eConsent: Everything You Need to Know | Quorum Review IRB
Electronic informed consent (eIC or eConsent) refers to software programs that provide a digital means of obtaining informed consent. It can be used in a traditional medical setting or as part of clinical research.
In December 2016, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) published joint guidance related to the use of eConsent, which acknowledged, “The research community is showing increasing interest in using electronic media to supplement or replace paper-based informed consent processes.”
Paper plays a major role in today’s research, and there are many reasons why our industry continues to rely on paper-based processes: regulatory uncertainty over alternatives, varying levels of technology integration at research sites, competing priorities, and even resistance to—or fear of—change. But paper-based processes can be inefficient, and the research industry is experiencing a shift in how informed consent is gathered. Several factors combined with the problems of paper consent put eConsent at the center of this shift:
- Slow integration of technology into clinical research
- The way technology changes our expectations and behavior
- The emphasis on participant recruitment and site performance
- The opportunities offered by digital technology
Many clinical trials sponsors have eConsent initiatives in play, whether developed independently or through industry work groups. As a large Institutional Review Board (IRB), Quorum Review IRB can affirm that the use of eConsent is growing—and it has become increasingly clear that the right eConsent solution has the potential to benefit research stakeholders, including sponsors, contract research organizations (CROs), research sites, and participants.
In the same way that digital technology changed how we interact with news media, books, and each other, eConsent will permanently change how researchers carry out consent discussions. Ultimately, those changes will give way to a revolution in what sponsors, CROs, IRBs, sites, and participants expect out of electronic informed consenting.
eConsent: A Powerful Tool
eConsent can be a powerful tool to facilitate the clinical research process, particularly as digital technology becomes more common in many people’s daily lives. eConsent has the potential to improve participant engagement, reduce consent documentation errors, and ensure compliance and security. Some studies suggest that participants retain more information through eConsents than with paper equivalents, and research monitors value the prospect of reviewing a site’s enrollment progress remotely. For all of these reasons, more and more researchers are interested in incorporating eConsent solutions into their trials.
eConsent, at its core, is the electronic presentation of the informed consent form (ICF). In addition, eConsent software offers other features, such as electronic signatures, instructional videos, interactive graphics, and remote monitoring. (Note: There is a difference between remote consent and eConsent. Remote consent is the process by which the consent discussion and the signing of the consent form take place when the researcher and prospective participant are in different locations—which is not normally the case. Whereas eConsent serves a broader range of studies than only those with remote consent.)
Evaluating eConsent Solutions
There are many considerations researchers must take into account when deciding whether to use eConsent. For example, researchers should consider whether eConsent is appropriate for their trial—for example, does the eConsent product in question account for the age of participants in a pediatric trial or accommodate legally authorized representatives in Alzheimer’s research? Researchers also should ensure that any solution they take complies with all relevant regulations, such as the requirements of Part 11 and HIPAA.
Finding the right eConsent solution can be challenging, but one thing that all researchers should demand of their solution is that it offers the ability to use a paper consent form without interrupting normal processing. They should also be aware of the time it takes to implement the solution, whether it will disrupt anticipated timelines, and its cost-effectiveness.
As of late 2017, a handful of eConsent platforms are available to researchers. The industry can reasonably expect to see that number increase, making it even more critical that researchers have the best tools for evaluating eConsent options at their disposal.
Fortunately, more and more materials and resources are available to researchers who may want to incorporate eConsent into their research. Not only have regulatory bodies such as the FDA, NIH, and OHRP published guidance and expectations documents, there are many consulting groups with regulatory and clinical trial expertise. Plus, any eConsent vendor should be able to demonstrate that its product complies with all technical and regulatory requirements, possibly through third-party assessments.
Barriers to Adoption
The FDA, in conjunction with other regulatory bodies, has given its blessing for the broadened use of eConsent in clinical trials. Yet eConsent adoption remains slow, possibly because of the number of regulations involved. Combined with the wide variety of available platforms, deciding on the best solution for a researcher’s needs can be a dizzying prospect. Many companies have seen very little eConsent use among their peers and may not know what to expect, which can lead to a perceived risk in adopting eConsent over existing paper processes.
Research stakeholders also may question the cost-effectiveness of current eConsent tools. Depending on the size of the study and its budget, the expense of adding eConsent may outweigh any expected advantages. In addition, some eConsent products require weeks or months to prepare, which can lengthen crucial study startup timelines. In short, added time, added expense, and uncertain regulatory requirements all may contribute to the apparent lack of adoption of eConsent.
Submitting an eConsent Study for IRB Review?
Depending on the solution used, the IRB review process for eConsent-enabled studies can be very simple or involve several steps. No matter what solution is used, the IRB must approve the paper and electronic versions of the consent form before the study can begin. The sponsor or researcher should indicate on submission forms that eConsent will be used for a given study in order to allow the IRB time to ensure appropriate reviewers partake in the initial review. In general the IRB will need to provide initial approval of the plan to conduct the study using eConsent, and then will review the final electronic consent document after it has been developed. For compliance purposes, this final document must accurately reflect the approved paper consent form. Any differences should be clearly documented and submitted for review by the IRB.
If your electronic consent form includes supplemental materials, such as a glossary of terms, graphics, images, or video, you must submit these materials for IRB review along with a description of how they will be used. Board review is generally required for changes to the informed consent or electronic informed consent throughout the life of the study.
The electronic version of the consent form should be submitted in a universal file format. Be sure to check with your reviewing IRB for specific submission requirements for eConsent-enabled studies.
And if you’re unsure how to prepare your study or your research site for the use of eConsent, it may be worthwhile to engage a consultant with appropriate regulatory knowledge to help in the early development stages of eConsent-enabled studies.