79C3C34C52B45572883A05D425EB0F82
32 CFR 219
https://www.govinfo.gov/content/pkg/CFR-2013-title32-vol2/pdf/CFR-2013-title32-vol2-part219.pdf
http://leaux.net/URLS/ConvertAPI Text Files/03E15AD6A2237F47049FC577B76864D2.en.txt
Examining the file media/Synopses/03E15AD6A2237F47049FC577B76864D2.html:
This file was generated: 2020-12-01 05:10:30
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000443: agencies).
p.000443: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000443: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000443: procedure(s) involved in the research.
p.000443: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000443: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000443: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000443: or supported under a program which is considered research for other purposes. For example, some
p.000443: demonstration and service programs may include research activities.
p.000443: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000443: for which a federal department or agency has
p.000443: specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug
p.000443: requirements administered by the Food and Drug Ad-
p.000443:
p.000443: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000443: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000443: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000443: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000443: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000443: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000443: when the investigator(s) do not participate in the activities being observed.
p.000443: 32 CFR Ch. I (7–1–13 Edition)
p.000443: ministration). It does not include re- search activities which are inciden- tally regulated by a federal
p.000443: department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility to
p.000443: regulate certain types of ac- tivities whether research or non-re- search in nature (for example,
p.000443: Wage and Hour requirements administered by the Department of Labor).
p.000443: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000443: con- ducting research obtains
p.000443: (1) Data through intervention or interaction with the individual, or
p.000443: (2) Identifiable private information.
p.000443: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000443: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000443: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000443: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
...
p.000445: [56 FR 28012, 28021, June 18, 1991, as amended
p.000445: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...
p.000447: following require- ments are satisfied:
p.000447: (1) Risks to subjects are minimized:
p.000447: (i) By using procedures which are consistent with sound research design and which do not
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
...
Political / Indigenous
Searching for indicator native:
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p.000448: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000448: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000448: appear to waive any of the subject’s legal rights, or releases or appears to release
p.000449: 449
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449: § 219.116
p.000449: the investigator, the sponsor, the insti- tution or its agents from liability for negligence.
p.000449: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000449: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000449: to each subject:
p.000449: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000449: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000449: and identification of any procedures which are experi- mental;
p.000449: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000449: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000449: research;
p.000449: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000449: might be advan- tageous to the subject;
p.000449: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000449: subject will be maintained;
p.000449: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000449: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000449: consist of, or where further information may be ob- tained;
p.000449: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000449: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000449: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000449: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000449: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000449: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000449: elements of in- formation shall also be provided to each subject:
p.000449: (1) A statement that the particular treatment or procedure may involve
p.000449: 32 CFR Ch. I (7–1–13 Edition)
...
Political / criminal
Searching for indicator criminal:
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p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
p.000442: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000442: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000442: policy:
p.000442: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000442: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000442: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000442: cur- ricula, or classroom management methods.
p.000442: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000442: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000442: through identifiers linked to the subjects; and
p.000442: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000442: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000442: employability, or reputation.
p.000442: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000442: (b)(2) of this section, if:
p.000442: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000442: 442
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442: Office of the Secretary of Defense § 219.101
p.000442:
p.000442:
p.000442: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000442: informa- tion will be maintained throughout the research and thereafter.
p.000442: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000442: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000442: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000442: subjects.
p.000442: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000442: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000442: (i) Public benefit or service pro- grams;
p.000442: (ii) Procedures for obtaining benefits or services under those programs;
p.000442: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
...
Political / political affiliation
Searching for indicator party:
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p.000446: tions in (to secure approval), or dis- approve all research activities covered by this policy.
p.000446: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000446: accordance with
p.000446: § 219.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000446: 219.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000446: the protection of the rights and welfare of subjects.
p.000446: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000446: with
p.000446: § 219.117.
p.000446: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000446: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000446: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000446: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000446: person or in writing.
p.000446: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000446: to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve or have a third
p.000446: party observe the consent process and the research.
p.000446: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000446: [56 FR 28012, 28021, June 18, 1991, as amended
p.000446: at 70 FR 36328, June 23, 2005]
p.000446:
p.000446: § 219.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000446: minor changes in approved re- search.
p.000446: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000446: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000446: be amended, as appropriate after consultation with other departments and agencies, through
p.000446: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000446: from the Office for Human Research
p.000447: 447
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447: § 219.111
p.000447: Protections, HHS, or any successor of- fice.
p.000447: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000447: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than
p.000447: mini- mal risk,
p.000447: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000447: approval is authorized.
...
p.000451: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000451: head finds an institution has materially failed to comply with the terms of this policy.
p.000451: (b) In making decisions about sup- porting or approving applications or proposals covered by this policy
p.000451: the de- partment or agency head may take into account, in addition to all other eligibility
p.000451: requirements and program criteria, factors such as whether the applicant has been subject to a termi-
p.000451: nation or suspension under paragarph
p.000451: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000451: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000451: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000451: welfare of human subjects (whether or not the research was subject to federal regulation).
p.000451: § 219.124 Conditions.
p.000451: With respect to any research project or any class of research projects the de- partment or agency head may
p.000451: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000451: addi- tional conditions are necessary for the protection of human subjects.
p.000451:
p.000451: PART 220—COLLECTION FROM THIRD PARTY PAYERS OF REA- SONABLE CHARGES FOR HEALTHCARE
p.000451: SERVICES
p.000451: Sec.
p.000451: 220.1 Purpose and applicability.
p.000451: 220.2 Statutory obligation of third party payer to pay.
p.000451: 220.3 Exclusions impermissible.
p.000451: 220.4 Reasonable terms and conditions of health plan permissible.
...
Political / stateless persons
Searching for indicator nation:
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p.000451: evaluation will take into consideration the risks to the sub- jects, the adequacy of protection against
p.000451: these risks, the potential bene- fits of the research to the subjects and others, and the importance
p.000451: of the knowledge gained or to be gained.
p.000451: (b) On the basis of this evaluation,
p.000451: the department or agency head may approve or disapprove the application or proposal, or enter into
p.000451: negotiations to develop an approvable one.
p.000451: § 219.121 [Reserved]
p.000451: § 219.122 Use of Federal funds.
p.000451: Federal funds administered by a de- partment or agency may not be ex-
p.000451: 32 CFR Ch. I (7–1–13 Edition)
p.000451: pended for research involving human subjects unless the requirements of this policy have been satisfied.
p.000451: § 219.123 Early termination of re- search support: Evaluation of appli- cations and proposals.
p.000451: (a) The department or agency head may require that department or agency support for any project be terminated
p.000451: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000451: head finds an institution has materially failed to comply with the terms of this policy.
p.000451: (b) In making decisions about sup- porting or approving applications or proposals covered by this policy
p.000451: the de- partment or agency head may take into account, in addition to all other eligibility
p.000451: requirements and program criteria, factors such as whether the applicant has been subject to a termi-
p.000451: nation or suspension under paragarph
p.000451: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000451: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000451: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000451: welfare of human subjects (whether or not the research was subject to federal regulation).
p.000451: § 219.124 Conditions.
p.000451: With respect to any research project or any class of research projects the de- partment or agency head may
p.000451: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000451: addi- tional conditions are necessary for the protection of human subjects.
p.000451:
p.000451: PART 220—COLLECTION FROM THIRD PARTY PAYERS OF REA- SONABLE CHARGES FOR HEALTHCARE
p.000451: SERVICES
p.000451: Sec.
p.000451: 220.1 Purpose and applicability.
p.000451: 220.2 Statutory obligation of third party payer to pay.
p.000451: 220.3 Exclusions impermissible.
p.000451: 220.4 Reasonable terms and conditions of health plan permissible.
