Human Subjects

Although this is not part of the NIH guidelines for reviewers, Human Subjects issues are worth brief consideration. 

In our experience, collection of qualitative data often raises new issues for Internal Review Boards (IRB).  This is often uncharted territory. 

For researchers -- we strongly recommend meeting with IRB members to review the grant proposal and discuss the steps that will be necessary to protect the identities of study participants.  Anticipate that working with IRB members will require an ongoing dialogue and probably involve educating IRB members about qualitative research methods.

For reviewers --  there should be some evidence that researchers are aware of the issues involved in protecting the identities of those participating in the study and that adequate steps will be taken to do this.

Some additional resources

Green, LA, Lowery, JC. Kowalski, CP, Wyszewianski, L. (2006). "Impact of Insitutional Review Board practice variation on observational health services research."  Health Services Research, 41(1), 214.

Pace, WD., Staton, EW., Holcomb, S. (2005). "Practice-based Research Network Studies in the Age of HIPAA" Annals of Family Medicine, 3 (Supp 1), S38-S45.

Wolf. LE., Walden, JF., Lo, B. (2005). "Human Subjects Issues and IRB Review in Practice-based Research."  Annals of Family Medicine, 3 (Supp 1), S30-S37.

Wolf, LE. Croughan, M. Lo, B. (2002). "The challenges of IRB review and human subjects protections in practice-based research." Medical Care, 40(6), 521-529.

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