with VA to conduct study.
p.000103:
p.000103:
p.000103:
p.000103: EPA grant to UC Berkeley; NERL augmented the existing research effort.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: NERL designed, contractor conducted
p.000103:
p.000103: Table A-1. (Continued)
p.000103: Study Date Size Type Brief Description
p.000103: NERL Role
...

p.000109: (16) The process of recruitment (e.g., advertisements) and the steps to be taken to protect privacy and
p.000109: confidentiality during recruitment
p.000109: (17) A description and explanation of any and all interventions
p.000109: (18) The measurements to be performed in the study, including environmental and biological sample
p.000109: collection, and other data and information that will be collected
p.000109: (19) If applicable, clinical and other tests involving the study participants that are to be carried out
p.000109: (20) The rules or criteria according to which subjects may be removed from the study or the study may be
p.000109: terminated
p.000109: (21) The methods of recording and reporting adverse events or reactions, and provisions for dealing with
p.000109: complications
p.000109: (22) The potential benefits of the research to subjects and to others
p.000109: (23) The expected benefits of the research to the population, including new knowledge that the study
p.000109: might generate
p.000109:
p.000109:
p.000109:
p.000111: 111
p.000111:
p.000111: (24) The means proposed to obtain individual informed consent and the procedure planned to communicate information to
p.000111: prospective subjects, including the name and position of the person responsible for obtaining consent
p.000111: (25) When a prospective subject is not capable of informed consent, satisfactory assurance
p.000111: that permission will be obtained from a duly authorized person, or, in the case of a child who is sufficiently mature
p.000111: to understand the implications of informed consent but has not reached the legal age of consent,
p.000111: that knowing agreement, or assent, will be obtained, as well as the permission of a parent, or a legal guardian
p.000111: or other duly authorized representative.
p.000111: (26) An account of any economic or other compensation or incentives to prospective subjects to participate, such as
p.000111: offers of cash payments, gifts, or free services or facilities, and of any financial
p.000111: obligations assumed by the subjects, such as payment for medical services
p.000111: (27) The plans and procedures and the persons responsible for communicating to
p.000111: subjects information arising from the study (on harm or benefit, for example) or from other research on the same
p.000111: topic that could affect subjects’ willingness to continue in the study
p.000111: (28) The plans to inform subjects about the results of the study
p.000111: (29) The provisions for protecting the confidentiality of personal data and respecting the privacy of subjects,
p.000111: including the precautions that are in place to prevent disclosure of the results of a
p.000111: subject’s genetic tests to immediate family relatives without the consent of the subject
...

p.000115: Study
p.000115: NHEXAS The National Human Exposure Assessment Survey NHLBI National Heart, Lung, and Blood
p.000115: Institute
p.000115: NHRPAC National Human Research Protections Advisory Committee NIH National Institutes of
p.000115: Health
p.000115: NRC National Research Council
p.000115: OHRP Office for Human Research Protections OMB Office of Management and Budget OSMB
p.000115: observational study monitoring board PM particulate matter
p.000115: Q&As questions and answers
p.000115: QAPP quality assurance project plan
p.000115: RfD reference dose
p.000115: SEAOES Scientific and Ethical Approaches for Observational Exposure Studies TEAL Tribal
p.000115: Efforts Against Lead
p.000115: TEAM Total Exposure Assessment Methodology TLV threshold limit value
p.000115: VOC volatile organic compound
p.000115: WHO World Health Organization
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116: Appendix F
p.000116: Glossary
p.000116:
p.000116:
p.000116:
p.000116: Agent. A chemical, mineralogical, biological, or physical entity that may cause deleterious effects in an organism
p.000116: after the organism is exposed to it [EPA/600/Z-92/001, May 1992].
p.000116: Assent. A child’s affirmative agreement to participate in research. Mere failure to object should not, absent
p.000116: affirmative agreement, be construed as assent [45 CFR 46.402(d)].
p.000116: Autonomy. The capability and capacity to govern oneself.
p.000116: Beneficence. The ethical obligation to maximize benefits and to minimize harms. This principle gives rise to norms
p.000116: requiring that the risks of research be reasonable in light of the expected benefits, that the research design be
p.000116: sound, and that the investigators be competent both to conduct the research and to safeguard the welfare of the
p.000116: research subjects. Beneficence further proscribes the deliberate infliction of harm on persons; this aspect of
p.000116: beneficence is sometimes expressed as a separate principle, nonmaleficence (do no harm).
p.000116: Child. A person who has not attained the age of 18 years [40 CFR 26.202(a)]
p.000116: Collateral observations. Potentially unsafe hazards, conditions, or situations unrelated to the research study that
p.000116: are observed by the research staff
p.000116: Common Rule. The Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects.” It was
p.000116: adopted by more than a dozen Federal departments or agencies in 1991, with EPA adapting it in Title 40 CFR Part 26
p.000116: Subpart A.
p.000116: Community-based participatory research (CBPR). Collaborative research with a community in which the community is
p.000116: involved in all phases of the research.
p.000116: A fundamental concept is that the research aims to combine knowledge with action and to achieve social
p.000116: change to improve health outcomes and eliminate health disparities.
p.000116: Confidentiality. The keeping safe or not redisclosing by one of the parties in a confidential relationship information
p.000116: that originally was disclosed in the confidential relationship
p.000116: Environmental justice. The fair treatment and meaningful involvement of all people regardless of race, color, national
p.000116: origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations,
p.000116: and policies
p.000116: Exposure. Contact of a chemical, physical, or biological agent with the outer boundary of an organism (e.g., a
...

