Electronic Data Capture and Informed Consent: New FDA Guidance

24 April, 2015, by ClinCaptureTeam

Informed consent under the FDA’s Food Drug and Cosmetic Act helps people understand the risks and potential benefits of a study, and a person must sign an informed consent document before joining a study to show he or she was provided relevant information and understands it.

Informed consent is now better aligned with electronic data capture.

Recent FDA Guidance on Electronic Informed Consent

Electronic data capture (EDC) for clinical studies offers numerous benefits over manual data capture, and those who use EDC must follow the same informed consent rules as those who don’t. Both the FDA and the European Medicines Agency offer guidance on informed consent and electronic data capture, and research sponsors and technology providers must remain informed of any changes in policies or guidance.

Research sponsors can now convey information related to the informed consent process in numerous ways, including audio-visual aids, graphics, interactive websites, and even podcasts, as long as the information provided is understandable and adequate. Electronic signatures are permitted, as long as they are in compliance with applicable FDA regulations, i.e. considered to be trustworthy, reliable, and generally equivalent to handwritten signatures on paper.

What Took the FDA So Long?

Because of the potentially monumental impact of their decisions, the FDA is careful to weigh their decisions and follow procedures with great deliberation before issuing guidance or making approvals. Technological changes have occurred at a rapid pace in recent years, and it has taken time to ensure that electronic informed consent options offer the necessary security measures to protect patient data while offering patients the information they need to make educated choices regarding participation in clinical studies. These issues are more complex when the needs of disabled or illiterate patients are taken into account, and when considering informed consent regarding children.

How Will This Ease the Clinical Trial Process?

Electronic informed consent has now been addressed by the FDA.

The new guidance explains how federal regulators will allow companies to use electronic media (such as interactive websites) to facilitate the informed consent process. A document titled “Use of Electronic Informed Consent in Clinical Investigations” states that informed consent in an EDC setting can speed up the trial enrollment process by allowing consent from locations outside a healthcare setting (such as a participant’s home).

Electronic informed consent is expected to benefit sponsors of clinical studies. For example, sponsors should have tighter version control over electronic consent forms. They can ensure that only the current, approved version is available for electronic signature to eliminate the possibility of subjects accidentally signing an out-of-date consent form. Moreover, they can track screening rates centrally across multiple research sites to better manage study enrollment. The ability to describe studies using interactive graphics and video is expected to be helpful in the consent process for pediatric studies, and studies involving people with low literacy rates.

What Are Some Potential Problems With Electronic Informed Consent?

Potential problems with electronic informed consent generally have to do with issues of secure data storage and patient privacy concerns. Participants in clinical studies must be informed of the risks involved with storing or viewing consent documents on their personal electronic devices, particularly should that device be lost, hacked, or subject to legal search for whatever reason. While paper copies of documents can be destroyed, electronic copies generally cannot be.

The FDA states that the computer systems that support electronic informed consent must be secured, offer only restricted access, and take measures to secure subjects’ identity, study participation, and personal information after consent is contained. When information covered under HIPAA is stored, all HIPAA requirements for privacy, security, and breach notification apply.

Conclusion

Today’s electronic data capture systems are fast, cut down on error rates, and can pull data into clinical studies from electronic medical records. What’s more, electronic transaction logs make auditing of source data simpler and store data in standard formats so it can be understood and analyzed more broadly. Challenges of expanding electronic data collection for clinical studies are being overcome every day, while costs drop and technologies evolve. The recent guidance offered by the FDA concerning electronic informed consent is just one example of such challenges being overcome. The ultimate result will be more accurate, successful, and timely clinical studies that can benefit people sooner.