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000445: proposal may be re- turned to the institution.
p.000445: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000445: [56 FR 28012, 28021, June 18, 1991, as amended
p.000445: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
...
p.000447: § 219.111 Criteria for IRB approval of research.
p.000447: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000447: following require- ments are satisfied:
p.000447: (1) Risks to subjects are minimized:
p.000447: (i) By using procedures which are consistent with sound research design and which do not
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000442: research con-
p.000442:
p.000442: 32 CFR Ch. I (7–1–13 Edition)
p.000442: ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the United States.
p.000442: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000442: regulated as defined in § 219.102(e), must comply with all sections of this policy.
p.000442: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000442: subject to regulation as defined in § 219.102(e) must be reviewed and approved, in compliance
p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
p.000442: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000442: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000442: policy:
p.000442: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000442: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000442: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000442: cur- ricula, or classroom management methods.
p.000442: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000442: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000442: through identifiers linked to the subjects; and
p.000442: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000442: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000442: employability, or reputation.
p.000442: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000442: (b)(2) of this section, if:
p.000442: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000442: 442
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442: Office of the Secretary of Defense § 219.101
p.000442:
p.000442:
p.000442: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000442: informa- tion will be maintained throughout the research and thereafter.
p.000442: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000442: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000442: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000442: subjects.
p.000442: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000442: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000442: (i) Public benefit or service pro- grams;
p.000442: (ii) Procedures for obtaining benefits or services under those programs;
p.000442: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000442: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000442: (6) Taste and food quality evaluation and consumer acceptance studies,
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442: Office of the Secretary of Defense § 219.101
p.000442:
p.000442:
p.000442: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000442: informa- tion will be maintained throughout the research and thereafter.
p.000442: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000442: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000442: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000442: subjects.
p.000442: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000442: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000442: (i) Public benefit or service pro- grams;
p.000442: (ii) Procedures for obtaining benefits or services under those programs;
p.000442: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000442: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000442: (6) Taste and food quality evaluation and consumer acceptance studies,
p.000442: (i) If wholesome foods without addi- tives are consumed or
p.000442: (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use
p.000442: found to be safe, or agricultural chemical or environ- mental contaminant at or below the level
p.000442: found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or
p.000442: the Food Safety and Inspection Service of the U.S. Department of Agri- culture.
p.000442: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000442: covered by this policy.
p.000442: (d) Department or agency heads may require that specific research activities or classes of research
p.000442: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000442: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000442: (e) Compliance with this policy re- quires compliance with pertinent fed-
p.000442:
p.000442: eral laws or regulations which provide additional protections for human sub- jects.
p.000442: (f) This policy does not affect any state or local laws or regulations which may otherwise be applicable and
p.000442: which provide additional protections for human subjects.
p.000442: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000442: which pro- vide additional protections to human subjects of research.
p.000442: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
p.000442: in the foreign countries to protect human subjects may differ from those set forth in this
p.000442: policy. (An example is a foreign institution which complies with guidelines consistent with the
...
p.000443: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000443: June 23, 2005]
p.000443: § 219.102 Definitions.
p.000443: (a) Department or agency head means the head of any federal department or agency and any other officer
p.000443: or em- ployee of any department or agency to whom authority has been delegated.
p.000443: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000443: agencies).
p.000443: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000443: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000443: procedure(s) involved in the research.
p.000443: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000443: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000443: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000443: or supported under a program which is considered research for other purposes. For example, some
p.000443: demonstration and service programs may include research activities.
p.000443: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000443: for which a federal department or agency has
p.000443: specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug
p.000443: requirements administered by the Food and Drug Ad-
p.000443:
p.000443: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000443: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000443: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000443: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000443: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000443: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000443: when the investigator(s) do not participate in the activities being observed.
p.000443: 32 CFR Ch. I (7–1–13 Edition)
p.000443: ministration). It does not include re- search activities which are inciden- tally regulated by a federal
p.000443: department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility to
p.000443: regulate certain types of ac- tivities whether research or non-re- search in nature (for example,
p.000443: Wage and Hour requirements administered by the Department of Labor).
p.000443: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000443: con- ducting research obtains
p.000443: (1) Data through intervention or interaction with the individual, or
p.000443: (2) Identifiable private information.
p.000443: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
...
Searching for indicator influence:
(return to top)
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
...
p.000448: § 219.103(b)(4) and § 219.103(b)(5).
p.000448: (7) Statements of significant new findings provided to subjects, as re- quired by § 219.116(b)(5).
p.000448: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000448: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000448: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000448: depart- ment or agency at reasonable times and in a reasonable manner.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000448: [56 FR 28012, 28021, June 18, 1991, as amended
p.000448: at 70 FR 36328, June 23, 2005]
p.000448:
p.000448: § 219.116 General requirements for in- formed consent.
p.000448: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000448: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000448: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000448: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000448: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000448: undue influence. The information that is given to the subject or the representative shall be in language
p.000448: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000448: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000448: appear to waive any of the subject’s legal rights, or releases or appears to release
p.000449: 449
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449: § 219.116
p.000449: the investigator, the sponsor, the insti- tution or its agents from liability for negligence.
p.000449: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000449: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000449: to each subject:
p.000449: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000449: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000449: and identification of any procedures which are experi- mental;
p.000449: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000449: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000449: research;
p.000449: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000446: project in which the member has a conflicting interest, except to provide information re- quested by
p.000446: the IRB.
p.000446: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000448: [56 FR 28012, 28021, June 18, 1991, as amended
p.000448: at 70 FR 36328, June 23, 2005]
p.000448: § 219.114 Cooperative research.
...
Searching for indicator mentally:
(return to top)
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000446: project in which the member has a conflicting interest, except to provide information re- quested by
p.000446: the IRB.
...
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000446: project in which the member has a conflicting interest, except to provide information re- quested by
p.000446: the IRB.
p.000446: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000446: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000446: These individuals may not vote with the IRB.
p.000446: § 219.108 IRB functions and oper- ations.
p.000446: In order to fulfill the requirements of this policy each IRB shall:
p.000446: (a) Follow written procedures in the same detail as described in
p.000446: § 219.103(b)(4) and, to the extent re- quired by, § 219.103(b)(5).
p.000446: (b) Except when an expedited review procedure is used (see § 219.110), review proposed research at
p.000446: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000446: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000446: approved, it shall receive the approval of a ma- jority of those members present at the meeting.
p.000446: § 219.109 IRB review of research.
p.000446: (a) An IRB shall review and have au- thority to approve, require modifica-
p.000446:
p.000446: tions in (to secure approval), or dis- approve all research activities covered by this policy.
p.000446: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000446: accordance with
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000445: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000446: project in which the member has a conflicting interest, except to provide information re- quested by
...
p.000447: (1) Risks to subjects are minimized:
p.000447: (i) By using procedures which are consistent with sound research design and which do not
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
...
p.000449: might be advan- tageous to the subject;
p.000449: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000449: subject will be maintained;
p.000449: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000449: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000449: consist of, or where further information may be ob- tained;
p.000449: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000449: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000449: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000449: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000449: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000449: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000449: elements of in- formation shall also be provided to each subject:
p.000449: (1) A statement that the particular treatment or procedure may involve
p.000449: 32 CFR Ch. I (7–1–13 Edition)
p.000449: risks to the subject (or to the embryo or fetus, if the subject is or may be- come pregnant) which
p.000449: are currently unforeseeable;
p.000449: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000449: investigator without regard to the subject’s con- sent;
p.000449: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000449: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000449: of participation by the subject;
p.000449: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000449: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000449: (6) The approximate number of sub- jects involved in the study.
p.000449: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000449: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000449: provided the IRB finds and documents that:
p.000449: (1) The research or demonstration project is to be conducted by or subject to the approval of state or
p.000449: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000449: (i) Public benefit of service programs;
p.000449: (ii) Procedures for obtaining benefits or services under those programs;
p.000449: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000449: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs; and
...
