79C3C34C52B45572883A05D425EB0F82

16 CFR 1028

https://www.govinfo.gov/content/pkg/CFR-2012-title16-vol2/pdf/CFR-2012-title16-vol2-part1028.pdf

http://leaux.net/URLS/ConvertAPI Text Files/06D6D4565141D629DEC050B3823898DA.en.txt

Examining the file media/Synopses/06D6D4565141D629DEC050B3823898DA.html:

This file was generated: 2020-12-01 05:08:26

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

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

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	prisoners	4
Political	Indigenous	native	1
Political	criminal	criminal	1
Political	political affiliation	party	1
Political	stateless persons	nation	1
Political	vulnerable	vulnerable	3
Health	Cognitive Impairment	cognitive	2
Health	Drug Usage	drug	3
Health	Drug Usage	influence	2
Health	Mentally Disabled	disabled	3
Health	Mentally Disabled	mentally	3
Health	Motherhood/Family	family	1
Health	Pregnant	pregnant	4
Social	Child	children	4
Social	Fetus/Neonate	fetus	1
Social	Linguistic Proficiency	language	2
Social	Police Officer	officer	1
Social	Racial Minority	race	1
Social	Soldier	military	1
Social	Student	student	1
Social	Women	women	4
Social	Youth/Minors	minor	3
Social	education	education	1
Social	education	educational	2
Social	embryo	embryo	1
Social	employees	employees	3
Social	gender	gender	2
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	6
General/Other	declaration of helsinki	helsinki	1

Political / Criminal Convictions

Searching for indicator prisoners:

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p.000109: all of the provisions of this policy to specific re- search activities or classes of research activities
p.000109: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the
p.000109: de- partment or agency head shall forward advance notices of these actions to the Office for Human
p.000109: Research Protec- tions, Department of Health and Human Services (HHS), or any
p.000109: suc- cessor office, and shall also publish them in the FEDERAL REGISTER or in such other
p.000109: manner as provided in de- partment or agency procedures. 1
p.000109: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
p.000109: June 28, 1991, as amended at 70 FR 36328,
p.000109: June 23, 2005]
p.000109: state or local laws or regulations which
p.000109:
p.000109: may otherwise be applicable and which provide additional protections for human subjects.
p.000109: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable
p.000109: and which pro- vide additional protections to human subjects of research.
p.000109: (h) When research covered by this policy takes place in foreign countries,
p.000109: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000109: 45 CFR part 46, subparts A-D. Some of the other Departments and Agencies have incor- porated all
p.000109: provisions of title 45 CFR part 46 into their policies and procedures as well. However, the
p.000109: exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C. The
p.000109: exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or
p.000109: observation of public
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: Consumer Product Safety Commission § 1028.102
p.000110:
p.000110:
p.000110: § 1028.102 Definitions.
p.000110: (a) Department or agency head means the head of any federal department or agency and any other
p.000110: officer or em- ployee of any department or agency to whom authority has been delegated.
p.000110: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000110: agencies).
p.000110: (c) Legally authorized representative means an individual or judicial or other body
p.000110: authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000110: participa- tion in the procedure(s) involved in the research.
p.000110: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000110: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet
p.000110: this definition constitute re- search for purposes of this policy, whether or not they
p.000110: are conducted or supported under a program which is considered research for other purposes. For
p.000110: example, some demonstration and service programs may include research activities.
...

p.000112: June 28, 1991, as amended at 70 FR 36328,
p.000112: June 23, 2005]
p.000112:
p.000112: §§ 1028.104–1028.106 [Reserved]
p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...

p.000114: (1) Risks to subjects are minimized:
p.000114: (i) By using procedures which are consistent with sound research design and which do not
p.000114: unnecessarily expose subjects to risk, and
p.000114: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
...

Political / Indigenous

Searching for indicator native:

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p.000115: representative. No informed consent, whether oral or written, may include any exculpatory
p.000115: language through which the subject or the rep- resentative is made to waive or appear to waive any
p.000115: of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the
p.000115: insti- tution or its agents from liability for negligence.
p.000115: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000115: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000115: to each subject:
p.000115: (1) A statement that the study in- volves research, an explanation of the
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116: Consumer Product Safety Commission § 1028.116
p.000116:
p.000116:
p.000116: purposes of the research and the ex- pected duration of the subject’s partici- pation, a description
p.000116: of the procedures to be followed, and identification of any procedures which are
p.000116: experi- mental;
p.000116: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000116: (3) A description of any benefits to the subject or to others which may rea- sonably be expected
p.000116: from the research;
p.000116: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any,
p.000116: that might be advan- tageous to the subject;
p.000116: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000116: subject will be maintained;
p.000116: (6) For research involving more than minimal risk, an explanation as to whether any compensation
p.000116: and an ex- planation as to whether any medical treatments are available if injury oc- curs and,
p.000116: if so, what they consist of, or where further information may be ob- tained;
p.000116: (7) An explanation of whom to con- tact for answers to pertinent questions about the research
p.000116: and research sub- jects’ rights, and whom to contact in the event of a research-related
p.000116: injury to the subject; and
p.000116: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or
p.000116: loss of benefits to which the subject is otherwise entitled, and the subject may discontinue par-
p.000116: ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000116: (b) Additional elements of informed consent. When appropriate, one or more of the
p.000116: following elements of in- formation shall also be provided to each subject:
p.000116: (1) A statement that the particular treatment or procedure may involve risks to the subject
...

Political / criminal

Searching for indicator criminal:

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p.000108:
p.000108: icy, by an institutional review board (IRB) that operates in accordance with the pertinent
p.000108: requirements of this pol- icy.
p.000108: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000108: involvement of human subjects will be in one or more of the following categories are exempt
p.000108: from this policy:
p.000108: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000108: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000108: strategies, or (ii) research on the effectiveness of or the comparison among instructional
p.000108: techniques, cur- ricula, or classroom management methods.
p.000108: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000108: (i) Information obtained is recorded in such a manner that human subjects can be identified,
p.000108: directly or through identifiers linked to the subjects; and
p.000108: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000108: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial
p.000108: standing, employability, or reputation.
p.000108: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures, or obser- vation of public behavior that is not
p.000108: exempt under paragraph (b)(2) of this section, if:
p.000108: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000108: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally
p.000108: identifiable informa- tion will be maintained throughout the research and thereafter.
p.000108: (4) Research, involving the collection or study of existing data, documents, records, pathological
p.000108: specimens, or di- agnostic specimens, if these sources are publicly available or if the information is
p.000108: recorded by the investigator in such a manner that subjects cannot be iden- tified, directly or
p.000108: through identifiers linked to the subjects.
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: § 1028.101
p.000109: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000109: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000109: (i) Public benefit or service pro- grams;
p.000109: (ii) Procedures for obtaining benefits or services under those programs;
...

Political / political affiliation

Searching for indicator party:

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p.000113: in accordance with
p.000113: § 1028.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000113: 1028.116, be given
p.000113:
p.000113: 16 CFR Ch. II (1–1–12 Edition)
p.000113: to the subjects when in the IRB’s judg- ment the information would meaning- fully add to the protection
p.000113: of the rights and welfare of subjects.
p.000113: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in
p.000113: accordance with
p.000113: § 1028.117.
p.000113: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or
p.000113: disapprove the pro- posed research activity, or of modifica- tions required to secure IRB approval of
p.000113: the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its
p.000113: written notifica- tion a statement of the reasons for its decision and give the investigator an
p.000113: opportunity to respond in person or in writing.
p.000113: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000113: to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve
p.000113: or have a third party observe the consent process and the research.
p.000113: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000113: [56 FR 28012, 28019, June 18, 1991, as amended
p.000113: at 70 FR 36328, June 23, 2005]
p.000113:
p.000113: § 1028.110 Expedited review proce- dures for certain kinds of research involving no more than
p.000113: minimal risk, and for minor changes in ap- proved research.
p.000113: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a
p.000113: list of categories of research that may be reviewed by the IRB through an expedited review
p.000113: procedure. The list will be amended, as appropriate after consultation with other departments
p.000113: and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REG-
p.000113: ISTER. A copy of the list is available from the Office for Human Research Protections, HHS,
p.000113: or any successor of- fice.
p.000113: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000113: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to
p.000113: involve no more than mini- mal risk,
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Consumer Product Safety Commission § 1028.113
p.000114:
p.000114:
...

Political / stateless persons

Searching for indicator nation:

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p.000118: the adequacy of protection against these risks, the potential bene- fits of the research to
p.000118: the subjects and others, and the importance of the knowledge gained or to be gained.
p.000118: (b) On the basis of this evaluation, the department or agency head may approve or disapprove
p.000118: the application or proposal, or enter into negotiations to develop an approvable one.
p.000118: § 1028.121 [Reserved]
p.000118: § 1028.122 Use of Federal funds.
p.000118: Federal funds administered by a de- partment or agency may not be ex- pended for research
p.000118: involving human subjects unless the requirements of this policy have been satisfied.
p.000118: § 1028.123 Early termination of re- search support: Evaluation of appli- cations and proposals.
p.000118: (a) The department or agency head may require that department or agency support for any project be
p.000118: terminated or suspended in the manner prescribed
p.000118:
p.000118: in applicable program requirements, when the department or agency head finds an institution
p.000118: has materially failed to comply with the terms of this policy.
p.000118: (b) In making decisions about sup- porting or approving applications or proposals covered by
p.000118: this policy the de- partment or agency head may take into account, in addition to all
p.000118: other eligibility requirements and program criteria, factors such as whether the applicant has been
p.000118: subject to a termi- nation or suspension under paragarph
p.000118: (a) of this section and whether the ap- plicant or the person or persons who would direct or
p.000118: has have directed the scientific and technical aspects of an activity has have, in the
p.000118: judgment of the department or agency head, mate- rially failed to discharge responsibility for the
p.000118: protection of the rights and welfare of human subjects (whether or not the research was subject to
p.000118: federal regulation).
p.000118: § 1028.124 Conditions.
p.000118: With respect to any research project or any class of research projects the de- partment or agency
p.000118: head may impose additional conditions prior to or at the time of approval when in the judgment of the
p.000118: department or agency head addi- tional conditions are necessary for the protection of human subjects.
p.000118:
p.000118: PART 1030—EMPLOYEE STANDARDS OF CONDUCT
p.000118: Subpart A—General
p.000118: Sec.
p.000118: 1030.101 Cross-references to employee eth- ical conduct standards and financial dis- closure
p.000118: regulations.
p.000118: Subparts B–D [Reserved]
p.000118:
p.000118: AUTHORITY: 5 U.S.C. 552a, 7301; 15 U.S.C. 2053(c).
p.000118: SOURCE: 61 FR 65458, Dec. 13, 1996, unless
p.000118: otherwise noted.
...

