79C3C34C52B45572883A05D425EB0F82
34 CFR 97
https://www.govinfo.gov/content/pkg/CFR-2010-title34-vol1/pdf/CFR-2010-title34-vol1-part97.pdf
http://leaux.net/URLS/ConvertAPI Text Files/3A276A47F2D7704F088B36EE8A1D07B6.en.txt
Examining the file media/Synopses/3A276A47F2D7704F088B36EE8A1D07B6.html:
This file was generated: 2020-12-01 05:12:57
| 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:
(return to top)
p.000308: or em- ployee of any department or agency to whom authority has been delegated.
p.000308: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000308: agencies).
p.000308: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000308: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000308: procedure(s) involved in the research.
p.000308: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000308: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000308: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000308: or supported under a program which is considered research for other purposes. For example, some
p.000308: demonstration and service programs may include research activities.
p.000308: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000308: for which a federal department or agency has specific responsibility for regulating as
p.000308:
p.000308: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000308: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000308: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000308: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000308: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000308: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000308: when the investigator(s) do not participate in the activities being observed.
p.000309: 309
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309: § 97.103
p.000309: a research activity, (for example, In- vestigational New Drug requirements administered by the Food and Drug
p.000309: Ad- ministration). It does not include re- search activities which are inciden- tally regulated by a
p.000309: federal department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility
p.000309: to regulate certain types of ac- tivities whether research or non-re- search in nature (for
p.000309: example, Wage and Hour requirements administered by the Department of Labor).
p.000309: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000309: con- ducting research obtains
p.000309: (1) Data through intervention or interaction with the individual, or
p.000309: (2) Identifiable private information.
p.000309: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000309: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
...
p.000311: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000313: following require- ments are satisfied:
p.000313: (1) Risks to subjects are minimized:
p.000313: (i) By using procedures which are consistent with sound research design and which do not
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
...
Political / Indigenous
Searching for indicator native:
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p.000314: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000314: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000314: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000314: sponsor, the insti- tution or its agents from liability for negligence.
p.000314: (a) Basic elements of informed consent.
p.000314: Except as provided in paragraph (c) or
p.000314: (d) of this section, in seeking informed consent the following information shall be provided to each subject:
p.000314: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000314: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000314: and identification of any procedures which are experi- mental;
p.000314: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000314: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000314: research;
p.000315: 315
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315: § 97.116
p.000315: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000315: might be advan- tageous to the subject;
p.000315: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000315: subject will be maintained;
p.000315: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000315: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000315: consist of, or where further information may be ob- tained;
p.000315: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000315: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000315: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000315: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000315: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000315: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000315: information shall also be provided to each subject:
p.000315: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000315: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
...
Political / criminal
Searching for indicator criminal:
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p.000307: subject to regulation as defined in § 97.102(e) must be reviewed and approved, in compli- ance with §§ 97.101,
p.000307: 97.102, and §§ 97.107 through 97.117 of this policy, by an in- stitutional review board (IRB) that op- erates
p.000307: in accordance with the pertinent requirements of this policy.
p.000307: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000307: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000307: policy:
p.000307: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000307: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000307: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000307: cur- ricula, or classroom management methods.
p.000307: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000307: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000307: through identifiers linked to the subjects; and
p.000307: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000307: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000307: employability, or reputation.
p.000307: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000307: (b)(2) of this section, if:
p.000307: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000307: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000307: informa- tion will be maintained throughout the research and thereafter.
p.000307: 34 CFR Subtitle A (7–1–10 Edition)
p.000307: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000307: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000307: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000307: subjects.
p.000307: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000307: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000307: (i) Public benefit or service pro- grams;
p.000307: (ii) Procedures for obtaining benefits or services under those programs;
p.000307: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000307: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
...
Political / political affiliation
Searching for indicator party:
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p.000312: approval), or dis- approve all research activities covered by this policy.
p.000312: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000312: accordance with
p.000312: § 97.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000312: 97.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000312: the protection of the rights and welfare of subjects.
p.000312: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000312: with
p.000312: § 97.117.
p.000312: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000312: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000312: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000312: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000312: person or in writing.
p.000312: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000312: 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.000312: party observe the consent process and the research.
p.000312: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000312: [56 FR 28012, 28021, June 18, 1991, as amended
p.000312: at 70 FR 36328, June 23, 2005]
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312:
p.000312: § 97.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000312: minor changes in approved re- search.
p.000312: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000312: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000312: be amended, as appropriate after consultation with other departments and agencies, through
p.000312: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000312: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000312: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000312: (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.000312: mini- mal risk,
p.000312: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000312: approval is authorized.
...
Political / stateless persons
Searching for indicator nation:
(return to top)
p.000317: of the knowledge gained or to be gained.
p.000317: (b) On the basis of this evaluation, the department or agency head may approve or disapprove the
p.000317: application or proposal, or enter into negotiations to develop an approvable one.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.121 [Reserved]
p.000317: § 97.122 Use of Federal funds.
p.000317: Federal funds administered by a de- partment or agency may not be ex- pended for research involving
p.000317: human subjects unless the requirements of this policy have been satisfied.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317: 34 CFR Subtitle A (7–1–10 Edition)
p.000317:
p.000317: § 97.123 Early termination of research support: Evaluation of applications and proposals.
p.000317: (a) The department or agency head may require that department or agency support for any project be terminated
p.000317: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000317: head finds an institution has materially failed to comply with the terms of this policy.
p.000317: (b) In making decisions about sup- porting or approving applications or proposals covered by this policy
p.000317: the de- partment or agency head may take into account, in addition to all other eligibility
p.000317: requirements and program criteria, factors such as whether the applicant has been subject to a termi-
p.000317: nation or suspension under paragarph
p.000317: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000317: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000317: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000317: welfare of human subjects (whether or not the research was subject to federal regulation).
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.124 Conditions.
p.000317: With respect to any research project or any class of research projects the de- partment or agency head may
p.000317: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000317: addi- tional conditions are necessary for the protection of human subjects.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: Subparts B–C [Reserved]
p.000317: Subpart D—Additional ED Protec- tions for Children Who Are Subjects in Research
p.000317:
p.000317: SOURCE: 62 FR 63221, Nov. 26, 1997, unless
p.000317: otherwise noted.
p.000318: 318
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...
p.000313:
p.000313: § 97.111
p.000313:
p.000313: § 97.111 Criteria for IRB approval of research.
p.000313: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000313: following require- ments are satisfied:
p.000313: (1) Risks to subjects are minimized:
p.000313: (i) By using procedures which are consistent with sound research design and which do not
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: § 97.101
p.000307: as defined in § 97.102(e), must comply with all sections of this policy.
p.000307: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000307: subject to regulation as defined in § 97.102(e) must be reviewed and approved, in compli- ance with §§ 97.101,
p.000307: 97.102, and §§ 97.107 through 97.117 of this policy, by an in- stitutional review board (IRB) that op- erates
p.000307: in accordance with the pertinent requirements of this policy.
p.000307: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000307: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000307: policy:
p.000307: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000307: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000307: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000307: cur- ricula, or classroom management methods.
p.000307: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000307: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000307: through identifiers linked to the subjects; and
p.000307: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000307: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000307: employability, or reputation.
p.000307: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000307: (b)(2) of this section, if:
p.000307: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000307: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000307: informa- tion will be maintained throughout the research and thereafter.
p.000307: 34 CFR Subtitle A (7–1–10 Edition)
p.000307: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000307: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000307: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000307: subjects.
p.000307: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000307: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000307: (i) Public benefit or service pro- grams;
p.000307: (ii) Procedures for obtaining benefits or services under those programs;
p.000307: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000307: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000307: (6) Taste and food quality evaluation and consumer acceptance studies,
p.000307: (i) If wholesome foods without addi- tives are consumed or
p.000307: (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000307: (b)(2) of this section, if:
p.000307: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000307: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000307: informa- tion will be maintained throughout the research and thereafter.
p.000307: 34 CFR Subtitle A (7–1–10 Edition)
p.000307: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000307: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000307: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000307: subjects.
p.000307: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000307: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000307: (i) Public benefit or service pro- grams;
p.000307: (ii) Procedures for obtaining benefits or services under those programs;
p.000307: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000307: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000307: (6) Taste and food quality evaluation and consumer acceptance studies,
p.000307: (i) If wholesome foods without addi- tives are consumed or
p.000307: (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use
p.000307: found to be safe, or agricultural chemical or environ- mental contaminant at or below the level
p.000307: found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or
p.000307: the Food Safety and Inspection Service of the U.S. Department of Agri- culture.
p.000307: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000307: covered by this policy.
p.000307: (d) Department or agency heads may require that specific research activities or classes of research
p.000307: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000307: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000307: (e) Compliance with this policy re- quires compliance with pertinent fed- eral laws or regulations which
p.000307: provide additional protections for human sub- jects.
p.000307: (f) This policy does not affect any state or local laws or regulations which
p.000308: 308
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308: Office of the Secretary, Education § 97.102
p.000308:
p.000308:
p.000308: may otherwise be applicable and which provide additional protections for human subjects.
p.000308: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000308: which pro- vide additional protections to human subjects of research.
p.000308: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
...
p.000308: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000308: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000308: or supported under a program which is considered research for other purposes. For example, some
p.000308: demonstration and service programs may include research activities.
p.000308: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000308: for which a federal department or agency has specific responsibility for regulating as
p.000308:
p.000308: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000308: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000308: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000308: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000308: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000308: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000308: when the investigator(s) do not participate in the activities being observed.
p.000309: 309
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309: § 97.103
p.000309: a research activity, (for example, In- vestigational New Drug requirements administered by the Food and Drug
p.000309: Ad- ministration). It does not include re- search activities which are inciden- tally regulated by a
p.000309: federal department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility
p.000309: to regulate certain types of ac- tivities whether research or non-re- search in nature (for
p.000309: example, Wage and Hour requirements administered by the Department of Labor).
p.000309: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000309: con- ducting research obtains
p.000309: (1) Data through intervention or interaction with the individual, or
p.000309: (2) Identifiable private information.
p.000309: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000309: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000309: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000309: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
p.000309: expect that no observation or recording is taking place, and informa- tion which has been provided for spe-
p.000309: cific purposes by an individual and which the individual can reasonably expect will not be made
p.000309: public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the
p.000309: identity of the subject is or may readily be ascertained by the investigator or associated with the in-
...
Searching for indicator influence:
(return to top)
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
...
p.000314: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000314: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000314: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000314: depart-
p.000314:
p.000314: ment or agency at reasonable times and in a reasonable manner.
p.000314: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000314: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000314: 3474; and 42 U.S.C. 300v–1(b))
p.000314: [56 FR 28012, 28021, June 18, 1991, as amended
p.000314: at 70 FR 36328, June 23, 2005]
p.000314:
p.000314: § 97.116 General requirements for in- formed consent.
p.000314: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000314: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000314: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000314: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000314: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000314: undue influence. The information that is given to the subject or the representative shall be in language
p.000314: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000314: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000314: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000314: sponsor, the insti- tution or its agents from liability for negligence.
p.000314: (a) Basic elements of informed consent.
p.000314: Except as provided in paragraph (c) or
p.000314: (d) of this section, in seeking informed consent the following information shall be provided to each subject:
p.000314: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000314: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000314: and identification of any procedures which are experi- mental;
p.000314: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000314: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000314: research;
p.000315: 315
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315: § 97.116
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
...
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000313: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000313: the department or agency head.
p.000313: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
...
Searching for indicator mentally:
(return to top)
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
...
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000313: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000313: the department or agency head.
...
Health / Motherhood/Family
Searching for indicator family:
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p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: § 97.108 IRB functions and operations.
p.000311: In order to fulfill the requirements of this policy each IRB shall:
p.000311: (a) Follow written procedures in the same detail as described in § 97.103(b)(4) and, to the extent
p.000311: required by,
p.000311: § 97.103(b)(5).
p.000311: (b) Except when an expedited review procedure is used (see § 97.110), review proposed research at
p.000311: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000311: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000311: approved,
p.000312: 312
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312: Office of the Secretary, Education § 97.110
p.000312:
p.000312:
p.000312: it shall receive the approval of a ma- jority of those members present at the meeting.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000313: (1) Risks to subjects are minimized:
p.000313: (i) By using procedures which are consistent with sound research design and which do not
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000313: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
...
p.000315: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000315: might be advan- tageous to the subject;
p.000315: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000315: subject will be maintained;
p.000315: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000315: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000315: consist of, or where further information may be ob- tained;
p.000315: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000315: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000315: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000315: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000315: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000315: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000315: information shall also be provided to each subject:
p.000315: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000315: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
p.000315: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000315: investigator without regard to the subject’s con- sent;
p.000315: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000315: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000315: of participation by the subject;
p.000315: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000315: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000315: 34 CFR Subtitle A (7–1–10 Edition)
p.000315: (6) The approximate number of sub- jects involved in the study.
p.000315: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000315: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000315: provided the IRB finds and documents that:
p.000315: (1) The research or demonstration project is to be conducted by or subject to the approval of state or
p.000315: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000315: (i) Public benefit of service programs;
p.000315: (ii) Procedures for obtaining benefits or services under those programs;
p.000315: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
...
