fy involved, the appropriateness of the « proposed initial and continuing review procedures in light of the probable risks, and the size and complexity of the institution. (ce) On the basis of this evaluation, the Secretary may approve or disapprove the assurance, ar enter inl Negotiations to develop an approvable one. The Secretary may, limit the period during which any particular approved assurance or class af approved assurances shall remain effective or otherwise condition or restrict approval. ; (f) Within 60 days after the date of submission to HHS of an application or proposal, an institution with an approved assurance covering the ptoposed research shall certify that the application or proposal has been reviewed and approved by the IRB. Cxher institutions shall certiy that the application or proposal has been upproved by the IRB withia 30 days after receipt of a request for such a verification from the Department. If the certification is not submitted within these time limits, the application or proposal may be returned to the institution. § 46.104 § 46,105 [Reserved] [Reserved] $ 46.106 [Reserved] $ 46.107 IRB membership. (a) Each ERB shall have at least five members, with varying backgrounds to promete complete and adequate review of research activities commonly conducted by the masuituuion. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members’ backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attiudes, to promote respect for its advice and counsel tn satepuarding the rights and welfare of human subjects. In addition to a eceateaeetaatoedademantacaent 45 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 ae lleecrone span aaneeener nirvana one rene amt Aenndraceae 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 persans knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, including but not limited to subjects covered by other subparts of this part, the IRE shall include one or more individuals who are primarily concerned with the welfare of these subjects. (b) No IRB nvay consist entircly of men or entirely of women, or entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in nonscientific areas; for exampie: lawyers, ethicists, members of the clergy. (d) Each IRE shall include at least one member whe is not otherwise affiliated with the institution and who is not part of the immediate family of a person who ts affiliated with the institution, (e) No IRB may have a member participating in the (RB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB, (f) An IRB may, in its discretion, invite individuals with competence in special areas to ussist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote wilh the IRB, $ 46.108 operations, In order to fulfill the requirements oF these regulations each IRB shail: (a) Follow written procedures as provided in § 46. 103(b)(4). TRB functions and rome A a mm ws mt Rn ert Ren dU rout NEA 9 geo ARN TER» ot KA Rd TT NR (b) Except when an expedited review procedure is used (see § 46.110), review proposed research at convened meetings at which a niajority of the members of the IRE 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, {c) Be responsible for reporting to the appropriate institutional officials and the Secretary! any serious or continuing noncompliance by investigators with the requirements and determinations of the IRB. § 46.199 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations. (bo) An IRB shall require that information given to subjects as part” of informed consent is in accordance with § 46.116. The IRB may require that information, in addition to that specifically mentioned in § 46.116, 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, {¢) An IRB shail require documentation of informed consent or may waive documentation in accordance with § 46.117. {d) An IRB shall notify ; investigators and the institution in + writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, if shall include in its written notification ' Reports should he tiled woth the Office for Protection from Research Risks, National Insintutes of Health, Department of Health and Human Services, Bethesda, Maryland 20205. 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"PegApproved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 AIA ALP AMEE NCTE MORSE MOP SEES SEE A Me NA A “de neces EY PMA Pyne ROR en a statement of the reasons for its - decigion and give the investigator an opportuaitly to respond in person or in writing. (c) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but nos less than once per year, and shall have authority to observe or have a third parity observe the consent process and the research. {46.110 Expedited review procedures for certain kinds of research Involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary has established, and published in the Federal Negister, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, through periodic republication in the Federal Register. (6) An IRB may review some or all ot the research appearing on the list through an expedited review procedure, if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Under an expedited review procedure, the review may be curried out by the IRB chairperson or by une or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in § 46. 108¢b). (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research eI amie CN a Ra proposals which have been approved under the procedure. (d) The Secretary may restrict, suspend, or terminate an institution's or IRB‘s wse of the expedited review procedure when necessary to protect the rights or welfare of subjects. §46.111 Criteria for IRB approval of research. (a} In order to approve research covered by these regulations the IRB shall determine that ail of the following requirements are satisfied: (i) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (i) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to sublects, and the importance of the knowledge that may reasonably be expected to result. In evaluating sisks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapics 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. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by § 46.116. PRE NTL “a ork nian RP a RP Eg: BAe Re cakes Ae ibe Hibtaibe ed atleast 0 sada; ROAR tas BU PAN as A et 45 CFR 46 (3) informed consent ¥ will be appropriately documented, in accordance with, and to the extent required by § 46.117. 6 (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects. (7) Where appropriate, there age adequate provisioas to protect the privacy of subjects ‘and to maintain the confidentiality of data. (b) Where some or all of the subjects are likely to be vulnerable to coercion or unduc influence, such as persons with acule or severe physical er mental tliness, or persons who are economically or educationally . disadvantaged, appropriate additional: safeguards have been included: in the study to protect the rights and welfare of these subjects. § 46.412 Review by institetion. Research covered by these regulations that has been approved by an IRD may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials g may not approve the research if it has rot been approved by an IRB. § 46.113 Suspension or termination of ERB approval of research, An IRB shall have authority. to} suspend or terminate approval of * research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the ARB 's action and shall -be reported’ promptly to the investigator, appropriate institutional officials, and the Secretary. ! ‘ Reports should be filed with the Office for Protection from Research Risks, National lnastituses of Health, Deparment of Health and Human Services, Bethesda, Maryland 20205. ¢ Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