Political / vulnerable

Searching for indicator vulnerable:

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p.000112: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000112: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
p.000112: June 28, 1991, as amended at 70 FR 36328,
p.000112: June 23, 2005]
p.000112:
p.000112: §§ 1028.104–1028.106 [Reserved]
p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
...

p.000114: following require- ments are satisfied:
p.000114: (1) Risks to subjects are minimized:
p.000114: (i) By using procedures which are consistent with sound research design and which do not
p.000114: unnecessarily expose subjects to risk, and
p.000114: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
...

Health / Cognitive Impairment

Searching for indicator cognitive:

(return to top)
p.000108: the federal govern- ment outside the United States.
p.000108: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not
p.000108: it is regulated as defined in § 1028.102(e), must comply with all sections of this policy.
p.000108: (2) Research that is neither con- ducted nor supported by a federal de- partment or
p.000108: agency but is subject to regulation as defined in § 1028.102(e) must be reviewed and
p.000108: approved, in compliance with §§ 1028.101, 1028.102, and 1028.107 through 1028.117 of this pol-
p.000108:
p.000108: icy, by an institutional review board (IRB) that operates in accordance with the pertinent
p.000108: requirements of this pol- icy.
p.000108: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000108: involvement of human subjects will be in one or more of the following categories are exempt
p.000108: from this policy:
p.000108: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000108: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000108: strategies, or (ii) research on the effectiveness of or the comparison among instructional
p.000108: techniques, cur- ricula, or classroom management methods.
p.000108: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000108: (i) Information obtained is recorded in such a manner that human subjects can be identified,
p.000108: directly or through identifiers linked to the subjects; and
p.000108: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000108: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial
p.000108: standing, employability, or reputation.
p.000108: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures, or obser- vation of public behavior that is not
p.000108: exempt under paragraph (b)(2) of this section, if:
p.000108: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000108: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally
p.000108: identifiable informa- tion will be maintained throughout the research and thereafter.
p.000108: (4) Research, involving the collection or study of existing data, documents, records, pathological
p.000108: specimens, or di- agnostic specimens, if these sources are publicly available or if the information is
p.000108: recorded by the investigator in such a manner that subjects cannot be iden- tified, directly or
p.000108: through identifiers linked to the subjects.
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: § 1028.101
p.000109: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000109: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000109: (i) Public benefit or service pro- grams;
p.000109: (ii) Procedures for obtaining benefits or services under those programs;
p.000109: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000109: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those
p.000109: programs.
p.000109: (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000108: identifiable informa- tion will be maintained throughout the research and thereafter.
p.000108: (4) Research, involving the collection or study of existing data, documents, records, pathological
p.000108: specimens, or di- agnostic specimens, if these sources are publicly available or if the information is
p.000108: recorded by the investigator in such a manner that subjects cannot be iden- tified, directly or
p.000108: through identifiers linked to the subjects.
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: § 1028.101
p.000109: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000109: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000109: (i) Public benefit or service pro- grams;
p.000109: (ii) Procedures for obtaining benefits or services under those programs;
p.000109: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000109: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those
p.000109: programs.
p.000109: (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without
p.000109: additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below
p.000109: the level and for a use found to be safe, or agricultural chemical or en- vironmental contaminant at
p.000109: or below the level found to be safe, by the Food and Drug Administration or approved by the
p.000109: Environmental Protection Agency or the Food Safety and Inspec- tion Service of the U.S. Department
p.000109: of Agriculture.
p.000109: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000109: covered by this policy.
p.000109: (d) Department or agency heads may require that specific research activities or classes of research
p.000109: activities con- ducted, supported, or otherwise subject to regulation by the department or agency
p.000109: but not otherwise covered by this policy, comply with some or all of the requirements of this
p.000109: policy.
p.000109: (e) Compliance with this policy re- quires compliance with pertinent fed- eral laws or regulations
p.000109: which provide additional protections for human sub- jects.
p.000109: (f) This policy does not affect any
p.000109:
p.000109: 16 CFR Ch. II (1–1–12 Edition)
p.000109: procedures normally followed in the foreign countries to protect human subjects may
p.000109: differ from those set forth in this policy. (An example is a foreign institution which
p.000109: complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of
p.000109: Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the
p.000109: protection of human research subjects is internationally recognized.) In these circumstances, if a
...

p.000110:
p.000110:
p.000110: § 1028.102 Definitions.
p.000110: (a) Department or agency head means the head of any federal department or agency and any other
p.000110: officer or em- ployee of any department or agency to whom authority has been delegated.
p.000110: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000110: agencies).
p.000110: (c) Legally authorized representative means an individual or judicial or other body
p.000110: authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000110: participa- tion in the procedure(s) involved in the research.
p.000110: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000110: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet
p.000110: this definition constitute re- search for purposes of this policy, whether or not they
p.000110: are conducted or supported under a program which is considered research for other purposes. For
p.000110: example, some demonstration and service programs may include research activities.
p.000110: (e) Research subject to regulation, and similar terms are intended to encom- pass those research
p.000110: activities for which a federal department or agency has specific responsibility for regulating as
p.000110: a research activity, (for example, In- vestigational New Drug requirements administered by the Food
p.000110: and Drug Ad- ministration). It does not include re- search activities which are inciden- tally
p.000110: regulated by a federal department or agency solely as part of the depart- ment’s or agency’s broader
p.000110: responsi- bility to regulate certain types of ac- tivities whether research or non-re- search in
p.000110: nature (for example, Wage and Hour requirements administered by the Department of Labor).
p.000110: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or
p.000110: student) con- ducting research obtains:
p.000110: (1) Data through intervention or interaction with the individual, or
p.000110:
p.000110: behavior, does not apply to research with children, subpart D, except for research in- volving
p.000110: observations of public behavior when the investigator(s) do not participate in the activities being observed.
p.000110:
p.000110: (2) Identifiable private information.
p.000110: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000110: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search
p.000110: purposes. Interaction includes communication or interpersonal con- tact between investigator and subject.
p.000110: ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000110: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion
...

Searching for indicator influence:

(return to top)
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
...

p.000115: §§ 1028.103(b)(4) and 1028.103(b)(5).
p.000115: (7) Statements of significant new findings provided to subjects, as re- quired by §
p.000115: 1028.116(b)(5).
p.000115: (b) The records required by this pol- icy shall be retained for at least 3 years, and
p.000115: records relating to research which is conducted shall be retained for at least 3 years after
p.000115: completion of the research. All records shall be acces- sible for inspection and copying by au- thorized
p.000115: representatives of the depart- ment or agency at reasonable times and in a reasonable manner.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000115: [56 FR 28012, 28019, June 18, 1991, as amended
p.000115: at 70 FR 36328, June 23, 2005]
p.000115:
p.000115: § 1028.116 General requirements for informed consent.
p.000115: Except as provided elsewhere in this policy, no investigator may involve a human being as a
p.000115: subject in research covered by this policy unless the inves- tigator has obtained the legally effec-
p.000115: tive informed consent of the subject or the subject’s legally authorized rep- resentative. An
p.000115: investigator shall seek such consent only under circumstances that provide the prospective subject or the
p.000115: representative sufficient oppor- tunity to consider whether or not to participate and that
p.000115: minimize the pos- sibility of coercion or undue influence. The information that is given to the
p.000115: subject or the representative shall be in language understandable to the sub- ject or the
p.000115: representative. No informed consent, whether oral or written, may include any exculpatory
p.000115: language through which the subject or the rep- resentative is made to waive or appear to waive any
p.000115: of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the
p.000115: insti- tution or its agents from liability for negligence.
p.000115: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000115: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000115: to each subject:
p.000115: (1) A statement that the study in- volves research, an explanation of the
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116: Consumer Product Safety Commission § 1028.116
p.000116:
p.000116:
p.000116: purposes of the research and the ex- pected duration of the subject’s partici- pation, a description
p.000116: of the procedures to be followed, and identification of any procedures which are
p.000116: experi- mental;
p.000116: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
...

Health / Mentally Disabled

Searching for indicator disabled:

(return to top)
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000113: project in which the member has a conflicting interest, except to provide information re-
p.000113: quested by the IRB.
p.000113: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to
...

p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000115: [56 FR 28012, 28019, June 18, 1991, as amended
p.000115: at 70 FR 36328, June 23, 2005]
p.000115: § 1028.114 Cooperative research.
...

Searching for indicator mentally:

(return to top)
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000113: project in which the member has a conflicting interest, except to provide information re-
p.000113: quested by the IRB.
p.000113: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to
...

p.000114: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
...

Health / Motherhood/Family

Searching for indicator family:

(return to top)
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000113: project in which the member has a conflicting interest, except to provide information re-
p.000113: quested by the IRB.
p.000113: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to
p.000113: assist in the review of issues which require expertise beyond or in addition to that available on
p.000113: the IRB. These individuals may not vote with the IRB.
p.000113: § 1028.108 IRB functions and oper- ations.
p.000113: In order to fulfill the requirements of this policy each IRB shall:
p.000113: (a) Follow written procedures in the same detail as described in
p.000113: § 1028.103(b)(4) and, to the extent re- quired by, § 1028.103(b)(5).
p.000113: (b) Except when an expedited review procedure is used (see § 1028.110), review proposed research at
p.000113: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000113: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000113: approved, it shall receive the approval of a ma- jority of those members present at the meeting.
p.000113: § 1028.109 IRB review of research.
p.000113: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000113: approval), or dis- approve all research activities covered by this policy.
...

