How Do REB Members Make Decisions? Research Speculations

1. How Do REB Members Make Decisions?Research Speculations Ivor A. Pritchard, Ph.D. Senior Advisor to the Director Office for Human Research Protections (OHRP/HHS/USA) Ivor.Pritchard@hhs.gov December 6, 2013

2. Do Research Ethics Boards (REBs) Always Make the Right Decisions? • Researchers sometimes dispute REB decisions • REBs presented with identical research proposals sometimes reach different decisions

3. Why do REBs make questionable or varying decisions about research projects? • The local circumstances are peculiar. • The REB members don’t know the facts. • The REB members don’t understand and apply the rules. • REB members exhibit psychological behavior. • REB members are influenced by each other in the group’s decision-making processes. • The REB members hold different ethical perspectives.

4. Question: Do REB members exhibit rational choice, i.e., do they make value decisions based on the expected utilities of the alternative courses of action? Note: REB conclusions are clearly amenable to rational choice analysis insofar as approval criteria, minimal risk judgments, etc. are determined in terms of risks and benefits.

5. A Contemporary Rational Choice Theorist • Embedded Video Clip

6. A Foundational Figure in Rational Choice Theory: Jeremy Bentham • Founder of Utilitarianism, the Principle of Utilityof the Greatest Happiness of the Greatest Number, and the Felicific Calculus

7. The Senses Wealth/Privation Skill/Awkwardness Amity/Enmity Good/Ill Name Piety Power Benevolence Malevolence Memory Imagination Expectation Association Relief (Bentham) The Kinds of Pleasure/Pain in the Felicific Calculus

8. The Factors of the Felicific Calculus of Pleasure/Pain • Intensity • Duration • Certainty or Uncertainty • Propinquity or Remoteness • Fecundity • Purity • Extent, the number of persons to whom it extends (Bentham)

9. Concern for Welfare: A Core TCPS Principle “The analysis, balance, and distribution of risks and potential benefits are critical to the ethics of research involving humans. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct research in a way that protects participants from any unnecessary or avoidable risks.” (Tri-Council Policy Statement (TCPS) 2010)

10. The TCPS Conception of Benefits “Research involving humans may produce benefits that positively affect the welfare of society as a whole through the advancement of knowledge for future generations, for participants themselves or for other individuals”.

11. The TCPS Conception of Harm “Harm is anything that has a negative effect on the welfare of participants, and the nature of the harm may be social behavioral, psychological, physical or economic.”

12. The TCPS Factors of Risk Assessment • Magnitude or Seriousness • Probability • Long-lasting/Transient

13. The Fallacy of Predicting Risk/Benefit Decisions based on Rational Choice or Expected Utility Theory: People do not make risk/benefit decisions based entirely on calculations of the objective risks and benefits involved in activities.

14. What are People’s Preferences Regarding Risks? Risk Preference Cases #1 & #2

15. Risk Preference Case #1:Which Treatment Approach is More Acceptable? • 600 people are exposed to a virus. • With treatment A, 200 people will survive. • With treatment B, there is a 1/3 chance of 600 surviving, and a 2/3 chance of no one surviving. • Do you prefer Treatment A or Treatment B? • [Treatment A is generally preferred]

16. Risk Preference Case #2: Which Treatment Approach is More Acceptable? • 600 people are exposed to a virus. • With treatment A, 400 people will die. • With treatment B, there is a 1/3 chance of no one dying, and a 2/3 chance of 600 dying. • Do you prefer Treatment A or Treatment B? • [Treatment B is generally preferred.]

17. Loss Aversion Familiarity Stigma Cultural Worldview Trust Status Affect Probability Neglect Status Quo Gender Race Group Interactions (Kahneman et al., Slovic et al., others) What factors influence variation in our assessments of acceptable levels of risk?

18. How will familiarity with the kind of risk influence REB members’ risk assessment judgments? • REB members unfamiliar with the risks of proposed research will judge those risks to be greater than investigators and REB members familiar with those risks. • Members of REBs that routinely review any type of research will judge the accompanying risks to be lower than members of REBs that do not routinely review such research.

19. Familiarity Bias and Minimal Risk “…’minimal risk’ research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those ordinarily encountered by participants in those aspects of their everyday life that relate to the research.” (TCPS)

20. Question: Do REB members all use the same standards regarding their choices? Note: REB approval and the approval criteria reflect choices about how the study should be conducted and what safeguards are needed to justify the risks.

21. Decision-making: 3 Survey Questions On a scale of 1 to 7, with 1= ‘Completely Disagree’ and 7= ‘Completely Agree’, rate yourself for the following 3 statements: • “Whenever I am in the car listening to the radio, I often check other stations to see if something better is playing, even if I am relatively satisfied with what I’m listening to.” • “I often find it difficult to shop for a gift for a friend.” • “No matter what I do, I have the highest standards for myself”. (Schwartz/APA)

22. Maximizers differ from Satisficers with respect to: • The amount of time they take to decide • The number of alternatives they consider • Their assessment of the decision • Their response to the decision (Schwartz, 2004)

23. The TCPS Risk Standard “Researchers and REBs must attempt to minimize the risks associated with answering any given research question.” “The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct research in a way that protects participants from any unnecessary or avoidable risks.”

24. A Satisficer’s rewrite: “Researchers and REBs must take reasonable precautions to reduce the risks associated with answering any given research question.” “The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct research in a way that includes reasonable precautions to protect participants from unnecessary or avoidable risks.”

25. The TCPS Potential Benefit Standard(s) “[Researchers and REBs] should attempt to achieve the most favourable balance of risks and potential benefits in a research proposal.” “The proportionate approach to REB review requires that a project have a favourable balance of risks and benefits in order to receive REB approval.”

26. The Common Rule’s Risk/Benefit Criterion “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result….” (45 CFR 46.111(a)(2))

27. A Maximizer’s rewrite: “Risks to subjects are outweighed to the greatest extent possible by the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result…”

28. Question: Do REB members sometimes agree without thinking? Note: REB members agree with other REB members or with prior REB decisions.

29. REB members sometimes decide without thinking things through • Reciprocation – We feel obliged to repay someone who gives us something. • Commitment and Consistency – Once we’ve made a decision, we’re inclined to make later decisions consistent with the original one. • Social Proof – If we see other people doing something, we tend to think that behavior is correct. (Cialdini, 2009)

30. REB members sometimes decide without thinking things through (continued) • Authority – We are inclined to defer to people who we view as being in positions of authority, based on their knowledge, power, etc. • Liking – We prefer to say ‘yes’ to people we know and like. (Cialdini, 2009)

31. Illustration: Who will REB members tend to agree with?

32. Hypothetical Conclusions • REBs make decisions about proposed research influenced by factors other than the objective nature of the proposed research itself or the risks involved, including individual members’ psychological characteristics, interpersonal influences, group decision-making dynamics, ethics, and the institutional context. • Influences on REB decisions are potentially predictable and manageable. • The decisions of investigators and participants are also influenced by nonrational factors.