79C3C34C52B45572883A05D425EB0F82
40 CFR 26
https://www.govinfo.gov/content/pkg/CFR-2011-title40-vol1/pdf/CFR-2011-title40-vol1-part26.pdf
http://leaux.net/URLS/ConvertAPI Text Files/53F5CB2FFF6A227B3890C307629DA9D4.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000283: the substitution of the foreign procedures in lieu of the proce- dural requirements provided in this
p.000283: policy. Except when otherwise required by statute, Executive Order, or the de- partment or agency head,
p.000283: notices of these actions as they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published
p.000283: as provided in department or agency procedures.
p.000283: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000283: of the provisions of this policy to specific re- search activities or classes of research activities
p.000283: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000283: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000283: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000283: and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de-
p.000283: partment or agency procedures. 1
p.000283: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000283: June 28, 1991, as amended at 70 FR 36328,
p.000283: June 23, 2005]
p.000283:
p.000283: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000283: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000283: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000283: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000283: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000283: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000283: when the investigator(s) do not participate in the activities being observed.
p.000283: 40 CFR Ch. I (7–1–11 Edition)
p.000283: § 26.102 Definitions.
p.000283: (a) Department or agency head means the head of any Federal department or agency and any other officer
p.000283: or em- ployee of any department or agency to whom authority has been delegated.
p.000283: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000283: agencies).
p.000283: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000283: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000283: procedure(s) involved in the research.
p.000283: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000283: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000283: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000283: or supported under a program which is considered research for other purposes. For example, some
...
p.000286: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000286: June 28, 1991, as amended at 70 FR 36328,
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000287: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000287: on the subjects for di- agnostic or treatment purposes.
p.000287: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
...
p.000296: this sec- tion.
p.000296: §§ 26.1103–26.1106 [Reserved]
p.000296: § 26.1107 IRB membership.
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
...
p.000298: (a) In order to approve research cov- ered by this subpart the IRB shall de- termine that all of the
p.000298: following re- quirements are satisfied:
p.000298: (1) Risks to subjects are minimized:
p.000298: (i) By using procedures which are consistent with sound research design and which do not
p.000298: unnecessarily expose subjects to risk, and
p.000298: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000298: or treat- ment purposes.
p.000298: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000298: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000298: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000298: guished from risks and benefits sub- jects would receive even if not partici- pating in the research).
p.000298: The IRB should not consider possible long-range effects of applying knowledge gained in the re- search (for
p.000298: example, the possible ef- fects of the research on public policy) as among those research risks that fall
p.000298: within the purview of its responsi- bility.
p.000298: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000298: the purposes of the research and the setting in which the research will be conducted and should be
p.000298: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000298: prisoners, mentally disabled persons, or economically or educationally dis- advantaged persons.
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 26.1112
p.000299: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000299: representa- tive, in accordance with, and to the ex- tent required by § 26.1116.
p.000299: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000299: required by
p.000299: § 26.1117.
p.000299: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000299: collected to en- sure the safety of subjects.
p.000299: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000299: con- fidentiality of data.
p.000299: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000299: as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional
p.000299: safeguards have been included in the study to protect the rights and welfare of these sub-
p.000299: jects.
p.000299: § 26.1112 Review by institution.
p.000299: Research covered by this subpart that has been approved by an IRB may be subject to further appropriate
p.000299: re- view and approval or disapproval by of- ficials of the institution. However, those officials may not
p.000299: approve the re- search if it has not been approved by an IRB.
p.000299:
p.000299: § 26.1113 Suspension or termination of IRB approval of research.
p.000299: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000299: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
p.000299: In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional
p.000299: studies may use joint review, reliance upon the review of another qualified IRB, or
p.000299: 40 CFR Ch. I (7–1–11 Edition)
...
Political / Indigenous
Searching for indicator native:
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p.000289: undue influence. The information that is given to the subject or the representative shall be in language
p.000289: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000289: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000289: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000289: sponsor, the insti- tution or its agents from liability for negligence.
p.000289: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000289: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000289: to each subject:
p.000289: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000289: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000289: and identification of any procedures which are experi- mental;
p.000289: 40 CFR Ch. I (7–1–11 Edition)
p.000289: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000289: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000289: research;
p.000289: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000289: might be advan- tageous to the subject;
p.000289: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000289: subject will be maintained;
p.000289: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000289: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000289: consist of, or where further information may be ob- tained;
p.000289: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000289: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000289: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000289: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000289: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000289: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000289: elements of in- formation shall also be provided to each subject:
p.000289: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000289: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
...
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
p.000292: are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart.
p.000292: (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to
p.000292: State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
p.000293: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000293: § 26.302 Definitions.
p.000293: The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition,
p.000293: observational research means any human research that does not meet the definition of research in- volving
p.000293: intentional exposure of a human subject in § 26.202(a).
p.000293: § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses.
p.000293: The provisions of 45 CFR 46.203 are applicable to this section.
p.000293: § 26.304 Additional protections for pregnant women and fetuses in- volved in observational
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000293: Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been
p.000293: delegated by the Administrator.
...
p.000300: the prospective subject or the representative sufficient opportunity to consider whether or not to
p.000300: partici- pate and that minimize the possibility of coercion or undue influence. The in- formation that is
p.000300: given to the subject or the representative shall be in lan- guage understandable to the subject or the
p.000300: representative. No informed con- sent, whether oral or written, may in- clude any exculpatory
p.000300: language through which the subject or the rep- resentative is made to waive or appear to waive any
p.000300: of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the insti- tution
p.000300: or its agents from liability for negligence.
p.000300: (a) Basic elements of informed con- sent. In seeking informed consent the following information shall be
p.000300: provided to each subject:
p.000300: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000300: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000300: and identification of any procedures which are experi- mental;
p.000300: (2) A description of any reasonably
p.000300: foreseeable risks or discomforts to the subject;
p.000300: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000300: research;
p.000300: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000300: might be advan- tageous to the subject;
p.000300: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000300: subject will be maintained;
p.000300: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000300: an ex- planation as to whether any medical treatments are available if injury oc-
p.000300:
p.000300: curs and, if so, what they consist of, or where further information may be ob- tained;
p.000300: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000300: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000300: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000300: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000300: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000300: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000300: elements of in- formation shall also be provided to each subject:
p.000300: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.000281: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000281: involvement
p.000282: 282
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282: Environmental Protection Agency § 26.101
p.000282:
p.000282:
p.000282: of human subjects will be in one or more of the following categories are exempt from this policy:
p.000282: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000282: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000282: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000282: cur- ricula, or classroom management methods.
p.000282: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000282: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000282: through identifiers linked to the subjects; and
p.000282: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000282: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000282: employability, or reputation.
p.000282: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000282: (b)(2) of this section, if:
p.000282: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000282: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000282: informa- tion will be maintained throughout the research and thereafter.
p.000282: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000282: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000282: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000282: subjects.
p.000282: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000282: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000282:
p.000282: (i) Public benefit or service pro- grams;
p.000282: (ii) Procedures for obtaining benefits or services under those programs;
p.000282: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000282: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000282: (6) Taste and food quality evaluation and consumer acceptance studies,
...
p.000304: An IRB or an institution may be re- instated to conduct studies subject to this part if the
p.000304: Administrator deter- mines, upon an evaluation of a written submission from the IRB or institution that explains
p.000304: the corrective action that the institution or IRB has taken or plans to take, that the IRB or insti- tution
p.000304: has provided adequate assurance that it will operate in compliance with the standards set forth in this part. No-
p.000304: tification of reinstatement shall be provided to all persons notified under
p.000304: § 26.1502(c).
p.000304: § 26.1506 Debarment.
p.000304: If EPA determines that an institu- tion or investigator repeatedly has not complied with or has committed
p.000304: an
p.000304:
p.000304: egregious violation of the applicable regulations in subparts A through L of this part, EPA may
p.000304: recommend that institution or investigator be declared ineligible to participate in EPA-sup- ported
p.000304: research (debarment). Debar- ment will be initiated in accordance with procedures specified at 2 CFR part
p.000304: 1532.
p.000304: [71 FR 6168, Feb. 6, 2006, as amended at 72 FR
p.000304: 2427, Jan. 19, 2007]
p.000304:
p.000304: § 26.1507 Actions alternative or addi- tional to disqualification.
p.000304: Disqualification of an IRB or of an institution is independent of, and nei- ther in lieu of nor a
p.000304: precondition to, other statutorily authorized pro- ceedings or actions. EPA may, at any time, on
p.000304: its own initiative or through the Department of Justice, institute any appropriate judicial
p.000304: proceedings (civil or criminal) and any other appro- priate regulatory action, in addition to or in lieu of, and
p.000304: before, at the time of, or after, disqualification. The Agency may also refer pertinent matters to an- other
p.000304: Federal, State, or local govern- ment agency for any action that that agency determines to be appropriate.
p.000304:
p.000304: Subpart P—Review of Proposed and Completed Human Research
p.000304: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000304: erwise noted.
p.000304:
p.000304: § 26.1601 EPA review of proposed human research.
p.000304: (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With respect to any
p.000304: research or any class of research, the Adminis- trator may recommend additional con- ditions which, in
p.000304: the judgment of the Administrator, are necessary for the protection of human subjects.
p.000304: (b) In reviewing proposals covered by this subpart, the Administrator may take into account factors
p.000304: such as whether the applicant has been subject to a termination or suspension under
p.000304: § 26.123(a) or § 26.1123 and whether the applicant or the person or persons who would direct or has/have
p.000304: directed the scientific and technical aspects of an activity has/have, in the judgment of the Administrator,
p.000304: materially failed to
p.000305: 305
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305: § 26.1602
p.000305: discharge responsibility for the protec- tion of the rights and welfare of human subjects (whether or not the
p.000305: research was subject to Federal regulation).
...
Political / political affiliation
Searching for indicator party:
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p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
...
p.000286: accordance with
p.000286: § 26.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000286: 26.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000286: the protection of the rights and welfare of subjects.
p.000286: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000286: with
p.000286: § 26.117.
p.000287: 287
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287: § 26.110
p.000287: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000287: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000287: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000287: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000287: person or in writing.
p.000287: (e) An IRB shall conduct continuing
p.000287: review of research covered by this pol- icy at intervals appropriate to the de- gree of risk, but not less
p.000287: than once per year, and shall have authority to ob- serve or have a third party observe the consent process and
p.000287: the research.
p.000287: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000287: [56 FR 28012, 28022, June 18, 1991, as amended
p.000287: at 70 FR 36328, June 23, 2005]
p.000287:
p.000287: § 26.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000287: minor changes in approved re- search.
p.000287: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000287: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000287: be amended, as appropriate after consultation with other departments and agencies, through
p.000287: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000287: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000287: (b) An IRB may use the expedited re-
p.000287: view procedure to review either or both of the following:
p.000287: (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.000287: mini- mal risk,
p.000287: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000287: approval is authorized.
p.000287: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or
...
p.000294: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
p.000295: (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be
p.000295: docu- mented.
p.000295:
p.000295: Subparts E–J [Reserved]
p.000295: Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving
p.000295: Intentional Exposure of Non-pregnant, Non-nursing Adults
p.000295: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000295: erwise noted.
p.000295:
p.000295: § 26.1101 To what does this subpart apply?
p.000295: (a) Except as provided in paragraph
p.000295: (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving
p.000295: intentional exposure of a human subject if, at any time prior to initiating such research, any person who
p.000295: conducted or supported such research intended:
p.000295: (1) To submit results of the research to EPA for consideration in connection with any action that may be
p.000295: performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7
p.000295: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000295: (2) To hold the results of the research for later inspection by EPA under the Federal Insecticide,
p.000295: Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic
p.000295: Act 21 U.S.C. 346a).
p.000295: (b) Unless otherwise required by the Administrator, research is exempt from this subpart if it
p.000295: involves only the collection or study of existing data, documents, records, pathological speci- mens, or
p.000295: diagnostic specimens from previously conducted studies, and if these sources are publicly available or
p.000295: if the information is recorded by the investigator in such a manner that subjects cannot be
...
p.000297: accordance with
p.000297: § 26.1116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000297: 26.1116 be given to the subjects when, in the IRB’s judg- ment, the information would meaning- fully add
p.000297: to the protection of the rights and welfare of subjects.
p.000297: (c) An IRB shall require documenta- tion of informed consent in accordance with § 26.1117.
p.000298: 298
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298: Environmental Protection Agency § 26.1111
p.000298:
p.000298:
p.000298: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000298: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000298: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000298: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000298: person or in writing.
p.000298: (e) An IRB shall conduct continuing
p.000298: review of research covered by this sub- part at intervals appropriate to the de- gree of risk, but not less than once
p.000298: per year, and shall have authority to ob- serve or have a third party observe the consent process and the
p.000298: research.
p.000298: § 26.1110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000298: minor changes in approved re- search.
p.000298: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000298: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000298: be amended, as appropriate after consultation with other departments and agencies, through
p.000298: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000298: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000298: (b)(1) An IRB may use the expedited
p.000298: review procedure to review either or both of the following:
p.000298: (i) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than
p.000298: mini- mal risk,
p.000298: (ii) Minor changes in previously ap- proved research during the period (of 1 year or less) for which
p.000298: approval is au- thorized.
p.000298: (2) Under an expedited review proce- dure, the review may be carried out by the IRB chairperson or by one or
p.000298: more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing
...
p.000301: (a) A discussion of:
p.000301: (1) The potential risks to human sub- jects;
p.000301: (2) The measures proposed to mini- mize risks to the human subjects;
p.000301: (3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue;
p.000301: (4) Alternative means of obtaining in- formation comparable to what would be collected through the proposed
p.000301: re- search; and
p.000301: (5) The balance of risks and benefits of the proposed research.
p.000301: (b) All information for subjects and written informed consent agreements as originally provided to the
p.000301: IRB, and as approved by the IRB.
p.000301: (c) Information about how subjects will be recruited, including any adver- tisements proposed to be used.
p.000301: (d) A description of the cir- cumstances and methods proposed for presenting information
p.000301: to potential human subjects for the purpose of ob- taining their informed consent.
p.000301: (e) All correspondence between the IRB and the investigators or sponsors.
p.000301: (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that
p.000301: re- search involving human subjects has been reviewed and approved by an IRB.
p.000301:
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Environmental Protection Agency § 26.1303
p.000302:
p.000302: Subpart L—Prohibition of Third- Party Research for Pesticides Involving Intentional Exposure of Human
p.000302: Subjects who are Children or Pregnant or Nurs- ing Women
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1201 To what does this subpart apply?
p.000302: Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject
p.000302: in- tended:
p.000302: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA
p.000302: under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
...
Political / stateless persons
Searching for indicator nation:
(return to top)
p.000291: the potential benefits of the re- search to the subjects and others, and the importance of the
p.000291: knowledge gained or to be gained.
p.000291: (b) On the basis of this evaluation,
p.000291: the department or agency head may approve or disapprove the application or proposal, or enter into
p.000291: negotiations to develop an approvable one.
p.000291: § 26.121 [Reserved]
p.000291: § 26.122 Use of Federal funds.
p.000291: Federal funds administered by a de- partment or agency may not be ex- pended for research involving
p.000291: human subjects unless the requirements of this policy have been satisfied.
p.000291: § 26.123 Early termination of research support: Evaluation of applications and proposals.
p.000291: (a) The department or agency head may require that department or agency support for any project be terminated
p.000291: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000291: head finds an institution has materially failed to comply with the terms of this policy.
p.000291: (b) In making decisions about sup-
p.000291: porting or approving applications or proposals covered by this policy the de- partment or agency head
p.000291: may take into account, in addition to all other
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Environmental Protection Agency § 26.301
p.000292:
p.000292:
p.000292: eligibility requirements and program criteria, factors such as whether the applicant has been subject to
p.000292: a termi- nation or suspension under paragraph
p.000292: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000292: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000292: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000292: welfare of human subjects (whether or not the research was subject to Federal regulation).
p.000292: § 26.124 Conditions.
p.000292: With respect to any research project or any class of research projects the de- partment or agency head may
p.000292: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000286:
p.000286:
p.000286: application or proposal may be re- turned to the institution.
p.000286: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000286: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000286: June 28, 1991, as amended at 70 FR 36328,
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
...
p.000287: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000287: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000287: on the subjects for di- agnostic or treatment purposes.
p.000287: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
...
p.000296: of Research, and
p.000296: (2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of
p.000296: this sec- tion.
p.000296: §§ 26.1103–26.1106 [Reserved]
p.000296: § 26.1107 IRB membership.
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000298:
p.000298: § 26.1111 Criteria for IRB approval of research.
p.000298: (a) In order to approve research cov- ered by this subpart the IRB shall de- termine that all of the
p.000298: following re- quirements are satisfied:
p.000298: (1) Risks to subjects are minimized:
p.000298: (i) By using procedures which are consistent with sound research design and which do not
p.000298: unnecessarily expose subjects to risk, and
p.000298: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000298: or treat- ment purposes.
p.000298: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000298: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000298: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000298: guished from risks and benefits sub- jects would receive even if not partici- pating in the research).
p.000298: The IRB should not consider possible long-range effects of applying knowledge gained in the re- search (for
p.000298: example, the possible ef- fects of the research on public policy) as among those research risks that fall
p.000298: within the purview of its responsi- bility.
p.000298: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000298: the purposes of the research and the setting in which the research will be conducted and should be
p.000298: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000298: prisoners, mentally disabled persons, or economically or educationally dis- advantaged persons.
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 26.1112
p.000299: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000299: representa- tive, in accordance with, and to the ex- tent required by § 26.1116.
p.000299: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000299: required by
p.000299: § 26.1117.
p.000299: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000299: collected to en- sure the safety of subjects.
p.000299: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000299: con- fidentiality of data.
p.000299: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000299: as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional
p.000299: safeguards have been included in the study to protect the rights and welfare of these sub-
p.000299: jects.
p.000299: § 26.1112 Review by institution.
p.000299: Research covered by this subpart that has been approved by an IRB may be subject to further appropriate
p.000299: re- view and approval or disapproval by of- ficials of the institution. However, those officials may not
p.000299: approve the re- search if it has not been approved by an IRB.
p.000299:
p.000299: § 26.1113 Suspension or termination of IRB approval of research.
p.000299: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000299: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000281: ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e),
p.000281: must comply with all sections of this policy.
p.000281: (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is
p.000281: subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101,
p.000281: § 26.102, and § 26.107 through § 26.117 of this policy, by an in- stitutional review board (IRB) that op- erates in
p.000281: accordance with the pertinent requirements of this policy.
p.000281: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000281: involvement
p.000282: 282
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282: Environmental Protection Agency § 26.101
p.000282:
p.000282:
p.000282: of human subjects will be in one or more of the following categories are exempt from this policy:
p.000282: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000282: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000282: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000282: cur- ricula, or classroom management methods.
p.000282: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000282: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000282: through identifiers linked to the subjects; and
p.000282: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000282: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000282: employability, or reputation.
p.000282: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000282: (b)(2) of this section, if:
p.000282: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000282: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000282: informa- tion will be maintained throughout the research and thereafter.
p.000282: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000282: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000282: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000282: subjects.
p.000282: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000282: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000282:
p.000282: (i) Public benefit or service pro- grams;
p.000282: (ii) Procedures for obtaining benefits or services under those programs;
p.000282: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000282: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000282: (6) Taste and food quality evaluation and consumer acceptance studies,
p.000282: (i) If wholesome foods without addi- tives are consumed or
p.000282: (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.000282: (b)(2) of this section, if:
p.000282: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000282: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000282: informa- tion will be maintained throughout the research and thereafter.
p.000282: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
p.000282: or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the
p.000282: investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the
p.000282: subjects.
p.000282: (5) Research and demonstration projects which are conducted by or sub- ject to the approval of
p.000282: department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine:
p.000282:
p.000282: (i) Public benefit or service pro- grams;
p.000282: (ii) Procedures for obtaining benefits or services under those programs;
p.000282: (iii) Possible changes in or alter- natives to those programs or proce- dures; or
p.000282: (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs.
p.000282: (6) Taste and food quality evaluation and consumer acceptance studies,
p.000282: (i) If wholesome foods without addi- tives are consumed or
p.000282: (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use
p.000282: found to be safe, or agricultural chemical or environ- mental contaminant at or below the level
p.000282: found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or
p.000282: the Food Safety and Inspection Service of the U.S. Department of Agri- culture.
p.000282: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000282: covered by this policy.
p.000282: (d) Department or agency heads may require that specific research activities or classes of research
p.000282: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000282: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000282: (e) Compliance with this policy re- quires compliance with pertinent Fed- eral laws or regulations which
p.000282: provide additional protections for human sub- jects.
p.000282: (f) This policy does not affect any State or local laws or regulations which may otherwise be
p.000282: applicable and which provide additional protections for human subjects.
p.000282: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000282: which pro- vide additional protections to human subjects of research.
p.000282: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
p.000282: in the foreign countries to protect human subjects may differ from those set forth in this
p.000282: policy. [An example is a foreign institution which complies
p.000283: 283
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283: § 26.102
...
p.000283: 40 CFR Ch. I (7–1–11 Edition)
p.000283: § 26.102 Definitions.
p.000283: (a) Department or agency head means the head of any Federal department or agency and any other officer
p.000283: or em- ployee of any department or agency to whom authority has been delegated.
p.000283: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000283: agencies).
p.000283: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000283: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000283: procedure(s) involved in the research.
p.000283: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000283: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000283: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000283: or supported under a program which is considered research for other purposes. For example, some
p.000283: demonstration and service programs may include research activities.
p.000283: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000283: for which a Federal department or agency has specific responsibility for regulating as a research activity,
p.000283: (for example, In- vestigational New Drug requirements administered by the Food and Drug Ad- ministration). It
p.000283: does not include re- search activities which are inciden- tally regulated by a Federal depart-
p.000283: ment or agency solely as part of the de- partment’s or agency’s broader respon- sibility to regulate certain types
p.000283: of ac- tivities whether research or non-re- search in nature (for example, Wage and Hour
p.000283: requirements administered by the Department of Labor).
p.000283: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000283: con- ducting research obtains
p.000283: (1) Data through intervention or interaction with the individual, or
p.000283: (2) Identifiable private information.
p.000283: Intervention includes both physical pro- cedures by which data are gathered (for
p.000284: 284
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284: Environmental Protection Agency § 26.103
p.000284:
p.000284:
p.000284: example, venipuncture) and manipula- tions of the subject or the subject’s en- vironment that are performed for
p.000284: re- search purposes. Interaction includes communication or interpersonal con- tact between investigator
p.000284: and subject. ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000284: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion which has
p.000284: been provided for spe- cific purposes by an individual and which the individual can reasonably
...