Social / Access to Social Goods
Searching for indicator access:
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p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
p.000320: interest of the child for the duration of the child’s participation in the re- search and who is not
p.000320: associated in any way (except in the role as advocate or member of the IRB) with the research, the
p.000320: investigator or investigators, or the guardian organization.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: PART 98—STUDENT RIGHTS IN RE- SEARCH, EXPERIMENTAL PRO- GRAMS, AND TESTING
p.000320: Sec.
p.000320: 98.1 Applicability of part.
p.000320: 98.2 Definitions.
p.000320: 98.3 Access to instructional material used in a research or experimentation pro- gram.
p.000320: 98.4 Protection of students’ privacy in ex- amination, testing, or treatment.
p.000320: 98.5 Information and investigation office.
p.000320: 98.6 Reports.
p.000320: 98.7 Filing a complaint.
p.000320: 98.8 Notice of the complaint.
p.000320: 98.9 Investigation and findings.
p.000320: 98.10 Enforcement of the findings.
p.000320: AUTHORITY: Sec. 514(a) of Pub. L. 93–380, 88 Stat. 574 (20 U.S.C. 1232h(a)); sec. 1250 of Pub.
p.000320: L. 95–561, 92 Stat. 2355–2356 (20 U.S.C.
p.000320: 1232h(b)); and sec. 408(a)(1) of Pub. L. 90–247, 88 Stat. 559–560, as amended (20 U.S.C. 1221e– 3(a)(1));
p.000320: sec. 414(a) of Pub. L. 96–88, 93 Stat. 685 (20 U.S.C. 3474(a)), unless otherwise noted.
p.000320: SOURCE: 49 FR 35321, Sept. 6, 1984, unless
p.000320: otherwise noted.
p.000320: § 98.1 Applicability of part.
p.000320: This part applies to any program ad- ministered by the Secretary of Edu- cation that:
p.000320: (a)(1) Was transferred to the Depart- ment by the Department of Education Organization Act (DEOA); and
...
Social / Age
Searching for indicator age:
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p.000318: (2) This subpart applies to research conducted or supported by the Depart- ment of Education outside the
p.000318: United States, but in appropriate cir- cumstances the Secretary may, under
p.000318: § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this
p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
p.000318: in the research, under the applicable law of the jurisdiction in which the re- search will be
p.000318: conducted.
p.000318: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000318: not, ab- sent affirmative agreement, be con- strued as assent.
p.000318: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000318: research.
p.000318: (d) Parent means a child’s biological or adoptive parent.
p.000318:
p.000318: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000318: of a child to general medical care.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.403 IRB duties.
p.000318: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research
p.000318: covered by this subpart and approve only research that satisfies the conditions of all ap- plicable sections of
p.000318: this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
...
p.000320: 97.407 and permission is to be obtained from parents, both parents must give their permission unless one
p.000320: parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal
p.000320: responsibility for the care and custody of the child.
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
p.000320: (b) of this section, provided an appro- priate mechanism for protecting the children who will
p.000320: participate as sub- jects in the research is substituted, and provided further that the waiver is not inconsistent
p.000320: with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and
p.000320: purpose of the activities described in the protocol, the risk and antici- pated benefit to the
p.000320: research subjects, and their age, maturity, status, and condition.
p.000320: (d) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000320: required by
p.000320: § 97.117.
p.000320: (e) If the IRB determines that assent is required, it shall also determine whether and how assent
p.000320: must be docu- mented.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: § 97.409 Wards.
p.000320: (a) Children who are wards of the State or any other agency, institution, or entity may be included in
p.000320: research approved under § 97.406 or § 97.407 only if that research is—
p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
...
Social / Child
Searching for indicator child:
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p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
p.000318: in the research, under the applicable law of the jurisdiction in which the re- search will be
p.000318: conducted.
p.000318: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000318: not, ab- sent affirmative agreement, be con- strued as assent.
p.000318: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000318: research.
p.000318: (d) Parent means a child’s biological or adoptive parent.
p.000318:
p.000318: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000318: of a child to general medical care.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.403 IRB duties.
p.000318: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research
p.000318: covered by this subpart and approve only research that satisfies the conditions of all ap- plicable sections of
p.000318: this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.404 Research not involving great- er than minimal risk.
p.000318: ED conducts or funds research in which the IRB finds that no greater than minimal risk to children
p.000318: is pre- sented, only if the IRB finds that ade- quate provisions are made for solic- iting the assent
p.000318: of the children and the permission of their parents or guard- ians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000318:
p.000318: § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000318: the individual subjects.
...
p.000319: parents or guardians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.408 Requirements for permission by parents or guardians and for as- sent by children.
p.000319: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000319: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, if in
p.000319: the judgment of the IRB the children are capable of providing assent. In determining whether chil- dren
p.000319: are capable of assenting, the IRB shall take into account the ages, matu- rity, and psychological state of
p.000319: the children involved. This judgment may be made for all children to be involved in research under a
p.000319: particular protocol, or for each child, as the IRB deems ap- propriate. If the IRB determines that the
p.000319: capability of some or all of the children is so limited that they cannot reasonably be consulted or
p.000319: that the intervention or procedure involved in the research holds out a prospect of di- rect benefit that is
p.000319: important to the health or well-being of the children and is available only in the context of the research,
p.000319: the assent of the children is not a necessary condition for pro- ceeding with the research. Even if
p.000319: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000319: requirement under circumstances in which consent may be waived in accord with § 97.116.
p.000319: (b) In addition to the determinations
p.000319: required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance
p.000319: with and to the extent that consent is required by
p.000319: § 97.116, that adequate provisions are
p.000320: 320
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320: Office of the Secretary, Education § 98.1
p.000320:
p.000320:
p.000320: made for soliciting the permission of each child’s parent(s) or guardian(s). If parental permission is to
p.000320: be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000320: under § 97.404 or § 97.405. If research is covered by §§ 97.406 and
p.000320: 97.407 and permission is to be obtained from parents, both parents must give their permission unless one
p.000320: parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal
p.000320: responsibility for the care and custody of the child.
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
p.000320: (b) of this section, provided an appro- priate mechanism for protecting the children who will
p.000320: participate as sub- jects in the research is substituted, and provided further that the waiver is not inconsistent
p.000320: with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and
p.000320: purpose of the activities described in the protocol, the risk and antici- pated benefit to the
p.000320: research subjects, and their age, maturity, status, and condition.
p.000320: (d) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000320: required by
p.000320: § 97.117.
p.000320: (e) If the IRB determines that assent is required, it shall also determine whether and how assent
p.000320: must be docu- mented.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: § 97.409 Wards.
p.000320: (a) Children who are wards of the State or any other agency, institution, or entity may be included in
p.000320: research approved under § 97.406 or § 97.407 only if that research is—
p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
p.000320: interest of the child for the duration of the child’s participation in the re- search and who is not
p.000320: associated in any way (except in the role as advocate or member of the IRB) with the research, the
p.000320: investigator or investigators, or the guardian organization.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: PART 98—STUDENT RIGHTS IN RE- SEARCH, EXPERIMENTAL PRO- GRAMS, AND TESTING
p.000320: Sec.
p.000320: 98.1 Applicability of part.
p.000320: 98.2 Definitions.
p.000320: 98.3 Access to instructional material used in a research or experimentation pro- gram.
p.000320: 98.4 Protection of students’ privacy in ex- amination, testing, or treatment.
p.000320: 98.5 Information and investigation office.
p.000320: 98.6 Reports.
p.000320: 98.7 Filing a complaint.
p.000320: 98.8 Notice of the complaint.
p.000320: 98.9 Investigation and findings.
p.000320: 98.10 Enforcement of the findings.
p.000320: AUTHORITY: Sec. 514(a) of Pub. L. 93–380, 88 Stat. 574 (20 U.S.C. 1232h(a)); sec. 1250 of Pub.
p.000320: L. 95–561, 92 Stat. 2355–2356 (20 U.S.C.
p.000320: 1232h(b)); and sec. 408(a)(1) of Pub. L. 90–247, 88 Stat. 559–560, as amended (20 U.S.C. 1221e– 3(a)(1));
p.000320: sec. 414(a) of Pub. L. 96–88, 93 Stat. 685 (20 U.S.C. 3474(a)), unless otherwise noted.
p.000320: SOURCE: 49 FR 35321, Sept. 6, 1984, unless
p.000320: otherwise noted.
p.000320: § 98.1 Applicability of part.
...
Searching for indicator children:
(return to top)
p.000307: 97.102 Definitions.
p.000307: 97.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department
p.000307: or Agency.
p.000307: 97.104–97.106 [Reserved]
p.000307: 97.107 IRB membership.
p.000307: 97.108 IRB functions and operations.
p.000307: 97.109 IRB review of research.
p.000307: 97.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000307: and for minor changes in approved research.
p.000307: 97.111 Criteria for IRB approval of research.
p.000307: 97.112 Review by institution.
p.000307: 97.113 Suspension or termination of IRB ap- proval of research.
p.000307: 97.114 Cooperative research.
p.000307: 97.115 IRB records.
p.000307: 97.116 General requirements for informed consent.
p.000307: 97.117 Documentation of informed consent.
p.000307: 97.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000307: 97.119 Research undertaken without the in- tention of involving human subjects.
p.000307: 97.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000307: supported by a Federal De- partment or Agency.
p.000307: 97.121 [Reserved]
p.000307: 97.122 Use of Federal funds.
p.000307: 97.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000307: 97.124 Conditions.
p.000307: Subparts B–C [Reserved]
p.000307: Subpart D—Additional ED Protections for Children Who are Subjects in Research
p.000307: 97.401 To what do these regulations apply?
p.000307: 97.402 Definitions.
p.000307: 97.403 IRB duties.
p.000307: 97.404 Research not involving greater than minimal risk.
p.000307: 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000307: the individual sub- jects.
p.000307: 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000307: individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
p.000307: 97.407 Research not otherwise approvable which presents an opportunity to under- stand, prevent, or
p.000307: alleviate a serious problem affecting the health or welfare of children.
p.000307: 97.408 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000307: 97.409 Wards.
p.000307: AUTHORITY: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000307: 3474; 42 U.S.C. 300v–1(b).
p.000307: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000307: unless otherwise noted.
p.000307:
p.000307: Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human
p.000307: Research Sub- jects)
p.000307: § 97.101 To what does this policy apply?
p.000307: (a) Except as provided in paragraph
p.000307: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000307: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000307: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000307: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000307: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000307: research con- ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
...
p.000308: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000308: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000308: procedure(s) involved in the research.
p.000308: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000308: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000308: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000308: or supported under a program which is considered research for other purposes. For example, some
p.000308: demonstration and service programs may include research activities.
p.000308: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000308: for which a federal department or agency has specific responsibility for regulating as
p.000308:
p.000308: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000308: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000308: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000308: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000308: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000308: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000308: when the investigator(s) do not participate in the activities being observed.
p.000309: 309
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309: § 97.103
p.000309: a research activity, (for example, In- vestigational New Drug requirements administered by the Food and Drug
p.000309: Ad- ministration). It does not include re- search activities which are inciden- tally regulated by a
p.000309: federal department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility
p.000309: to regulate certain types of ac- tivities whether research or non-re- search in nature (for
p.000309: example, Wage and Hour requirements administered by the Department of Labor).
p.000309: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000309: con- ducting research obtains
p.000309: (1) Data through intervention or interaction with the individual, or
p.000309: (2) Identifiable private information.
p.000309: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000309: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000309: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000309: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
...
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
...
p.000313: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000313: following require- ments are satisfied:
p.000313: (1) Risks to subjects are minimized:
p.000313: (i) By using procedures which are consistent with sound research design and which do not
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
...
p.000317: the de- partment or agency head may take into account, in addition to all other eligibility
p.000317: requirements and program criteria, factors such as whether the applicant has been subject to a termi-
p.000317: nation or suspension under paragarph
p.000317: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000317: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000317: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000317: welfare of human subjects (whether or not the research was subject to federal regulation).
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.124 Conditions.
p.000317: With respect to any research project or any class of research projects the de- partment or agency head may
p.000317: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000317: addi- tional conditions are necessary for the protection of human subjects.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: Subparts B–C [Reserved]
p.000317: Subpart D—Additional ED Protec- tions for Children Who Are Subjects in Research
p.000317:
p.000317: SOURCE: 62 FR 63221, Nov. 26, 1997, unless
p.000317: otherwise noted.
p.000318: 318
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318: Office of the Secretary, Education § 97.405
p.000318:
p.000318:
p.000318: § 97.401 To what do these regulations apply?
p.000318: (a) This subpart applies to all re- search involving children as subjects conducted or supported
p.000318: by the Depart- ment of Education.
p.000318: (1) This subpart applies to research conducted by Department employees.
p.000318: (2) This subpart applies to research conducted or supported by the Depart- ment of Education outside the
p.000318: United States, but in appropriate cir- cumstances the Secretary may, under
p.000318: § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this
p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
p.000318: in the research, under the applicable law of the jurisdiction in which the re- search will be
p.000318: conducted.
p.000318: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000318: not, ab- sent affirmative agreement, be con- strued as assent.
p.000318: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000318: research.
p.000318: (d) Parent means a child’s biological or adoptive parent.
p.000318:
p.000318: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000318: of a child to general medical care.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.403 IRB duties.
p.000318: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research
p.000318: covered by this subpart and approve only research that satisfies the conditions of all ap- plicable sections of
p.000318: this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.404 Research not involving great- er than minimal risk.
p.000318: ED conducts or funds research in which the IRB finds that no greater than minimal risk to children
p.000318: is pre- sented, only if the IRB finds that ade- quate provisions are made for solic- iting the assent
p.000318: of the children and the permission of their parents or guard- ians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000318:
p.000318: § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000318: the individual subjects.
p.000318: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000318: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
p.000318: subject, or by a mon- itoring procedure that is likely to con- tribute to the subject’s well-being, only if the IRB
p.000318: finds that—
p.000318: (a) The risk is justified by the antici- pated benefit to the subjects;
p.000318: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000318: as that presented by available alternative approaches; and
p.000318: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000318: parents or guardians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000319: 319
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319: § 97.406
p.000319:
p.000319: § 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000319: individual sub- jects, but likely to yield generaliz- able knowledge about the subject’s disorder or
p.000319: condition.
p.000319: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000319: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual
p.000319: subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000319: only if the IRB finds that—
p.000319: (a) The risk represents a minor in- crease over minimal risk;
p.000319: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000319: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000319: educational situations;
p.000319: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000319: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000319: condition; and
p.000319: (d) Adequate provisions are made for soliciting assent of the children and permission of their
p.000319: parents or guard- ians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al-
p.000319: leviate a serious problem affecting the health or welfare of children.
p.000319: ED conducts or funds research that the IRB does not believe meets the re- quirements of § 97.404, § 97.405,
p.000319: or § 97.406 only if—
p.000319: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000319: prevention, or alleviation of a serious problem af- fecting the health or welfare of chil- dren; and
p.000319: (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example:
p.000319: science, medi- cine, education, ethics, law) and fol- lowing opportunity for public review and
p.000319: comment, has determined either that—
p.000319: 34 CFR Subtitle A (7–1–10 Edition)
p.000319: (1) The research in fact satisfies the conditions of § 97.404, § 97.405, or § 97.406, as applicable; or
p.000319: (2)(i) The research presents a reason- able opportunity to further the under- standing, prevention, or
p.000319: alleviation of a serious problem affecting the health or welfare of children;
p.000319: (ii) The research will be conducted in accordance with sound ethical prin- ciples; and
p.000319: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000319: parents or guardians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.408 Requirements for permission by parents or guardians and for as- sent by children.
p.000319: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000319: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, if in
p.000319: the judgment of the IRB the children are capable of providing assent. In determining whether chil- dren
p.000319: are capable of assenting, the IRB shall take into account the ages, matu- rity, and psychological state of
p.000319: the children involved. This judgment may be made for all children to be involved in research under a
p.000319: particular protocol, or for each child, as the IRB deems ap- propriate. If the IRB determines that the
p.000319: capability of some or all of the children is so limited that they cannot reasonably be consulted or
p.000319: that the intervention or procedure involved in the research holds out a prospect of di- rect benefit that is
p.000319: important to the health or well-being of the children and is available only in the context of the research,
p.000319: the assent of the children is not a necessary condition for pro- ceeding with the research. Even if
p.000319: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000319: requirement under circumstances in which consent may be waived in accord with § 97.116.
p.000319: (b) In addition to the determinations
p.000319: required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance
p.000319: with and to the extent that consent is required by
p.000319: § 97.116, that adequate provisions are
p.000320: 320
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320: Office of the Secretary, Education § 98.1
p.000320:
p.000320:
p.000320: made for soliciting the permission of each child’s parent(s) or guardian(s). If parental permission is to
p.000320: be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000320: under § 97.404 or § 97.405. If research is covered by §§ 97.406 and
p.000320: 97.407 and permission is to be obtained from parents, both parents must give their permission unless one
p.000320: parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal
p.000320: responsibility for the care and custody of the child.
