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Chapter XV - Knowledge of Local Research Context

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This chapter describes how the GA IRB fulfills its responsibilities relative to ensuring that the IRB has adequate knowledge of local research context prior to approving research.

The regulations at 32 CFR 219.103(d) require that the adequacy of IRBs be evaluated “in light of the anticipated scope of the institution’s research activities, the types of participant populations likely to be involved, . . . and the size and complexity of the institution.” Furthermore, 32 CFR 219.107(a) requires that IRBs be “(i) sufficiently qualified through . . . 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; and (ii) 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 regulations also require that IRBs must be capable of ensuring that (i) selection of participants is equitable; (ii) privacy of participants is protected and confidentiality of data is maintained; (iii) informed consent is sought in language understandable to the participant and under conditions that minimize the possibility of coercion or undue influence; and (iv) appropriate safeguards protect the rights and welfare of vulnerable participants (32 CFR 219.111(a)(3)(a)(4),(a)(7),(b), and 219.116).

The GA IRB is geographically distant from most sites and institutions forwhich it serves as the IRB of Record; this necessitates that the IRB chair or other designated members evaluate important site-related issues during its review of protocols. Among these considerations are the following:

  • The anticipated scope of the research activities;
  • The types of participant populations likely to beinvolved;
  • The size and complexity of the institution conducting the research;
  • Institutional commitments, regulations, and policies;
  • Applicable laws, including country, state and local laws;
  • Standards of professional conduct and practice;
  • Methods for equitable selection of participants;
  • Methods for protection of privacy of participants;
  • Methods for maintenance of confidentiality of data;
  • Language(s) understood by prospective participants;
  • Methods of minimizing the possibility of undue influence or coercion in seeking consent;
  • Safeguards to protect the rights and welfare of vulnerable and specialpopulations; AND
  • Cultural and religious considerations.

The GA IRB will apply knowledge of the local research context to ensurethat:

  • Selection of participants is equitable;
  • Privacy of participants is protected, and confidentiality of data ismaintained;
  • Informed consent is sought in language understandable to the participant and under conditions that minimize the possibility of coercion or undueinfluence;
  • Appropriate safeguards protect the rights and welfare of vulnerable participants and special populations;
  • Local cultural, religious and community norms arerespected;
  • As appropriate, the research provides enduring enhanced infrastructure orimproved programs that are beneficial to the community.

The GA IRB will obtain information about the local research context through one or more of the following mechanisms:

  • Written materials;
  • Discussions with appropriate consultants;
  • Personal knowledge of the local research context on the part of IRB members and consultants through extended, direct experience with the research institution, its participant populations, and its surrounding community;
  • Review of the proposed research by appropriate subject matterexperts;
  • Systematic and documented interchange between the GA IRB and the research institution. Such interchanges may include, but are not limited to:
    • Review of relevant written materials such as institutional policies, guidance documents, memoranda, and standard operating procedures;
    • Discussions with appropriate consultants knowledgeable about thelocal research context;
    • Interactions with designated institutional liaisons such as the Human Protection Administrator (HPA);
    • Visits to the research site;
    • Review of applicable state and local laws, as well as cultural standards andnorms applicable to the study location and/or targetpopulation;
    • Presentations to the IRB by institutional representatives regarding local target populations for research, site-specific cultural institutional practices and special safeguards in place for the protection of research participants.

Research reviewed by the GA IRB is subject to state laws. The following are examples of state laws that may be relevant to research reviewed by theIRB:

  • Defining age of majority;
  • Reporting of abuse;
  • Reporting of infectious diseases;
  • Reporting of sepsis;
  • Defining who can serve asthe legally authorized representative (LAR) for the participant.
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