0A4F4F9BD490A749D5437F821CF06DF1
Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
https://www.usaid.gov/sites/default/files/documents/1864/200mbe.pdf
http://leaux.net/URLS/ConvertAPI Text Files/0715B93AB6FC7FD0FBF7B8D4F307FCDC.en.txt
Examining the file media/Synopses/0715B93AB6FC7FD0FBF7B8D4F307FCDC.html:
This file was generated: 2020-07-14 04:08:43
| 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
Political / Illegal Activity
Searching for indicator crime:
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p.000003: advance intent to contribute to generalizable knowledge with a formal scientific protocol.
p.000003:
p.000003: (b) Human Subject – This means a living individual about whom an investigator obtains
p.000003:
p.000003: (1) data through intervention or interaction, or
p.000003:
p.000003: (2) identifiable private information.
p.000003:
p.000003: (c) Intervention – This includes physical procedures and manipulations of the subject or the subject’s environment
p.000003: for research purposes.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: (d) Interaction – This includes communication between the investigator and the subject.
p.000004:
p.000004: (e) Private information includes information about behavior in which an individual can reasonably expect that no
p.000004: observation is taking place, or information for specific purposes (such as a medical record) that individuals can
p.000004: reasonably expect will not be made public. Private information must also be readily individually identifiable (i.e.
p.000004: the subject's identity is or may be readily ascertained by the investigator or the subject's identity readily
p.000004: associated with the information.)
p.000004:
p.000004: Thus, simple observational studies of public behavior (including television and internet chat rooms) do not involve
p.000004: human subjects, as defined, because there is no intervention or interaction and the behavior is not private. Also,
p.000004: studies based on data otherwise collected for non-research purposes do not constitute human subjects research unless
p.000004: individual identity is readily identifiable. Examples include: programmatic data such as service statistics, school
p.000004: attendance data, crime statistics, election returns, vital statistics, and pathologic specimens collected for
p.000004: therapeutic purposes (where such information does not readily identify individuals.)
p.000004:
p.000004: (f) Exemptions – Certain research is exempt under the Policy. Ordinarily, institutions can make the
p.000004: determination that an activity is exempt, but the CHSO has final authority:
p.000004:
p.000004: (1) Survey and certain similar research – 22 CFR 225.101(b)(2). The Common Rule exempts survey and certain
p.000004: similar research, except in situations where each of two things occurs: first, the information would allow subjects to
p.000004: be identified (either directly or through identifiers linked to the subject), and second, "any disclosure of the human
p.000004: subject’s responses outside the research could reasonably place the subject at risk of criminal or civil liability or
p.000004: be damaging to the subjects' financial standing, employability or reputation." Thus, survey and similar research
p.000004: under formal human subjects protection is "covered" only when both privacy/confidentiality might be compromised through
p.000004: identification and the nature of the information disclosed is very sensitive. In determining whether there might be a
p.000004: reasonable risk of damage related to divulging the sensitive information, etc., it is not enough that there be merely
...
Political / criminal
Searching for indicator criminal:
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p.000002: ".. a systematic investigation including research development, testing and evaluation designed to develop or contribute
p.000002: to generalizable knowledge."
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: Further, as described in the Belmont Report "...the term 'research' designates an activity designed to test a
p.000003: hypothesis, permit conclusions to be drawn, and thereby to develop or to contribute to generalizable knowledge.
p.000003: Research is usually described in a formal protocol that sets forth an
p.000003: objective and a set of procedures to reach that objective."
p.000003:
p.000003: Thus, a key aspect of research is that there be a systematic design in advance, generally utilizing a scientific
p.000003: approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide
p.000003: variety of activities, including the following:
p.000003:
p.000003: • Experiments,
p.000003: • Observational studies,
p.000003: • Surveys,
p.000003: • Tests, and
p.000003: • Recordings designed to contribute to generalizable knowledge.
p.000003:
p.000003: It generally does not include such operational activities as the following:
p.000003:
p.000003: • Medical care;
p.000003: • Quality assurance;
p.000003: • Quality improvement;
p.000003: • Certain aspects of public health practice, such as routine outbreak investigations and disease monitoring;
p.000003: • Program evaluation;
p.000003: • Fiscal or program audits;
p.000003: • Journalism;
p.000003: • History;
p.000003: • Biography;
p.000003: • Philosophy;
p.000003: • "Fact-finding" inquiries such as criminal, civil and congressional investigations,
p.000003: • Intelligence gathering; and
p.000003: • Simple data collection or data collection for other purposes.
p.000003:
p.000003: However, some of these activities may include or constitute research in the specific circumstance where there is clear
p.000003: advance intent to contribute to generalizable knowledge with a formal scientific protocol.
p.000003:
p.000003: (b) Human Subject – This means a living individual about whom an investigator obtains
p.000003:
p.000003: (1) data through intervention or interaction, or
p.000003:
p.000003: (2) identifiable private information.
p.000003:
p.000003: (c) Intervention – This includes physical procedures and manipulations of the subject or the subject’s environment
p.000003: for research purposes.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: (d) Interaction – This includes communication between the investigator and the subject.
p.000004:
p.000004: (e) Private information includes information about behavior in which an individual can reasonably expect that no
p.000004: observation is taking place, or information for specific purposes (such as a medical record) that individuals can
p.000004: reasonably expect will not be made public. Private information must also be readily individually identifiable (i.e.
p.000004: the subject's identity is or may be readily ascertained by the investigator or the subject's identity readily
p.000004: associated with the information.)
p.000004:
p.000004: Thus, simple observational studies of public behavior (including television and internet chat rooms) do not involve
p.000004: human subjects, as defined, because there is no intervention or interaction and the behavior is not private. Also,
p.000004: studies based on data otherwise collected for non-research purposes do not constitute human subjects research unless
p.000004: individual identity is readily identifiable. Examples include: programmatic data such as service statistics, school
p.000004: attendance data, crime statistics, election returns, vital statistics, and pathologic specimens collected for
p.000004: therapeutic purposes (where such information does not readily identify individuals.)
p.000004:
p.000004: (f) Exemptions – Certain research is exempt under the Policy. Ordinarily, institutions can make the
p.000004: determination that an activity is exempt, but the CHSO has final authority:
p.000004:
p.000004: (1) Survey and certain similar research – 22 CFR 225.101(b)(2). The Common Rule exempts survey and certain
p.000004: similar research, except in situations where each of two things occurs: first, the information would allow subjects to
p.000004: be identified (either directly or through identifiers linked to the subject), and second, "any disclosure of the human
p.000004: subject’s responses outside the research could reasonably place the subject at risk of criminal or civil liability or
p.000004: be damaging to the subjects' financial standing, employability or reputation." Thus, survey and similar research
p.000004: under formal human subjects protection is "covered" only when both privacy/confidentiality might be compromised through
p.000004: identification and the nature of the information disclosed is very sensitive. In determining whether there might be a
p.000004: reasonable risk of damage related to divulging the sensitive information, etc., it is not enough that there be merely
p.000004: some hypothetically possible risk that can be construed. Rather, the risks resulting from disclosure must be readily
p.000004: appreciable and significant.
p.000004:
p.000004: (2) Research involving the collection or study of existing data or specimens – 22 CFR 225.101(b)(4).
p.000004: "Existing" means existing at the time the research is conducted. "Existing" includes sources such as vital records
p.000004: routinely created on an ongoing basis without alteration, even though some may be created after the start of the
p.000004: research. This research is exempt if these sources are publicly available or if the information is recorded by the
p.000004: investigator in such a manner that subjects cannot be identified directly or through identifiers. Thus, the key point
p.000004: is how the data are recorded. The research would remain exempt if the investigator had access to identifiable
p.000004: information (such as medical records) but did not record identifiers. Moreover, consistent with the definition of
...
Health / Drug Usage
Searching for indicator drug:
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p.000005: requirements per se.
p.000005:
p.000005: (i) Minimal Risk – As defined in the Common Rule this "... means that the probability and magnitude of the harm
p.000005: or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in
p.000005: daily life or during the performance of routine physical or psychological examinations or tests." In making this
p.000005: assessment, the risk/harm/discomfort of daily life or routine tests in their totality should be weighed against those
p.000005: of the research, not necessarily whether any specific risk/harm discomfort in the research matches that of daily life
p.000005: or such tests. Moreover, it means the risks/harm/discomfort encountered inherent to the daily lives of the population
p.000005: or class of research subjects involved and the additional risk/harm/discomfort added by the research. Thus, a treadmill
p.000005: test of low intensity might be minimal risk for the population in general, but more than minimal risk for research
p.000005: conducted with a group of cardiac patients. Likewise, measuring blood levels of a drug with serious side effects
p.000005: among a group of patients already receiving it for therapy might be considered minimal risk, whereas administering the
p.000005: same drug solely for research purposes and measuring it among the healthy population could be more than minimal risk.
p.000005: This standard should not be interpreted to mean that additional highly risky or potentially harmful interventions are
p.000005: considered minimal risk for certain severely ill patients simply because such patients are subject to such
p.000005: interventions as part of their treatment. Many non-exempt surveys may be
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: considered minimal risk since they do not exceed the harm or discomfort of certain psychological examinations or tests
p.000006: or those ordinarily encountered in daily life.