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
p.000295: (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be
p.000295: docu- mented.
p.000295:
p.000295: Subparts E–J [Reserved]
p.000295: Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving
p.000295: Intentional Exposure of Non-pregnant, Non-nursing Adults
p.000295: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000295: erwise noted.
p.000295:
p.000295: § 26.1101 To what does this subpart apply?
p.000295: (a) Except as provided in paragraph
p.000295: (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving
p.000295: intentional exposure of a human subject if, at any time prior to initiating such research, any person who
p.000295: conducted or supported such research intended:
p.000295: (1) To submit results of the research to EPA for consideration in connection with any action that may be
p.000295: performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7
p.000295: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000295: (2) To hold the results of the research for later inspection by EPA under the Federal Insecticide,
p.000295: Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic
p.000295: Act 21 U.S.C. 346a).
p.000295: (b) Unless otherwise required by the Administrator, research is exempt from this subpart if it
p.000295: involves only the collection or study of existing data, documents, records, pathological speci- mens, or
p.000295: diagnostic specimens from previously conducted studies, and if these sources are publicly available or
p.000295: if the information is recorded by the investigator in such a manner that subjects cannot be
p.000295: identified, directly or through identifiers linked to the subjects.
p.000295: 40 CFR Ch. I (7–1–11 Edition)
p.000295: (c) The Administrator retains final judgment as to whether a particular activity within the scope of
p.000295: paragraphs
p.000295: (a) and (b) of this section is covered by this subpart.
p.000295: (d) Compliance with this subpart re- quires compliance with pertinent Fed- eral laws or regulations which
p.000295: provide additional protections for human sub- jects.
p.000295: (e) This subpart does not affect any State or local laws or regulations which may otherwise be
p.000295: applicable and which provide additional protections for human subjects. Reference to State or local laws in this
p.000295: subpart is intended to include the laws of federally recog- nized American Indian and Alaska Na- tive Tribal
p.000295: Governments.
p.000295: (f) This subpart does not affect any foreign laws or regulations which may otherwise be applicable and
p.000295: which pro- vide additional protections to human subjects of research.
p.000295: (g) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000295: consider any available information relevant to de- termining the intent of a person who conducts or
...
p.000301: to potential human subjects for the purpose of ob- taining their informed consent.
p.000301: (e) All correspondence between the IRB and the investigators or sponsors.
p.000301: (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that
p.000301: re- search involving human subjects has been reviewed and approved by an IRB.
p.000301:
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Environmental Protection Agency § 26.1303
p.000302:
p.000302: Subpart L—Prohibition of Third- Party Research for Pesticides Involving Intentional Exposure of Human
p.000302: Subjects who are Children or Pregnant or Nurs- ing Women
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1201 To what does this subpart apply?
p.000302: Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject
p.000302: in- tended:
p.000302: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA
p.000302: under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000302: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000302: people, products, or ac- tivities.
p.000302: § 26.1202 Definitions.
p.000302: The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the
p.000302: definitions at 45 CFR 46.202(a) through (f) and at 45 CFR
p.000302:
p.000302: 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18
p.000302: years.
p.000302:
p.000302: § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support
p.000302: re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: [71 FR 36175, June 23, 2006]
p.000302:
p.000302: Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human
p.000302: Research
p.000302:
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1301 To what does this subpart apply?
p.000302: This subpart applies to any person who submits a report containing the results of any human research if:
p.000302: (a) The report is submitted after April 7, 2006, and
p.000302: (b) The report is submitted for con- sideration in connection with any ac- tion that may be performed
p.000302: by EPA under the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section
p.000302: 408 of the Federal Food, Drug, and Cosmetic Act (21
p.000302: U.S.C. 346a).
p.000302: § 26.1302 Definitions.
p.000302: The definitions in § 26.102 shall apply to this subpart as well.
p.000302:
p.000302: § 26.1303 Submission of information pertaining to ethical conduct of completed human research.
p.000302: Any person who submits to EPA data derived from human research covered by this subpart shall provide at
p.000302: the time of submission information con- cerning the ethical conduct of such re- search. To the extent
p.000302: available to the submitter and not previously provided
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 26.1501
p.000303: to EPA, such information should in- clude:
p.000303: (a) Copies of all of the records rel- evant to the research specified by
p.000303: § 26.1115(a) to be prepared and main- tained by an IRB.
p.000303: (b) Copies of all of the records rel- evant to the information identified in
p.000303: § 26.1125(a) through (f).
p.000303: (c) Copies of sample records used to document informed consent as speci- fied by § 26.1117, but not
p.000303: identifying any subjects of the research.
p.000303: (d) If any of the information listed in paragraphs (a) through (c) of this sec- tion is not provided, the
p.000303: person shall describe the efforts made to obtain the information.
p.000303: Subpart N [Reserved]
p.000303: Subpart O—Administrative Actions for Noncompliance
p.000303: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000303: erwise noted.
p.000303:
p.000303: § 26.1501 To what does this subpart apply?
...
p.000305: re- views.
p.000305:
p.000305: § 26.1603 Operation of the Human Studies Review Board.
p.000305: EPA shall establish and operate a Human Studies Review Board as fol- lows:
p.000305: (a) Membership. The Human Studies Review Board shall consist of members who are not employed by EPA,
p.000305: who meet the ethics and other requirements for special government employees, and who have expertise in
p.000305: fields appro- priate for the scientific and ethical re- view of human research, including re- search
p.000305: ethics, biostatistics, and human toxicology.
p.000305: (b) Responsibilities. The Human Stud- ies Review Board shall comment on the scientific and ethical aspects
p.000305: of re- search proposals and reports of com- pleted research with human subjects submitted by EPA for
p.000305: its review and, on request, advise EPA on ways to strengthen its programs for protection of human
p.000305: subjects of research.
p.000305:
p.000305: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA
p.000305: Actions
p.000305:
p.000305: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000305: erwise noted.
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
...
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p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
...
p.000288: (7) Statements of significant new findings provided to subjects, as re- quired by § 26.116(b)(5).
p.000289: 289
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289: § 26.116
p.000289: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000289: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000289: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000289: depart- ment or agency at reasonable times and in a reasonable manner.
p.000289: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000289: [56 FR 28012, 28022, June 18, 1991, as amended
p.000289: at 70 FR 36328, June 23, 2005]
p.000289:
p.000289: § 26.116 General requirements for in- formed consent.
p.000289: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000289: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000289: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000289: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000289: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000289: undue influence. The information that is given to the subject or the representative shall be in language
p.000289: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000289: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000289: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000289: sponsor, the insti- tution or its agents from liability for negligence.
p.000289: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000289: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000289: to each subject:
p.000289: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000289: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000289: and identification of any procedures which are experi- mental;
p.000289: 40 CFR Ch. I (7–1–11 Edition)
p.000289: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000289: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000289: research;
p.000289: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000289: might be advan- tageous to the subject;
...
p.000298: the purposes of the research and the setting in which the research will be conducted and should be
p.000298: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000298: prisoners, mentally disabled persons, or economically or educationally dis- advantaged persons.
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 26.1112
p.000299: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000299: representa- tive, in accordance with, and to the ex- tent required by § 26.1116.
p.000299: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000299: required by
p.000299: § 26.1117.
p.000299: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000299: collected to en- sure the safety of subjects.
p.000299: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000299: con- fidentiality of data.
p.000299: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000299: as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional
p.000299: safeguards have been included in the study to protect the rights and welfare of these sub-
p.000299: jects.
p.000299: § 26.1112 Review by institution.
p.000299: Research covered by this subpart that has been approved by an IRB may be subject to further appropriate
p.000299: re- view and approval or disapproval by of- ficials of the institution. However, those officials may not
p.000299: approve the re- search if it has not been approved by an IRB.
p.000299:
p.000299: § 26.1113 Suspension or termination of IRB approval of research.
p.000299: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000299: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
p.000299: In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional
...
p.000299: (6) Written procedures for the IRB in the same detail as described in
p.000299: § 26.1108(a) and § 26.1108(b).
p.000299: (7) Statements of significant new findings provided to subjects, as re- quired by § 26.1116(b)(5).
p.000299: (b) The records required by this sub- part shall be retained for at least 3 years, and records
p.000299: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000299: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of EPA at
p.000299: rea- sonable times and in a reasonable man- ner.
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Environmental Protection Agency § 26.1116
p.000300:
p.000300:
p.000300: § 26.1116 General requirements for in- formed consent.
p.000300: No investigator may involve a human being as a subject in research covered by this subpart unless the
p.000300: investigator has obtained the legally effective in- formed consent of the subject or the subject’s legally
p.000300: authorized representa- tive. An investigator shall seek such consent only under circumstances that provide
p.000300: the prospective subject or the representative sufficient opportunity to consider whether or not to
p.000300: partici- pate and that minimize the possibility of coercion or undue influence. The in- formation that is
p.000300: given to the subject or the representative shall be in lan- guage understandable to the subject or the
p.000300: representative. No informed con- sent, whether oral or written, may in- clude any exculpatory
p.000300: language through which the subject or the rep- resentative is made to waive or appear to waive any
p.000300: of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the insti- tution
p.000300: or its agents from liability for negligence.
p.000300: (a) Basic elements of informed con- sent. In seeking informed consent the following information shall be
p.000300: provided to each subject:
p.000300: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000300: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000300: and identification of any procedures which are experi- mental;
p.000300: (2) A description of any reasonably
p.000300: foreseeable risks or discomforts to the subject;
p.000300: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000300: research;
p.000300: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000300: might be advan- tageous to the subject;
p.000300: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000300: subject will be maintained;
...
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p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
...
p.000296: gator and subject. ‘‘Private informa- tion’’ includes information about be- havior that occurs in
p.000296: a context in which an individual can reasonably ex- pect that no observation or recording is taking place,
p.000296: and information which has been provided for specific purposes by an individual and which the indi- vidual
p.000296: can reasonably expect will not be made public (for example, a medical record). Private information must be
p.000296: individually identifiable (i.e., the iden- tity of the subject is or may readily be ascertained by the investigator
p.000296: or asso- ciated with the information) in order for obtaining the information to con- stitute research
p.000296: involving human sub- jects.
p.000296: (f) IRB means an institutional review
p.000296: board established in accord with and for the purposes expressed in this part.
p.000296: (g) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000296: may be con- ducted at an institution within the constraints set forth by the IRB and by
p.000296:
p.000296: other institutional and Federal re- quirements.
p.000296: (h) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000296: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000296: performance of rou- tine physical or psychological exami- nations or tests.
p.000296: (i) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000296: exposure to the substance experienced by a human subject participating in the study would not have
p.000296: occurred but for the human subject’s participation in the study.
p.000296: (j) Person means any person, as that term is defined in FIFRA section 2(s) (7
p.000296: U.S.C. 136), except:
p.000296: (1) A federal agency that is subject to the provisions of the Federal Policy for the Protection of Human Subjects
p.000296: of Research, and
p.000296: (2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of
p.000296: this sec- tion.
p.000296: §§ 26.1103–26.1106 [Reserved]
p.000296: § 26.1107 IRB membership.
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
...
Health / Mentally Disabled
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p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000286: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000286: These individuals may not vote with the IRB.
p.000286: § 26.108 IRB functions and operations.
...
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
p.000288: § 26.114 Cooperative research.
p.000288: Cooperative research projects are those projects covered by this policy which involve more than one
...
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
p.000297:
p.000297: § 26.1108 IRB functions and oper- ations.
p.000297: In order to fulfill the requirements of this subpart each IRB shall:
...
p.000298: (1) Risks to subjects are minimized:
p.000298: (i) By using procedures which are consistent with sound research design and which do not
p.000298: unnecessarily expose subjects to risk, and
p.000298: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000298: or treat- ment purposes.
p.000298: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000298: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000298: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000298: guished from risks and benefits sub- jects would receive even if not partici- pating in the research).
p.000298: The IRB should not consider possible long-range effects of applying knowledge gained in the re- search (for
p.000298: example, the possible ef- fects of the research on public policy) as among those research risks that fall
p.000298: within the purview of its responsi- bility.
p.000298: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000298: the purposes of the research and the setting in which the research will be conducted and should be
p.000298: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000298: prisoners, mentally disabled persons, or economically or educationally dis- advantaged persons.
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 26.1112
p.000299: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000299: representa- tive, in accordance with, and to the ex- tent required by § 26.1116.
p.000299: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000299: required by
p.000299: § 26.1117.
p.000299: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000299: collected to en- sure the safety of subjects.
p.000299: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000299: con- fidentiality of data.
p.000299: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000299: as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional
p.000299: safeguards have been included in the study to protect the rights and welfare of these sub-
p.000299: jects.
p.000299: § 26.1112 Review by institution.
p.000299: Research covered by this subpart that has been approved by an IRB may be subject to further appropriate
p.000299: re- view and approval or disapproval by of- ficials of the institution. However, those officials may not
p.000299: approve the re- search if it has not been approved by an IRB.
p.000299:
p.000299: § 26.1113 Suspension or termination of IRB approval of research.
p.000299: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000299: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
p.000299: In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional
p.000299: studies may use joint review, reliance upon the review of another qualified IRB, or
p.000299: 40 CFR Ch. I (7–1–11 Edition)
p.000299: similar arrangements aimed at avoid- ance of duplication of effort.
p.000299: § 26.1115 IRB records.
...
Searching for indicator mentally:
(return to top)
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000286: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000286: These individuals may not vote with the IRB.
...
p.000287: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
p.000288: § 26.114 Cooperative research.
p.000288: Cooperative research projects are those projects covered by this policy which involve more than one
...
p.000296: this sec- tion.
p.000296: §§ 26.1103–26.1106 [Reserved]
p.000296: § 26.1107 IRB membership.
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
p.000297:
...
p.000298: following re- quirements are satisfied:
p.000298: (1) Risks to subjects are minimized:
p.000298: (i) By using procedures which are consistent with sound research design and which do not
p.000298: unnecessarily expose subjects to risk, and
p.000298: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000298: or treat- ment purposes.
p.000298: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000298: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000298: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000298: guished from risks and benefits sub- jects would receive even if not partici- pating in the research).
p.000298: The IRB should not consider possible long-range effects of applying knowledge gained in the re- search (for
p.000298: example, the possible ef- fects of the research on public policy) as among those research risks that fall
p.000298: within the purview of its responsi- bility.
p.000298: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account
p.000298: the purposes of the research and the setting in which the research will be conducted and should be
p.000298: particularly cognizant of the special problems of research in- volving vulnerable populations, such as
p.000298: prisoners, mentally disabled persons, or economically or educationally dis- advantaged persons.
p.000299: 299
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299:
p.000299: § 26.1112
p.000299: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000299: representa- tive, in accordance with, and to the ex- tent required by § 26.1116.
p.000299: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000299: required by
p.000299: § 26.1117.
p.000299: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000299: collected to en- sure the safety of subjects.
p.000299: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000299: con- fidentiality of data.
p.000299: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000299: as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional
p.000299: safeguards have been included in the study to protect the rights and welfare of these sub-
p.000299: jects.
p.000299: § 26.1112 Review by institution.
p.000299: Research covered by this subpart that has been approved by an IRB may be subject to further appropriate
p.000299: re- view and approval or disapproval by of- ficials of the institution. However, those officials may not
p.000299: approve the re- search if it has not been approved by an IRB.
p.000299:
p.000299: § 26.1113 Suspension or termination of IRB approval of research.
p.000299: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000299: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
p.000299: In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional
p.000299: studies may use joint review, reliance upon the review of another qualified IRB, or
p.000299: 40 CFR Ch. I (7–1–11 Edition)
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000286: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000286: These individuals may not vote with the IRB.
p.000286: § 26.108 IRB functions and operations.
p.000286: In order to fulfill the requirements of this policy each IRB shall:
p.000286: (a) Follow written procedures in the same detail as described in § 26.103(b)(4) and, to the extent
p.000286: required by,
p.000286: § 26.103(b)(5).
p.000286: (b) Except when an expedited review procedure is used (see § 26.110), review proposed research at
p.000286: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000286: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000286: approved, it shall receive the approval of a ma- jority of those members present at the meeting.
p.000286: § 26.109 IRB review of research.
p.000286: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000286: approval), or dis- approve all research activities covered by this policy.
p.000286: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000286: accordance with
...
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
p.000297:
p.000297: § 26.1108 IRB functions and oper- ations.
p.000297: In order to fulfill the requirements of this subpart each IRB shall:
p.000297: (a) Follow written procedures:
p.000297: (1) For conducting its initial and con- tinuing review of research and for re- porting its findings and
p.000297: actions to the investigator and the institution;
p.000297: (2) For determining which projects require review more often than annu- ally and which
p.000297: projects need verification from sources other than the investigator that no material changes
p.000297: have occurred since previous IRB review;
p.000297: 40 CFR Ch. I (7–1–11 Edition)
p.000297: (3) For ensuring prompt reporting to the IRB of proposed changes in re- search activity; and
p.000297: (4) For ensuring that changes in ap- proved research, during the period for which IRB approval has
p.000297: already been given, may not be initiated without IRB review and approval except where necessary to
p.000297: eliminate apparent imme- diate hazards to the human subjects.
p.000297: (b) Follow written procedures for en- suring prompt reporting to the IRB, appropriate institutional
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000281: or Agency.
p.000281: 26.104–26.106 [Reserved]
p.000281: 26.107 IRB membership.
p.000281: 26.108 IRB functions and operations.
p.000281: 26.109 IRB review of research.
p.000281: 26.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.111 Criteria for IRB approval of research.
p.000281: 26.112 Review by institution.
p.000281: 26.113 Suspension or termination of IRB ap- proval of research.
p.000281: 26.114 Cooperative research.
p.000281: 26.115 IRB records.
p.000281: 26.116 General requirements for informed consent.
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
p.000281: pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000281: Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects
p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
p.000281: pregnant women (and therefore their fetuses), nursing women, or children.
p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
p.000281: ducted by Federal civilian employees or military personnel, except that each department or agency head may
p.000281: adopt such procedural modifications as may be appropriate from an administrative standpoint. It also
p.000281: includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment
p.000281: outside the United States.
p.000281: (1) Research that is conducted or sup-
...
p.000286: June 28, 1991, as amended at 70 FR 36328,
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
...
p.000287: on the subjects for di- agnostic or treatment purposes.
p.000287: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
p.000288: § 26.114 Cooperative research.
...
p.000289: might be advan- tageous to the subject;
p.000289: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000289: subject will be maintained;
p.000289: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000289: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000289: consist of, or where further information may be ob- tained;
p.000289: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000289: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000289: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000289: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000289: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000289: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000289: elements of in- formation shall also be provided to each subject:
p.000289: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000289: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
p.000289: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000289: investigator without regard to the subject’s con- sent;
p.000289: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000289: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000289: of participation by the subject;
p.000290: 290
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290: Environmental Protection Agency § 26.117
p.000290:
p.000290:
p.000290: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000290: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000290: (6) The approximate number of sub- jects involved in the study.
p.000290: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000290: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000290: provided the IRB finds and documents that:
p.000290: (1) The research or demonstration project is to be conducted by or subject to the approval of State or
p.000290: local gov- ernment officials and is designed to study, evaluate, or otherwise examine:
p.000290: (i) Public benefit of service programs;
...
p.000291: may take into account, in addition to all other
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Environmental Protection Agency § 26.301
p.000292:
p.000292:
p.000292: eligibility requirements and program criteria, factors such as whether the applicant has been subject to
p.000292: a termi- nation or suspension under paragraph
p.000292: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000292: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000292: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000292: welfare of human subjects (whether or not the research was subject to Federal regulation).
p.000292: § 26.124 Conditions.
p.000292: With respect to any research project or any class of research projects the de- partment or agency head may
p.000292: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
p.000292: are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart.
p.000292: (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to
p.000292: State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
p.000293: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000293: § 26.302 Definitions.
p.000293: The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition,
p.000293: observational research means any human research that does not meet the definition of research in- volving
p.000293: intentional exposure of a human subject in § 26.202(a).
p.000293: § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses.
p.000293: The provisions of 45 CFR 46.203 are applicable to this section.
p.000293: § 26.304 Additional protections for pregnant women and fetuses in- volved in observational
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
...