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
p.000320: (b) of this section, provided an appro- priate mechanism for protecting the children who will
p.000320: participate as sub- jects in the research is substituted, and provided further that the waiver is not inconsistent
p.000320: with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and
p.000320: purpose of the activities described in the protocol, the risk and antici- pated benefit to the
p.000320: research subjects, and their age, maturity, status, and condition.
p.000320: (d) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000320: required by
p.000320: § 97.117.
p.000320: (e) If the IRB determines that assent is required, it shall also determine whether and how assent
p.000320: must be docu- mented.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: § 97.409 Wards.
p.000320: (a) Children who are wards of the State or any other agency, institution, or entity may be included in
p.000320: research approved under § 97.406 or § 97.407 only if that research is—
p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
p.000320: interest of the child for the duration of the child’s participation in the re- search and who is not
p.000320: associated in any way (except in the role as advocate or member of the IRB) with the research, the
p.000320: investigator or investigators, or the guardian organization.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: PART 98—STUDENT RIGHTS IN RE- SEARCH, EXPERIMENTAL PRO- GRAMS, AND TESTING
p.000320: Sec.
p.000320: 98.1 Applicability of part.
p.000320: 98.2 Definitions.
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315: § 97.116
p.000315: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000315: might be advan- tageous to the subject;
p.000315: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000315: subject will be maintained;
p.000315: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000315: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000315: consist of, or where further information may be ob- tained;
p.000315: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000315: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000315: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000315: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000315: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000315: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000315: information shall also be provided to each subject:
p.000315: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000315: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
p.000315: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000315: investigator without regard to the subject’s con- sent;
p.000315: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000315: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000315: of participation by the subject;
p.000315: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000315: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000315: 34 CFR Subtitle A (7–1–10 Edition)
p.000315: (6) The approximate number of sub- jects involved in the study.
p.000315: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000315: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000315: provided the IRB finds and documents that:
p.000315: (1) The research or demonstration project is to be conducted by or subject to the approval of state or
p.000315: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000315: (i) Public benefit of service programs;
p.000315: (ii) Procedures for obtaining benefits or services under those programs;
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000314: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000314: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000314: depart-
p.000314:
p.000314: ment or agency at reasonable times and in a reasonable manner.
p.000314: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000314: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000314: 3474; and 42 U.S.C. 300v–1(b))
p.000314: [56 FR 28012, 28021, June 18, 1991, as amended
p.000314: at 70 FR 36328, June 23, 2005]
p.000314:
p.000314: § 97.116 General requirements for in- formed consent.
p.000314: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000314: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000314: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000314: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000314: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000314: undue influence. The information that is given to the subject or the representative shall be in language
p.000314: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000314: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000314: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000314: sponsor, the insti- tution or its agents from liability for negligence.
p.000314: (a) Basic elements of informed consent.
p.000314: Except as provided in paragraph (c) or
p.000314: (d) of this section, in seeking informed consent the following information shall be provided to each subject:
p.000314: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000314: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000314: and identification of any procedures which are experi- mental;
p.000314: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000314: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000314: research;
p.000315: 315
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315: § 97.116
p.000315: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000315: might be advan- tageous to the subject;
p.000315: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000315: subject will be maintained;
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000308: those provided in this policy, the department or agency head may approve the substitution of the
p.000308: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000308: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
p.000308: they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department
p.000308: or agency procedures.
p.000308: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000308: of the provisions of this policy to specific re- search activities or classes of research activities
p.000308: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000308: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000308: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000308: and shall also publish them in the FEDERAL REGISTER or in
p.000308:
p.000308: such other manner as provided in de- partment or agency procedures. 1
p.000308: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000308: 3474; and 42 U.S.C. 300v–1(b))
p.000308: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000308: June 28, 1991, as amended at 70 FR 36328,
p.000308: June 23, 2005]
p.000308:
p.000308: § 97.102 Definitions.
p.000308: (a) Department or agency head means the head of any federal department or agency and any other officer
p.000308: or em- ployee of any department or agency to whom authority has been delegated.
p.000308: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000308: agencies).
p.000308: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000308: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000308: procedure(s) involved in the research.
p.000308: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000308: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000308: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000308: or supported under a program which is considered research for other purposes. For example, some
p.000308: demonstration and service programs may include research activities.
p.000308: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000308: for which a federal department or agency has specific responsibility for regulating as
p.000308:
p.000308: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000308: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000308: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000311: certification must be submitted with the application or pro- posal or by such later date as may be
p.000311: prescribed by the department or agen- cy to which the application or proposal is submitted. Under no condition
p.000311: shall research covered by § 97.103 of the Pol- icy be supported prior to receipt of the certification that the
p.000311: research has been reviewed and approved by the IRB. In- stitutions without an approved assur- ance covering
p.000311: the research shall certify within 30 days after receipt of a request for such a certification from the de-
p.000311: partment or agency, that the applica- tion or proposal has been approved by the IRB. If the certification is
p.000311: not sub- mitted within these time limits, the application or proposal may be re- turned to the
p.000311: institution.
p.000311: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000307: 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000307: individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
p.000307: 97.407 Research not otherwise approvable which presents an opportunity to under- stand, prevent, or
p.000307: alleviate a serious problem affecting the health or welfare of children.
p.000307: 97.408 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000307: 97.409 Wards.
p.000307: AUTHORITY: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000307: 3474; 42 U.S.C. 300v–1(b).
p.000307: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000307: unless otherwise noted.
p.000307:
p.000307: Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human
p.000307: Research Sub- jects)
p.000307: § 97.101 To what does this policy apply?
p.000307: (a) Except as provided in paragraph
p.000307: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000307: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000307: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000307: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000307: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000307: research con- ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: § 97.101
p.000307: as defined in § 97.102(e), must comply with all sections of this policy.
p.000307: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000307: subject to regulation as defined in § 97.102(e) must be reviewed and approved, in compli- ance with §§ 97.101,
p.000307: 97.102, and §§ 97.107 through 97.117 of this policy, by an in- stitutional review board (IRB) that op- erates
p.000307: in accordance with the pertinent requirements of this policy.
p.000307: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000307: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000307: policy:
p.000307: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000307: educational practices, such as (i) research on reg- ular and special education instruc- tional
...
Social / Student
Searching for indicator student:
(return to top)
p.000308: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000308: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000308: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000308: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000308: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000308: when the investigator(s) do not participate in the activities being observed.
p.000309: 309
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309:
p.000309: § 97.103
p.000309: a research activity, (for example, In- vestigational New Drug requirements administered by the Food and Drug
p.000309: Ad- ministration). It does not include re- search activities which are inciden- tally regulated by a
p.000309: federal department or agency solely as part of the depart- ment’s or agency’s broader responsi- bility
p.000309: to regulate certain types of ac- tivities whether research or non-re- search in nature (for
p.000309: example, Wage and Hour requirements administered by the Department of Labor).
p.000309: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000309: con- ducting research obtains
p.000309: (1) Data through intervention or interaction with the individual, or
p.000309: (2) Identifiable private information.
p.000309: Intervention includes both physical pro- cedures by which data are gathered (for example, venipuncture) and
p.000309: manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes.
p.000309: Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private
p.000309: information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably
p.000309: expect that no observation or recording is taking place, and informa- tion which has been provided for spe-
p.000309: cific purposes by an individual and which the individual can reasonably expect will not be made
p.000309: public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the
p.000309: identity of the subject is or may readily be ascertained by the investigator or associated with the in-
p.000309: formation) in order for obtaining the information to constitute research in- volving human subjects.
p.000309: (g) IRB means an institutional review
p.000309: board established in accord with and for the purposes expressed in this pol- icy.
p.000309: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000309: may be con- ducted at an institution within the constraints set forth by the IRB and by other
p.000309: institutional and federal require- ments.
...
p.000320: (a) Children who are wards of the State or any other agency, institution, or entity may be included in
p.000320: research approved under § 97.406 or § 97.407 only if that research is—
p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
p.000320: interest of the child for the duration of the child’s participation in the re- search and who is not
p.000320: associated in any way (except in the role as advocate or member of the IRB) with the research, the
p.000320: investigator or investigators, or the guardian organization.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: PART 98—STUDENT RIGHTS IN RE- SEARCH, EXPERIMENTAL PRO- GRAMS, AND TESTING
p.000320: Sec.
p.000320: 98.1 Applicability of part.
p.000320: 98.2 Definitions.
p.000320: 98.3 Access to instructional material used in a research or experimentation pro- gram.
p.000320: 98.4 Protection of students’ privacy in ex- amination, testing, or treatment.
p.000320: 98.5 Information and investigation office.
p.000320: 98.6 Reports.
p.000320: 98.7 Filing a complaint.
p.000320: 98.8 Notice of the complaint.
p.000320: 98.9 Investigation and findings.
p.000320: 98.10 Enforcement of the findings.
p.000320: AUTHORITY: Sec. 514(a) of Pub. L. 93–380, 88 Stat. 574 (20 U.S.C. 1232h(a)); sec. 1250 of Pub.
p.000320: L. 95–561, 92 Stat. 2355–2356 (20 U.S.C.
p.000320: 1232h(b)); and sec. 408(a)(1) of Pub. L. 90–247, 88 Stat. 559–560, as amended (20 U.S.C. 1221e– 3(a)(1));
p.000320: sec. 414(a) of Pub. L. 96–88, 93 Stat. 685 (20 U.S.C. 3474(a)), unless otherwise noted.
p.000320: SOURCE: 49 FR 35321, Sept. 6, 1984, unless
p.000320: otherwise noted.
p.000320: § 98.1 Applicability of part.
p.000320: This part applies to any program ad- ministered by the Secretary of Edu- cation that:
p.000320: (a)(1) Was transferred to the Depart- ment by the Department of Education Organization Act (DEOA); and
...
Social / Women
Searching for indicator women:
(return to top)
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: § 97.108 IRB functions and operations.
p.000311: In order to fulfill the requirements of this policy each IRB shall:
p.000311: (a) Follow written procedures in the same detail as described in § 97.103(b)(4) and, to the extent
p.000311: required by,
p.000311: § 97.103(b)(5).
...
p.000313: (i) By using procedures which are consistent with sound research design and which do not
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
p.000313: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000313: the purposes of the research and the setting in which the research will be conducted and should be
p.000313: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000313: children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally
p.000313: disadvantaged persons.
p.000313: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000313: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000313: the department or agency head.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: Office of the Secretary, Education § 97.101
p.000307:
p.000307:
p.000307: has met any repayment obligation im- posed upon it under § 86.301(b)(1) of this part.
p.000307: (b) In addition to the requirements of paragraph (a) of this section, the IHE shall comply with the
p.000307: requirements and procedures for reinstatement of eligibility applicable to any Federal program under
p.000307: which it desires to re- ceive Federal financial assistance.
p.000307: (Authority: 20 U.S.C. 1145g)
p.000307: [55 FR 33581, Aug. 16, 1990, as amended at 61
p.000307: FR 66225, Dec. 17, 1996]
p.000307:
p.000307: PART 97—PROTECTION OF HUMAN SUBJECTS
p.000307: Subpart A—Federal Policy for the Protec- tion of Human Subjects (Basic ED Pol- icy for Protection of Human
p.000307: Research Subjects)
p.000307: Sec.
p.000307: 97.101 To what does this policy apply?
p.000307: 97.102 Definitions.
p.000307: 97.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department
p.000307: or Agency.
p.000307: 97.104–97.106 [Reserved]
p.000307: 97.107 IRB membership.
p.000307: 97.108 IRB functions and operations.
p.000307: 97.109 IRB review of research.
p.000307: 97.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000307: and for minor changes in approved research.
p.000307: 97.111 Criteria for IRB approval of research.
p.000307: 97.112 Review by institution.
p.000307: 97.113 Suspension or termination of IRB ap- proval of research.
p.000307: 97.114 Cooperative research.
p.000307: 97.115 IRB records.
p.000307: 97.116 General requirements for informed consent.
p.000307: 97.117 Documentation of informed consent.
p.000307: 97.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000307: 97.119 Research undertaken without the in- tention of involving human subjects.
p.000307: 97.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000307: supported by a Federal De- partment or Agency.
p.000307: 97.121 [Reserved]
p.000307: 97.122 Use of Federal funds.
p.000307: 97.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000307: 97.124 Conditions.
p.000307: Subparts B–C [Reserved]
p.000307: Subpart D—Additional ED Protections for Children Who are Subjects in Research
p.000307: 97.401 To what do these regulations apply?
p.000307: 97.402 Definitions.
p.000307: 97.403 IRB duties.
p.000307: 97.404 Research not involving greater than minimal risk.
p.000307: 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000307: the individual sub- jects.
