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The practice of medicine vs. clinical research: Regulatory and ethical implications for research informed consent

Patricia Blount (pblount@protocolsbydesign.com) is Managing Director of ProtocolsByDesign LLC, Mercer Island, WA. Barbara Vimont (bvimont@akronchildrens.org) is Director, Compliance & Privacy, at Akron Children’s Hospital, Akron, OH.

Clinical research can blur the lines between research and the practice of medicine for both physician-investigators and institutional review boards (IRBs). The question faced is, “Is it research or patient care?” The key to answering this question lies in what is intended by the physician. This intent has a significant bearing on the protection of human subjects through research informed consent.

The U.S. Food and Drug Administration (FDA) bases its separation of medical practice from clinical research not on the level of risk or the potential for benefit, but rather on the doctor’s “intent.” Medical practice is characterized by a doctor’s intent to benefit individual patients whereas clinical research is characterized by the doctor’s intent to contribute to generalizable knowledge that benefits future patients.[1] Intent is the FDA’s regulatory dividing line between the practice of medicine, which the FDA does not regulate, and research with drugs, biologics, vaccines, and devices, which the FDA does regulate, including those previously approved by the FDA and in routine use in the care of patients.[2]

The Belmont Report[3] established an ethical code of conduct in research with human subjects in 1979 after the Tuskegee Syphilis Study became widely known in the early 1970s.[4] The Belmont Report outlines three principles of ethical conduct of research: respect for persons, beneficence, and justice.[5] Federal regulations protecting the rights and welfare of human subjects are based on these principals, as are the FDA regulatory requirements for IRBs.[6]

Written informed consent is the default regulatory requirement that is intended to ensure respect for persons through investigator documentation that each subject volunteered to participate in research.[7] Only in very limited studies under FDA oversight could written informed consent be waived by the IRB.[8] However, in 2017, the FDA issued guidance allowing written informed consent to be waived or altered by the IRB for minimal-risk research (defined at 21 C.F.R. § 56.102(i) ) when the waiver will not adversely affect the rights and welfare of subjects and the investigation could not be practicably carried out without the waiver.[9]

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