Social / Child
Searching for indicator children:
(return to top)
p.000443: procedure(s) involved in the research.
p.000443: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000443: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000443: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000443: or supported under a program which is considered research for other purposes. For example, some
p.000443: demonstration and service programs may include research activities.
p.000443: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000443: for which a federal department or agency has
p.000443: specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug
p.000443: requirements administered by the Food and Drug Ad-
p.000443:
p.000443: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000443: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000443: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000443: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000443: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000443: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000443: when the investigator(s) do not participate in the activities being observed.
p.000443: 32 CFR Ch. I (7–1–13 Edition)
p.000443: ministration). It does not include re- search activities which are inciden- tally regulated by a federal
p.000443: department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility to
p.000443: regulate certain types of ac- tivities whether research or non-re- search in nature (for example,
p.000443: Wage and Hour requirements administered by the Department of Labor).
p.000443: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000443: con- ducting research obtains
p.000443: (1) Data through intervention or interaction with the individual, or
p.000443: (2) Identifiable private information.
p.000443: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000443: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000443: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000443: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
p.000443: expect that no observation or recording is taking place, and informa- tion which has been provided for spe-
p.000443: cific purposes by an individual and which the individual can reasonably expect will not be made
p.000443: public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the
...
p.000445: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000445: [56 FR 28012, 28021, June 18, 1991, as amended
p.000445: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
...
p.000447: following require- ments are satisfied:
p.000447: (1) Risks to subjects are minimized:
p.000447: (i) By using procedures which are consistent with sound research design and which do not
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000449: might be advan- tageous to the subject;
p.000449: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000449: subject will be maintained;
p.000449: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000449: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000449: consist of, or where further information may be ob- tained;
p.000449: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000449: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000449: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000449: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000449: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000449: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000449: elements of in- formation shall also be provided to each subject:
p.000449: (1) A statement that the particular treatment or procedure may involve
p.000449: 32 CFR Ch. I (7–1–13 Edition)
p.000449: risks to the subject (or to the embryo or fetus, if the subject is or may be- come pregnant) which
p.000449: are currently unforeseeable;
p.000449: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000449: investigator without regard to the subject’s con- sent;
p.000449: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000449: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000449: of participation by the subject;
p.000449: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000449: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000449: (6) The approximate number of sub- jects involved in the study.
p.000449: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000449: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000449: provided the IRB finds and documents that:
p.000449: (1) The research or demonstration project is to be conducted by or subject to the approval of state or
p.000449: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000449: (i) Public benefit of service programs;
p.000449: (ii) Procedures for obtaining benefits or services under those programs;
p.000449: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000448: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000448: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000448: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000448: depart- ment or agency at reasonable times and in a reasonable manner.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000448: [56 FR 28012, 28021, June 18, 1991, as amended
p.000448: at 70 FR 36328, June 23, 2005]
p.000448:
p.000448: § 219.116 General requirements for in- formed consent.
p.000448: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000448: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000448: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000448: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000448: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000448: undue influence. The information that is given to the subject or the representative shall be in language
p.000448: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000448: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000448: appear to waive any of the subject’s legal rights, or releases or appears to release
p.000449: 449
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449:
p.000449: § 219.116
p.000449: the investigator, the sponsor, the insti- tution or its agents from liability for negligence.
p.000449: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000449: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000449: to each subject:
p.000449: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000449: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000449: and identification of any procedures which are experi- mental;
p.000449: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000449: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000449: research;
p.000449: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000449: might be advan- tageous to the subject;
p.000449: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000449: subject will be maintained;
p.000449: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000442: those provided in this policy, the department or agency head may approve the substitution of the
p.000442: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000442: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
p.000442: they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department
p.000442: or agency procedures.
p.000442: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000442: of the provisions of this policy to specific re- search activities or classes of research activities
p.000442: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000442: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000442: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000442: and shall also publish them in the FEDERAL REGISTER or in
p.000443: 443
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443: § 219.102
p.000443: such other manner as provided in de- partment or agency procedures. 1
p.000443: [56 FR 28012, 28021, June 18, 1991, as amended
p.000443: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000443: June 23, 2005]
p.000443: § 219.102 Definitions.
p.000443: (a) Department or agency head means the head of any federal department or agency and any other officer
p.000443: or em- ployee of any department or agency to whom authority has been delegated.
p.000443: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000443: agencies).
p.000443: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000443: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000443: procedure(s) involved in the research.
p.000443: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000443: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000443: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000443: or supported under a program which is considered research for other purposes. For example, some
p.000443: demonstration and service programs may include research activities.
p.000443: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000443: for which a federal department or agency has
p.000443: specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug
p.000443: requirements administered by the Food and Drug Ad-
p.000443:
p.000443: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000445: certify that each appli- cation or proposal for research covered by the assurance and by § 219.103 of this Policy has
p.000445: been reviewed and approved by the IRB. Such certification must be submitted with the application or pro-
p.000445: 32 CFR Ch. I (7–1–13 Edition)
p.000445: posal or by such later date as may be prescribed by the department or agen- cy to which the application or
p.000445: proposal is submitted. Under no condition shall research covered by § 219.103 of the Pol- icy be supported prior
p.000445: to receipt of the certification that the research has been reviewed and approved by the IRB. In- stitutions
p.000445: without an approved assur- ance covering the research shall certify within 30 days after receipt of a request for
p.000445: such a certification from the de- partment or agency, that the applica- tion or proposal has been
p.000445: approved by the IRB. If the certification is not sub- mitted within these time limits, the application or
p.000445: proposal may be re- turned to the institution.
p.000445: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000445: [56 FR 28012, 28021, June 18, 1991, as amended
p.000445: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000442: 219.112 Review by institution.
p.000442: 219.113 Suspension or termination of IRB approval of research.
p.000442: 219.114 Cooperative research.
p.000442: 219.115 IRB records.
p.000442: 219.116 General requirements for informed consent.
p.000442: 219.117 Documentation of informed consent.
p.000442: 219.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000442: 219.119 Research undertaken without the in- tention of involving human subjects.
p.000442: 219.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000442: supported by a Federal De- partment or Agency.
p.000442: 219.121 [Reserved]
p.000442: 219.122 Use of Federal funds.
p.000442: 219.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000442: 219.124 Conditions.
p.000442: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000442: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000442: unless otherwise noted.
p.000442:
p.000442: § 219.101 To what does this policy apply?
p.000442: (a) Except as provided in paragraph
p.000442: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000442: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000442: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000442: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000442: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000442: research con-
p.000442:
p.000442: 32 CFR Ch. I (7–1–13 Edition)
p.000442: ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the United States.
p.000442: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000442: regulated as defined in § 219.102(e), must comply with all sections of this policy.
p.000442: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000442: subject to regulation as defined in § 219.102(e) must be reviewed and approved, in compliance
p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
p.000442: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000442: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000442: policy:
p.000442: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000442: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000442: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
...