Searching for indicator children:

(return to top)
p.000024: 24
p.000024: 2.4. Ensuring a Favorable Risk-Benefit Ratio
p.000025: 25
p.000025: 2.4.1. Designing in Benefits for the Participants
p.000025: 25
p.000025: 2.4.2. Assessing Benefits and Risks of Study Participation 25
p.000025: 2.5. Independent Scientific and Ethical Review
p.000026: 26
p.000026: 2.5.1. Scientific Peer Review
p.000027: 27
p.000027: 2.5.2. Conflicts of Interest
p.000027: 27
p.000027: 2.5.3. Develop the Human Subjects Protocol for Institutional Review Board Review 28
p.000027: 2.5.4. Ethical Review
p.000029: 29
p.000029: 2.5.5. Internal U.S. EPA Review of Scientific and Ethical Issues 29
p.000029: 2.6. Informed Consent
p.000029: 29
p.000029: 2.7. Ensuring That Participant Behaviors Are Not Changed Adversely Because of
p.000029: Being in the Study
p.000030: 30
p.000030: 2.8. Criteria and Standards for Monitoring Scientific and Ethical Issues 30
p.000030: 3. Ensuring Protection of Vulnerable Groups
p.000035: 35
p.000035: 3.1. Identification of Vulnerable Groups
p.000035: 35
p.000035: vii
p.000035:
p.000035: 3.2. Justification for Involving Vulnerable Persons in Observational Research 36
p.000035: 3.3. Minimal Risk and Vulnerable Groups
p.000037: 37
p.000037: 3.4. Research Involving Children
p.000037: 37
p.000037: 3.5. Women as Research Subjects
p.000038: 38
p.000038: 3.6. Other Potentially Vulnerable Groups
p.000039: 39
p.000039: 4. Privacy, Confidentiality, and Other Concerns Related to Observational
p.000039: Human Exposure Studies
p.000041: 41
p.000041: 4.1. Privacy Issues
p.000041: 41
p.000041: 4.2. Confidentiality
p.000042: 42
p.000042: 4.2.1. Confidentiality of Information
p.000043: 43
p.000043: 4.2.2. Confidentiality of Participation
p.000044: 44
p.000044: 4.3. Collateral Observations
p.000044: 44
p.000044: 4.3.1. Potential Nonstudy Hazards in the Residence 44
p.000044: 4.3.2. Collateral Observations with Mandated Reporting Requirements 45
p.000044: 4.3.3. Hazard Communication
p.000045: 45
p.000045: 4.3.4. Planning and Staff Training
p.000046: 46
p.000046: 4.4. Third-Party Issues
p.000046: 46
p.000046: 4.4.1. Determining Whether a Third Party Is a Human Subject 47
p.000046: 4.4.2. Informing Third Parties of Research Activities 47
p.000046: 4.4.3. Research Results and Third Parties
p.000047: 47
p.000047: 4.5. Data and Safety Monitoring and Oversight
p.000048: 48
p.000048: 5. Creating an Appropriate Relationship Between the Participant and Researcher 51
p.000048: 5.1. Informed Consent
p.000052: 52
p.000052: 5.1.1. Information
p.000052: 52
p.000052: 5.1.2. Comprehension
p.000054: 54
p.000054: 5.1.3. Voluntary Participation
p.000055: 55
p.000055: 5.2. Payments to Research Participants
p.000056: 56
p.000056: 5.2.1. Types and Amounts of Payments Offered in Research Studies 56
p.000056: 5.2.2. Regulations and Guidance Regarding Payment to Research Participants 58
p.000056: 5.2.3. Payments When Children or Other Vulnerable Populations Are Involved 59
p.000056: 5.2.4. Payments in Observational Human Exposure Studies 61
p.000056: 5.3. Research Rights and Grievance Procedures
p.000061: 61
p.000061: 5.3.1. Ombudsman
p.000061: 61
p.000061: 5.3.2. Community Advisory Board
p.000062: 62
p.000062: 5.4. Creating a Supportive Environment for Research and Interaction 62
p.000062: 5.5. Recruitment Strategies
p.000062: 62
p.000062: 5.6. Retention Strategies
p.000063: 63
p.000063: 5.7. Ensuring Recruitment or Retention Methods Will Not Lead to Unacceptable Risk 64
p.000063: 6. Building and Maintaining Appropriate Community and Stakeholder Relationships 67
p.000063: 6.1. Approaches to Community Involvement
p.000068: 68
p.000068: 6.2. Issues in Community Involvement
p.000071: 71
p.000071: 6.2.1. Defining “Community”
p.000071: 71
p.000071: 6.2.2. Identifying Who Represents the Community 71
p.000071: 6.2.3. Building Relationships and Trust
p.000072: 72
p.000072: 6.2.4. Importance of Language and Communications with the Community 73
p.000072: 6.2.5. Recognizing and Addressing Cultural Differences 73
p.000072: 6.2.6. Honesty, Power Relationships, and Partnerships 74
p.000072: 6.2.7. Building a Lasting Infrastructure
p.000074: 74
p.000074: 6.3. Community Involvement in Observational Human Exposure Studies 75
...

