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eConsent: Busting regulatory myths

‘eConsent improves the way consent is obtained, helps keep participants better informed and easily tracks study progress results’


By Neetu Pundir, director, Go To Market strategy, CRF Health

One of the major obstacles for researchers when deciding whether to adopt an eConsent approach within their study has been a lack of understanding surrounding regulatory support. While many would believe that there is little or no regulatory support for this innovative new technology, this is not actually the case. This article looks at some of the common misconceptions.

Myth #1: Regulators are more likely to approve data collected via a paper-based approach because it is tried and tested

Regulators have instead recognised that paper-based informed consent can lead to frequent regulatory breaches, resulting in fines, delays, litigation and even trial failure. As a result, regulators are driving changes on electronic informed consent and proposing best practices on how it should be used. The US Food and Drug Administration (FDA), The European Medicines Agency (EMA), The Office of the Human Research Protection Program (OHRP), The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and E-Sign Act have all expressed the benefits of proper usage of electronic informed consent.

It is critical for researchers to involve regulators and Institutional Review Boards (IRBs) or Ethics Committees (ECs) as early as possible and at every step in the process.

Myth #2: There are no definite guidelines to follow which means we cannot ensure our eConsent approach will be accepted by regulators

In 2016, the FDA released its draft guidance, ‘Use of Electronic Informed Consent in Clinical Investigations, Questions and Answers’, on the recommended approach and considerations to eConsent in clinical trials. These industry guidelines can assist researchers to set up a process that can improve audit readiness and data integrity for regulators. There are also several industry collaborations that have introduced practical recommendations and guidance to support the use of eConsent. One of these is TransCelerate Biopharma’s eConsent initiative, which seeks to facilitate broad adoption of this technology and has provided a framework for eConsent digital components, as well as a toolkit for sponsors outlining internal and external procedures, with the aim of creating a common approach.

Myth #3: Regulatory authorities in some countries will not accept eConsent

There is no specific regulation from any country that prohibits the use of eConsent and there is generally a lot of support for providing patients with an electronic consent form since it helps improve their understanding of the study. That said, there are certain jurisdictions that do not permit the use of electronic signatures, or digitally captured handwritten signatures; however, these regulations do not impact the use of eConsent. For trials in these countries, researchers can opt for a hybrid approach in which the consent process is recorded electronically but the signature is completed on a paper version of the consent form generated by the eConsent system.

Myth #4: Regulators are hesitant to support eConsent because it carries data security and privacy risks

Patient privacy and security must be managed regardless of whether paper or electronic methods are used. eConsent systems have put effective measures in place to address these risks. For example, the identity of the person who is providing consent can be confirmed in several ways, including via digital signature, password or biometrics. Regulatory officials require eConsent vendors to ensure security and integrity when using electronic signatures, based upon the use of identification codes in combination with passwords. All Protected Health Information (PHI) is securely encrypted and has limited access rights within an eConsent system.

Myth #5: Proving subject comprehension to regulators is more difficult with an electronic solution compared to paper-based consent

As mentioned, most regulators are aware of the issues with paper-based informed consent and champion eConsent due to its potential to deliver significant improvements to the consent process. One of these improvements is the opportunity to present information in a better and more engaging way, with the ability to assess an individual’s comprehension built into the system. Having an interactive interface, along with various multimedia that are typically included within eConsent, may help facilitate not only the subject’s understanding of the information presented, but also his/her ability to retain the information. eConsent solutions also provide a clear auditable record for every subject, including questions asked and date-time signature stamps. This also makes the data defensible and supports better documentation for each subject who has consented, as well as allowing sponsors to improve future consent forms.

In summary, eConsent is a technology that, when properly used, mitigates the risk categories identified and ensures the consent process meets the regulatory requirements. Its capability to improve how consent is collected, to better inform participants and to easily track study progress results in higher quality data throughout the course of the trial and has led to eConsent being increasingly adopted by study teams.

Neetu Pundir is Director of Go To Market Strategy at CRF Health,

10th December 2018

From: Regulatory



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