Health / Pregnant

Searching for indicator pregnant:

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p.000112: June 23, 2005]
p.000112:
p.000112: §§ 1028.104–1028.106 [Reserved]
p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000113: project in which the member has a conflicting interest, except to provide information re-
p.000113: quested by the IRB.
...

p.000114: unnecessarily expose subjects to risk, and
p.000114: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
...

p.000116: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000116: subject will be maintained;
p.000116: (6) For research involving more than minimal risk, an explanation as to whether any compensation
p.000116: and an ex- planation as to whether any medical treatments are available if injury oc- curs and,
p.000116: if so, what they consist of, or where further information may be ob- tained;
p.000116: (7) An explanation of whom to con- tact for answers to pertinent questions about the research
p.000116: and research sub- jects’ rights, and whom to contact in the event of a research-related
p.000116: injury to the subject; and
p.000116: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or
p.000116: loss of benefits to which the subject is otherwise entitled, and the subject may discontinue par-
p.000116: ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000116: (b) Additional elements of informed consent. When appropriate, one or more of the
p.000116: following elements of in- formation shall also be provided to each subject:
p.000116: (1) A statement that the particular treatment or procedure may involve risks to the subject
p.000116: (or to the embryo or fetus, if the subject is or may be- come pregnant) which are
p.000116: currently unforeseeable;
p.000116: (2) Anticipated circumstances under which the subject’s participation may be terminated by
p.000116: the investigator without regard to the subject’s con- sent;
p.000116:
p.000116: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000116: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly
p.000116: termination of participation by the subject;
p.000116: (5) A statement that significant new findings developed during the course of the research which may
p.000116: relate to the subject’s willingness to continue par- ticipation will be provided to the sub- ject;
p.000116: and
p.000116: (6) The approximate number of sub- jects involved in the study.
p.000116: (c) An IRB may approve a consent procedure which does not include, or which alters, some or
p.000116: all of the ele- ments of informed consent set forth above, or waive the requirement to ob- tain
p.000116: informed consent provided the IRB finds and documents that:
p.000116: (1) The research or demonstration project is to be conducted by or subject to the approval of
p.000116: state or local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000116: (i) Public benefit of service programs;
p.000116: (ii) Procedures for obtaining benefits or services under those programs;
...

Searching for indicator children:

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p.000110: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet
p.000110: this definition constitute re- search for purposes of this policy, whether or not they
p.000110: are conducted or supported under a program which is considered research for other purposes. For
p.000110: example, some demonstration and service programs may include research activities.
p.000110: (e) Research subject to regulation, and similar terms are intended to encom- pass those research
p.000110: activities for which a federal department or agency has specific responsibility for regulating as
p.000110: a research activity, (for example, In- vestigational New Drug requirements administered by the Food
p.000110: and Drug Ad- ministration). It does not include re- search activities which are inciden- tally
p.000110: regulated by a federal department or agency solely as part of the depart- ment’s or agency’s broader
p.000110: responsi- bility to regulate certain types of ac- tivities whether research or non-re- search in
p.000110: nature (for example, Wage and Hour requirements administered by the Department of Labor).
p.000110: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or
p.000110: student) con- ducting research obtains:
p.000110: (1) Data through intervention or interaction with the individual, or
p.000110:
p.000110: behavior, does not apply to research with children, subpart D, except for research in- volving
p.000110: observations of public behavior when the investigator(s) do not participate in the activities being observed.
p.000110:
p.000110: (2) Identifiable private information.
p.000110: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000110: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search
p.000110: purposes. Interaction includes communication or interpersonal con- tact between investigator and subject.
p.000110: ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000110: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion
p.000110: which has been provided for spe- cific purposes by an individual and which the
p.000110: individual can reasonably expect will not be made public (for ex- ample, a medical record). Private
p.000110: infor- mation must be individually identifi- able (i.e., the identity of the subject is or may
p.000110: readily be ascertained by the investigator or associated with the in- formation) in order for
p.000110: obtaining the information to constitute research in- volving human subjects.
p.000110: (g) IRB means an institutional review board established in accord with and for the purposes expressed
p.000110: in this pol- icy.
p.000110: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000110: may be con- ducted at an institution within the constraints set forth by the IRB and by
p.000110: other institutional and federal require- ments.
...

p.000112: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
p.000112: June 28, 1991, as amended at 70 FR 36328,
p.000112: June 23, 2005]
p.000112:
p.000112: §§ 1028.104–1028.106 [Reserved]
p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...

p.000114: following require- ments are satisfied:
p.000114: (1) Risks to subjects are minimized:
p.000114: (i) By using procedures which are consistent with sound research design and which do not
p.000114: unnecessarily expose subjects to risk, and
p.000114: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
...

Searching for indicator fetus:

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p.000116: that might be advan- tageous to the subject;
p.000116: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000116: subject will be maintained;
p.000116: (6) For research involving more than minimal risk, an explanation as to whether any compensation
p.000116: and an ex- planation as to whether any medical treatments are available if injury oc- curs and,
p.000116: if so, what they consist of, or where further information may be ob- tained;
p.000116: (7) An explanation of whom to con- tact for answers to pertinent questions about the research
p.000116: and research sub- jects’ rights, and whom to contact in the event of a research-related
p.000116: injury to the subject; and
p.000116: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or
p.000116: loss of benefits to which the subject is otherwise entitled, and the subject may discontinue par-
p.000116: ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
p.000116: (b) Additional elements of informed consent. When appropriate, one or more of the
p.000116: following elements of in- formation shall also be provided to each subject:
p.000116: (1) A statement that the particular treatment or procedure may involve risks to the subject
p.000116: (or to the embryo or fetus, if the subject is or may be- come pregnant) which are
p.000116: currently unforeseeable;
p.000116: (2) Anticipated circumstances under which the subject’s participation may be terminated by
p.000116: the investigator without regard to the subject’s con- sent;
p.000116:
p.000116: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000116: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly
p.000116: termination of participation by the subject;
p.000116: (5) A statement that significant new findings developed during the course of the research which may
p.000116: relate to the subject’s willingness to continue par- ticipation will be provided to the sub- ject;
p.000116: and
p.000116: (6) The approximate number of sub- jects involved in the study.
p.000116: (c) An IRB may approve a consent procedure which does not include, or which alters, some or
p.000116: all of the ele- ments of informed consent set forth above, or waive the requirement to ob- tain
p.000116: informed consent provided the IRB finds and documents that:
p.000116: (1) The research or demonstration project is to be conducted by or subject to the approval of
p.000116: state or local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000116: (i) Public benefit of service programs;
...

Searching for indicator language:

(return to top)
p.000115: (b) The records required by this pol- icy shall be retained for at least 3 years, and
p.000115: records relating to research which is conducted shall be retained for at least 3 years after
p.000115: completion of the research. All records shall be acces- sible for inspection and copying by au- thorized
p.000115: representatives of the depart- ment or agency at reasonable times and in a reasonable manner.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000115: [56 FR 28012, 28019, June 18, 1991, as amended
p.000115: at 70 FR 36328, June 23, 2005]
p.000115:
p.000115: § 1028.116 General requirements for informed consent.
p.000115: Except as provided elsewhere in this policy, no investigator may involve a human being as a
p.000115: subject in research covered by this policy unless the inves- tigator has obtained the legally effec-
p.000115: tive informed consent of the subject or the subject’s legally authorized rep- resentative. An
p.000115: investigator shall seek such consent only under circumstances that provide the prospective subject or the
p.000115: representative sufficient oppor- tunity to consider whether or not to participate and that
p.000115: minimize the pos- sibility of coercion or undue influence. The information that is given to the
p.000115: subject or the representative shall be in language understandable to the sub- ject or the
p.000115: representative. No informed consent, whether oral or written, may include any exculpatory
p.000115: language through which the subject or the rep- resentative is made to waive or appear to waive any
p.000115: of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the
p.000115: insti- tution or its agents from liability for negligence.
p.000115: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000115: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000115: to each subject:
p.000115: (1) A statement that the study in- volves research, an explanation of the
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116: Consumer Product Safety Commission § 1028.116
p.000116:
p.000116:
p.000116: purposes of the research and the ex- pected duration of the subject’s partici- pation, a description
p.000116: of the procedures to be followed, and identification of any procedures which are
p.000116: experi- mental;
p.000116: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000116: (3) A description of any benefits to the subject or to others which may rea- sonably be expected
p.000116: from the research;
p.000116: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any,
p.000116: that might be advan- tageous to the subject;
p.000116: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000116: subject will be maintained;
...

Searching for indicator officer:

(return to top)
p.000109: manner as provided in de- partment or agency procedures. 1
p.000109: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
p.000109: June 28, 1991, as amended at 70 FR 36328,
p.000109: June 23, 2005]
p.000109: state or local laws or regulations which
p.000109:
p.000109: may otherwise be applicable and which provide additional protections for human subjects.
p.000109: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable
p.000109: and which pro- vide additional protections to human subjects of research.
p.000109: (h) When research covered by this policy takes place in foreign countries,
p.000109: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000109: 45 CFR part 46, subparts A-D. Some of the other Departments and Agencies have incor- porated all
p.000109: provisions of title 45 CFR part 46 into their policies and procedures as well. However, the
p.000109: exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C. The
p.000109: exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or
p.000109: observation of public
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: Consumer Product Safety Commission § 1028.102
p.000110:
p.000110:
p.000110: § 1028.102 Definitions.
p.000110: (a) Department or agency head means the head of any federal department or agency and any other
p.000110: officer or em- ployee of any department or agency to whom authority has been delegated.
p.000110: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000110: agencies).
p.000110: (c) Legally authorized representative means an individual or judicial or other body
p.000110: authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000110: participa- tion in the procedure(s) involved in the research.
p.000110: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000110: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet
p.000110: this definition constitute re- search for purposes of this policy, whether or not they
p.000110: are conducted or supported under a program which is considered research for other purposes. For
p.000110: example, some demonstration and service programs may include research activities.
p.000110: (e) Research subject to regulation, and similar terms are intended to encom- pass those research
p.000110: activities for which a federal department or agency has specific responsibility for regulating as
p.000110: a research activity, (for example, In- vestigational New Drug requirements administered by the Food
p.000110: and Drug Ad- ministration). It does not include re- search activities which are inciden- tally
...

Searching for indicator race:

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p.000112: by § 1028.103 of this Policy has been reviewed and ap- proved by the IRB. Such certification must
p.000112: be submitted with the application or proposal or by such later date as may be prescribed by
p.000112: the department or agency to which the application or proposal is submitted. Under no condi- tion shall
p.000112: research covered by § 1028.103 of the Policy be supported prior to re- ceipt of the certification
p.000112: that the re- search has been reviewed and approved by the IRB. Institutions without an ap-
p.000112:
p.000112: proved assurance covering the research shall certify within 30 days after re- ceipt of a request
p.000112: for such a certifi- cation from the department or agency, that the application or proposal has
p.000112: been approved by the IRB. If the cer- tification is not submitted within these time limits, the
p.000112: application or proposal may be returned to the institution.
p.000112: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000112: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
p.000112: June 28, 1991, as amended at 70 FR 36328,
p.000112: June 23, 2005]
p.000112:
p.000112: §§ 1028.104–1028.106 [Reserved]
p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
...