p.000001: research question and justification of the research effort during the problem conceptualization phase. If human
p.000001: subjects research is justified for the study, the scientific and ethical approaches are described in the study
p.000001: design and the human subjects research protocol. The basic elements that should be included in the
p.000001: study design and in the human subjects research protocol are described, and researchers are advised to consider
p.000001: alternative and innovative study designs that maximize the benefits to the study participants and their
p.000001: community. Information is provided on both scientific peer review and ethical review, and the integration
p.000001: of the two. Mandated procedures for review by external peers, by Institutional Review Boards (IRBs),
p.000001: and by the EPA Human Subjects Research Review Official (HSRRO) are detailed.
p.000001:
p.000001: to the authors as they have developed this document. Those references are listed in Table 1-4,
p.000001: which is replicated below.
p.000001: The authors also have relied extensively on the
p.000001: Problem Conceptualization
p.000001:
p.000001: Planning
p.000001: Define & Justify the Study
p.000001:
p.000001: advice of an expert panel that convened in November 2006 to provide advice and guidance about the structure and
p.000001: content of this document. The Expert Panel consisted of 11 nationally recognized authorities from
p.000001: diverse fields ― exposure science, environmental health, bioethics, epidemiology, community-based research, law,
p.000001: research in minority communities, public health, toxicology, pediatrics, and children’s environmental
p.000001: health.
p.000001: The Expert Panel Workshop resulted in suggestions
p.000001: & Scoping
p.000001:
p.000001:
p.000001: Independent Review
p.000001:
p.000001:
p.000001: Agency HSRRO
p.000001: Review
p.000001: Develop Study Design
p.000001:
p.000001:
p.000001: Peer Review
p.000001: Scientific & Ethical Review
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: HSRRO
p.000001: Review
p.000001: Develop Human Subjects Protocol
p.000001:
p.000001:
p.000001: IRB Review
p.000001: Ethical & Scientific Review
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Disapprove No Study
p.000001:
p.000001: for both the structure and the content of this document (ERG, 2007). Following the advice of the Expert Panel,
p.000001:
p.000001: Implement Study
p.000001: Approve Conduct Study
p.000001:
p.000001: this document is organized in seven sections.
p.000001: & Monitor Progress
p.000001: Criteria OK
p.000001: Continue Study
p.000001: Implement
p.000001: & Monitor
p.000001: Criteria Exceeded
p.000001: Terminate Study
p.000001:
p.000001:
p.000001: 1 See, for example, the writings of Beauchamp and Childress in Principles of Biomedical Ethics (Beauchamp and
p.000001: Childress, 2001) and the discussion of “What Makes Clinical Research Ethical?” by Emanuel, Wendler, and Grady (Emanuel
p.000001: et al., 2000).
p.000001: Stages in the Development of a NERL Observational Human Exposure Study
p.000001:
p.000002: 2
p.000002:
p.000002:
p.000002: Table 1-4. Important References in Developing This Document:
p.000002: Some Recent Developments in Defining the Ethics of Conducting Research Involving Human Participants
...

p.002002:
p.002002: Developed by the Council for International Organizations of Medical Sciences particularly for use in developing
p.002002: countries, the guidelines relate mainly to ethical justification and scientific validity of research; ethical review;
p.002002: informed consent; vulnerability of individuals, groups, communities, and populations; women as research subjects;
p.002002: equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury;
p.002002: strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health care
p.002002: services.
p.002002:
p.002002:
p.002003: 2003
p.002003:
p.002003: Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC, 2003)
p.002003:
p.002003: This NRC publication targets policymakers, research administrators, research sponsors, IRB members, and investigators.
p.002003: It examines three key ethical issues: (1) obtaining informed, voluntary consent from prospective participants; (2)
p.002003: guaranteeing the confidentiality of information collected from participants, which is a particularly challenging
p.002003: problem in social sciences research; and
p.002003: (3) using appropriate review procedures for minimal-risk research.
p.002003:
p.002003:
p.002005: 2005
p.002005:
p.002005: Ethical Considerations for Research on Housing- Related Health Hazards Involving Children, (NRC & IOM, 2005)
p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
p.002005: potential ethical concerns, such as issues involving adequacy of informed consent, parents' perception of risk, duties
p.002005: of researchers to child subjects and their parents, the role of IRBs, and the authority of parents to provide
p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000003: 3
p.000003:
p.000003: Section 3. Ensuring protection of vulnerable groups: Protections afforded by EPA’s human subjects rules
p.000003: and the ethical concerns of involving such groups in observational research. Special requirements for the
p.000003: protection of potentially vulnerable groups, including children, prisoners, pregnant women, handicapped
p.000003: persons, mentally disabled persons, and economically or educationally disadvantaged persons, throughout the
p.000003: planning and implementation process are described.
p.000003: Section 4. Addressing privacy and other concerns related to observational human exposure studies:
p.000003: Ethical issues and regulatory requirements concerning privacy, including third-party involvement and
p.000003: observations of nonstudy hazards. Unlike clinical research that is conducted in an institutional
p.000003: setting, observational human exposure studies take place in the participants’ “personal” environments as
p.000003: they go about their everyday lives, presenting an even greater challenge in meeting the ethical obligation to respect
p.000003: the privacy of the participants.
p.000003: Section 5. Creating an appropriate relationship between participant and investigator: Issues surrounding
p.000003: recruitment, informed consent, payment, and the researcher’s need to support the welfare of the
p.000003: participants. An appropriate relationship built on openness and trust requires strong and
p.000003: effective bidirectional communication. Informed consent ensures that the participant understands the
...

