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Home PI eAlert Back Issues No. 34: Research Compliance: Can a non-MD, who is trained, handle the consent process for a participant in a clinical trial or other study?

Jun 21

No. 34: Research Compliance: Can a non-MD, who is trained, handle the consent process for a participant in a clinical trial or other study?

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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.

Comments (10)
Director of Research and Education
written by Anonymous, June 14, 2010
Co-Investigators who are intervening with subjects and have the proper training and qualifications are able to consent study subjects. However,that information must be stated in the IRB study documents and the co-investigators must be authorized to consent subjects by the PI.
Professor and Director of Neuropsychopharmacology Research and Center for Clinical Studies, Department of Psychiatry, Mercer University School of Medicine
written by Samuel D. Shillcutt, harm.D.,Ph.D., June 21, 2010
I agree that a non-physician, with training in GCP and approval by IRB, can participate in a clinical trial as principle investigator and can appropriately consent a subject for trial participation. I have successfully and safely conducted 22 trials as principle investigator. During these trials, there has been a clear distinction between co-investigator/sub-investigator responsibilities particularly concerning those that are to be performed by physician and non-physician investigators and these responsibilities are approved by the sponsor and IRB(s) prior to initiation of the trial.
Research Associate, City College of New York, CUNY, New York 10031
written by Vidyasagar Sriramoju MD, June 21, 2010
I agree with the expert comments on this question. According Angela R Holder LLM of Yale, in her paper published in 1985, "Criteria for qualification to do biomedical research on human beings are not related directly to licensure status. They are related to acceptability as a member of the institutional community and demonstrated performance capacity".

I advise the readers to refer the following article for in depth review of topic simillar to this.
1.The Unlicensed Physician in the Research Institution
Angela R. Holder, IRB: Ethics and Human Research, Vol. 7, No. 3 (May - Jun., 1985), pp. 5-6 Published by: The Hastings Center
Stable URL: http://www.jstor.org/stable/3563628
written by Risk Averse, June 21, 2010
With the previous comments all agreeing, I get neervous. This is all a little too pat for me. In some clinics and hospitals the professionals of all stripes all wear white lab coats (even some medical students!) I submit that in most cases this buffaloes the patient who is a study candidate to "assume" the person talkng to them is an MD. Most patients do not understand the gradations and niches within a big center; anybody in a white coat is assumed to have appropriate authority.(Hence the old joke about even the painters being able do perform GYN exams).My point: shouldn't the non-MD, no matter how qualified elsewise, be required to reveal to the patient he/she is NOT an MD, but is nonetheless fully informed etc. Failing such revelations, if I were a plaintiff's attorney, I would surely pursue courtroom testimony along the following lines for a patient injured in the study: "And did you not assume the white-coated person explaining the risks was an MD? (Of course) Did he/she ever tell you he/she was NOT an MD? (No) Would it have made a difference in your intensity of belief in the risks being described for this study? (Of course; or, It might have). Need I go farther with how bad this could be made to look? I don't give a damn what the regs say or don't say. Maybe it's all legal. But HOW WILL IT LOOK TO A JURY?. I recommend this "court " ezine take a recess until you get comment from a clinical risk manager and a plaintf's attorney who altruistically cares about hospital risk avoidance.
Manager, Regulatory Services for Spectrum, Stanford School of Medicine
written by Jennifer Brown, RN, June 21, 2010
Even though the FDA has minimal formal guidance or regulatory direction regarding the informed consent process, the agency has recently finalized a new guidance on Investigator Responsibilities, which addresses training and supervision of persons to whom study activities are delegated. http://www.fda.gov/downloads/D...187772.pdf Additionally, there are several recent Warning Letters which remind us that the regulations do require that persons performing study activities be qualified by education and training. If the study is complex and involves novel medical treatment, it is a good idea to make sure a physician is available to answer questions that may come up during consenting that a non-physician may not be qualified to answer.
Professor of Reproductive Biology in Obstetrics and Gynecology, Washington U School of Medicine-St. Louis
written by Frederick Sweet, June 21, 2010
Let us recall that the concept -- indeed principles -- of informed consent emerged in 1947 out of the Nuremberg Tribunal that had convicted Nazi doctors (who had complied with the letter of Third Reich's laws) of crimes against humanity. After convictions had been handed down by the Tribunal, the ten points of the Nuremberg Code were drafted.

The discussion above mainly focuses on the introductory sentence in Point #1 in the Nuremberg Code that states: "The voluntary consent of the human subject is absolutely essential..." Indeed, compliance with this and subsequent American medical legal standards seem entirely focused on consent. Yet the remainder of Point #1 that is equally important states, the experimental subject: " ... should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision."

That leaves open the question of how well in our increasingly bureaucratic, one-size-fits-all world each individual subject can make an "understanding and enlightened decision?" Indeed, this is alluded to in the concluding comments (above) by Kristin H. West.

In answer to the question: "Can a non-MD, who is trained, handle the consent process for a participant in a clinical trial or other study?" must be provided not by the Principle Investigator but rather by the prospective experimental subject(s) to be consistent with the spirit of the Nuremberg Code.
Profession of Medical Education / Bioethics
written by Martin H.Greenberg , MD,FAAP, June 22, 2010
While I agree that there are many situations where a non - MD can be responsible to obtain the informed consent for a reseach project. Where I would insist the PI [ MD or other clinician should obtain consent are those studies where quality of life issues are a concern [ ie late stage cancer or other situations where a patient may have a terminal or life-threatening problem.
Research Coordinator
written by Cindy Mendenhall, CCTA, June 23, 2010
I think it is ok for a, "non-m.d." to present the informed consent to a potential subject, however you should make sure the delegation of authority log is up to date and signed and dated by the PI. You should also assure that you document that a PI or Sub-I was in the office to answer questions and either the subject did not wish to speak to the physician or they did speak to the physician. You should document that the potential subject (or subject if re-consenting) new they had the option to speak to the physician if they wanted to. Things are a little "gray" in this area when it comes to the CFR's and in my experience, when the FDA is gray, the site should be very black and white on what they did! You should also have an SOP stating the way the Informed consent should be handled including having a PI or sub-I in the office to answer questions if the potential subject wants to talk with the physician. In my opinion there is no such thing as "over documentation!
written by Herr Doktor, June 23, 2010
I have great respect for Dr. Sweet personally, but his comments above about the Nuremburg Code are so opaque and convoluted I can't make heads or tails of them.. Can somebody please restate the nub of his advice, or at least his stance? Is he saying the patient should explain the clinical study to himself?
Principal Investigaor of Many Studies
written by Samuel W. Boellner, MD, July 12, 2010
It is really in the best interest of the patient and family for the Princiapl Investigator to be involved in the consent process. This process should also be addressed and explained in the sites SOPs. In all the studies that I have conducted, I have been involved with the consent process as well as the coordinator or sub investigagtors.

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