Source: http://ecfr.io/Title-40/pt40.1.26
Timestamp: 2018-10-18 17:56:02
Document Index: 572551872

Matched Legal Cases: ['art 26', 'art 26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26', '§26']

[40 CFR 26] Title 40 Part 26 : Code of Federal Regulations ';
Title 40 Part 26
§26.105 [Reserved]
§26.106 [Reserved]
(b) The exemptions at §26.101(b)(1) through (b)(6) are applicable to this subpart.
(c) The provisions of §26.101(c) through (i) are applicable to this subpart. References to State or local laws in this subpart and in §26.101(f) are intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.
(a) This subpart applies to all observational research involving children as subjects, conducted or supported by EPA. References to State or local laws in this subpart and in §26.101(f) are intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments. This includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees.
(b) Exemptions at §26.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at §26.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §26.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.
(g) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the observational research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the observational research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with §26.116(d).
(e) Compliance with this subpart requires compliance with pertinent Federal laws or regulations which provide additional protections for human subjects.
(f) This subpart does not affect any State or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. Reference to State or local laws in this subpart is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.
(g) This subpart does not affect any foreign laws or regulations which may otherwise be applicable and which provide additional protections to human subjects of research.
[71 FR 6168, Feb. 6, 2006, as amended at 78 FR 10543, Feb. 14, 2013]
(d) Research means a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this subpart, whether or not they are considered research for other purposes. For example, some demonstration and service programs may include research activities.
(e) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
(3) “Intervention” includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
(i) Research involving intentional exposure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject's participation in the study.
(j) Person means any person, as that term is defined in FIFRA section 2(s) (7 U.S.C. 136), except:
(2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of this section.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities which are presented for its approval. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as prisoners or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
In order to fulfill the requirements of this subpart each IRB shall:
(1) For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
(2) For determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
(3) For ensuring prompt reporting to the IRB of proposed changes in research activity; and
(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Environmental Protection Agency of:
(2) Any instance of serious or continuing noncompliance with this subpart of the requirements or determinations of the IRB; or
(c) Except when an expedited review procedure is used (see §26.1110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §26.1116. The IRB may require that information, in addition to that specifically mentioned in §26.1116 be given to the subjects when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.
(e) An IRB shall conduct continuing review of research covered by this subpart at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(b)(1) An IRB may use the expedited review procedure to review either or both of the following:
(i) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
(ii) Minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized.
(d) The Administrator may restrict, suspend, or terminate, an institution's or IRB's use of the expedited review procedure for research covered by this subpart.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §26.1117.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as prisoners, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
(a) An IRB shall prepare and maintain adequate documentation of IRB activities, including the following:
(5) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, a member of governing panel or board, stockholder, paid or unpaid consultant.
(6) Written procedures for the IRB in the same detail as described in §26.1108(a) and §26.1108(b).
(7) Statements of significant new findings provided to subjects, as required by §26.1116(b)(5).
(b) The records required by this subpart shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of EPA at reasonable times and in a reasonable manner.
(a) Basic elements of informed consent. In seeking informed consent the following information shall be provided to each subject:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject may become pregnant) which are currently unforeseeable;
(c) The informed consent requirements in this subpart are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
(d) Nothing in this subpart is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law.
(e) If the research involves intentional exposure of subjects to a pesticide, the subjects of the research must be informed of the identity of the pesticide and the nature of its pesticidal function.
(1) A written consent document that embodies the elements of informed consent required by §26.1116. This form may be read to the subject, but in any event, the investigator must give the subject adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by §26.1116 have been presented orally to the subject. When this method is used, there must be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject. Only the short form itself is to be signed by the subject. However, the witness must sign both the short form and a copy of the summary, and the person actually obtaining consent must sign a copy of the summary. A copy of the summary must be given to the subject, in addition to a copy of the short form.
[78 FR 10543, Feb. 14, 2013]
The definitions in §26.102 apply to this subpart as well.