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Oversight of Social Behavioral Research

Behavioral Research and the Belmont Report. ?It is important to distinguish between biomedical and behavioral research."?The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.". Behavioral Research and

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Oversight of Social Behavioral Research

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    1. Oversight of Social & Behavioral Research

    2. Behavioral Research and the Belmont Report “It is important to distinguish between biomedical and behavioral research.” “The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.”

    3. Behavioral Research and 45 CFR 46 Section 102 (f): Definition of a “Human Subject” The research “… obtains…(2) identifiable private information…(which) includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation… is taking place.”

    4. Social & Psychological Risk Social & Psychological risks are real risks

    5. IRB Responsibilities Identify Risks Determine that risks are minimized Determine that “risks to subjects are reasonable in relation to anticipated benefits” Determine that subjects are adequately informed about “any reasonably foreseeable risks or discomforts” Comes from Common Rule Sections 111 (Criteria for IRB Approval of Research) and 116 (General Requirements for Informed Consent) IRB cannot rely on the investigator to identify risk. “Dr. Frankenstein” Example - Achievement Motivation in Black Children IRB can call on outside experts to advise on determinations. Comes from Common Rule Sections 111 (Criteria for IRB Approval of Research) and 116 (General Requirements for Informed Consent) IRB cannot rely on the investigator to identify risk. “Dr. Frankenstein” Example - Achievement Motivation in Black Children IRB can call on outside experts to advise on determinations.

    6. Identifying Risks IRBs should not rely solely on investigators to identify risks

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