Concerns raised over FDA’s informed consent draft guidance

By Zachary Brennan

- Last updated on GMT

Related tags Draft guidance Clinical trial Informed consent Clinical research

Concerns raised over FDA’s informed consent draft guidance
The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.

The draft guidance focuses not only on the elements to be included in a consent form but on the ways to avoid coercion or undue influence of a prospective patient.

Of the 23 posted comments – out of a total of 353 comments that were received – the vast majority, and especially those from academics, took issue with specifics of the guidance.  Allison Blodget, a member of an Institutional Review Board, calls for sample language to be simplified “to provide readers with text that better exemplifies everyday language that is understandable to the subject or the representative​.”

Similarly, IRB Ethical and Independent Review Services says it sees “very little new in it but it is helpful to have the multitude of FAQs and informal guidance in one place​.” The IRB goes on to chide the agency for failing to include information about the use of social media, the internet or video conferencing “in discussion of the recruitment part of the consent process or for transmission of information although all are being used​.”

Overwhelming Patients?

The Baylor College of Medicine’s office of research announced its concern with the way the guidance may over-complicate matters. “Our general concern with the guidance is that it may be used by many institutions and oversight bodies in such a way as to further complicate the informed consent process, as well as to increase substantially the burden of documentation for both investigators and IRBs​,” the college says.

In many cases, Baylor says, the proposed guidance “appears to require that the informed consent document include so much detail that it will be impossible not to overwhelm subjects. Although we agree that use of addenda and charts can be helpful in simplifying the presentation of the information, we do not think that use of these tools will overcome the problem​.”

Baylor went further than most other commenters in its condemnation of the draft guidance, noting, “We are concerned that the examples given have the potential to create an enormous burden on IRBs, and conversely, to harm vulnerable populations in particular by creating insurmountable barriers to the conduct of research in these populations​.”

Meanwhile, CRO Quintiles, which sent its comments back in 2006 for a previous version of the draft guidance, recommends that the guidance “provide a definition of ‘for cause’ and ‘directed’ inspections​” of clinical investigators.  “Because this guidance is intended for the clinical investigator, it would be helpful to address the different types of FDA inspections​,” Quintiles says.

The Good Clinical Practice Alliance Europe (GCPA) also took issue with the “unclear​” regulatory framework for the enrolment of the children of minor parents in clinical research.

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