p.000006:
p.000006: (j) Multiple Site Research – 22 CFR 225.114 addresses cooperative research. Each institution is responsible for
p.000006: safeguarding subjects’ rights and following appropriate procedures. However, institutions may rely on the review of
p.000006: another qualified IRB. The types of research, the levels of risk, and the kinds of sites where cooperative research
p.000006: takes place vary widely and the need for considerable adaptability is recognized. For example, the mere fact that
p.000006: research occurs at a certain place (such as a health department, school, or supermarket) does not mean that "place"
p.000006: would be considered a research institution. If a site is only opening its doors to researchers or data abstractors, or
p.000006: is merely providing data, it is not considered a research institution. While it is not necessary that every site or
...
p.000008: (b) To make a determination that another system besides (a) above provides “at least equivalent" protection, a
p.000008: justification memorandum is required for an individual or class of research activities which is cleared by the Agency's
p.000008: CHSO (designee or successor) and is signed by the AA/GH (or designee.) Such a justification memorandum must describe
p.000008: how the alternative system provides the "three pillars" of protection described above under section 2(b)(1-3). In
p.000008: assessing equivalency, the general concept should be whether the system provides a level of protection that is
p.000008: equivalent overall when viewed in toto and not whether any specific component (e.g. the precise make-up of the IRB
p.000008: equivalent) is identical. Each determination of "at least equivalent" protection, including the determination for a
p.000008: class of activities, will be published in the Federal Register or otherwise in accordance with 22 CFR 225.101(h).
p.000008:
p.000008: 6. Applicability of the Policy to Various Types of Research and Research-Related Activities
p.000008:
p.000008: The following listed activities are guidelines for helping to assist in determining applicability of the Policy to a
p.000008: particular activity. They are not intended to be totally inclusive.
p.000008:
p.000008: (a) Experimental Biomedical Research – The Policy clearly applies to experimental biomedical research related to
p.000008: prevention, transmission, treatment, or curing of human diseases and to prevention of pregnancy; including the
p.000008: following:
p.000008:
p.000008: • Vaccine and drug development;
p.000008: • Clinical trials of new drugs, devices, and vaccines; and
p.000008: • Experimental studies of disease transmission involving human subjects.
p.000008:
p.000008: (b) Survey Research/Demographic Data Collection
p.000008:
p.000008: (1) Survey research in which no individual identifiers are collected or in which the data collected are not highly
p.000008: sensitive is exempt (See 22 CFR 225.101(b)(2) & (3)). Research with identifiers involving highly sensitive questions
p.000008: is not exempt, for example, surveys of high-risk sexual behavior and of HIV infection. Surveys generally considered
p.000008: exempt would include typical censuses, surveys of reproduction and contraceptive use, and standard nutrition surveys.
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: (2) Studies, such as surveys involving anthropometry and the gathering of human material through relatively
p.000009: non-invasive means, can be exempt as described in section 6(b)(1) above. Examples include such relatively benign
p.000009: procedures as collection of hair, nail clippings, external secretions, saliva, breast milk, oral, rectal or genital
p.000009: swabs, data via physical sensors applied to the surface of the body, etc. In and of itself, collection of such
p.000009: materials does not remove exemption. However, if such gathering of human material is more invasive, such as blood
p.000009: sampling, then this research is not exempt.
p.000009:
p.000009: (3) Anthropologic/ethnographic research is considered survey research as broadly defined and the same rules apply.
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000008: equivalent) is identical. Each determination of "at least equivalent" protection, including the determination for a
p.000008: class of activities, will be published in the Federal Register or otherwise in accordance with 22 CFR 225.101(h).
p.000008:
p.000008: 6. Applicability of the Policy to Various Types of Research and Research-Related Activities
p.000008:
p.000008: The following listed activities are guidelines for helping to assist in determining applicability of the Policy to a
p.000008: particular activity. They are not intended to be totally inclusive.
p.000008:
p.000008: (a) Experimental Biomedical Research – The Policy clearly applies to experimental biomedical research related to
p.000008: prevention, transmission, treatment, or curing of human diseases and to prevention of pregnancy; including the
p.000008: following:
p.000008:
p.000008: • Vaccine and drug development;
p.000008: • Clinical trials of new drugs, devices, and vaccines; and
p.000008: • Experimental studies of disease transmission involving human subjects.
p.000008:
p.000008: (b) Survey Research/Demographic Data Collection
p.000008:
p.000008: (1) Survey research in which no individual identifiers are collected or in which the data collected are not highly
p.000008: sensitive is exempt (See 22 CFR 225.101(b)(2) & (3)). Research with identifiers involving highly sensitive questions
p.000008: is not exempt, for example, surveys of high-risk sexual behavior and of HIV infection. Surveys generally considered
p.000008: exempt would include typical censuses, surveys of reproduction and contraceptive use, and standard nutrition surveys.
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: (2) Studies, such as surveys involving anthropometry and the gathering of human material through relatively
p.000009: non-invasive means, can be exempt as described in section 6(b)(1) above. Examples include such relatively benign
p.000009: procedures as collection of hair, nail clippings, external secretions, saliva, breast milk, oral, rectal or genital
p.000009: swabs, data via physical sensors applied to the surface of the body, etc. In and of itself, collection of such
p.000009: materials does not remove exemption. However, if such gathering of human material is more invasive, such as blood
p.000009: sampling, then this research is not exempt.
p.000009:
p.000009: (3) Anthropologic/ethnographic research is considered survey research as broadly defined and the same rules apply.
p.000009: Clearly, informed consent in this context is often unnecessary, impractical, and may be waivable (See section 7(a)
p.000009: below).
p.000009:
p.000009: (c) Epidemiologic Research – A number of epidemiologic studies are seen as survey research and treated accordingly
p.000009: (22 CFR 225.101(b)(2)). As described above (section 6(b)(1)), when no individual identifiers are collected or when
p.000009: data are not highly sensitive, this research is exempt. Epidemiologic approaches include the following:
p.000009:
p.000009: (1) Case-Control and Cohort Studies. Generally treat as survey research.
p.000009:
p.000009: (2) Surveillance. 22 CFR 225.101(b)(4) exempts research involving existing publicly available data, records and
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000009: reasonably be expected as part of their normal job or as part of normal service delivery improvement, then such data
p.000009: gathering about staff is also exempt.
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (e) Research on Diagnostic Tests – Research to develop or assess diagnostic tests on blood, urine, etc., while not
p.000010: well-delineated in the Policy, can span several research categories.
p.000010:
p.000010: (1) Research on existing specimens is generally exempt if sources are publicly available or subjects cannot be
p.000010: identified.
p.000010:
p.000010: (2) Research on newly collected materials may be treated as survey research, but otherwise will not qualify for
p.000010: exemption per 22 CFR 225.101 (b) (2 or 3) if it includes invasive procedures, such as blood collection.
p.000010:
p.000010: (3) Research on existing standard of care diagnostic methods (e.g. comparing two techniques for diagnosing
p.000010: Chlamydia, both of which are commonly used in programs) may be treated as operations research.
p.000010:
p.000010: (4) Other diagnostic research, such as a new test versus an existing test, may be considered experimental
p.000010: biomedical research when the results of such testing will potentially lead to important treatment changes for the
p.000010: individual.
p.000010:
p.000010: (f) Education Research – Education research involving special subjects, such as children and mentally disabled
p.000010: individuals, is covered by the Policy. Much educational research is exempted under 22 CFR 225.101(b)(1), including
p.000010: research in educational settings involving normal educational practices.
p.000010:
p.000010: 7. Balancing Protection with Burden
p.000010:
p.000010: (a) Recognizing the importance and contribution of research to prevent much human mortality and morbidity,
p.000010: implementation of the Policy at USAID is intended to provide adequate protection of human research subjects, while
p.000010: avoiding imposition of undue burden on the research process and people. Common sense, practicality, and flexibility are
p.000010: essential, especially in areas other than experimental biomedical research (the original focus of development of the
p.000010: Policy) where there is no issue of causing appreciable physical harm. In the area of epidemiologic research, for
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
p.000010: for the informed consent procedure to consist simply of a legitimate statement that participation is voluntary and that
...
Searching for indicator mentally:
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p.000009: about staff or otherwise having staff perform additional or different work than would ordinarily be part of what could
p.000009: reasonably be expected as part of their normal job or as part of normal service delivery improvement, then such data
p.000009: gathering about staff is also exempt.
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (e) Research on Diagnostic Tests – Research to develop or assess diagnostic tests on blood, urine, etc., while not
p.000010: well-delineated in the Policy, can span several research categories.
p.000010:
p.000010: (1) Research on existing specimens is generally exempt if sources are publicly available or subjects cannot be
p.000010: identified.
p.000010:
p.000010: (2) Research on newly collected materials may be treated as survey research, but otherwise will not qualify for
p.000010: exemption per 22 CFR 225.101 (b) (2 or 3) if it includes invasive procedures, such as blood collection.
p.000010:
p.000010: (3) Research on existing standard of care diagnostic methods (e.g. comparing two techniques for diagnosing
p.000010: Chlamydia, both of which are commonly used in programs) may be treated as operations research.
p.000010:
p.000010: (4) Other diagnostic research, such as a new test versus an existing test, may be considered experimental
p.000010: biomedical research when the results of such testing will potentially lead to important treatment changes for the
p.000010: individual.
p.000010:
p.000010: (f) Education Research – Education research involving special subjects, such as children and mentally disabled
p.000010: individuals, is covered by the Policy. Much educational research is exempted under 22 CFR 225.101(b)(1), including
p.000010: research in educational settings involving normal educational practices.
p.000010:
p.000010: 7. Balancing Protection with Burden
p.000010:
p.000010: (a) Recognizing the importance and contribution of research to prevent much human mortality and morbidity,
p.000010: implementation of the Policy at USAID is intended to provide adequate protection of human research subjects, while
p.000010: avoiding imposition of undue burden on the research process and people. Common sense, practicality, and flexibility are
p.000010: essential, especially in areas other than experimental biomedical research (the original focus of development of the
p.000010: Policy) where there is no issue of causing appreciable physical harm. In the area of epidemiologic research, for
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
...