Social / Student
Searching for indicator student:
(return to top)
p.000443: specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug
p.000443: requirements administered by the Food and Drug Ad-
p.000443:
p.000443: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000443: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000443: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000443: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000443: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000443: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000443: when the investigator(s) do not participate in the activities being observed.
p.000443: 32 CFR Ch. I (7–1–13 Edition)
p.000443: ministration). It does not include re- search activities which are inciden- tally regulated by a federal
p.000443: department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility to
p.000443: regulate certain types of ac- tivities whether research or non-re- search in nature (for example,
p.000443: Wage and Hour requirements administered by the Department of Labor).
p.000443: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000443: con- ducting research obtains
p.000443: (1) Data through intervention or interaction with the individual, or
p.000443: (2) Identifiable private information.
p.000443: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000443: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000443: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000443: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
p.000443: expect that no observation or recording is taking place, and informa- tion which has been provided for spe-
p.000443: cific purposes by an individual and which the individual can reasonably expect will not be made
p.000443: public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the
p.000443: identity of the subject is or may readily be ascertained by the investigator or associated with the in-
p.000443: formation) in order for obtaining the information to constitute research in- volving human subjects.
p.000443: (g) IRB means an institutional review board established in accord with and for the purposes expressed in this
p.000443: pol- icy.
p.000443: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000443: may be con- ducted at an institution within the constraints set forth by the IRB and by other
p.000443: institutional and federal require- ments.
...
Social / Women
Searching for indicator women:
(return to top)
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000446: project in which the member has a conflicting interest, except to provide information re- quested by
p.000446: the IRB.
p.000446: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000446: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000446: These individuals may not vote with the IRB.
p.000446: § 219.108 IRB functions and oper- ations.
p.000446: In order to fulfill the requirements of this policy each IRB shall:
p.000446: (a) Follow written procedures in the same detail as described in
p.000446: § 219.103(b)(4) and, to the extent re- quired by, § 219.103(b)(5).
p.000446: (b) Except when an expedited review procedure is used (see § 219.110), review proposed research at
...
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000447: or treat- ment purposes.
p.000447: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000447: importance of the knowledge that may reasonably be expected to result. In evaluating risks
p.000447: 32 CFR Ch. I (7–1–13 Edition)
p.000447: and benefits, the IRB should consider only those risks and benefits that may result from the research
p.000447: (as distin- guished from risks and benefits of therapies subjects would receive even if not participating
p.000447: in the research). The IRB should not consider possible long- range effects of applying knowledge
p.000447: gained in the research (for example, the possible effects of the research on public policy) as among
p.000447: those research risks that fall within the purview of its responsibility.
p.000447: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000447: the purposes of the research and the setting in which the research will be conducted and should be
p.000447: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000447: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000447: disadvantaged persons.
p.000447: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000447: representa- tive, in accordance with, and to the ex- tent required by § 219.116.
p.000447: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000447: required by
p.000447: § 219.117.
p.000447: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000447: collected to en- sure the safety of subjects.
p.000447: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442: Pt. 219
p.000442: PART 219—PROTECTION OF HUMAN SUBJECTS
p.000442: Sec.
p.000442: 219.101 To what does this policy apply?
p.000442: 219.102 Definitions.
p.000442: 219.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department or
p.000442: Agency.
p.000442: 219.104–219.106 [Reserved]
p.000442: 219.107 IRB membership.
p.000442: 219.108 IRB functions and operations.
p.000442: 219.109 IRB review of research.
p.000442: 219.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000442: and for minor changes in approved research.
p.000442: 219.111 Criteria for IRB approval of re- search.
p.000442: 219.112 Review by institution.
p.000442: 219.113 Suspension or termination of IRB approval of research.
p.000442: 219.114 Cooperative research.
p.000442: 219.115 IRB records.
p.000442: 219.116 General requirements for informed consent.
p.000442: 219.117 Documentation of informed consent.
p.000442: 219.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000442: 219.119 Research undertaken without the in- tention of involving human subjects.
p.000442: 219.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000442: supported by a Federal De- partment or Agency.
p.000442: 219.121 [Reserved]
p.000442: 219.122 Use of Federal funds.
p.000442: 219.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000442: 219.124 Conditions.
p.000442: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000442: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000442: unless otherwise noted.
p.000442:
p.000442: § 219.101 To what does this policy apply?
p.000442: (a) Except as provided in paragraph
p.000442: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000442: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000442: to make the policy applicable to such research. This includes research conducted by federal civilian
...
p.000446: the protection of the rights and welfare of subjects.
p.000446: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000446: with
p.000446: § 219.117.
p.000446: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000446: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000446: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000446: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000446: person or in writing.
p.000446: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000446: to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve or have a third
p.000446: party observe the consent process and the research.
p.000446: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000446: [56 FR 28012, 28021, June 18, 1991, as amended
p.000446: at 70 FR 36328, June 23, 2005]
p.000446:
p.000446: § 219.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000446: minor changes in approved re- search.
p.000446: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000446: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000446: be amended, as appropriate after consultation with other departments and agencies, through
p.000446: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000446: from the Office for Human Research
p.000447: 447
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447: § 219.111
p.000447: Protections, HHS, or any successor of- fice.
p.000447: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000447: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than
p.000447: mini- mal risk,
p.000447: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000447: approval is authorized.
p.000447: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or
p.000447: more ex- perienced reviewers designated by the chairperson from among members of the IRB. In reviewing the
p.000447: research, the reviewers may exercise all of the au- thorities of the IRB except that the re- viewers may not
p.000447: disapprove the re- search. A research activity may be dis- approved only after review in accord- ance with
p.000447: the non-expedited procedure set forth in § 219.108(b).
p.000447: (c) Each IRB which uses an expedited
p.000447: review procedure shall adopt a method for keeping all members advised of re- search proposals which have
p.000447: been ap- proved under the procedure.
p.000447: (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an
p.000447: institu- tion’s or IRB’s use of the expedited re- view procedure.
p.000447: [56 FR 28012, 28021, June 18, 1991, as amended
p.000447: at 70 FR 36328, June 23, 2005]
p.000447:
p.000447: § 219.111 Criteria for IRB approval of research.
p.000447: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000447: following require- ments are satisfied:
p.000447: (1) Risks to subjects are minimized:
p.000447: (i) By using procedures which are consistent with sound research design and which do not
p.000447: unnecessarily expose subjects to risk, and
p.000447: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
...
Social / education
Searching for indicator education:
(return to top)
p.000442: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000442: research con-
p.000442:
p.000442: 32 CFR Ch. I (7–1–13 Edition)
p.000442: ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the United States.
p.000442: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000442: regulated as defined in § 219.102(e), must comply with all sections of this policy.
p.000442: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000442: subject to regulation as defined in § 219.102(e) must be reviewed and approved, in compliance
p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
p.000442: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000442: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000442: policy:
p.000442: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000442: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000442: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000442: cur- ricula, or classroom management methods.
p.000442: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000442: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000442: through identifiers linked to the subjects; and
p.000442: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000442: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000442: employability, or reputation.
p.000442: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000442: (b)(2) of this section, if:
p.000442: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000442: 442
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442: Office of the Secretary of Defense § 219.101
p.000442:
p.000442:
p.000442: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
...
