Current regulations and guidelines identify specific subject populations as vulnerable. Regulations and guidelines generally stipulate protections with regard to the process of informed consent. Recent clinical trials suggest that satisfying the legal requirements for additional safeguards may not protect subjects to the extent we may desire. We present proposed guidelines for the protection of decisionally impaired subjects throughout the course of the trial.
Bibliographical noteFunding Information:
Existing guidelines and guidance come from a variety of sources. For clinical trials funded by the Department of Health and Human Services, which includes the National Institutes of Health, vulnerable subjects and the required additional safeguards are described in what is known as the “Common Rule.” Eighteen Federal departments and agencies are required to adhere to the Common Rule in the conduct of clinical trials. Fifteen have included the Common Rule text into their chapters of the Code of Federal Regulations (). Three other agencies have incorporated the Common Rule either by legislation or Executive Order. The Food and Drug Administration (FDA) also has the Common Rule protections with some modifications written into the regulations covered by their jurisdiction. ,
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- Vulnerable subjects
- clinical trials
- decisional impairment