Searching for indicator military:

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p.000108: 1028.113 Suspension or termination of IRB approval of research.
p.000108: 1028.114 Cooperative research.
p.000108: 1028.115 IRB records.
p.000108: 1028.116 General requirements for informed consent.
p.000108: 1028.117 Documentation of informed con- sent.
p.000108: 1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000108: 1028.119 Research undertaken without the intention of involving human subjects.
p.000108: 1028.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000108: supported by a Federal De- partment or Agency.
p.000108: 1028.121 [Reserved]
p.000108: 1028.122 Use of Federal funds.
p.000108: 1028.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000108: 1028.124 Conditions.
p.000108: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000108: SOURCE: 56 FR 28012, 28019, June 18, 1991,
p.000108: unless otherwise noted.
p.000108:
p.000108: § 1028.101 To what does this policy apply?
p.000108: (a) Except as provided in paragraph
p.000108: (b) of this section, this policy applies to all research involving human sub- jects conducted,
p.000108: supported or otherwise subject to regulation by any federal de- partment or agency which takes appro-
p.000108: priate administrative action to make the policy applicable to such research. This includes research
p.000108: conducted by federal civilian employees or military personnel, except that each department or agency
p.000108: head may adopt such proce- dural modifications as may be appro- priate from an administrative
p.000108: stand- point. It also includes research con- ducted, supported, or otherwise subject to regulation by
p.000108: the federal govern- ment outside the United States.
p.000108: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not
p.000108: it is regulated as defined in § 1028.102(e), must comply with all sections of this policy.
p.000108: (2) Research that is neither con- ducted nor supported by a federal de- partment or
p.000108: agency but is subject to regulation as defined in § 1028.102(e) must be reviewed and
p.000108: approved, in compliance with §§ 1028.101, 1028.102, and 1028.107 through 1028.117 of this pol-
p.000108:
p.000108: icy, by an institutional review board (IRB) that operates in accordance with the pertinent
p.000108: requirements of this pol- icy.
p.000108: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000108: involvement of human subjects will be in one or more of the following categories are exempt
p.000108: from this policy:
p.000108: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000108: educational practices, such as (i) research on reg- ular and special education instruc- tional
...

Searching for indicator student:

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p.000110: participa- tion in the procedure(s) involved in the research.
p.000110: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000110: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet
p.000110: this definition constitute re- search for purposes of this policy, whether or not they
p.000110: are conducted or supported under a program which is considered research for other purposes. For
p.000110: example, some demonstration and service programs may include research activities.
p.000110: (e) Research subject to regulation, and similar terms are intended to encom- pass those research
p.000110: activities for which a federal department or agency has specific responsibility for regulating as
p.000110: a research activity, (for example, In- vestigational New Drug requirements administered by the Food
p.000110: and Drug Ad- ministration). It does not include re- search activities which are inciden- tally
p.000110: regulated by a federal department or agency solely as part of the depart- ment’s or agency’s broader
p.000110: responsi- bility to regulate certain types of ac- tivities whether research or non-re- search in
p.000110: nature (for example, Wage and Hour requirements administered by the Department of Labor).
p.000110: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or
p.000110: student) con- ducting research obtains:
p.000110: (1) Data through intervention or interaction with the individual, or
p.000110:
p.000110: behavior, does not apply to research with children, subpart D, except for research in- volving
p.000110: observations of public behavior when the investigator(s) do not participate in the activities being observed.
p.000110:
p.000110: (2) Identifiable private information.
p.000110: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000110: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search
p.000110: purposes. Interaction includes communication or interpersonal con- tact between investigator and subject.
p.000110: ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000110: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion
p.000110: which has been provided for spe- cific purposes by an individual and which the
p.000110: individual can reasonably expect will not be made public (for ex- ample, a medical record). Private
p.000110: infor- mation must be individually identifi- able (i.e., the identity of the subject is or may
p.000110: readily be ascertained by the investigator or associated with the in- formation) in order for
p.000110: obtaining the information to constitute research in- volving human subjects.
p.000110: (g) IRB means an institutional review board established in accord with and for the purposes expressed
p.000110: in this pol- icy.
...

Searching for indicator women:

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p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000113: project in which the member has a conflicting interest, except to provide information re-
p.000113: quested by the IRB.
p.000113: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to
p.000113: assist in the review of issues which require expertise beyond or in addition to that available on
p.000113: the IRB. These individuals may not vote with the IRB.
p.000113: § 1028.108 IRB functions and oper- ations.
p.000113: In order to fulfill the requirements of this policy each IRB shall:
p.000113: (a) Follow written procedures in the same detail as described in
...

p.000114: unnecessarily expose subjects to risk, and
p.000114: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000114: or treat- ment purposes.
p.000114: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
p.000114: and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and
p.000114: benefits, the IRB should consider only those risks and benefits that may result from the
p.000114: research (as distin- guished from risks and benefits of therapies subjects would receive even
p.000114: if not participating in the research). The IRB should not consider possible long- range effects of
p.000114: applying knowledge gained in the research (for example,
p.000114:
p.000114: the possible effects of the research on public policy) as among those research risks that fall within
p.000114: the purview of its responsibility.
p.000114: (3) Selection of subjects is equitable. In making this assessment the IRB should take into
p.000114: account the purposes of the research and the setting in which the research will be
p.000114: conducted and should be particularly cognizant of the special problems of research in- volving
p.000114: vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
p.000114: economi- cally or educationally disadvantaged persons.
p.000114: (4) Informed consent will be sought from each prospective subject or the subject’s legally
p.000114: authorized representa- tive, in accordance with, and to the ex- tent required by § 1028.116.
p.000114: (5) Informed consent will be appro- priately documented, in accordance with, and to the
p.000114: extent required by
p.000114: § 1028.117.
p.000114: (6) When appropriate, the research plan makes adequate provision for monitoring the
p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
...

Searching for indicator minor:

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p.000108: first accrued, the agency may not collect by salary offset unless facts material to the Govern-
p.000108: ment’s right to collect were not known and could not reasonably have been known by the official or
p.000108: officials who were charged with the responsibility for discovery and collection of such debts.
p.000108: (b) [Reserved]
p.000108: § 1027.11 Non-waiver of rights.
p.000108: An employee’s involuntary payment of all or any part of a debt collected under these
p.000108: regulations will not be construed as a waiver of any rights that the employee may have
p.000108: under 5
p.000108: U.S.C. 5514 or any other provision of law.
p.000108:
p.000108: § 1027.12 Interest, penalties, and ad- ministrative costs.
p.000108: Charges may be assessed on a debt for interest, penalties, and administra- tive costs in accordance
p.000108: with 31 U.S.C. 3717 and the Federal Claims Collection Standards, 4 CFR 101.1 et seq.
p.000108:
p.000108: PART 1028—PROTECTION OF HUMAN SUBJECTS
p.000108: Sec.
p.000108: 1028.101 To what does this policy apply? 1028.102 Definitions.
p.000108: 1028.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department
p.000108: or Agency.
p.000108: 1028.104–1028.106 [Reserved]
p.000108: 1028.107 IRB membership.
p.000108: 1028.108 IRB functions and operations. 1028.109 IRB review of research.
p.000108: 1028.110 Expedited review procedures for certain kinds of research involving no more than
p.000108: minimal risk, and for minor changes in approved research.
p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Consumer Product Safety Commission § 1028.101
p.000108:
p.000108:
p.000108: 1028.111 Criteria for IRB approval of re- search.
p.000108: 1028.112 Review by institution.
p.000108: 1028.113 Suspension or termination of IRB approval of research.
p.000108: 1028.114 Cooperative research.
p.000108: 1028.115 IRB records.
p.000108: 1028.116 General requirements for informed consent.
p.000108: 1028.117 Documentation of informed con- sent.
p.000108: 1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000108: 1028.119 Research undertaken without the intention of involving human subjects.
p.000108: 1028.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000108: supported by a Federal De- partment or Agency.
p.000108: 1028.121 [Reserved]
p.000108: 1028.122 Use of Federal funds.
p.000108: 1028.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000108: 1028.124 Conditions.
p.000108: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000108: SOURCE: 56 FR 28012, 28019, June 18, 1991,
p.000108: unless otherwise noted.
p.000108:
p.000108: § 1028.101 To what does this policy apply?
p.000108: (a) Except as provided in paragraph
p.000108: (b) of this section, this policy applies to all research involving human sub- jects conducted,
...

p.000113: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in
p.000113: accordance with
p.000113: § 1028.117.
p.000113: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or
p.000113: disapprove the pro- posed research activity, or of modifica- tions required to secure IRB approval of
p.000113: the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its
p.000113: written notifica- tion a statement of the reasons for its decision and give the investigator an
p.000113: opportunity to respond in person or in writing.
p.000113: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000113: to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve
p.000113: or have a third party observe the consent process and the research.
p.000113: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000113: [56 FR 28012, 28019, June 18, 1991, as amended
p.000113: at 70 FR 36328, June 23, 2005]
p.000113:
p.000113: § 1028.110 Expedited review proce- dures for certain kinds of research involving no more than
p.000113: minimal risk, and for minor changes in ap- proved research.
p.000113: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a
p.000113: list of categories of research that may be reviewed by the IRB through an expedited review
p.000113: procedure. The list will be amended, as appropriate after consultation with other departments
p.000113: and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REG-
p.000113: ISTER. A copy of the list is available from the Office for Human Research Protections, HHS,
p.000113: or any successor of- fice.
p.000113: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000113: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to
p.000113: involve no more than mini- mal risk,
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Consumer Product Safety Commission § 1028.113
p.000114:
p.000114:
p.000114: (2) Minor changes in previously ap- proved research during the period (of one year or less) for
p.000114: which approval is authorized.
p.000114: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one
p.000114: or more ex- perienced reviewers designated by the chairperson from among members of the IRB. In
p.000114: reviewing the research, the reviewers may exercise all of the au- thorities of the IRB except that
p.000114: the re- viewers may not disapprove the re- search. A research activity may be dis- approved
p.000114: only after review in accord- ance with the non-expedited procedure set forth in § 1028.108(b).
p.000114: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members
p.000114: advised of re- search proposals which have been ap- proved under the procedure.
p.000114: (d) The department or agency head may restrict, suspend, terminate, or choose not to
p.000114: authorize an institu- tion’s or IRB’s use of the expedited re- view procedure.
p.000114: [56 FR 28012, 28019, June 18, 1991, as amended
p.000114: at 70 FR 36328, June 23, 2005]
p.000114:
p.000114: § 1028.111 Criteria for IRB approval of research.
p.000114: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000114: following require- ments are satisfied:
p.000114: (1) Risks to subjects are minimized:
p.000114: (i) By using procedures which are consistent with sound research design and which do not
p.000114: unnecessarily expose subjects to risk, and
...

