SOP #13 IRB Determination of Minimal Risk

IRB Determination of Minimal Risk

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 13
Effective Date: 10/8/2021

1. Policy

The Regulatory definition of minimal risk is: 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 examination or tests (45 CFR 46.102(i). The regulatory definition of minimal risk is problematic and imperfect. This SOP is a guide in making minimal risk determinations.

2. Purpose

The determination whether research involves no more than minimal risk is a critical issue for IRB review. Minimal risk decisions are important for eligibility for exemptions or expedited review, waiver of consent or documentation of consent, research involving prisoners, and assessing risk in research involving children. Although not regulatory, minimal risk criteria are often used for assessing whether an amendment to research is minor.

3. Concepts

“Probability and magnitude of harms or discomfort.” Risks or harms may be physical (heart attack, pain threshold), psychological (distress, anxiety), social (reputation), or economic (employment). IRB’s must determine whether the risk is low or high. The IRB must also determine how probable the risk may be, a risk may be high (loss of employment) but the probability of that risk in the research study may be relatively low. If the probability is low enough it may still qualify as minimal risk.

A second concept of risk is that these harms or discomforts are those which are “ordinarily encountered in daily life.” This might include the risk of riding in a car or tasting food. Privacy and confidentiality appear to be common risks in everyday life. Social technology stores enormous data collection on everything we do on the internet and is mostly uncontrolled and done without consent or knowledge. The IRB must make their best decision whether a risk is comparable to that ordinarily encountered in everyday life.

A third concept is that harms or discomforts are compared to those “during the performance of routine physical or psychological examination or tests.” A blood draw may be considered in this category compared to a lumbar puncture or biopsy. Lumbar puncture and biopsy are routinely done but not without risk. The IRB must make its decision based on what is considered “routine.”

4. Children

Subpart D for research involving children requires categories of risk involving children (CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist). The first category (§ 46.404) is research involving not more than minimal risk. The second category (§ 46.405) is for research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. The third category (§ 46.406) is for research involving greater than minimal risk and no prospect of direct benefit to the individual subject, but likely to yield generalizable knowledge. The § 406 category is permissible if the risk represents a minor increase over minimal risk.

Physical risk is easy to identify and quantify and make determination about. Social science risks are much more difficult. Most social science risk is minimal risk and exempt. Although some social science research involves significant risk such as studies in domestic violence, criminal activity or socially stigmatizing information. The IRB must determine whether sensitive questions may cause emotional distress and harm. The IRB needs to remember that even in research involving no greater than minimal risk, investigators and IRB’s have an ethical obligation to treat subjects fairly and respect their rights (informed consent).

5. IRB Assessment

  1. Is the risk, harm or discomfort comparable to those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests?
  2. What is the magnitude of the risk, harm or discomfort – how big is the risk? The IRB may use a scale where 10 is the highest and 0-1 the lowest.
  3. What is the probability of the risk, harm or discomfort occurring in the research? How likely is it that the risk occurs, given the protections the researcher has proposed? The IRB should make this determination without regard to the magnitude of the risk. The IRB may use the risk scale to help make this determination.
  4. It is good practice that the IRB document how the minimal risk decision is made.

References

IRB EasyEd – Volume 1 Number 1. The Definition of Minimal Risk Copyright © 2015 Apex Ethical

This is a new policy per the 2018 Common Rule Requirements.

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