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
p.000295: (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be
p.000295: docu- mented.
p.000295:
p.000295: Subparts E–J [Reserved]
p.000295: Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving
p.000295: Intentional Exposure of Non-pregnant, Non-nursing Adults
p.000295: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000295: erwise noted.
p.000295:
p.000295: § 26.1101 To what does this subpart apply?
p.000295: (a) Except as provided in paragraph
p.000295: (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving
p.000295: intentional exposure of a human subject if, at any time prior to initiating such research, any person who
p.000295: conducted or supported such research intended:
p.000295: (1) To submit results of the research to EPA for consideration in connection with any action that may be
p.000295: performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7
p.000295: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000295: (2) To hold the results of the research for later inspection by EPA under the Federal Insecticide,
p.000295: Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic
p.000295: Act 21 U.S.C. 346a).
p.000295: (b) Unless otherwise required by the Administrator, research is exempt from this subpart if it
p.000295: involves only the collection or study of existing data, documents, records, pathological speci- mens, or
p.000295: diagnostic specimens from previously conducted studies, and if these sources are publicly available or
p.000295: if the information is recorded by the investigator in such a manner that subjects cannot be
p.000295: identified, directly or through identifiers linked to the subjects.
p.000295: 40 CFR Ch. I (7–1–11 Edition)
...
p.000300: might be advan- tageous to the subject;
p.000300: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000300: subject will be maintained;
p.000300: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000300: an ex- planation as to whether any medical treatments are available if injury oc-
p.000300:
p.000300: curs and, if so, what they consist of, or where further information may be ob- tained;
p.000300: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000300: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000300: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000300: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000300: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000300: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000300: elements of in- formation shall also be provided to each subject:
p.000300: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000300: the embryo or fetus, if the subject may become pregnant) which are currently unfore- seeable;
p.000300: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000300: investigator without regard to the subject’s con- sent;
p.000300: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000300: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000300: of participation by the subject;
p.000300: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000300: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000300: (6) The approximate number of sub- jects involved in the study.
p.000300: (c) The informed consent require- ments in this subpart are not intended to preempt any applicable
p.000300: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000300: consent to be le- gally effective.
p.000300: (d) Nothing in this subpart is in- tended to limit the authority of a phy- sician to provide
p.000300: emergency medical
p.000301: 301
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: § 26.1117
p.000301: care, to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
p.000301: (e) If the research involves inten- tional exposure of subjects to a pes- ticide, the subjects of
...
p.000301: (4) Alternative means of obtaining in- formation comparable to what would be collected through the proposed
p.000301: re- search; and
p.000301: (5) The balance of risks and benefits of the proposed research.
p.000301: (b) All information for subjects and written informed consent agreements as originally provided to the
p.000301: IRB, and as approved by the IRB.
p.000301: (c) Information about how subjects will be recruited, including any adver- tisements proposed to be used.
p.000301: (d) A description of the cir- cumstances and methods proposed for presenting information
p.000301: to potential human subjects for the purpose of ob- taining their informed consent.
p.000301: (e) All correspondence between the IRB and the investigators or sponsors.
p.000301: (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that
p.000301: re- search involving human subjects has been reviewed and approved by an IRB.
p.000301:
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Environmental Protection Agency § 26.1303
p.000302:
p.000302: Subpart L—Prohibition of Third- Party Research for Pesticides Involving Intentional Exposure of Human
p.000302: Subjects who are Children or Pregnant or Nurs- ing Women
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1201 To what does this subpart apply?
p.000302: Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject
p.000302: in- tended:
p.000302: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA
p.000302: under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000302: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000302: people, products, or ac- tivities.
p.000302: § 26.1202 Definitions.
p.000302: The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the
p.000302: definitions at 45 CFR 46.202(a) through (f) and at 45 CFR
p.000302:
p.000302: 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18
p.000302: years.
p.000302:
p.000302: § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support
p.000302: re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: [71 FR 36175, June 23, 2006]
p.000302:
p.000302: Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human
p.000302: Research
p.000302:
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1301 To what does this subpart apply?
p.000302: This subpart applies to any person who submits a report containing the results of any human research if:
p.000302: (a) The report is submitted after April 7, 2006, and
p.000302: (b) The report is submitted for con- sideration in connection with any ac- tion that may be performed
p.000302: by EPA under the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section
p.000302: 408 of the Federal Food, Drug, and Cosmetic Act (21
p.000302: U.S.C. 346a).
p.000302: § 26.1302 Definitions.
p.000302: The definitions in § 26.102 shall apply to this subpart as well.
p.000302:
p.000302: § 26.1303 Submission of information pertaining to ethical conduct of completed human research.
p.000302: Any person who submits to EPA data derived from human research covered by this subpart shall provide at
p.000302: the time of submission information con- cerning the ethical conduct of such re- search. To the extent
p.000302: available to the submitter and not previously provided
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 26.1501
p.000303: to EPA, such information should in- clude:
...
p.000305: of re- search proposals and reports of com- pleted research with human subjects submitted by EPA for
p.000305: its review and, on request, advise EPA on ways to strengthen its programs for protection of human
p.000305: subjects of research.
p.000305:
p.000305: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA
p.000305: Actions
p.000305:
p.000305: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000305: erwise noted.
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence
p.000306: that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to
p.000306: seriously harm participants or failed to obtain in- formed consent), or was significantly deficient
p.000306: relative to the ethical stand- ards prevailing at the time the re- search was conducted. This
p.000306: prohibition is in addition to the prohibition in
p.000306: § 26.1703.
p.000306:
p.000306: § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted after April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated after April 7, 2006, un- less EPA has adequate information to
p.000306: determine that the research was con- ducted in substantial compliance with subparts A through L of this part,
p.000306: or if conducted in a foreign country, under procedures at least as protective as those in subparts A
p.000306: through L of this part. This prohibition is in addition to the prohibition in § 26.1703.
p.000306:
p.000306: § 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise
p.000306: unaccept- able research.
p.000306: This section establishes the exclusive criteria and procedure by which EPA may decide to rely on data from
p.000306: re- search that is not acceptable under the standards in §§ 26.1703 through 26.1705. EPA may rely on such data
p.000306: only if all the conditions in paragraphs (a) through (d) of this section are satisfied:
p.000306: (a) EPA has obtained the views of the Human Studies Review Board con- cerning the proposal to rely on the
p.000306: oth- erwise unacceptable data,
p.000306: (b) EPA has provided an opportunity for public comment on the proposal to rely on the otherwise
p.000306: unacceptable data,
p.000306: (c) EPA has determined that relying on the data is crucial to a decision that would impose a more stringent
p.000306: regu- latory restriction that would improve protection of public health, such as a limitation on the use
...
Social / Age
Searching for indicator age:
(return to top)
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
...
p.000294: § 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or
p.000294: guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent
p.000294: is sufficient for research to be conducted under § 26.404 or § 26.405.
p.000294: (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a
p.000294: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000294: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
p.000295: (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be
p.000295: docu- mented.
p.000295:
p.000295: Subparts E–J [Reserved]
p.000295: Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving
p.000295: Intentional Exposure of Non-pregnant, Non-nursing Adults
p.000295: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000295: erwise noted.
p.000295:
p.000295: § 26.1101 To what does this subpart apply?
p.000295: (a) Except as provided in paragraph
p.000295: (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving
p.000295: intentional exposure of a human subject if, at any time prior to initiating such research, any person who
p.000295: conducted or supported such research intended:
p.000295: (1) To submit results of the research to EPA for consideration in connection with any action that may be
p.000295: performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7
p.000295: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000295: (2) To hold the results of the research for later inspection by EPA under the Federal Insecticide,
...
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000302: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000302: people, products, or ac- tivities.
p.000302: § 26.1202 Definitions.
p.000302: The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the
p.000302: definitions at 45 CFR 46.202(a) through (f) and at 45 CFR
p.000302:
p.000302: 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18
p.000302: years.
p.000302:
p.000302: § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support
p.000302: re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: [71 FR 36175, June 23, 2006]
p.000302:
p.000302: Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human
p.000302: Research
p.000302:
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1301 To what does this subpart apply?
p.000302: This subpart applies to any person who submits a report containing the results of any human research if:
p.000302: (a) The report is submitted after April 7, 2006, and
p.000302: (b) The report is submitted for con- sideration in connection with any ac- tion that may be performed
p.000302: by EPA under the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section
p.000302: 408 of the Federal Food, Drug, and Cosmetic Act (21
p.000302: U.S.C. 346a).
p.000302: § 26.1302 Definitions.
...
Social / Child
Searching for indicator child:
(return to top)
p.000281: 26.114 Cooperative research.
p.000281: 26.115 IRB records.
p.000281: 26.116 General requirements for informed consent.
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
p.000281: pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000281: Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects
p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
...
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
p.000281: pregnant women (and therefore their fetuses), nursing women, or children.
p.000281: 40 CFR Ch. I (7–1–11 Edition)
...
p.000292: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000292: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000292: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000292: welfare of human subjects (whether or not the research was subject to Federal regulation).
p.000292: § 26.124 Conditions.
p.000292: With respect to any research project or any class of research projects the de- partment or agency head may
p.000292: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
p.000292: are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart.
p.000292: (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to
p.000292: State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
...
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000293: Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been
p.000293: delegated by the Administrator.
p.000293: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000293: not, ab- sent affirmative agreement, be con- strued as assent.
p.000293: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000293: research.
p.000293: (d) Parent means a child’s biological or adoptive parent.
p.000293: (e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent
p.000293: on be- half of a child to general medical care.
p.000293: (f) Observational research means any research with human subjects that does not meet the
p.000293: definition of re- search involving intentional exposure of a human subject in § 26.202(a).
p.000293: (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000293: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000293: the performance of rou- tine physical or psychological exami- nations or tests.
p.000293: § 26.403 IRB duties.
p.000293: In addition to other responsibilities assigned to IRBs under this part, each
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Environmental Protection Agency § 26.406
p.000294:
p.000294:
p.000294: IRB shall review observational re- search covered by this subpart and ap- prove only research that
p.000294: satisfies the conditions of all applicable sections of this subpart.
p.000294: § 26.404 Observational research not in- volving greater than minimal risk.
p.000294: EPA will conduct or fund observa- tional research in which the IRB finds that no greater than
p.000294: minimal risk to children is presented, only if the IRB finds that adequate provisions are made for
...
p.000294: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000294: parents or guardians, as set forth in § 26.406.
p.000294: § 26.406 Requirements for permission by parents or guardians and for as- sent by children.
p.000294: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, when
p.000294: in the judgment of the IRB the children are capable of pro- viding assent. In determining whether
p.000294: children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological
p.000294: state of the children involved. This judgment
p.000294:
p.000294: may be made for all children to be in- volved in research under a particular protocol, or for each
p.000294: child, as the IRB deems appropriate. If the IRB deter- mines that the capability of some or all of
p.000294: the children is so limited that they cannot reasonably be consulted or that the intervention or procedure in-
p.000294: volved in the observational research holds out a prospect of direct benefit that is important to the
p.000294: health or well- being of the children and is available only in the context of the research, the assent of the
p.000294: children is not a nec- essary condition for proceeding with the observational research. Even where
p.000294: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000294: requirement under circumstances in which consent may be waived in accord with
p.000294: § 26.116(d).
p.000294: (b) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine, in accordance with and to the extent that consent is required by
p.000294: § 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or
p.000294: guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent
p.000294: is sufficient for research to be conducted under § 26.404 or § 26.405.
p.000294: (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a
p.000294: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000294: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
...
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000302: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000302: people, products, or ac- tivities.
p.000302: § 26.1202 Definitions.
p.000302: The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the
p.000302: definitions at 45 CFR 46.202(a) through (f) and at 45 CFR
p.000302:
p.000302: 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18
p.000302: years.
p.000302:
p.000302: § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support
p.000302: re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: [71 FR 36175, June 23, 2006]
p.000302:
p.000302: Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human
p.000302: Research
p.000302:
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1301 To what does this subpart apply?
p.000302: This subpart applies to any person who submits a report containing the results of any human research if:
p.000302: (a) The report is submitted after April 7, 2006, and
p.000302: (b) The report is submitted for con- sideration in connection with any ac- tion that may be performed
p.000302: by EPA under the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section
p.000302: 408 of the Federal Food, Drug, and Cosmetic Act (21
p.000302: U.S.C. 346a).
p.000302: § 26.1302 Definitions.
p.000302: The definitions in § 26.102 shall apply to this subpart as well.
p.000302:
p.000302: § 26.1303 Submission of information pertaining to ethical conduct of completed human research.
p.000302: Any person who submits to EPA data derived from human research covered by this subpart shall provide at
p.000302: the time of submission information con- cerning the ethical conduct of such re- search. To the extent
p.000302: available to the submitter and not previously provided
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 26.1501
p.000303: to EPA, such information should in- clude:
p.000303: (a) Copies of all of the records rel- evant to the research specified by
p.000303: § 26.1115(a) to be prepared and main- tained by an IRB.
...
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence
p.000306: that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to
p.000306: seriously harm participants or failed to obtain in- formed consent), or was significantly deficient
p.000306: relative to the ethical stand- ards prevailing at the time the re- search was conducted. This
p.000306: prohibition is in addition to the prohibition in
p.000306: § 26.1703.
p.000306:
p.000306: § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted after April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated after April 7, 2006, un- less EPA has adequate information to
p.000306: determine that the research was con- ducted in substantial compliance with subparts A through L of this part,
p.000306: or if conducted in a foreign country, under procedures at least as protective as those in subparts A
...
Searching for indicator children:
(return to top)
p.000281: or Agency.
p.000281: 26.104–26.106 [Reserved]
p.000281: 26.107 IRB membership.
p.000281: 26.108 IRB functions and operations.
p.000281: 26.109 IRB review of research.
p.000281: 26.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.111 Criteria for IRB approval of research.
p.000281: 26.112 Review by institution.
p.000281: 26.113 Suspension or termination of IRB ap- proval of research.
p.000281: 26.114 Cooperative research.
p.000281: 26.115 IRB records.
p.000281: 26.116 General requirements for informed consent.
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
p.000281: pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000281: Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects
p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
p.000281: pregnant women (and therefore their fetuses), nursing women, or children.
p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
p.000281: ducted by Federal civilian employees or military personnel, except that each department or agency head may
...
p.000283: notices of these actions as they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published
p.000283: as provided in department or agency procedures.
p.000283: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000283: of the provisions of this policy to specific re- search activities or classes of research activities
p.000283: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000283: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000283: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000283: and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de-
p.000283: partment or agency procedures. 1
p.000283: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000283: June 28, 1991, as amended at 70 FR 36328,
p.000283: June 23, 2005]
p.000283:
p.000283: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000283: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000283: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000283: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000283: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000283: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000283: when the investigator(s) do not participate in the activities being observed.
p.000283: 40 CFR Ch. I (7–1–11 Edition)
p.000283: § 26.102 Definitions.
p.000283: (a) Department or agency head means the head of any Federal department or agency and any other officer
p.000283: or em- ployee of any department or agency to whom authority has been delegated.
p.000283: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000283: agencies).
p.000283: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000283: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000283: procedure(s) involved in the research.
p.000283: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000283: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000283: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000283: or supported under a program which is considered research for other purposes. For example, some
p.000283: demonstration and service programs may include research activities.
p.000283: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000283: for which a Federal department or agency has specific responsibility for regulating as a research activity,
...
p.000286: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000286: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000286: June 28, 1991, as amended at 70 FR 36328,
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
...
p.000287: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
p.000287: on the subjects for di- agnostic or treatment purposes.
p.000287: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
...
p.000291: may take into account, in addition to all other
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Environmental Protection Agency § 26.301
p.000292:
p.000292:
p.000292: eligibility requirements and program criteria, factors such as whether the applicant has been subject to
p.000292: a termi- nation or suspension under paragraph
p.000292: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000292: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000292: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000292: welfare of human subjects (whether or not the research was subject to Federal regulation).
p.000292: § 26.124 Conditions.
p.000292: With respect to any research project or any class of research projects the de- partment or agency head may
p.000292: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
...
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
p.000293: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000293: § 26.302 Definitions.
p.000293: The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition,
p.000293: observational research means any human research that does not meet the definition of research in- volving
p.000293: intentional exposure of a human subject in § 26.202(a).
p.000293: § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses.
p.000293: The provisions of 45 CFR 46.203 are applicable to this section.
p.000293: § 26.304 Additional protections for pregnant women and fetuses in- volved in observational
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
...
p.000293: on be- half of a child to general medical care.
p.000293: (f) Observational research means any research with human subjects that does not meet the
p.000293: definition of re- search involving intentional exposure of a human subject in § 26.202(a).
p.000293: (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000293: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000293: the performance of rou- tine physical or psychological exami- nations or tests.
p.000293: § 26.403 IRB duties.
p.000293: In addition to other responsibilities assigned to IRBs under this part, each
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Environmental Protection Agency § 26.406
p.000294:
p.000294:
p.000294: IRB shall review observational re- search covered by this subpart and ap- prove only research that
p.000294: satisfies the conditions of all applicable sections of this subpart.
p.000294: § 26.404 Observational research not in- volving greater than minimal risk.
p.000294: EPA will conduct or fund observa- tional research in which the IRB finds that no greater than
p.000294: minimal risk to children is presented, only if the IRB finds that adequate provisions are made for
p.000294: soliciting the assent of the children and the permission of their parents or guardians, as set
p.000294: forth in
p.000294: § 26.406.
p.000294: § 26.405 Observational research involv- ing greater than minimal risk but presenting the prospect of
p.000294: direct benefit to the individual subjects.
p.000294: If the IRB finds that an intervention or procedure presents more than mini- mal risk to children, EPA will
p.000294: not con- duct or fund observational research that includes such an intervention or procedure unless the
p.000294: IRB finds and doc- uments that:
p.000294: (a) The intervention or procedure holds out the prospect of direct benefit to the individual subject or is
p.000294: likely to contribute to the subject’s well-being;
p.000294: (b) The risk is justified by the antici- pated benefit to the subjects;
p.000294: (c) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000294: as that presented by available alternative approaches; and
p.000294: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000294: parents or guardians, as set forth in § 26.406.
p.000294: § 26.406 Requirements for permission by parents or guardians and for as- sent by children.
p.000294: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, when
p.000294: in the judgment of the IRB the children are capable of pro- viding assent. In determining whether
p.000294: children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological
p.000294: state of the children involved. This judgment
p.000294:
p.000294: may be made for all children to be in- volved in research under a particular protocol, or for each
p.000294: child, as the IRB deems appropriate. If the IRB deter- mines that the capability of some or all of
p.000294: the children is so limited that they cannot reasonably be consulted or that the intervention or procedure in-
p.000294: volved in the observational research holds out a prospect of direct benefit that is important to the
p.000294: health or well- being of the children and is available only in the context of the research, the assent of the
p.000294: children is not a nec- essary condition for proceeding with the observational research. Even where
p.000294: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000294: requirement under circumstances in which consent may be waived in accord with
p.000294: § 26.116(d).
p.000294: (b) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine, in accordance with and to the extent that consent is required by
p.000294: § 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or
p.000294: guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent
p.000294: is sufficient for research to be conducted under § 26.404 or § 26.405.
p.000294: (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a
p.000294: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000294: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
p.000295: (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be
p.000295: docu- mented.
p.000295:
p.000295: Subparts E–J [Reserved]
p.000295: Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving
p.000295: Intentional Exposure of Non-pregnant, Non-nursing Adults
p.000295: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000295: erwise noted.
p.000295:
p.000295: § 26.1101 To what does this subpart apply?
p.000295: (a) Except as provided in paragraph
p.000295: (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving
p.000295: intentional exposure of a human subject if, at any time prior to initiating such research, any person who
...
p.000301: (3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue;
p.000301: (4) Alternative means of obtaining in- formation comparable to what would be collected through the proposed
p.000301: re- search; and
p.000301: (5) The balance of risks and benefits of the proposed research.
p.000301: (b) All information for subjects and written informed consent agreements as originally provided to the
p.000301: IRB, and as approved by the IRB.
p.000301: (c) Information about how subjects will be recruited, including any adver- tisements proposed to be used.
p.000301: (d) A description of the cir- cumstances and methods proposed for presenting information
p.000301: to potential human subjects for the purpose of ob- taining their informed consent.
p.000301: (e) All correspondence between the IRB and the investigators or sponsors.
p.000301: (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that
p.000301: re- search involving human subjects has been reviewed and approved by an IRB.
p.000301:
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Environmental Protection Agency § 26.1303
p.000302:
p.000302: Subpart L—Prohibition of Third- Party Research for Pesticides Involving Intentional Exposure of Human
p.000302: Subjects who are Children or Pregnant or Nurs- ing Women
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1201 To what does this subpart apply?
p.000302: Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject
p.000302: in- tended:
p.000302: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA
p.000302: under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
...
p.000305: subjects of research.
p.000305:
p.000305: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA
p.000305: Actions
p.000305:
p.000305: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000305: erwise noted.
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence
p.000306: that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to
p.000306: seriously harm participants or failed to obtain in- formed consent), or was significantly deficient
p.000306: relative to the ethical stand- ards prevailing at the time the re- search was conducted. This
p.000306: prohibition is in addition to the prohibition in
p.000306: § 26.1703.
p.000306:
p.000306: § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted after April 7, 2006.
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000281: 26.111 Criteria for IRB approval of research.
p.000281: 26.112 Review by institution.
p.000281: 26.113 Suspension or termination of IRB ap- proval of research.
p.000281: 26.114 Cooperative research.
p.000281: 26.115 IRB records.
p.000281: 26.116 General requirements for informed consent.
