Minimal Risk and Common Sense

1
Minimal Risk and Common Sense

• Richard T. Campbell
• Department of Sociology and
• Health Research and Policy Centers
• University of Illinois at Chicago
• (With thanks and apologies to Bob Levine and Joan
  Sieber)

2
Definition of Minimal Risk in Common Rule

• 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
Problems with Definition

• Seems clear enough worst harm should not be
  serious and probability of harm should be low.
• But both IRBs and investigators have trouble
  with it. Why?

4
Two Major Problems

• Definition conflates risk and harm and
  applies the word minimal to both.
• Fails to make clear that by definition harms
  ordinarily encountered in daily life or during
  the performance of routine physical or
  psychological examinations or tests are
  encountered by everyone with virtual certainty,
  that is, with a probability of 1.0.

5
Defining Harm and Discomfort

• Common rule points us to routine physical and
  psychological exams.
• Other examples of daily life hassles
• Getting a traffic ticket
• Being involved in a minor fender bender
• Having a tooth filled
• Dealing with a childs routine illness
• Having a minor argument at work
• Losing something important e. g. keys.

6
Defining Risk

• To say that something is risky in ordinary
  discourse usually means that we expect that some
  serious harm may result from a particular
  behavior or from exposure to a particular
  substance or some other aspect of ones
  environment.
• But this definition is imprecise and gets us in
  trouble quickly.

7
Risk as Probability

• A precise definition of risk refers to the rate
  at which some event occurs in the population.
• We have the number of events in the numerator and
  the size of the population in the denominator.
• Straight probability (235/13,335)
• Events per 100,000
• Odds (e. g. 1 in 385)

8
Risk as Uncertainty

• A second, very different and less precise
  definition of risk involves the notion of
  uncertainty.
• Here risk means that I cant quantify the
  probability and perhaps not even the nature of
  the bad outcome.
• The stock market is risky.

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A classic example of the confusion that results

• Sometimes economists distinguish between risk and
  uncertainty. Risk refers to a situation where we
  can list all of the outcomes and assign
  probabilities to them. Uncertainty refers to
  situations where were may neither be able to list
  the outcomes or assign the probabilities. Except
  where we make explicit distinctions, we will
  simplify our exposition by using the two terms
  interchangeably. Folland et al., 2001, p. 143)

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Where We Would Like to Be
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Things we should try to do

• Keep the distinction between risk (as
  probability) and harm (as magnitude) clear.
• Ask ourselves if we can state the worst harm(s)
  that can result in a study.
• Ask ourselves if we have some reasonable estimate
  of the probability of various harms.

12
Variability in Risk

• Not everyone necessarily carries the same risks.
• We recognize this in various ways
• Exclusion criteria
• Providing support such as counseling.

13
Absolute versus relative risk

• If we apply the daily life standard, whose life
  are we talking about?
• Many populations have much higher background
  risks than the investigator.
• Should we evaluate risk relative to average
  people or the population being studied?

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Voluntary and Involuntary Risks

• We all experience risks over which we have no
  control, e.g. an unpredictable illness.
• We also accept certain risks on a daily basis,
  e.g. whenever we get in a car.
• We ask respondents to accept some risk in a
  study, usually at no benefit to themselves.
• But the daily life standard refers to risks that
  we accept with the expectation of some benefit.

15
Harm to One Person versus Harm to at Least One
Person
16
Minimal Risk Issues In Two Major Issues in Social
Science

• Confidentiality
• Psychological Harms

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Confidentiality

• In many studies the only serious harm that could
  befall a subject is the exposure of private
  information.
• We need to protect data.
• We tend to be cavalier about this, the data will
  be kept in a locked file drawer.
• We need to help people develop adequate plans for
  safe guarding data and information.
• With a decent plan in place, the probability of
  harm is low, but the magnitude of harm is high.

18
Psychological Harms

• Jeff Cohen Social and psychological harms are
  real harms.
• Yes, but perhaps of not great magnitude in most
  cases, and
• Serious harm is improbable, but
• Some persons may be at greater risk.
• Here, we are likely to have more uncertainty than
  known probability.

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Summary

• Minimal risk issues are moot if research is
  exempt.
• If IRBs and investigators took minimal risk
  seriously we would all be better off.
• Under current rules, many minimal risk studies
  require expedited review. In many places this
  is tantamount to full review and should not be.
• I think that if minimal risk applies review
  light is appropriate.