Searching for indicator educational:
(return to top)
p.000442: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000442: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000442: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000442: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000442: research con-
p.000442:
p.000442: 32 CFR Ch. I (7–1–13 Edition)
p.000442: ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the United States.
p.000442: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000442: regulated as defined in § 219.102(e), must comply with all sections of this policy.
p.000442: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000442: subject to regulation as defined in § 219.102(e) must be reviewed and approved, in compliance
p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
p.000442: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000442: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000442: policy:
p.000442: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000442: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000442: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000442: cur- ricula, or classroom management methods.
p.000442: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000442: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000442: through identifiers linked to the subjects; and
p.000442: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000442: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000442: employability, or reputation.
p.000442: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000442: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000442: (b)(2) of this section, if:
p.000442: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000442: 442
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442:
p.000442: Office of the Secretary of Defense § 219.101
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000449: research;
p.000449: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000449: might be advan- tageous to the subject;
p.000449: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000449: subject will be maintained;
p.000449: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000449: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000449: consist of, or where further information may be ob- tained;
p.000449: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000449: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000449: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000449: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000449: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000449: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000449: elements of in- formation shall also be provided to each subject:
p.000449: (1) A statement that the particular treatment or procedure may involve
p.000449: 32 CFR Ch. I (7–1–13 Edition)
p.000449: risks to the subject (or to the embryo or fetus, if the subject is or may be- come pregnant) which
p.000449: are currently unforeseeable;
p.000449: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000449: investigator without regard to the subject’s con- sent;
p.000449: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000449: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000449: of participation by the subject;
p.000449: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000449: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000449: (6) The approximate number of sub- jects involved in the study.
p.000449: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000449: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000449: provided the IRB finds and documents that:
p.000449: (1) The research or demonstration project is to be conducted by or subject to the approval of state or
p.000449: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000449: (i) Public benefit of service programs;
p.000449: (ii) Procedures for obtaining benefits or services under those programs;
...
Social / employees
Searching for indicator employees:
(return to top)
p.000442: 219.111 Criteria for IRB approval of re- search.
p.000442: 219.112 Review by institution.
p.000442: 219.113 Suspension or termination of IRB approval of research.
p.000442: 219.114 Cooperative research.
p.000442: 219.115 IRB records.
p.000442: 219.116 General requirements for informed consent.
p.000442: 219.117 Documentation of informed consent.
p.000442: 219.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000442: 219.119 Research undertaken without the in- tention of involving human subjects.
p.000442: 219.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000442: supported by a Federal De- partment or Agency.
p.000442: 219.121 [Reserved]
p.000442: 219.122 Use of Federal funds.
p.000442: 219.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000442: 219.124 Conditions.
p.000442: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000442: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000442: unless otherwise noted.
p.000442:
p.000442: § 219.101 To what does this policy apply?
p.000442: (a) Except as provided in paragraph
p.000442: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000442: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000442: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000442: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000442: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000442: research con-
p.000442:
p.000442: 32 CFR Ch. I (7–1–13 Edition)
p.000442: ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the United States.
p.000442: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000442: regulated as defined in § 219.102(e), must comply with all sections of this policy.
p.000442: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000442: subject to regulation as defined in § 219.102(e) must be reviewed and approved, in compliance
p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
p.000442: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000442: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000442: policy:
p.000442: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000442: educational practices, such as (i) research on reg- ular and special education instruc- tional
...
p.000444: (ii) for determining which projects re- quire review more often than annually and which projects need
p.000444: verification from sources other than the investiga- tors that no material changes have oc- curred since
p.000444: previous IRB review; and
p.000444: (iii) for ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000444: ensuring that such changes in approved research, during the period for which IRB ap- proval has
p.000444: already been given, may not be initiated without IRB review and approval except when necessary to
p.000445: 445
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445: §§ 219.104–219.106
p.000445: eliminate apparent immediate hazards to the subject.
p.000445: (5) Written procedures for ensuring prompt reporting to the IRB, appro- priate institutional
p.000445: officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or
p.000445: others or any serious or continuing noncompliance with this policy or the requirements or deter-
p.000445: minations of the IRB and (ii) any sus- pension or termination of IRB ap- proval.
p.000445: (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on
p.000445: behalf of the institution the obligations im- posed by this policy and shall be filed in such form and
p.000445: manner as the depart- ment or agency head prescribes.
p.000445: (d) The department or agency head will evaluate all assurances submitted in accordance with this policy
p.000445: through such officers and employees of the de- partment or agency and such experts or consultants engaged
p.000445: for this purpose as the department or agency head de- termines to be appropriate. The depart- ment or agency
p.000445: head’s evaluation will take into consideration the adequacy of the proposed IRB in light of the an-
p.000445: ticipated scope of the institution’s re- search activities and the types of sub- ject populations likely
p.000445: to be involved, the appropriateness of the proposed ini- tial and continuing review procedures in light of the
p.000445: probable risks, and the size and complexity of the institution.
p.000445: (e) On the basis of this evaluation,
p.000445: the department or agency head may approve or disapprove the assurance, or enter into negotiations to
p.000445: develop an approvable one. The department or agency head may limit the period dur- ing which any
p.000445: particular approved as- surance or class of approved assurances shall remain effective or otherwise condition
p.000445: or restrict approval.
p.000445: (f) Certification is required when the research is supported by a federal de- partment or agency and not
p.000445: otherwise exempted or waived under § 219.101 (b) or (i). An institution with an approved assurance shall
p.000445: certify that each appli- cation or proposal for research covered by the assurance and by § 219.103 of this Policy has
p.000445: been reviewed and approved by the IRB. Such certification must be submitted with the application or pro-
p.000445: 32 CFR Ch. I (7–1–13 Edition)
p.000445: posal or by such later date as may be prescribed by the department or agen- cy to which the application or
p.000445: proposal is submitted. Under no condition shall research covered by § 219.103 of the Pol- icy be supported prior
...
p.000450: projects in which human subjects’ involvement will depend upon
p.000451: 451
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451: § 219.119
p.000451: completion of instruments, prior ani- mal studies, or purification of com- pounds. These applications
p.000451: need not be reviewed by an IRB before an award may be made. However, except for re- search exempted
p.000451: or waived under
p.000451: § 219.101 (b) or (i), no human subjects may be involved in any project sup- ported by these awards
p.000451: until the project has been reviewed and approved by the IRB, as provided in this policy, and
p.000451: certification submitted, by the in- stitution, to the department or agency.
p.000451: § 219.119 Research undertaken with- out the intention of involving human subjects.
p.000451: In the event research is undertaken without the intention of involving human subjects, but it
p.000451: is later pro- posed to involve human subjects in the research, the research shall first be re- viewed and approved
p.000451: by an IRB, as pro- vided in this policy, a certification sub- mitted, by the institution, to the de- partment or
p.000451: agency, and final approval given to the proposed change by the de- partment or agency.
p.000451: § 219.120 Evaluation and disposition of applications and proposals for re- search to be conducted or
p.000451: sup- ported by a Federal Department or Agency.