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
p.000281: pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000281: Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects
p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
...
p.000289: research;
p.000289: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000289: might be advan- tageous to the subject;
p.000289: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000289: subject will be maintained;
p.000289: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000289: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000289: consist of, or where further information may be ob- tained;
p.000289: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000289: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000289: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000289: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000289: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000289: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000289: elements of in- formation shall also be provided to each subject:
p.000289: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000289: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
p.000289: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000289: investigator without regard to the subject’s con- sent;
p.000289: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000289: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000289: of participation by the subject;
p.000290: 290
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290: Environmental Protection Agency § 26.117
p.000290:
p.000290:
p.000290: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000290: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000290: (6) The approximate number of sub- jects involved in the study.
p.000290: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000290: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000290: provided the IRB finds and documents that:
p.000290: (1) The research or demonstration project is to be conducted by or subject to the approval of State or
...
p.000292: a termi- nation or suspension under paragraph
p.000292: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000292: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000292: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000292: welfare of human subjects (whether or not the research was subject to Federal regulation).
p.000292: § 26.124 Conditions.
p.000292: With respect to any research project or any class of research projects the de- partment or agency head may
p.000292: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
p.000292: are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart.
p.000292: (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to
p.000292: State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
p.000293: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000293: § 26.302 Definitions.
p.000293: The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition,
p.000293: observational research means any human research that does not meet the definition of research in- volving
p.000293: intentional exposure of a human subject in § 26.202(a).
p.000293: § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses.
p.000293: The provisions of 45 CFR 46.203 are applicable to this section.
p.000293: § 26.304 Additional protections for pregnant women and fetuses in- volved in observational
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
...
p.000300: research;
p.000300: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000300: might be advan- tageous to the subject;
p.000300: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000300: subject will be maintained;
p.000300: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000300: an ex- planation as to whether any medical treatments are available if injury oc-
p.000300:
p.000300: curs and, if so, what they consist of, or where further information may be ob- tained;
p.000300: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000300: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000300: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000300: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000300: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000300: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000300: elements of in- formation shall also be provided to each subject:
p.000300: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000300: the embryo or fetus, if the subject may become pregnant) which are currently unfore- seeable;
p.000300: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000300: investigator without regard to the subject’s con- sent;
p.000300: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000300: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000300: of participation by the subject;
p.000300: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000300: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000300: (6) The approximate number of sub- jects involved in the study.
p.000300: (c) The informed consent require- ments in this subpart are not intended to preempt any applicable
p.000300: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000300: consent to be le- gally effective.
p.000300: (d) Nothing in this subpart is in- tended to limit the authority of a phy- sician to provide
p.000300: emergency medical
p.000301: 301
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: § 26.1117
p.000301: care, to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
...
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000302: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000302: people, products, or ac- tivities.
p.000302: § 26.1202 Definitions.
p.000302: The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the
p.000302: definitions at 45 CFR 46.202(a) through (f) and at 45 CFR
p.000302:
p.000302: 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18
p.000302: years.
p.000302:
p.000302: § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support
p.000302: re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: [71 FR 36175, June 23, 2006]
p.000302:
p.000302: Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human
p.000302: Research
p.000302:
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1301 To what does this subpart apply?
p.000302: This subpart applies to any person who submits a report containing the results of any human research if:
p.000302: (a) The report is submitted after April 7, 2006, and
p.000302: (b) The report is submitted for con- sideration in connection with any ac- tion that may be performed
p.000302: by EPA under the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section
p.000302: 408 of the Federal Food, Drug, and Cosmetic Act (21
p.000302: U.S.C. 346a).
p.000302: § 26.1302 Definitions.
p.000302: The definitions in § 26.102 shall apply to this subpart as well.
p.000302:
p.000302: § 26.1303 Submission of information pertaining to ethical conduct of completed human research.
p.000302: Any person who submits to EPA data derived from human research covered by this subpart shall provide at
p.000302: the time of submission information con- cerning the ethical conduct of such re- search. To the extent
p.000302: available to the submitter and not previously provided
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 26.1501
p.000303: to EPA, such information should in- clude:
p.000303: (a) Copies of all of the records rel- evant to the research specified by
...
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence
p.000306: that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to
p.000306: seriously harm participants or failed to obtain in- formed consent), or was significantly deficient
p.000306: relative to the ethical stand- ards prevailing at the time the re- search was conducted. This
p.000306: prohibition is in addition to the prohibition in
p.000306: § 26.1703.
p.000306:
p.000306: § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted after April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated after April 7, 2006, un- less EPA has adequate information to
p.000306: determine that the research was con- ducted in substantial compliance with subparts A through L of this part,
p.000306: or if conducted in a foreign country, under procedures at least as protective as those in subparts A
...
Searching for indicator fetuses:
(return to top)
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
p.000281: pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000281: Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects
p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
...
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
p.000281: pregnant women (and therefore their fetuses), nursing women, or children.
p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
...
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
p.000292: are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart.
p.000292: (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to
p.000292: State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
p.000293: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000293: § 26.302 Definitions.
p.000293: The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition,
p.000293: observational research means any human research that does not meet the definition of research in- volving
p.000293: intentional exposure of a human subject in § 26.202(a).
p.000293: § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses.
p.000293: The provisions of 45 CFR 46.203 are applicable to this section.
p.000293: § 26.304 Additional protections for pregnant women and fetuses in- volved in observational
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
...
p.000305: its review and, on request, advise EPA on ways to strengthen its programs for protection of human
p.000305: subjects of research.
p.000305:
p.000305: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA
p.000305: Actions
p.000305:
p.000305: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000305: erwise noted.
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence
p.000306: that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to
p.000306: seriously harm participants or failed to obtain in- formed consent), or was significantly deficient
p.000306: relative to the ethical stand- ards prevailing at the time the re- search was conducted. This
p.000306: prohibition is in addition to the prohibition in
p.000306: § 26.1703.
p.000306:
p.000306: § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289: § 26.116
p.000289: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000289: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000289: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000289: depart- ment or agency at reasonable times and in a reasonable manner.
p.000289: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000289: [56 FR 28012, 28022, June 18, 1991, as amended
p.000289: at 70 FR 36328, June 23, 2005]
p.000289:
p.000289: § 26.116 General requirements for in- formed consent.
p.000289: Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
p.000289: research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of
p.000289: the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent
p.000289: only under circumstances that provide the prospective subject or the representative sufficient oppor-
p.000289: tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or
p.000289: undue influence. The information that is given to the subject or the representative shall be in language
p.000289: understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include
p.000289: any exculpatory language through which the subject or the rep- resentative is made to waive or
p.000289: appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the
p.000289: sponsor, the insti- tution or its agents from liability for negligence.
p.000289: (a) Basic elements of informed con- sent. Except as provided in paragraph
p.000289: (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided
p.000289: to each subject:
p.000289: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000289: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000289: and identification of any procedures which are experi- mental;
p.000289: 40 CFR Ch. I (7–1–11 Edition)
p.000289: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000289: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000289: research;
p.000289: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000289: might be advan- tageous to the subject;
p.000289: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000289: subject will be maintained;
p.000289: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
...
p.000299: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000299: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of EPA at
p.000299: rea- sonable times and in a reasonable man- ner.
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Environmental Protection Agency § 26.1116
p.000300:
p.000300:
p.000300: § 26.1116 General requirements for in- formed consent.
p.000300: No investigator may involve a human being as a subject in research covered by this subpart unless the
p.000300: investigator has obtained the legally effective in- formed consent of the subject or the subject’s legally
p.000300: authorized representa- tive. An investigator shall seek such consent only under circumstances that provide
p.000300: the prospective subject or the representative sufficient opportunity to consider whether or not to
p.000300: partici- pate and that minimize the possibility of coercion or undue influence. The in- formation that is
p.000300: given to the subject or the representative shall be in lan- guage understandable to the subject or the
p.000300: representative. No informed con- sent, whether oral or written, may in- clude any exculpatory
p.000300: language through which the subject or the rep- resentative is made to waive or appear to waive any
p.000300: of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the insti- tution
p.000300: or its agents from liability for negligence.
p.000300: (a) Basic elements of informed con- sent. In seeking informed consent the following information shall be
p.000300: provided to each subject:
p.000300: (1) A statement that the study in- volves research, an explanation of the purposes of the research and
p.000300: the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed,
p.000300: and identification of any procedures which are experi- mental;
p.000300: (2) A description of any reasonably
p.000300: foreseeable risks or discomforts to the subject;
p.000300: (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the
p.000300: research;
p.000300: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000300: might be advan- tageous to the subject;
p.000300: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000300: subject will be maintained;
p.000300: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000300: an ex- planation as to whether any medical treatments are available if injury oc-
p.000300:
p.000300: curs and, if so, what they consist of, or where further information may be ob- tained;
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000283: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000283: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000283: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000283: and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de-
p.000283: partment or agency procedures. 1
p.000283: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000283: June 28, 1991, as amended at 70 FR 36328,
p.000283: June 23, 2005]
p.000283:
p.000283: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000283: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000283: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000283: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000283: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000283: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000283: when the investigator(s) do not participate in the activities being observed.
p.000283: 40 CFR Ch. I (7–1–11 Edition)
p.000283: § 26.102 Definitions.
p.000283: (a) Department or agency head means the head of any Federal department or agency and any other officer
p.000283: or em- ployee of any department or agency to whom authority has been delegated.
p.000283: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000283: agencies).
p.000283: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000283: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000283: procedure(s) involved in the research.
p.000283: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000283: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000283: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000283: or supported under a program which is considered research for other purposes. For example, some
p.000283: demonstration and service programs may include research activities.
p.000283: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000283: for which a Federal department or agency has specific responsibility for regulating as a research activity,
p.000283: (for example, In- vestigational New Drug requirements administered by the Food and Drug Ad- ministration). It
p.000283: does not include re- search activities which are inciden- tally regulated by a Federal depart-
...
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000293: Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been
p.000293: delegated by the Administrator.
p.000293: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000293: not, ab- sent affirmative agreement, be con- strued as assent.
p.000293: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000293: research.
p.000293: (d) Parent means a child’s biological or adoptive parent.
p.000293: (e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent
p.000293: on be- half of a child to general medical care.
p.000293: (f) Observational research means any research with human subjects that does not meet the
p.000293: definition of re- search involving intentional exposure of a human subject in § 26.202(a).
p.000293: (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000293: research are not greater in and of themselves than those ordinarily encountered in daily life or during
...
p.000295: applicable and which provide additional protections for human subjects. Reference to State or local laws in this
p.000295: subpart is intended to include the laws of federally recog- nized American Indian and Alaska Na- tive Tribal
p.000295: Governments.
p.000295: (f) This subpart does not affect any foreign laws or regulations which may otherwise be applicable and
p.000295: which pro- vide additional protections to human subjects of research.
p.000295: (g) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000295: consider any available information relevant to de- termining the intent of a person who conducts or
p.000295: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000295: such intent existed if:
p.000295: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000295: research to EPA; or
p.000295: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000295: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000295: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000295: people, products, or ac- tivities.
p.000295: § 26.1102 Definitions.
p.000295: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000295: Agency (EPA) and any other officer or em- ployee of EPA to whom authority has been delegated.
p.000295: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000295: agencies).
p.000296: 296
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Environmental Protection Agency § 26.1107
p.000296:
p.000296:
p.000296: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000296: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000296: procedure(s) involved in the research.
p.000296: (d) Research means a systematic in- vestigation, including research, devel- opment, testing and
p.000296: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000296: definition constitute re- search for purposes of this subpart, whether or not they are considered
p.000296: re- search for other purposes. For example, some demonstration and service pro- grams may include research
p.000296: activities.
p.000296: (e) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000296: con- ducting research obtains:
p.000296: (1) Data through intervention or interaction with the individual, or
p.000296: (2) Identifiable private information.
p.000296: (3) ‘‘Intervention’’ includes both physical procedures by which data are gathered (for example,
...
p.000302: available to the submitter and not previously provided
p.000303: 303
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303:
p.000303: § 26.1501
p.000303: to EPA, such information should in- clude:
p.000303: (a) Copies of all of the records rel- evant to the research specified by
p.000303: § 26.1115(a) to be prepared and main- tained by an IRB.
p.000303: (b) Copies of all of the records rel- evant to the information identified in
p.000303: § 26.1125(a) through (f).
p.000303: (c) Copies of sample records used to document informed consent as speci- fied by § 26.1117, but not
p.000303: identifying any subjects of the research.
p.000303: (d) If any of the information listed in paragraphs (a) through (c) of this sec- tion is not provided, the
p.000303: person shall describe the efforts made to obtain the information.
p.000303: Subpart N [Reserved]
p.000303: Subpart O—Administrative Actions for Noncompliance
p.000303: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000303: erwise noted.
p.000303:
p.000303: § 26.1501 To what does this subpart apply?
p.000303: This subpart applies to any human research subject to subparts A through L of this part. References to State
p.000303: or local laws in this subpart are intended to include the laws of federally recog- nized American Indian
p.000303: and Alaska Na- tive Tribal Governments.
p.000303: § 26.1502 Lesser administrative ac- tions.
p.000303: (a) If apparent noncompliance with the applicable regulations in subparts A through L of this part concerning
p.000303: the operation of an IRB is observed by an officer or employee of EPA or of any State duly designated
p.000303: by the Adminis- trator during an inspection. EPA may send a letter describing the noncompli- ance to the IRB
p.000303: and to the parent in- stitution. The agency will require that the IRB or the parent institution re-
p.000303: spond to this letter within a reasonable time period specified by EPA and de- scribe the corrective actions
p.000303: that will be taken by the IRB, the institution, or both to achieve compliance with these regulations.
p.000303: (b) On the basis of the IRB’s or the
p.000303: institution’s response, EPA may sched- ule a reinspection to confirm the ade-
p.000303: 40 CFR Ch. I (7–1–11 Edition)
p.000303: quacy of corrective actions. In addi- tion, until the IRB or the parent insti- tution takes appropriate
p.000303: corrective ac- tion, the Agency may:
p.000303: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the
p.000303: institution or reviewed by the IRB;
p.000303: (2) Direct that no new subjects be added to ongoing studies subject to this part;
p.000303: (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
p.000303: (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human
p.000303: subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest of
p.000303: the deficiencies in the operation of the IRB.
...
p.000306: only if all the conditions in paragraphs (a) through (d) of this section are satisfied:
p.000306: (a) EPA has obtained the views of the Human Studies Review Board con- cerning the proposal to rely on the
p.000306: oth- erwise unacceptable data,
p.000306: (b) EPA has provided an opportunity for public comment on the proposal to rely on the otherwise
p.000306: unacceptable data,
p.000306: (c) EPA has determined that relying on the data is crucial to a decision that would impose a more stringent
p.000306: regu- latory restriction that would improve protection of public health, such as a limitation on the use
p.000306: of a pesticide, than could be justified without relying on the data, and
p.000306: (d) EPA publishes a full explanation of its decision to rely on the otherwise unacceptable data, including a
p.000306: thor- ough discussion of the ethical defi- ciencies of the underlying research and the full rationale
p.000306: for finding that the standard in paragraph (c) of this sec- tion was met.
p.000306:
p.000306: PART 27—PROGRAM FRAUD CIVIL REMEDIES
p.000306: Sec.
p.000306: 27.1 Basis and purpose.
p.000306: 27.2 Definitions.
p.000306: 27.3 Basis for civil penalties and assess- ments.
p.000306: 27.4 Investigation.
p.000306: 27.5 Review by the reviewing official.
p.000306: 27.6 Prerequisites for issuing a complaint.
p.000306: 27.7 Complaint.
p.000306: 27.8 Service of complaint.
p.000306: 27.9 Answer.
p.000306: 27.10 Default upon failure to file an answer.
p.000306: 27.11 Referral of complaint and answer to the presiding officer.
p.000306: 27.12 Notice of hearing.
p.000306: 27.13 Parties to the hearing.
p.000306: 27.14 Separation of functions.
p.000306: 27.15 Ex parte contacts.
p.000306: 27.16 Disqualification of the reviewing offi- cial or presiding officer.
p.000306: 27.17 Rights of parties.
...
Social / Racial Minority
Searching for indicator race:
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p.000285: or by such later date as may be prescribed by the department or agen- cy to which the application or
p.000285: proposal is submitted. Under no condition shall research covered by § 26.103 of the Pol- icy be supported
p.000285: prior to receipt of the certification that the research has been reviewed and approved by the IRB. In- stitutions
p.000285: without an approved assur- ance covering the research shall certify within 30 days after receipt of a request for
p.000285: such a certification from the de- partment or agency, that the applica- tion or proposal has been
p.000285: approved by the IRB. If the certification is not sub- mitted within these time limits, the
p.000286: 286
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286: Environmental Protection Agency § 26.109
p.000286:
p.000286:
p.000286: application or proposal may be re- turned to the institution.
p.000286: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000286: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000286: June 28, 1991, as amended at 70 FR 36328,
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
...
p.000296: (h) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research
p.000296: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000296: performance of rou- tine physical or psychological exami- nations or tests.
p.000296: (i) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000296: exposure to the substance experienced by a human subject participating in the study would not have
p.000296: occurred but for the human subject’s participation in the study.
p.000296: (j) Person means any person, as that term is defined in FIFRA section 2(s) (7
p.000296: U.S.C. 136), except:
p.000296: (1) A federal agency that is subject to the provisions of the Federal Policy for the Protection of Human Subjects
p.000296: of Research, and
p.000296: (2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of
p.000296: this sec- tion.
p.000296: §§ 26.1103–26.1106 [Reserved]
p.000296: § 26.1107 IRB membership.
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
...
Social / Soldier
Searching for indicator military:
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p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
p.000281: ducted by Federal civilian employees or military personnel, except that each department or agency head may
p.000281: adopt such procedural modifications as may be appropriate from an administrative standpoint. It also
p.000281: includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment
p.000281: outside the United States.
p.000281: (1) Research that is conducted or sup-
p.000281: ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e),
p.000281: must comply with all sections of this policy.
p.000281: (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is
p.000281: subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101,
p.000281: § 26.102, and § 26.107 through § 26.117 of this policy, by an in- stitutional review board (IRB) that op- erates in
p.000281: accordance with the pertinent requirements of this policy.
p.000281: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000281: involvement
p.000282: 282
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282: Environmental Protection Agency § 26.101
p.000282:
p.000282:
p.000282: of human subjects will be in one or more of the following categories are exempt from this policy:
p.000282: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
...
Social / Student
Searching for indicator student:
(return to top)
p.000283: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000283: procedure(s) involved in the research.
p.000283: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000283: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000283: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000283: or supported under a program which is considered research for other purposes. For example, some
p.000283: demonstration and service programs may include research activities.
p.000283: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000283: for which a Federal department or agency has specific responsibility for regulating as a research activity,
p.000283: (for example, In- vestigational New Drug requirements administered by the Food and Drug Ad- ministration). It
p.000283: does not include re- search activities which are inciden- tally regulated by a Federal depart-
p.000283: ment or agency solely as part of the de- partment’s or agency’s broader respon- sibility to regulate certain types
p.000283: of ac- tivities whether research or non-re- search in nature (for example, Wage and Hour
p.000283: requirements administered by the Department of Labor).
p.000283: (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000283: con- ducting research obtains
p.000283: (1) Data through intervention or interaction with the individual, or
p.000283: (2) Identifiable private information.
p.000283: Intervention includes both physical pro- cedures by which data are gathered (for
p.000284: 284
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284: Environmental Protection Agency § 26.103
p.000284:
p.000284:
p.000284: example, venipuncture) and manipula- tions of the subject or the subject’s en- vironment that are performed for
p.000284: re- search purposes. Interaction includes communication or interpersonal con- tact between investigator
p.000284: and subject. ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000284: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion which has
p.000284: been provided for spe- cific purposes by an individual and which the individual can reasonably
p.000284: expect will not be made public (for ex- ample, a medical record). Private infor- mation must be individually
p.000284: identifi- able (i.e., the identity of the subject is or may readily be ascertained by the investigator or
p.000284: associated with the in- formation) in order for obtaining the information to constitute research in-
p.000284: volving human subjects.
p.000284: (g) IRB means an institutional review board established in accord with and for the purposes expressed in this
p.000284: pol- icy.
p.000284: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
...
p.000295: § 26.1102 Definitions.
p.000295: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000295: Agency (EPA) and any other officer or em- ployee of EPA to whom authority has been delegated.
p.000295: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000295: agencies).
p.000296: 296
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Environmental Protection Agency § 26.1107
p.000296:
p.000296:
p.000296: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000296: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000296: procedure(s) involved in the research.
p.000296: (d) Research means a systematic in- vestigation, including research, devel- opment, testing and
p.000296: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000296: definition constitute re- search for purposes of this subpart, whether or not they are considered
p.000296: re- search for other purposes. For example, some demonstration and service pro- grams may include research
p.000296: activities.
p.000296: (e) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000296: con- ducting research obtains:
p.000296: (1) Data through intervention or interaction with the individual, or
p.000296: (2) Identifiable private information.
p.000296: (3) ‘‘Intervention’’ includes both physical procedures by which data are gathered (for example,
p.000296: venipuncture) and manipulations of the subject or the subject’s environment that are per- formed for
p.000296: research purposes. Inter- action includes communication or interpersonal contact between investi-
p.000296: gator and subject. ‘‘Private informa- tion’’ includes information about be- havior that occurs in
p.000296: a context in which an individual can reasonably ex- pect that no observation or recording is taking place,
p.000296: and information which has been provided for specific purposes by an individual and which the indi- vidual
p.000296: can reasonably expect will not be made public (for example, a medical record). Private information must be
p.000296: individually identifiable (i.e., the iden- tity of the subject is or may readily be ascertained by the investigator
p.000296: or asso- ciated with the information) in order for obtaining the information to con- stitute research
p.000296: involving human sub- jects.
p.000296: (f) IRB means an institutional review
p.000296: board established in accord with and for the purposes expressed in this part.
p.000296: (g) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000296: may be con- ducted at an institution within the constraints set forth by the IRB and by
p.000296:
p.000296: other institutional and Federal re- quirements.
