August 29, 2013

Digital Informed Consent Could Speed, Streamline Medical Research

By Lee Aase, Director, Mayo Clinic Social Media Network

Lee Aase croppedObsolete notions of the appropriate process for informed consent are among the main obstacles to social networking platforms achieving their potential in facilitating medical research. Moreover, they prevent us from effectively meeting the expectations of our patients.

The inherent power of social tools is their ability to overcome barriers of time and space. But if the informed consent process must continue to take place in face-to-face encounters or by using standard mail services, this substantially reduces the potential for social tools to make a difference.

An article published today in Clinical Informatics News suggests that this may be about to change.

In an industry-wide effort to make clinical trials more patient-centric, sponsors are beginning to look at the informed consent process as more than a dry but mandatory paper document that describes the study protocol in all its complexities to potential study volunteers. Driven by a desire to streamline clinical trials, meet strict timelines, and embrace suggestions from an Institute of Medicine report on improving clinical trial quality through a more patient-centric view, sponsors are poised for meaningful change.

At the same time, input from the Food and Drug Administration is spurring interest in a better informed consent process. In August 2013, a new FDA guidance on risk-based monitoring was released, which states that use of electronic informed consent may facilitate sponsor oversight of human subject protection.

While the FDA's non-binding guidance isn't directly about electronic informed consent, its statement that "Use of electronic informed consent may also facilitate sponsor oversight of human subject protection" assumes that e-consent is appropriate in at least some circumstances.

Given that the FDA has suggested that electronic informed consent has a place in protection of human research subjects, this seems to seems to be an opportune time to examine the role of social tools in research recruitment in a way that would make a difference.

Having personally filled out a paper-based informed consent document for a study, I believe a low-cost video explaining the main points could help potential participants better understand what they're signing. And those who still have questions could get them answered in a secure way, either by encrypted text-based messaging or in a live encrypted video chat.

Many studies have difficulty reaching recruitment goals, and part of the problem is identifying and consenting participants, which is time consuming both for study personnel and potential subjects. I believe an electronic consent process could make recruitment staff more efficient, saving them the time of repetitive explanations, and instead letting them focus on answering specific questions.

What do you think? How could an electronic consent program be designed to ensure that potential participants are fully informed before they give consent?

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Digital Informed Consent Could Speed, Streamline Medical Research
Digital Informed Consent Could Speed, Streamline Medical Research | Mayo Clinic Social Media Network
Use of electronic informed consent may also facilitate sponsor oversight of human subject protection

Tags: Legal & Ethical Issues

Excellent observations, Lee! E-consents hold the potential reduce errors (they eliminate the risk of missing information or signatures), improve subject understanding and accelerate subject enrollment. These points were covered recently in a presentation at the 2013 ACRP Global Conference (see link). Much of the work that I have been involved with has centered on the notion of e-consent solutions aiding investigators with educating patients about a given study. In terms of recruitment, as you observed, the greatest benefit of e-consent tools may lie in their ability to assist with subject identification. My experience has been that the more “knowledgeable” the e-consent tool is about a particular group of subjects, the more effective it can be at facilitating subject recruitment. Note that the foregoing is of course dependent on those potential subjects having given their consent to the electronic scrutiny of their medical histories and IRB approval has been secured when indicated. In addition, the evolving Meaningful Use requirements will continue to expand opportunities in the area of Digital Informed Consent! Exciting times!

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