a 1 a statement of the reason: for its decunon and pive the investipetor ar apporurlty to respond if writing. fey An IRB shall conduct conGnuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have aulbority iv Obscive or have a third party observe the consent process and the research. Person oF th §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 Register, & list of categories of research that may be reviewed by the IRB through an expedited review procedure, The list will be amended, a appropriate, through periodic republication in the Federal Register. (b) An IRB may review some or all of the research appearing on the list through an expedited review procedure, if the research involves 1 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 carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from arnong 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 tesearch 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 proposals which have been approved under the procedure (d) The Secretary aay restuet, suspend, of terminate an inshitution’s or IRB’s use of the expediicd review procedure when necessary to protect the rights or wellare of subjects. $46.91! Criteris for IRB approval of research. (a) In order to approve research covered by these regulations the IRB shail determine that all of the following requirements are satisfied: (f) 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 (ti) 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 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 of therapies 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. . Pege8 aj - CIA-RDP96-00789R003000020002-5 45 CFR 46 (5) informed consent will be enpropristel v “documented. in cordance with, and to the extent required by § 46.117, (6) Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects. (7) Where appropriate, there arc auequale provisions 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 ta coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally ; disadvantaged. appropriate additionsl. safeguards have been included in the study to protect the rights and welfare of these subjects. § 46.112 Review by institution. Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials ¢ may not approve the research if it has not been approved by an IRB. § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority. 104 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 Institutes of Health, Deparment of Health and Human Services, Bethesda, Maryland 202¢s. Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
iB abi Nett TC Daag tA gen RAEN EP ws “EE MUM = «8 T £ 46.114 Cooperative research. ; Cooperative research projects are hose piayects, nannaily supgoned through grants, contracts, or similar arrangements, which involve institutions in addition to the grantee or prime contractor (such as a coniractor with the grantee, or a subcontractor with the prime camractor? in such instances, ue 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 institutions May use joint review, reliance upon the review of another qualified IRB, OF Sifiiter arrangements aimed at avoidance of duplication of effort. $ 46.115 IRB records.” (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB 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 shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members 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 activities, a8 CFR 46" ny | elease 2003/09/10 : CIA-RDP96-00789R003000020002-5 (4) Copres of all correspandence hetween the FPR and the INVESTIEGLOES | (5) A hist of IRB members as required by § $0. 103(ba(3). (6) Written procedures for the IRB as required 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 STINET The tegally effective” ubjecl's legally authorizear’ SEMETMMative. 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 Participate and that minimize the Possibility of coercion or unduc influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or. writen, may include any exculpatory language through which the subject or the representative is made to 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 from liability for negligence. (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in Page 9 rr stching informed consent the _, Provided to each subject: "PA statement that the study invelves rescanfi, an caplanation of the purposes of the research and the expected duration of the subject's Participation, a description of the Procedures to be followed, and x identification of any procedures «which are experimental: i) QF A description of any reasonably | foreseeable risks or discomforts to the 4 subject: | @® A description of any benefits to 3 the subject or to others which may creasonably be expected from the research; + @4A disclosure of appropriate t alternative procedures or courses of treatment, if any, that might be ; advantageous to the subject: GST A statement describing the ‘extent, if any, to which confidentiality of records identifying the subject will be maintained; + GB For research involving more than minimal risk, an explanation as , to whether any compensation and an , explanation as to whether any medical treatments are available if _ Injury occurs and, if so, what they " consist of, or where further infogpation nay be obtained: Ap) An explanation of whom to contact for answers to pertinent ; questions about the research and \fesearch subjects’ rights, and whom to contact in the event of a research- related injury to the Subject; and . A statement 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 each subject: Me oats ’ at Vf v Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
Asta vio: at in! Aa “Trees, some cr all of the fin orrred consent pe! , or waive the aicnts to obtain informed provided the IRB linds and “opts that: ihe research involves no more iaimimal risk to the subjects; The wartver or alteration will versely affeet the rights and : ac oi the subjects, mOYE w+ The research could not i «ably be carried out without the r vi OF alleration, and “”. Whenever appropriate, the <'% will be provided with +. sii pertinent information after ai <ipation, ae ‘The informed consent ‘: - srements in these regulations are - ontended to preempt any “cable federal, state, or local laws Mon require additional information «*  diiclosed in order for informed “sit to be legally effective. Nothing in these regulations is ded to limit the authority of a wt clu to provide emergency hy “cal Gare, to the extent the tur’! sician is permitted to do so under ply? cable federal, state, or local law. ‘6.417 Documentation of : ‘ 4 smed consent. ti, .) Except as provided in ” graph (c) of this section, her smed consent shall