IRBs Scrutinizing Remote Consent, Screening, and Participation in Study Protocols
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IRBs are seeing a surge in study protocols that include remote recruitment, consent, and participation, raising ethical and regulatory considerations for investigators. “We are seeing more requests for remote recruitment and consent to allow for continued enrollment in this new environment,” reports Rhonda Oilepo, MS, CIP, CHRC, CHPC, assistant vice president for human research administration at UT Southwestern in Dallas.
Previously, study protocols occasionally included remote consent, but it was usually completed via phone or mail. “Now, we are seeing requests for approval of video meetings, electronic consent, and electronic data capture,” Oilepo says.
UT Southwestern’s IRB asks investigators several questions: How will you confirm the identity of the participant? What system for electronic consent and data capture will you use to ensure your study meets 21 CFR Part 11 compliance for FDA-regulated clinical investigations? How will you confirm children will not be accidentally enrolled when the IRB has not approved the study to enroll children? How will the witness requirement be met (if applicable)?
“Remote recruitment and consent should not be considered as an opportunity for less conversation,” Oilepo notes. “Instead, the conversation should still be substantial.”
For IRBs, concerns about remote processes are not entirely new; investigators have been using social media for recruitment for years. Recently, this expanded to remote consent processes, electronic signatures, and remote interactions with research subjects. “We’ve been doing this for years in the context of web-based surveys and the like. But it has only been relatively recently that other types of research have started taking advantage of remote interactions,” says Bruce Gordon, MD, assistant vice chancellor for regulatory affairs and executive chairman of the IRB at the University of Nebraska Medical Center in Omaha.
To the extent that remote technologies, whether they are web-based, app-based, video-based, or phone-based, can be used to facilitate conversations between researchers and prospective subjects, “we wholeheartedly support them. Anything that facilitates the process of consent is to be encouraged,” Gordon offers.
However, it is critical to remember face-to-face contact remains the best way to conduct the process of informed consent. Remote processes should not be used as an alternative if face-to-face contact is safe and practical. Thus, says Gordon, “investigators who want to use remote processes as an alternative, as opposed to use as an adjunct, will need to show why the remote processes are superior to face to face.”
One of the big advantages of remote consent is it could open research participation to people who might not otherwise have been able to participate due to inability to travel long distances or competing demands like work or child care. “But the concern is that these potential participants might be exactly the people who don’t have the technology or the internet access or bandwidth to fully utilize these technologies,” Gordon says.
The person from rural Nebraska with a four-hour drive to Omaha who cannot participate in a clinical trial because of the distance or time is quite possibly the same person who does not have broadband internet to allow for a remote visit.
At Northwestern University, questions are raised as to whether a lot of the research that previously required visits to the medical center could be conducted remotely. “The thought was that remote research could increase participation rates,” says Mary McDermott, MD, professor of medicine at Northwestern University’s Feinberg School of Medicine.
As a physician scientist who conducts research on peripheral artery disease at a medical center, McDermott expressed some concerns about whether remote informed consent could be obtained ethically. She and a colleague authored a paper that offers ethical considerations for scientists and funding organizations.1
One important question is whether remote consent can be obtained with the same integrity as it can in person. For example, the investigator cannot be certain the remote participant is fully engaged. It may be more difficult to establish a rapport or assess understanding with a remote participant.
“Establishing rapport is important in informed consent because if a participant feels comfortable with the research staff, they may feel more comfortable asking questions or indicating when something is not clear,” McDermott explains.
For both IRBs and investigators, there are advantages and disadvantages of obtaining informed consent remotely. Advantages include the potential for wider accessibility of the research to potential participants. Investigators should consider whether they can as easily establish rapport, whether participants will feel comfortable asking questions, and whether investigators can fully assess understanding of the participant.
Important considerations include the degree of risk of participation and whether the research itself is conducted remotely. “If the participant must attend the medical center to participate, it seems reasonable that investigators would also obtain consent in person,” McDermott says.
After they were asked to take face-to-face contact out of studies if at all possible when the COVID-19 pandemic hit, researchers at the University of Illinois Chicago (UIC) came up with many acceptable alternatives. “They did need to come back to the IRB for approval to make changes, or to change the nature of the study if it presented different risks and benefits,” says Jonathan Klein, MD, MPH, professor of pediatrics and associate vice chancellor for research.