Health / ill
Searching for indicator ill:
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p.000005: of the research, not necessarily whether any specific risk/harm discomfort in the research matches that of daily life
p.000005: or such tests. Moreover, it means the risks/harm/discomfort encountered inherent to the daily lives of the population
p.000005: or class of research subjects involved and the additional risk/harm/discomfort added by the research. Thus, a treadmill
p.000005: test of low intensity might be minimal risk for the population in general, but more than minimal risk for research
p.000005: conducted with a group of cardiac patients. Likewise, measuring blood levels of a drug with serious side effects
p.000005: among a group of patients already receiving it for therapy might be considered minimal risk, whereas administering the
p.000005: same drug solely for research purposes and measuring it among the healthy population could be more than minimal risk.
p.000005: This standard should not be interpreted to mean that additional highly risky or potentially harmful interventions are
p.000005: considered minimal risk for certain severely ill patients simply because such patients are subject to such
p.000005: interventions as part of their treatment. Many non-exempt surveys may be
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: considered minimal risk since they do not exceed the harm or discomfort of certain psychological examinations or tests
p.000006: or those ordinarily encountered in daily life.
p.000006:
p.000006: (j) Multiple Site Research – 22 CFR 225.114 addresses cooperative research. Each institution is responsible for
p.000006: safeguarding subjects’ rights and following appropriate procedures. However, institutions may rely on the review of
p.000006: another qualified IRB. The types of research, the levels of risk, and the kinds of sites where cooperative research
p.000006: takes place vary widely and the need for considerable adaptability is recognized. For example, the mere fact that
p.000006: research occurs at a certain place (such as a health department, school, or supermarket) does not mean that "place"
p.000006: would be considered a research institution. If a site is only opening its doors to researchers or data abstractors, or
p.000006: is merely providing data, it is not considered a research institution. While it is not necessary that every site or
p.000006: every institution provide its own IRB review (an IRB may be "remote" from the site of the actual research), it is
p.000006: important that the IRB review and oversight that is conducted is explicitly considered competent and cognizant of the
p.000006: conditions and situations in the sites under its purview. One specific mechanism is a cooperative amendment to
p.000006: assurances of institutions participating in cooperative research, which can be agreed to by those institutions, and
...
Social / Access to Social Goods
Searching for indicator access:
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p.000004: be damaging to the subjects' financial standing, employability or reputation." Thus, survey and similar research
p.000004: under formal human subjects protection is "covered" only when both privacy/confidentiality might be compromised through
p.000004: identification and the nature of the information disclosed is very sensitive. In determining whether there might be a
p.000004: reasonable risk of damage related to divulging the sensitive information, etc., it is not enough that there be merely
p.000004: some hypothetically possible risk that can be construed. Rather, the risks resulting from disclosure must be readily
p.000004: appreciable and significant.
p.000004:
p.000004: (2) Research involving the collection or study of existing data or specimens – 22 CFR 225.101(b)(4).
p.000004: "Existing" means existing at the time the research is conducted. "Existing" includes sources such as vital records
p.000004: routinely created on an ongoing basis without alteration, even though some may be created after the start of the
p.000004: research. This research is exempt if these sources are publicly available or if the information is recorded by the
p.000004: investigator in such a manner that subjects cannot be identified directly or through identifiers. Thus, the key point
p.000004: is how the data are recorded. The research would remain exempt if the investigator had access to identifiable
p.000004: information (such as medical records) but did not record identifiers. Moreover, consistent with the definition of
p.000004: human subject, identification needs to be readily ascertainable. Research would remain exempt, for example, if
p.000004: identity is linked only by legitimate encryption or other procedures that make it very difficult for investigators to
p.000004: identify individuals.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: (3) Public Benefit or Service Programs – 22 CFR 225. (101)(b)(5). This exemption to study, evaluate, or
p.000005: otherwise examine public service or benefit programs is broadly written. However, the exemption is generally
p.000005: interpreted to be limited to research on the process or outcomes of service delivery (e.g., programmatic research or
p.000005: operations research.)
p.000005:
p.000005: (g) Informed consent to promote communication and understanding – (22 CFR 225.116 and 117): Recognizing that
p.000005: communication is an imperfect human process, in the interest of better human subjects protection, it is important to
p.000005: recognize the informed consent process as a process of communication and not just a legal requirement. The consent
p.000005: form should not be confused with the informed consent process. In the interest of good communication, the process
p.000005: should promote: simple understandable language, emphasis on the required and most important information, and avoidance
...
p.000007: Recipient institutions may be of two categories:
p.000007:
p.000007: (1) Many have a “Federal-wide Assurance” of Compliance (FWA) issued and administered by the Department of Health
p.000007: and Human Services (DHHS) that applies to all Federally-funded research. Under the FWA, the implementation procedures
p.000007: and interpretations of the respective Federal funding agency govern its application.
p.000007:
p.000007: (2) If no FWA exists, the institution must provide an acceptable "assurance" to USAID describing how it will
p.000007: comply with the Policy (see section 8 below).
p.000007:
p.000007: (b) Research in Foreign Countries – There are generally three mechanisms by which USAID supports research in
p.000007: foreign countries:
p.000007:
p.000007: (1) The primary funding recipient is a U.S.-based institution, with the research carried out in another country.
p.000007: In this situation, the primary recipient is responsible for complying or assuring compliance in detail with the Policy
p.000007: as described above under either an FWA or USAID- approved assurance governing the research. USAID encourages, but does
p.000007: not require, the host-country collaborators of U.S.-based institutions to use an in-country IRB.
p.000007:
p.000007: (2) The recipient is a United Nations (U.N.) agency (e.g. the World Health Organization (WHO)) .
p.000007:
p.000007: (3) The primary recipient is a host country government or non-government institution.
p.000007:
p.000007: In the last two cases, there are three ways acceptable standards can be applied:
p.000007:
p.000007: (i) An FWA or a USAID-specific assurance as with U.S. institutions.
p.000007:
p.000007: (ii) Access to an appropriate USAID-accepted research system, such as through a WHO/ Council for International
p.000007: Organizations of Medical Science (CIOMS)-approved Ethical Committee (see section 4(a) below) either directly or through
p.000007: a collaborative arrangement.
p.000007:
p.000007: (iii) An alternative human subjects system can be employed if it can be determined (by the AA/GH or designee) to be
p.000007: “at least equivalent” to the Policy (as delineated in section 5 below).
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: 5. Determination that Alternative Protection Procedures are "at Least Equivalent" to the Policy
p.000008:
p.000008: (a) 22 CFR 225.101(h) describes the use of alternative protection of human subjects systems when research is
p.000008: conducted outside the U.S. It specifically cites the example of "...a foreign institution which complies with
p.000008: guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either
p.000008: by sovereign states or by an organization whose function for the protection of human subjects is internationally
p.000008: recognized." Research supported through or adhering to the standards established by United Nations agencies, such as
p.000008: WHO, is considered to qualify as affording such "at least equivalent" protection.
p.000008:
p.000008: (b) To make a determination that another system besides (a) above provides “at least equivalent" protection, a
p.000008: justification memorandum is required for an individual or class of research activities which is cleared by the Agency's
...
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
p.000010: for the informed consent procedure to consist simply of a legitimate statement that participation is voluntary and that
p.000010: information will be kept confidential. In circumstances where consent is required, but written consent is
p.000010: inappropriate in a given culture or population, verbal consent may be appropriate, but it must be witnessed and
p.000010: documented in writing.
p.000010:
p.000010: (b) Additional situations call for practicality. For example, where a series surveys or other similar research
p.000010: activities are highly standardized or systematized, review and approval of such research as a group or class by an IRB
p.000010: may be appropriate. Likewise, it may be reasonable to review and approve certain outbreak investigations as a class,
p.000010: in advance, because of the emergency nature of such research.
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: 8. Right of Access of USAID Officials to Records
p.000011:
p.000011: To implement and monitor human subjects research activities properly, it is essential that USAID reserve the right to
p.000011: speak with subjects and inspect any relevant records, and to prohibit research which presents unacceptable risks.
p.000011: Appropriate language to that effect must be included in contracts, grants, and other support documents, as well as in
p.000011: informed consent documents.
p.000011:
p.000011: 9. Compliance
p.000011:
p.000011: (a) All research activities involving human subjects that are funded by USAID must adhere to the procedures set
p.000011: forth in the Policy, or have a system that provides "at least equivalent" protection which has been approved by the
p.000011: AA/GH or designee. Compliance with USAID human subjects procedures is the primary responsibility of the organization
p.000011: receiving USAID support. To help ensure observance of USAID's human subjects procedures by such recipients,
p.000011: appropriate language must be included in funding documents, when appropriate.
p.000011:
p.000011: (b) Unless the research is conducted under an applicable Federal-wide Assurance (FWA) or qualifies as affording
p.000011: "at least equivalent" protection as described in section 5 above, the recipient must provide USAID with a satisfactory
p.000011: written "assurance" that it will comply with the requirements set forth in the Policy. An assurance such as from a
p.000011: primary USAID-supported institution can also cover the activities of collaborating institutions. As described in 22
...
