Guidance

The concept of justice is one of the fundamental ethical principles in the Belmont Report. It is described as the idea that “equals ought to be treated equally,” with “equality” being based on various factors. This principle is relevant to research involving human participants due to the historical hardships and burdens placed on vulnerable populations, such as those experienced during the Tuskegee syphilis study.

In the federal regulations governing research involving human participants, justice is applied through the directive that the IRB must ensure the selection of participants is equitable.

Investigators must provide the following information to enable the IRB to determine whether the selection of participants is equitable:

1. The purpose of the research and the setting in which the research would be conducted.
2. Whether prospective participants would be vulnerable to coercion or undue influence.
3. The selection (inclusion/exclusion) criteria.
4. Participant recruitment and enrollment procedures.
5. The amount and timing of payments to participants.

IRB members are directed to determine that selection of participants is equitable as part of the overall criteria for approval. In determining whether selection of participants is equitable, consideration should be given to the following points:

1. The purpose of the research and the setting in which the research would be conducted.

• • Equitable selection of participants requires that researchers attempt to recruit potential participants who are appropriate to answer the scientific question. The nature of the research should require inclusion of the proposed subject population.
  • Benefits resulting from the research should be distributed fairly. Other groups of potential participants should be considered for inclusion if they have a greater need to receive any of the anticipated benefits.
  • Burdens resulting from the research should be distributed fairly. If the proposed subject population is already burdened, it may be unfair to ask them to accept an additional burden.

2. Whether prospective participants would be vulnerable to coercion or undue influence and what measures are being proposed to minimize coercion or undue influence to these vulnerable participants.

• • The researcher must justify the involvement of participants who may either be susceptible to pressure or who are already burdened (i.e., economically or educationally disadvantaged persons).
  • The selection process should not overprotect potential participants who are considered vulnerable so that they are denied opportunities to participate in research.

3. The selection (inclusion/exclusion) criteria.

• • Evaluate the selection criteria (inclusion and exclusion criteria) to determine that participants are not excluded for non-scientific reasons. For example, if recruitment of minorities into a research study would be more expensive, this fact does not count as a reason why minorities should be excluded from participation in research. NOTE: As of July 1, 2023, the University of Utah IRB requires each non-exempt study to have provisions for including people who speak Spanish. Please see the Investigator Guidance Series: Including Spanish-Speaking Individuals in Research for additional guidance.
  • If there are any groups of people who might be more susceptible to the risks presented by the study and therefore ought to be excluded from the research, the procedures for identifying such individuals should be adequate.

4. Participant recruitment and enrollment procedures.

• • A research study may have fair selection criteria but use recruitment methods that lead to inequitable selection. If the participants are susceptible to pressures, there should be mechanisms in place that may reduce the pressures or minimize their impact. For more information and the guidelines provided to investigators, refer to the Investigator Guidance Series: Recruitment Methods and the Investigator Guidance Series: Advertisements.

5. The amount and timing of payments to participants.

• • The amount of payment to participants, the proposed method of payments and/or the timing of disbursement of payments should not present undue influence or coercion. For more information and the guidelines provided to investigators, refer to the Investigator Guidance Series: Compensation.

Federal Regulations

45 CFR 46.111(a)(3): Criteria for IRB approval of research. “In order to approve research covered by this policy the IRB shall determine that… (3) Selection of participants is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.”

21 CFR 56.111(a)(3): Criteria for IRB approval of research. “In order to approve research covered by these regulations the IRB shall determine that… (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.”

Documents and References

Investigator Guidance Series: Recruitment Methods: https://irb.utah.edu/guidance-series/recruitment-methods/

Investigator Guidance Series: Advertisements: https://irb.utah.edu/guidance-series/advertisements/

Investigator Guidance Series: Compensation: https://irb.utah.edu/guidance-series/compensation-of-research-subjects/

Investigator Guidance Series: Including Spanish-Speaking Individuals in Research: https://irb.utah.edu/guidance-series/including-spanish-speaking-individuals-in-research/

Tuskeegee Syphilis Study: http://www.cdc.gov/tuskegee/timeline.htm

Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

Points to Consider