Researchers came up with all kinds of modified processes. “The IRB worked quite hard to process the modifications that were requested as rapidly as possible,” says Klein, noting UIC’s colleges maintain hundreds of active protocols at any point in time.
Staff provided guidance for researchers to consider before submitting study protocols to the IRB for review. “Researchers realized that video platforms, both HIPAA-secure and not, could be incorporated into research in ways that weren’t thought about previously,” Klein says.
The research community now routinely uses hybrid modalities for consent and study procedures. Face-to-face activities sometimes are necessary, as with studies on fall prevention, “but we are not always defaulting to that,” Klein notes. “There is no question that it changed the nature of some people’s work. They realized they could do more remotely than they thought.”
One creative researcher figured out a way to preprogram tablets, which could be mailed or delivered to participants so they could complete follow-up questionnaires at home, with the tablets dropped off or picked up later. “Obviously, the IRB had to review that. But it was a very creative solution, which protected the subjects as well as the research study staff,” Klein recalls.
For IRBs, there have been some new considerations with remote processes. If participants arrive on site, there is a way to ensure confidentiality. If study activities are conducted via Zoom, email, or text, it opens the possibility the participant’s confidentiality could be compromised. “When you have someone physically in the clinic, you don’t have to think about who might be listening to the conversation,” Klein observes. “If participants are being asked for sensitive information, protecting the subject’s privacy needs to have some extra thought.”
Researchers might ask participants to wear headsets when on calls, or ask questions with a “yes/no/maybe” or numeric response. Remote processes “didn’t change the nature of protecting research subjects from harm or disclosure or violating confidentiality, it just changes how the modalities would affect those things,” Klein explains.
Remote processes have made community outreach and engaging with diverse populations easier. “Some of the things that people learned out of this have definitely made it easier for more people to have access to participation in research,” Klein says.
Before the pandemic, recruitment for clinical trials “was traditionally restricted to the four walls of a clinical trial site,” says Harsha Rajasimha, PhD, founder and CEO of Jeeva Informatics Solutions, a Virginia-based decentralized clinical trials software company. Physician researchers usually explained all aspects of the study to patients during a brief one-on-one consultation. “This consultation usually lasts about 15 minutes, during which the investigator repeats the same explanation to one patient at a time,” Rajasimha says.
The risks and benefits of participating in the study, samples or data to be collected, medical procedures, and the travel involved all were covered during the in-person discussion. This process assured IRBs that each participant received personal attention from investigators. “But the process also had its disadvantages. Most patients feel they have limited time to ask questions or seek clarifications,” Rajasimha reports.
Even patients who already decided to enroll in the study had to travel to the trial site to complete formalities. Informed consent forms, some dozens of pages long, had to be reviewed and signed during short consultations. “In this traditional paradigm, underrepresented minorities remain disadvantaged, as they are less likely to access the healthcare system due to a variety of issues,” Rajasimha notes.
The pandemic forced clinical investigators to do things differently. “Researchers had to open up to the possibility of venturing out on the internet, social media, and other channels such as emails and texts,” Rajasimha says.
There were some unexpected positive developments. Asking questions via chat or videoconference gave people the chance to carefully consider the study, at which point they could sign the informed consent electronically. Some IRBs asked researchers to verify patients understood the risks of participation. “This might include a scored online quiz to assess individual patients’ comprehension about the study,” Rajasimha offers.
IRBs also are asking if software tools or apps are easy for prospective participants to use, and whether the tools support multiple languages and can accommodate participants with disabilities. Rajasimha has seen many IRBs scrutinize remote processes, even though some of the same concerns existed with previous processes. “The same IRBs that did not question the possible illegibility of handwriting or authenticity of time stamps on paper-based processes are now demanding much more for the electronic processes,” Rajasimha says.
Even for onsite processes, there always was the possibility of human errors, fraud, or abuse. The same is true of digital processes. “However, IRBs also need to weigh in on the changing context, times, tech advances, and the greater good,” Rajasimha says. Researchers can reach wider populations beyond a 50-mile radius. The work is shifting toward where the patients are located, meaning more participation from rural residents and underrepresented minorities. As a result, says Rajasimha, “this model is sure to improve diversity, equity, and inclusion.”
REFERENCE
McDermott MM, Newman AB. Remote research and clinical trial integrity during and after the coronavirus pandemic. JAMA 2021;325:1935-1936.