Social / Child
Searching for indicator children:
(return to top)
p.000009: about staff or otherwise having staff perform additional or different work than would ordinarily be part of what could
p.000009: reasonably be expected as part of their normal job or as part of normal service delivery improvement, then such data
p.000009: gathering about staff is also exempt.
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (e) Research on Diagnostic Tests – Research to develop or assess diagnostic tests on blood, urine, etc., while not
p.000010: well-delineated in the Policy, can span several research categories.
p.000010:
p.000010: (1) Research on existing specimens is generally exempt if sources are publicly available or subjects cannot be
p.000010: identified.
p.000010:
p.000010: (2) Research on newly collected materials may be treated as survey research, but otherwise will not qualify for
p.000010: exemption per 22 CFR 225.101 (b) (2 or 3) if it includes invasive procedures, such as blood collection.
p.000010:
p.000010: (3) Research on existing standard of care diagnostic methods (e.g. comparing two techniques for diagnosing
p.000010: Chlamydia, both of which are commonly used in programs) may be treated as operations research.
p.000010:
p.000010: (4) Other diagnostic research, such as a new test versus an existing test, may be considered experimental
p.000010: biomedical research when the results of such testing will potentially lead to important treatment changes for the
p.000010: individual.
p.000010:
p.000010: (f) Education Research – Education research involving special subjects, such as children and mentally disabled
p.000010: individuals, is covered by the Policy. Much educational research is exempted under 22 CFR 225.101(b)(1), including
p.000010: research in educational settings involving normal educational practices.
p.000010:
p.000010: 7. Balancing Protection with Burden
p.000010:
p.000010: (a) Recognizing the importance and contribution of research to prevent much human mortality and morbidity,
p.000010: implementation of the Policy at USAID is intended to provide adequate protection of human research subjects, while
p.000010: avoiding imposition of undue burden on the research process and people. Common sense, practicality, and flexibility are
p.000010: essential, especially in areas other than experimental biomedical research (the original focus of development of the
p.000010: Policy) where there is no issue of causing appreciable physical harm. In the area of epidemiologic research, for
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000004: information (such as medical records) but did not record identifiers. Moreover, consistent with the definition of
p.000004: human subject, identification needs to be readily ascertainable. Research would remain exempt, for example, if
p.000004: identity is linked only by legitimate encryption or other procedures that make it very difficult for investigators to
p.000004: identify individuals.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: (3) Public Benefit or Service Programs – 22 CFR 225. (101)(b)(5). This exemption to study, evaluate, or
p.000005: otherwise examine public service or benefit programs is broadly written. However, the exemption is generally
p.000005: interpreted to be limited to research on the process or outcomes of service delivery (e.g., programmatic research or
p.000005: operations research.)
p.000005:
p.000005: (g) Informed consent to promote communication and understanding – (22 CFR 225.116 and 117): Recognizing that
p.000005: communication is an imperfect human process, in the interest of better human subjects protection, it is important to
p.000005: recognize the informed consent process as a process of communication and not just a legal requirement. The consent
p.000005: form should not be confused with the informed consent process. In the interest of good communication, the process
p.000005: should promote: simple understandable language, emphasis on the required and most important information, and avoidance
p.000005: of "information overload," without large amounts of additional information of marginal use to the consent process. The
p.000005: process should also promote good communication techniques, such as active listening, individualizing, and requesting
p.000005: restatement by the subject.
p.000005:
p.000005: (h) Waiver or Alteration of Informed Consent – 22 CFR 225.116 (d) provides conditions for waiving or altering the
p.000005: informed consent procedure for research involving no more than minimal risk. A key condition is that "The research
p.000005: could not be practicably carried out without the waiver or alteration." The determination that the research could not
p.000005: be practicably carried out is not a matter of mere inconvenience to the research process. Rather, there need be a
p.000005: plausible concern that either the conduct or the findings of the research might be adversely affected by the consent
p.000005: process. An adverse effect might include a substantial delay or increase in cost. Examples of situations where waiver
p.000005: or alteration of informed consent may often be justified are minimal risk (and non-exempt) social science methods
p.000005: involving deception, and surveys and cultural anthropology where implementation of all or part of the informed consent
...
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
p.000010: for the informed consent procedure to consist simply of a legitimate statement that participation is voluntary and that
p.000010: information will be kept confidential. In circumstances where consent is required, but written consent is
p.000010: inappropriate in a given culture or population, verbal consent may be appropriate, but it must be witnessed and
p.000010: documented in writing.
p.000010:
p.000010: (b) Additional situations call for practicality. For example, where a series surveys or other similar research
p.000010: activities are highly standardized or systematized, review and approval of such research as a group or class by an IRB
p.000010: may be appropriate. Likewise, it may be reasonable to review and approve certain outbreak investigations as a class,
p.000010: in advance, because of the emergency nature of such research.
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: 8. Right of Access of USAID Officials to Records
p.000011:
p.000011: To implement and monitor human subjects research activities properly, it is essential that USAID reserve the right to
p.000011: speak with subjects and inspect any relevant records, and to prohibit research which presents unacceptable risks.
p.000011: Appropriate language to that effect must be included in contracts, grants, and other support documents, as well as in
p.000011: informed consent documents.
p.000011:
p.000011: 9. Compliance
p.000011:
p.000011: (a) All research activities involving human subjects that are funded by USAID must adhere to the procedures set
p.000011: forth in the Policy, or have a system that provides "at least equivalent" protection which has been approved by the
p.000011: AA/GH or designee. Compliance with USAID human subjects procedures is the primary responsibility of the organization
p.000011: receiving USAID support. To help ensure observance of USAID's human subjects procedures by such recipients,
p.000011: appropriate language must be included in funding documents, when appropriate.
p.000011:
p.000011: (b) Unless the research is conducted under an applicable Federal-wide Assurance (FWA) or qualifies as affording
p.000011: "at least equivalent" protection as described in section 5 above, the recipient must provide USAID with a satisfactory
p.000011: written "assurance" that it will comply with the requirements set forth in the Policy. An assurance such as from a
p.000011: primary USAID-supported institution can also cover the activities of collaborating institutions. As described in 22
p.000011: CFR 225.103(b)(1), the assurance must include: a statement of principles governing the institution's responsibilities,
p.000011: designation of one or more IRBs, a list of IRB members, written procedures which the IRB will follow, and written
p.000011: procedures for ensuring prompt reporting of unanticipated problems to the IRB. Assurances may be for a single research
p.000011: project or for multiple projects.
p.000011:
p.000011:
p.000011: 200mbe_122606_w011007_cd46
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000011: informed consent documents.
p.000011:
p.000011: 9. Compliance
p.000011:
p.000011: (a) All research activities involving human subjects that are funded by USAID must adhere to the procedures set
p.000011: forth in the Policy, or have a system that provides "at least equivalent" protection which has been approved by the
p.000011: AA/GH or designee. Compliance with USAID human subjects procedures is the primary responsibility of the organization
p.000011: receiving USAID support. To help ensure observance of USAID's human subjects procedures by such recipients,
p.000011: appropriate language must be included in funding documents, when appropriate.
p.000011:
p.000011: (b) Unless the research is conducted under an applicable Federal-wide Assurance (FWA) or qualifies as affording
p.000011: "at least equivalent" protection as described in section 5 above, the recipient must provide USAID with a satisfactory
p.000011: written "assurance" that it will comply with the requirements set forth in the Policy. An assurance such as from a
p.000011: primary USAID-supported institution can also cover the activities of collaborating institutions. As described in 22
p.000011: CFR 225.103(b)(1), the assurance must include: a statement of principles governing the institution's responsibilities,
p.000011: designation of one or more IRBs, a list of IRB members, written procedures which the IRB will follow, and written
p.000011: procedures for ensuring prompt reporting of unanticipated problems to the IRB. Assurances may be for a single research
p.000011: project or for multiple projects.
p.000011:
p.000011:
p.000011: 200mbe_122606_w011007_cd46
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000009: does not meet the definition of research.
p.000009:
p.000009: (3) Other epidemiologic studies utilizing existing data or specimens. Generally exempt under 22 CFR
p.000009: 225.101(b)(4).
p.000009:
p.000009: (4) Outbreak Investigations. These are often carried out as a public health practice and often may not meet the
p.000009: definition of research. Otherwise treat as survey research, but recognize the need for expedited procedures (See
p.000009: section 7(b) below).
p.000009:
p.000009: (d) Operations Research – Operational/operations research or service delivery research includes research on
p.000009: service delivery systems for the purpose of understanding how they function and how to improve efficiency and
p.000009: effectiveness. It includes making alterations or making observations of how services are provided among acceptable
p.000009: alternatives (e.g., comparing differences in clinic hours or evaluating the impact of adding new services.) It is
p.000009: generally exempt under 22 CFR 225.101(b)(5), which exempts research on public benefit or service programs.
p.000009: Nevertheless, operations research in highly sensitive areas involving issues of privacy, such as sensitive sexual
p.000009: behavior, may need special attention regarding matters such as confidentiality and often formal protection procedures
p.000009: should be applied. When research into service delivery includes working with staff, and involves gathering information
p.000009: about staff or otherwise having staff perform additional or different work than would ordinarily be part of what could
p.000009: reasonably be expected as part of their normal job or as part of normal service delivery improvement, then such data
p.000009: gathering about staff is also exempt.