45 5 Ab Ptoved For F For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 $ 46.114 Cooperative research. Cooperative research projects are those projects, nonnally supported through grants, contracts, or similar arrangements, which involve institutions in addition to the grantee or prime contractor (such as a gomractor with the grantee, or a subcontractor with the prime contractor). In such instances, the grantee or prime contractor remains responsible to the Department for safeguarding the rights and welfare of human subjects. Also, when cooperating institutions conduct some or all of the research involving some or all of these subjects, each cooperating institution shall comply with these regulations as though it received funds for its participation in the project directly from the Department, except that in complying with these regulations institu¢ions may use joint review, reliance upon the review of another qualified IRB, or similar arrangements armed at avoidance of duplication of effort. {40.115 IRB records.” (a) An institudion, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRE activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects, (2) Minutes of IRB meetings which shail be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of mentbers voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution, (3) Records of continuing review acuvites. SPE A RT TRG Me EE UR ST RE SE SR IR ESR ED SEE I ee (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members as required by § 46. 103(b)(3). (6) Writlen procedures for the IRB as requiced by § 46.103(b)(4). (7) Statements of significant new findings provided to subjects, as required by § 46.116(b)(5). (b) The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Department at reasonable times and in a reasonable manner. $ 46.116 General requirements for informed consent. Except as provided elsewhere in this or other subparts, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative, An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participaie and that minimize the possibility of coercion or unduc influence. The information that is given to the subject or the representative shal] be in language understandable to the, subject or the represemtative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made ta waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents trom liability for negligence. (a) Basic elements of informed . consent. Except as provided in paragraph (c) or (a) of this section, in Page 9 cr ERA eI Pre secking informed consent the following information shall be provided to each subject: “I CE) A statement that the study involves research, an explanation of the purposes of the research and the | expected duration of the subject's : participation, a description of the ® procedures to be followed, and 4 identification of any procedures « which are experimental; H (2) A description of any reasonably , foreseeable risks or discomforts to the 4 subject; ~ (3) A description of any benefits to : the subject or to others which may « reasonably be expected from the Aresearch: i (4) A disclosure of appropriate ‘alternative procedures or courses of “treatment, if any, that might be advantageous (o the subject; (5) A statement describing the ‘extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as _ to whether any compensation and an UV . explanation as to whether any medical treatments are available if injury Occurs and, if so, what they " consist of, of where further information nmiay be obtained; (7) An explanation of whom to contact for answers to pertinent . questions about the research and esearch subjects’ rights, and whom to contact in the event of a research- related injury to the subject; and (8) A staternent that participation is voluntary, refusal to participate will involve no penalty or loss of benefits .to which the subject is otherwise entitled, and the subject may j discontinue participation at any time without penalty or loss of benefits to -which the subject is otherwise “entitled. “(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to cach subject: Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
a > (CD A statement that the particular 2 treatment or procedure may involve a Lyisks to the subject (or to the embryo for fetus, if the subject is or may Ebecore pregnant) which are currently zunforeseeable; => (2) Amicipated circumstances a under which the subject's : participation may be terminated by z.the investigator without regard to the Asubject's consent, 4 (3) Any additional costs to the wsubject that may result from ‘participation in the research: , (4) The consequences of a «subject's decision to withdraw from gthe research and procedures for jorderly termination of participation Phy the subject; h (5) A statement that significant 4 new findings developed during the j course of the research which may #relate to the subject's willingness to jeontinuc participation will be 4 provided to the subject; and # (6) The approximate number of ~gubjects involved in the study. ic) An IRB may. APRLOVS &.comient pmeedure ¥  docs.nouinelude: or which valterg isome or alhaf. the oles menta of informed consent set forch above, or waive the requirement to ubtain informed consent provided the IRB finds and documents that: (1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) programs under the Social Security Act, or other public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs, and (2) The research could not practicably be carried out without the waiver or alteration. (d) Aa IRB roay approve “a consent procedure which does not includes, or PEE eet ol BARR ST Ba FP a aS PS Se a which alters, some or all of the elements of informed consent set forth above; or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1) The research involves no more than minimal risk to the subjects, (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects, (3) The research could not practicably be carried out without the waiver or alteration, and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e} The informed consent requirements in these regulations 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. (f} Nothing in these regulations 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, 846.117 Documentation of : informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. (b} Except as provided in paragraph (c) of this section, the consent form may be either of the follawine: (1) A written consent document that embodies the elements of . informed consent required by 446.116. This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator shall give either the subject or the representative RRS SRR 5 EES SATA PR ve onda ene adie acl be Scamlabeae 1 RRC EER EY 34721 SBT A SIRE HNO rgifproved For Release Z0n00808 cia-Roese-an7anRanasoa1sn0an.s_*S 7" adequate opportunity to read it before it is sipned; or (2) A “short form’ written 7 consent document stating that the ) elements of informed consent required by § 46.116 have beer presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Caly the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the «immary, and the person actually obuaning consent shail sign a copy of the summary. A copy of the sununary shall be given to the subject or the representative, in addition to a copy of the “short form." (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the | consent document and the principal risk would be potential harm resulting from a breach of confidentiality, Each subject will be asked whether the subject wants documeniation linking the subject with the research, and the subject's wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent ts normally required outside of the research context. la cases where the documentation requirement 1s waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. § 46.118 Applications and proposals jacking definite plans for involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts are submitted to the Department with the knowledge that subjects may be involved within the € Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9