p.000451: (a) The department or agency head will evaluate all applications and pro- posals involving human subjects
p.000451: sub- mitted to the department or agency through such officers and employees of the department or agency and
p.000451: such ex- perts and consultants as the depart- ment or agency head determines to be appropriate. This
p.000451: evaluation will take into consideration the risks to the sub- jects, the adequacy of protection against
p.000451: these risks, the potential bene- fits of the research to the subjects and others, and the importance
p.000451: of the knowledge gained or to be gained.
p.000451: (b) On the basis of this evaluation,
p.000451: the department or agency head may approve or disapprove the application or proposal, or enter into
p.000451: negotiations to develop an approvable one.
p.000451: § 219.121 [Reserved]
p.000451: § 219.122 Use of Federal funds.
p.000451: Federal funds administered by a de- partment or agency may not be ex-
p.000451: 32 CFR Ch. I (7–1–13 Edition)
p.000451: pended for research involving human subjects unless the requirements of this policy have been satisfied.
p.000451: § 219.123 Early termination of re- search support: Evaluation of appli- cations and proposals.
p.000451: (a) The department or agency head may require that department or agency support for any project be terminated
p.000451: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000451: head finds an institution has materially failed to comply with the terms of this policy.
p.000451: (b) In making decisions about sup- porting or approving applications or proposals covered by this policy
p.000451: the de- partment or agency head may take into account, in addition to all other eligibility
...
Social / gender
Searching for indicator gender:
(return to top)
p.000445: been reviewed and approved by the IRB. Such certification must be submitted with the application or pro-
p.000445: 32 CFR Ch. I (7–1–13 Edition)
p.000445: posal or by such later date as may be prescribed by the department or agen- cy to which the application or
p.000445: proposal is submitted. Under no condition shall research covered by § 219.103 of the Pol- icy be supported prior
p.000445: to receipt of the certification that the research has been reviewed and approved by the IRB. In- stitutions
p.000445: without an approved assur- ance covering the research shall certify within 30 days after receipt of a request for
p.000445: such a certification from the de- partment or agency, that the applica- tion or proposal has been
p.000445: approved by the IRB. If the certification is not sub- mitted within these time limits, the application or
p.000445: proposal may be re- turned to the institution.
p.000445: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000445: [56 FR 28012, 28021, June 18, 1991, as amended
p.000445: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000445: June 23, 2005]
p.000445:
p.000445: §§ 219.104–219.106 [Reserved]
p.000445: § 219.107 IRB membership.
p.000445: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000445: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000445: qualified through the experience and expertise of its members, and the diversity of the members,
p.000445: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000445: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000445: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000445: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000445: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000445: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000445: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000445: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000445: to the in- clusion of one or more individuals who
p.000446: 446
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446:
p.000446: Office of the Secretary of Defense § 219.110
p.000446:
p.000446:
p.000446: are knowledgeable about and experi- enced in working with these subjects.
p.000446: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000446: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000446: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000446: profession.
p.000446: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000446: least one member whose primary concerns are in nonscientific areas.
p.000446: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000446: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000446: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000446: project in which the member has a conflicting interest, except to provide information re- quested by
p.000446: the IRB.
p.000446: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000446: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000446: These individuals may not vote with the IRB.
p.000446: § 219.108 IRB functions and oper- ations.
p.000446: In order to fulfill the requirements of this policy each IRB shall:
p.000446: (a) Follow written procedures in the same detail as described in
p.000446: § 219.103(b)(4) and, to the extent re- quired by, § 219.103(b)(5).
p.000446: (b) Except when an expedited review procedure is used (see § 219.110), review proposed research at
p.000446: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000446: one member whose primary concerns are in nonscientific areas. In order for the research to be
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000449: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000449: consent provided the IRB finds and documents that:
p.000449: (1) The research involves no more than minimal risk to the subjects;
p.000450: 450
p.000450:
p.000450:
p.000450:
p.000450:
p.000450:
p.000450:
p.000450:
p.000450: Office of the Secretary of Defense § 219.118
p.000450:
p.000450:
p.000450: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000450: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000450: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000450: participa- tion.
p.000450: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000450: applicable federal, state, or local laws which require addi- tional information to be disclosed in order for
p.000450: informed consent to be le- gally effective.
p.000450: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care,
p.000450: to the extent the physician is permitted to do so under applicable federal, state, or local law.
p.000450: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000450: [56 FR 28012, 28021, June 18, 1991, as amended
p.000450: at 70 FR 36328, June 23, 2005]
p.000450:
p.000450: § 219.117 Documentation of informed consent.
p.000450: (a) Except as provided in paragraph
p.000450: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000450: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000450: shall be given to the per- son signing the form.
p.000450: (b) Except as provided in paragraph
p.000450: (c) of this section, the consent form may be either of the following:
p.000450: (1) A written consent document that embodies the elements of informed consent required by § 219.116. This
p.000450: form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any event,
p.000450: the investigator shall give either the subject or the rep- resentative adequate opportunity to read it before it
p.000450: is signed; or
p.000450: (2) A short form written consent doc-
p.000450: ument stating that the elements of in- formed consent required by § 219.116 have been presented orally
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000442: Sec.
p.000442: 219.101 To what does this policy apply?
p.000442: 219.102 Definitions.
p.000442: 219.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department or
p.000442: Agency.
p.000442: 219.104–219.106 [Reserved]
p.000442: 219.107 IRB membership.
p.000442: 219.108 IRB functions and operations.
p.000442: 219.109 IRB review of research.
p.000442: 219.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000442: and for minor changes in approved research.
p.000442: 219.111 Criteria for IRB approval of re- search.
p.000442: 219.112 Review by institution.
p.000442: 219.113 Suspension or termination of IRB approval of research.
p.000442: 219.114 Cooperative research.
p.000442: 219.115 IRB records.
p.000442: 219.116 General requirements for informed consent.
p.000442: 219.117 Documentation of informed consent.
p.000442: 219.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000442: 219.119 Research undertaken without the in- tention of involving human subjects.
p.000442: 219.120 Evaluation and disposition of appli- cations and proposals for research to be conducted or
p.000442: supported by a Federal De- partment or Agency.
p.000442: 219.121 [Reserved]
p.000442: 219.122 Use of Federal funds.
p.000442: 219.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000442: 219.124 Conditions.
p.000442: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
p.000442: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000442: unless otherwise noted.
p.000442:
p.000442: § 219.101 To what does this policy apply?
p.000442: (a) Except as provided in paragraph
p.000442: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000442: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000442: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000442: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000442: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000442: research con-
p.000442:
p.000442: 32 CFR Ch. I (7–1–13 Edition)
p.000442: ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the United States.
p.000442: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000442: regulated as defined in § 219.102(e), must comply with all sections of this policy.
p.000442: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000442: subject to regulation as defined in § 219.102(e) must be reviewed and approved, in compliance
p.000442: with § 219.101, § 219.102, and
p.000442: § 219.107 through § 219.117 of this policy, by an institutional review board (IRB) that operates in
p.000442: accordance with the pertinent requirements of this policy.
