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Risk 1 - Definition

Minimal Risk is not what your instinct says is pretty low risk or risk you would accept. It is a regulatory term defined in 45 CFR 46.102(i). Although much has been written about this definition (read mostly by IRB administrators), its consistent use can be very elusive.  

Minimal Risk Definition

46.102(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."

When the definition is used, the reviewer will need to make a yes/no decision about whether the identified risks meet this test.  To make a decision they have their background and expertise, the internet, your application, any references or background you include and the possibility of asking for an external consultant. The burden is on you to demonstrate an understanding of the risks and the methods used to make sure they are minimized.  

A.  The daily life of whom?

The definition does not specirically say whose daily life is to be considered. Is it a conceptualized “Everyman” as found in the law? If so, is it all those in the community, region, country or world? 

  • Is it the risks of daily life to a like group of people?  If this is the stance then many risky studies can become minimal risk.  The risk of a new combination of drugs might be no increase over the risks of the standard drug combinations taken by that group.
  • Most IRBs set the standard as the Everyman of some conceptual Average American. As every IRB has members from vastly different walks of life and as no member is merely average, each IRB is likely to reach differing conclusion.

B.  Doing what in daily life or during procedures?

Again, these must be procedures that our conceptualized Average American Everyman might encounter on a daily basis or might encounter during a routine physical or psychological examination.

The definition distinguishes risks from routine tests or examinations. Having a skin growth (mole, skin cancer, warts) removed, reviewing a Beck depression scale or completing a test in a magazine or on Facebook are quite usual and pose a routine risk. What do lots of people do or experience on a daily basis? The question for a reviewer is whether an equivalence can be found that is ordinarily encountered in daily life.

C.  What is the harm?

The nature of the harm should be named or specified instead of simply referring to “a risk”. It is a risk of something specific happening. The harm can be physical, mental, emotional, social, legal, financial or community. The definition includes discomfort. Discomfort is quite subjective but must again be evaluated by the IRB members.  

D.  Probability of harm

Risk is a statement of probability that a given harm might occur. Presumably a high probability of a mild harm is minimal risk. A harm of 1 on a 10 point scale with a 99% probabilitiy is still a harm of 1. What about a low probability of a high magnitude harm? Is a harm of 10 with a 0.0005 probability still a 10? Probably. But does it meet the "minimal risk" definition if the probability is vanishingly small? (The consent form rules only ask it be listed if it is "reasonably foreseeable".) 

E.  What is the severity of the Harm?

For the person who has become the 1 in the 1/1000 ratio, what is the predicted severity or magnitude of the harm? What is the most likely result and what is the worst-case result? What can be done to minimize the severity? In biomedical studies death is often the worst-case scenario. With survey studies, the magnitude might be a question that might lead one to have a psychotic event or to be identified as a part of a stigmatized group.

Last Updated ( Friday, 02 June 2017 11:09 )