p.000003:
p.000003: CIOMS (The Council for International Organizations of Medical Sciences) (2008). International Ethical Guidelines for
p.000003: Epidemiological Studies. World Health Organization. Geneva, Switzerland. Available:
p.000003: http://www.cioms.ch/080221feb_2008.pdf [accessed 25
p.000003: April 2008].
p.000003:
p.000003: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000003: Biomedical Research Involving Human Subjects. World Health Organization. Geneva, Switzerland. Available:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000004:
p.000004: Emanuel EJ, Wendler D, Grady C (2000). What Makes Clinical Research Ethical? JAMA 20:2701-2711.
p.000004:
p.000004: ERG (Eastern Research Group) (2007). Report on the Workshop to Discuss State-of-the-Science Approaches for
p.000004: Observational Exposure Measurement Studies. Held in Durham, North Carolina on November 28-29, 2006. Final Report:
p.000004: January 25, 2007. (PB2007-108905).
p.000004:
p.000004: NRC (National Research Council) (2003) Protecting Participants and Facilitating Social and Behavioral Sciences
p.000004: Research. Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=10638
p.000004: [accessed 12 June 2007].
p.000004:
p.000004: NRC & IOM (National Research Council and Institute of Medicine) (2005). Ethical Considerations for Research on
p.000004: Housing-Related Health Hazards Involving Children.
p.000004: Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=11450 [accessed 12
p.000004: June 2007].
p.000004: U.S. DHEW (U.S. Department of Health, Education, and Welfare) (1979) The Belmont Report: Ethical Principles and
p.000004: Guidelines for the Protection of Human Subjects of Research. National Commission for the Protection of Human Subjects
p.000004: of Biomedical and Behavioral Research. Available: http://ohsr.od.nih.gov/guidelines/belmont.html [accessed 12 June
p.000004: 2007].
p.000004:
p.000004: U.S. EPA (U.S. Environmental Protection Agency) (2000) Comments on the Use of Data from the Testing of Human Subjects:
p.000004: A Report by the Science Advisory Board and the FIFRA Scientific Advisory Panel. United States Environmental Protection
p.000004: Agency, Science Advisory Board, EPA-SAB-EC-00-017. Available: http://yosemite.epa.gov/sab/SABPRODUCT.NSF/E3AE0F3
p.000004: 0D7430436852571A7005325E8/$File/ec0017.pdf [accessed 12 June 2007].
p.000004:
p.000004: U.S. HHS (U.S. Department of Health and Human Services) (1993). Protecting Human Research Subjects: Institutional
p.000004: Review Board Guidebook. Office for Human Research Protections. Available: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
p.000004: [accessed 12 June 2007].
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
...

p.000008: for a population’s longitudinal exposure to fine PM.
p.000008: Resolved questions in NAS review of PM science and provided a “generally consistent finding that ambient particle
p.000008: concentrations are a key determinant of the longitudinal variation in personal exposure.” (NRC, 2004). These results
p.000008: have been instrumental in support of the National Ambient Air Quality Standard for PM (U.S. EPA, 1999).
p.000008:
p.000008:
p.000008: Volatile Organic Compounds (VOCs)
p.000008:
p.000008: EPA's Total Exposure Assessment Methodology (TEAM) studies found levels of about a dozen common organic pollutants to
p.000008: be 2- to 5-times higher inside homes than outside. Use of products containing organic chemicals may result in very high
p.000008: and persistent pollutant levels.
p.000008:
p.000008: EPA, States, and the Consumer Product Safety Commission worked together to influence manufacturers to voluntarily
p.000008: reduce emissions of toxic chemicals from consumer products, building materials, and furnishings, and to develop
p.000008: mitigation strategies and educational materials to teach people how to reduce their contact with chemicals indoors. As
p.000008: a result, contact with toxic chemicals indoors has been reduced (see www.cpsc.gov/CPSCPUB/PUBS/450.html).
p.000008:
p.000008:
p.000008: Formaldehyde
p.000008:
p.000008: Studies found elevated formaldehyde levels indoors and helped identify indoor sources.
p.000008:
p.000008: EPA worked with HUD, CPSC, and other agencies to limit formaldehyde in building or consumer products and to educate the
p.000008: public on how to reduce exposures (see www. epa.gov/iaq/formalde.html).
p.000008:
p.000008:
p.000008: EPA has adopted additional protections for children and pregnant or nursing mothers in Subparts B through
p.000008: D. These sections apply to all research either conducted or funded by EPA and are, therefore, directly applicable to
p.000008: NERL’s observational human exposure studies.4 Subpart B prohibits EPA from conducting or supporting research
p.000008: that involves intentional exposure of “a pregnant woman (and, thereby, her fetus), a nursing woman,
p.000008: or a child.” NERL researchers conducting (or funding) observational human exposure studies must comply
p.000008: with all of these regulatory requirements, including seeking review and approval by an IRB and by the
p.000008: Agency’s Human Subjects Research Review Official (HSRRO) before beginning any human subjects research.
p.000008: EPA’s human subjects rules also define a variety of fundamental terms⎯from “human subject” to “research” to
p.000008: “intentional exposure” to “observational research.” Understanding these regulatory definitions is vital for
p.000008: NERL researchers to comply with the regulatory requirements.5
p.000008: To more effectively ensure the protection of human subjects, NERL scientists and managers need to
p.000008: understand the ethical principles and issues that prompted the development of the
p.000008: regulatory requirements in the first place and to be knowledgeable
p.000008:
p.000008:
...