...
p.000442: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000442: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
p.000442: they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department
p.000442: or agency procedures.
p.000442: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000442: of the provisions of this policy to specific re- search activities or classes of research activities
p.000442: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000442: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000442: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000442: and shall also publish them in the FEDERAL REGISTER or in
p.000443: 443
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443: § 219.102
p.000443: such other manner as provided in de- partment or agency procedures. 1
p.000443: [56 FR 28012, 28021, June 18, 1991, as amended
p.000443: at 56 FR 29756, June 28, 1991; 70 FR 36328,
p.000443: June 23, 2005]
p.000443: § 219.102 Definitions.
p.000443: (a) Department or agency head means the head of any federal department or agency and any other officer
p.000443: or em- ployee of any department or agency to whom authority has been delegated.
p.000443: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000443: agencies).
p.000443: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000443: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000443: procedure(s) involved in the research.
p.000443: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000443: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000443: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000443: or supported under a program which is considered research for other purposes. For example, some
p.000443: demonstration and service programs may include research activities.
p.000443: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000443: for which a federal department or agency has
p.000443: specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug
p.000443: requirements administered by the Food and Drug Ad-
p.000443:
p.000443: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000443: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
...
p.000446: (a) An IRB shall review and have au- thority to approve, require modifica-
p.000446:
p.000446: tions in (to secure approval), or dis- approve all research activities covered by this policy.
p.000446: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000446: accordance with
p.000446: § 219.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000446: 219.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000446: the protection of the rights and welfare of subjects.
p.000446: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000446: with
p.000446: § 219.117.
p.000446: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000446: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000446: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000446: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000446: person or in writing.
p.000446: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000446: to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve or have a third
p.000446: party observe the consent process and the research.
p.000446: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000446: [56 FR 28012, 28021, June 18, 1991, as amended
p.000446: at 70 FR 36328, June 23, 2005]
p.000446:
p.000446: § 219.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000446: minor changes in approved re- search.
p.000446: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000446: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000446: be amended, as appropriate after consultation with other departments and agencies, through
p.000446: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000446: from the Office for Human Research
p.000447: 447
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447:
p.000447: § 219.111
p.000447: Protections, HHS, or any successor of- fice.
p.000447: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000447: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than
p.000447: mini- mal risk,
...
p.000447: con- fidentiality of data.
p.000447: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000447: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000447: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000447: rights and welfare of these subjects.
p.000447: § 219.112 Review by institution.
p.000447: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000447: review and approval or disapproval by officials
p.000448: 448
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448:
p.000448: Office of the Secretary of Defense § 219.116
p.000448:
p.000448:
p.000448: of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB.
p.000448: § 219.113 Suspension or termination of IRB approval of research.
p.000448: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000448: [56 FR 28012, 28021, June 18, 1991, as amended
p.000448: at 70 FR 36328, June 23, 2005]
p.000448: § 219.114 Cooperative research.
p.000448: Cooperative research projects are those projects covered by this policy which involve more than one
p.000448: institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for
p.000448: safeguarding the rights and welfare of human subjects and for complying with this policy. With the
p.000448: approval of the department or agency head, an institution participating in a cooperative project may enter
p.000448: into a joint review arrangement, rely upon the review of another qualified IRB, or make similar
p.000448: arrangements for avoid- ing duplication of effort.
p.000448: § 219.115 IRB records.
p.000448: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000448: documentation of IRB activities, including the following:
p.000448: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
...
p.000449: (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000449: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000449: consent provided the IRB finds and documents that:
p.000449: (1) The research involves no more than minimal risk to the subjects;
p.000450: 450
p.000450:
p.000450:
p.000450:
p.000450:
p.000450:
p.000450:
p.000450:
p.000450: Office of the Secretary of Defense § 219.118
p.000450:
p.000450:
p.000450: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000450: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000450: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000450: participa- tion.
p.000450: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000450: applicable federal, state, or local laws which require addi- tional information to be disclosed in order for
p.000450: informed consent to be le- gally effective.
p.000450: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care,
p.000450: to the extent the physician is permitted to do so under applicable federal, state, or local law.
p.000450: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000450: [56 FR 28012, 28021, June 18, 1991, as amended
p.000450: at 70 FR 36328, June 23, 2005]
p.000450:
p.000450: § 219.117 Documentation of informed consent.
p.000450: (a) Except as provided in paragraph
p.000450: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000450: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000450: shall be given to the per- son signing the form.
p.000450: (b) Except as provided in paragraph
p.000450: (c) of this section, the consent form may be either of the following:
p.000450: (1) A written consent document that embodies the elements of informed consent required by § 219.116. This
p.000450: form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any event,
p.000450: the investigator shall give either the subject or the rep- resentative adequate opportunity to read it before it
p.000450: is signed; or
p.000450: (2) A short form written consent doc-
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000442: the Food Safety and Inspection Service of the U.S. Department of Agri- culture.
p.000442: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000442: covered by this policy.
p.000442: (d) Department or agency heads may require that specific research activities or classes of research
p.000442: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000442: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000442: (e) Compliance with this policy re- quires compliance with pertinent fed-
p.000442:
p.000442: eral laws or regulations which provide additional protections for human sub- jects.
p.000442: (f) This policy does not affect any state or local laws or regulations which may otherwise be applicable and
p.000442: which provide additional protections for human subjects.
p.000442: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000442: which pro- vide additional protections to human subjects of research.
p.000442: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
p.000442: in the foreign countries to protect human subjects may differ from those set forth in this
p.000442: policy. (An example is a foreign institution which complies with guidelines consistent with the
p.000442: World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign
p.000442: states or by an organization whose function for the protection of human research subjects is
p.000442: internationally recognized.) In these circumstances, if a department or agency head determines that the
p.000442: proce- dures prescribed by the institution af- ford protections that are at least equivalent to
p.000442: those provided in this policy, the department or agency head may approve the substitution of the
p.000442: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000442: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
p.000442: they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department
p.000442: or agency procedures.
p.000442: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000442: of the provisions of this policy to specific re- search activities or classes of research activities
p.000442: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000442: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000442: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000442: and shall also publish them in the FEDERAL REGISTER or in
p.000443: 443
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443:
p.000443: § 219.102
p.000443: such other manner as provided in de- partment or agency procedures. 1
...
Orphaned Trigger Words
p.000443: con- ducting research obtains
p.000443: (1) Data through intervention or interaction with the individual, or
p.000443: (2) Identifiable private information.
p.000443: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000443: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000443: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000443: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
p.000443: expect that no observation or recording is taking place, and informa- tion which has been provided for spe-
p.000443: cific purposes by an individual and which the individual can reasonably expect will not be made
p.000443: public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the
p.000443: identity of the subject is or may readily be ascertained by the investigator or associated with the in-
p.000443: formation) in order for obtaining the information to constitute research in- volving human subjects.
p.000443: (g) IRB means an institutional review board established in accord with and for the purposes expressed in this
p.000443: pol- icy.
p.000443: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000443: may be con- ducted at an institution within the constraints set forth by the IRB and by other
p.000443: institutional and federal require- ments.
p.000443: (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000443: research are not greater in and of themselves than those ordinarily encountered in daily
p.000444: 444
p.000444:
p.000444:
p.000444:
p.000444:
p.000444:
p.000444:
p.000444:
p.000444: Office of the Secretary of Defense § 219.103
p.000444:
p.000444:
p.000444: life or during the performance of rou- tine physical or psychological exami- nations or tests.
p.000444: (j) Certification means the official no- tification by the institution to the sup- porting department or agency,
p.000444: in ac- cordance with the requirements of this policy, that a research project or activ- ity involving human
p.000444: subjects has been reviewed and approved by an IRB in ac- cordance with an approved assurance.
p.000444: § 219.103 Assuring compliance with this policy—research conducted or supported by any Federal Depart-
p.000444: ment or Agency.
