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Compliance In Focus
Posted by Paul Cobb on Fri, Oct 31, 2014

FDA New Guidance on Informed Consent: Updates to Required Elements

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informedFDA New Guidance on Informed Consent consent process:  Informed Consent Information Sheet: Guidance for IRBs,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).

  • 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.

  • 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

  • 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?

Please share any other thoughts on this topic:

Photo Credit: Marc Roberts

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Topics: Informed Consent, FDA Guidance, Required Elements


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