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (e) Research on Diagnostic Tests – Research to develop or assess diagnostic tests on blood, urine, etc., while not
p.000010: well-delineated in the Policy, can span several research categories.
p.000010:
p.000010: (1) Research on existing specimens is generally exempt if sources are publicly available or subjects cannot be
p.000010: identified.
p.000010:
p.000010: (2) Research on newly collected materials may be treated as survey research, but otherwise will not qualify for
p.000010: exemption per 22 CFR 225.101 (b) (2 or 3) if it includes invasive procedures, such as blood collection.
p.000010:
p.000010: (3) Research on existing standard of care diagnostic methods (e.g. comparing two techniques for diagnosing
p.000010: Chlamydia, both of which are commonly used in programs) may be treated as operations research.
p.000010:
p.000010: (4) Other diagnostic research, such as a new test versus an existing test, may be considered experimental
p.000010: biomedical research when the results of such testing will potentially lead to important treatment changes for the
p.000010: individual.
p.000010:
p.000010: (f) Education Research – Education research involving special subjects, such as children and mentally disabled
p.000010: individuals, is covered by the Policy. Much educational research is exempted under 22 CFR 225.101(b)(1), including
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000002: (sometimes referred to as the “Common Rule”) as USAID regulation (referred to herein in this document as the Policy –
p.000002: see 22 CFR 225). The Policy sets standards for the protection of human research subjects that USAID follows when
p.000002: research activities supported by USAID involve human subjects. Safeguarding the rights and welfare of human subjects
p.000002: involved in research supported by USAID is the primary responsibility of the organization to which support is awarded.
p.000002: No research involving human subjects may be undertaken unless the research is approved as outlined in the Policy. The
p.000002: Policy sets forth detailed guidance that allows for some latitude in adaptation of the Policy to the specific situation
p.000002: of each agency, including administrative procedures and interpretation.
p.000002:
p.000002: This document is a companion to the Policy. Its purpose is to describe how the Policy is implemented and interpreted
p.000002: by USAID. It is intended especially to help Cognizant Technical Officers (CTOs), Technical Advisors (TAs,) Mission
p.000002: staff, and USAID recipients to understand and apply the Policy when supporting or conducting research involving human
p.000002: subjects. CTOs, TAs and Mission staff are the first line of responsibility in assessing applicability of the Policy to
p.000002: a particular research project.
p.000002: For Bureaus/Missions with research activities covered by the Policy, they are responsible for reading the Policy and
p.000002: for ensuring that those organizations receiving USAID funds for research are adhering to requirements set forth in the
p.000002: Policy. USAID's Cognizant Human Subjects Officer (CHSO or successor) assists with guidance and interpretation of the
p.000002: Policy. The CHSO, located in USAID/Washington, is appointed by the Assistant Administrator Global Health (AA/GH).
p.000002: Ultimate Agency authority for decisions regarding human subjects' protection has been delegated to the CHSO.
p.000002:
p.000002: 2. Basic Principles of Human Research Subjects Protection
p.000002:
p.000002: (a) The 1979 report, of the President’s Commission for the Study of Ethical Programs in Medicine and Biomedical
p.000002: and Behavioral Research, or “Belmont Report”, laid out much of the ethical principles for the Common Rule. Human
p.000002: subjects’ considerations are essential to the design and implementation of research projects. USAID strongly supports
p.000002: vigorous efforts to protect human subjects as provided for by the Policy. Much of the Policy itself is primarily
p.000002: oriented towards experimental biomedical research, but some other types of research are included (see section 5 for
p.000002: application of the Policy to various other types of research, and for exemptions).
p.000002:
p.000002: (b) Human subjects research rests on three pillars of protection:
p.000002:
p.000002: (1) Review of the research by a properly constituted ethical committee or Institutional Review Board (IRB);
p.000002:
p.000002: (2) A meaningful assessment of risks and benefits by the IRB; and
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: (3) A meaningful informed consent procedure for research subjects.
p.000002:
...
Social / education
Searching for indicator education:
(return to top)
p.000002: ethical decisions, and instead it vests the major responsibility of ethical decision making with the IRB. IRB actions
p.000002: must be based on ethical principles (such as outlined in the Belmont Report.) IRB board members should fully recognize
p.000002: that ethical decisions involve a balance among such principles (such as respect for persons, beneficence, and justice)
p.000002: and the importance of the knowledge that may reasonably be expected to result from proposed research (the requirement
p.000002: for which is itself grounded in the principle of beneficence.)
p.000002:
p.000002: In order to carry out its mandate, institutions conducting research and IRBs are empowered with very wide discretion
p.000002: within the bounds of the Common Rule. Recognizing the wide range of situations under which research may occur, the IRB
p.000002: should strive, above all else, to do "the right thing" as it sees it. The regulation allows for considerable
p.000002: flexibility to serve that purpose. In the interest of promoting human subjects protection, it is important for
p.000002: institutions and IRBs to take a facilitative, collegial, and educational approach to investigators, rather than a
p.000002: burdensome adversarial one. The IRB should encourage investigators to embrace ethical behavior by acting to facilitate
p.000002: ethical research and it should not be seen as an obstacle to the conduct of research. To that end, institutions and
p.000002: IRBs should promote education efforts for researchers and other staff, and they are encouraged to use their broad
p.000002: discretion to adopt creative administrative and other means to reduce administrative burden and maximize attention to
p.000002: the most important ethical issues.
p.000002:
p.000002: (d) The Policy recognizes that foreign countries may often present special situations and it provides mechanisms
p.000002: to help deal with these (see 22 CFR 225.101(h)). As provided for in the Policy, USAID will accept legitimate foreign
p.000002: procedural systems, for example, an institution which complies with the guidelines of the World Medical Assembly
p.000002: Declaration, as long as they are determined to provide protection "at least equivalent" to the Policy. Substantive
p.000002: application of the "three pillars" should generally satisfy this requirement. (See “at least equivalent” procedure
p.000002: below.) As noted in 22 CFR 225.101(g), the research must also conform to legal and other requirements governing
p.000002: research with human subjects in the country where it is conducted.
p.000002:
p.000002: (e) USAID's implementation of the Policy recognizes the highly diverse situations and methodologies for conducting
p.000002: research and seeks to avoid undue burden that might be imposed by its application, while protecting human subjects. It
p.000002: emphasizes practicality, flexibility, and common sense. In cases where all or part of the research is subcontracted to
p.000002: another institution, the prime contractor/recipient is responsible for complying in detail with the Policy. Because
p.000002: USAID conducts no research itself directly, no need is foreseen for an internal USAID IRB per se to review research
...
p.000009: should be applied. When research into service delivery includes working with staff, and involves gathering information
p.000009: about staff or otherwise having staff perform additional or different work than would ordinarily be part of what could
p.000009: reasonably be expected as part of their normal job or as part of normal service delivery improvement, then such data
p.000009: gathering about staff is also exempt.
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (e) Research on Diagnostic Tests – Research to develop or assess diagnostic tests on blood, urine, etc., while not
p.000010: well-delineated in the Policy, can span several research categories.
p.000010:
p.000010: (1) Research on existing specimens is generally exempt if sources are publicly available or subjects cannot be
p.000010: identified.
p.000010:
p.000010: (2) Research on newly collected materials may be treated as survey research, but otherwise will not qualify for
p.000010: exemption per 22 CFR 225.101 (b) (2 or 3) if it includes invasive procedures, such as blood collection.
p.000010:
p.000010: (3) Research on existing standard of care diagnostic methods (e.g. comparing two techniques for diagnosing
p.000010: Chlamydia, both of which are commonly used in programs) may be treated as operations research.
p.000010:
p.000010: (4) Other diagnostic research, such as a new test versus an existing test, may be considered experimental
p.000010: biomedical research when the results of such testing will potentially lead to important treatment changes for the
p.000010: individual.
p.000010:
p.000010: (f) Education Research – Education research involving special subjects, such as children and mentally disabled
p.000010: individuals, is covered by the Policy. Much educational research is exempted under 22 CFR 225.101(b)(1), including
p.000010: research in educational settings involving normal educational practices.
p.000010:
p.000010: 7. Balancing Protection with Burden
p.000010:
p.000010: (a) Recognizing the importance and contribution of research to prevent much human mortality and morbidity,
p.000010: implementation of the Policy at USAID is intended to provide adequate protection of human research subjects, while
p.000010: avoiding imposition of undue burden on the research process and people. Common sense, practicality, and flexibility are
p.000010: essential, especially in areas other than experimental biomedical research (the original focus of development of the
p.000010: Policy) where there is no issue of causing appreciable physical harm. In the area of epidemiologic research, for
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
...
