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Michael Causey

FDA Compliance

FDA Plays Catch-Up

It’s a brave new world of electronic consent

Published: Thursday, April 23, 2015 - 13:47

Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises faster, cheaper access to potential trial participants, and unimagined data streams to boot, the guidance comes at an important time for the clinical trial world.

Never accused of being early adopters of technology, clinical trial folks need to heed the FDA’s new guidance. Used properly, it can serve as something of a road map as everyone veers into previously unchartered territory.

First, understand the FDA’s expectations as laid out in the new guidance. It expects subjects to receive enough information to allow for an informed decision, and an easy way to ask questions and receive jargon-free answers.

When using an eIC, the FDA requires it to contain all elements of traditional IC, but also requires that any interactive eIC program be easy to navigate, including a way for the subject to stop and return to it later. Further, eIC tools must meet any subject’s physical limitations, e.g., poor vision or impaired motor skills. Perhaps most importantly, the eIC “must be presented in a manner that minimizes the possibility of coercion or undue influence” regarding the subject’s decision to participate in a study.

The FDA requires an investigator to obtain the informed consent, but if the investigator delegates the responsibility, it’s his or her obligation to hire a surrogate with demonstrable credentials. Nothing new there. But it gets a little more complicated when it comes to eIC. For example, consent can be handled remotely. However, when the consent process isn’t personally witnessed by study personnel, the eIC should include a method to ensure that the person giving consent is the person participating, or the subject’s legally authorized representative. The subject must also have the opportunity to ask questions and receive answers before actually signing electronically.

A subjects’ questions can be answered in a number of ways, including text message, phone calls, and videoconferencing. The data and communications must be secure. Subjects should also be told in advance how and when they will receive answers to questions and given information on how to contact an appropriate individual with questions about the investigation, the subjects’ rights, and whom to contact in the event that a research-related injury occurs.

The FDA also issues some eIC direction to institutional review boards. “A critical part” of an institutional review board’s responsibility is to ensure that there’s an adequate, informed consent process in place that protects the rights and welfare of subjects participating in clinical investigations. Further, the agency recommends, but does not outright require, that an investigator discuss plans for using eIC with the institutional review board before finalizing development of the eIC to ensure that the institutional review board agrees that a particular format may be used for obtaining informed consent.

The FDA remains neutral when it comes to archiving documents. That said, the agency does weigh in on “cloud” and other remote storage solutions. Data privacy laws and regulations that apply to the remote site, in addition to those that apply to the research site itself, “may apply and should be considered.”

Finally, the agency reminds us that when one of its cheerful investigators is waiting in your lobby, he or she will be expecting access to records and reports made by the investigator, including site-specific versions of eICs, materials submitted to IRBs for review and approval, all amendments to the site-specific eICs, and all subject-specific signed eICs. Any updates to the documentation must also be available for review.

Comments on the guidance are due May 8, 2015. When submitting your input, refer to docket No. FDA-2015-D-0390

First published April 9, 2015, on the AssurX blog.

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About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.