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Compliance In Focus
Posted by Shawn Kennedy on Fri, Jul 18, 2014

New Draft Guidance Released: Informed Consent Information Sheet!

It should come as no surprise that FDA has released a new draft guidance regarding informed New Draft Guidance Released by FDAconsent.  Every year, FDAs Bioresearch Monitoring Program (BIMO) releases summative information on the results of the inspections they have conducted on their website.  The results of the inspections conducted are a yearly focus of IMARC as we try to make sense of what the FDA is most concerned with regarding the conduct of research involving human subjects.  Almost inevitably, the most frequent citation from an FDA inspection at a clinical investigation site pertains to improper or inadequate informed consent.  Given that informed consent is one of the most important parts of the research process, it makes sense in that FDA is sharing yet again their “current views” on the concept.

The previous FDA guidance on a guide to informed consent was last released in September 1998.  The current guidance, once finalized, will replace and supersede that one.  We seek to provide the reader with an overview of some items included that are more detailed than the requirements spelled out in 21 CFR Part 50.  As always, with draft guidance, FDA seeks comments and suggestions based on the document for 60 days from its release.   Comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Here is a list of some of FDAs current thinking on the topic:

  • Care to avoid coercion and undue influence should be taken when an employing party seeks to enroll its employees, the investigator is also the prospective subject’s physician, and when the research involves the surgical implantation of an investigational device and informed consent is obtained in the pre-operative area.
  • Overstating claims of potential benefit, including statements like "FDA has given permission for the clinical investigation to proceed" or "FDA has approved the clinical investigation” should be avoided.
  • Informed consent forms should be provided to the subject in a language understandable to them which means not only in their native language, but at their reading level.
  • The following statement is recommended regarding exculpatory language: “In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research.”
  • Potential subjects should first be informed of care they would receive if they do not participate in the research, followed then by the information about the study.
  • Risks should include those pertaining to the research, as well as those related to standard of care received during the course of participation.
  • Payments to subjects may be provided for expenses and inconveniences, and should be outlined in the consent form.
  • The guidance provides examples for compensation and medical treatment in the event of a research related injury, whether it will or will not be provided.
  • Regarding contacts, “FDA recommends that the individual or office named for questions about subjects' rights not be part of the investigational team. Subjects may be hesitant to report specific concerns or identify possible problems to someone who is part of the investigational team.”
  • The guidance reminds of the requirement for the subject to date the consent form, and expands to say that while the regulations do not require the signed/dated copy be provided to the subject, FDA recommends this.
  • “In those cases where the subject provides consent on the same day that he/she begins participation in the clinical investigation, the subject's case history must document that the subject provided consent prior to participation in the research.”
  • “Some subjects may wish to participate simultaneously in more than one clinical trial or enroll in a single clinical investigation multiple times. FDA strongly discourages these practices as enrollment in more than one clinical investigation could increase risks to subjects, particularly because they may be exposed to more than one investigational product for which the safety profile may not be well understood.”

These are just a sample of the points that resonated with us when reviewing the draft guidance.  By the very nature of it being a “draft” guidance, the final release may differ.  We’ll be sure to generate a follow-up blog when it becomes final.  In the meantime, we’d love to hear your thoughts on it.  Do you feel it covers all of the concepts you have always wished FDA would make more clear regarding the informed consent process?

Photo Credit: marcospozo


Topics: New Draft Guidance, Informed Consent Information Sheet, FDA


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