p.000008: years later, the core HHS regulations (Subpart A) were adopted by almost all of the Federal
p.000008: departments and agencies that conducted or sponsored human subjects research as the “Common Rule.”
p.000008: Since 1991, ethical thought and regulatory processes for the protection of human subjects have continued to
p.000008: evolve and grow. For example, many ethicists expand the elements contained in the principle of
p.000008: beneficence from the Belmont Report into two principles:
p.000008: (1) beneficence, meaning to prevent or remove harm and
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: to maximize the possible benefits; and
p.000009: (2) nonmaleficence, meaning not to inflict harm (Beauchamp and Childress, 2001).
p.000009:
p.000009: Table 1-2. The Belmont Report— Principles and Recommendations
p.000009:
p.000009: Ethical Principle Regulatory Manifestation
p.000009: addressed many important scientific and ethical issues on this topic, including the National Research
p.000009: Council (NRC) in its report, Protecting Participants and Facilitating Social and Behavioral Sciences
p.000009: Research (NRC, 2003), a joint NRC and Institute of Medicine (NRC & IOM, 2005) committee in the report on
p.000009: Ethical Considerations for Research on Housing-Related Health Hazards Involving Children; the Council
p.000009: for
p.000009:
p.000009: Respect for Persons
p.000009: • Individuals should be treated as autonomous agents.
p.000009: • Persons with diminished autonomy are entitled to protection.
p.000009:
p.000009: Beneficence
p.000009: • Human subjects should not be harmed.
p.000009: • Research should maximize possible benefits and minimize possible harms.
p.000009: Justice
p.000009: • The benefits and risks of research must be distributed fairly.
p.000009: Informed Consent
p.000009: • Subjects must be given the opportunity to choose what will or will not happen to them
p.000009: • The consent process must include
p.000009: (1) information,
p.000009: (2) comprehension, and
p.000009: (3) voluntariness
p.000009: Assessment of Risks and Benefits
p.000009: • The nature and scope of risks and benefits must be assessed in a systematic manner.
p.000009:
p.000009:
p.000009: Selection of Subjects
p.000009: • There must be fair procedures and outcomes in the selection of research subjects.
p.000009: International Organizations of Medical Sciences (CIOMS) under the World Health Organization in
p.000009: its International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002) and
p.000009: in the International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008); and
...

p.002002:
p.002002: Developed by the Council for International Organizations of Medical Sciences particularly for use in developing
p.002002: countries, the guidelines relate mainly to ethical justification and scientific validity of research; ethical review;
p.002002: informed consent; vulnerability of individuals, groups, communities, and populations; women as research subjects;
p.002002: equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury;
p.002002: strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health care
p.002002: services.
p.002002:
p.002002:
p.002003: 2003
p.002003:
p.002003: Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC, 2003)
p.002003:
p.002003: This NRC publication targets policymakers, research administrators, research sponsors, IRB members, and investigators.
p.002003: It examines three key ethical issues: (1) obtaining informed, voluntary consent from prospective participants; (2)
p.002003: guaranteeing the confidentiality of information collected from participants, which is a particularly challenging
p.002003: problem in social sciences research; and
p.002003: (3) using appropriate review procedures for minimal-risk research.
p.002003:
p.002003:
p.002005: 2005
p.002005:
p.002005: Ethical Considerations for Research on Housing- Related Health Hazards Involving Children, (NRC & IOM, 2005)
p.002005:
p.002005: This National Research Council and Institute of Medicine report reviews the challenges and ethical issues in conducting
p.002005: housing-related health hazards research in the wake of the Maryland Court of Appeals ruling in the case of Grimes v.
p.002005: Kennedy Krieger Institute that has led to substantial controversy and confusion. The ruling highlighted a range of
p.002005: potential ethical concerns, such as issues involving adequacy of informed consent, parents' perception of risk, duties
p.002005: of researchers to child subjects and their parents, the role of IRBs, and the authority of parents to provide
p.002005: permission for their children to participate in research. This report offers much needed recommendations and practical
p.002005: guidance for the ethical conduct of this type of research.
p.002005:
p.002005:
p.002006: 2006
p.002006:
p.002006: EPA adds Additional Human Subjects Protections at
p.002006: 40 CFR 26
p.002006:
p.002006: EPA added additional human subjects protections in the Code of Federal Regulations to govern its actions. Subparts B
p.002006: through D apply to research conducted or supported by EPA and are directly applicable to NERL and this document.
p.002006: Subpart B prohibits research involving intentional exposure of children, pregnant women (and their fetuses), or nursing
p.002006: women. Subparts C and D provide additional protections for observational research involving pregnant women and their
p.002006: fetuses (Subpart C) and for children (Subpart D). Subparts K through M and O through Q apply to EPA’s use of
p.002006: third-party human research data.
p.002006:
p.002006:
p.002008: 2008
p.002008:
p.002008: International Ethical Guidelines for Epidemiological Studies (CIOMS, 2008)
p.002008:
p.002008: This document builds on the CIOMS (2002) document (see above) and extends the discussion to address the special
p.002008: features of epidemiological studies.