...
p.000312: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000312: with
p.000312: § 97.117.
p.000312: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000312: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000312: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000312: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000312: person or in writing.
p.000312: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000312: 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.000312: party observe the consent process and the research.
p.000312: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000312: [56 FR 28012, 28021, June 18, 1991, as amended
p.000312: at 70 FR 36328, June 23, 2005]
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312:
p.000312: § 97.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000312: minor changes in approved re- search.
p.000312: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000312: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000312: be amended, as appropriate after consultation with other departments and agencies, through
p.000312: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000312: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000312: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000312: (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.000312: mini- mal risk,
p.000312: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000312: approval is authorized.
p.000312: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or
p.000312: more ex- perienced reviewers designated by the chairperson from among members of the IRB. In reviewing the
p.000312: research, the reviewers may exercise all of the au- thorities of the IRB except that the re- viewers may not
p.000312: disapprove the re- search. A research activity may be dis- approved only after review in accord- ance with
p.000312: the non-expedited procedure set forth in § 97.108(b).
p.000312: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of
p.000312: re- search proposals which have been ap- proved under the procedure.
p.000312: (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an
p.000312: institu- tion’s or IRB’s use of the expedited re- view procedure.
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312: [56 FR 28012, 28021, June 18, 1991, as amended
p.000312: at 70 FR 36328, June 23, 2005]
p.000313: 313
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313: § 97.111
p.000313:
p.000313: § 97.111 Criteria for IRB approval of research.
p.000313: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000313: following require- ments are satisfied:
p.000313: (1) Risks to subjects are minimized:
...
p.000318: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000318: as that presented by available alternative approaches; and
p.000318: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000318: parents or guardians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000319: 319
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319: § 97.406
p.000319:
p.000319: § 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000319: individual sub- jects, but likely to yield generaliz- able knowledge about the subject’s disorder or
p.000319: condition.
p.000319: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000319: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual
p.000319: subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000319: only if the IRB finds that—
p.000319: (a) The risk represents a minor in- crease over minimal risk;
p.000319: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000319: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000319: educational situations;
p.000319: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000319: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000319: condition; and
p.000319: (d) Adequate provisions are made for soliciting assent of the children and permission of their
p.000319: parents or guard- ians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al-
p.000319: leviate a serious problem affecting the health or welfare of children.
p.000319: ED conducts or funds research that the IRB does not believe meets the re- quirements of § 97.404, § 97.405,
p.000319: or § 97.406 only if—
p.000319: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
...
Social / education
Searching for indicator education:
(return to top)
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: Office of the Secretary, Education § 97.101
p.000307:
p.000307:
p.000307: has met any repayment obligation im- posed upon it under § 86.301(b)(1) of this part.
p.000307: (b) In addition to the requirements of paragraph (a) of this section, the IHE shall comply with the
p.000307: requirements and procedures for reinstatement of eligibility applicable to any Federal program under
p.000307: which it desires to re- ceive Federal financial assistance.
p.000307: (Authority: 20 U.S.C. 1145g)
p.000307: [55 FR 33581, Aug. 16, 1990, as amended at 61
p.000307: FR 66225, Dec. 17, 1996]
p.000307:
p.000307: PART 97—PROTECTION OF HUMAN SUBJECTS
p.000307: Subpart A—Federal Policy for the Protec- tion of Human Subjects (Basic ED Pol- icy for Protection of Human
p.000307: Research Subjects)
p.000307: Sec.
p.000307: 97.101 To what does this policy apply?
p.000307: 97.102 Definitions.
p.000307: 97.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department
p.000307: or Agency.
p.000307: 97.104–97.106 [Reserved]
p.000307: 97.107 IRB membership.
p.000307: 97.108 IRB functions and operations.
p.000307: 97.109 IRB review of research.
p.000307: 97.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000307: and for minor changes in approved research.
p.000307: 97.111 Criteria for IRB approval of research.
p.000307: 97.112 Review by institution.
p.000307: 97.113 Suspension or termination of IRB ap- proval of research.
...
p.000307: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000307: research con- ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: § 97.101
p.000307: as defined in § 97.102(e), must comply with all sections of this policy.
p.000307: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000307: subject to regulation as defined in § 97.102(e) must be reviewed and approved, in compli- ance with §§ 97.101,
p.000307: 97.102, and §§ 97.107 through 97.117 of this policy, by an in- stitutional review board (IRB) that op- erates
p.000307: in accordance with the pertinent requirements of this policy.
p.000307: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000307: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000307: policy:
p.000307: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000307: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000307: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000307: cur- ricula, or classroom management methods.
p.000307: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000307: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000307: through identifiers linked to the subjects; and
p.000307: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000307: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000307: employability, or reputation.
p.000307: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000307: (b)(2) of this section, if:
p.000307: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000307: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000307: informa- tion will be maintained throughout the research and thereafter.
p.000307: 34 CFR Subtitle A (7–1–10 Edition)
p.000307: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
...
p.000307: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000307: (6) Taste and food quality evaluation and consumer acceptance studies,
p.000307: (i) If wholesome foods without addi- tives are consumed or
p.000307: (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use
p.000307: found to be safe, or agricultural chemical or environ- mental contaminant at or below the level
p.000307: found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or
p.000307: the Food Safety and Inspection Service of the U.S. Department of Agri- culture.
p.000307: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000307: covered by this policy.
p.000307: (d) Department or agency heads may require that specific research activities or classes of research
p.000307: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000307: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000307: (e) Compliance with this policy re- quires compliance with pertinent fed- eral laws or regulations which
p.000307: provide additional protections for human sub- jects.
p.000307: (f) This policy does not affect any state or local laws or regulations which
p.000308: 308
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308: Office of the Secretary, Education § 97.102
p.000308:
p.000308:
p.000308: may otherwise be applicable and which provide additional protections for human subjects.
p.000308: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000308: which pro- vide additional protections to human subjects of research.
p.000308: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
p.000308: in the foreign countries to protect human subjects may differ from those set forth in this
p.000308: policy. (An example is a foreign institution which complies with guidelines consistent with the
p.000308: World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign
p.000308: states or by an organization whose function for the protection of human research subjects is
p.000308: internationally recognized.) In these circumstances, if a department or agency head determines that the
p.000308: proce- dures prescribed by the institution af- ford protections that are at least equivalent to
p.000308: those provided in this policy, the department or agency head may approve the substitution of the
p.000308: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000308: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
...
p.000309: supported by a federal department or agency shall provide written assurance satisfactory to the department or
p.000309: agency head that it will comply with the requirements set forth in this policy. In lieu of re- quiring
p.000309: submission of an assurance, in- dividual department or agency heads shall accept the existence of a current
p.000309: assurance, appropriate for the research in question, on file with the Office for Human Research Protections,
p.000309: HHS, or any successor office, and approved for federalwide use by that office. When the existence of
p.000309: an HHS-approved as- surance is accepted in lieu of requiring submission of an assurance, reports (except
p.000309: certification) required by this policy to be made to department and agency heads shall also be made to the
p.000309: Office for Human Research Protec- tions, (HHS), or any successor office.
p.000309: (b) Departments and agencies will
p.000309: conduct or support research covered by this policy only if the institution has an assurance approved as
p.000309: provided in this section, and only if the institution has certified to the department or agency head that
p.000309: the research has been reviewed and approved by an IRB pro- vided for in the assurance, and will be subject
p.000309: to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall
p.000309: at a minimum include:
p.000309: (1) A statement of principles gov-
p.000309: erning the institution in the discharge
p.000310: 310
p.000310:
p.000310:
p.000310:
p.000310:
p.000310:
p.000310:
p.000310:
p.000310: Office of the Secretary, Education § 97.103
p.000310:
p.000310:
p.000310: of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or
p.000310: sponsored by the institution, regardless of whether the research is subject to federal regu- lation. This
p.000310: may include an appro- priate existing code, declaration, or statement of ethical principles, or
p.000310: a statement formulated by the institu- tion itself. This requirement does not preempt provisions of this
p.000310: policy appli- cable to department- or agency-sup- ported or regulated research and need not be
p.000310: applicable to any research ex- empted or waived under § 97.101 (b) or (i).
p.000310: (2) Designation of one or more IRBs
p.000310: established in accordance with the re- quirements of this policy, and for which provisions are
p.000310: made for meeting space and sufficient staff to support the IRB’s review and recordkeeping du- ties.
p.000310: (3) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of
p.000310: experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief
p.000310: anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each
p.000310: member and the institution; for example: full-time employee, part-time employee, member of governing panel or
p.000310: board, stockholder, paid or unpaid consultant. Changes in IRB member- ship shall be reported to the
...
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: § 97.108 IRB functions and operations.
p.000311: In order to fulfill the requirements of this policy each IRB shall:
p.000311: (a) Follow written procedures in the same detail as described in § 97.103(b)(4) and, to the extent
p.000311: required by,
p.000311: § 97.103(b)(5).
p.000311: (b) Except when an expedited review procedure is used (see § 97.110), review proposed research at
p.000311: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000311: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000311: approved,
p.000312: 312
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312: Office of the Secretary, Education § 97.110
p.000312:
p.000312:
p.000312: it shall receive the approval of a ma- jority of those members present at the meeting.
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312:
p.000312: § 97.109 IRB review of research.
p.000312: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000312: approval), or dis- approve all research activities covered by this policy.
p.000312: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000312: accordance with
p.000312: § 97.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000312: 97.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000312: the protection of the rights and welfare of subjects.
p.000312: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000312: with
p.000312: § 97.117.
p.000312: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000312: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000312: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
...
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000313: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000313: the department or agency head.
p.000313: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: [56 FR 28012, 28021, June 18, 1991, as amended
p.000313: at 70 FR 36328, June 23, 2005]
p.000313: § 97.114 Cooperative research.
p.000313: Cooperative research projects are those projects covered by this policy which involve more than one
p.000313: institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for
p.000313: safeguarding the rights and welfare of human subjects and for complying with this policy. With the
p.000313: approval of the department or agency
p.000314: 314
p.000314:
p.000314:
p.000314:
p.000314:
p.000314:
p.000314:
p.000314:
p.000314: Office of the Secretary, Education § 97.116
p.000314:
p.000314:
p.000314: head, an institution participating in a cooperative project may enter into a joint review arrangement,
p.000314: rely upon the review of another qualified IRB, or make similar arrangements for avoid- ing duplication of effort.
p.000314: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000314: 3474; and 42 U.S.C. 300v–1(b))
p.000314:
p.000314: § 97.115 IRB records.
p.000314: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000314: documentation of IRB activities, including the following:
p.000314: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000314: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000314: reports of injuries to sub- jects.
p.000314: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000314: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000314: abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the
p.000314: discussion of controverted issues and their resolution.
p.000314: (3) Records of continuing review ac- tivities.
p.000314: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000314: (5) A list of IRB members in the same detail as described is § 97.103(b)(3).
p.000314: (6) Written procedures for the IRB in the same detail as described in
p.000314: § 97.103(b)(4) and § 97.103(b)(5).
...
p.000315: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000315: consent provided the IRB finds and documents that:
p.000315: (1) The research involves no more than minimal risk to the subjects;
p.000315: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000315: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000315: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000315: participa- tion.
p.000315: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000315: applicable federal, state, or local laws which require addi- tional information to be disclosed in order for
p.000315: informed consent to be le- gally effective.
p.000315: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care,
p.000315: to the extent the physician is permitted to do
p.000316: 316
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316: Office of the Secretary, Education § 97.118
p.000316:
p.000316:
p.000316: so under applicable federal, state, or local law.
p.000316: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000316: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000316: 3474; and 42 U.S.C. 300v–1(b))
p.000316: [56 FR 28012, 28021, June 18, 1991, as amended
p.000316: at 70 FR 36328, June 23, 2005]
p.000316:
p.000316: § 97.117 Documentation of informed consent.
p.000316: (a) Except as provided in paragraph
p.000316: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000316: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000316: shall be given to the per- son signing the form.
p.000316: (b) Except as provided in paragraph
p.000316: (c) of this section, the consent form may be either of the following:
p.000316: (1) A written consent document that embodies the elements of informed consent required by § 97.116.
p.000316: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000316: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000316: before it is signed; or
...
p.000317: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000317: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000317: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000317: welfare of human subjects (whether or not the research was subject to federal regulation).
