Model Federal Policy for Protection of Human Research Subjects

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Model Federal Folicy for Protection of Human Research Subjects Cef in it ions. Assuriny Compliance with This Policy - Research Co c duct d or Supported by Any Federal Department or Agency. IRB Functions and *rations. IRB Review of Research. Expedited Review Procedures for Certain Kinds of . Research Involving No Mre t h a n Minimal Risk, and for Minor Changes i n Approved Research. Review by Institution.

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Suspension or Ternination of I W Approval of Research. General Requirements for Info-med Consent. mcumentation of Informed Consent. Applications and Proposals Lacking Cef inite Plans for Involvement of Human Subjects. Research Undertaken Without the Intention of Involving Human Subjects. Evaluation and Disposition of Applications and Propcsals for Research to be Conducted or Supported by a Federal Department or Agency. Use of Federal Funds. Early Termination of Research Support; Evaluation of Applications and Proposals. To What Does This Policy Apply? Except as provided in paragraph (b) k l m , this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by federal civilian anployees or militaq personnel, except that each department or agency head may adopt such procedural modifications as may k

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appropriate frcm an administrative stand pint. includes research conducted, supported, or otherwise Subject to regulation by the federal government outside the United (1) Research that is conducted or supported by a federal deparbnent or agency whether or not it is regulated as defined inSec.l02(e) must canply with all sections of this pl icy. (2) Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in Sec.l02(e) mst be reviewed and approved, i n compliance with Secs.101, 102, and 107 through 117 of this policy, by an institutional review bard(IRB)that operates i n accordance with the pertinent requirements of this policy. (b) Unless otherwise required by deparbnent or agency heads, research activities in which the only involvement of human subjects will be i n one or more of the f oll ming categories are exempt fran this policy: (1) Research conducted in established or can mn ly accepted educational settings, involving normal educational practices, such as (i)research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the canparison among instructional techniques,curricula, or class rm management methods. (2) Research involving the use of educational tests (cq n it ive, procedures or observation of public behavior, unless : (i) information obtained is recorded i n such a manner that hllman

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subjects can be identified,directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects ' responses cuts ide the research could r.?asonably place the subjects at risk of criminal or civil liability or be damaging to the subjects ' financial standing or employability. (3) ' Research involving the use of educational tests (cognitive,diagnostic,aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph (2),if : (i)the human subjects are elected or appointed public officials or candidates for public office ; or (11) federal statute(s)require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and (4) Research involving the collection or study of existing data, documents, records,pathological specimens, or diagnostic specimens, i f these sources are publicly available or ifthe information is recorded s y ',.e investigator in such a manner that subjects cannot be identified,directly or through identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or subject to t h e approval of department or agency heads, and which are designed to study,evaluate, or otherwise examine: (1)public benefit or service programs; (ii) procedures for obtaining benefits or services under those pr q rams ; (iii)possible changes i n or alternatives to those prcgr*s or procedures; or (iv) possible changes i n methods or levels of payment for benefits or services under those programs.

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(6)Taste and food quality evaluation studies,if wholesane foods without chemical additives are consLPned or if a limited amount of a food is consumed that contains a food additive or agricultural chemical a t or belm a level approved by the Food and Drug Administration, the Environmental Protection Agency, or the Animal Plant Health Inspection Service of the U.S. Dep arm nt (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy. (d) Cepartment or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the department or agency but not otherwise covered by this policy, ccmply with surte or all of the requirements of this ( e ) Canpliance with t h i s policy requires canpliance with pertinent federal laws or regulations which provide additional protections for human subjects. (f)This policy does not affect any state or local laws or regulations which may otherwise be applicable and which provide additional protections for human Subjects. (9) This policy does not affect any foreign laws or regulations which may otherwise be applicable and which provide additional protections to human subjects of research. (h) When research covered by this policy takes place in foreign countries, procedures normally fol lw d in the foreign countries to protect human subjects may differ fran those set forth in this policy. [An example is a foreign institution

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which can plies with yui de lines consistent with the 1975 world Medical Assembly Declaration(Helsinki 11) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally re cq niz ed. ] In these circumstances, ifa department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided i n this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published i n the FEDERAL REGISTER or will be otherwise published as provided i n department or ageccy procedures. (i) Unless otherwise required by law,dep arm nt or agency heads may waive the applicability of saw or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy. otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Protection fran Research Risks, Department of Health and Human Sen ices (HHS), and shall also publish them inthe FEDERAL REGISTER or i n such other manner as provided i n department or agency procedures.