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000303: § 26.1502 Lesser administrative ac- tions.
p.000303: (a) If apparent noncompliance with the applicable regulations in subparts A through L of this part concerning
p.000303: the operation of an IRB is observed by an officer or employee of EPA or of any State duly designated
p.000303: by the Adminis- trator during an inspection. EPA may send a letter describing the noncompli- ance to the IRB
p.000303: and to the parent in- stitution. The agency will require that the IRB or the parent institution re-
p.000303: spond to this letter within a reasonable time period specified by EPA and de- scribe the corrective actions
p.000303: that will be taken by the IRB, the institution, or both to achieve compliance with these regulations.
p.000303: (b) On the basis of the IRB’s or the
p.000303: institution’s response, EPA may sched- ule a reinspection to confirm the ade-
p.000303: 40 CFR Ch. I (7–1–11 Edition)
p.000303: quacy of corrective actions. In addi- tion, until the IRB or the parent insti- tution takes appropriate
p.000303: corrective ac- tion, the Agency may:
p.000303: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the
p.000303: institution or reviewed by the IRB;
p.000303: (2) Direct that no new subjects be added to ongoing studies subject to this part;
p.000303: (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
p.000303: (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human
p.000303: subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest of
p.000303: the deficiencies in the operation of the IRB.
p.000303: (c) The parent institution is pre- sumed to be responsible for the oper- ation of an IRB, and EPA
p.000303: will ordi- narily direct any administrative action under this subpart against the institu- tion. However,
p.000303: depending on the evi- dence of responsibility for deficiencies, determined during the investigation, EPA
p.000303: may restrict its administrative actions to the IRB or to a component of the parent institution determined
p.000303: to be responsible for formal designation of the IRB.
p.000303: § 26.1503 Disqualification of an IRB or an institution.
p.000303: (a) Whenever the IRB or the institu- tion has failed to take adequate steps to correct the noncompliance
p.000303: stated in the letter sent by the Agency under
p.000303: § 26.1502(a) and the EPA Administrator determines that this noncompliance may justify the disqualification
p.000303: of the IRB or of the parent institution, the Administrator may institute appro- priate proceedings.
p.000303: (b) The Administrator may disqualify an IRB or the parent institution from studies subject to this part if
p.000303: the Ad- ministrator determines that:
p.000303: (1) The IRB has refused or repeatedly failed to comply with any of the regu- lations set forth in this part, and
...
Social / Women
Searching for indicator women:
(return to top)
p.000281: 26.107 IRB membership.
p.000281: 26.108 IRB functions and operations.
p.000281: 26.109 IRB review of research.
p.000281: 26.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.111 Criteria for IRB approval of research.
p.000281: 26.112 Review by institution.
p.000281: 26.113 Suspension or termination of IRB ap- proval of research.
p.000281: 26.114 Cooperative research.
p.000281: 26.115 IRB records.
p.000281: 26.116 General requirements for informed consent.
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
p.000281: pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000281: Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects
p.000281: in Observational Research Conducted or Supported by EPA
p.000281: 26.301 To what does this subpart apply?
p.000281: 26.302 Definitions.
p.000281: 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses.
p.000281: 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research.
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
p.000281: 26.1301 To what does this subpart apply? 26.1302 Definitions.
p.000281: 26.1303 Submission of information per- taining to ethical conduct of completed human research.
p.000281: Subpart N [Reserved]
p.000281: Subpart O—Administrative Actions for Noncompliance
p.000281: 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions.
p.000281: 26.1503 Disqualification of an IRB or an in- stitution.
p.000281: 26.1504 Public disclosure of information re- garding revocation.
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
p.000281: pregnant women (and therefore their fetuses), nursing women, or children.
p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
...
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000286: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000286: These individuals may not vote with the IRB.
p.000286: § 26.108 IRB functions and operations.
p.000286: In order to fulfill the requirements of this policy each IRB shall:
p.000286: (a) Follow written procedures in the same detail as described in § 26.103(b)(4) and, to the extent
p.000286: required by,
p.000286: § 26.103(b)(5).
p.000286: (b) Except when an expedited review procedure is used (see § 26.110), review proposed research at
...
p.000287: on the subjects for di- agnostic or treatment purposes.
p.000287: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
p.000287: importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits,
p.000287: the IRB should consider only those risks and benefits that may result from the research (as distin-
p.000287: guished from risks and benefits of therapies subjects would receive even if not participating in the
p.000287: research). The IRB should not consider possible long- range effects of applying knowledge gained in
p.000287: the research (for example, the possible effects of the research on public policy) as among those
p.000287: research risks that fall within the purview of its responsibility.
p.000287: (3) Selection of subjects is equitable.
p.000287: In making this assessment the IRB should take into account the purposes of the research and the
p.000287: setting in which the research will be conducted and should be particularly cognizant of
p.000288: 288
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288:
p.000288: Environmental Protection Agency § 26.115
p.000288:
p.000288:
p.000288: the special problems of research in- volving vulnerable populations, such as children, prisoners,
p.000288: pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons.
p.000288: (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized
p.000288: representa- tive, in accordance with, and to the ex- tent required by § 26.116.
p.000288: (5) Informed consent will be appro- priately documented, in accordance with, and to the extent
p.000288: required by
p.000288: § 26.117.
p.000288: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
p.000288: § 26.114 Cooperative research.
...
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292: Environmental Protection Agency § 26.301
p.000292:
p.000292:
p.000292: eligibility requirements and program criteria, factors such as whether the applicant has been subject to
p.000292: a termi- nation or suspension under paragraph
p.000292: (a) of this section and whether the ap- plicant or the person or persons who would direct or has have
p.000292: directed the scientific and technical aspects of an activity has have, in the judgment of the department
p.000292: or agency head, mate- rially failed to discharge responsibility for the protection of the rights and
p.000292: welfare of human subjects (whether or not the research was subject to Federal regulation).
p.000292: § 26.124 Conditions.
p.000292: With respect to any research project or any class of research projects the de- partment or agency head may
p.000292: impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head
p.000292: addi- tional conditions are necessary for the protection of human subjects.
p.000292:
p.000292: Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human
p.000292: Subjects who are Children or Pregnant or Nursing Women
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.201 To what does this subpart apply?
p.000292: (a) This subpart applies to all re- search involving intentional exposure of any human subject who
p.000292: is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The requirements of this subpart
p.000292: are in addition to those imposed under the other subparts of this part.
p.000292: § 26.202 Definitions.
p.000292: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions
p.000292: at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.
p.000292:
p.000292: (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000292: exposure to the substance experienced by a human subject participating in the study would not have
p.000292: occurred but for the human subject’s participation in the study.
p.000292: (b) A child is a person who has not at- tained the age of 18 years.
p.000292: § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of
p.000292: any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.
p.000292: Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support
p.000292: research involving intentional exposure of any human subject who is a pregnant woman (and
p.000292: therefore her fetus), a nursing woman, or a child.
p.000292: [71 FR 36175, June 23, 2006]
p.000292:
p.000292: Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved
p.000292: as Subjects in Observational Research Conducted or Supported by EPA
p.000292: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000292: erwise noted.
p.000292:
p.000292: § 26.301 To what does this subpart apply?
p.000292: (a) Except as provided in paragraph
p.000292: (b) of this section, this subpart applies to all observational research involving human subjects who
p.000292: are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection
p.000292: Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any
p.000292: facility by EPA employ- ees.
p.000292: (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart.
p.000292: (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to
p.000292: State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally
p.000293: 293
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293:
p.000293: § 26.302
p.000293: recognized American Indian and Alas- ka Native Tribal Governments.
p.000293: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000293: § 26.302 Definitions.
p.000293: The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition,
p.000293: observational research means any human research that does not meet the definition of research in- volving
p.000293: intentional exposure of a human subject in § 26.202(a).
p.000293: § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses.
p.000293: The provisions of 45 CFR 46.203 are applicable to this section.
p.000293: § 26.304 Additional protections for pregnant women and fetuses in- volved in observational
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
...
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
p.000297:
p.000297: § 26.1108 IRB functions and oper- ations.
p.000297: In order to fulfill the requirements of this subpart each IRB shall:
p.000297: (a) Follow written procedures:
p.000297: (1) For conducting its initial and con- tinuing review of research and for re- porting its findings and
p.000297: actions to the investigator and the institution;
p.000297: (2) For determining which projects require review more often than annu- ally and which
...
p.000301: (4) Alternative means of obtaining in- formation comparable to what would be collected through the proposed
p.000301: re- search; and
p.000301: (5) The balance of risks and benefits of the proposed research.
p.000301: (b) All information for subjects and written informed consent agreements as originally provided to the
p.000301: IRB, and as approved by the IRB.
p.000301: (c) Information about how subjects will be recruited, including any adver- tisements proposed to be used.
p.000301: (d) A description of the cir- cumstances and methods proposed for presenting information
p.000301: to potential human subjects for the purpose of ob- taining their informed consent.
p.000301: (e) All correspondence between the IRB and the investigators or sponsors.
p.000301: (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that
p.000301: re- search involving human subjects has been reviewed and approved by an IRB.
p.000301:
p.000302: 302
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302:
p.000302: Environmental Protection Agency § 26.1303
p.000302:
p.000302: Subpart L—Prohibition of Third- Party Research for Pesticides Involving Intentional Exposure of Human
p.000302: Subjects who are Children or Pregnant or Nurs- ing Women
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1201 To what does this subpart apply?
p.000302: Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject
p.000302: in- tended:
p.000302: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA
p.000302: under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
...
p.000305: of re- search proposals and reports of com- pleted research with human subjects submitted by EPA for
p.000305: its review and, on request, advise EPA on ways to strengthen its programs for protection of human
p.000305: subjects of research.
p.000305:
p.000305: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA
p.000305: Actions
p.000305:
p.000305: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000305: erwise noted.
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
p.000306: The definitions in § 26.1102 and
p.000306: § 26.1202 shall apply to this subpart as well.
p.000306:
p.000306: § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who
p.000306: are pregnant women (and therefore their fetuses), nursing women, or children.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on
p.000306: data from any re- search involving intentional exposure of any human subject who is a preg- nant woman
p.000306: (and therefore her fetus), a nursing woman, or a child.
p.000306: [71 FR 36175, June 23, 2006]
p.000306:
p.000306: § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted before April 7, 2006.
p.000306: Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on
p.000306: data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence
p.000306: that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to
p.000306: seriously harm participants or failed to obtain in- formed consent), or was significantly deficient
p.000306: relative to the ethical stand- ards prevailing at the time the re- search was conducted. This
p.000306: prohibition is in addition to the prohibition in
p.000306: § 26.1703.
p.000306:
p.000306: § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con-
p.000306: ducted after April 7, 2006.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: Environmental Protection Agency Pt. 26
p.000281:
p.000281: PART 26—PROTECTION OF HUMAN SUBJECTS
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Con- ducted or Supported by EPA
p.000281: Sec.
p.000281: 26.101 To what does this policy apply?
p.000281: 26.102 Definitions.
p.000281: 26.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department
p.000281: or Agency.
p.000281: 26.104–26.106 [Reserved]
p.000281: 26.107 IRB membership.
p.000281: 26.108 IRB functions and operations.
p.000281: 26.109 IRB review of research.
p.000281: 26.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.111 Criteria for IRB approval of research.
p.000281: 26.112 Review by institution.
p.000281: 26.113 Suspension or termination of IRB ap- proval of research.
p.000281: 26.114 Cooperative research.
p.000281: 26.115 IRB records.
p.000281: 26.116 General requirements for informed consent.
p.000281: 26.117 Documentation of informed consent.
p.000281: 26.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000281: 26.119 Research undertaken without the in- tention of involving human subjects.
p.000281: 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or
p.000281: supported by a Federal De- partment or Agency.
p.000281: 26.121 [Reserved]
p.000281: 26.122 Use of Federal funds.
p.000281: 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals.
p.000281: 26.124 Conditions.
p.000281:
p.000281: Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of
p.000281: Human Sub- jects who are Children or Pregnant or Nursing Women
p.000281: 26.201 To what does this subpart apply?
p.000281: 26.202 Definitions.
p.000281: 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human
p.000281: subject who is a
p.000281:
...
p.000281: 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000281: Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational
p.000281: Research Conducted or Supported by EPA
p.000281: 26.401 To what does this subpart apply?
p.000281: 26.402 Definitions.
p.000281: 26.403 IRB duties.
p.000281: 26.404 Observational research not involving greater than minimal risk.
p.000281: 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct
p.000281: benefit to the indi- vidual subjects.
p.000281: 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren.
p.000281: Subparts E–J [Reserved]
p.000281: Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional
p.000281: Exposure of Non-pregnant, Non-nursing Adults
p.000281: 26.1101 To what does this subpart apply? 26.1102 Definitions.
p.000281: 26.1103–26.1106 [Reserved]
p.000281: 26.1107 IRB membership.
p.000281: 26.1108 IRB functions and operations. 26.1109 IRB review of research.
p.000281: 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk,
p.000281: and for minor changes in approved research.
p.000281: 26.1111 Criteria for IRB approval of re- search.
p.000281: 26.1112 Review by institution.
p.000281: 26.1113 Suspension or termination of IRB approval of research.
p.000281: 26.1114 Cooperative research.
p.000281: 26.1115 IRB records.
p.000281: 26.1116 General requirements for informed consent.
p.000281: 26.1117 Documentation of informed consent.
p.000281: 281
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281:
p.000281: § 26.101
p.000281: 26.1118–26.1122 [Reserved]
p.000281: 26.1123 Early termination of research. 26.1124 [Reserved]
p.000281: 26.1125 Prior submission of proposed human research for EPA review.
p.000281: Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of
p.000281: Human Subjects who are Children or Pregnant or Nurs- ing Women
p.000281: 26.1201 To what does this subpart apply? 26.1202 Definitions.
p.000281: 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman
p.000281: (and therefore her fetus), a nursing woman, or a child.
p.000281: Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
...
p.000286: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000286: with
p.000286: § 26.117.
p.000287: 287
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287: § 26.110
p.000287: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000287: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000287: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000287: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000287: person or in writing.
p.000287: (e) An IRB shall conduct continuing
p.000287: review of research covered by this pol- icy at intervals appropriate to the de- gree of risk, but not less
p.000287: than once per year, and shall have authority to ob- serve or have a third party observe the consent process and
p.000287: the research.
p.000287: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000287: [56 FR 28012, 28022, June 18, 1991, as amended
p.000287: at 70 FR 36328, June 23, 2005]
p.000287:
p.000287: § 26.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000287: minor changes in approved re- search.
p.000287: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000287: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000287: be amended, as appropriate after consultation with other departments and agencies, through
p.000287: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000287: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000287: (b) An IRB may use the expedited re-
p.000287: view procedure to review either or both of the following:
p.000287: (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.000287: mini- mal risk,
p.000287: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000287: approval is authorized.
p.000287: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or
p.000287: more ex- perienced reviewers designated by the chairperson from among members of
p.000287: 40 CFR Ch. I (7–1–11 Edition)
p.000287: the IRB. In reviewing the research, the reviewers may exercise all of the au- thorities of the IRB except that
p.000287: the re- viewers may not disapprove the re- search. A research activity may be dis- approved only after
p.000287: review in accord- ance with the non-expedited procedure set forth in § 26.108(b).
p.000287: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of
p.000287: re- search proposals which have been ap- proved under the procedure.
p.000287: (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an
p.000287: institu- tion’s or IRB’s use of the expedited re- view procedure.
p.000287: [56 FR 28012, 28022, June 18, 1991, as amended
p.000287: at 70 FR 36328, June 23, 2005]
p.000287:
p.000287: § 26.111 Criteria for IRB approval of research.
p.000287: (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the
p.000287: following require- ments are satisfied:
p.000287: (1) Risks to subjects are minimized:
p.000287: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily
p.000287: expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed
...
p.000297: (c) An IRB shall require documenta- tion of informed consent in accordance with § 26.1117.
p.000298: 298
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298: Environmental Protection Agency § 26.1111
p.000298:
p.000298:
p.000298: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000298: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000298: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000298: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000298: person or in writing.
p.000298: (e) An IRB shall conduct continuing
p.000298: review of research covered by this sub- part at intervals appropriate to the de- gree of risk, but not less than once
p.000298: per year, and shall have authority to ob- serve or have a third party observe the consent process and the
p.000298: research.
p.000298: § 26.1110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000298: minor changes in approved re- search.
p.000298: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000298: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000298: be amended, as appropriate after consultation with other departments and agencies, through
p.000298: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000298: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000298: (b)(1) An IRB may use the expedited
p.000298: review procedure to review either or both of the following:
p.000298: (i) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than
p.000298: mini- mal risk,
p.000298: (ii) Minor changes in previously ap- proved research during the period (of 1 year or less) for which
p.000298: approval is au- thorized.
p.000298: (2) Under an expedited review proce- dure, the review may be carried out by the IRB chairperson or by one or
p.000298: more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing
p.000298: the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may
p.000298: not disapprove the re- search. A research activity may be dis-
p.000298:
p.000298: approved only after review in accord- ance with the non-expedited procedure set forth in § 26.1108(b).
p.000298: (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of
p.000298: re- search proposals which have been ap- proved under the procedure.
p.000298: (d) The Administrator may restrict, suspend, or terminate, an institution’s or IRB’s use of the expedited
p.000298: review procedure for research covered by this subpart.
p.000298:
p.000298: § 26.1111 Criteria for IRB approval of research.
p.000298: (a) In order to approve research cov- ered by this subpart the IRB shall de- termine that all of the
p.000298: following re- quirements are satisfied:
p.000298: (1) Risks to subjects are minimized:
p.000298: (i) By using procedures which are consistent with sound research design and which do not
p.000298: unnecessarily expose subjects to risk, and
p.000298: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic
p.000298: or treat- ment purposes.
...
Social / education
Searching for indicator education:
(return to top)
p.000281: includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment
p.000281: outside the United States.
p.000281: (1) Research that is conducted or sup-
p.000281: ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e),
p.000281: must comply with all sections of this policy.
p.000281: (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is
p.000281: subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101,
p.000281: § 26.102, and § 26.107 through § 26.117 of this policy, by an in- stitutional review board (IRB) that op- erates in
p.000281: accordance with the pertinent requirements of this policy.
p.000281: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000281: involvement
p.000282: 282
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282: Environmental Protection Agency § 26.101
p.000282:
p.000282:
p.000282: of human subjects will be in one or more of the following categories are exempt from this policy:
p.000282: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000282: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000282: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000282: cur- ricula, or classroom management methods.
p.000282: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000282: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000282: through identifiers linked to the subjects; and
p.000282: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000282: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000282: employability, or reputation.
p.000282: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000282: (b)(2) of this section, if:
p.000282: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000282: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000282: informa- tion will be maintained throughout the research and thereafter.
p.000282: (4) Research, involving the collection or study of existing data, documents, records, pathological specimens,
...
Searching for indicator educational:
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p.000281: ducted by Federal civilian employees or military personnel, except that each department or agency head may
p.000281: adopt such procedural modifications as may be appropriate from an administrative standpoint. It also
p.000281: includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment
p.000281: outside the United States.
p.000281: (1) Research that is conducted or sup-
p.000281: ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e),
p.000281: must comply with all sections of this policy.
p.000281: (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is
p.000281: subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101,
p.000281: § 26.102, and § 26.107 through § 26.117 of this policy, by an in- stitutional review board (IRB) that op- erates in
p.000281: accordance with the pertinent requirements of this policy.
p.000281: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000281: involvement
p.000282: 282
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282: Environmental Protection Agency § 26.101
p.000282:
p.000282:
p.000282: of human subjects will be in one or more of the following categories are exempt from this policy:
p.000282: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
p.000282: educational practices, such as (i) research on reg- ular and special education instruc- tional
p.000282: strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
p.000282: cur- ricula, or classroom management methods.
p.000282: (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures or observa- tion of public behavior, unless:
p.000282: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or
p.000282: through identifiers linked to the subjects; and
p.000282: (ii) Any disclosure of the human sub- jects’ responses outside the research could reasonably place the
p.000282: subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
p.000282: employability, or reputation.
p.000282: (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000282: proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph
p.000282: (b)(2) of this section, if:
p.000282: (i) The human subjects are elected or appointed public officials or candidates for public office; or
p.000282: (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable
p.000282: informa- tion will be maintained throughout the research and thereafter.
...
p.000293: research.
p.000293: The provisions of 45 CFR 46.204 are applicable to this section.
p.000293: § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
p.000293: The provisions of 45 CFR 46.206 are applicable to this section.
p.000293:
p.000293: Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in
p.000293: Observational Re- search Conducted or Sup- ported by EPA
p.000293: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000293: erwise noted.
p.000293:
p.000293: § 26.401 To what does this subpart apply?
p.000293: (a) This subpart applies to all obser- vational research involving children as subjects, conducted or
p.000293: supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000293: Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been
p.000293: delegated by the Administrator.
p.000293: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000293: not, ab- sent affirmative agreement, be con- strued as assent.
p.000293: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000293: research.
...
Social / embryo
Searching for indicator embryo:
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p.000289: research;
p.000289: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000289: might be advan- tageous to the subject;
p.000289: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000289: subject will be maintained;
p.000289: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000289: an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they
p.000289: consist of, or where further information may be ob- tained;
p.000289: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000289: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000289: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000289: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000289: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000289: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000289: elements of in- formation shall also be provided to each subject:
p.000289: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000289: the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable;
p.000289: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000289: investigator without regard to the subject’s con- sent;
p.000289: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000289: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000289: of participation by the subject;
p.000290: 290
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290:
p.000290: Environmental Protection Agency § 26.117
p.000290:
p.000290:
p.000290: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000290: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000290: (6) The approximate number of sub- jects involved in the study.
p.000290: (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000290: ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent
p.000290: provided the IRB finds and documents that:
p.000290: (1) The research or demonstration project is to be conducted by or subject to the approval of State or
...
p.000300: research;
p.000300: (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that
p.000300: might be advan- tageous to the subject;
p.000300: (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the
p.000300: subject will be maintained;
p.000300: (6) For research involving more than minimal risk, an explanation as to whether any compensation and
p.000300: an ex- planation as to whether any medical treatments are available if injury oc-
p.000300:
p.000300: curs and, if so, what they consist of, or where further information may be ob- tained;
p.000300: (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research
p.000300: sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and
p.000300: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
p.000300: benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time
p.000300: without penalty or loss of benefits to which the subject is otherwise entitled.
p.000300: (b) Additional elements of informed consent. When appropriate, one or more of the following
p.000300: elements of in- formation shall also be provided to each subject:
p.000300: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000300: the embryo or fetus, if the subject may become pregnant) which are currently unfore- seeable;
p.000300: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000300: investigator without regard to the subject’s con- sent;
p.000300: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000300: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000300: of participation by the subject;
p.000300: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000300: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000300: (6) The approximate number of sub- jects involved in the study.
p.000300: (c) The informed consent require- ments in this subpart are not intended to preempt any applicable
p.000300: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000300: consent to be le- gally effective.
p.000300: (d) Nothing in this subpart is in- tended to limit the authority of a phy- sician to provide
p.000300: emergency medical
p.000301: 301
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: § 26.1117
p.000301: care, to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
...