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.124 Conditions.
p.000317: With respect to any research project or any class of research projects the de- partment or agency head may
p.000317: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000317: addi- tional conditions are necessary for the protection of human subjects.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: Subparts B–C [Reserved]
p.000317: Subpart D—Additional ED Protec- tions for Children Who Are Subjects in Research
p.000317:
p.000317: SOURCE: 62 FR 63221, Nov. 26, 1997, unless
p.000317: otherwise noted.
p.000318: 318
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318: Office of the Secretary, Education § 97.405
p.000318:
p.000318:
p.000318: § 97.401 To what do these regulations apply?
p.000318: (a) This subpart applies to all re- search involving children as subjects conducted or supported
p.000318: by the Depart- ment of Education.
p.000318: (1) This subpart applies to research conducted by Department employees.
p.000318: (2) This subpart applies to research conducted or supported by the Depart- ment of Education outside the
p.000318: United States, but in appropriate cir- cumstances the Secretary may, under
p.000318: § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this
p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
...
p.000319: educational situations;
p.000319: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000319: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000319: condition; and
p.000319: (d) Adequate provisions are made for soliciting assent of the children and permission of their
p.000319: parents or guard- ians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al-
p.000319: leviate a serious problem affecting the health or welfare of children.
p.000319: ED conducts or funds research that the IRB does not believe meets the re- quirements of § 97.404, § 97.405,
p.000319: or § 97.406 only if—
p.000319: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000319: prevention, or alleviation of a serious problem af- fecting the health or welfare of chil- dren; and
p.000319: (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example:
p.000319: science, medi- cine, education, ethics, law) and fol- lowing opportunity for public review and
p.000319: comment, has determined either that—
p.000319: 34 CFR Subtitle A (7–1–10 Edition)
p.000319: (1) The research in fact satisfies the conditions of § 97.404, § 97.405, or § 97.406, as applicable; or
p.000319: (2)(i) The research presents a reason- able opportunity to further the under- standing, prevention, or
p.000319: alleviation of a serious problem affecting the health or welfare of children;
p.000319: (ii) The research will be conducted in accordance with sound ethical prin- ciples; and
p.000319: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000319: parents or guardians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.408 Requirements for permission by parents or guardians and for as- sent by children.
p.000319: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000319: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, if in
...
p.000319: the children involved. This judgment may be made for all children to be involved in research under a
p.000319: particular protocol, or for each child, as the IRB deems ap- propriate. If the IRB determines that the
p.000319: capability of some or all of the children is so limited that they cannot reasonably be consulted or
p.000319: that the intervention or procedure involved in the research holds out a prospect of di- rect benefit that is
p.000319: important to the health or well-being of the children and is available only in the context of the research,
p.000319: the assent of the children is not a necessary condition for pro- ceeding with the research. Even if
p.000319: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000319: requirement under circumstances in which consent may be waived in accord with § 97.116.
p.000319: (b) In addition to the determinations
p.000319: required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance
p.000319: with and to the extent that consent is required by
p.000319: § 97.116, that adequate provisions are
p.000320: 320
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320: Office of the Secretary, Education § 98.1
p.000320:
p.000320:
p.000320: made for soliciting the permission of each child’s parent(s) or guardian(s). If parental permission is to
p.000320: be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000320: under § 97.404 or § 97.405. If research is covered by §§ 97.406 and
p.000320: 97.407 and permission is to be obtained from parents, both parents must give their permission unless one
p.000320: parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal
p.000320: responsibility for the care and custody of the child.
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
...
p.000320: investigator or investigators, or the guardian organization.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: PART 98—STUDENT RIGHTS IN RE- SEARCH, EXPERIMENTAL PRO- GRAMS, AND TESTING
p.000320: Sec.
p.000320: 98.1 Applicability of part.
p.000320: 98.2 Definitions.
p.000320: 98.3 Access to instructional material used in a research or experimentation pro- gram.
p.000320: 98.4 Protection of students’ privacy in ex- amination, testing, or treatment.
p.000320: 98.5 Information and investigation office.
p.000320: 98.6 Reports.
p.000320: 98.7 Filing a complaint.
p.000320: 98.8 Notice of the complaint.
p.000320: 98.9 Investigation and findings.
p.000320: 98.10 Enforcement of the findings.
p.000320: AUTHORITY: Sec. 514(a) of Pub. L. 93–380, 88 Stat. 574 (20 U.S.C. 1232h(a)); sec. 1250 of Pub.
p.000320: L. 95–561, 92 Stat. 2355–2356 (20 U.S.C.
p.000320: 1232h(b)); and sec. 408(a)(1) of Pub. L. 90–247, 88 Stat. 559–560, as amended (20 U.S.C. 1221e– 3(a)(1));
p.000320: sec. 414(a) of Pub. L. 96–88, 93 Stat. 685 (20 U.S.C. 3474(a)), unless otherwise noted.
p.000320: SOURCE: 49 FR 35321, Sept. 6, 1984, unless
p.000320: otherwise noted.
p.000320: § 98.1 Applicability of part.
p.000320: This part applies to any program ad- ministered by the Secretary of Edu- cation that:
p.000320: (a)(1) Was transferred to the Depart- ment by the Department of Education Organization Act (DEOA); and
...
Searching for indicator educational:
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p.000307: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000307: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000307: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000307: research con- ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: § 97.101
p.000307: as defined in § 97.102(e), must comply with all sections of this policy.
p.000307: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000307: subject to regulation as defined in § 97.102(e) must be reviewed and approved, in compli- ance with §§ 97.101,
p.000307: 97.102, and §§ 97.107 through 97.117 of this policy, by an in- stitutional review board (IRB) that op- erates
p.000307: in accordance with the pertinent requirements of this policy.
p.000307: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000307: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000307: policy:
p.000307: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000307: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000307: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000307: cur- ricula, or classroom management methods.
p.000307: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000307: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000307: through identifiers linked to the subjects; and
p.000307: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000307: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000307: employability, or reputation.
p.000307: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000307: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000307: (b)(2) of this section, if:
p.000307: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000307: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000307: informa- tion will be maintained throughout the research and thereafter.
...
p.000317: Subparts B–C [Reserved]
p.000317: Subpart D—Additional ED Protec- tions for Children Who Are Subjects in Research
p.000317:
p.000317: SOURCE: 62 FR 63221, Nov. 26, 1997, unless
p.000317: otherwise noted.
p.000318: 318
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318: Office of the Secretary, Education § 97.405
p.000318:
p.000318:
p.000318: § 97.401 To what do these regulations apply?
p.000318: (a) This subpart applies to all re- search involving children as subjects conducted or supported
p.000318: by the Depart- ment of Education.
p.000318: (1) This subpart applies to research conducted by Department employees.
p.000318: (2) This subpart applies to research conducted or supported by the Depart- ment of Education outside the
p.000318: United States, but in appropriate cir- cumstances the Secretary may, under
p.000318: § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this
p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
p.000318: in the research, under the applicable law of the jurisdiction in which the re- search will be
p.000318: conducted.
p.000318: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000318: not, ab- sent affirmative agreement, be con- strued as assent.
p.000318: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000318: research.
...
p.000318: parents or guardians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000319: 319
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319: § 97.406
p.000319:
p.000319: § 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000319: individual sub- jects, but likely to yield generaliz- able knowledge about the subject’s disorder or
p.000319: condition.
p.000319: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000319: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual
p.000319: subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000319: only if the IRB finds that—
p.000319: (a) The risk represents a minor in- crease over minimal risk;
p.000319: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000319: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000319: educational situations;
p.000319: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000319: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000319: condition; and
p.000319: (d) Adequate provisions are made for soliciting assent of the children and permission of their
p.000319: parents or guard- ians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al-
p.000319: leviate a serious problem affecting the health or welfare of children.
p.000319: ED conducts or funds research that the IRB does not believe meets the re- quirements of § 97.404, § 97.405,
p.000319: or § 97.406 only if—
p.000319: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000319: prevention, or alleviation of a serious problem af- fecting the health or welfare of chil- dren; and
p.000319: (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example:
...
Social / embryo
Searching for indicator embryo:
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p.000314: research;
p.000315: 315
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315:
p.000315: § 97.116
p.000315: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000315: might be advan- tageous to the subject;
p.000315: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000315: subject will be maintained;
p.000315: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000315: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000315: consist of, or where further information may be ob- tained;
p.000315: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000315: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000315: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000315: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000315: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000315: (b) Additional elements of informed con- sent. When appropriate, one or more of the following elements of
p.000315: information shall also be provided to each subject:
p.000315: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000315: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
p.000315: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000315: investigator without regard to the subject’s con- sent;
p.000315: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000315: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000315: of participation by the subject;
p.000315: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000315: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000315: 34 CFR Subtitle A (7–1–10 Edition)
p.000315: (6) The approximate number of sub- jects involved in the study.
p.000315: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000315: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000315: provided the IRB finds and documents that:
p.000315: (1) The research or demonstration project is to be conducted by or subject to the approval of state or
p.000315: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000315: (i) Public benefit of service programs;
p.000315: (ii) Procedures for obtaining benefits or services under those programs;
...
Social / employees
Searching for indicator employees:
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p.000307: the individual sub- jects.
p.000307: 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000307: individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
p.000307: 97.407 Research not otherwise approvable which presents an opportunity to under- stand, prevent, or
p.000307: alleviate a serious problem affecting the health or welfare of children.
p.000307: 97.408 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000307: 97.409 Wards.
p.000307: AUTHORITY: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000307: 3474; 42 U.S.C. 300v–1(b).
p.000307: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000307: unless otherwise noted.
p.000307:
p.000307: Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human
p.000307: Research Sub- jects)
p.000307: § 97.101 To what does this policy apply?
p.000307: (a) Except as provided in paragraph
p.000307: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000307: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000307: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000307: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000307: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000307: research con- ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: § 97.101
p.000307: as defined in § 97.102(e), must comply with all sections of this policy.
p.000307: (2) Research that is neither con- ducted nor supported by a federal de- partment or agency but is
p.000307: subject to regulation as defined in § 97.102(e) must be reviewed and approved, in compli- ance with §§ 97.101,
p.000307: 97.102, and §§ 97.107 through 97.117 of this policy, by an in- stitutional review board (IRB) that op- erates
p.000307: in accordance with the pertinent requirements of this policy.
p.000307: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000307: involvement of human subjects will be in one or more of the following categories are exempt from this
p.000307: policy:
p.000307: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000307: educational practices, such as (i) research on reg- ular and special education instruc- tional
...
p.000310: actions to the investigator and the institution;
p.000310: (ii) for determining which projects re- quire review more often than annually and which projects need
p.000310: verification from sources other than the investiga- tors that no material changes have oc- curred since
p.000310: previous IRB review; and
p.000310: (iii) for ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000310: ensuring that such changes in approved research,
p.000310:
p.000310: during the period for which IRB ap- proval has already been given, may not be initiated without IRB
p.000310: review and approval except when necessary to eliminate apparent immediate hazards to the subject.
p.000310: (5) Written procedures for ensuring prompt reporting to the IRB, appro- priate institutional
p.000310: officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or
p.000310: others or any serious or continuing noncompliance with this policy or the requirements or deter-
p.000310: minations of the IRB and (ii) any sus- pension or termination of IRB ap- proval.
p.000310: (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on
p.000310: behalf of the institution the obligations im- posed by this policy and shall be filed in such form and
p.000310: manner as the depart- ment or agency head prescribes.
p.000310: (d) The department or agency head will evaluate all assurances submitted in accordance with this policy
p.000310: through such officers and employees of the de- partment or agency and such experts or consultants engaged
p.000310: for this purpose as the department or agency head de- termines to be appropriate. The depart- ment or agency
p.000310: head’s evaluation will take into consideration the adequacy of the proposed IRB in light of the an-
p.000310: ticipated scope of the institution’s re- search activities and the types of sub- ject populations likely
p.000310: to be involved, the appropriateness of the proposed ini- tial and continuing review procedures in light of the
p.000310: probable risks, and the size and complexity of the institution.
p.000310: (e) On the basis of this evaluation,
p.000310: the department or agency head may approve or disapprove the assurance, or enter into negotiations to
p.000310: develop an approvable one. The department or agency head may limit the period dur- ing which any
p.000310: particular approved as- surance or class of approved assurances shall remain effective or otherwise condition
p.000310: or restrict approval.
p.000310: (f) Certification is required when the research is supported by a federal de- partment or agency and not
p.000310: otherwise exempted or waived under § 97.101 (b) or (i). An institution with an approved as- surance shall certify that
p.000310: each applica- tion or proposal for research covered
p.000311: 311
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311: §§ 97.104–97.106
p.000311: by the assurance and by § 97.103 of this Policy has been reviewed and approved by the IRB. Such
p.000311: certification must be submitted with the application or pro- posal or by such later date as may be
...
p.000316: § 97.101 (b) or (i), no human subjects
p.000316: may be involved in any project sup- ported by these awards until the project has been reviewed and
p.000316: approved by the IRB, as provided in this policy, and certification submitted, by the in- stitution, to the
p.000316: department or agency.
p.000316: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000316: 3474; and 42 U.S.C. 300v–1(b))
p.000317: 317
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317: § 97.119
p.000317:
p.000317: § 97.119 Research undertaken without the intention of involving human subjects.
p.000317: In the event research is undertaken without the intention of involving human subjects, but it
p.000317: is later pro- posed to involve human subjects in the research, the research shall first be re- viewed and approved
p.000317: by an IRB, as pro- vided in this policy, a certification sub- mitted, by the institution, to the de- partment or
p.000317: agency, and final approval given to the proposed change by the de- partment or agency.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.120 Evaluation and disposition of applications and proposals for re- search to be conducted or
p.000317: sup- ported by a Federal Department or Agency.
p.000317: (a) The department or agency head will evaluate all applications and pro- posals involving human subjects
p.000317: sub- mitted to the department or agency through such officers and employees of the department or agency and
p.000317: such ex- perts and consultants as the depart- ment or agency head determines to be appropriate. This
p.000317: evaluation will take into consideration the risks to the sub- jects, the adequacy of protection against
p.000317: these risks, the potential bene- fits of the research to the subjects and others, and the importance
p.000317: of the knowledge gained or to be gained.
p.000317: (b) On the basis of this evaluation, the department or agency head may approve or disapprove the
p.000317: application or proposal, or enter into negotiations to develop an approvable one.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.121 [Reserved]
p.000317: § 97.122 Use of Federal funds.
p.000317: Federal funds administered by a de- partment or agency may not be ex- pended for research involving
p.000317: human subjects unless the requirements of this policy have been satisfied.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317: 34 CFR Subtitle A (7–1–10 Edition)
p.000317:
p.000317: § 97.123 Early termination of research support: Evaluation of applications and proposals.
p.000317: (a) The department or agency head may require that department or agency support for any project be terminated
p.000317: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000317: head finds an institution has materially failed to comply with the terms of this policy.
...
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.124 Conditions.
p.000317: With respect to any research project or any class of research projects the de- partment or agency head may
p.000317: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000317: addi- tional conditions are necessary for the protection of human subjects.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: Subparts B–C [Reserved]
p.000317: Subpart D—Additional ED Protec- tions for Children Who Are Subjects in Research
p.000317:
p.000317: SOURCE: 62 FR 63221, Nov. 26, 1997, unless
p.000317: otherwise noted.
p.000318: 318
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318: Office of the Secretary, Education § 97.405
p.000318:
p.000318:
p.000318: § 97.401 To what do these regulations apply?
p.000318: (a) This subpart applies to all re- search involving children as subjects conducted or supported
p.000318: by the Depart- ment of Education.
p.000318: (1) This subpart applies to research conducted by Department employees.
p.000318: (2) This subpart applies to research conducted or supported by the Depart- ment of Education outside the
p.000318: United States, but in appropriate cir- cumstances the Secretary may, under
p.000318: § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this
p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
...