Searching for indicator educational:
(return to top)
p.000002:
p.000002: (2) A meaningful assessment of risks and benefits by the IRB; and
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: (3) A meaningful informed consent procedure for research subjects.
p.000002:
p.000002: (c) Trust in the honest, conscientious judgment of the human beings who serve on IRBs is pivotal to the entire
p.000002: system of protection of research subjects. Indeed, the system recognizes that there is no simple formula to apply to
p.000002: ethical decisions, and instead it vests the major responsibility of ethical decision making with the IRB. IRB actions
p.000002: must be based on ethical principles (such as outlined in the Belmont Report.) IRB board members should fully recognize
p.000002: that ethical decisions involve a balance among such principles (such as respect for persons, beneficence, and justice)
p.000002: and the importance of the knowledge that may reasonably be expected to result from proposed research (the requirement
p.000002: for which is itself grounded in the principle of beneficence.)
p.000002:
p.000002: In order to carry out its mandate, institutions conducting research and IRBs are empowered with very wide discretion
p.000002: within the bounds of the Common Rule. Recognizing the wide range of situations under which research may occur, the IRB
p.000002: should strive, above all else, to do "the right thing" as it sees it. The regulation allows for considerable
p.000002: flexibility to serve that purpose. In the interest of promoting human subjects protection, it is important for
p.000002: institutions and IRBs to take a facilitative, collegial, and educational approach to investigators, rather than a
p.000002: burdensome adversarial one. The IRB should encourage investigators to embrace ethical behavior by acting to facilitate
p.000002: ethical research and it should not be seen as an obstacle to the conduct of research. To that end, institutions and
p.000002: IRBs should promote education efforts for researchers and other staff, and they are encouraged to use their broad
p.000002: discretion to adopt creative administrative and other means to reduce administrative burden and maximize attention to
p.000002: the most important ethical issues.
p.000002:
p.000002: (d) The Policy recognizes that foreign countries may often present special situations and it provides mechanisms
p.000002: to help deal with these (see 22 CFR 225.101(h)). As provided for in the Policy, USAID will accept legitimate foreign
p.000002: procedural systems, for example, an institution which complies with the guidelines of the World Medical Assembly
p.000002: Declaration, as long as they are determined to provide protection "at least equivalent" to the Policy. Substantive
p.000002: application of the "three pillars" should generally satisfy this requirement. (See “at least equivalent” procedure
p.000002: below.) As noted in 22 CFR 225.101(g), the research must also conform to legal and other requirements governing
p.000002: research with human subjects in the country where it is conducted.
p.000002:
p.000002: (e) USAID's implementation of the Policy recognizes the highly diverse situations and methodologies for conducting
p.000002: research and seeks to avoid undue burden that might be imposed by its application, while protecting human subjects. It
...
p.000006: approved by the sponsoring agency, to document the terms of reliance on another institution's IRB.
p.000006:
p.000006: (k) Continuing Review and Promoting More Active Oversight – IRBs must conduct continuing review of covered
p.000006: research at least annually. IRBs have considerable latitude in what the review entails. The key concept is that the
p.000006: review be substantive and meaningful. In some cases it may involve a complete review of the entire protocol by the
p.000006: full IRB together with any additional changes, events, and findings. It may also include observations of the research
p.000006: or the consent process. In other instances, IRBs may adopt more expeditious procedures, for example relying on
p.000006: findings of a principal reviewer or on research progress reports. The IRB may consider a biomedical or other
p.000006: intervention study closed when all active participation of the subjects has ended and the investigator is no longer
p.000006: accessing private identifiable information. Once a study is closed, it is a good idea to have reasonable ongoing
p.000006: procedures in place as appropriate and practicable, to protect confidentiality and to provide feedback of relevant
p.000006: emerging information to subjects.
p.000006:
p.000006: As with any undertaking, a sense of priority is important in dealing with human subjects research, and institutions are
p.000006: encouraged to exercise more active oversight beyond the minimum requirement of the Common Rule for certain higher risk
p.000006: research, as appropriate. More active oversight could include such activities as the following:
p.000006:
p.000006: • Special educational outreach to investigators and other appropriate stake holders,
p.000006: • Site visits and observations of research activities,
p.000006: • Research participant interviews as appropriate,
p.000006: • Ongoing IRB briefings of research progress,
p.000006: • Timely monitoring and evaluation of untoward events, and
p.000006: • Data monitoring and safety boards.
p.000006:
p.000006: (l) Promoting Ethical Behavior in Areas Exempt from the Policy – Even though certain classes of research are
p.000006: exempt under the Common Rule, they should not be considered exempt from common ethical standards. For example, a
p.000006: certain survey may be exempt, but it is common courtesy and otherwise generally reasonable to ask permission and
p.000006: provide some simple information to
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: respondents. Likewise, research on existing specimens might not record identifiers and thus be exempt, but researchers
p.000007: should still strive to protect individual privacy. The interest in promoting ethical behavior outside the common rule
p.000007: is not intended as a mandate for more structured procedures, but rather to advance a cultural norm of ethical behavior
p.000007: for research and non-research activities alike, to be exercised with discretion by institutions and individuals.
p.000007:
p.000007: 4. Application in Various Research Locations
p.000007:
p.000007: (a) Research in the U.S. – When research takes place in the U.S., it must conform to all aspects of the Policy.
p.000007: Recipient institutions may be of two categories:
p.000007:
p.000007: (1) Many have a “Federal-wide Assurance” of Compliance (FWA) issued and administered by the Department of Health
...
p.000009: gathering about staff is also exempt.
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (e) Research on Diagnostic Tests – Research to develop or assess diagnostic tests on blood, urine, etc., while not
p.000010: well-delineated in the Policy, can span several research categories.
p.000010:
p.000010: (1) Research on existing specimens is generally exempt if sources are publicly available or subjects cannot be
p.000010: identified.
p.000010:
p.000010: (2) Research on newly collected materials may be treated as survey research, but otherwise will not qualify for
p.000010: exemption per 22 CFR 225.101 (b) (2 or 3) if it includes invasive procedures, such as blood collection.
p.000010:
p.000010: (3) Research on existing standard of care diagnostic methods (e.g. comparing two techniques for diagnosing
p.000010: Chlamydia, both of which are commonly used in programs) may be treated as operations research.
p.000010:
p.000010: (4) Other diagnostic research, such as a new test versus an existing test, may be considered experimental
p.000010: biomedical research when the results of such testing will potentially lead to important treatment changes for the
p.000010: individual.
p.000010:
p.000010: (f) Education Research – Education research involving special subjects, such as children and mentally disabled
p.000010: individuals, is covered by the Policy. Much educational research is exempted under 22 CFR 225.101(b)(1), including
p.000010: research in educational settings involving normal educational practices.
p.000010:
p.000010: 7. Balancing Protection with Burden
p.000010:
p.000010: (a) Recognizing the importance and contribution of research to prevent much human mortality and morbidity,
p.000010: implementation of the Policy at USAID is intended to provide adequate protection of human research subjects, while
p.000010: avoiding imposition of undue burden on the research process and people. Common sense, practicality, and flexibility are
p.000010: essential, especially in areas other than experimental biomedical research (the original focus of development of the
p.000010: Policy) where there is no issue of causing appreciable physical harm. In the area of epidemiologic research, for
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
p.000010: for the informed consent procedure to consist simply of a legitimate statement that participation is voluntary and that
p.000010: information will be kept confidential. In circumstances where consent is required, but written consent is
...
Social / philosophical differences/differences of opinion
Searching for indicator philosophy:
(return to top)
p.000002:
p.000002: (a) Research – The Common Rule defines research as
p.000002: ".. a systematic investigation including research development, testing and evaluation designed to develop or contribute
p.000002: to generalizable knowledge."
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: Further, as described in the Belmont Report "...the term 'research' designates an activity designed to test a
p.000003: hypothesis, permit conclusions to be drawn, and thereby to develop or to contribute to generalizable knowledge.
p.000003: Research is usually described in a formal protocol that sets forth an
p.000003: objective and a set of procedures to reach that objective."
p.000003:
p.000003: Thus, a key aspect of research is that there be a systematic design in advance, generally utilizing a scientific
p.000003: approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide
p.000003: variety of activities, including the following:
p.000003:
p.000003: • Experiments,
p.000003: • Observational studies,
p.000003: • Surveys,
p.000003: • Tests, and
p.000003: • Recordings designed to contribute to generalizable knowledge.
p.000003:
p.000003: It generally does not include such operational activities as the following:
p.000003:
p.000003: • Medical care;
p.000003: • Quality assurance;
p.000003: • Quality improvement;
p.000003: • Certain aspects of public health practice, such as routine outbreak investigations and disease monitoring;
p.000003: • Program evaluation;
p.000003: • Fiscal or program audits;
p.000003: • Journalism;
p.000003: • History;
p.000003: • Biography;
p.000003: • Philosophy;
p.000003: • "Fact-finding" inquiries such as criminal, civil and congressional investigations,
p.000003: • Intelligence gathering; and
p.000003: • Simple data collection or data collection for other purposes.
p.000003:
p.000003: However, some of these activities may include or constitute research in the specific circumstance where there is clear
p.000003: advance intent to contribute to generalizable knowledge with a formal scientific protocol.
p.000003:
p.000003: (b) Human Subject – This means a living individual about whom an investigator obtains
p.000003:
p.000003: (1) data through intervention or interaction, or
p.000003:
p.000003: (2) identifiable private information.
p.000003:
p.000003: (c) Intervention – This includes physical procedures and manipulations of the subject or the subject’s environment
p.000003: for research purposes.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: (d) Interaction – This includes communication between the investigator and the subject.
p.000004:
p.000004: (e) Private information includes information about behavior in which an individual can reasonably expect that no
p.000004: observation is taking place, or information for specific purposes (such as a medical record) that individuals can
p.000004: reasonably expect will not be made public. Private information must also be readily individually identifiable (i.e.
p.000004: the subject's identity is or may be readily ascertained by the investigator or the subject's identity readily
p.000004: associated with the information.)
p.000004:
p.000004: Thus, simple observational studies of public behavior (including television and internet chat rooms) do not involve
p.000004: human subjects, as defined, because there is no intervention or interaction and the behavior is not private. Also,
...
