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					Evaluation of Risk and Benefit in
   Human Subjects Research

        Felice Levine, Ph.D.
        American Educational
        Research Association
              What is “Risk?”

   CFR, Sec 102 (i):
      “Minimal risk means that the probability and
      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 or psychological examinations
      or tests.”
               What is “Harm?”

   Types of Harm
       Inconvenience
       Physical
       Psychological
       Social
       Economic
       Legal
        Defining Risk and Harm

   “Risk” refers to a probability that some
    harm will occur

   “Harm” refers to specific outcome or event

   CFR conflates the two and assumes
    “minimal” for both
Defining the Daily Life Standard

The “daily life” standard refers to:

    low magnitude harms with a high probability
    harms that are transient and easily
     ameliorated with time or debriefing
Daily Life Standard (continued)

   Routine physical or psychological tests
       Some discomfort or stress
       Low magnitude
       Short duration
   Daily life encounters
       Hassles, arguments, minor accidents
       Happen to most people over time
          Decreasing Risk

Risk is not fixed; ameliorating conditions
and strategies can alter risk level

Protections should be commensurate with
risk level.
           SBS Working Group
Clarify “minimal risk:”

   Distinguish probability and magnitude of harm
   Clarify “daily life” standard
      Involves low-level harms
      Involves transient harms that are easily
           SBS Working Group
Examine “expedited review” categories:

   Considerable variability in interpretation of
    what qualifies
   Time frame for expedited review
     Investigator Responsibilities
   Describe types of harms that may occur
   State likelihood that such harms occur
   Describe efforts to minimize risk
       Select procedure with less risk for subjects
       Adopt procedures to decrease risk (e.g., methods to
        protect confidentiality of data)
       Develop procedures to deal with harms that occur
   Describe expected benefits if any
            IRB Responsibilities
   Identify risks to subjects
   Determine that risks to subjects are minimized
   Determine that risks are reasonable in relation
    to anticipated benefits (if any)
   Determine that subjects are informed about any
    foreseeable risks or discomforts, as well as any
    benefits which may be expected
                  IRB Approval
   Expedited Review
       Risks are minimal

   Full Board Review
       Risks are minimized
       Risks are reasonable in relation to benefits
       Should consider differences among subjects
        and subject populations
               OHRP Guidance
   Develop educational materials on types of harms
    in SBS research are needed

   Amendments to the list of expedited review
    categories are needed to account for more
    minimal risk research

   Distinguish between magnitude and probability
    of harm and clarify relationship to “daily life”
     OHRP Guidance (continued)

   Provide educational materials on best
    ways to:
       Safeguard raw data and electronic files
       Conceal the identities of individuals or groups
       Evaluate level of harm for different
        populations (some subject populations may
        be more vulnerable)

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