Social / gender
Searching for indicator gender:
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p.000311: certification must be submitted with the application or pro- posal or by such later date as may be
p.000311: prescribed by the department or agen- cy to which the application or proposal is submitted. Under no condition
p.000311: shall research covered by § 97.103 of the Pol- icy be supported prior to receipt of the certification that the
p.000311: research has been reviewed and approved by the IRB. In- stitutions without an approved assur- ance covering
p.000311: the research shall certify within 30 days after receipt of a request for such a certification from the de-
p.000311: partment or agency, that the applica- tion or proposal has been approved by the IRB. If the certification is
p.000311: not sub- mitted within these time limits, the application or proposal may be re- turned to the
p.000311: institution.
p.000311: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
p.000311: category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: § 97.108 IRB functions and operations.
p.000311: In order to fulfill the requirements of this policy each IRB shall:
p.000311: (a) Follow written procedures in the same detail as described in § 97.103(b)(4) and, to the extent
p.000311: required by,
p.000311: § 97.103(b)(5).
p.000311: (b) Except when an expedited review procedure is used (see § 97.110), review proposed research at
p.000311: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
...
Social / parents
Searching for indicator parent:
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p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
p.000318: in the research, under the applicable law of the jurisdiction in which the re- search will be
p.000318: conducted.
p.000318: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000318: not, ab- sent affirmative agreement, be con- strued as assent.
p.000318: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000318: research.
p.000318: (d) Parent means a child’s biological or adoptive parent.
p.000318:
p.000318: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000318: of a child to general medical care.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.403 IRB duties.
p.000318: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research
p.000318: covered by this subpart and approve only research that satisfies the conditions of all ap- plicable sections of
p.000318: this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.404 Research not involving great- er than minimal risk.
p.000318: ED conducts or funds research in which the IRB finds that no greater than minimal risk to children
p.000318: is pre- sented, only if the IRB finds that ade- quate provisions are made for solic- iting the assent
p.000318: of the children and the permission of their parents or guard- ians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000318:
...
p.000319: capability of some or all of the children is so limited that they cannot reasonably be consulted or
p.000319: that the intervention or procedure involved in the research holds out a prospect of di- rect benefit that is
p.000319: important to the health or well-being of the children and is available only in the context of the research,
p.000319: the assent of the children is not a necessary condition for pro- ceeding with the research. Even if
p.000319: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000319: requirement under circumstances in which consent may be waived in accord with § 97.116.
p.000319: (b) In addition to the determinations
p.000319: required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance
p.000319: with and to the extent that consent is required by
p.000319: § 97.116, that adequate provisions are
p.000320: 320
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320: Office of the Secretary, Education § 98.1
p.000320:
p.000320:
p.000320: made for soliciting the permission of each child’s parent(s) or guardian(s). If parental permission is to
p.000320: be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000320: under § 97.404 or § 97.405. If research is covered by §§ 97.406 and
p.000320: 97.407 and permission is to be obtained from parents, both parents must give their permission unless one
p.000320: parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal
p.000320: responsibility for the care and custody of the child.
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
p.000320: (b) of this section, provided an appro- priate mechanism for protecting the children who will
p.000320: participate as sub- jects in the research is substituted, and provided further that the waiver is not inconsistent
p.000320: with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and
p.000320: purpose of the activities described in the protocol, the risk and antici- pated benefit to the
p.000320: research subjects, and their age, maturity, status, and condition.
p.000320: (d) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000320: required by
p.000320: § 97.117.
p.000320: (e) If the IRB determines that assent is required, it shall also determine whether and how assent
p.000320: must be docu- mented.
...
Searching for indicator parents:
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p.000318:
p.000318: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000318: of a child to general medical care.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.403 IRB duties.
p.000318: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research
p.000318: covered by this subpart and approve only research that satisfies the conditions of all ap- plicable sections of
p.000318: this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.404 Research not involving great- er than minimal risk.
p.000318: ED conducts or funds research in which the IRB finds that no greater than minimal risk to children
p.000318: is pre- sented, only if the IRB finds that ade- quate provisions are made for solic- iting the assent
p.000318: of the children and the permission of their parents or guard- ians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000318:
p.000318: § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000318: the individual subjects.
p.000318: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000318: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
p.000318: subject, or by a mon- itoring procedure that is likely to con- tribute to the subject’s well-being, only if the IRB
p.000318: finds that—
p.000318: (a) The risk is justified by the antici- pated benefit to the subjects;
p.000318: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000318: as that presented by available alternative approaches; and
p.000318: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000318: parents or guardians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000319: 319
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319: § 97.406
p.000319:
p.000319: § 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000319: individual sub- jects, but likely to yield generaliz- able knowledge about the subject’s disorder or
p.000319: condition.
p.000319: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000319: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual
p.000319: subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000319: only if the IRB finds that—
p.000319: (a) The risk represents a minor in- crease over minimal risk;
p.000319: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000319: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000319: educational situations;
p.000319: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000319: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000319: condition; and
p.000319: (d) Adequate provisions are made for soliciting assent of the children and permission of their
p.000319: parents or guard- ians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al-
p.000319: leviate a serious problem affecting the health or welfare of children.
p.000319: ED conducts or funds research that the IRB does not believe meets the re- quirements of § 97.404, § 97.405,
p.000319: or § 97.406 only if—
p.000319: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000319: prevention, or alleviation of a serious problem af- fecting the health or welfare of chil- dren; and
p.000319: (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example:
p.000319: science, medi- cine, education, ethics, law) and fol- lowing opportunity for public review and
p.000319: comment, has determined either that—
p.000319: 34 CFR Subtitle A (7–1–10 Edition)
p.000319: (1) The research in fact satisfies the conditions of § 97.404, § 97.405, or § 97.406, as applicable; or
p.000319: (2)(i) The research presents a reason- able opportunity to further the under- standing, prevention, or
p.000319: alleviation of a serious problem affecting the health or welfare of children;
p.000319: (ii) The research will be conducted in accordance with sound ethical prin- ciples; and
p.000319: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000319: parents or guardians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.408 Requirements for permission by parents or guardians and for as- sent by children.
p.000319: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000319: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, if in
p.000319: the judgment of the IRB the children are capable of providing assent. In determining whether chil- dren
p.000319: are capable of assenting, the IRB shall take into account the ages, matu- rity, and psychological state of
p.000319: the children involved. This judgment may be made for all children to be involved in research under a
p.000319: particular protocol, or for each child, as the IRB deems ap- propriate. If the IRB determines that the
p.000319: capability of some or all of the children is so limited that they cannot reasonably be consulted or
p.000319: that the intervention or procedure involved in the research holds out a prospect of di- rect benefit that is
p.000319: important to the health or well-being of the children and is available only in the context of the research,
p.000319: the assent of the children is not a necessary condition for pro- ceeding with the research. Even if
p.000319: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000319: requirement under circumstances in which consent may be waived in accord with § 97.116.
p.000319: (b) In addition to the determinations
p.000319: required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance
p.000319: with and to the extent that consent is required by
p.000319: § 97.116, that adequate provisions are
p.000320: 320
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320:
p.000320: Office of the Secretary, Education § 98.1
p.000320:
p.000320:
p.000320: made for soliciting the permission of each child’s parent(s) or guardian(s). If parental permission is to
p.000320: be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000320: under § 97.404 or § 97.405. If research is covered by §§ 97.406 and
p.000320: 97.407 and permission is to be obtained from parents, both parents must give their permission unless one
p.000320: parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal
p.000320: responsibility for the care and custody of the child.
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
p.000320: (b) of this section, provided an appro- priate mechanism for protecting the children who will
p.000320: participate as sub- jects in the research is substituted, and provided further that the waiver is not inconsistent
p.000320: with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and
p.000320: purpose of the activities described in the protocol, the risk and antici- pated benefit to the
p.000320: research subjects, and their age, maturity, status, and condition.
p.000320: (d) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000320: required by
p.000320: § 97.117.
p.000320: (e) If the IRB determines that assent is required, it shall also determine whether and how assent
p.000320: must be docu- mented.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: § 97.409 Wards.
p.000320: (a) Children who are wards of the State or any other agency, institution, or entity may be included in
p.000320: research approved under § 97.406 or § 97.407 only if that research is—
p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000315: (2) The research could not prac- ticably be carried out without the waiver or alteration.
p.000315: (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000315: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000315: consent provided the IRB finds and documents that:
p.000315: (1) The research involves no more than minimal risk to the subjects;
p.000315: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000315: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000315: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000315: participa- tion.
p.000315: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000315: applicable federal, state, or local laws which require addi- tional information to be disclosed in order for
p.000315: informed consent to be le- gally effective.
p.000315: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care,
p.000315: to the extent the physician is permitted to do
p.000316: 316
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316: Office of the Secretary, Education § 97.118
p.000316:
p.000316:
p.000316: so under applicable federal, state, or local law.
p.000316: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000316: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000316: 3474; and 42 U.S.C. 300v–1(b))
p.000316: [56 FR 28012, 28021, June 18, 1991, as amended
p.000316: at 70 FR 36328, June 23, 2005]
p.000316:
p.000316: § 97.117 Documentation of informed consent.
p.000316: (a) Except as provided in paragraph
p.000316: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000316: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000316: shall be given to the per- son signing the form.
p.000316: (b) Except as provided in paragraph
p.000316: (c) of this section, the consent form may be either of the following:
p.000316: (1) A written consent document that embodies the elements of informed consent required by § 97.116.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: Office of the Secretary, Education § 97.101
p.000307:
p.000307:
p.000307: has met any repayment obligation im- posed upon it under § 86.301(b)(1) of this part.
p.000307: (b) In addition to the requirements of paragraph (a) of this section, the IHE shall comply with the
p.000307: requirements and procedures for reinstatement of eligibility applicable to any Federal program under
p.000307: which it desires to re- ceive Federal financial assistance.
p.000307: (Authority: 20 U.S.C. 1145g)
p.000307: [55 FR 33581, Aug. 16, 1990, as amended at 61
p.000307: FR 66225, Dec. 17, 1996]
p.000307:
p.000307: PART 97—PROTECTION OF HUMAN SUBJECTS
p.000307: Subpart A—Federal Policy for the Protec- tion of Human Subjects (Basic ED Pol- icy for Protection of Human
p.000307: Research Subjects)
p.000307: Sec.
p.000307: 97.101 To what does this policy apply?
p.000307: 97.102 Definitions.
p.000307: 97.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department
p.000307: or Agency.
p.000307: 97.104–97.106 [Reserved]
p.000307: 97.107 IRB membership.
p.000307: 97.108 IRB functions and operations.
p.000307: 97.109 IRB review of research.
p.000307: 97.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000307: and for minor changes in approved research.
p.000307: 97.111 Criteria for IRB approval of research.
p.000307: 97.112 Review by institution.
p.000307: 97.113 Suspension or termination of IRB ap- proval of research.
p.000307: 97.114 Cooperative research.
p.000307: 97.115 IRB records.
p.000307: 97.116 General requirements for informed consent.
p.000307: 97.117 Documentation of informed consent.
p.000307: 97.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000307: 97.119 Research undertaken without the in- tention of involving human subjects.
p.000307: 97.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000307: supported by a Federal De- partment or Agency.
p.000307: 97.121 [Reserved]
p.000307: 97.122 Use of Federal funds.
p.000307: 97.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000307: 97.124 Conditions.
p.000307: Subparts B–C [Reserved]
p.000307: Subpart D—Additional ED Protections for Children Who are Subjects in Research
p.000307: 97.401 To what do these regulations apply?
p.000307: 97.402 Definitions.
p.000307: 97.403 IRB duties.
p.000307: 97.404 Research not involving greater than minimal risk.
p.000307: 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000307: the individual sub- jects.
p.000307: 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000307: individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
p.000307: 97.407 Research not otherwise approvable which presents an opportunity to under- stand, prevent, or
p.000307: alleviate a serious problem affecting the health or welfare of children.
p.000307: 97.408 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000307: 97.409 Wards.
p.000307: AUTHORITY: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000307: 3474; 42 U.S.C. 300v–1(b).
p.000307: SOURCE: 56 FR 28012, 28021, June 18, 1991,
p.000307: unless otherwise noted.
p.000307:
p.000307: Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human
p.000307: Research Sub- jects)
p.000307: § 97.101 To what does this policy apply?
p.000307: (a) Except as provided in paragraph
p.000307: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000307: otherwise subject to regulation by any federal de- partment or agency which takes appro- priate administrative action
p.000307: to make the policy applicable to such research. This includes research conducted by federal civilian
p.000307: employees or military personnel, except that each department or agency head may adopt such proce- dural
p.000307: modifications as may be appro- priate from an administrative stand- point. It also includes
p.000307: research con- ducted, supported, or otherwise subject to regulation by the federal govern- ment outside the
p.000307: United States.
p.000307: (1) Research that is conducted or sup- ported by a federal department or agency, whether or not it is
p.000307: regulated
p.000307: 307
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307:
p.000307: § 97.101
p.000307: as defined in § 97.102(e), must comply with all sections of this policy.