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.002008:
p.000012: 12
p.000012:
p.000012: address all of the relevant issues for their particular study to ensure that the specific elements of
p.000012: the study will safeguard and protect the human research subjects.
p.000012: In addition to being an information resource for NERL researchers, this document provides useful
p.000012: information for contractors and grantees funded by NERL to consider during the design and implementation of
p.000012: their exposure science research. Although not its intended audience, this document also may prove to be useful
p.000012: to other researchers, within and outside of EPA, who are involved in observational human exposure
p.000012: studies.
p.000012:
p.000012: 1.4 Process for Developing the Document
p.000012: This document was written by exposure science researchers in EPA’s NERL, with substantial input from experts
p.000012: within and outside of the Agency. Information relevant to the process and the document has been routinely
p.000012: posted on the EPA Web site at http://www.epa.gov/nerl/sots.
p.000012: NERL staff began this work by hosting a series of stakeholder meetings in the summer of 2006 to seek
p.000012: input on the content and format of the document. In November 2006, NERL convened an expert panel to
p.000012: provide its advice and guidance about the scope and content of this document. The Expert Panel consisted of
p.000012: 11 nationally recognized authorities in diverse fields: exposure science, environmental health,
p.000012: bioethics, epidemiology law, community-based research, research in minority communities, public health,
p.000012: toxicology, pediatrics, children’s environmental health, etc. Details about the Expert Panel and the workshop can
p.000012: be found in Appendix B. The summary report from the Expert Panel may be accessed
p.000012: online at http://www.epa.gov/nerl/sots/workshop-report.pdf.
p.000012: The structure and content of the current report follow the recommendations of the Expert
p.000012: Panel. Specifically, the Expert Panel recommended that this document should include the following six major
p.000012: topic areas:
p.000012: (1) elements to be considered in study conceptualization,
p.000012: (2) ensuring protection of vulnerable groups,
p.000012: (3) addressing privacy and other concerns related to observational human exposure studies,
p.000012: (4) creating an appropriate relationship between the participant and investigator,
p.000012: (5) building and maintaining appropriate community and stakeholder relationships, and
p.000012: (6) designing and implementing strategies for effective communication.
p.000012: These recommendations include pragmatic steps that NERL scientists can undertake during the development and
p.000012: implementation of observational human exposure studies. Note that each step may require consideration and
p.000012: application of multiple ethical and scientific principles, and the same ethical principle may
p.000012: be fundamental to several of the topic areas. As a result, the same ethical principle may be discussed in
p.000012: several sections throughout this document.
p.000012: Using the advice of the Expert Panel, an internal review draft of the document was written. Based on the
...

p.000013: April 2008].
p.000013:
p.000013: CIOMS (The Council for International Organizations of Medical Sciences) (2002). International Ethical Guidelines for
p.000013: Biomedical Research Involving Human Subjects.
p.000013: Geneva, Switzerland: CIOMS. Available: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed 12 June 2007].
p.000013:
p.000013: Emanuel EJ, Wendler D, Grady C (2000). What Makes Clinical Research Ethical? JAMA 283(20): 2701-2711.
p.000013:
p.000013: NEAC (National Ethics Advisory Committee) (2006). Ethical Guidelines for Observational Studies: Observational research
p.000013: audits and related activities. Wellington, New Zealand: Ministry of Health. Available:
p.000013: http://www.neac.health.govt.nz/moh.nsf/indexcm/neac­ resources-publications-ethicalguidelines.
p.000013:
p.000013: NRC (National Research Council) (2004) Research Priorities for Airborne Particulate Matter: IV. Continuing Research
p.000013: Progress. Washington, DC: The National Academies Press. Available: http://books.nap.edu/openbook.php?record_id=10957
p.000013: [accessed 16 August 2007].
p.000013:
p.000013: NRC (National Research Council) (2003) Protecting Participants and Facilitating Social and Behavioral Sciences
p.000013: Research. Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=10638
p.000013: [accessed 12 June 2007].
p.000013:
p.000013: NRC & IOM (National Research Council and Institute of Medicine) (2005). Ethical Considerations for Research on
p.000013: Housing-Related Health Hazards Involving Children.
p.000013: Washington, DC: The National Academies Press. Available: http://books.nap.edu/catalog.php?record_id=11450 [accessed 12
p.000013: June 2007].
p.000013:
p.000013: U.S. DHEW (U.S. Department of Health, Education, and Welfare) (1979) The Belmont Report: Ethical Principles and
p.000013: Guidelines for the Protection of Human Subjects of Research. National Commission for the Protection of Human Subjects
p.000013: of Biomedical and Behavioral Research. Available: http://ohsr.od.nih.gov/guidelines/belmont.html [accessed 12 June
p.000013: 2007].
p.000013:
p.000013: U.S. EPA (U.S. Environmental Protection Agency) (1999). Air Quality Criteria for Particulate Matter. Environmental
p.000013: Protection Agency, National Center for Environmental
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: Assessment, Office of Research and Development. EPA/600/P-99/002.
p.000014:
p.000014: U.S. EPA (U.S. Environmental Protection Agency) (1992). Guidelines for Exposure Assessment. Environmental Protection
p.000014: Agency, Risk Assessment Forum. EPA/600/Z­ 92/001. Available: http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_
p.000014: id=429103 [accessed 15 April 2008].
p.000014:
p.000014: U.S. HHS (U.S. Department of Health and Human Services) (1993). Protecting Human Research Subjects: Institutional
...

