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When auditing clinical trials, look out for subtle nuances

Health Care Auditing Strategies, November 1, 2005

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A 'checklist mentality' may cause you to miss risks related to voluntary participation

By Lynn Gordon, Esq.

The Common Rule provides a number of protections for human research subjects. A fundamental right that should be reflected in the informed consent and other communications provided to patients is that their participation is voluntary. Auditors should look closely at whether it is clear to a patient that his or her participation in a clinical research trial is, in fact, voluntary.

Although this may seem like a simple concept, and the word "voluntary" is typically included both in consent forms and in any solicitations for participation, federal regulations require that patients understand this to mean that their participation is voluntary throughout the entire process.

In other words, participants should understand their right to drop out of a study at any time without threat of penalty. In a consent form, auditors should not stop once they see a statement that says participation is voluntary, or even a statement that says the participant is free to discontinue his or her participation at any time. They should read on to make sure there are no contradictory statements that might reduce or eliminate the voluntary nature of continued participation.

This is an excerpt from a member only article. To read the article in its entirety, please login.

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