By Mitchell Parrish and Kay Neth
Quorum Review IRB recently aired a webinar on how eConsent optimizes research for sponsors and CROs, and what organizations should look for when evaluating electronic informed consent solutions. Viewers had a lot of great questions, and we’re here to answer them all. In Part 1 of this series, our expert presenters addressed questions around compliance, security, and accessibility. In Part 2, Mitchell and Kay answer questions about researcher roles and responsibilities and the IRB review process for eConsent.
Researcher Roles and Responsibilities
Q: Will the sponsor, site, or vendor be responsible for updating the eConsent tool with the most up-to-date version of the ICF?
A: The sponsor is responsible, as it has always been, with updating the actual consent form and its content and ensuring IRB review and approval is obtained. However, the eConsent vendor should have the mechanism for taking the current version of the consent form and updating the consent form in the eConsent solution accordingly.
Q: If a sponsor is in one state conducting a research study through a database, but is [enrolling] a patient in Indiana or California, do the state laws (i.e. Indiana or California) apply? Or does [the state law] in which the sponsor is actually conducting the study apply?
A: The consent form should address the laws of the state, or states, where participants might sign it. For example, if a participant will sign a consent form in Hammond, Indiana, the consent form should comply with Indiana state law—even if the research institution is just across the border and fewer than 30 miles away in Chicago, Illinois.
When you are choosing an eConsent vendor, ensure that the vendor understands how state law impacts consent forms—and how the IRB interprets and applies state law in consent forms. An eConsent vendor’s development process and functionality should play well with the IRB’s requirements and processes for integrating state-specific consent form text into the consent form for a site located in that state.
Q: Will the tracking signature function include the PI’s signature? Even if they are not the consenter?
A: Yes. An effectively designed eConsent application will track whether all necessary signatories have signed a given consent form—including the investigator.
In the scenario where the investigator is a required signatory but the consent discussion is conducted by a delegated member of the study team, an eConsent tool should;
- Note whether the investigator has signed the consent form (and whether the completion of the consenting process for a given participant—and therefore enrollment—is pending the investigator’s signature).
- Facilitate routing of the consent form to the investigator after the participant and designated staff member have signed. An eConsent application should also permit the investigator to access and electronically sign the consent form within the e application (instead of traditional waiting and routing of paper-and-ink records).
Signatory scenarios—meaning, rules around who signs the form and when—are shaped by sponsor and site policies, the nature of the study, and IRB determinations. An eConsent product must be flexible enough to accommodate, and track, signatory scenarios that will or could arise in completing a given consent form.
Q: eConsent stores the e-signed document—can this signed document be printed out by sites? We’ve had some sites decline to use eConsent as their site’s SOP requires they have a hard copy of the signed document in their source document.
A: In addition to accommodating participants who prefer paper-based consenting processes, an eConsent tool should meet the needs of sites with SOPs that require signed hard copy consent forms in the source document. The eConsent tool must allow site staff to easily print a digitally signed consent form for recordkeeping.
eConsent also offers a safety net of sorts: A digitally signed consent document, automatically stored within the eConsent tool, can be reprinted and added to the source file if it is ever lost. A photocopy of a hand-signed paper consent form is not so easily replaced.
Q: Will eConsenting meet the PI’s responsibilities to explain the research to a subject and also give the subject ample opportunity to have all questions answered?
A: With the right functionality, eConsent will enhance, not compromise, the consenting process.
The FDA and OHRP anticipated questions about the impact of eConsent on how consent is conducted, and who conducts it, in in their jointly prepared December 2016 Use of Electronic Informed Consent: Questions and Answers – Guidance for Institutional Review Boards, Investigators, and Sponsors.
The guidance affirms that “[I]nformed consent must include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity for the subject to ask questions and consider whether or not to participate (45 CFR 46.116 and 21 CFR 50.20).” Moreover, “… the responsibility for obtaining informed consent remains with the investigator and the study personnel to which responsibility has been appropriately delegated. The investigator cannot delegate authority to obtain informed consent to the electronic system.”
An eConsent solution does not replace study staff’s role in the consenting process. Rather, it provides site staff with new tools to fulfill their regulatory and ethical obligations during that process.
Q: Has anyone had experience with IRBs approving eConsent or remote consenting? What seem to be the main points of concern from an IRB perspective?
A: The FDA’s December 2016 Final Guidance speaks to remote consenting. The Guidance notes that eConsent can be used to provide remote access to the consent materials, to conduct the consent process remotely, and to obtain data from remote locations. Therefore, it is clear that remote consenting is permissible.
If an IRB were to raise concerns, it would likely be in the following areas, which are also addressed in the FDA’s Guidance:
1) With remote consenting, the participant’s signature may not be personally witnessed. To address this concern, the eConsent solution must be Part 11-compliant, in that it includes a method to ensure that the person electronically signing the consent is the participant or is the participant’s legally authorized representative.
2) With remote consenting, the investigator must still ensure that the participant has sufficient time and the ability to ask questions and to have these questions answered. In other words, remote consenting should include a plan for how the consent discussion will occur, whether through a combination of electronic messaging, telephone calls, video conferencing, or a live chat with the investigator or delegated study staff.
3) With remote consenting, information may be shared electronically. Therefore, if an eConsent solution is used to facilitate this remote consenting, it must comply with applicable security regulations (i.e. Part 11 and HIPAA).
Q: Will Quorum work prospectively with an IT company who wants to enter the eConsent process? Would it have to be associated with a submitted protocol or could it be done beforehand? Would there be a fee for this?
A: Quorum welcomes opportunities to work with eConsent vendors—as part of a submitted protocol or in advance of review of a submission. If the work with the vendor is related to a submission that is under our purview as an IRB, then additional charges are not typically incurred.
Q: How do e-consent solutions manage obtaining IRB stamps of approval on the informed consent forms?
A: The approach to stamping a consent form that will be accessed via an eConsent application is dependent on the vendor. For example, an IRB might provide the vendor with a stamped copy of the consent form, which the vendor then integrates into the eConsent tool. If the vendor does not have a history of integration with the IRB, how the stamp is obtained is an important question to vet early in the eConsent development process. Sites’ procedures or polices might require the stamp on the consent form, regardless of whether it is a paper copy or digitized.
As eConsent adoption increases, however, the stamp might become a ghost of the paper-based consenting past. Consider: The FDA and OHRP do not require a stamp on the consent form— they call for the consent form to be readily identifiable as the current, IRB-approved form, and a stamp is one mechanism to accomplish this. An eConsent solution has potentially other, more effective means of ensuring and documenting that the consent form is current and IRB-approved. In addition, an eConsent system should be able to deliver the current IRB-approved consent form directly into the devices used to access it, which reduces the risk of the site or participant referring to an outdated or otherwise incorrect version. Finally, consider that a stamp in effect assumes a paper form, or a paper-like presentation of information. Over time, the built-in version control functionality of eConsent to verify that the consent content is current and IRB-approved will allow for more flexibility in what consent looks like and the types of media used in consenting.
More to Come
In Part 3 of this blog, Mitchell and Kay will address questions integration, implementation and eConsent security.