Federal regulatory agencies acknowledged in recent draft guidance that research informed consent is moving in directions not quite imagined several decades ago.

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) published draft guidance for industry, clinical investigators, and IRBs in the “Use of an Electronic Informed Consent in Clinical Investigations” in the March 9, 2015, Federal Register.

The agencies note that this is part of their efforts to harmonize their regulatory requirements and guidance for human subject research.1

The FDA’s draft guidance applies to FDA-regulated clinical investigations, but OHRP might adopt the same positions and recommendations for non-clinical research.1

“FDA actively worked with OHRP in developing its draft guidance document on this topic,” says Irene Stith-Coleman, PhD, director of the division of policy and assurances, OHRP.

Before deciding whether to issue a final joint guidance document on the topic, OHRP and FDA will review and consider all submitted comments, Stith-Coleman adds.

The FDA’s Q&A states that electronic informed consent (eIC) must contain all elements of informed consent required by FDA regulation, and if it’s interactive, it should be easy to navigate. Subjects should have the ability to move forward or backward within the system and to stop and continue at a later time. The eIC also should be presented in a manner that minimizes possible coercion or undue influence.2

FDA also says that when written IC is required, electronic signatures can be used and is equivalent to handwritten signatures. Clinical trial sites could use an encrypted digital signature, electronic signature pad, voice print, or digital fingerprint, for instance. The electronic system also must capture and record the date of the signature.2

In general, central IRBs are very supportive of electronic informed consent, says John Isidor, JD, chief executive officer of Human Subject Protection Consulting in Cincinnati. Isidor also is an editorial advisory board member for IRB Advisor.

The electronic consent process provides opportunities for helping research participants better understand a study, he notes.

“Hyperlinks to videos and things like that could assist subjects in their understanding,” he says.

The only issue is the electronic signature, Isidor adds.

Technology that would provide a secure electronic signature could be very expensive for research institutions, potentially making eIC cost prohibitive, he says.

“I was at a recent meeting where electronic informed consent was discussed by a sponsor, and he said a template would cost between $100,000 and $300,000,” Isidor says.

It also seems probable that eIC would require sites to present subjects with self-contained tablets, which are easier to control than using computers that are integrated into their computer systems, he adds.

Electronic informed consent already is widely used in social-behavioral research and studies conducted on the Internet, Isidor notes.

“I don’t believe [the guidance] is anything novel or ahead of the curve,” he says. “It’s behind the curve, but those who are more risk averse might wait for a comment from a federal regulator before they engage in research with electronic informed consent.”

References

  1. Draft guidance for industry, clinical investigators, and institutional review boards – use of an electronic informed consent in clinical investigations – questions and answers; availability. Fed Reg. 2015;80(45):12497-12498.
  2. Use of electronic informed consent in clinical investigations, questions and answers. FDA. March 2015. Available online at http://1.usa.gov/1NRO7lP.