Herky Hints for HawkIRB: Eligibility Criteria
Equitable Selection of Subjects
By Rachel Kinker, MPH
Eligibility criteria are the inclusion and exclusion requirements that determine if a participant can join a research study. The IRB will review the eligibility criteria to assess potential risks, to determine if the research team has minimized these risks, to ensure ethical research by reducing undue burden to participants, and to assess if the eligibility criteria are well defined and relevant to the research question.
Section VI. Subjects
In question VI.13, respond to each bulleted item. If there is only one subject population, indicate that in your response.
If there are two (or more) subject groups, descriptions of the groups should be provided in separate paragraphs throughout all sections where participant groups are described.
In question VI.14 provide an estimate of the total number of subjects that would be eligible for inclusion in each of the study populations. You can utilize recent census or UIHC patient data (when applicable) to determine the total number of potentially eligible participants.
Section VII.D Project Description
When answering questions in Section VII.D, make sure the screening questions provided before and after enrollment match the eligibility criteria listed in Section VI.13. If there are multiple subject groups, provide descriptions of the groups in separate paragraphs.
Descriptions of exclusion criteria should be specific and not too broad. For example, don’t exclude “all neurological conditions” if just certain types of conditions would interfere with study participation.
If you plan to ask the subject screening questions before they give consent to participate, select the ‘Yes’ option on VII. D.19.
You will then need to complete questions VII.D.20-24. List all the questions that the research team will ask the subject (or their parent/legal guardian/legally authorized representative) before the subject signs the consent document. Screening questions should be attached to the application if the list is too long to add in the IRB application. Do not include screening information that you obtain from other sources (medical records, referral source etc.).
Alternatively, if you plan to ask extensive questions or questions about sensitive topics (illegal drug use, illegal behavior, mental illness etc.) the IRB could also request the research team to ask these questions after the subject enrolls in the study and has signed a consent document.
If you plan to conduct screening procedures or ask additional questions after the subject has signed the consent document, select the ‘Yes’ option for VII.D. 25, then list and describe the screening procedures in VII.D.26.
Make sure the inclusion/exclusion criteria described in VI.13 are consistent with the information entered in either VII.D.20 or VII.D.26.
You can find more information in the UI Standard Operating Procedures and Researcher Guide Section II. part 7 “HawkIRB Section VI Subject Enrollment” and Section II. Part 11 “HawkIRB Section VII.D Recruitment & Consent Process”.
Questions about this topic? Email the HSO Education and Outreach team or come to Office Hours to speak directly to a member of the HSO team.
Have an idea for a future Herky Hint for HawkIRB? Let us know!
Equitable Selection of Subjects
By Emily Shultz, CIP
One of the HHS criteria for IRB approval (45 CFR 46.111) is that the selection of subjects is equitable. Based on the Belmont Report’s ethical principle of Justice, equitable subject selection means that the participants in the research should not have an unequal share of the risks and benefits of the research, and that the research plan should include or exclude people based on scientifically valid reasons rather than convenience.
The National Institutes of Health (NIH) provides a tip sheet that outlines factors for consideration and suggested questions to guide members of the institutional review board (IRB) in their review of new project applications.
Purpose of the research
What is the scientific question that is being asked?
Which potential participants will benefit most from the research and can answer the research question?
Inclusion/exclusion criteria
Are the inclusion/exclusion criteria based on the scientific question under study?
Proposed research setting
Has the setting been chosen only because it is convenient?
Will the location provide access to appropriate participants (those who can help answer the scientific question under study) in an equitable manner?
Could the setting be perceived as coercive?
Recruitment methods
Is the recruitment strategy fair?
Do the recruitment methods and materials support an equitable selection of participants?
Compensation
Is the compensation fair or could it result in undue influence?
Potential participants who could be considered vulnerable
If participants lack the capacity to consent, is there a scientific necessity to enroll these participants related to the research question?
If these potentially vulnerable participants have capacity to consent, could they otherwise be subject to coercion or undue influence?
These questions can also help researchers design their inclusion/exclusion criteria for the study population and determine the appropriate recruitment methods to reach their study goals. Online training on equitable selection of subjects is available from The Office for Human Research Protections (OHRP).
For information on completing the sections of HawkIRB related to subject selection, see this month’s Herky Hints for Hawk IRB: Eligibility Criteria.
Questions? You can email the IRB or come to Office Hours to speak directly to a member of the HSO team.
Have an idea for an IRB Connection newsletter article? Let us know!