Searching for indicator education:

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p.000108: head may adopt such proce- dural modifications as may be appro- priate from an administrative
p.000108: stand- point. It also includes research con- ducted, supported, or otherwise subject to regulation by
p.000108: the federal govern- ment outside the United States.
p.000108: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not
p.000108: it is regulated as defined in § 1028.102(e), must comply with all sections of this policy.
p.000108: (2) Research that is neither con- ducted nor supported by a federal de- partment or
p.000108: agency but is subject to regulation as defined in § 1028.102(e) must be reviewed and
p.000108: approved, in compliance with §§ 1028.101, 1028.102, and 1028.107 through 1028.117 of this pol-
p.000108:
p.000108: icy, by an institutional review board (IRB) that operates in accordance with the pertinent
p.000108: requirements of this pol- icy.
p.000108: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000108: involvement of human subjects will be in one or more of the following categories are exempt
p.000108: from this policy:
p.000108: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000108: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000108: strategies, or (ii) research on the effectiveness of or the comparison among instructional
p.000108: techniques, cur- ricula, or classroom management methods.
p.000108: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000108: (i) Information obtained is recorded in such a manner that human subjects can be identified,
p.000108: directly or through identifiers linked to the subjects; and
p.000108: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000108: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial
p.000108: standing, employability, or reputation.
p.000108: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures, or obser- vation of public behavior that is not
p.000108: exempt under paragraph (b)(2) of this section, if:
p.000108: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000108: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally
p.000108: identifiable informa- tion will be maintained throughout the research and thereafter.
...

Searching for indicator educational:

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p.000108: priate administrative action to make the policy applicable to such research. This includes research
p.000108: conducted by federal civilian employees or military personnel, except that each department or agency
p.000108: head may adopt such proce- dural modifications as may be appro- priate from an administrative
p.000108: stand- point. It also includes research con- ducted, supported, or otherwise subject to regulation by
p.000108: the federal govern- ment outside the United States.
p.000108: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not
p.000108: it is regulated as defined in § 1028.102(e), must comply with all sections of this policy.
p.000108: (2) Research that is neither con- ducted nor supported by a federal de- partment or
p.000108: agency but is subject to regulation as defined in § 1028.102(e) must be reviewed and
p.000108: approved, in compliance with §§ 1028.101, 1028.102, and 1028.107 through 1028.117 of this pol-
p.000108:
p.000108: icy, by an institutional review board (IRB) that operates in accordance with the pertinent
p.000108: requirements of this pol- icy.
p.000108: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000108: involvement of human subjects will be in one or more of the following categories are exempt
p.000108: from this policy:
p.000108: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000108: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000108: strategies, or (ii) research on the effectiveness of or the comparison among instructional
p.000108: techniques, cur- ricula, or classroom management methods.
p.000108: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000108: (i) Information obtained is recorded in such a manner that human subjects can be identified,
p.000108: directly or through identifiers linked to the subjects; and
p.000108: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000108: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial
p.000108: standing, employability, or reputation.
p.000108: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement),
p.000108: survey proce- dures, interview procedures, or obser- vation of public behavior that is not
p.000108: exempt under paragraph (b)(2) of this section, if:
p.000108: (i) The human subjects are elected or appointed public officials or candidates for public office; or
...

Searching for indicator embryo:

Searching for indicator employees:

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p.000108: 1028.112 Review by institution.
p.000108: 1028.113 Suspension or termination of IRB approval of research.
p.000108: 1028.114 Cooperative research.
p.000108: 1028.115 IRB records.
p.000108: 1028.116 General requirements for informed consent.
p.000108: 1028.117 Documentation of informed con- sent.
p.000108: 1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000108: 1028.119 Research undertaken without the intention of involving human subjects.
p.000108: 1028.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000108: supported by a Federal De- partment or Agency.
p.000108: 1028.121 [Reserved]
p.000108: 1028.122 Use of Federal funds.
p.000108: 1028.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000108: 1028.124 Conditions.
p.000108: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000108: SOURCE: 56 FR 28012, 28019, June 18, 1991,
p.000108: unless otherwise noted.
p.000108:
p.000108: § 1028.101 To what does this policy apply?
p.000108: (a) Except as provided in paragraph
p.000108: (b) of this section, this policy applies to all research involving human sub- jects conducted,
p.000108: supported or otherwise subject to regulation by any federal de- partment or agency which takes appro-
p.000108: priate administrative action to make the policy applicable to such research. This includes research
p.000108: conducted by federal civilian employees or military personnel, except that each department or agency
p.000108: head may adopt such proce- dural modifications as may be appro- priate from an administrative
p.000108: stand- point. It also includes research con- ducted, supported, or otherwise subject to regulation by
p.000108: the federal govern- ment outside the United States.
p.000108: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not
p.000108: it is regulated as defined in § 1028.102(e), must comply with all sections of this policy.
p.000108: (2) Research that is neither con- ducted nor supported by a federal de- partment or
p.000108: agency but is subject to regulation as defined in § 1028.102(e) must be reviewed and
p.000108: approved, in compliance with §§ 1028.101, 1028.102, and 1028.107 through 1028.117 of this pol-
p.000108:
p.000108: icy, by an institutional review board (IRB) that operates in accordance with the pertinent
p.000108: requirements of this pol- icy.
p.000108: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000108: involvement of human subjects will be in one or more of the following categories are exempt
p.000108: from this policy:
p.000108: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000108: educational practices, such as (i) research on reg- ular and special education instruc- tional
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p.000111: material changes have occurred since previous IRB review; and
p.000111: (iii) For ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000111: ensuring that such changes in approved research, during the period for which IRB ap- proval
p.000111: has already been given, may not be initiated without IRB review and approval except when
p.000111: necessary to eliminate apparent immediate hazards to the subject.
p.000111: (5) Written procedures for ensuring prompt reporting to the IRB, appro- priate institutional
p.000111: officials, and the department or agency head of (i) any unanticipated problems involving risks to
p.000111: subjects or others or any serious or continuing noncompliance with this
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p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112: Consumer Product Safety Commission § 1028.107
p.000112:
p.000112:
p.000112: policy or the requirements or deter- minations of the IRB and (ii) any sus- pension or
p.000112: termination of IRB ap- proval.
p.000112: (c) The assurance shall be executed by an individual authorized to act for the institution and to
p.000112: assume on behalf of the institution the obligations im- posed by this policy and shall be filed in
p.000112: such form and manner as the depart- ment or agency head prescribes.
p.000112: (d) The department or agency head will evaluate all assurances submitted in accordance with this
p.000112: policy through such officers and employees of the de- partment or agency and such experts or
p.000112: consultants engaged for this purpose as the department or agency head de- termines to be appropriate. The
p.000112: depart- ment or agency head’s evaluation will take into consideration the adequacy of the proposed IRB
p.000112: in light of the an- ticipated scope of the institution’s re- search activities and the types of sub-
p.000112: ject populations likely to be involved, the appropriateness of the proposed ini- tial and continuing
p.000112: review procedures in light of the probable risks, and the size and complexity of the institution.
p.000112: (e) On the basis of this evaluation, the department or agency head may approve or disapprove
p.000112: the assurance, or enter into negotiations to develop an approvable one. The department or
p.000112: agency head may limit the period dur- ing which any particular approved as- surance or class of approved
p.000112: assurances shall remain effective or otherwise condition or restrict approval.
p.000112: (f) Certification is required when the research is supported by a federal de- partment or agency
p.000112: and not otherwise exempted or waived under § 1028.101 (b) or (i). An institution with an approved
p.000112: assurance shall certify that each appli- cation or proposal for research covered by the assurance and
p.000112: by § 1028.103 of this Policy has been reviewed and ap- proved by the IRB. Such certification must
p.000112: be submitted with the application or proposal or by such later date as may be prescribed by
p.000112: the department or agency to which the application or proposal is submitted. Under no condi- tion shall
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p.000117: applications need not be reviewed by an IRB before an award may be made. However, except for re-
p.000117: search exempted or waived under
p.000117: § 1028.101 (b) or (i), no human subjects may be involved in any project sup- ported by these
p.000117: awards until the project has been reviewed and approved by the IRB, as provided in this policy,
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p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Consumer Product Safety Commission Pt. 1030
p.000118:
p.000118:
p.000118: and certification submitted, by the in- stitution, to the department or agency.
p.000118: § 1028.119 Research undertaken with- out the intention of involving human subjects.
p.000118: In the event research is undertaken without the intention of involving human subjects,
p.000118: but it is later pro- posed to involve human subjects in the research, the research shall first be
p.000118: re- viewed and approved by an IRB, as pro- vided in this policy, a certification sub- mitted, by the
p.000118: institution, to the de- partment or agency, and final approval given to the proposed change by the
p.000118: de- partment or agency.
p.000118: § 1028.120 Evaluation and disposition of applications and proposals for research to be conducted or
p.000118: sup- ported by a Federal Department or Agency.
p.000118: (a) The department or agency head will evaluate all applications and pro- posals involving human
p.000118: subjects sub- mitted to the department or agency through such officers and employees of the
p.000118: department or agency and such ex- perts and consultants as the depart- ment or agency head
p.000118: determines to be appropriate. This evaluation will take into consideration the risks to the sub- jects,
p.000118: the adequacy of protection against these risks, the potential bene- fits of the research to
p.000118: the subjects and others, and the importance of the knowledge gained or to be gained.
p.000118: (b) On the basis of this evaluation, the department or agency head may approve or disapprove
p.000118: the application or proposal, or enter into negotiations to develop an approvable one.
p.000118: § 1028.121 [Reserved]
p.000118: § 1028.122 Use of Federal funds.
p.000118: Federal funds administered by a de- partment or agency may not be ex- pended for research
p.000118: involving human subjects unless the requirements of this policy have been satisfied.
p.000118: § 1028.123 Early termination of re- search support: Evaluation of appli- cations and proposals.
p.000118: (a) The department or agency head may require that department or agency support for any project be
p.000118: terminated or suspended in the manner prescribed
p.000118:
p.000118: in applicable program requirements, when the department or agency head finds an institution
p.000118: has materially failed to comply with the terms of this policy.
p.000118: (b) In making decisions about sup- porting or approving applications or proposals covered by
p.000118: this policy the de- partment or agency head may take into account, in addition to all
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Searching for indicator gender:

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p.000112: be submitted with the application or proposal or by such later date as may be prescribed by
p.000112: the department or agency to which the application or proposal is submitted. Under no condi- tion shall
p.000112: research covered by § 1028.103 of the Policy be supported prior to re- ceipt of the certification
p.000112: that the re- search has been reviewed and approved by the IRB. Institutions without an ap-
p.000112:
p.000112: proved assurance covering the research shall certify within 30 days after re- ceipt of a request
p.000112: for such a certifi- cation from the department or agency, that the application or proposal has
p.000112: been approved by the IRB. If the cer- tification is not submitted within these time limits, the
p.000112: application or proposal may be returned to the institution.
p.000112: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000112: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
p.000112: June 28, 1991, as amended at 70 FR 36328,
p.000112: June 23, 2005]
p.000112:
p.000112: §§ 1028.104–1028.106 [Reserved]
p.000112: § 1028.107 IRB membership.
p.000112: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000112: review of research activities commonly con- ducted by the institution. The IRB shall be
p.000112: sufficiently qualified through the experience and expertise of its members, and the
p.000112: diversity of the members, including consideration of race, gender, and cultural backgrounds and
p.000112: sensitivity to such issues as com- munity attitudes, to promote respect for its advice and
p.000112: counsel in safe- guarding the rights and welfare of human subjects. In addition to
p.000112: pos- sessing the professional competence necessary to review specific research activities, the IRB
p.000112: shall be able to as- certain the acceptability of proposed research in terms of institutional com-
p.000112: mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB
p.000112: shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research
p.000112: that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or
p.000112: handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or
p.000112: more individuals who are knowledgeable about and experi- enced in working with these subjects.
p.000112: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of
p.000112: men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes,
p.000112: so long as no selection is made to the IRB on the basis of gender. No
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p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 1028.108
p.000113: IRB may consist entirely of members of one profession.
p.000113: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas
p.000113: and at least one member whose primary concerns are in nonscientific areas.
p.000113: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the
p.000113: institution and who is not part of the immediate family of a person who is affiliated with the
p.000113: insti- tution.
p.000113: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000113: project in which the member has a conflicting interest, except to provide information re-
p.000113: quested by the IRB.
p.000113: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to
p.000113: assist in the review of issues which require expertise beyond or in addition to that available on
p.000113: the IRB. These individuals may not vote with the IRB.
p.000113: § 1028.108 IRB functions and oper- ations.
p.000113: In order to fulfill the requirements of this policy each IRB shall:
p.000113: (a) Follow written procedures in the same detail as described in
p.000113: § 1028.103(b)(4) and, to the extent re- quired by, § 1028.103(b)(5).
p.000113: (b) Except when an expedited review procedure is used (see § 1028.110), review proposed research at
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General/Other / Public Emergency

Searching for indicator emergency:

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p.000116: all of the ele- ments of informed consent set forth in this section, or waive the requirements to
p.000116: obtain informed consent provided the IRB finds and documents that:
p.000116: (1) The research involves no more than minimal risk to the subjects;
p.000116: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000116: (3) The research could not prac- ticably be carried out without the waiver or
p.000116: alteration; and
p.000116: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information
p.000116: after participa- tion.
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p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: § 1028.117
p.000117: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000117: applicable federal, state, or local laws which require addi- tional information to be disclosed
p.000117: in order for informed consent to be le- gally effective.
p.000117: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency
p.000117: medical care, to the extent the physician is permitted to do so under applicable federal, state, or
p.000117: local law.
p.000117: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000117: [56 FR 28012, 28019, June 18, 1991, as amended
p.000117: at 70 FR 36328, June 23, 2005]
p.000117:
p.000117: § 1028.117 Documentation of informed consent.
p.000117: (a) Except as provided in paragraph
p.000117: (c) of this section, informed consent shall be documented by the use of a written consent
p.000117: form approved by the IRB and signed by the subject or the subject’s legally authorized representa-
p.000117: tive. A copy shall be given to the per- son signing the form.
p.000117: (b) Except as provided in paragraph
p.000117: (c) of this section, the consent form may be either of the following:
p.000117: (1) A written consent document that embodies the elements of informed consent required by
p.000117: § 1028.116. This form may be read to the subject or the subject’s legally authorized representa- tive,
p.000117: but in any event, the investigator shall give either the subject or the rep- resentative adequate
p.000117: opportunity to read it before it is signed; or
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General/Other / Relationship to Authority

Searching for indicator authority:

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p.000108: or Agency.
p.000108: 1028.104–1028.106 [Reserved]
p.000108: 1028.107 IRB membership.
p.000108: 1028.108 IRB functions and operations. 1028.109 IRB review of research.
p.000108: 1028.110 Expedited review procedures for certain kinds of research involving no more than
p.000108: minimal risk, and for minor changes in approved research.
p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Consumer Product Safety Commission § 1028.101
p.000108:
p.000108:
p.000108: 1028.111 Criteria for IRB approval of re- search.
p.000108: 1028.112 Review by institution.
p.000108: 1028.113 Suspension or termination of IRB approval of research.
p.000108: 1028.114 Cooperative research.
p.000108: 1028.115 IRB records.
p.000108: 1028.116 General requirements for informed consent.
p.000108: 1028.117 Documentation of informed con- sent.
p.000108: 1028.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000108: 1028.119 Research undertaken without the intention of involving human subjects.
p.000108: 1028.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000108: supported by a Federal De- partment or Agency.
p.000108: 1028.121 [Reserved]
p.000108: 1028.122 Use of Federal funds.
p.000108: 1028.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000108: 1028.124 Conditions.
p.000108: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000108: SOURCE: 56 FR 28012, 28019, June 18, 1991,
p.000108: unless otherwise noted.
p.000108:
p.000108: § 1028.101 To what does this policy apply?
p.000108: (a) Except as provided in paragraph
p.000108: (b) of this section, this policy applies to all research involving human sub- jects conducted,
p.000108: supported or otherwise subject to regulation by any federal de- partment or agency which takes appro-
p.000108: priate administrative action to make the policy applicable to such research. This includes research
p.000108: conducted by federal civilian employees or military personnel, except that each department or agency
p.000108: head may adopt such proce- dural modifications as may be appro- priate from an administrative
p.000108: stand- point. It also includes research con- ducted, supported, or otherwise subject to regulation by
p.000108: the federal govern- ment outside the United States.
p.000108: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not
p.000108: it is regulated as defined in § 1028.102(e), must comply with all sections of this policy.
p.000108: (2) Research that is neither con- ducted nor supported by a federal de- partment or
p.000108: agency but is subject to regulation as defined in § 1028.102(e) must be reviewed and
p.000108: approved, in compliance with §§ 1028.101, 1028.102, and 1028.107 through 1028.117 of this pol-
p.000108:
...

p.000109: June 28, 1991, as amended at 70 FR 36328,
p.000109: June 23, 2005]
p.000109: state or local laws or regulations which
p.000109:
p.000109: may otherwise be applicable and which provide additional protections for human subjects.
p.000109: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable
p.000109: and which pro- vide additional protections to human subjects of research.
p.000109: (h) When research covered by this policy takes place in foreign countries,
p.000109: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000109: 45 CFR part 46, subparts A-D. Some of the other Departments and Agencies have incor- porated all
p.000109: provisions of title 45 CFR part 46 into their policies and procedures as well. However, the
p.000109: exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C. The
p.000109: exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or
p.000109: observation of public
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: Consumer Product Safety Commission § 1028.102
p.000110:
p.000110:
p.000110: § 1028.102 Definitions.
p.000110: (a) Department or agency head means the head of any federal department or agency and any other
p.000110: officer or em- ployee of any department or agency to whom authority has been delegated.
p.000110: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000110: agencies).
p.000110: (c) Legally authorized representative means an individual or judicial or other body
p.000110: authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s
p.000110: participa- tion in the procedure(s) involved in the research.
p.000110: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000110: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet
p.000110: this definition constitute re- search for purposes of this policy, whether or not they
p.000110: are conducted or supported under a program which is considered research for other purposes. For
p.000110: example, some demonstration and service programs may include research activities.
p.000110: (e) Research subject to regulation, and similar terms are intended to encom- pass those research
p.000110: activities for which a federal department or agency has specific responsibility for regulating as
p.000110: a research activity, (for example, In- vestigational New Drug requirements administered by the Food
p.000110: and Drug Ad- ministration). It does not include re- search activities which are inciden- tally
p.000110: regulated by a federal department or agency solely as part of the depart- ment’s or agency’s broader
...

p.000113: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is
p.000113: in accordance with
p.000113: § 1028.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000113: 1028.116, be given
p.000113:
p.000113: 16 CFR Ch. II (1–1–12 Edition)
p.000113: to the subjects when in the IRB’s judg- ment the information would meaning- fully add to the protection
p.000113: of the rights and welfare of subjects.
p.000113: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in
p.000113: accordance with
p.000113: § 1028.117.
p.000113: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or
p.000113: disapprove the pro- posed research activity, or of modifica- tions required to secure IRB approval of
p.000113: the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its
p.000113: written notifica- tion a statement of the reasons for its decision and give the investigator an
p.000113: opportunity to respond in person or in writing.
p.000113: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000113: to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve
p.000113: or have a third party observe the consent process and the research.
p.000113: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000113: [56 FR 28012, 28019, June 18, 1991, as amended
p.000113: at 70 FR 36328, June 23, 2005]
p.000113:
p.000113: § 1028.110 Expedited review proce- dures for certain kinds of research involving no more than
p.000113: minimal risk, and for minor changes in ap- proved research.
p.000113: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a
p.000113: list of categories of research that may be reviewed by the IRB through an expedited review
p.000113: procedure. The list will be amended, as appropriate after consultation with other departments
p.000113: and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REG-
p.000113: ISTER. A copy of the list is available from the Office for Human Research Protections, HHS,
p.000113: or any successor of- fice.
p.000113: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000113: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to
p.000113: involve no more than mini- mal risk,
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
...

