Research Compliance
Dear Research Community:

The UHCMC IRBs have reviewed our policies in connection with the process of seeking accreditation of its Human Research Protection Program with the accreditation body AAHRPP (Association for the Accreditation of Human Research Protection Programs). As a result, we want to provide further guidance for addressing the inclusion of illiterate and non-English speaking subjects; and pregnant women and fetuses in research studies. While many research studies may not directly target these populations, there is the potential for inclusion of someone from one of the above referenced in a research protocol if the individual meets all other inclusion criteria.

Beginning February 19, 2007, the following items must be appropriately addressed in initial and continuing review protocol submissions to secure UHCMC IRB approval.

Illiterate subjects; non-English speaking subjects; and pregnant women and fetuses.
• To comply with the ethical principles of the Belmont Report, illiterate and non-English speaking subjects, cannot be unfairly excluded from research without good reason. As a result, the UHCMC IRB will review all submissions (both initial and at continuing review) to ensure that their inclusion/exclusion is justified, based on the type of research and the potential benefit to subjects.

• In addition, if a study wishes to collect data from pregnant women and fetuses, as they area vulnerable population, their inclusion must be described and fully justified; and comply with 45 CFR 46 Subpart B.

The following sections provide additional guidance for submissions, as well as links to relevant IRB policies.
1) In the research plan, discuss the plan for the inclusion of illiterate individuals, or an appropriate justification for their exclusion. Please see UHCMC IRB policy “Informed Consent” for illiterate subjects for more information: Other Vulnerable Populations

2) In the research plan, discuss the informed consent process for the inclusion of non-English speaking individuals; or if they are to be excluded, provide a rationale and justification for their exclusion. Please see UHCMC IRB policy regarding “Informed consent” for non-English speaking individuals for more information Documentation of Informed Consent

3) If applicable, include information in the research plan to address the inclusion of pregnant women and fetus. Also if necessary, revise the research plan (protocol) and consent form to discuss what happens if a woman of childbearing age becomes pregnant. If they will remain in the study, or pregnancy follow up data will be collected, revise the protocol to indicate inclusion of Pregnant Women, Human Fetuses, and Neonates If they become pregnant and are to be withdrawn, please discuss how they will be safely withdrawn from the study. Additional information regarding elements required in a Pregnancy Risk Assessment may be found on the OHRP website:Research involving pregnant women or fetuses

4) For examples and additional explanation of the above requirements, please reference “The Belmont Report: Practical Application to IRB Protocol Submission Requirements” accompanying this notice.

It is hoped that these links will provide investigators and their research staff with the appropriate amount of information so that they can include enough information necessary on these topics when creating the protocol. Advance review of these topics will assist in a smooth review and approval process for your protocols. If there are any questions, please contact the UHCMC IRB Office or the UHCMC Office of Research Compliance.

We would like to thank you for your cooperation with these matters and your continued commitment in the protection of human subjects in research.


Philip A. Cola, M.A.
Vice President for Research