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The first in a projected series of new white papers on timely issues in drug and medical device research and development from the Association of Clinical Research Professionals (ACRP) focuses on clearing up potential misunderstandings about the critical process of informed consent, which must be conducted with volunteers for clinical trials.
Now available for download at no cost on ACRP's website, "The Process of Informed Consent" white paper was developed by members of ACRP's Regulatory Affairs Committee to reflect best practices for principal investigators (PIs) and clinical research coordinators (CRCs) seeking to obtain valid and appropriate informed consent from patients to participate in research, as an important protection of the rights and welfare of these human subjects.
Following longstanding practice, obtainment of informed consent involves both the "consent dialogue" between PIs/CRCs and patients, and documentation of the patient's consent on an informed consent form that has been approved for the specific study by the appropriate institutional review board/independent ethics committee. Unfortunately, according to the white paper's authors, in the United States, the current Department of Health and Human Services and Food and Drug Administration regulations setting the requirements for informed consent do not address this important and sometimes delicate "process" in sufficient detail.
Indeed, the federal regulations on informed consent requirements first promulgated in 1981 have never been revised or updated since then, despite the remarkable evolution of medicine with its sophisticated healthcare technologies. At the same time, the field of research ethics has also evolved, including the understanding of, and emphasis on, informed consent by clinical research professionals.
There have been many national and international working groups, as well as numerous ACRP conference sessions, devoted to identifying ways to improve informed consent, and, according to the white paper, "Given the current length and complexity of informed consent forms, the need for research personnel to engage prospective subjects in an effective informed consent process has become critical."