p.000114: data collected to en- sure the safety of subjects.
p.000114: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to
p.000114: maintain the con- fidentiality of data.
p.000114: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
p.000114: such as children, prisoners, pregnant women, mentally disabled persons, or economically or
p.000114: educationally disadvantaged persons, additional safeguards have been in- cluded in the study
p.000114: to protect the rights and welfare of these subjects.
p.000114: § 1028.112 Review by institution.
p.000114: Research covered by this policy that has been approved by an IRB may be subject to further
p.000114: appropriate review and approval or disapproval by officials of the institution. However, those offi- cials
p.000114: may not approve the research if it has not been approved by an IRB.
p.000114:
p.000114: § 1028.113 Suspension or termination of IRB approval of research.
p.000114: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted
p.000114: in accord- ance with the IRB’s requirements or
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000115: [56 FR 28012, 28019, June 18, 1991, as amended
p.000115: at 70 FR 36328, June 23, 2005]
p.000115: § 1028.114 Cooperative research.
p.000115: Cooperative research projects are those projects covered by this policy which involve more
p.000115: than one institu- tion. In the conduct of cooperative re- search projects, each institution is re-
p.000115: sponsible for safeguarding the rights and welfare of human subjects and for complying with this
p.000115: policy. With the approval of the department or agency head, an institution participating in a cooperative
p.000115: project may enter into a joint review arrangement, rely upon the review of another qualified
p.000115: IRB, or make similar arrangements for avoid- ing duplication of effort.
p.000115: § 1028.115 IRB records.
p.000115: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
...

p.000116: alteration.
p.000116: (d) An IRB may approve a consent procedure which does not include, or which alters, some or
p.000116: all of the ele- ments of informed consent set forth in this section, or waive the requirements to
p.000116: obtain informed consent provided the IRB finds and documents that:
p.000116: (1) The research involves no more than minimal risk to the subjects;
p.000116: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000116: (3) The research could not prac- ticably be carried out without the waiver or
p.000116: alteration; and
p.000116: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information
p.000116: after participa- tion.
p.000117: 117
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: § 1028.117
p.000117: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000117: applicable federal, state, or local laws which require addi- tional information to be disclosed
p.000117: in order for informed consent to be le- gally effective.
p.000117: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency
p.000117: medical care, to the extent the physician is permitted to do so under applicable federal, state, or
p.000117: local law.
p.000117: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000117: [56 FR 28012, 28019, June 18, 1991, as amended
p.000117: at 70 FR 36328, June 23, 2005]
p.000117:
p.000117: § 1028.117 Documentation of informed consent.
p.000117: (a) Except as provided in paragraph
p.000117: (c) of this section, informed consent shall be documented by the use of a written consent
p.000117: form approved by the IRB and signed by the subject or the subject’s legally authorized representa-
p.000117: tive. A copy shall be given to the per- son signing the form.
p.000117: (b) Except as provided in paragraph
p.000117: (c) of this section, the consent form may be either of the following:
p.000117: (1) A written consent document that embodies the elements of informed consent required by
p.000117: § 1028.116. This form may be read to the subject or the subject’s legally authorized representa- tive,
p.000117: but in any event, the investigator shall give either the subject or the rep- resentative adequate
p.000117: opportunity to read it before it is signed; or
...

p.000118: this policy the de- partment or agency head may take into account, in addition to all
p.000118: other eligibility requirements and program criteria, factors such as whether the applicant has been
p.000118: subject to a termi- nation or suspension under paragarph
p.000118: (a) of this section and whether the ap- plicant or the person or persons who would direct or
p.000118: has have directed the scientific and technical aspects of an activity has have, in the
p.000118: judgment of the department or agency head, mate- rially failed to discharge responsibility for the
p.000118: protection of the rights and welfare of human subjects (whether or not the research was subject to
p.000118: federal regulation).
p.000118: § 1028.124 Conditions.
p.000118: With respect to any research project or any class of research projects the de- partment or agency
p.000118: head may impose additional conditions prior to or at the time of approval when in the judgment of the
p.000118: department or agency head addi- tional conditions are necessary for the protection of human subjects.
p.000118:
p.000118: PART 1030—EMPLOYEE STANDARDS OF CONDUCT
p.000118: Subpart A—General
p.000118: Sec.
p.000118: 1030.101 Cross-references to employee eth- ical conduct standards and financial dis- closure
p.000118: regulations.
p.000118: Subparts B–D [Reserved]
p.000118:
p.000118: AUTHORITY: 5 U.S.C. 552a, 7301; 15 U.S.C. 2053(c).
p.000118: SOURCE: 61 FR 65458, Dec. 13, 1996, unless
p.000118: otherwise noted.
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

(return to top)
p.000109: the level and for a use found to be safe, or agricultural chemical or en- vironmental contaminant at
p.000109: or below the level found to be safe, by the Food and Drug Administration or approved by the
p.000109: Environmental Protection Agency or the Food Safety and Inspec- tion Service of the U.S. Department
p.000109: of Agriculture.
p.000109: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000109: covered by this policy.
p.000109: (d) Department or agency heads may require that specific research activities or classes of research
p.000109: activities con- ducted, supported, or otherwise subject to regulation by the department or agency
p.000109: but not otherwise covered by this policy, comply with some or all of the requirements of this
p.000109: policy.
p.000109: (e) Compliance with this policy re- quires compliance with pertinent fed- eral laws or regulations
p.000109: which provide additional protections for human sub- jects.
p.000109: (f) This policy does not affect any
p.000109:
p.000109: 16 CFR Ch. II (1–1–12 Edition)
p.000109: procedures normally followed in the foreign countries to protect human subjects may
p.000109: differ from those set forth in this policy. (An example is a foreign institution which
p.000109: complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of
p.000109: Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the
p.000109: protection of human research subjects is internationally recognized.) In these circumstances, if a
p.000109: department or agency head determines that the proce- dures prescribed by the institution af- ford
p.000109: protections that are at least equivalent to those provided in this policy, the department
p.000109: or agency head may approve the substitution of the foreign procedures in lieu of the proce- dural
p.000109: requirements provided in this policy. Except when otherwise required by statute, Executive Order, or
p.000109: the de- partment or agency head, notices of these actions as they occur will be pub- lished in the
p.000109: FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures.
p.000109: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or
p.000109: all of the provisions of this policy to specific re- search activities or classes of research activities
p.000109: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the
p.000109: de- partment or agency head shall forward advance notices of these actions to the Office for Human
p.000109: Research Protec- tions, Department of Health and Human Services (HHS), or any
p.000109: suc- cessor office, and shall also publish them in the FEDERAL REGISTER or in such other
p.000109: manner as provided in de- partment or agency procedures. 1
p.000109: [56 FR 28012, 28019, June 18, 1991; 56 FR 29756,
...

Orphaned Trigger Words

p.000110: observations of public behavior when the investigator(s) do not participate in the activities being observed.
p.000110:
p.000110: (2) Identifiable private information.
p.000110: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000110: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search
p.000110: purposes. Interaction includes communication or interpersonal con- tact between investigator and subject.
p.000110: ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000110: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion
p.000110: which has been provided for spe- cific purposes by an individual and which the
p.000110: individual can reasonably expect will not be made public (for ex- ample, a medical record). Private
p.000110: infor- mation must be individually identifi- able (i.e., the identity of the subject is or may
p.000110: readily be ascertained by the investigator or associated with the in- formation) in order for
p.000110: obtaining the information to constitute research in- volving human subjects.
p.000110: (g) IRB means an institutional review board established in accord with and for the purposes expressed
p.000110: in this pol- icy.
p.000110: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000110: may be con- ducted at an institution within the constraints set forth by the IRB and by
p.000110: other institutional and federal require- ments.
p.000110: (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000110: research are not greater in and of themselves than those ordinarily encountered in daily life or
p.000110: during the performance of rou- tine physical or psychological exami- nations or tests.
p.000110: (j) Certification means the official no- tification by the institution to the sup- porting department or
p.000110: agency, in ac- cordance with the requirements of this policy, that a research project or activ- ity
p.000110: involving human subjects has been reviewed and approved by an IRB in ac- cordance with an approved
p.000110: assurance.
p.000111: 111
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: § 1028.103
p.000111:
p.000111: § 1028.103 Assuring compliance with this policy—research conducted or supported by any Federal Depart-
p.000111: ment or Agency.
p.000111: (a) Each institution engaged in re- search which is covered by this policy and which is conducted
p.000111: or supported by a Federal department or agency shall provide written assurance satisfactory to the
p.000111: department or agency head that it will comply with the requirements set forth in this policy.
p.000111: In lieu of re- quiring submission of an assurance, in- dividual department or agency heads shall
p.000111: accept the existence of a current assurance, appropriate for the research in question, on file with the
p.000111: Office for Human Research Protections, HHS, or any successor office, and approved for federalwide use by
p.000111: that office. When the existence of an HHS-approved as- surance is accepted in lieu of requiring
p.000111: submission of an assurance, reports (except certification) required by this policy to be made
p.000111: to department and agency heads shall also be made to the Office for Human Research Protec-
p.000111: tions, HHS, or any successor office.
p.000111: (b) Departments and agencies will conduct or support research covered by this policy only if the
p.000111: institution has an assurance approved as provided in this section, and only if the institution has
p.000111: certified to the department or agency head that the research has been reviewed and approved by an
p.000111: IRB pro- vided for in the assurance, and will be subject to continuing review by the IRB.
p.000111: Assurances applicable to federally supported or conducted research shall at a minimum include:
p.000111: (1) A statement of principles gov- erning the institution in the discharge of its
p.000111: responsibilities for protecting the rights and welfare of human subjects of research conducted at or
p.000111: sponsored by the institution, regardless of whether the research is subject to federal regu- lation.
p.000111: This may include an appro- priate existing code, declaration, or statement of ethical
p.000111: principles, or a statement formulated by the institu- tion itself. This requirement does not
p.000111: preempt provisions of this policy appli- cable to department- or agency-sup- ported or regulated
p.000111: research and need not be applicable to any research ex- empted or waived under § 1028.101 (b) or
p.000111: (i).
p.000111:
p.000111: 16 CFR Ch. II (1–1–12 Edition)
p.000111: (2) Designation of one or more IRBs established in accordance with the re- quirements of this
p.000111: policy, and for which provisions are made for meeting space and sufficient staff to support the
p.000111: IRB’s review and recordkeeping du- ties.
p.000111: (3) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications
p.000111: of experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s
p.000111: chief anticipated contributions to IRB deliberations; and any employ- ment or other
p.000111: relationship between each member and the institution; for example: full-time employee, part-time
p.000111: employee, member of governing panel or board, stockholder, paid or unpaid consultant. Changes in
p.000111: IRB member- ship shall be reported to the depart- ment or agency head, unless in accord with §
p.000111: 1028.103(a) of this policy, the ex- istence of an HHS-approved assurance is accepted. In this case,
p.000111: change in IRB membership shall be reported to the Office for Human Research Protec- tions,
p.000111: HHS, or any successor office.
p.000111: (4) Written procedures which the IRB will follow:
p.000111: (i) For conducting its initial and con- tinuing review of research and for re- porting its findings and
p.000111: actions to the investigator and the institution;
p.000111: (ii) For determining which projects require review more often than annu- ally and which
p.000111: projects need verification from sources other than the investigators that no
p.000111: material changes have occurred since previous IRB review; and
p.000111: (iii) For ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000111: ensuring that such changes in approved research, during the period for which IRB ap- proval
p.000111: has already been given, may not be initiated without IRB review and approval except when ...