be (w!mented by the use of a written be ent form approved by the IRB pale sapned by the subject or the _<ct’s legally authorized e iopemtative. E wis hi Except a as provided in graph (c) of this section, the emt form may be either of the swing: {} A written consent document (/ embudies the elements of . jiped consent required by te 116. This form may be read to : ubject or the subject's legally janved representative, but in any . the investigator shall give . «the subject or the representative pare ae aH Tystl- tag! wh sad or Release 2003/09/10 : CIA-RDP96- 00789R003000020002-5 adequate opportunity to read it before if is cipned: or (2) AL 'shon form’* written 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. Only 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 «:mmary, and the person actually obuuning consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the ‘‘short src OE AE esac Tor oF the” investigator¥o (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 documentation linking the subject with the research, and the subject's wishes will govern; or requirement is waived, the [RB require the investigator to provide subjects with a written statement regarding the research. may § 46.118 Applications and proposals lacking 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 2003/09/10 : CIA-RDP96-00789R003000020002-5 45 CFR 46 a AE AAS ht €
_ cASCPR 46 poproved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 => Approved For Release 2003/09/10 : Cl re ‘oe Piss af funding, but definite plans tebe se ermally be set forth te che sPrliauon or proposal. These include activities such as institutional (ype yients (including bloc grants) where selection of specific projects is thy insutution’s responsibility; research training grants where the activities involving subjects remain to be sclected, and projects in which human subjects’ involvement will depend upon completion of instruments, prior animal Studics, or Purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for reseaich described in § 46.101(b), no human subjects may be tnvolved in any Project supported by these awards until the project has been reviewed and approved by the IRB, as provided in these regulations, and certification subrnitted to the Department. §$ 46.119 Research undertaken without the intention of involving human subjects. In the event research (conducted ur funded by the Department) is undertaken without the intention of involving human subjects, but it is later proposed to use human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in these regulations, a certification submitted to the Department, and final approval given to the proposed change by the Department. § 46.120 Evaluation and disposition of applications and proposals, (a) The Secretary will evaluate all applications and proposals involving human subjects submitted to the Department through such officers and employees of the Department and such experts and consultants as the Secretary determines to be appropriate. This evaluation will take into consideration the risks to the Subjects, the adequacy of protection agaist these risks, the potential benetity of the proposed research to the subjects and others, and the IMiperianc. a: the bnowiedpe ta by gained. (b) On the basis of this evaluation, the Secretary may approve or disapprove the application or Proposal, or enter into negotiations to develop an approvable one. $ 46.121 Investigational new drug or device 30-day delay requirement. When an institution is required to prepare or to submit a certification with an application or proposal under these regulations, and the application of proposal involves an investigational new drug (within the meaning of 21 U.S.C. 355(i) or 357(d)) or a significant risk device (as defined in 21 CFR 812.3(m)), the institution shall identify the drug or device in the certification. The institution shall also state whether the 30-day interval required for investigational new drugs by 21 CFR 312, 1(a) and for significant risk devices by 21 CFR 812.30 has elapsed, or whether the Food and Drug Administration has waived that requirement. {f the 30-day interval has expired, the institution shall State whether the Food and Drug Administration has requested that the Sponsor ‘continue to withhold or restrict the use of the drug or device in human subjects. If the 30-day interval has not expired, and a waiver has not been received, the institution shall send a statement to the Department upon expiration of the interval. The Department will not consider a certification acceptable until the institution has submitted a Statement that the 30-day interval has elapsed, and the Food and Drug Administration has not requested it to limit the use of the drug or device, or that the Food and Drug Administration has waived the 30-day interval, -. §$ 46.122 Use of Federal funds. Federal funds administered by the Department may not be expended for research involving human subjects unless the requirement of these é Page 11 Feeccauons, including sll «ut parte nf (hess repulations, heve been salisticd, § 46.123 Early termination of reseurch funding; evaluation of subsequent applications and propasals, (a) The Secretary may require that Department funding: for any project be terminated or suspended in the manner prescribed in applicable Program requirements, when the Secretary finds an institution has materially failed to comply with the terms of these regulations. (b) In making decisions about funding applications or proposals cavered by these regulations the Secretary may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or Suspension under paragraph (a) of this Section and whether the applicant or the person who would direct the scientific and technical aspects of an activity has in the judgment of the Secretary materially failed to discharge responsibility for the Protection of the rights and welfare of human subjects (whether or not Department funds were involved). § 46.124 Conditions. With respect to any research Project or any class of research Projects the Secretary may impose additional conditions prior to or at the time of funding when in the Secretary's judgment additional conditions are necessary for the Protection of human subjects. Subpart B— Additional Protections Pertaining to Research Development, and Related “Activities Involving Fetuses,” Pregnant Women, and Human {n Vitro Fertilization? Source: 40 FR 33528, Aug. 8. 1975, 43 FR 17358, January 11, 1978, 43 FR 51559, November 3, 1978 § 46.201 Applicability. (a) The regulations in this subpart are applicable to all Department of Health, Education, and Welfare Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5