p.000444: (a) Each institution engaged in re- search which is covered by this policy and which is conducted or
p.000444: supported by a federal department or agency shall provide written assurance satisfactory to the department or
p.000444: agency head that it will comply with the requirements set forth in this policy. In lieu of re- quiring
p.000444: submission of an assurance, in- dividual department or agency heads shall accept the existence of a current
p.000444: assurance, appropriate for the research in question, on file with the Office for Human Research Protections,
p.000444: HHS, or any successor office, and approved for federalwide use by that office. When the existence of
p.000444: an HHS-approved as- surance is accepted in lieu of requiring submission of an assurance, reports (except
p.000444: certification) required by this policy to be made to department and agency heads shall also be made to the
p.000444: Office for Human Research Protec- tions, HHS, or any successor office.
p.000444: (b) Departments and agencies will
p.000444: conduct or support research covered by this policy only if the institution has an assurance approved as
p.000444: provided in this section, and only if the institution has certified to the department or agency head that
p.000444: the research has been reviewed and approved by an IRB pro- vided for in the assurance, and will be subject
p.000444: to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall
p.000444: at a minimum include:
p.000444: (1) A statement of principles gov- erning the institution in the discharge of its responsibilities for
p.000444: protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution,
p.000444: regardless of whether
p.000444:
p.000444: the research is subject to federal regu- lation. This may include an appro- priate existing code,
p.000444: declaration, or statement of ethical principles, or a statement formulated by the institu- tion
p.000444: itself. This requirement does not preempt provisions of this policy appli- cable to department- or
p.000444: agency-sup- ported or regulated research and need not be applicable to any research ex- empted or waived
p.000444: under § 219.101 (b) or (i).
p.000444: (2) Designation of one or more IRBs established in accordance with the re- quirements of this
p.000444: policy, and for which provisions are made for meeting space and sufficient staff to support the
p.000444: IRB’s review and recordkeeping du- ties.
p.000444: (3) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of
p.000444: experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief
p.000444: anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each
p.000444: member and the institution; for example: full-time employee, part-time employee, member of governing panel or
p.000444: board, stockholder, paid or unpaid consultant. Changes in IRB member- ship shall be reported to the
p.000444: depart- ment or agency head, unless in accord with § 219.103(a) of this policy, the ex- istence of an
p.000444: HHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office
p.000444: for Human Research Protec- tions, HHS, or any successor office.
p.000444: (4) Written procedures which the IRB
p.000444: will follow (i) for conducting its initial and continuing review of research and for reporting its findings and
p.000444: actions to the investigator and the institution;
p.000444: (ii) for determining which projects re- quire review more often than annually and which projects need
p.000444: verification from sources other than the investiga- tors that no material changes have oc- curred since
p.000444: previous IRB review; and
p.000444: (iii) for ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000444: ensuring that such changes in approved research, during the period for which IRB ap- proval has
p.000444: already been given, may not be initiated without IRB review and approval except when necessary to
p.000445: 445
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445:
p.000445: §§ 219.104–219.106
...
p.000448: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000448: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000448: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000448: the department or agency head.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000448: [56 FR 28012, 28021, June 18, 1991, as amended
p.000448: at 70 FR 36328, June 23, 2005]
p.000448: § 219.114 Cooperative research.
p.000448: Cooperative research projects are those projects covered by this policy which involve more than one
p.000448: institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for
p.000448: safeguarding the rights and welfare of human subjects and for complying with this policy. With the
p.000448: approval of the department or agency head, an institution participating in a cooperative project may enter
p.000448: into a joint review arrangement, rely upon the review of another qualified IRB, or make similar
p.000448: arrangements for avoid- ing duplication of effort.
p.000448: § 219.115 IRB records.
p.000448: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000448: documentation of IRB activities, including the following:
p.000448: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000448: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000448: reports of injuries to sub- jects.
p.000448: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000448: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000448: abstaining; the
p.000448:
p.000448: basis for requiring changes in or dis- approving research; and a written sum- mary of the discussion of
p.000448: controverted issues and their resolution.
p.000448: (3) Records of continuing review ac- tivities.
p.000448: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000448: (5) A list of IRB members in the same detail as described is § 219.103(b)(3).
p.000448: (6) Written procedures for the IRB in the same detail as described in
p.000448: § 219.103(b)(4) and § 219.103(b)(5).
p.000448: (7) Statements of significant new findings provided to subjects, as re- quired by § 219.116(b)(5).
p.000448: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000448: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000448: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000448: depart- ment or agency at reasonable times and in a reasonable manner.
p.000448: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000448: [56 FR 28012, 28021, June 18, 1991, as amended
p.000448: at 70 FR 36328, June 23, 2005]
p.000448:
p.000448: § 219.116 General requirements for in- formed consent.
...
p.000450: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000450: shall be given to the per- son signing the form.
p.000450: (b) Except as provided in paragraph
p.000450: (c) of this section, the consent form may be either of the following:
p.000450: (1) A written consent document that embodies the elements of informed consent required by § 219.116. This
p.000450: form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any event,
p.000450: the investigator shall give either the subject or the rep- resentative adequate opportunity to read it before it
p.000450: is signed; or
p.000450: (2) A short form written consent doc-
p.000450: ument stating that the elements of in- formed consent required by § 219.116 have been presented orally
p.000450: to the sub- ject or the subject’s legally authorized representative. When this method is used, there
p.000450: shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is
p.000450:
p.000450: to be said to the subject or the rep- resentative. Only the short form itself is to be signed by the
p.000450: subject or the representative. However, the witness shall sign both the short form and a copy of the
p.000450: summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary
p.000450: shall be given to the subject or the representative, in addition to a copy of the short form.
p.000450: (c) An IRB may waive the require- ment for the investigator to obtain a signed consent form for
p.000450: some or all subjects if it finds either:
p.000450: (1) That the only record linking the subject and the research would be the consent document and the
p.000450: principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be
p.000450: asked whether the sub- ject wants documentation linking the subject with the research, and the sub- ject’s
p.000450: wishes will govern; or
p.000450: (2) That the research presents no more than minimal risk of harm to subjects and involves no
p.000450: procedures for which written consent is normally re- quired outside of the research context.
p.000450: In cases in which the documentation requirement is waived, the IRB may re- quire the investigator to provide
p.000450: sub- jects with a written statement regard- ing the research.
p.000450: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000450: [56 FR 28012, 28021, June 18, 1991, as amended
p.000450: at 70 FR 36328, June 23, 2005]
p.000450:
p.000450: § 219.118 Applications and proposals lacking definite plans for involve- ment of human subjects.
p.000450: Certain types of applications for grants, cooperative agreements, or con- tracts are submitted to
p.000450: departments or agencies with the knowledge that sub- jects may be involved within the period of support, but
p.000450: definite plans would not normally be set forth in the applica- tion or proposal. These include activi- ties
p.000450: such as institutional type grants when selection of specific projects is the institution’s
p.000450: responsibility; re- search training grants in which the ac- tivities involving subjects remain to be selected; and
p.000450: projects in which human subjects’ involvement will depend upon
p.000451: 451
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451: § 219.119
p.000451: completion of instruments, prior ani- mal studies, or purification of com- pounds. These applications
p.000451: need not be reviewed by an IRB before an award may be made. However, except for re- search exempted
p.000451: or waived under
p.000451: § 219.101 (b) or (i), no human subjects may be involved in any project sup- ported by these awards
...
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