FDA New Guidance on Informed Consent: Updates to Required Elements

FDA New Guidance on Informed Consent: Updates to Required Elements
Many research personnel think that 
risks need to be disclosed in the informed 
consent form. Not so, says the FDA.
In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.   
While the new guidance is, in many ways, an expansion of current practices, there are several aspects that are noteworthy. It’s important to consider the evolution of FDA thinking regarding Code of Federal Regulations (CFR) required elements of informed consent. (21 CFR 50.25)

1)  Description of Clinical Investigation: A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.  (21 CFR 50.25(a)(1).)
Update: There is increased focus on ensuring that potential subjects understand that participation in clinical trials is primarily meant to test the investigational device/drug and not strictly to contribute to personal health. The FDA recommends updating the sequence of the informed consent document to first describe treatment options that could be received outside of the research or as standard of care. This should then be followed by a description of the treatments that are available in the trial.
Spin: This is a fairly large departure from the way that information is currently presented in most trials; the description of the research is nearly always presented before alternative or standard of care options. Informed consent documents and processes will need to be altered to reflect this revised sequence.     

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2)  Risks and Discomforts: A description of any reasonably foreseeable risks or discomforts to the subject.  (21 CFR 50.25(a)(2).)

Update:  FDA recommends that all possible risks do not need to be described, particularly if such a description could be overwhelming for the subject to read. Risks that are serious and more likely to occur should be included.

Spin: Although this is primarily in line with previous requirements, there is a common idea among research personnel that all risks need to be disclosed in the informed consent form. Re-education and re-training may be required to incorporate this idea in to practice. 
3)  Confidentiality: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.  (21 CFR 50.25(a)(5).)

Update: There is a new emphasis on the fact that informed consent documents should not state or imply that FDA needs permission from the subject to access medical records. In addition, the consent should not guarantee absolute confidentiality by FDA. 
Spin: This is not a well-known fact to many people involved in clinical research. It may be necessary to revise consent forms and consenting discussions in order to ensure that this is explicitly understood by research personnel and potential subjects.
How do you think this new guidance will impact the informed consent process?
Do you think that these new ways of thinking about informed consent are improvements?
Reprinted with permission of IMARC Research Inc.
Paul Cobb joined IMARC after working as an epidemiology intern in the Division for Heart Disease and Stroke Prevention at the Centers for Disease Control and Prevention. While at CDC, he worked on multiple statistical surveillance projects analyzing the relationship between sodium intake, insulin resistance, and cardiovascular outcomes. During the same time, Paul pursued his Master of Public Health degree at Emory University in Behavioral Sciences and Health Education. Prior to that, he spent five years working in multiple clinical research roles including assistant site manager, psychiatric rater, and research coordinator. His expertise lies in central nervous system, cardiovascular, metabolic, and rheumatoid therapeutic areas.
Paul joined IMARC in May, 2013 and has monitored studies investigating treatments for thoracic aneurysms, aortic dissection and transection, and robotic devices for percutaneous coronary intervention. His diverse background in surveillance, biostatistics, and site level roles creates a unique perspective on monitoring clinical trials. He is able to balance the data-driven nature of the work with the need to serve as both a collaborator and adviser for research sites. Paul follows an upstream prevention model of monitoring in which he strives to identify, correct, and raise awareness of potential issues before they become problems. 
Paul has earned CCRC credentials through the Association of Clinical Research Professionals and is a Certified Health Education Specialist through the National Commission for Health Education Credentialing. He received his Master of Public Health from The Rollins School of Public Health at Emory University and his Bachelor of Arts degree in psychology from The University of Michigan.