...
p.000308: states or by an organization whose function for the protection of human research subjects is
p.000308: internationally recognized.) In these circumstances, if a department or agency head determines that the
p.000308: proce- dures prescribed by the institution af- ford protections that are at least equivalent to
p.000308: those provided in this policy, the department or agency head may approve the substitution of the
p.000308: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000308: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
p.000308: they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department
p.000308: or agency procedures.
p.000308: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000308: of the provisions of this policy to specific re- search activities or classes of research activities
p.000308: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000308: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000308: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000308: and shall also publish them in the FEDERAL REGISTER or in
p.000308:
p.000308: such other manner as provided in de- partment or agency procedures. 1
p.000308: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000308: 3474; and 42 U.S.C. 300v–1(b))
p.000308: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000308: June 28, 1991, as amended at 70 FR 36328,
p.000308: June 23, 2005]
p.000308:
p.000308: § 97.102 Definitions.
p.000308: (a) Department or agency head means the head of any federal department or agency and any other officer
p.000308: or em- ployee of any department or agency to whom authority has been delegated.
p.000308: (b) Institution means any public or private entity or agency (including fed- eral, state, and other
p.000308: agencies).
p.000308: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000308: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000308: procedure(s) involved in the research.
p.000308: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000308: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000308: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000308: or supported under a program which is considered research for other purposes. For example, some
p.000308: demonstration and service programs may include research activities.
p.000308: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000308: for which a federal department or agency has specific responsibility for regulating as
p.000308:
p.000308: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000308: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000308: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000308: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
...
p.000309: cific purposes by an individual and which the individual can reasonably expect will not be made
p.000309: public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the
p.000309: identity of the subject is or may readily be ascertained by the investigator or associated with the in-
p.000309: formation) in order for obtaining the information to constitute research in- volving human subjects.
p.000309: (g) IRB means an institutional review
p.000309: board established in accord with and for the purposes expressed in this pol- icy.
p.000309: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000309: may be con- ducted at an institution within the constraints set forth by the IRB and by other
p.000309: institutional and federal require- ments.
p.000309: (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000309: research are
p.000309: 34 CFR Subtitle A (7–1–10 Edition)
p.000309: not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000309: performance of rou- tine physical or psychological exami- nations or tests.
p.000309: (j) Certification means the official no- tification by the institution to the sup- porting department or agency,
p.000309: in ac- cordance with the requirements of this policy, that a research project or activ- ity involving human
p.000309: subjects has been reviewed and approved by an IRB in ac- cordance with an approved assurance.
p.000309: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000309: 3474; and 42 U.S.C. 300v–1(b))
p.000309:
p.000309: § 97.103 Assuring compliance with this policy—research conducted or sup- ported by any Federal Department or
p.000309: Agency.
p.000309: (a) Each institution engaged in re- search which is covered by this policy and which is conducted or
p.000309: supported by a federal department or agency shall provide written assurance satisfactory to the department or
p.000309: agency head that it will comply with the requirements set forth in this policy. In lieu of re- quiring
p.000309: submission of an assurance, in- dividual department or agency heads shall accept the existence of a current
p.000309: assurance, appropriate for the research in question, on file with the Office for Human Research Protections,
p.000309: HHS, or any successor office, and approved for federalwide use by that office. When the existence of
p.000309: an HHS-approved as- surance is accepted in lieu of requiring submission of an assurance, reports (except
p.000309: certification) required by this policy to be made to department and agency heads shall also be made to the
p.000309: Office for Human Research Protec- tions, (HHS), or any successor office.
p.000309: (b) Departments and agencies will
p.000309: conduct or support research covered by this policy only if the institution has an assurance approved as
p.000309: provided in this section, and only if the institution has certified to the department or agency head that
p.000309: the research has been reviewed and approved by an IRB pro- vided for in the assurance, and will be subject
p.000309: to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall
p.000309: at a minimum include:
...
p.000310: develop an approvable one. The department or agency head may limit the period dur- ing which any
p.000310: particular approved as- surance or class of approved assurances shall remain effective or otherwise condition
p.000310: or restrict approval.
p.000310: (f) Certification is required when the research is supported by a federal de- partment or agency and not
p.000310: otherwise exempted or waived under § 97.101 (b) or (i). An institution with an approved as- surance shall certify that
p.000310: each applica- tion or proposal for research covered
p.000311: 311
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311:
p.000311: §§ 97.104–97.106
p.000311: by the assurance and by § 97.103 of this Policy has been reviewed and approved by the IRB. Such
p.000311: certification must be submitted with the application or pro- posal or by such later date as may be
p.000311: prescribed by the department or agen- cy to which the application or proposal is submitted. Under no condition
p.000311: shall research covered by § 97.103 of the Pol- icy be supported prior to receipt of the certification that the
p.000311: research has been reviewed and approved by the IRB. In- stitutions without an approved assur- ance covering
p.000311: the research shall certify within 30 days after receipt of a request for such a certification from the de-
p.000311: partment or agency, that the applica- tion or proposal has been approved by the IRB. If the certification is
p.000311: not sub- mitted within these time limits, the application or proposal may be re- turned to the
p.000311: institution.
p.000311: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: [56 FR 28012, 28021, June 18, 1991; 56 FR 29756,
p.000311: June 28, 1991, as amended at 70 FR 36328,
p.000311: June 23, 2005]
p.000311: §§ 97.104–97.106 [Reserved]
p.000311: § 97.107 IRB membership.
p.000311: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000311: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000311: qualified through the experience and expertise of its members, and the diversity of the members,
p.000311: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000311: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000311: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000311: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000311: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000311: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000311: IRB regularly reviews research that involves a vulnerable
p.000311: 34 CFR Subtitle A (7–1–10 Edition)
...
p.000311: persons, consideration shall be given to the in- clusion of one or more individuals who are
p.000311: knowledgeable about and experi- enced in working with these subjects.
p.000311: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000311: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000311: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000311: profession.
p.000311: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000311: least one member whose primary concerns are in nonscientific areas.
p.000311: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000311: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000311: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000311: project in which the member has a conflicting interest, except to provide information re- quested by
p.000311: the IRB.
p.000311: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000311: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000311: These individuals may not vote with the IRB.
p.000311: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000311: 3474; and 42 U.S.C. 300v–1(b))
p.000311: § 97.108 IRB functions and operations.
p.000311: In order to fulfill the requirements of this policy each IRB shall:
p.000311: (a) Follow written procedures in the same detail as described in § 97.103(b)(4) and, to the extent
p.000311: required by,
p.000311: § 97.103(b)(5).
p.000311: (b) Except when an expedited review procedure is used (see § 97.110), review proposed research at
p.000311: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000311: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000311: approved,
p.000312: 312
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312:
p.000312: Office of the Secretary, Education § 97.110
p.000312:
p.000312:
p.000312: it shall receive the approval of a ma- jority of those members present at the meeting.
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312:
p.000312: § 97.109 IRB review of research.
p.000312: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000312: approval), or dis- approve all research activities covered by this policy.
p.000312: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000312: accordance with
p.000312: § 97.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000312: 97.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000312: the protection of the rights and welfare of subjects.
p.000312: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000312: with
p.000312: § 97.117.
p.000312: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000312: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000312: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000312: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000312: person or in writing.
p.000312: (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate
p.000312: 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.000312: party observe the consent process and the research.
p.000312: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000312: [56 FR 28012, 28021, June 18, 1991, as amended
p.000312: at 70 FR 36328, June 23, 2005]
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312:
p.000312: § 97.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000312: minor changes in approved re- search.
p.000312: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000312: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000312: be amended, as appropriate after consultation with other departments and agencies, through
p.000312: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000312: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000312: (b) An IRB may use the expedited re- view procedure to review either or both of the following:
p.000312: (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.000312: mini- mal risk,
p.000312: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000312: approval is authorized.
p.000312: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or
p.000312: more ex- perienced reviewers designated by the chairperson from among members of the IRB. In reviewing the
p.000312: research, the reviewers may exercise all of the au- thorities of the IRB except that the re- viewers may not
p.000312: disapprove the re- search. A research activity may be dis- approved only after review in accord- ance with
p.000312: the non-expedited procedure set forth in § 97.108(b).
p.000312: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of
p.000312: re- search proposals which have been ap- proved under the procedure.
p.000312: (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an
p.000312: institu- tion’s or IRB’s use of the expedited re- view procedure.
p.000312: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000312: 3474; and 42 U.S.C. 300v–1(b))
p.000312: [56 FR 28012, 28021, June 18, 1991, as amended
p.000312: at 70 FR 36328, June 23, 2005]
p.000313: 313
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313:
p.000313: § 97.111
p.000313:
p.000313: § 97.111 Criteria for IRB approval of research.
p.000313: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000313: following require- ments are satisfied:
p.000313: (1) Risks to subjects are minimized:
p.000313: (i) By using procedures which are consistent with sound research design and which do not
p.000313: unnecessarily expose subjects to risk, and
p.000313: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000313: or treat- ment purposes.
p.000313: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000313: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000313: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000313: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000313: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000313: the research (for example, the possible effects of the research on public policy) as among those
p.000313: research risks that fall within the purview of its responsibility.
...
p.000313: representa- tive, in accordance with, and to the ex- tent required by § 97.116.
p.000313: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000313: required by
p.000313: § 97.117.
p.000313: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000313: collected to en- sure the safety of subjects.
p.000313: 34 CFR Subtitle A (7–1–10 Edition)
p.000313: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000313: con- fidentiality of data.
p.000313: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000313: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000313: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000313: rights and welfare of these subjects.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: § 97.112 Review by institution.
p.000313: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000313: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000313: research if it has not been approved by an IRB.
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313:
p.000313: § 97.113 Suspension or termination of IRB approval of research.
p.000313: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000313: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000313: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000313: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000313: the department or agency head.
p.000313: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000313: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000313: 3474; and 42 U.S.C. 300v–1(b))
p.000313: [56 FR 28012, 28021, June 18, 1991, as amended
p.000313: at 70 FR 36328, June 23, 2005]
p.000313: § 97.114 Cooperative research.
p.000313: Cooperative research projects are those projects covered by this policy which involve more than one
p.000313: institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for
p.000313: safeguarding the rights and welfare of human subjects and for complying with this policy. With the
p.000313: approval of the department or agency
p.000314: 314
p.000314:
p.000314:
p.000314:
p.000314:
p.000314:
p.000314:
p.000314:
p.000314: Office of the Secretary, Education § 97.116
p.000314:
p.000314:
p.000314: head, an institution participating in a cooperative project may enter into a joint review arrangement,
p.000314: rely upon the review of another qualified IRB, or make similar arrangements for avoid- ing duplication of effort.
p.000314: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000314: 3474; and 42 U.S.C. 300v–1(b))
p.000314:
p.000314: § 97.115 IRB records.
p.000314: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000314: documentation of IRB activities, including the following:
p.000314: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000314: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000314: reports of injuries to sub- jects.
p.000314: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000314: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000314: abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the
p.000314: discussion of controverted issues and their resolution.
p.000314: (3) Records of continuing review ac- tivities.
p.000314: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000314: (5) A list of IRB members in the same detail as described is § 97.103(b)(3).
p.000314: (6) Written procedures for the IRB in the same detail as described in
p.000314: § 97.103(b)(4) and § 97.103(b)(5).
p.000314: (7) Statements of significant new findings provided to subjects, as re- quired by § 97.116(b)(5).
p.000314: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000314: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000314: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000314: depart-
p.000314:
p.000314: ment or agency at reasonable times and in a reasonable manner.
p.000314: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000314: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000314: 3474; and 42 U.S.C. 300v–1(b))
p.000314: [56 FR 28012, 28021, June 18, 1991, as amended
p.000314: at 70 FR 36328, June 23, 2005]
p.000314:
p.000314: § 97.116 General requirements for in- formed consent.
p.000314: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000314: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000314: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000314: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000314: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000314: undue influence. The information that is given to the subject or the representative shall be in language
p.000314: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000314: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000314: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000314: sponsor, the insti- tution or its agents from liability for negligence.
...
p.000315: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs; and
p.000315: (2) The research could not prac- ticably be carried out without the waiver or alteration.
p.000315: (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000315: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000315: consent provided the IRB finds and documents that:
p.000315: (1) The research involves no more than minimal risk to the subjects;
p.000315: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000315: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000315: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000315: participa- tion.
p.000315: (e) The informed consent require- ments in this policy are not intended to preempt any
p.000315: applicable federal, state, or local laws which require addi- tional information to be disclosed in order for
p.000315: informed consent to be le- gally effective.
p.000315: (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care,
p.000315: to the extent the physician is permitted to do
p.000316: 316
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316:
p.000316: Office of the Secretary, Education § 97.118
p.000316:
p.000316:
p.000316: so under applicable federal, state, or local law.
p.000316: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000316: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000316: 3474; and 42 U.S.C. 300v–1(b))
p.000316: [56 FR 28012, 28021, June 18, 1991, as amended
p.000316: at 70 FR 36328, June 23, 2005]
p.000316:
p.000316: § 97.117 Documentation of informed consent.
p.000316: (a) Except as provided in paragraph
p.000316: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000316: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000316: shall be given to the per- son signing the form.
p.000316: (b) Except as provided in paragraph
p.000316: (c) of this section, the consent form may be either of the following:
p.000316: (1) A written consent document that embodies the elements of informed consent required by § 97.116.
p.000316: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000316: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000316: before it is signed; or
p.000316: (2) A short form written consent doc- ument stating that the elements of in- formed consent required by
p.000316: § 97.116 have been presented orally to the sub- ject or the subject’s legally authorized representative.
