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Consent for CDC research; a reference for developing consent forms and oral scripts
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November 1998
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By Havlak, Russ
[PDF-1.66 MB]
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Description:The Centers for Disease Control and Prevention (CDC) has had an Institutional Review Board (IRB) for almost 30 years. The IRB's role is to review proposed studies and approve those which comply with 45 Code of Federal Regulations, Part 46 (45 CFR Part 46), the federal regulations that govern research involving human participants. However, the guiding vision of the IRB has less to do with review and approval than with the idea of helping all of CDC to carry out ethical research. The CDC IRBs have reviewed a couple of thousand study protocols over the years, giving them insight into the strengths of CDC research and weaknesses common to the process. Top among the problem areas are consent documents--both written forms and oral consent scripts. Consent in human participant research should be a process that continues from the time participants sign up for a study to the time they complete the study or withdraw from it. The consent form or oral consent script is but one piece of that process, but a piece which the IRB is obligated to take very seriously. This is a reference to help CDC investigators write research consent forms and scripts that conform to the Federal Regulations. It draws on the wisdom gained by the IRB and offers suggested wording similar to that found in CDC consent forms the IRB has approved. No attributions are cited, but this does not lessen the appreciation to the many CDC investigators who contributed to this reference.
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Content Notes:Written by Russ Havlak.
"November 1998."
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