Social / employees
Searching for indicator employees:
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p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
p.000281: ducted by Federal civilian employees or military personnel, except that each department or agency head may
p.000281: adopt such procedural modifications as may be appropriate from an administrative standpoint. It also
p.000281: includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment
p.000281: outside the United States.
p.000281: (1) Research that is conducted or sup-
p.000281: ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e),
p.000281: must comply with all sections of this policy.
p.000281: (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is
p.000281: subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101,
p.000281: § 26.102, and § 26.107 through § 26.117 of this policy, by an in- stitutional review board (IRB) that op- erates in
p.000281: accordance with the pertinent requirements of this policy.
p.000281: (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only
p.000281: involvement
p.000282: 282
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282:
p.000282: Environmental Protection Agency § 26.101
p.000282:
p.000282:
p.000282: of human subjects will be in one or more of the following categories are exempt from this policy:
p.000282: (1) Research conducted in established or commonly accepted educational set- tings, involving normal
...
p.000285: and for reporting its findings and actions to the investigator and the institution;
p.000285: (ii) for determining which projects re- quire review more often than annually and which projects need
p.000285: verification from sources other than the investiga- tors that no material changes have oc- curred since
p.000285: previous IRB review; and
p.000285: (iii) for ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000285: ensuring that such changes in approved research, during the period for which IRB ap- proval has
p.000285: already been given, may not be initiated without IRB review and approval except when necessary to
p.000285: eliminate apparent immediate hazards to the subject.
p.000285: (5) Written procedures for ensuring prompt reporting to the IRB, appro- priate institutional
p.000285: officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or
p.000285: others or any serious or continuing noncompliance with this policy or the requirements or deter-
p.000285: minations of the IRB and (ii) any sus- pension or termination of IRB ap- proval.
p.000285: (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on
p.000285: behalf of the institution the obligations im- posed by this policy and shall be filed
p.000285: 40 CFR Ch. I (7–1–11 Edition)
p.000285: in such form and manner as the depart- ment or agency head prescribes.
p.000285: (d) The department or agency head will evaluate all assurances submitted in accordance with this policy
p.000285: through such officers and employees of the de- partment or agency and such experts or consultants engaged
p.000285: for this purpose as the department or agency head de- termines to be appropriate. The depart- ment or agency
p.000285: head’s evaluation will take into consideration the adequacy of the proposed IRB in light of the an-
p.000285: ticipated scope of the institution’s re- search activities and the types of sub- ject populations likely
p.000285: to be involved, the appropriateness of the proposed ini- tial and continuing review procedures in light of the
p.000285: probable risks, and the size and complexity of the institution.
p.000285: (e) On the basis of this evaluation, the department or agency head may approve or disapprove the
p.000285: assurance, or enter into negotiations to develop an approvable one. The department or agency head may
p.000285: limit the period dur- ing which any particular approved as- surance or class of approved assurances shall
p.000285: remain effective or otherwise condition or restrict approval.
p.000285: (f) Certification is required when the research is supported by a Federal de- partment or agency and not
p.000285: otherwise exempted or waived under § 26.101 (b) or (i). An institution with an approved as- surance shall certify that
p.000285: each applica- tion or proposal for research covered by the assurance and by § 26.103 of this Policy has
p.000285: been reviewed and approved by the IRB. Such certification must be submitted with the application or pro- posal
p.000285: or by such later date as may be prescribed by the department or agen- cy to which the application or
p.000285: proposal is submitted. Under no condition shall research covered by § 26.103 of the Pol- icy be supported
...
p.000291: responsibility; re- search training grants in which the ac- tivities involving subjects remain to be selected; and
p.000291: projects in which human subjects’ involvement will depend upon completion of instruments, prior ani- mal
p.000291: studies, or purification of com- pounds. These applications need not be reviewed by an IRB before an
p.000291: award may be made. However, except for re- search exempted or waived under
p.000291: § 26.101 (b) or (i), no human subjects may be involved in any project sup- ported by these
p.000291: awards until the project has been reviewed and approved by the IRB, as provided in this policy, and
p.000291: certification submitted, by the in- stitution, to the department or agency.
p.000291: § 26.119 Research undertaken without the intention of involving human subjects.
p.000291: In the event research is undertaken without the intention of involving human subjects, but it
p.000291: is later pro- posed to involve human subjects in the
p.000291: 40 CFR Ch. I (7–1–11 Edition)
p.000291: research, the research shall first be re- viewed and approved by an IRB, as pro- vided in this policy, a certification
p.000291: sub- mitted, by the institution, to the de- partment or agency, and final approval given to the proposed change
p.000291: by the de- partment or agency.
p.000291: § 26.120 Evaluation and disposition of applications and proposals for re- search to be conducted or
p.000291: sup- ported by a Federal Department or Agency.
p.000291: The department or agency head will evaluate all applications and proposals involving human subjects submitted
p.000291: to the department or agency through such officers and employees of the depart- ment or agency and such
p.000291: experts and consultants as the department or agen- cy head determines to be appropriate. This evaluation will
p.000291: take into consid- eration the risks to the subjects, the adequacy of protection against these risks,
p.000291: the potential benefits of the re- search to the subjects and others, and the importance of the
p.000291: knowledge gained or to be gained.
p.000291: (b) On the basis of this evaluation,
p.000291: the department or agency head may approve or disapprove the application or proposal, or enter into
p.000291: negotiations to develop an approvable one.
p.000291: § 26.121 [Reserved]
p.000291: § 26.122 Use of Federal funds.
p.000291: Federal funds administered by a de- partment or agency may not be ex- pended for research involving
p.000291: human subjects unless the requirements of this policy have been satisfied.
p.000291: § 26.123 Early termination of research support: Evaluation of applications and proposals.
p.000291: (a) The department or agency head may require that department or agency support for any project be terminated
p.000291: or suspended in the manner prescribed in applicable program requirements, when the department or agency
p.000291: head finds an institution has materially failed to comply with the terms of this policy.
p.000291: (b) In making decisions about sup-
p.000291: porting or approving applications or proposals covered by this policy the de- partment or agency head
p.000291: may take into account, in addition to all other
p.000292: 292
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
p.000292:
...
p.000305: re- views.
p.000305: § 26.1602 EPA review of completed human research.
p.000305: (a) When considering data under FIFRA or FFDCA from research in- volving intentional exposure
p.000305: of hu- mans, EPA shall review the material submitted under § 26.1303 and other available,
p.000305: relevant information and document its conclusions regarding the scientific and ethical conduct of the re- search.
p.000305: (b) EPA shall submit its review of data from human research covered by subpart Q, together with the
p.000305: available supporting materials, to the Human Studies Review Board if EPA decides to rely on the data and:
p.000305: (1) The data are derived from re- search initiated after April 7, 2006, or
p.000305: (2) The data are derived from re- search initiated before April 7, 2006, and the research was
p.000305: conducted for the
p.000305: 40 CFR Ch. I (7–1–11 Edition)
p.000305: purpose of identifying or measuring a toxic effect.
p.000305: (c) In its discretion, EPA may submit data from research not covered by paragraph (b) of this section
p.000305: to the Human Studies Review Board for their review.
p.000305: (d) EPA shall notify the submitter of the research of the results of the EPA and Human Studies Review Board
p.000305: re- views.
p.000305:
p.000305: § 26.1603 Operation of the Human Studies Review Board.
p.000305: EPA shall establish and operate a Human Studies Review Board as fol- lows:
p.000305: (a) Membership. The Human Studies Review Board shall consist of members who are not employed by EPA,
p.000305: who meet the ethics and other requirements for special government employees, and who have expertise in
p.000305: fields appro- priate for the scientific and ethical re- view of human research, including re- search
p.000305: ethics, biostatistics, and human toxicology.
p.000305: (b) Responsibilities. The Human Stud- ies Review Board shall comment on the scientific and ethical aspects
p.000305: of re- search proposals and reports of com- pleted research with human subjects submitted by EPA for
p.000305: its review and, on request, advise EPA on ways to strengthen its programs for protection of human
p.000305: subjects of research.
p.000305:
p.000305: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA
p.000305: Actions
p.000305:
p.000305: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000305: erwise noted.
p.000305:
p.000305: § 26.1701 To what does this subpart apply?
p.000305: This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal
p.000305: Insecticide, Fungicide, and Rodenticide Act (7
p.000305: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on
p.000305: scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects.
p.000306: 306
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306:
p.000306: Environmental Protection Agency Pt. 27
p.000306:
p.000306:
p.000306: § 26.1702 Definitions.
...
Social / gender
Searching for indicator gender:
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p.000285: proposal is submitted. Under no condition shall research covered by § 26.103 of the Pol- icy be supported
p.000285: prior to receipt of the certification that the research has been reviewed and approved by the IRB. In- stitutions
p.000285: without an approved assur- ance covering the research shall certify within 30 days after receipt of a request for
p.000285: such a certification from the de- partment or agency, that the applica- tion or proposal has been
p.000285: approved by the IRB. If the certification is not sub- mitted within these time limits, the
p.000286: 286
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286:
p.000286: Environmental Protection Agency § 26.109
p.000286:
p.000286:
p.000286: application or proposal may be re- turned to the institution.
p.000286: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000286: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000286: June 28, 1991, as amended at 70 FR 36328,
p.000286: June 23, 2005]
p.000286:
p.000286: §§ 26.104–26.106 [Reserved]
p.000286: § 26.107 IRB membership.
p.000286: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000286: of research activities commonly con- ducted by the institution. The IRB shall be sufficiently
p.000286: qualified through the experience and expertise of its members, and the diversity of the members,
p.000286: including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com-
p.000286: munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and
p.000286: welfare of human subjects. In addition to pos- sessing the professional competence necessary to
p.000286: review specific research activities, the IRB shall be able to as- certain the acceptability of
p.000286: proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of
p.000286: professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an
p.000286: IRB regularly reviews research that involves a vulnerable category of subjects, such as children,
p.000286: prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given
p.000286: to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working
p.000286: with these subjects.
p.000286: (b) Every nondiscriminatory effort
p.000286: will be made to ensure that no IRB consists entirely of men or entirely of women, including the
p.000286: institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the
p.000286: IRB on the basis of gender. No IRB may consist entirely of members of one profession.
p.000286: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000286: least one member whose primary concerns are in nonscientific areas.
p.000286:
p.000286: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000286: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000286: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000286: project in which the member has a conflicting interest, except to provide information re- quested by
p.000286: the IRB.
p.000286: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000286: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000286: These individuals may not vote with the IRB.
p.000286: § 26.108 IRB functions and operations.
p.000286: In order to fulfill the requirements of this policy each IRB shall:
p.000286: (a) Follow written procedures in the same detail as described in § 26.103(b)(4) and, to the extent
p.000286: required by,
p.000286: § 26.103(b)(5).
p.000286: (b) Except when an expedited review procedure is used (see § 26.110), review proposed research at
p.000286: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000286: one member whose primary concerns are in nonscientific areas. In order for the research to be
...
p.000296: are not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000296: performance of rou- tine physical or psychological exami- nations or tests.
p.000296: (i) Research involving intentional expo- sure of a human subject means a study of a substance in which the
p.000296: exposure to the substance experienced by a human subject participating in the study would not have
p.000296: occurred but for the human subject’s participation in the study.
p.000296: (j) Person means any person, as that term is defined in FIFRA section 2(s) (7
p.000296: U.S.C. 136), except:
p.000296: (1) A federal agency that is subject to the provisions of the Federal Policy for the Protection of Human Subjects
p.000296: of Research, and
p.000296: (2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of
p.000296: this sec- tion.
p.000296: §§ 26.1103–26.1106 [Reserved]
p.000296: § 26.1107 IRB membership.
p.000296: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review
p.000296: of research activities which are pre- sented for its approval. The IRB shall be sufficiently
p.000296: qualified through the experience and expertise of its mem- bers, and the diversity of the members, including
p.000296: consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at-
p.000296: titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human
p.000296: subjects. In addition to possessing the profes- sional competence necessary to review specific
p.000296: research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms
p.000296: of institutional commitments and regula- tions, applicable law, and standards of professional conduct and
p.000296: practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB
p.000297: 297
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297:
p.000297: § 26.1108
p.000297: regularly reviews research that in- volves a vulnerable category of sub- jects, such as
p.000297: prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more
p.000297: individuals who are knowl- edgeable about and experienced in working with these subjects.
p.000297: (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000297: entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as
p.000297: no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one
p.000297: profession.
p.000297: (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at
p.000297: least one member whose primary concerns are in nonscientific areas.
p.000297: (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and
p.000297: who is not part of the immediate family of a person who is affiliated with the insti- tution.
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
p.000297:
p.000297: § 26.1108 IRB functions and oper- ations.
p.000297: In order to fulfill the requirements of this subpart each IRB shall:
p.000297: (a) Follow written procedures:
p.000297: (1) For conducting its initial and con- tinuing review of research and for re- porting its findings and
p.000297: actions to the investigator and the institution;
p.000297: (2) For determining which projects require review more often than annu- ally and which
p.000297: projects need verification from sources other than the investigator that no material changes
p.000297: have occurred since previous IRB review;
p.000297: 40 CFR Ch. I (7–1–11 Edition)
...
Social / parents
Searching for indicator parent:
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p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000293: Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been
p.000293: delegated by the Administrator.
p.000293: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000293: not, ab- sent affirmative agreement, be con- strued as assent.
p.000293: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000293: research.
p.000293: (d) Parent means a child’s biological or adoptive parent.
p.000293: (e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent
p.000293: on be- half of a child to general medical care.
p.000293: (f) Observational research means any research with human subjects that does not meet the
p.000293: definition of re- search involving intentional exposure of a human subject in § 26.202(a).
p.000293: (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000293: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000293: the performance of rou- tine physical or psychological exami- nations or tests.
p.000293: § 26.403 IRB duties.
p.000293: In addition to other responsibilities assigned to IRBs under this part, each
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Environmental Protection Agency § 26.406
p.000294:
p.000294:
p.000294: IRB shall review observational re- search covered by this subpart and ap- prove only research that
p.000294: satisfies the conditions of all applicable sections of this subpart.
p.000294: § 26.404 Observational research not in- volving greater than minimal risk.
p.000294: EPA will conduct or fund observa- tional research in which the IRB finds that no greater than
...
p.000294: child, as the IRB deems appropriate. If the IRB deter- mines that the capability of some or all of
p.000294: the children is so limited that they cannot reasonably be consulted or that the intervention or procedure in-
p.000294: volved in the observational research holds out a prospect of direct benefit that is important to the
p.000294: health or well- being of the children and is available only in the context of the research, the assent of the
p.000294: children is not a nec- essary condition for proceeding with the observational research. Even where
p.000294: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000294: requirement under circumstances in which consent may be waived in accord with
p.000294: § 26.116(d).
p.000294: (b) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine, in accordance with and to the extent that consent is required by
p.000294: § 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or
p.000294: guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent
p.000294: is sufficient for research to be conducted under § 26.404 or § 26.405.
p.000294: (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a
p.000294: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000294: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
...
p.000303: to EPA, such information should in- clude:
p.000303: (a) Copies of all of the records rel- evant to the research specified by
p.000303: § 26.1115(a) to be prepared and main- tained by an IRB.
p.000303: (b) Copies of all of the records rel- evant to the information identified in
p.000303: § 26.1125(a) through (f).
p.000303: (c) Copies of sample records used to document informed consent as speci- fied by § 26.1117, but not
p.000303: identifying any subjects of the research.
p.000303: (d) If any of the information listed in paragraphs (a) through (c) of this sec- tion is not provided, the
p.000303: person shall describe the efforts made to obtain the information.
p.000303: Subpart N [Reserved]
p.000303: Subpart O—Administrative Actions for Noncompliance
p.000303: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000303: erwise noted.
p.000303:
p.000303: § 26.1501 To what does this subpart apply?
p.000303: This subpart applies to any human research subject to subparts A through L of this part. References to State
p.000303: or local laws in this subpart are intended to include the laws of federally recog- nized American Indian
p.000303: and Alaska Na- tive Tribal Governments.
p.000303: § 26.1502 Lesser administrative ac- tions.
p.000303: (a) If apparent noncompliance with the applicable regulations in subparts A through L of this part concerning
p.000303: the operation of an IRB is observed by an officer or employee of EPA or of any State duly designated
p.000303: by the Adminis- trator during an inspection. EPA may send a letter describing the noncompli- ance to the IRB
p.000303: and to the parent in- stitution. The agency will require that the IRB or the parent institution re-
p.000303: spond to this letter within a reasonable time period specified by EPA and de- scribe the corrective actions
p.000303: that will be taken by the IRB, the institution, or both to achieve compliance with these regulations.
p.000303: (b) On the basis of the IRB’s or the
p.000303: institution’s response, EPA may sched- ule a reinspection to confirm the ade-
p.000303: 40 CFR Ch. I (7–1–11 Edition)
p.000303: quacy of corrective actions. In addi- tion, until the IRB or the parent insti- tution takes appropriate
p.000303: corrective ac- tion, the Agency may:
p.000303: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the
p.000303: institution or reviewed by the IRB;
p.000303: (2) Direct that no new subjects be added to ongoing studies subject to this part;
p.000303: (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
p.000303: (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human
p.000303: subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest of
p.000303: the deficiencies in the operation of the IRB.
p.000303: (c) The parent institution is pre- sumed to be responsible for the oper- ation of an IRB, and EPA
p.000303: will ordi- narily direct any administrative action under this subpart against the institu- tion. However,
p.000303: depending on the evi- dence of responsibility for deficiencies, determined during the investigation, EPA
p.000303: may restrict its administrative actions to the IRB or to a component of the parent institution determined
p.000303: to be responsible for formal designation of the IRB.
p.000303: § 26.1503 Disqualification of an IRB or an institution.
p.000303: (a) Whenever the IRB or the institu- tion has failed to take adequate steps to correct the noncompliance
p.000303: stated in the letter sent by the Agency under
p.000303: § 26.1502(a) and the EPA Administrator determines that this noncompliance may justify the disqualification
p.000303: of the IRB or of the parent institution, the Administrator may institute appro- priate proceedings.
p.000303: (b) The Administrator may disqualify an IRB or the parent institution from studies subject to this part if
p.000303: the Ad- ministrator determines that:
p.000303: (1) The IRB has refused or repeatedly failed to comply with any of the regu- lations set forth in this part, and
p.000303: (2) The noncompliance adversely af- fects the rights or welfare of the human subjects of
p.000303: research.
p.000303: (c) If the Administrator determines that disqualification is appropriate,
p.000304: 304
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304:
p.000304: Environmental Protection Agency § 26.1601
p.000304:
p.000304:
p.000304: the Administrator will issue an order that explains the basis for the deter- mination and that prescribes
p.000304: any ac- tions to be taken with regard to ongo- ing human research, covered by sub- parts A through L
p.000304: of this part, con- ducted under the review of the IRB. EPA will send notice of the disquali- fication
p.000304: to the IRB and the parent in- stitution. Other parties with a direct interest, such as sponsors and
p.000304: inves- tigators, may also be sent a notice of the disqualification. In addition, the agency may elect to
p.000304: publish a notice of its action in the FEDERAL REGISTER.
p.000304: (d) EPA may refuse to consider in
p.000304: support of a regulatory decision the data from human research, covered by subparts A through L of this
p.000304: part, that was reviewed by an IRB or conducted at an institution during the period of disqualification,
p.000304: unless the IRB or the parent institution is reinstated as pro- vided in § 26.1505, or unless such
p.000304: re- search is deemed scientifically sound and crucial to the protection of public health, under the
p.000304: procedure defined in
p.000304: § 26.1706.
p.000304: § 26.1504 Public disclosure of informa- tion regarding revocation.
p.000304: A determination that EPA has dis- qualified an institution from studies subject to this part and the
p.000304: adminis- trative record regarding that deter- mination are disclosable to the public under 40 CFR part 2.
p.000304: § 26.1505 Reinstatement of an IRB or an institution.
p.000304: An IRB or an institution may be re- instated to conduct studies subject to this part if the
p.000304: Administrator deter- mines, upon an evaluation of a written submission from the IRB or institution that explains
p.000304: the corrective action that the institution or IRB has taken or plans to take, that the IRB or insti- tution
p.000304: has provided adequate assurance that it will operate in compliance with the standards set forth in this part. No-
p.000304: tification of reinstatement shall be provided to all persons notified under
p.000304: § 26.1502(c).
p.000304: § 26.1506 Debarment.
p.000304: If EPA determines that an institu- tion or investigator repeatedly has not complied with or has committed
p.000304: an
p.000304:
p.000304: egregious violation of the applicable regulations in subparts A through L of this part, EPA may
p.000304: recommend that institution or investigator be declared ineligible to participate in EPA-sup- ported
p.000304: research (debarment). Debar- ment will be initiated in accordance with procedures specified at 2 CFR part
p.000304: 1532.
...
