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RESEARCH COMPLIANCE

Can a non-MD, who is trained, handle the consent process for a participant in a clinical trial or other study?

Reader Question: Is a person with physician credentials the only person able to sign the consent form with a potential study candidate? If a non-MD is appropriately trained in good clinical practice (GCP), institutional review board (IRB) rules and regulations, and has a solid understanding of the study, can that person conduct the process of obtaining informed consent?

Expert Comments: Neither federal regulations on informed consent [Food and Drug Administration (FDA) regulations at 21 CFR Part 50 and Health and Human Services regulations at 45 CFR Part 46] nor FDA/HHS Guidance for Industry on Good Clinical Practice (GCP) [ICH-E6] specifically require that the person obtaining informed consent from a study participant be credentialed as a physician.

The regulations have plenty of “drill down” on exactly what must be stated in an informed consent, but say very little about who should conduct the consent process, other than the general statement that the “investigator” is responsible for obtaining informed consent.

In terms of signatures, interestingly, federal regulations require only one signature on a standard written consent document — that of the subject or his/her legally authorized representative. However, GCP requirements, which cover most drug and device trials, do mandate that the “person who conducted the informed-consent discussion” sign the written informed consent document. [Guidelines for Good Clinical Practice Section 4.8.8].

Nevertheless, GCP requirements don’t require a physician’s signature on the form. Rather, they simply say that the investigator, or his/her designee, is responsible for obtaining informed consent, and that person must sign the form.

FDA guidance on this topic of who may obtain consent is helpful. (FDA Guide to Informed Consent). It makes clear that, although the investigator has overall responsibility for the consent process, the “FDA does not require the investigator to personally conduct the consent interview.”

The FDA lets the investigator delegate the task of obtaining informed consent to another person. The agency doesn’t require that this person be a physician but does state that he/she should be “knowledgeable about the research.” FDA guidance also notes that the IRB should be aware of who will conduct the informed-consent process, and many IRBs require these individuals to have completed appropriate training in that process.

So you’re definitely on the right track by making sure the person getting consent knows the study and is trained in GCP and IRB rules.

Be careful about specific study requirements, though. Some study sponsors may specify in the protocol or study agreement that a physician conduct the consent process. Therefore, remember to check your study documentation.

In addition, because the informed-consent process requires a discussion of study procedures and alternative courses of treatment, you may need a physician to address these issues and/or answer a subject’s questions on these topics.

Overall, although there is no explicit requirement to have a physician sign an informed-consent form or conduct the consent discussion, you should definitely have a physician associated with the study available to field questions and concerns that may require a physician’s expertise.

Comments by Kristin H. West, JD, associate vice president and director, Office of Research Compliance, Emory University.