The clinical research community is showing greater interest in electronic informed consent. And they should. Electronic consenting offers benefits that traditional paper-based consenting does not. But with electronic consenting technology comes new complexity.
To address the regulatory and IRB complexity of electronic consenting, Quorum Review IRB recently hosted a webinar presented by Mitchell Parrish. In this blog post, I’ll discuss electronic consenting basics presented in the webinar, summarizing Parrish’s presentation and providing my own commentary. In a future post, I’ll examine the types of electronic consent and the technologies used to facilitate that consent, which Parrish also discussed in his presentation.
The full webinar recording and slides can be accessed at Quorum’s Review‘s website. In addition to covering electronic consent, the webinar addresses electronic data monitoring and storage. If these topics interest you, the webinar is well worth your time, and I highly recommend it.
So how do you know if electronic informed consent might be appropriate for your study? Parrish offers the following advice:
Of course, to follow this recommendation, you must be familiar with the types of research appropriate for electronic consenting, as well as the benefits and challenges of its adoption. Thankfully, Parrish did a great job of addressing these topics. Read on for a summary of Parrish’s points, as well as my commentary on the information presented.
When Is Electronic Consenting Appropriate?
Parrish provided examples of when electronic consenting may be appropriate, along with a sample scenario for each example.
- Online survey studies
Patients are asked their activity and pain level 3 months after receiving composite femoral components for hip arthroplasty.
- Online screening
Potential subjects are asked a series of questions about their health history to determine eligibility in a study testing a novel drug for Rheumatoid Arthritis. Since these screening questions do not require an office visit, potential subjects can be both consented and screened electronically.
- Submitting Bio Specimens via mail/Fedex
A company conducting genetics research is collecting buccal samples for analysis.
- Previously collected tissue research
Cosmetic surgery patients are contacted for their consent to use their discarded tissue to test a new topical drug for hair growth.
- In-person paperless survey research
Patients with pancreatic cancer at an outpatient oncology infusion site are provided an iPad in which to answer questions about experienced side effects.
These examples provide excellent guidance and inspiration for clinical researchers considering electronic consenting for their research studies. In addition, I’d add at-home clinical trials as a possibility, which Pfizer is pioneering with its “trial in a box.”
Before incorporating electronic consenting into your study, it’s important to understand the benefits and challenges.
Benefits of Electronic Consenting for Participants
According to Parrish, the benefits to participants include:
- Convenience – Do not have to go to a research site
- Less pressure and anxiety – Can review the consent form and consult with family members without feeling pressure to sign right away
- More informed – Participants can review the consent form at their leisure, allowing them to make a more informed decision. In addition, supplementing consent forms with electronic technologies could help participants better understand the research.
- More engaged – Electronic technologies can engage patients more than traditional paper consent documents.
I’m particularly excited about the third and fourth benefit, more informed and engaged participants. In my opinion, electronic consent is strong in these areas because of its ability to incorporate two communication mediums, non-linear text and non-text communication.
Incorporating Non-Linear Text
Traditional paper consent documents are inherently linear, meaning they have a concrete progression of beginning, middle, and end. The reader has little ability to direct the course of reading or easily skip between topics. In contrast, non-linear text offers a more self-directed, associative learning experience for readers, potentially resulting in greater comprehension.Because non-linear text offers self-direction that linear text does not, incorporation of non-linear text could result in more informed participants. This non-linear element can be incorporated into electronic consenting in a variety of ways.
For example, hypertext, a form of non-linear text, allows readers to easily skip to other text with a simple mouse click. Imagine a participant being able to click or hover over a term in an informed consent document, which would then present that participant with a definition. A paper document, on the other hand, requires that participants flip through multiple pages to try and locate a previously defined term.
Incorporating Non-Text Mediums
Additionally, informed consent documents need not be limited to text at all in the future. Electronic consenting allows us to supplement text with other communication mediums, resulting in a more immersive and comprehensive consent process. Video or interactive graphics, for example, could aid in participant comprehension, leading to more informed participants.
