An Institutional Review Board (IRB)—also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB)—is an administrative body protecting the rights, privacy, and welfare of clinical research participants. Its members are responsible for reviewing research plans and have the authority to approve, disapprove, monitor, and ask for modifications.
IRBs are increasingly supportive of eConsent solutions—perhaps because they are all too familiar with paper-based consent issues such as outdated ICFs and lack of traceability. Even so, researchers may find themselves in need of guidance as they prepare for an eConsent IRB review.
What does the eConsent IRB review process look like?
From an IRB point of view, reviewing an eConsent study is different from reviewing a paper-based consent study. When considering an eConsent study, the IRB considers both the informational content and the platform participants will use. Screenshots will not suffice, as reviewers need to engage with the content in the same context as a participant will—including any hyperlinked content or interactive sections.
During the review, the IRB will consider the overall length and presentation of information. They’ll also want to see technical concepts broken down and medical jargon eliminated or explained whenever possible. This article will break down the steps of eConsent review and the key considerations researchers should be prepared to address.
Expect local differences
Countries and regions differ in policy regarding eConsent, so researchers need to familiarize themselves with their applicable IRB guidelines. In general, however, IRB and ethics committee have consistent requirements for paper and electronic consent, which include:
- IRB-approved language and format
- All elements of informed consent as required by HHS or FDA
- Signatures of participant and researcher
- Study staff involvement
- A copy of consent provided to the participant
What to include in your eConsent IRB submission
A well-prepared eConsent submission will result in fewer requests for changes by the IRB—saving your trial both time and money. Must-have items in an IRB submission include information about the consent workflow, assessment of patient comprehension, the wording of documents, the eSignature process, and any special circumstances. Let’s look at each of these more closely.
1. The consent process
The informed consent section of the IRB application form should include a description of whether the consent discussion will be face-to-face, remote, or a combination.
If the consent procedures will not happen face-to-face, then the IRB will consider whether the procedures will be as effective and meet the goals of the informed consent process. Therefore, when using eConsent, it’s important to address the following questions:
- Who will conduct this discussion?
- How will participants provide proof of identification?
- How will participants be approached for consent?
- Who is introducing consent?
- When will participants be asked to provide consent?
- What platform will be used for remote consent discussion? (eg. phone, Skype, Castor eConsent videoconferencing, etc.)
2. Patient comprehension assessment
An IRB submission should also clearly explain how researchers will ensure patients meet the criteria of informed consent. Explanations should answer questions such as:
- How will the study be explained to participants?
- How will their understanding be assessed?
- How will questions be answered?
3. The wording of documents
Some studies plan to use a mix of paper consent and eConsent. In such a case, the wording in the eConsent document might be different than that of the paper consent form. (For example, it may reference the collection of email addresses or the use of video chats.) If this is the case, then the eConsent text should be provided to the IRB as a separate document. However, if the exact same wording will be used for both processes, then this should be clearly noted in the submission.
4. eSignature process
An electronic signature is an integral aspect of eConsent, but eSignature requirements vary by country—a factor impacting global eConsent adoption. While not every country accepts both eConsent and eSignature, the situation is evolving and it is anticipated that eSignature acceptance will soon become universal.
In the US, for example, a valid electronic signature for consent can be the subject’s typed name or even simply a checkmark or an X—as long as the symbol is logically associated with the person making it. When reviewing the e-Signature element of a study, an IRB will want answers to the following questions:
- How will the electronic signature be created?
- How can the signature be proven legitimate?
Also, in order to satisfy HIPAA regulatory requirements, an electronic signature is only valid if there is an option “for the signatory to receive a printed or emailed copy of the contract.” An IRB application should therefore include a description of how participants will be provided with a copy of their signed consent document. For example,
- Can participants download a PDF of the signed consent?
- Will the site staff download the PDF, print it, and send a paper copy to each participant?
- Will site staff send an emailed version to each participant?*
*In this scenario, the IRB application needs to 1) include the collection of email addresses as part of the data security plan and 2) show how participants will be informed of such in the privacy/confidentiality section of the consent form.
5. Special circumstances
Finally, an IRB submission may need a section to address special circumstances related to eConsent. These would be customized to meet a trial’s unique needs. For example, this section might contain answers to questions such as:
- How will assent and parental permissions be obtained for minors? What if two-parent signatures are needed?
- How will the translation be addressed for non-English speaking participants? How will consent be witnessed in this scenario?
- What if a participant doesn’t have the right technology to use eConsent?
My paper-based study is approved and I want to switch to eConsent. Now what?
If the research is already approved but now needs to be modified to incorporate eConsent processes, then an Amendment should be submitted for IRB review. It should include:
- The rationale for making these changes.
- A statement of whether the eConsent is a temporary (eg. to support social distancing) or permanent addition to the study.
The need to track changes and amendments
An IRB often asks for modifications to a proposed study and reviews it again once changes are made. An IRB review can be an extended and iterative process, requiring careful documentation along each step.
A well-prepared IRB submission can greatly reduce modifications or the risk of rejection. If you are planning on using eConsent in a trial, clearly document in your submission how it will be used and cover potential questions that the IRB may have. This will give you the best chance of early success in obtaining approval and moving into patient recruitment.
At Castor, we are thrilled to see eConsent studies gaining momentum and IRB reviewers’ eagerness to embrace this new age of progress. If you want help setting up a study that meets IRB requirements, reach out to our friendly team members. We’re not only knowledgeable about all things eConsent—we’re also thrilled to help sponsors and study designers.