Evaluation of Risk and Benefit in Human Subjects Research

1
Evaluation of Risk and Benefit in Human Subjects
Research

• Felice Levine, Ph.D.
• American Educational
• Research Association

2
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.

3
What is Harm?

• Types of Harm
• Inconvenience
• Physical
• Psychological
• Social
• Economic
• Legal

4
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

5
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

6
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

7
Decreasing Risk

• Risk is not fixed ameliorating conditions and
  strategies can alter risk level
• Protections should be commensurate with risk
  level.

8
SBS Working Group Recommendation

• Clarify minimal risk
• Distinguish probability and magnitude of harm
• Clarify daily life standard
• Involves low-level harms
• Involves transient harms that are easily
  ameliorated

9
SBS Working Group Recommendation

• Examine expedited review categories
• Considerable variability in interpretation of
  what qualifies
• Time frame for expedited review

10
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

11
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

12
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

13
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
  standard

14
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)