Searching for indicator parents:
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p.000293: definition of re- search involving intentional exposure of a human subject in § 26.202(a).
p.000293: (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000293: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000293: the performance of rou- tine physical or psychological exami- nations or tests.
p.000293: § 26.403 IRB duties.
p.000293: In addition to other responsibilities assigned to IRBs under this part, each
p.000294: 294
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294:
p.000294: Environmental Protection Agency § 26.406
p.000294:
p.000294:
p.000294: IRB shall review observational re- search covered by this subpart and ap- prove only research that
p.000294: satisfies the conditions of all applicable sections of this subpart.
p.000294: § 26.404 Observational research not in- volving greater than minimal risk.
p.000294: EPA will conduct or fund observa- tional research in which the IRB finds that no greater than
p.000294: minimal risk to children is presented, only if the IRB finds that adequate provisions are made for
p.000294: soliciting the assent of the children and the permission of their parents or guardians, as set
p.000294: forth in
p.000294: § 26.406.
p.000294: § 26.405 Observational research involv- ing greater than minimal risk but presenting the prospect of
p.000294: direct benefit to the individual subjects.
p.000294: If the IRB finds that an intervention or procedure presents more than mini- mal risk to children, EPA will
p.000294: not con- duct or fund observational research that includes such an intervention or procedure unless the
p.000294: IRB finds and doc- uments that:
p.000294: (a) The intervention or procedure holds out the prospect of direct benefit to the individual subject or is
p.000294: likely to contribute to the subject’s well-being;
p.000294: (b) The risk is justified by the antici- pated benefit to the subjects;
p.000294: (c) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects
p.000294: as that presented by available alternative approaches; and
p.000294: (d) Adequate provisions are made for soliciting the assent of the children and permission of their
p.000294: parents or guardians, as set forth in § 26.406.
p.000294: § 26.406 Requirements for permission by parents or guardians and for as- sent by children.
p.000294: (a) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, when
p.000294: in the judgment of the IRB the children are capable of pro- viding assent. In determining whether
p.000294: children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological
p.000294: state of the children involved. This judgment
p.000294:
p.000294: may be made for all children to be in- volved in research under a particular protocol, or for each
p.000294: child, as the IRB deems appropriate. If the IRB deter- mines that the capability of some or all of
p.000294: the children is so limited that they cannot reasonably be consulted or that the intervention or procedure in-
p.000294: volved in the observational research holds out a prospect of direct benefit that is important to the
p.000294: health or well- being of the children and is available only in the context of the research, the assent of the
p.000294: children is not a nec- essary condition for proceeding with the observational research. Even where
p.000294: the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000294: requirement under circumstances in which consent may be waived in accord with
p.000294: § 26.116(d).
p.000294: (b) In addition to the determinations required under other applicable sec- tions of this subpart, the
p.000294: IRB shall de- termine, in accordance with and to the extent that consent is required by
p.000294: § 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or
p.000294: guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent
p.000294: is sufficient for research to be conducted under § 26.404 or § 26.405.
p.000294: (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a
p.000294: research protocol is designed for conditions or for a subject population for which parental or guard- ian permission
p.000294: is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it
p.000294: may replace the consent require- ments in subpart A of this part and paragraph (b) of this section
p.000294: with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as
p.000294: subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal,
p.000294: State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na-
p.000294: ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the
p.000294: research sub- jects, and their age, maturity, status, and condition.
p.000295: 295
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295:
p.000295: § 26.1101
p.000295: (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent
p.000295: required by
p.000295: § 26.117.
p.000295: (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be
p.000295: docu- mented.
p.000295:
p.000295: Subparts E–J [Reserved]
p.000295: Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving
p.000295: Intentional Exposure of Non-pregnant, Non-nursing Adults
p.000295: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000295: erwise noted.
p.000295:
p.000295: § 26.1101 To what does this subpart apply?
p.000295: (a) Except as provided in paragraph
p.000295: (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving
p.000295: intentional exposure of a human subject if, at any time prior to initiating such research, any person who
p.000295: conducted or supported such research intended:
p.000295: (1) To submit results of the research to EPA for consideration in connection with any action that may be
p.000295: performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7
p.000295: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000295: (2) To hold the results of the research for later inspection by EPA under the Federal Insecticide,
p.000295: Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic
p.000295: Act 21 U.S.C. 346a).
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000290: for benefits or services under those programs; and
p.000290: (2) The research could not prac- ticably be carried out without the waiver or alteration.
p.000290: (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000290: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000290: consent provided the IRB finds and documents that:
p.000290: (1) The research involves no more than minimal risk to the subjects;
p.000290: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000290: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000290: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000290: participa- tion.
p.000290: (e) The informed consent require- ments in this policy are not intended to preempt any applicable
p.000290: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000290: consent to be le- gally effective.
p.000290: (f) Nothing in this policy is intended to limit the authority of a physician to
p.000290:
p.000290: provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State,
p.000290: or local law.
p.000290: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000290: [56 FR 28012, 28022, June 18, 1991, as amended
p.000290: at 70 FR 36328, June 23, 2005]
p.000290:
p.000290: § 26.117 Documentation of informed consent.
p.000290: (a) Except as provided in paragraph
p.000290: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000290: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000290: shall be given to the per- son signing the form.
p.000290: (b) Except as provided in paragraph
p.000290: (c) of this section, the consent form may be either of the following:
p.000290: (1) A written consent document that embodies the elements of informed consent required by § 26.116.
p.000290: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000290: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000290: before it is signed; or
p.000290: (2) A short form written consent doc- ument stating that the elements of in- formed consent required by
...
p.000300: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000300: the embryo or fetus, if the subject may become pregnant) which are currently unfore- seeable;
p.000300: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000300: investigator without regard to the subject’s con- sent;
p.000300: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000300: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000300: of participation by the subject;
p.000300: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000300: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000300: (6) The approximate number of sub- jects involved in the study.
p.000300: (c) The informed consent require- ments in this subpart are not intended to preempt any applicable
p.000300: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000300: consent to be le- gally effective.
p.000300: (d) Nothing in this subpart is in- tended to limit the authority of a phy- sician to provide
p.000300: emergency medical
p.000301: 301
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: § 26.1117
p.000301: care, to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
p.000301: (e) If the research involves inten- tional exposure of subjects to a pes- ticide, the subjects of
p.000301: the research must be informed of the identity of the pesticide and the nature of its pes- ticidal
p.000301: function.
p.000301: § 26.1117 Documentation of informed consent.
p.000301: (a) Informed consent shall be docu- mented by the use of a written consent form approved by the IRB and
p.000301: signed by the subject or the subject’s legally authorized representative. A copy shall be given to the
p.000301: person signing the form.
p.000301: (b) The consent form may be either of the following:
p.000301: (1) A written consent document that embodies the elements of informed consent required by § 26.1116.
p.000301: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000301: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000301: before it is signed; or
p.000301: (2) A short form written consent doc- ument stating that the elements of in- formed consent required by §
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000281: 26.1505 Reinstatement of an IRB or an insti- tution.
p.000281: 26.1506 Debarment.
p.000281: 26.1507 Actions alternative or additional to disqualification.
p.000281: Subpart P—Review of Proposed and Completed Human Research
p.000281: 26.1601 EPA review of proposed human re- search.
p.000281: 26.1602 EPA review of completed human re- search.
p.000281: 26.1603 Operation of the Human Studies Re- view Board.
p.000281: Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
p.000281: 26.1701 To what does this subpart apply? 26.1702 Definitions.
p.000281: 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are
p.000281: pregnant women (and therefore their fetuses), nursing women, or children.
p.000281: 40 CFR Ch. I (7–1–11 Edition)
p.000281: 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted before April 7, 2006.
p.000281: 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults
p.000281: conducted after April 7, 2006.
p.000281: 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable
p.000281: research.
p.000281: AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1);
p.000281: 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b).
p.000281: SOURCE: 56 FR 28012, 28022, June 18, 1991,
p.000281: unless otherwise noted.
p.000281:
p.000281: Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by
p.000281: EPA
p.000281: § 26.101 To what does this policy apply?
p.000281: (a) Except as provided in paragraph
p.000281: (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or
p.000281: otherwise subject to regulation by any Federal department or agency which takes ap- propriate
p.000281: administrative action to make the policy applicable to such re- search. This includes research con-
p.000281: ducted by Federal civilian employees or military personnel, except that each department or agency head may
p.000281: adopt such procedural modifications as may be appropriate from an administrative standpoint. It also
p.000281: includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment
p.000281: outside the United States.
p.000281: (1) Research that is conducted or sup-
p.000281: ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e),
p.000281: must comply with all sections of this policy.
p.000281: (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is
p.000281: subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101,
...
p.000283: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000283: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000283: and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de-
p.000283: partment or agency procedures. 1
p.000283: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000283: June 28, 1991, as amended at 70 FR 36328,
p.000283: June 23, 2005]
p.000283:
p.000283: 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title
p.000283: 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions
p.000283: of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR
p.000283: 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR
p.000283: 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not
p.000283: apply to research with children, subpart D, except for research in- volving observations of public behavior
p.000283: when the investigator(s) do not participate in the activities being observed.
p.000283: 40 CFR Ch. I (7–1–11 Edition)
p.000283: § 26.102 Definitions.
p.000283: (a) Department or agency head means the head of any Federal department or agency and any other officer
p.000283: or em- ployee of any department or agency to whom authority has been delegated.
p.000283: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000283: agencies).
p.000283: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000283: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000283: procedure(s) involved in the research.
p.000283: (d) Research means a systematic in- vestigation, including research devel- opment, testing and
p.000283: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000283: definition constitute re- search for purposes of this policy, whether or not they are conducted
p.000283: or supported under a program which is considered research for other purposes. For example, some
p.000283: demonstration and service programs may include research activities.
p.000283: (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities
p.000283: for which a Federal department or agency has specific responsibility for regulating as a research activity,
p.000283: (for example, In- vestigational New Drug requirements administered by the Food and Drug Ad- ministration). It
p.000283: does not include re- search activities which are inciden- tally regulated by a Federal depart-
p.000283: ment or agency solely as part of the de- partment’s or agency’s broader respon- sibility to regulate certain types
...
p.000286: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000286: accordance with
p.000286: § 26.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000286: 26.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to
p.000286: the protection of the rights and welfare of subjects.
p.000286: (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance
p.000286: with
p.000286: § 26.117.
p.000287: 287
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287: § 26.110
p.000287: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000287: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000287: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000287: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000287: person or in writing.
p.000287: (e) An IRB shall conduct continuing
p.000287: review of research covered by this pol- icy at intervals appropriate to the de- gree of risk, but not less
p.000287: than once per year, and shall have authority to ob- serve or have a third party observe the consent process and
p.000287: the research.
p.000287: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000287: [56 FR 28012, 28022, June 18, 1991, as amended
p.000287: at 70 FR 36328, June 23, 2005]
p.000287:
p.000287: § 26.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000287: minor changes in approved re- search.
p.000287: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000287: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000287: be amended, as appropriate after consultation with other departments and agencies, through
p.000287: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000287: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000287: (b) An IRB may use the expedited re-
p.000287: view procedure to review either or both of the following:
p.000287: (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.000287: mini- mal risk,
p.000287: (2) Minor changes in previously ap- proved research during the period (of one year or less) for which
p.000287: approval is authorized.
...
p.000288: collected to en- sure the safety of subjects.
p.000288: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000288: con- fidentiality of data.
p.000288: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000288: as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally
p.000288: disadvantaged persons, additional safeguards have been in- cluded in the study to protect the
p.000288: rights and welfare of these subjects.
p.000288: § 26.112 Review by institution.
p.000288: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000288: review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the
p.000288: research if it has not been approved by an IRB.
p.000288: § 26.113 Suspension or termination of IRB approval of research.
p.000288: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
p.000288: § 26.114 Cooperative research.
p.000288: Cooperative research projects are those projects covered by this policy which involve more than one
p.000288: institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for
p.000288: safeguarding the rights and welfare of human subjects and for complying with this policy. With the
p.000288: approval of the department or agency head, an institution participating in a cooperative project may enter
p.000288: into a joint review arrangement, rely upon the review of another qualified IRB, or make similar
p.000288: arrangements for avoid- ing duplication of effort.
p.000288: § 26.115 IRB records.
p.000288: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000288: documentation of IRB activities, including the following:
p.000288: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
...
p.000290: alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment
p.000290: for benefits or services under those programs; and
p.000290: (2) The research could not prac- ticably be carried out without the waiver or alteration.
p.000290: (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the
p.000290: ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed
p.000290: consent provided the IRB finds and documents that:
p.000290: (1) The research involves no more than minimal risk to the subjects;
p.000290: (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
p.000290: (3) The research could not prac- ticably be carried out without the waiver or alteration; and
p.000290: (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after
p.000290: participa- tion.
p.000290: (e) The informed consent require- ments in this policy are not intended to preempt any applicable
p.000290: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000290: consent to be le- gally effective.
p.000290: (f) Nothing in this policy is intended to limit the authority of a physician to
p.000290:
p.000290: provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State,
p.000290: or local law.
p.000290: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000290: [56 FR 28012, 28022, June 18, 1991, as amended
p.000290: at 70 FR 36328, June 23, 2005]
p.000290:
p.000290: § 26.117 Documentation of informed consent.
p.000290: (a) Except as provided in paragraph
p.000290: (c) of this section, informed consent shall be documented by the use of a written consent form
p.000290: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000290: shall be given to the per- son signing the form.
p.000290: (b) Except as provided in paragraph
p.000290: (c) of this section, the consent form may be either of the following:
p.000290: (1) A written consent document that embodies the elements of informed consent required by § 26.116.
p.000290: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000290: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000290: before it is signed; or
...
p.000293: include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in-
p.000293: cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA
p.000293: employ- ees.
p.000293: (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to
p.000293: 40 CFR Ch. I (7–1–11 Edition)
p.000293: this subpart. The exemption at
p.000293: § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at §
p.000293: 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not
p.000293: apply to research cov- ered by this subpart, except for re- search involving observation of public
p.000293: behavior when the investigator(s) do not participate in the activities being observed.
p.000293: (c) The exceptions, additions, and
p.000293: provisions for waiver as they appear in
p.000293: § 26.101(c) through (i) are applicable to this subpart.
p.000293: § 26.402 Definitions.
p.000293: The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms
p.000293: are defined:
p.000293: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000293: Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been
p.000293: delegated by the Administrator.
p.000293: (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should
p.000293: not, ab- sent affirmative agreement, be con- strued as assent.
p.000293: (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in
p.000293: research.
p.000293: (d) Parent means a child’s biological or adoptive parent.
p.000293: (e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent
p.000293: on be- half of a child to general medical care.
p.000293: (f) Observational research means any research with human subjects that does not meet the
p.000293: definition of re- search involving intentional exposure of a human subject in § 26.202(a).
p.000293: (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000293: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000293: the performance of rou- tine physical or psychological exami- nations or tests.
p.000293: § 26.403 IRB duties.
p.000293: In addition to other responsibilities assigned to IRBs under this part, each
...
p.000295: paragraphs
p.000295: (a) and (b) of this section is covered by this subpart.
p.000295: (d) Compliance with this subpart re- quires compliance with pertinent Fed- eral laws or regulations which
p.000295: provide additional protections for human sub- jects.
p.000295: (e) This subpart does not affect any State or local laws or regulations which may otherwise be
p.000295: applicable and which provide additional protections for human subjects. Reference to State or local laws in this
p.000295: subpart is intended to include the laws of federally recog- nized American Indian and Alaska Na- tive Tribal
p.000295: Governments.
p.000295: (f) This subpart does not affect any foreign laws or regulations which may otherwise be applicable and
p.000295: which pro- vide additional protections to human subjects of research.
p.000295: (g) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000295: consider any available information relevant to de- termining the intent of a person who conducts or
p.000295: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000295: such intent existed if:
p.000295: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000295: research to EPA; or
p.000295: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000295: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000295: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000295: people, products, or ac- tivities.
p.000295: § 26.1102 Definitions.
p.000295: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection
p.000295: Agency (EPA) and any other officer or em- ployee of EPA to whom authority has been delegated.
p.000295: (b) Institution means any public or private entity or agency (including Federal, State, and other
p.000295: agencies).
p.000296: 296
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296:
p.000296: Environmental Protection Agency § 26.1107
p.000296:
p.000296:
p.000296: (c) Legally authorized representative means an individual or judicial or other body authorized under
p.000296: applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the
p.000296: procedure(s) involved in the research.
p.000296: (d) Research means a systematic in- vestigation, including research, devel- opment, testing and
p.000296: evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this
p.000296: definition constitute re- search for purposes of this subpart, whether or not they are considered
p.000296: re- search for other purposes. For example, some demonstration and service pro- grams may include research
p.000296: activities.
p.000296: (e) Human subject means a living indi- vidual about whom an investigator (whether professional or student)
p.000296: con- ducting research obtains:
p.000296: (1) Data through intervention or interaction with the individual, or
p.000296: (2) Identifiable private information.
p.000296: (3) ‘‘Intervention’’ includes both physical procedures by which data are gathered (for example,
...
p.000297: accordance with
p.000297: § 26.1116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000297: 26.1116 be given to the subjects when, in the IRB’s judg- ment, the information would meaning- fully add
p.000297: to the protection of the rights and welfare of subjects.
p.000297: (c) An IRB shall require documenta- tion of informed consent in accordance with § 26.1117.
p.000298: 298
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298:
p.000298: Environmental Protection Agency § 26.1111
p.000298:
p.000298:
p.000298: (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove
p.000298: the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research
p.000298: activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica-
p.000298: tion a statement of the reasons for its decision and give the investigator an opportunity to respond in
p.000298: person or in writing.
p.000298: (e) An IRB shall conduct continuing
p.000298: review of research covered by this sub- part at intervals appropriate to the de- gree of risk, but not less than once
p.000298: per year, and shall have authority to ob- serve or have a third party observe the consent process and the
p.000298: research.
p.000298: § 26.1110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for
p.000298: minor changes in approved re- search.
p.000298: (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of
p.000298: categories of research that may be reviewed by the IRB through an expedited review procedure. The list will
p.000298: be amended, as appropriate after consultation with other departments and agencies, through
p.000298: periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available
p.000298: from the Office for Human Research Protections, HHS, or any successor of- fice.
p.000298: (b)(1) An IRB may use the expedited
p.000298: review procedure to review either or both of the following:
p.000298: (i) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than
p.000298: mini- mal risk,
p.000298: (ii) Minor changes in previously ap- proved research during the period (of 1 year or less) for which
p.000298: approval is au- thorized.
p.000298: (2) Under an expedited review proce- dure, the review may be carried out by the IRB chairperson or by one or
p.000298: more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing
...
p.000299: required by
p.000299: § 26.1117.
p.000299: (6) When appropriate, the research plan makes adequate provision for monitoring the data
p.000299: collected to en- sure the safety of subjects.
p.000299: (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the
p.000299: con- fidentiality of data.
p.000299: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such
p.000299: as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional
p.000299: safeguards have been included in the study to protect the rights and welfare of these sub-
p.000299: jects.
p.000299: § 26.1112 Review by institution.
p.000299: Research covered by this subpart that has been approved by an IRB may be subject to further appropriate
p.000299: re- view and approval or disapproval by of- ficials of the institution. However, those officials may not
p.000299: approve the re- search if it has not been approved by an IRB.
p.000299:
p.000299: § 26.1113 Suspension or termination of IRB approval of research.
p.000299: An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in
p.000299: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
p.000299: In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional
p.000299: studies may use joint review, reliance upon the review of another qualified IRB, or
p.000299: 40 CFR Ch. I (7–1–11 Edition)
p.000299: similar arrangements aimed at avoid- ance of duplication of effort.
p.000299: § 26.1115 IRB records.
p.000299: (a) An IRB shall prepare and main- tain adequate documentation of IRB activities, including the
p.000299: following:
p.000299: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000299: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000299: reports of injuries to sub- jects.
p.000299: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000299: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000299: abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the
p.000299: discussion of controverted issues and their resolution.
...
p.000300: elements of in- formation shall also be provided to each subject:
p.000300: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to
p.000300: the embryo or fetus, if the subject may become pregnant) which are currently unfore- seeable;
p.000300: (2) Anticipated circumstances under which the subject’s participation may be terminated by the
p.000300: investigator without regard to the subject’s con- sent;
p.000300: (3) Any additional costs to the sub- ject that may result from participation in the research;
p.000300: (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination
p.000300: of participation by the subject;
p.000300: (5) A statement that significant new findings developed during the course of the research which may relate to
p.000300: the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and
p.000300: (6) The approximate number of sub- jects involved in the study.
p.000300: (c) The informed consent require- ments in this subpart are not intended to preempt any applicable
p.000300: Federal, State, or local laws which require addi- tional information to be disclosed in order for informed
p.000300: consent to be le- gally effective.
p.000300: (d) Nothing in this subpart is in- tended to limit the authority of a phy- sician to provide
p.000300: emergency medical
p.000301: 301
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: § 26.1117
p.000301: care, to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law.
p.000301: (e) If the research involves inten- tional exposure of subjects to a pes- ticide, the subjects of
p.000301: the research must be informed of the identity of the pesticide and the nature of its pes- ticidal
p.000301: function.
p.000301: § 26.1117 Documentation of informed consent.
p.000301: (a) Informed consent shall be docu- mented by the use of a written consent form approved by the IRB and
p.000301: signed by the subject or the subject’s legally authorized representative. A copy shall be given to the
p.000301: person signing the form.
p.000301: (b) The consent form may be either of the following:
p.000301: (1) A written consent document that embodies the elements of informed consent required by § 26.1116.
p.000301: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000301: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000301: before it is signed; or
...
