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by Jim Gearhart

The FDA’s Proposed New Guidance about Informed Consent


In July the FDA proposed replacing its 17-year old guidance on informed consent with a newer version. Informed consent means that anyone who signs up for a study should do so willingly and with as full an understanding of the research as possible.  This new guidance reflects the FDA’s latest thinking about the process of informed consent, the regulations that guide it, and the proper roles of those responsible for it.

While both the current and the proposed versions of the guidance stress that the consenting process must be more than presenting a document to sign, the new language suggests a change in emphasis. The 1998 guidance puts a signed consent form front and center: “…the consent form document should be the basis for a meaningful exchange between the investigator and subject.” (Emphasis mine) But the 2014 version reflects a demotion of sorts for the printed word: “…(O)btaining a subject’s oral or written informed consent is only part of the consent process.” (Emphases mine) Throughout this new version the FDA distinguishes between the informed consent process and the informed consent document. The guidance also encourages options to text-only consent forms, such as telephone interviews in some cases, or presenting information as graphs, tables, or diagrams instead of written explanations.

Quorum’s regulatory team has reviewed the draft guidance and does not anticipate any changes to Quorum’s process due to the guidance. In the meantime, here is an informal comparison of the new guidance versus the old. This blog will look at what’s changed, what’s been added, and what new emphases are apparent. (Please note that this guidance is not yet official; it’s a draft version. The FDA is accepting public comments until September 15, and will release its final guidance after that.

Comparing Old to New
Stack_PapersThe most obvious change from the old document to the new is the length. While the underlying regulations about informed consent in research are the same, the FDA’s discussion of them has expanded from seven to 42 pages. This new draft definitely is more comprehensive than its predecessor; it has more practical examples, more discussion about the practicalities of informing research participants, and more references to related guidance documents.  The FDA is capturing almost 20 years of changes in research, in technology, and in the country’s demographics. All told, maybe a six-fold expansion in size isn’t as much as it seems.

Brand New Issues
The draft guidance addresses issues that the previous version didn’t mention. For the most part, the FDA has commented on these issues in other documents, and is now pulling those comments into one place.

  •  Investigators’ Conflicts of Interest. Twice the draft guidance discusses the possible relevance of a researcher’s financial ties to a study. The guidance does not require any specific disclosures, but urges the IRB reviewing committees to take them under consideration.
  • Recruitment of Study Subjects: The FDA has said elsewhere than advertisements start the process that educates subjects about research. Now the agency’s viewpoint appears here, as part of a comprehensive discussion about informing participants about a study.
  • Diminished Capacity: The previous guidance had no mention of working with test subjects who may not have full capacity to make decision. This draft guidance devotes a page to it, and it’s an important addition. The intense study of conditions such as Alzheimer’s Disease frequently raises challenging ethical questions when research on people begins.
  • A Sponsors Role in Multisite Studies. The guidance discuss what a research sponsor’s role in the consent process can be.  Acknowledging that role, providing guidelines for it, marks a change from the last version, which said nothing about a sponsor’s participation in research.
  • Alternatives to In-person Consent Discussions A welcome update to the 17-year old guidance is a section that refers to newer technologies and the potential to use them in the consent process (e.g., electronic versions of documents, communication by email or secure portal, etc.). The guidance provides examples of when the consenting process could include something other than an in-person interview.
  • Assent in Children. The FDA has incorporated guidance from elsewhere to present the agency’s concerns over the complex and sensitive task of ensuring a child’s assent and parents’ consent when children are involved in clinical research.

Expanded or Emphasized Topics

  • Discussion about non-English speakers in research has more details than before. The 1995 guidance required that translations be ‘understandable.’ The document uses quotes just as I did there, without elaboration. Now the FDA drills down to explain that understandable means the the language and its reading level should be appropriate for a non-English speaker.
  • Speaking of readability, the guidance goes into more depth about the complexity of the consent form’s language. Although the guidance stops short of requiring a particular reading level, it encourages some alternatives such as tables or visual aids. The FDA document mentions the common standard of an 8th grade reading level, but it neither requires nor overtly recommends it.

Those are some highlights of the new guidance. This update has more detail, more specifics, and more centrally-gathered guidance for ensuring people understand what they’re doing when they sign up for a clinical trial. See the full text of the guidance for more information, and keep an eye out for a review of the final guidance from Quorum Review.



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