p.000115:
p.000115:
p.000115: § 1028.114
p.000115: that has been associated with unex- pected serious harm to subjects. Any suspension or
p.000115: termination of approval shall include a statement of the rea- sons for the IRB’s action and shall
p.000115: be reported promptly to the investigator, appropriate institutional officials, and the department or agency
p.000115: head.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000115: [56 FR 28012, 28019, June 18, 1991, as amended
p.000115: at 70 FR 36328, June 23, 2005]
p.000115: § 1028.114 Cooperative research.
p.000115: Cooperative research projects are those projects covered by this policy which involve more
p.000115: than one institu- tion. In the conduct of cooperative re- search projects, each institution is re-
p.000115: sponsible for safeguarding the rights and welfare of human subjects and for complying with this
p.000115: policy. With the approval of the department or agency head, an institution participating in a cooperative
p.000115: project may enter into a joint review arrangement, rely upon the review of another qualified
p.000115: IRB, or make similar arrangements for avoid- ing duplication of effort.
p.000115: § 1028.115 IRB records.
p.000115: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000115: documentation of IRB activities, including the following:
p.000115: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany
p.000115: the proposals, ap- proved sample consent documents, progress reports submitted by inves-
p.000115: tigators, and reports of injuries to sub- jects.
p.000115: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the
p.000115: meetings; actions taken by the IRB; the vote on these ac- tions including the number of members
p.000115: voting for, against, and abstaining; the basis for requiring changes in or dis- approving research;
p.000115: and a written sum- mary of the discussion of controverted issues and their resolution.
p.000115: (3) Records of continuing review ac- tivities.
p.000115: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000115: (5) A list of IRB members in the same detail as described is § 1028.103(b)(3).
p.000115:
p.000115: 16 CFR Ch. II (1–1–12 Edition)
p.000115: (6) Written procedures for the IRB in the same detail as described in
p.000115: §§ 1028.103(b)(4) and 1028.103(b)(5).
p.000115: (7) Statements of significant new findings provided to subjects, as re- quired by §
p.000115: 1028.116(b)(5).
p.000115: (b) The records required by this pol- icy shall be retained for at least 3 years, and
p.000115: records relating to research which is conducted shall be retained for at least 3 years after
p.000115: completion of the research. All records shall be acces- sible for inspection and copying by au- thorized
p.000115: representatives of the depart- ment or agency at reasonable times and in a reasonable manner.
p.000115: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000115: [56 FR 28012, 28019, June 18, 1991, as amended
p.000115: at 70 FR 36328, June 23, 2005]
p.000115: ...

p.000117: medical care, to the extent the physician is permitted to do so under applicable federal, state, or
p.000117: local law.
p.000117: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000117: [56 FR 28012, 28019, June 18, 1991, as amended
p.000117: at 70 FR 36328, June 23, 2005]
p.000117:
p.000117: § 1028.117 Documentation of informed consent.
p.000117: (a) Except as provided in paragraph
p.000117: (c) of this section, informed consent shall be documented by the use of a written consent
p.000117: form approved by the IRB and signed by the subject or the subject’s legally authorized representa-
p.000117: tive. A copy shall be given to the per- son signing the form.
p.000117: (b) Except as provided in paragraph
p.000117: (c) of this section, the consent form may be either of the following:
p.000117: (1) A written consent document that embodies the elements of informed consent required by
p.000117: § 1028.116. This form may be read to the subject or the subject’s legally authorized representa- tive,
p.000117: but in any event, the investigator shall give either the subject or the rep- resentative adequate
p.000117: opportunity to read it before it is signed; or
p.000117: (2) A short form written consent doc- ument stating that the elements of in- formed consent required
p.000117: by § 1028.116 have been presented orally to the sub- ject or the subject’s legally authorized
p.000117: representative. When this method is used, there shall be a witness to the oral
p.000117: presentation. Also, the IRB shall approve a written summary of what is to be said to the
p.000117: subject or the rep- resentative. Only the short form itself is to be signed by the subject or
p.000117: the representative. However, the witness shall sign both the short form and a copy of the
p.000117: summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of
p.000117: the summary shall be given to the subject
p.000117:
p.000117: 16 CFR Ch. II (1–1–12 Edition)
p.000117: or the representative, in addition to a copy of the short form.
p.000117: (c) An IRB may waive the require- ment for the investigator to obtain a signed consent form
p.000117: for some or all subjects if it finds either:
p.000117: (1) That the only record linking the subject and the research would be the consent document and
p.000117: the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will
p.000117: be asked whether the sub- ject wants documentation linking the subject with the research, and the
p.000117: sub- ject’s wishes will govern; or
p.000117: (2) That the research presents no more than minimal risk of harm to subjects and involves
p.000117: no procedures for which written consent is normally re- quired outside of the research context. In cases
p.000117: in which the documentation requirement is waived, the IRB may re- quire the investigator to provide
p.000117: sub- jects with a written statement regard-
p.000117: ing the research.
p.000117: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000117: [56 FR 28012, 28019, June 18, 1991, as amended
p.000117: at 70 FR 36328, June 23, 2005]
p.000117:
p.000117: § 1028.118 Applications and proposals lacking definite plans for involve- ment of human subjects.
p.000117: Certain types of applications for grants, cooperative agreements, or con- tracts are submitted
p.000117: to departments or agencies with the knowledge that sub- jects may be involved within the period of
p.000117: support, but definite plans would not normally be set forth in the applica- tion or proposal. These
p.000117: include activi- ties such as institutional type grants when selection of specific projects is the
p.000117: institution’s responsibility; re- search training grants in which the ac- tivities involving
p.000117: subjects remain to be selected; and projects in which human subjects’ involvement will depend upon
p.000117: completion of instruments, prior ani- mal studies, or purification of com- pounds. These
p.000117: applications need not be reviewed by an IRB before an award may be made. However, except for re-
p.000117: search exempted or waived under
p.000117: § 1028.101 (b) or (i), no human subjects may be involved in any project sup- ported by these
p.000117: awards until the project has been reviewed and approved by the IRB, as provided in this policy,
p.000118: 118 ...

Appendix

Indicator List

Indicator	Vulnerability
authority	Relationship to Authority
children	Child
cognitive	Cognitive Impairment
criminal	criminal
disabled	Mentally Disabled
drug	Drug Usage
education	education
educational	education
embryo	embryo
emergency	Public Emergency
employees	employees
family	Motherhood/Family
fetus	Fetus/Neonate
gender	gender
helsinki	declaration of helsinki
influence	Drug Usage
language	Linguistic Proficiency
mentally	Mentally Disabled
military	Soldier
minor	Youth/Minors
nation	stateless persons
native	Indigenous
officer	Police Officer
party	political affiliation
pregnant	Pregnant
prisoners	Criminal Convictions
race	Racial Minority
student	Student
vulnerable	vulnerable
women	Women

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
disabled	['mentally']
drug	['influence']
education	['educational']
educational	['education']
influence	['drug']
mentally	['disabled']

Trigger Words

capacity

coercion

consent

cultural

harm

protect

protection

risk

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	prisoners	4
Political	Indigenous	native	1
Political	criminal	criminal	1
Political	political affiliation	party	1
Political	stateless persons	nation	1
Political	vulnerable	vulnerable	3
Health	Cognitive Impairment	cognitive	2
Health	Drug Usage	drug	3
Health	Drug Usage	influence	2
Health	Mentally Disabled	disabled	3
Health	Mentally Disabled	mentally	3
Health	Motherhood/Family	family	1
Health	Pregnant	pregnant	4
Social	Child	children	4
Social	Fetus/Neonate	fetus	1
Social	Linguistic Proficiency	language	2
Social	Police Officer	officer	1
Social	Racial Minority	race	1
Social	Soldier	military	1
Social	Student	student	1
Social	Women	women	4
Social	Youth/Minors	minor	3
Social	education	education	1
Social	education	educational	2
Social	embryo	embryo	1
Social	employees	employees	3
Social	gender	gender	2
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	6
General/Other	declaration of helsinki	helsinki	1

16 CFR 1028

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Criminal Convictions

Political / Indigenous

Political / criminal

Political / political affiliation

Political / stateless persons

Political / vulnerable

Health / Cognitive Impairment

Health / Drug Usage

Health / Mentally Disabled

Health / Motherhood/Family

Health / Pregnant

Social / Child

Social / Fetus/Neonate

Social / Linguistic Proficiency

Social / Police Officer

Social / Racial Minority

Social / Soldier

Social / Student

Social / Women

Social / Youth/Minors

Social / education

Social / embryo

Social / employees

Social / gender

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / declaration of helsinki

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input