p.000017: different fields of research—social behavioral, economic, biological, medical, epidemiological,
p.000017: and exposure science. NERL has used observational human exposure studies to understand how people come into
p.000017: contact with pollutants in their everyday lives, with the ultimate goal of protecting public health. NERL’s
p.000017: exposure research program addresses critical science needs directly related to Agency goals for protection of
p.000017: human health. The research program is driven by key exposure science questions that may be generated from a
p.000017: number of different sources, including legislative mandates (e.g., the Food Quality Protection
p.000017: Act, the
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Clean Air Act, the Safe Drinking Water Act), program offices or research planning groups in the
p.000018: Agency, scientific peers and researchers, or collaborators. Communities also may identify
p.000018: concerns about exposures in their locales. NERL’s observational human exposure studies collect data to improve
p.000018: exposure and risk assessments, to develop risk management strategies, and to substantiate informational
p.000018: and educational materials for use by EPA program offices (e.g., Office of Pollution Prevention and Toxic
p.000018: Substances, Office of Air and Radiation, Office of Children’s Health Protection).
p.000018: Emanuel et al. (2000) contend that an ethical research study must provide a worthwhile social or
p.000018: scientific value. Ideally, observational human exposure studies can provide both a scientific value and a social
p.000018: value to the participants and their community when feasible. Whenever possible, researchers should work
p.000018: with communities to develop studies that can help address community problems and maximize the
p.000018: benefit to the participants and the community, both of which also assume a burden for participation in a
p.000018: research study.
p.000018: The study problems addressed in past observational human exposure studies conducted or supported by NERL
p.000018: have varied substantially, as described in Appendix A of this document. As shown in Table A-1, NERL’s studies
p.000018: have addressed exposures to particulate matter (PM), air toxics, persistent organic chemicals, and nonpersistent
p.000018: chemicals including pesticides. The studies have examined single routes of exposure (air) and multimedia
p.000018: exposures, including dietary exposure. The studies range from small-scale pilot studies to large
p.000018: probability-based samples. They have included cross- sectional, longitudinal, and convenience samples. Table A-1
p.000018: demonstrates that many of the studies are small in scale and were intended to test a methodology to see if it may
p.000018: prove useful for a subsequent large-scale probabilistic human exposure research effort. Both
p.000018: small-scale and large-scale human exposure studies do involve human subjects. This means that the studies
...

p.000021: the number of samples and perhaps biasing the data.
p.000021: It is critical that sample size be determined at the time of study conceptualization and planning and
p.000021: not after the study already has been conducted. Researchers must include experts with the appropriate
p.000021: statistical expertise on the research team at its very inception. For additional information and insight, readers
p.000021: should refer to biostatistics books, Web sites, and other references (Lenth, 2001; Castelloe, 2000; Kraemer and
p.000021: Thiemann, 1987; Van Belle and Fisher, 2004; Wackerly et al., 2001; Dallal, 2001) about this very important topic.
p.000021:
p.000021: 2.2.4 Representativeness of the Sample
p.000021: In addition to concerns about the sample size being sufficient to provide statistically significant results,
p.000021: researchers also must be concerned about the individuals who participate in a study and of what group
p.000021: or population they may be representative. Research, as defined in the Common Rule, is “a
p.000021: systematic investigation … designed to develop or contribute to generalizable knowledge.” How
p.000021: “generalizable” the
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: results of an observational study may be depends on the representativeness of the sample (the participants). A
p.000022: review of former NERL studies (Table A-1) shows a wide variety of approaches to selecting the participants,
p.000022: both probability sampling and nonprobability sampling. Some of the studies have involved randomized sampling (e.g.,
p.000022: NHAPS, NHEXAS), selecting a cohort of interest and then using a randomized sample (e.g., Children’s Total
p.000022: Exposure to Persistent Pesticides and Other Persistent Organic Pollutants [CTEPP], DEARS) or a
p.000022: convenience sample (e.g., some panel studies), purposeful selection (judgment sampling) by
p.000022: the research team (for methods testing studies), recruiting the whole population in a locale or of a particular
p.000022: cohort (e.g., as proposed for the National Children’s Study [NCS]), or simply a convenience sample (in small
p.000022: pilot studies).
p.000022: The approach used to select the participants has depended on the objectives of the study. Research to
p.000022: understand and describe the distribution of exposures in the general population (like NHEXAS) or of the
p.000022: population or cohort in a particular state or region (like CTEPP or Agricultural Health Study [AHS]), has
p.000022: required a large number of randomly-selected participants. Randomized selection is recognized
p.000022: as a valid statistical method to get a sample that is representative of the larger population
p.000022: from which the participants were selected. Pilot studies performed to evaluate a method or to estimate
p.000022: the likely range of exposure concentrations often have employed either purposeful sampling, where
p.000022: the researchers use information on the relevant characteristics of the population to select those
p.000022: participants who will exhibit a wide range of activity levels or potential exposure concentrations, or
p.000022: convenience sampling, where the researchers select the most accessible members of a population
p.000022: NERL’s observational human exposure studies also have routinely collected information about the
p.000022: participants’ activities by using questionnaires and surveys. Survey design is both a science and an
p.000022: art because the design of surveys is based on statistics and science, but designing a good and effective questionnaire
p.000022: is often an art that requires understanding the individuals being surveyed. Text Box 2-3 identifies some of the
...