General/Other / Other Country
Searching for indicator another country:
(return to top)
p.000006: provide some simple information to
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: respondents. Likewise, research on existing specimens might not record identifiers and thus be exempt, but researchers
p.000007: should still strive to protect individual privacy. The interest in promoting ethical behavior outside the common rule
p.000007: is not intended as a mandate for more structured procedures, but rather to advance a cultural norm of ethical behavior
p.000007: for research and non-research activities alike, to be exercised with discretion by institutions and individuals.
p.000007:
p.000007: 4. Application in Various Research Locations
p.000007:
p.000007: (a) Research in the U.S. – When research takes place in the U.S., it must conform to all aspects of the Policy.
p.000007: Recipient institutions may be of two categories:
p.000007:
p.000007: (1) Many have a “Federal-wide Assurance” of Compliance (FWA) issued and administered by the Department of Health
p.000007: and Human Services (DHHS) that applies to all Federally-funded research. Under the FWA, the implementation procedures
p.000007: and interpretations of the respective Federal funding agency govern its application.
p.000007:
p.000007: (2) If no FWA exists, the institution must provide an acceptable "assurance" to USAID describing how it will
p.000007: comply with the Policy (see section 8 below).
p.000007:
p.000007: (b) Research in Foreign Countries – There are generally three mechanisms by which USAID supports research in
p.000007: foreign countries:
p.000007:
p.000007: (1) The primary funding recipient is a U.S.-based institution, with the research carried out in another country.
p.000007: In this situation, the primary recipient is responsible for complying or assuring compliance in detail with the Policy
p.000007: as described above under either an FWA or USAID- approved assurance governing the research. USAID encourages, but does
p.000007: not require, the host-country collaborators of U.S.-based institutions to use an in-country IRB.
p.000007:
p.000007: (2) The recipient is a United Nations (U.N.) agency (e.g. the World Health Organization (WHO)) .
p.000007:
p.000007: (3) The primary recipient is a host country government or non-government institution.
p.000007:
p.000007: In the last two cases, there are three ways acceptable standards can be applied:
p.000007:
p.000007: (i) An FWA or a USAID-specific assurance as with U.S. institutions.
p.000007:
p.000007: (ii) Access to an appropriate USAID-accepted research system, such as through a WHO/ Council for International
p.000007: Organizations of Medical Science (CIOMS)-approved Ethical Committee (see section 4(a) below) either directly or through
p.000007: a collaborative arrangement.
p.000007:
p.000007: (iii) An alternative human subjects system can be employed if it can be determined (by the AA/GH or designee) to be
p.000007: “at least equivalent” to the Policy (as delineated in section 5 below).
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: 5. Determination that Alternative Protection Procedures are "at Least Equivalent" to the Policy
p.000008:
p.000008: (a) 22 CFR 225.101(h) describes the use of alternative protection of human subjects systems when research is
p.000008: conducted outside the U.S. It specifically cites the example of "...a foreign institution which complies with
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000010: essential, especially in areas other than experimental biomedical research (the original focus of development of the
p.000010: Policy) where there is no issue of causing appreciable physical harm. In the area of epidemiologic research, for
p.000010: example, informed consent may not be necessary nor practical and might pose a major impediment to conducting the
p.000010: research. 22 CFR 225.116 and 22 CFR 225.117 describe appropriate mechanisms for altering or waiving the informed
p.000010: consent procedure, which requires IRB approval. It might also well be reasonable in many instances of survey research
p.000010: for the informed consent procedure to consist simply of a legitimate statement that participation is voluntary and that
p.000010: information will be kept confidential. In circumstances where consent is required, but written consent is
p.000010: inappropriate in a given culture or population, verbal consent may be appropriate, but it must be witnessed and
p.000010: documented in writing.
p.000010:
p.000010: (b) Additional situations call for practicality. For example, where a series surveys or other similar research
p.000010: activities are highly standardized or systematized, review and approval of such research as a group or class by an IRB
p.000010: may be appropriate. Likewise, it may be reasonable to review and approve certain outbreak investigations as a class,
p.000010: in advance, because of the emergency nature of such research.
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: 8. Right of Access of USAID Officials to Records
p.000011:
p.000011: To implement and monitor human subjects research activities properly, it is essential that USAID reserve the right to
p.000011: speak with subjects and inspect any relevant records, and to prohibit research which presents unacceptable risks.
p.000011: Appropriate language to that effect must be included in contracts, grants, and other support documents, as well as in
p.000011: informed consent documents.
p.000011:
p.000011: 9. Compliance
p.000011:
p.000011: (a) All research activities involving human subjects that are funded by USAID must adhere to the procedures set
p.000011: forth in the Policy, or have a system that provides "at least equivalent" protection which has been approved by the
p.000011: AA/GH or designee. Compliance with USAID human subjects procedures is the primary responsibility of the organization
p.000011: receiving USAID support. To help ensure observance of USAID's human subjects procedures by such recipients,
p.000011: appropriate language must be included in funding documents, when appropriate.
p.000011:
p.000011: (b) Unless the research is conducted under an applicable Federal-wide Assurance (FWA) or qualifies as affording
p.000011: "at least equivalent" protection as described in section 5 above, the recipient must provide USAID with a satisfactory
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: research activities supported by USAID involve human subjects. Safeguarding the rights and welfare of human subjects
p.000002: involved in research supported by USAID is the primary responsibility of the organization to which support is awarded.
p.000002: No research involving human subjects may be undertaken unless the research is approved as outlined in the Policy. The
p.000002: Policy sets forth detailed guidance that allows for some latitude in adaptation of the Policy to the specific situation
p.000002: of each agency, including administrative procedures and interpretation.
p.000002:
p.000002: This document is a companion to the Policy. Its purpose is to describe how the Policy is implemented and interpreted
p.000002: by USAID. It is intended especially to help Cognizant Technical Officers (CTOs), Technical Advisors (TAs,) Mission
p.000002: staff, and USAID recipients to understand and apply the Policy when supporting or conducting research involving human
p.000002: subjects. CTOs, TAs and Mission staff are the first line of responsibility in assessing applicability of the Policy to
p.000002: a particular research project.
p.000002: For Bureaus/Missions with research activities covered by the Policy, they are responsible for reading the Policy and
p.000002: for ensuring that those organizations receiving USAID funds for research are adhering to requirements set forth in the
p.000002: Policy. USAID's Cognizant Human Subjects Officer (CHSO or successor) assists with guidance and interpretation of the
p.000002: Policy. The CHSO, located in USAID/Washington, is appointed by the Assistant Administrator Global Health (AA/GH).
p.000002: Ultimate Agency authority for decisions regarding human subjects' protection has been delegated to the CHSO.
p.000002:
p.000002: 2. Basic Principles of Human Research Subjects Protection
p.000002:
p.000002: (a) The 1979 report, of the President’s Commission for the Study of Ethical Programs in Medicine and Biomedical
p.000002: and Behavioral Research, or “Belmont Report”, laid out much of the ethical principles for the Common Rule. Human
p.000002: subjects’ considerations are essential to the design and implementation of research projects. USAID strongly supports
p.000002: vigorous efforts to protect human subjects as provided for by the Policy. Much of the Policy itself is primarily
p.000002: oriented towards experimental biomedical research, but some other types of research are included (see section 5 for
p.000002: application of the Policy to various other types of research, and for exemptions).
p.000002:
p.000002: (b) Human subjects research rests on three pillars of protection:
p.000002:
p.000002: (1) Review of the research by a properly constituted ethical committee or Institutional Review Board (IRB);
p.000002:
p.000002: (2) A meaningful assessment of risks and benefits by the IRB; and
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: (3) A meaningful informed consent procedure for research subjects.
p.000002:
p.000002: (c) Trust in the honest, conscientious judgment of the human beings who serve on IRBs is pivotal to the entire
...
p.000003: (c) Intervention – This includes physical procedures and manipulations of the subject or the subject’s environment
p.000003: for research purposes.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: (d) Interaction – This includes communication between the investigator and the subject.
p.000004:
p.000004: (e) Private information includes information about behavior in which an individual can reasonably expect that no
p.000004: observation is taking place, or information for specific purposes (such as a medical record) that individuals can
p.000004: reasonably expect will not be made public. Private information must also be readily individually identifiable (i.e.
p.000004: the subject's identity is or may be readily ascertained by the investigator or the subject's identity readily
p.000004: associated with the information.)