Benefits of Electronic Consenting for Researchers
According to Parrish, electronic consenting also has several benefits for researchers.
- Higher Enrollment? – Increased convenience for subjects could lead to higher enrollment, though there is not much data on this subject
- True Informed Consent – As discussed previously, electronic consent could help participants to be more informed, in turn allowing researchers to be more compliant and more ethical.
- More Compliant Participants – As discussed previously, participants could also be more engaged. With higher engagement often comes greater compliance.
- Convenience – No in-person appointment scheduling
- No travel reimbursement – No commuting or parking costs
- Paperless – Ability to manage documents electronically
- Industry Leader – Researchers have the opportunity to establish themselves as innovators in improving consent processes
- Increased capability – Can conduct studies with a larger participant base and more varied types of research due to ability to consent participants remotely
In the final item on this list, Parrish notes that the ability to consent participants remotely results in increased research capability. More specifically, researchers have access to a larger participant base and more varied research types due to this newfound capability. I’d add that electronic consent also increases capability with regard to patient recruitment strategies.
Availability of Additional Patient Recruitment Strategies
For example, social media can be a challenge for protocol-specific recruitment because it generally lacks robust geotargeting options (among other reasons). As a result, you risk devoting resources to attract potential participants who are not in the geographic vicinity of a research site. In contrast, online advertising on social, search, and other online platforms typically offers robust geotargeting options, allowing you to manage the location of participants you attract.
By conducting consent and other aspects of a study electronically, you can remove the need for geotargeting. Geography is no longer important when you can recruit from anywhere. An excellent example of this benefit is the recent success of Mayo Clinic in recruiting participants for a spontaneous coronary artery dissection (SCAD) study.
Mayo had great success recruiting participants via social media, in large part, because the study was conducted remotely and Mayo could recruit participants nationally and internationally. With electronic consenting, more remote studies are possible, making recruitment mediums like social media more viable.
If Mayo’s social media success interests you, you might want to check out a previous post:
Social Media for Patient Recruitment: 6 Key Factors in Mayo Clinic’s Success
Challenges of Electronic Consenting for Participants
As noted by Parrish, electronic consenting can be challenging from a participant perspective in a couple of ways.
- Consent discussion – More difficult or limited consent discussion with research staff
- Confidentiality – Access to consent documentation or answers to screening questions
Though electronic consenting can help patients become more informed in the ways discussed previously, it can also limit consent discussion. In particular, the lack of in-person discussion may prevent participants from getting all of their questions answered and fully engaging with the study information.
As a former research coordinator, I have seen many informed consent discussions, so I certainly appreciate the importance of in-person communication during consent. Face-to-face discussions typically have a natural conversational flow that encourage questions and dialogue in a way that electronic consenting might not. And these discussions also give research staff the insight needed to identify weak points in participant comprehension.
However, this challenge can be largely overcome when approached thoughtfully. For example, participant comprehension about key aspects of participation can be verified with “quizzes.” Or phone calls and secure video chat can help you mimic in-person consenting.
It’s important that researchers recognize this potential challenge and make a concerted effort to overcome it.
Challenges of Electronic Consenting for Researchers
Parrish also describes the challenges of electronic consenting for researchers, which are:
- Expense – High initial expense for infrastructure and technology to manage online documents and establish systems to validate electronic consent
- Verification – Confirming legitimacy of signature and identity of participant
- Compliance – Acceptability to auditors and in compliance, where applicable, with 21 CFR Part 11
In my opinion, verification is an area that requires particular vigilance on the part of researchers. A number of newer technologies are available on this front, and I expect that the sophistication of verification systems will continue to advance.
I’ve discussed the types of research well-suited for electronic consent, as well as the benefits and challenges of its adoption. With an understanding of these basics, you are better positioned to determine if electronic consenting is right for your study. But it’s important to understand electronic consenting technologies as well. Stay tuned when I address that topic in a followup blog post.
Do you have experience with electronic consenting? Are you considering electronic consenting for a study? Do you have benefits or challenges to add? Share your thoughts in comments below.
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