Office of Research Compliance

Institutional Review Board
Follow Up Report - AAHRPP Site Visit

The site visit for accreditation of the CMU Human Research Protection Program went very well, but the site visitors noted several concerns. Most involved procedures and can be addressed in a straightforward way by IRB members and staff, but some required changes in the application forms, which will affect investigators.

1. More space to describe methods. This change is directed to investigators who have asked for more space on the application form to describe their experimental methods and to IRB reviewers who noted that they did not have enough information to adequately assess risks to subjects. Investigators now have the option of uploading a separate document for this section. It can be formatted in different ways (such as required by journals or grant agencies) and can include figures.

Note: The CMU IRB reviews research that covers a wide range of topics from sociology to physiology. This change may not be relevant to proposals in all fields of research.

2. Include grant applications or contract proposals. Investigators who are submitting contract proposals for work that involves human subjects must now submit copies of proposals with their IRB applications. (These proposals can be referenced within an IRB application and they can be used to describe methodology and discuss risks and how risks will be mitigated).

3. Community engagement. Community engagement in research has emerged as an area of emphasis in federal grant programs and in human research protections, and investigators and IRB members must become accustomed to thinking about it when writing and reviewing applications.

?Community? is a very broad term; it defines a group of persons who share some characteristic such as ethnicity or language, religion, political views, disease or medical condition, or membership in a street gang. Some examples of community engagement in research ? which are already used by CMU researchers - are formally requesting permission of community representatives to conduct research within the group and offering to share research results with the group. More examples will be discussed in forthcoming guidance.

During the coming year, new questions about community engagement will appear on the various application forms. They are not meant to impose additional burdens, but they are meant to stimulate thinking about what investigators might normally do anyway.

4. New consent form templates. Changes have been made in the various consent form templates, including the forms for assent by adults unable to consent on their own behalf, legally authorized representative consent/permission form, and parent or guardian consent/permission form.

It is very important that investigators use the most current forms, which can be downloaded from IRBNet.

Bob Bienkowski

Robert S Bienkowski, PhD-CIP-CHRC
Director, Office of Research Compliance
Central Michigan University

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