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(a) "Department or ayency head" means the head of any federal department or agency and any other officer or employee of any department or agency to whan authority has been (b) "Institution" means any public or private entity or agency ( including federal, state, and other agencies). or judicial or other W y authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (d) "Research" means a systematic investigation, including research developnt, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which - meet this definition constitute "research" for purposes of this policy, whether or not they are conducted under a prcgram which is considered research for other purposes. For example, sane "demonstration" and "service" prqrams may include are intended to e ncq as s those research activities for which a federal department or agency has specific respnsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). activities which are incidentally regulated by a federal It does not include research

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deparbwnt or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor). an investigator (whether professional or student) research obtains ( 1) data through intervention or with the individual, or ( 2) identifiable private information. "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; 'I Interaction" includes communication or interpersonal contact between investigator and Subject. 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 (1.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. that the resehrch has been reviewed and may be conducted at

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an institution within tne constraints set forth by the I N and by other institutional and federal requirements. 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 o r psycholqical examinations or tests. (i) "Certification" means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human sublects has been revieed and approved by an IRB in accordance with an Sec.103 Assuring Canpliance with This policy - Research Conducted or Supported by Any Federal Department (a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a federal department or agency shall provide written assurance satisfactory to the deparQnent or agency head that it will canyly with the requirements set forth in this policy. ( b ) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certifi& to the deparmnt or agency head that the research has been reviewed and approved by an

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IRB provided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum (1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the riyhts and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to federal regulation. This may include an appropriate existing code, declaration, or statement of etnical principles, or a statement formulated by the institution itself. This requirement does not preempt supported or regulated research and need not be applicable ( 2 ) Designation of one or more IRBSestablished in accordance with the requirements of this policy, and for which provisions are made for meeting space and sufficient staff t o support the IRB's review and recordkeeping duties. (31 A list of the 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 I& deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, member of governing panel or bpard, .

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stockholder, paia or unpaid consultant. Charyes in IRB membership shall be reported to the department or agency head. (4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) for determining whicn projects require review more often than annually and which projects need verification fran scurces other than the investigators that no material changes have occurred since previous IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuriny that such changes in approved research, during the period for which IRB approval has already k e n given, may not be initiated without IRB review and approval except when necessary to eliminate apparent inmediate hazards to the Subject. ( 5 ) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the deparbnent or agency head (i) any unanticipated problems or scientific misconduct involving risks to human subjects or others; (11) any allegation or finding of serious or continuiny noncanpliance with this policy or the requirements or csterminations of the IRB; and (iii) any suspension or termination of IRB approval. (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and 'mnner as the department or agency head prescribes.

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(d) The department or ayency head will evaluate all officers and employees of the department or ayency and such experts or consultants engaged for this p u p e as the department or ayency head determines to be appropriate. The department or agency head's evaluation will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's research activities and the types of subject populations likely to be involved, the appropriateness of the proposed initial and continuing review procedures in light of the probable risks, ana the size and canplexity of (e) (3the basis of this evaluation, the department or ayency head may approve or disapprove the assurance, or enter into negotiations to develop an approvable one. department or agency head may limit the period during which any particular approved assurance or class of approved assurances shall remain effective or otherwise condition or (f) In lieu of negotiating a separate assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, approved by and on file with the Office for Protection fran (9)Certification is required when the research is supported by a federal department or agency and not otherwise

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exempted or waived under Secs.lOl(b) or (1). submission of an application or propcsal for approval or support, an institution with an approved assurance covering the research shall certify that the application or prop al Along with the ' has been reviewed and approved by the IRB. Institutions without a n approved assurance covering the research shall certify with'in 30 days after receipt of a request for such a certification fran the department or agency, that the application or prop al has been approved by the IKB. the certification is not su hit ted within these the …