p.000024:
p.000024: 2.4 Ensuring a Favorable Risk-Benefit Ratio
p.000024: 2.4.1 Designing in Benefits for the Participants
p.000024: Study designs vary depending on the objectives of the study, existing knowledge on the research question, and
p.000024: the hazard being studied (NRC & IOM, 2005). Recent ethical discussions about study designs in human subjects
p.000024: research (cf., Recommendation 7.1, p. 143, NRC & IOM [2005] and Emanuel et al. [2000]) support the development
p.000024: of innovative study designs to maximize the benefit9 to the study participants, as well as to
p.000024: the community and the greater society beyond. Observational human exposure studies generally collect data that
p.000024: contribute to generalizable knowledge that will benefit the community and society as a whole, but they often do not
p.000024: provide obvious direct benefit to study participants. Therefore, it is important to include elements
p.000024: in the study design that can offer benefits to the participants wherever possible. This is not always
p.000024: straightforward, but one way that participants, as well as communities, can benefit from these studies is
p.000024: by incorporating strong educational components into the conduct of the research. For example, brochures, videos,
p.000024: and other materials that educate study participants on safety around the home or on how to reduce their
p.000024: exposure to chemicals can be distributed during the study. EPA’s program offices, including the Office of
p.000024: Children’s Health Protection, the Office of Pollution Prevention and Toxics, the Office of Pesticide Programs,
p.000024: the Office of Drinking Water, and others have Web sites with substantial amounts of informational
p.000024: and educational materials available that could be distributed to study participants. Other organizations, such as
p.000024: the American Lung Association, the American Cancer Society, the American Academy of Pediatrics (AAP),
p.000024: and various environmental groups, have materials of which study participants may not be aware that could be used
p.000024: as educational materials when relevant.
p.000024: In addition, approaches that provide direct benefits to study participants will need to be tailored to
p.000024: the particular study population and community. Feedback from potential participants in focus groups and
p.000024: input from community representatives may be useful in identifying these approaches.
p.000024:
p.000024:
p.000024:
p.000024: 9 Payment to participants is never considered a benefit of a study.
p.000024: 2.4.2 Assessing Benefits and Risks of Study Participation
p.000024: For all research involving human participants, the Common Rule requires researchers to ensure that
p.000024: potential risks “are reasonable in relation to the anticipated benefits,” and that risks are
p.000024: minimized (40 CFR 26.111). It is most useful if the assessment of benefits and risks is begun early in
p.000024: the scoping and planning phase of a study.
p.000024: Unlike some biomedical research that involves the study of interventions or procedures that hold out the
p.000024: prospect of direct diagnostic, therapeutic, or preventative benefit for the study participants, observational
p.000024: human exposure studies often do not have a similar prospect of direct benefit to the participant. Therefore, the
p.000024: risk- benefit balance is based on the balance between the risks to the participants and the expected benefits to
p.000024: society (generalizable knowledge). The risks to participants must be reasonable [40 CFR 26.111(a)(2)] in
p.000024: relation to the importance of the knowledge gained. This assessment of the risk-benefit balance,
p.000024: therefore, needs to be performed in the initial planning of the study to be included in the justification for the
p.000024: study (Section 2.2).
p.000024: If there is no prospect of direct participant benefit, and the study participants are children, moreover, EPA
p.000024: is permitted to conduct or support only those observational human exposure studies that meet both the regulatory
p.000024: definition of “observational” and the regulatory definition of “minimal risk.” The latter is defined in
p.000024: the Common Rule at 40 CFR 26.102(i) and reiterated in Subpart D of the EPA Rule at 40 CFR 26.402(g):
p.000024: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not
p.000024: greater in and of themselves than those ordinarily encountered in daily life or during the
p.000024: performance of routine physical or psychological examinations or tests.” In applying this definition, EPA
p.000024: adheres to the consensus standard that the reference population for this definition is normal children living
p.000024: in safe, healthy environments. In its discussion of the perception of risks and benefits, the NRC & IOM (2005) report
p.000024: on housing health hazards in children notes that the children participating in these studies may be at
p.000024: risk for physical harms or adverse health outcomes because they live in housing (or otherwise occupy
p.000024: environments) with health hazards. However, such risks are not introduced by the research but, rather, would be present
p.000024: whether or not the children were involved in a research study. As a consequence, the study still
p.000024: would meet the regulatory criteria for minimal risk as long as the research itself introduced no risks over
p.000024: and above those minimal risks
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: experienced by normal children living in safe healthy environments.
p.000025: However, the existence of greater than minimal background risks that are not introduced by the research,
p.000025: nonetheless, raises additional ethical considerations. The joint NRC & IOM Committee on Research on Housing- Related
p.000025: Health Hazards Involving Children discussed the ethical arguments that arise when scientists conduct research that
p.000025: observes children in poor-quality housing. They point out that a researcher’s first duty of beneficence
p.000025: under the Common Rule requires that the risks of the research actions be proportionate to
p.000025: [“reasonable in relation to