...
p.000316: of the summary. A copy of the summary shall be given to the subject or the representative, in addition
p.000316: to a copy of the short form.
p.000316: (c) An IRB may waive the require-
p.000316: ment for the investigator to obtain a signed consent form for some or all subjects if it finds
p.000316: either:
p.000316: (1) That the only record linking the subject and the research would be the consent document and the
p.000316: principal
p.000316:
p.000316: risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked
p.000316: whether the sub- ject wants documentation linking the subject with the research, and the sub- ject’s wishes will
p.000316: govern; or
p.000316: (2) That the research presents no more than minimal risk of harm to subjects and involves no
p.000316: procedures for which written consent is normally re- quired outside of the research context.
p.000316: In cases in which the documentation requirement is waived, the IRB may re- quire the investigator to provide
p.000316: sub- jects with a written statement regard- ing the research.
p.000316: (Approved by the Office of Management and Budget under Control Number 0990–0260.)
p.000316: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000316: 3474; and 42 U.S.C. 300v–1(b))
p.000316: [56 FR 28012, 28021, June 18, 1991, as amended
p.000316: at 70 FR 36328, June 23, 2005]
p.000316:
p.000316: § 97.118 Applications and proposals lacking definite plans for involve- ment of human subjects.
p.000316: Certain types of applications for grants, cooperative agreements, or con- tracts are submitted to
p.000316: departments or agencies with the knowledge that sub- jects may be involved within the period of support, but
p.000316: definite plans would not normally be set forth in the applica- tion or proposal. These include activi- ties
p.000316: such as institutional type grants when selection of specific projects is the institution’s
p.000316: responsibility; re- search training grants in which the ac- tivities involving subjects remain to be selected; and
p.000316: projects in which human subject’s involvement will depend upon completion of instruments, prior ani- mal
p.000316: studies, or purification of com- pounds. These applications need not be reviewed by an IRB before an
p.000316: award may be made. However, except for re- search exempted or waived under
p.000316: § 97.101 (b) or (i), no human subjects
p.000316: may be involved in any project sup- ported by these awards until the project has been reviewed and
p.000316: approved by the IRB, as provided in this policy, and certification submitted, by the in- stitution, to the
p.000316: department or agency.
p.000316: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000316: 3474; and 42 U.S.C. 300v–1(b))
p.000317: 317
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317:
p.000317: § 97.119
p.000317:
p.000317: § 97.119 Research undertaken without the intention of involving human subjects.
p.000317: In the event research is undertaken without the intention of involving human subjects, but it
p.000317: is later pro- posed to involve human subjects in the research, the research shall first be re- viewed and approved
p.000317: by an IRB, as pro- vided in this policy, a certification sub- mitted, by the institution, to the de- partment or
p.000317: agency, and final approval given to the proposed change by the de- partment or agency.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.120 Evaluation and disposition of applications and proposals for re- search to be conducted or
p.000317: sup- ported by a Federal Department or Agency.
p.000317: (a) The department or agency head will evaluate all applications and pro- posals involving human subjects
p.000317: sub- mitted to the department or agency through such officers and employees of the department or agency and
p.000317: such ex- perts and consultants as the depart- ment or agency head determines to be appropriate. This
p.000317: evaluation will take into consideration the risks to the sub- jects, the adequacy of protection against
p.000317: these risks, the potential bene- fits of the research to the subjects and others, and the importance
p.000317: of the knowledge gained or to be gained.
p.000317: (b) On the basis of this evaluation, the department or agency head may approve or disapprove the
p.000317: application or proposal, or enter into negotiations to develop an approvable one.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.121 [Reserved]
p.000317: § 97.122 Use of Federal funds.
p.000317: Federal funds administered by a de- partment or agency may not be ex- pended for research involving
p.000317: human subjects unless the requirements of this policy have been satisfied.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317: 34 CFR Subtitle A (7–1–10 Edition)
p.000317:
p.000317: § 97.123 Early termination of research support: Evaluation of applications and proposals.
p.000317: (a) The department or agency head may require that department or agency support for any project be terminated
p.000317: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000317: head finds an institution has materially failed to comply with the terms of this policy.
p.000317: (b) In making decisions about sup- porting or approving applications or proposals covered by this policy
p.000317: the de- partment or agency head may take into account, in addition to all other eligibility
p.000317: requirements and program criteria, factors such as whether the applicant has been subject to a termi-
p.000317: nation or suspension under paragarph
p.000317: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000317: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000317: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000317: welfare of human subjects (whether or not the research was subject to federal regulation).
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: § 97.124 Conditions.
p.000317: With respect to any research project or any class of research projects the de- partment or agency head may
p.000317: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000317: addi- tional conditions are necessary for the protection of human subjects.
p.000317: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000317: 3474; and 42 U.S.C. 300v–1(b))
p.000317:
p.000317: Subparts B–C [Reserved]
p.000317: Subpart D—Additional ED Protec- tions for Children Who Are Subjects in Research
p.000317:
p.000317: SOURCE: 62 FR 63221, Nov. 26, 1997, unless
p.000317: otherwise noted.
p.000318: 318
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318:
p.000318: Office of the Secretary, Education § 97.405
p.000318:
p.000318:
p.000318: § 97.401 To what do these regulations apply?
p.000318: (a) This subpart applies to all re- search involving children as subjects conducted or supported
p.000318: by the Depart- ment of Education.
p.000318: (1) This subpart applies to research conducted by Department employees.
p.000318: (2) This subpart applies to research conducted or supported by the Depart- ment of Education outside the
p.000318: United States, but in appropriate cir- cumstances the Secretary may, under
p.000318: § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this
p.000318: subpart for that re- search.
p.000318: (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The
p.000318: exemption in
p.000318: § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(2)
p.000318: for research involving survey or interview proce- dures or observations of public behav- ior does not
p.000318: apply to research covered by this subpart, except for research in- volving observation of public behavior when
p.000318: the investigator or investigators do not participate in the activities being observed.
p.000318: (c) The exceptions, additions, and provisions for waiver as they appear in
p.000318: § 97.101(c) through (i) are applicable to this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318: § 97.402 Definitions.
p.000318: The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this
p.000318: subpart:
p.000318: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved
p.000318: in the research, under the applicable law of the jurisdiction in which the re- search will be
p.000318: conducted.
p.000318: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000318: not, ab- sent affirmative agreement, be con- strued as assent.
p.000318: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000318: research.
p.000318: (d) Parent means a child’s biological or adoptive parent.
p.000318:
p.000318: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000318: of a child to general medical care.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.403 IRB duties.
p.000318: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research
p.000318: covered by this subpart and approve only research that satisfies the conditions of all ap- plicable sections of
p.000318: this subpart.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b)).
p.000318:
p.000318: § 97.404 Research not involving great- er than minimal risk.
p.000318: ED conducts or funds research in which the IRB finds that no greater than minimal risk to children
p.000318: is pre- sented, only if the IRB finds that ade- quate provisions are made for solic- iting the assent
p.000318: of the children and the permission of their parents or guard- ians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000318:
p.000318: § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000318: the individual subjects.
p.000318: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000318: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
p.000318: subject, or by a mon- itoring procedure that is likely to con- tribute to the subject’s well-being, only if the IRB
p.000318: finds that—
p.000318: (a) The risk is justified by the antici- pated benefit to the subjects;
p.000318: (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000318: as that presented by available alternative approaches; and
p.000318: (c) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000318: parents or guardians, as set forth in § 97.408.
p.000318: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000318: 3474; and 42 U.S.C. 300v–1(b))
p.000319: 319
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319:
p.000319: § 97.406
p.000319:
p.000319: § 97.406 Research involving greater than minimal risk and no prospect of direct benefit to
p.000319: individual sub- jects, but likely to yield generaliz- able knowledge about the subject’s disorder or
p.000319: condition.
p.000319: ED conducts or funds research in which the IRB finds that more than minimal risk to children is
p.000319: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual
p.000319: subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000319: only if the IRB finds that—
p.000319: (a) The risk represents a minor in- crease over minimal risk;
p.000319: (b) The intervention or procedure presents experiences to subjects that are reasonably
p.000319: commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or
p.000319: educational situations;
p.000319: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or
p.000319: condi- tion that is of vital importance for the understanding or amelioration of the subjects’ disorder or
p.000319: condition; and
p.000319: (d) Adequate provisions are made for soliciting assent of the children and permission of their
p.000319: parents or guard- ians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al-
p.000319: leviate a serious problem affecting the health or welfare of children.
p.000319: ED conducts or funds research that the IRB does not believe meets the re- quirements of § 97.404, § 97.405,
p.000319: or § 97.406 only if—
p.000319: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000319: prevention, or alleviation of a serious problem af- fecting the health or welfare of chil- dren; and
p.000319: (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example:
p.000319: science, medi- cine, education, ethics, law) and fol- lowing opportunity for public review and
p.000319: comment, has determined either that—
p.000319: 34 CFR Subtitle A (7–1–10 Edition)
p.000319: (1) The research in fact satisfies the conditions of § 97.404, § 97.405, or § 97.406, as applicable; or
p.000319: (2)(i) The research presents a reason- able opportunity to further the under- standing, prevention, or
p.000319: alleviation of a serious problem affecting the health or welfare of children;
p.000319: (ii) The research will be conducted in accordance with sound ethical prin- ciples; and
p.000319: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their
p.000319: parents or guardians, as set forth in § 97.408.
p.000319: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000319: 3474; and 42 U.S.C. 300v–1(b))
p.000319:
p.000319: § 97.408 Requirements for permission by parents or guardians and for as- sent by children.
p.000319: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000319: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, if in
p.000319: the judgment of the IRB the children are capable of providing assent. In determining whether chil- dren
p.000319: are capable of assenting, the IRB shall take into account the ages, matu- rity, and psychological state of
p.000319: the children involved. This judgment may be made for all children to be involved in research under a
p.000319: particular protocol, or for each child, as the IRB deems ap- propriate. If the IRB determines that the
p.000319: capability of some or all of the children is so limited that they cannot reasonably be consulted or
p.000319: that the intervention or procedure involved in the research holds out a prospect of di- rect benefit that is
p.000319: important to the health or well-being of the children and is available only in the context of the research,
...
p.000320: (c) In addition to the provisions for waiver contained in § 97.116, if the IRB determines that a
p.000320: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000320: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may
p.000320: waive the consent requirements in subpart A of this part and paragraph
p.000320: (b) of this section, provided an appro- priate mechanism for protecting the children who will
p.000320: participate as sub- jects in the research is substituted, and provided further that the waiver is not inconsistent
p.000320: with Federal, State, or local law. The choice of an appropriate mechanism depends upon the nature and
p.000320: purpose of the activities described in the protocol, the risk and antici- pated benefit to the
p.000320: research subjects, and their age, maturity, status, and condition.
p.000320: (d) Permission by parents or guard- ians must be documented in accordance with and to the extent
p.000320: required by
p.000320: § 97.117.
p.000320: (e) If the IRB determines that assent is required, it shall also determine whether and how assent
p.000320: must be docu- mented.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: § 97.409 Wards.
p.000320: (a) Children who are wards of the State or any other agency, institution, or entity may be included in
p.000320: research approved under § 97.406 or § 97.407 only if that research is—
p.000320: (1) Related to their status as wards; or
p.000320: (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings
p.000320:
p.000320: in which the majority of children in- volved as subjects are not wards.
p.000320: (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment
p.000320: of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the
p.000320: child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The
p.000320: advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
p.000320: interest of the child for the duration of the child’s participation in the re- search and who is not
p.000320: associated in any way (except in the role as advocate or member of the IRB) with the research, the
p.000320: investigator or investigators, or the guardian organization.
p.000320: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
p.000320: 3474; and 42 U.S.C. 300v–1(b))
p.000320:
p.000320: PART 98—STUDENT RIGHTS IN RE- SEARCH, EXPERIMENTAL PRO- GRAMS, AND TESTING
p.000320: Sec.
p.000320: 98.1 Applicability of part.
p.000320: 98.2 Definitions.
p.000320: 98.3 Access to instructional material used in a research or experimentation pro- gram.
p.000320: 98.4 Protection of students’ privacy in ex- amination, testing, or treatment.
p.000320: 98.5 Information and investigation office.
p.000320: 98.6 Reports.
p.000320: 98.7 Filing a complaint.
p.000320: 98.8 Notice of the complaint.
p.000320: 98.9 Investigation and findings.
p.000320: 98.10 Enforcement of the findings.
p.000320: AUTHORITY: Sec. 514(a) of Pub. L. 93–380, 88 Stat. 574 (20 U.S.C. 1232h(a)); sec. 1250 of Pub.
p.000320: L. 95–561, 92 Stat. 2355–2356 (20 U.S.C.
p.000320: 1232h(b)); and sec. 408(a)(1) of Pub. L. 90–247, 88 Stat. 559–560, as amended (20 U.S.C. 1221e– 3(a)(1));
p.000320: sec. 414(a) of Pub. L. 96–88, 93 Stat. 685 (20 U.S.C. 3474(a)), unless otherwise noted.
p.000320: SOURCE: 49 FR 35321, Sept. 6, 1984, unless
p.000320: otherwise noted.
p.000320: § 98.1 Applicability of part.
p.000320: This part applies to any program ad- ministered by the Secretary of Edu- cation that:
p.000320: (a)(1) Was transferred to the Depart- ment by the Department of Education Organization Act (DEOA); and
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000307: covered by this policy.
p.000307: (d) Department or agency heads may require that specific research activities or classes of research
p.000307: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000307: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000307: (e) Compliance with this policy re- quires compliance with pertinent fed- eral laws or regulations which
p.000307: provide additional protections for human sub- jects.
p.000307: (f) This policy does not affect any state or local laws or regulations which
p.000308: 308
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308:
p.000308: Office of the Secretary, Education § 97.102
p.000308:
p.000308:
p.000308: may otherwise be applicable and which provide additional protections for human subjects.
p.000308: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000308: which pro- vide additional protections to human subjects of research.
p.000308: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
p.000308: in the foreign countries to protect human subjects may differ from those set forth in this
p.000308: policy. (An example is a foreign institution which complies with guidelines consistent with the
p.000308: World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign
p.000308: states or by an organization whose function for the protection of human research subjects is
p.000308: internationally recognized.) In these circumstances, if a department or agency head determines that the
p.000308: proce- dures prescribed by the institution af- ford protections that are at least equivalent to
p.000308: those provided in this policy, the department or agency head may approve the substitution of the
p.000308: foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise
p.000308: required by statute, Executive Order, or the de- partment or agency head, notices of these actions as
p.000308: they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department
p.000308: or agency procedures.
p.000308: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000308: of the provisions of this policy to specific re- search activities or classes of research activities
p.000308: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000308: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000308: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000308: and shall also publish them in the FEDERAL REGISTER or in
p.000308:
p.000308: such other manner as provided in de- partment or agency procedures. 1
p.000308: (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| 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 |
| parent | parents |
| parents | parents |
| 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 |
|---|
| child | ['children'] |
| children | ['child'] |
| disabled | ['mentally'] |
| drug | ['influence'] |
| education | ['educational'] |
| educational | ['education'] |
| influence | ['drug'] |
| mentally | ['disabled'] |
| parent | ['parents'] |
| parents | ['parent'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input