p.000004:
p.000004: Thus, simple observational studies of public behavior (including television and internet chat rooms) do not involve
p.000004: human subjects, as defined, because there is no intervention or interaction and the behavior is not private. Also,
p.000004: studies based on data otherwise collected for non-research purposes do not constitute human subjects research unless
p.000004: individual identity is readily identifiable. Examples include: programmatic data such as service statistics, school
p.000004: attendance data, crime statistics, election returns, vital statistics, and pathologic specimens collected for
p.000004: therapeutic purposes (where such information does not readily identify individuals.)
p.000004:
p.000004: (f) Exemptions – Certain research is exempt under the Policy. Ordinarily, institutions can make the
p.000004: determination that an activity is exempt, but the CHSO has final authority:
p.000004:
p.000004: (1) Survey and certain similar research – 22 CFR 225.101(b)(2). The Common Rule exempts survey and certain
p.000004: similar research, except in situations where each of two things occurs: first, the information would allow subjects to
p.000004: be identified (either directly or through identifiers linked to the subject), and second, "any disclosure of the human
p.000004: subject’s responses outside the research could reasonably place the subject at risk of criminal or civil liability or
p.000004: be damaging to the subjects' financial standing, employability or reputation." Thus, survey and similar research
p.000004: under formal human subjects protection is "covered" only when both privacy/confidentiality might be compromised through
p.000004: identification and the nature of the information disclosed is very sensitive. In determining whether there might be a
p.000004: reasonable risk of damage related to divulging the sensitive information, etc., it is not enough that there be merely
p.000004: some hypothetically possible risk that can be construed. Rather, the risks resulting from disclosure must be readily
p.000004: appreciable and significant.
p.000004:
p.000004: (2) Research involving the collection or study of existing data or specimens – 22 CFR 225.101(b)(4).
p.000004: "Existing" means existing at the time the research is conducted. "Existing" includes sources such as vital records
...
Orphaned Trigger Words
p.000002: Policy. USAID's Cognizant Human Subjects Officer (CHSO or successor) assists with guidance and interpretation of the
p.000002: Policy. The CHSO, located in USAID/Washington, is appointed by the Assistant Administrator Global Health (AA/GH).
p.000002: Ultimate Agency authority for decisions regarding human subjects' protection has been delegated to the CHSO.
p.000002:
p.000002: 2. Basic Principles of Human Research Subjects Protection
p.000002:
p.000002: (a) The 1979 report, of the President’s Commission for the Study of Ethical Programs in Medicine and Biomedical
p.000002: and Behavioral Research, or “Belmont Report”, laid out much of the ethical principles for the Common Rule. Human
p.000002: subjects’ considerations are essential to the design and implementation of research projects. USAID strongly supports
p.000002: vigorous efforts to protect human subjects as provided for by the Policy. Much of the Policy itself is primarily
p.000002: oriented towards experimental biomedical research, but some other types of research are included (see section 5 for
p.000002: application of the Policy to various other types of research, and for exemptions).
p.000002:
p.000002: (b) Human subjects research rests on three pillars of protection:
p.000002:
p.000002: (1) Review of the research by a properly constituted ethical committee or Institutional Review Board (IRB);
p.000002:
p.000002: (2) A meaningful assessment of risks and benefits by the IRB; and
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: (3) A meaningful informed consent procedure for research subjects.
p.000002:
p.000002: (c) Trust in the honest, conscientious judgment of the human beings who serve on IRBs is pivotal to the entire
p.000002: system of protection of research subjects. Indeed, the system recognizes that there is no simple formula to apply to
p.000002: ethical decisions, and instead it vests the major responsibility of ethical decision making with the IRB. IRB actions
p.000002: must be based on ethical principles (such as outlined in the Belmont Report.) IRB board members should fully recognize
p.000002: that ethical decisions involve a balance among such principles (such as respect for persons, beneficence, and justice)
p.000002: and the importance of the knowledge that may reasonably be expected to result from proposed research (the requirement
p.000002: for which is itself grounded in the principle of beneficence.)
p.000002:
p.000002: In order to carry out its mandate, institutions conducting research and IRBs are empowered with very wide discretion
p.000002: within the bounds of the Common Rule. Recognizing the wide range of situations under which research may occur, the IRB
p.000002: should strive, above all else, to do "the right thing" as it sees it. The regulation allows for considerable
p.000002: flexibility to serve that purpose. In the interest of promoting human subjects protection, it is important for
p.000002: institutions and IRBs to take a facilitative, collegial, and educational approach to investigators, rather than a
p.000002: burdensome adversarial one. The IRB should encourage investigators to embrace ethical behavior by acting to facilitate
p.000002: ethical research and it should not be seen as an obstacle to the conduct of research. To that end, institutions and
...
p.000003: • "Fact-finding" inquiries such as criminal, civil and congressional investigations,
p.000003: • Intelligence gathering; and
p.000003: • Simple data collection or data collection for other purposes.
p.000003:
p.000003: However, some of these activities may include or constitute research in the specific circumstance where there is clear
p.000003: advance intent to contribute to generalizable knowledge with a formal scientific protocol.
p.000003:
p.000003: (b) Human Subject – This means a living individual about whom an investigator obtains
p.000003:
p.000003: (1) data through intervention or interaction, or
p.000003:
p.000003: (2) identifiable private information.
p.000003:
p.000003: (c) Intervention – This includes physical procedures and manipulations of the subject or the subject’s environment
p.000003: for research purposes.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: (d) Interaction – This includes communication between the investigator and the subject.
p.000004:
p.000004: (e) Private information includes information about behavior in which an individual can reasonably expect that no
p.000004: observation is taking place, or information for specific purposes (such as a medical record) that individuals can
p.000004: reasonably expect will not be made public. Private information must also be readily individually identifiable (i.e.
p.000004: the subject's identity is or may be readily ascertained by the investigator or the subject's identity readily
p.000004: associated with the information.)
p.000004:
p.000004: Thus, simple observational studies of public behavior (including television and internet chat rooms) do not involve
p.000004: human subjects, as defined, because there is no intervention or interaction and the behavior is not private. Also,
p.000004: studies based on data otherwise collected for non-research purposes do not constitute human subjects research unless
p.000004: individual identity is readily identifiable. Examples include: programmatic data such as service statistics, school
p.000004: attendance data, crime statistics, election returns, vital statistics, and pathologic specimens collected for
p.000004: therapeutic purposes (where such information does not readily identify individuals.)
p.000004:
p.000004: (f) Exemptions – Certain research is exempt under the Policy. Ordinarily, institutions can make the
p.000004: determination that an activity is exempt, but the CHSO has final authority:
p.000004:
p.000004: (1) Survey and certain similar research – 22 CFR 225.101(b)(2). The Common Rule exempts survey and certain
p.000004: similar research, except in situations where each of two things occurs: first, the information would allow subjects to
p.000004: be identified (either directly or through identifiers linked to the subject), and second, "any disclosure of the human
p.000004: subject’s responses outside the research could reasonably place the subject at risk of criminal or civil liability or
p.000004: be damaging to the subjects' financial standing, employability or reputation." Thus, survey and similar research
p.000004: under formal human subjects protection is "covered" only when both privacy/confidentiality might be compromised through
p.000004: identification and the nature of the information disclosed is very sensitive. In determining whether there might be a
p.000004: reasonable risk of damage related to divulging the sensitive information, etc., it is not enough that there be merely
p.000004: some hypothetically possible risk that can be construed. Rather, the risks resulting from disclosure must be readily
p.000004: appreciable and significant.
p.000004:
p.000004: (2) Research involving the collection or study of existing data or specimens – 22 CFR 225.101(b)(4).
p.000004: "Existing" means existing at the time the research is conducted. "Existing" includes sources such as vital records
p.000004: routinely created on an ongoing basis without alteration, even though some may be created after the start of the
p.000004: research. This research is exempt if these sources are publicly available or if the information is recorded by the
p.000004: investigator in such a manner that subjects cannot be identified directly or through identifiers. Thus, the key point
p.000004: is how the data are recorded. The research would remain exempt if the investigator had access to identifiable
p.000004: information (such as medical records) but did not record identifiers. Moreover, consistent with the definition of
p.000004: human subject, identification needs to be readily ascertainable. Research would remain exempt, for example, if
p.000004: identity is linked only by legitimate encryption or other procedures that make it very difficult for investigators to
p.000004: identify individuals.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: (3) Public Benefit or Service Programs – 22 CFR 225. (101)(b)(5). This exemption to study, evaluate, or
p.000005: otherwise examine public service or benefit programs is broadly written. However, the exemption is generally
p.000005: interpreted to be limited to research on the process or outcomes of service delivery (e.g., programmatic research or
p.000005: operations research.)
p.000005:
p.000005: (g) Informed consent to promote communication and understanding – (22 CFR 225.116 and 117): Recognizing that
p.000005: communication is an imperfect human process, in the interest of better human subjects protection, it is important to
p.000005: recognize the informed consent process as a process of communication and not just a legal requirement. The consent
p.000005: form should not be confused with the informed consent process. In the interest of good communication, the process
p.000005: should promote: simple understandable language, emphasis on the required and most important information, and avoidance
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| another country | Other Country |
| authority | Relationship to Authority |
| children | Child |
| crime | Illegal Activity |
| criminal | criminal |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| ill | ill |
| job | Occupation |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| officer | Police Officer |
| philosophy | philosophical differences/differences of opinion |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| disabled | ['mentally'] |
| education | ['educational'] |
| educational | ['education'] |
| mentally | ['disabled'] |
Trigger Words
consent
cultural
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input