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1201 To what does this subpart apply?
p.000302: Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject
p.000302: in- tended:
p.000302: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA
p.000302: under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal
p.000302: Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
p.000302: (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and
p.000302: Rodenticide Act (7
p.000302: U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a).
p.000302: (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may
p.000302: consider any available information relevant to de- termining the intent of a person who conducts or
p.000302: supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume
p.000302: such intent existed if:
p.000302: (1) The person or the person’s agent has submitted or made available for in- spection the results of such
p.000302: research to EPA; or
p.000302: (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under
p.000302: FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be
p.000302: relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of
p.000302: people, products, or ac- tivities.
p.000302: § 26.1202 Definitions.
p.000302: The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the
p.000302: definitions at 45 CFR 46.202(a) through (f) and at 45 CFR
p.000302:
p.000302: 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18
p.000302: years.
p.000302:
p.000302: § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support
p.000302: re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant
p.000302: woman (and therefore her fetus), a nursing woman, or a child.
p.000302: [71 FR 36175, June 23, 2006]
p.000302:
p.000302: Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human
p.000302: Research
p.000302:
p.000302: SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth-
p.000302: erwise noted.
p.000302:
p.000302: § 26.1301 To what does this subpart apply?
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000282: the Food Safety and Inspection Service of the U.S. Department of Agri- culture.
p.000282: (c) Department or agency heads re- tain final judgment as to whether a particular activity is
p.000282: covered by this policy.
p.000282: (d) Department or agency heads may require that specific research activities or classes of research
p.000282: activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not
p.000282: otherwise covered by this policy, comply with some or all of the requirements of this policy.
p.000282: (e) Compliance with this policy re- quires compliance with pertinent Fed- eral laws or regulations which
p.000282: provide additional protections for human sub- jects.
p.000282: (f) This policy does not affect any State or local laws or regulations which may otherwise be
p.000282: applicable and which provide additional protections for human subjects.
p.000282: (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and
p.000282: which pro- vide additional protections to human subjects of research.
p.000282: (h) When research covered by this policy takes place in foreign countries, procedures normally followed
p.000282: in the foreign countries to protect human subjects may differ from those set forth in this
p.000282: policy. [An example is a foreign institution which complies
p.000283: 283
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283:
p.000283: § 26.102
p.000283: with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki
p.000283: amended 1989) issued either by sovereign states or by an organization whose function for the protection of
p.000283: human research subjects is internationally recognized.] In these circumstances, if a department or
p.000283: agency head determines that the proce- dures prescribed by the institution af- ford protections that are
p.000283: at least equivalent to those provided in this policy, the department or agency head may approve
p.000283: the substitution of the foreign procedures in lieu of the proce- dural requirements provided in this
p.000283: policy. Except when otherwise required by statute, Executive Order, or the de- partment or agency head,
p.000283: notices of these actions as they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published
p.000283: as provided in department or agency procedures.
p.000283: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000283: of the provisions of this policy to specific re- search activities or classes of research activities
p.000283: otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-
p.000283: partment or agency head shall forward advance notices of these actions to the Office for Human Research
p.000283: Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office,
p.000283: and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de-
p.000283: partment or agency procedures. 1
p.000283: [56 FR 28012, 28022, June 18, 1991, 56 FR 29756,
p.000283: June 28, 1991, as amended at 70 FR 36328,
p.000283: June 23, 2005]
...
p.000304: erwise noted.
p.000304:
p.000304: § 26.1601 EPA review of proposed human research.
p.000304: (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With respect to any
p.000304: research or any class of research, the Adminis- trator may recommend additional con- ditions which, in
p.000304: the judgment of the Administrator, are necessary for the protection of human subjects.
p.000304: (b) In reviewing proposals covered by this subpart, the Administrator may take into account factors
p.000304: such as whether the applicant has been subject to a termination or suspension under
p.000304: § 26.123(a) or § 26.1123 and whether the applicant or the person or persons who would direct or has/have
p.000304: directed the scientific and technical aspects of an activity has/have, in the judgment of the Administrator,
p.000304: materially failed to
p.000305: 305
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305:
p.000305: § 26.1602
p.000305: discharge responsibility for the protec- tion of the rights and welfare of human subjects (whether or not the
p.000305: research was subject to Federal regulation).
p.000305: (c) When research covered by subpart K takes place in foreign countries, pro- cedures normally followed in the
p.000305: for- eign countries to protect human sub- jects may differ from those set forth in subpart K. (An example is a
p.000305: foreign in- stitution which complies with guide- lines consistent with the World Med- ical Assembly
p.000305: Declaration of Helsinki, issued either by sovereign states or by an organization whose function for the
p.000305: protection of human research subjects is internationally recognized.) In these circumstances, if the
p.000305: Administrator de- termines that the procedures pre- scribed by the institution afford pro- tections
p.000305: that are at least equivalent to those provided in subpart K, the Ad- ministrator may approve the substi-
p.000305: tution of the foreign procedures in lieu of the procedural requirements pro- vided in subpart K.
p.000305: (d) Following initial evaluation of
p.000305: the protocol by Agency staff, EPA shall submit the protocol and all sup- porting materials,
p.000305: together with the staff evaluation, to the Human Studies Review Board.
p.000305: (e) EPA shall notify the submitter of the proposal of the results of the EPA and Human Studies Review Board
p.000305: re- views.
p.000305: § 26.1602 EPA review of completed human research.
p.000305: (a) When considering data under FIFRA or FFDCA from research in- volving intentional exposure
p.000305: of hu- mans, EPA shall review the material submitted under § 26.1303 and other available,
p.000305: relevant information and document its conclusions regarding the scientific and ethical conduct of the re- search.
p.000305: (b) EPA shall submit its review of data from human research covered by subpart Q, together with the
p.000305: available supporting materials, to the Human Studies Review Board if EPA decides to rely on the data and:
p.000305: (1) The data are derived from re- search initiated after April 7, 2006, or
...
Orphaned Trigger Words
p.000283: Intervention includes both physical pro- cedures by which data are gathered (for
p.000284: 284
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284: Environmental Protection Agency § 26.103
p.000284:
p.000284:
p.000284: example, venipuncture) and manipula- tions of the subject or the subject’s en- vironment that are performed for
p.000284: re- search purposes. Interaction includes communication or interpersonal con- tact between investigator
p.000284: and subject. ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an
p.000284: individual can rea- sonably expect that no observation or recording is taking place, and informa- tion which has
p.000284: been provided for spe- cific purposes by an individual and which the individual can reasonably
p.000284: expect will not be made public (for ex- ample, a medical record). Private infor- mation must be individually
p.000284: identifi- able (i.e., the identity of the subject is or may readily be ascertained by the investigator or
p.000284: associated with the in- formation) in order for obtaining the information to constitute research in-
p.000284: volving human subjects.
p.000284: (g) IRB means an institutional review board established in accord with and for the purposes expressed in this
p.000284: pol- icy.
p.000284: (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and
p.000284: may be con- ducted at an institution within the constraints set forth by the IRB and by other
p.000284: institutional and Federal re- quirements.
p.000284: (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the
p.000284: research are not greater in and of themselves than those ordinarily encountered in daily life or during
p.000284: the performance of rou- tine physical or psychological exami- nations or tests.
p.000284: (j) Certification means the official no- tification by the institution to the sup- porting department or agency,
p.000284: in ac- cordance with the requirements of this policy, that a research project or activ- ity involving human
p.000284: subjects has been reviewed and approved by an IRB in ac- cordance with an approved assurance.
p.000284: § 26.103 Assuring compliance with this policy—research conducted or sup- ported by any Federal Department or
p.000284: Agency.
p.000284: (a) Each institution engaged in re- search which is covered by this policy and which is conducted or
p.000284: supported by a Federal department or agency shall
p.000284:
p.000284: provide written assurance satisfactory to the department or agency head that it will comply with the
p.000284: requirements set forth in this policy. In lieu of re- quiring submission of an assurance, in- dividual
p.000284: department or agency heads shall accept the existence of a current assurance, appropriate for the research in
p.000284: question, on file with the Office for Human Research Protections, HHS, or any successor office, and
p.000284: approved for federalwide use by that office. When the existence of an HHS-approved as- surance is
p.000284: accepted in lieu of requiring submission of an assurance, reports (except certification) required by this
p.000284: policy to be made to department and agency heads shall also be made to the Office for Human Research
p.000284: Protec- tions, HHS, or any successor office.
p.000284: (b) Departments and agencies will conduct or support research covered by this policy only if the
p.000284: institution has an assurance approved as provided in this section, and only if the institution has certified
p.000284: to the department or agency head that the research has been reviewed and approved by an IRB pro- vided for
p.000284: in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to
p.000284: federally supported or conducted research shall at a minimum include:
p.000284: (1) A statement of principles gov- erning the institution in the discharge of its responsibilities for
p.000284: protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution,
p.000284: regardless of whether the research is subject to Federal regu- lation. This may include an appro- priate
p.000284: existing code, declaration, or statement of ethical principles, or a statement formulated by the
p.000284: institu- tion itself. This requirement does not preempt provisions of this policy appli- cable to department-
p.000284: or agency-sup- ported or regulated research and need not be applicable to any research ex- empted or
p.000284: waived under § 26.101 (b) or (i).
p.000284: (2) Designation of one or more IRBs established in accordance with the re- quirements of this
p.000284: policy, and for which provisions are made for meeting space and sufficient staff to support the
p.000284: IRB’s review and recordkeeping duties.
p.000285: 285
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285: § 26.103
p.000285: (3) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of
p.000285: experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief
p.000285: anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each
p.000285: member and the institution; for example: full-time employee, part-time employee, member of governing panel or
p.000285: board, stockholder, paid or unpaid consultant. Changes in IRB member- ship shall be reported to the
p.000285: depart- ment or agency head, unless in accord with § 26.103(a) of this policy, the exist- ence of an
p.000285: HHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the
p.000285: Office for Human Research Protec- tions, HHS, or any successor office.
p.000285: (4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research
p.000285: and for reporting its findings and actions to the investigator and the institution;
p.000285: (ii) for determining which projects re- quire review more often than annually and which projects need
p.000285: verification from sources other than the investiga- tors that no material changes have oc- curred since
p.000285: previous IRB review; and
p.000285: (iii) for ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for
p.000285: ensuring that such changes in approved research, during the period for which IRB ap- proval has
p.000285: already been given, may not be initiated without IRB review and approval except when necessary to
p.000285: eliminate apparent immediate hazards to the subject.
...
p.000288: accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm
p.000288: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000288: IRB’s action and shall be reported promptly to the investigator,
p.000288:
p.000288: appropriate institutional officials, and the department or agency head.
p.000288: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000288: [56 FR 28012, 28022, June 18, 1991, as amended
p.000288: at 70 FR 36328, June 23, 2005]
p.000288: § 26.114 Cooperative research.
p.000288: Cooperative research projects are those projects covered by this policy which involve more than one
p.000288: institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for
p.000288: safeguarding the rights and welfare of human subjects and for complying with this policy. With the
p.000288: approval of the department or agency head, an institution participating in a cooperative project may enter
p.000288: into a joint review arrangement, rely upon the review of another qualified IRB, or make similar
p.000288: arrangements for avoid- ing duplication of effort.
p.000288: § 26.115 IRB records.
p.000288: (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate
p.000288: documentation of IRB activities, including the following:
p.000288: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000288: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000288: reports of injuries to sub- jects.
p.000288: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000288: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000288: abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the
p.000288: discussion of controverted issues and their resolution.
p.000288: (3) Records of continuing review ac- tivities.
p.000288: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000288: (5) A list of IRB members in the same detail as described is § 26.103(b)(3).
p.000288: (6) Written procedures for the IRB in the same detail as described in
p.000288: § 26.103(b)(4) and § 26.103(b)(5).
p.000288: (7) Statements of significant new findings provided to subjects, as re- quired by § 26.116(b)(5).
p.000289: 289
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289:
p.000289: § 26.116
p.000289: (b) The records required by this pol- icy shall be retained for at least 3 years, and records
p.000289: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000289: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the
p.000289: depart- ment or agency at reasonable times and in a reasonable manner.
p.000289: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000289: [56 FR 28012, 28022, June 18, 1991, as amended
p.000289: at 70 FR 36328, June 23, 2005]
p.000289:
...
p.000290: approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy
p.000290: shall be given to the per- son signing the form.
p.000290: (b) Except as provided in paragraph
p.000290: (c) of this section, the consent form may be either of the following:
p.000290: (1) A written consent document that embodies the elements of informed consent required by § 26.116.
p.000290: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000290: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000290: before it is signed; or
p.000290: (2) A short form written consent doc- ument stating that the elements of in- formed consent required by
p.000290: § 26.116 have been presented orally to the sub- ject or the subject’s legally authorized representative.
p.000290: When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall
p.000290: approve a written summary of what is to be said to the subject or the rep- resentative. Only the short
p.000290: form itself is to be signed by the subject or the representative. However, the witness shall sign
p.000290: both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy
p.000290: of the summary. A copy of the summary shall be given to the subject or the representative, in addition
p.000290: to a copy of the short form.
p.000290: (c) An IRB may waive the require- ment for the investigator to obtain a signed consent form for
p.000290: some or all subjects if it finds either:
p.000290: (1) That the only record linking the subject and the research would be the consent document and the
p.000290: principal risk would be potential harm resulting
p.000291: 291
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291:
p.000291: § 26.118
p.000291: from a breach of confidentiality. Each subject will be asked whether the sub- ject wants documentation
p.000291: linking the subject with the research, and the sub- ject’s wishes will govern; or
p.000291: (2) That the research presents no more than minimal risk of harm to subjects and involves no
p.000291: procedures for which written consent is normally re- quired outside of the research context.
p.000291: In cases in which the documentation requirement is waived, the IRB may re- quire the investigator to provide
p.000291: sub- jects with a written statement regard- ing the research.
p.000291: (Approved by the Office of Management and Budget under Control Number 0990–0260)
p.000291: [56 FR 28012, 28022, June 18, 1991, as amended
p.000291: at 70 FR 36328, June 23, 2005]
p.000291:
p.000291: § 26.118 Applications and proposals lacking definite plans for involve- ment of human subjects.
p.000291: Certain types of applications for grants, cooperative agreements, or con- tracts are submitted to
p.000291: departments or agencies with the knowledge that sub- jects may be involved within the period of support, but
p.000291: definite plans would not normally be set forth in the applica- tion or proposal. These include activi- ties
p.000291: such as institutional type grants when selection of specific projects is the institution’s
p.000291: responsibility; re- search training grants in which the ac- tivities involving subjects remain to be selected; and
p.000291: projects in which human subjects’ involvement will depend upon completion of instruments, prior ani- mal
p.000291: studies, or purification of com- pounds. These applications need not be reviewed by an IRB before an
p.000291: award may be made. However, except for re- search exempted or waived under
p.000291: § 26.101 (b) or (i), no human subjects may be involved in any project sup- ported by these
p.000291: awards until the project has been reviewed and approved by the IRB, as provided in this policy, and
p.000291: certification submitted, by the in- stitution, to the department or agency.
...
p.000297: (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any
p.000297: project in which the member has a conflicting interest, except to provide information re- quested by
p.000297: the IRB.
p.000297: (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist
p.000297: in the review of issues which require expertise beyond or in addition to that available on the IRB.
p.000297: These individuals may not vote with the IRB.
p.000297:
p.000297: § 26.1108 IRB functions and oper- ations.
p.000297: In order to fulfill the requirements of this subpart each IRB shall:
p.000297: (a) Follow written procedures:
p.000297: (1) For conducting its initial and con- tinuing review of research and for re- porting its findings and
p.000297: actions to the investigator and the institution;
p.000297: (2) For determining which projects require review more often than annu- ally and which
p.000297: projects need verification from sources other than the investigator that no material changes
p.000297: have occurred since previous IRB review;
p.000297: 40 CFR Ch. I (7–1–11 Edition)
p.000297: (3) For ensuring prompt reporting to the IRB of proposed changes in re- search activity; and
p.000297: (4) For ensuring that changes in ap- proved research, during the period for which IRB approval has
p.000297: already been given, may not be initiated without IRB review and approval except where necessary to
p.000297: eliminate apparent imme- diate hazards to the human subjects.
p.000297: (b) Follow written procedures for en- suring prompt reporting to the IRB, appropriate institutional
p.000297: officials, and the Environmental Protection Agency of:
p.000297: (1) Any unanticipated problems in- volving risks to human subjects or oth- ers;
p.000297: (2) Any instance of serious or con- tinuing noncompliance with this sub- part of the requirements or
p.000297: determina- tions of the IRB; or
p.000297: (3) Any suspension or termination of IRB approval.
p.000297: (c) Except when an expedited review procedure is used (see § 26.1110), review proposed research at
p.000297: convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least
p.000297: one member whose primary concerns are in nonscientific areas. In order for the research to be
p.000297: approved, it shall receive the approval of a ma- jority of those members present at the meeting.
p.000297: § 26.1109 IRB review of research.
p.000297: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000297: approval), or dis- approve all research activities covered by this subpart.
p.000297: (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in
p.000297: accordance with
p.000297: § 26.1116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in §
p.000297: 26.1116 be given to the subjects when, in the IRB’s judg- ment, the information would meaning- fully add
p.000297: to the protection of the rights and welfare of subjects.
p.000297: (c) An IRB shall require documenta- tion of informed consent in accordance with § 26.1117.
p.000298: 298
p.000298:
p.000298:
p.000298:
...
p.000299: to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the
p.000299: IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and
p.000299: the Administrator of EPA.
p.000299: § 26.1114 Cooperative research.
p.000299: In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional
p.000299: studies may use joint review, reliance upon the review of another qualified IRB, or
p.000299: 40 CFR Ch. I (7–1–11 Edition)
p.000299: similar arrangements aimed at avoid- ance of duplication of effort.
p.000299: § 26.1115 IRB records.
p.000299: (a) An IRB shall prepare and main- tain adequate documentation of IRB activities, including the
p.000299: following:
p.000299: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the
p.000299: proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and
p.000299: reports of injuries to sub- jects.
p.000299: (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings;
p.000299: actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and
p.000299: abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the
p.000299: discussion of controverted issues and their resolution.
p.000299: (3) Records of continuing review ac- tivities.
p.000299: (4) Copies of all correspondence be- tween the IRB and the investigators.
p.000299: (5) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of
p.000299: experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief
p.000299: anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each
p.000299: member and the institution, for example, full-time employee, a member of governing panel or board,
p.000299: stock- holder, paid or unpaid consultant.
p.000299: (6) Written procedures for the IRB in the same detail as described in
p.000299: § 26.1108(a) and § 26.1108(b).
p.000299: (7) Statements of significant new findings provided to subjects, as re- quired by § 26.1116(b)(5).
p.000299: (b) The records required by this sub- part shall be retained for at least 3 years, and records
p.000299: relating to research which is conducted shall be retained for at least 3 years after completion of the
p.000299: research. All records shall be acces- sible for inspection and copying by au- thorized representatives of EPA at
p.000299: rea- sonable times and in a reasonable man- ner.
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300:
p.000300: Environmental Protection Agency § 26.1116
p.000300:
p.000300:
p.000300: § 26.1116 General requirements for in- formed consent.
p.000300: No investigator may involve a human being as a subject in research covered by this subpart unless the
p.000300: investigator has obtained the legally effective in- formed consent of the subject or the subject’s legally
...
p.000301: (a) Informed consent shall be docu- mented by the use of a written consent form approved by the IRB and
p.000301: signed by the subject or the subject’s legally authorized representative. A copy shall be given to the
p.000301: person signing the form.
p.000301: (b) The consent form may be either of the following:
p.000301: (1) A written consent document that embodies the elements of informed consent required by § 26.1116.
p.000301: This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any
p.000301: event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it
p.000301: before it is signed; or
p.000301: (2) A short form written consent doc- ument stating that the elements of in- formed consent required by §
p.000301: 26.1116 have been presented orally to the sub- ject or the subject’s legally authorized representative.
p.000301: When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall
p.000301: approve a written summary of what is to be said to the subject or the rep- resentative. Only the short
p.000301: form itself is to be signed by the subject or the representative. However, the witness shall sign
p.000301: both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy
p.000301: of the summary. A copy of the summary shall be given to the subject or the representative, in addition
p.000301: to a copy of the short form.
p.000301: §§ 26.1118–26.1122 [Reserved]
p.000301: § 26.1123 Early termination of re- search.
p.000301: The Administrator may require that any project covered by this subpart be
p.000301: 40 CFR Ch. I (7–1–11 Edition)
p.000301: terminated or suspended when the Ad- ministrator finds that an IRB, investi- gator, sponsor, or institution
p.000301: has mate- rially failed to comply with the terms of this subpart.
p.000301: § 26.1124 [Reserved]
p.000301: § 26.1125 Prior submission of proposed human research for EPA review.
p.000301: Any person or institution who in- tends to conduct or sponsor human re- search covered by §
p.000301: 26.1101(a) shall, after receiving approval from all appro- priate IRBs, submit to EPA prior to initiating
p.000301: such research all informa- tion relevant to the proposed research specified by § 26.1115(a), and the
p.000301: fol- lowing additional information, to the extent not already included:
p.000301: (a) A discussion of:
p.000301: (1) The potential risks to human sub- jects;
p.000301: (2) The measures proposed to mini- mize risks to the human subjects;
p.000301: (3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue;
p.000301: (4) Alternative means of obtaining in- formation comparable to what would be collected through the proposed
p.000301: re- search; and
p.000301: (5) The balance of risks and benefits of the proposed research.
p.000301: (b) All information for subjects and written informed consent agreements as originally provided to the
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 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 |
| fetuses | 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 |
| substance | Drug Usage |
| threat | Threat of Stigma |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disabled | ['mentally'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| influence | ['drug', 'substance'] |
| mentally | ['disabled'] |
| parent | ['parents'] |
| parents | ['parent'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
harm
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input