Canadian researchers have published new guidelines intended to make consent forms used in clinical research easier for patients to understand.

The guidelines describe 75 core elements for consent forms that are intended to ensure transparency and improve participants’ understanding of their involvement in research studies. For example, the guidelines suggest explaining technical or scientific words or replacing them with everyday words as much as possible. They advise using bullet points, graphics, or tables to help describe complex procedures. In addition, the guidelines suggest that a consent form succinctly describes who will receive identifiable patient data, what data the parties will receive, where data will be sent, and for what purpose.

“We expect that researchers will deploy this template to make consent forms shorter, with the aim of aiding comprehension and encouraging more equitable, diverse, and inclusive participation in research,” wrote lead guidance author Holly Longstaff, PhD, director of Research Integration and Innovation at British Columbia’s Provincial Health Services Authority, and co-authors. “The shorter amount of text also makes translation less expensive and better enables use of participant-centered communication tools such as images, videos, infographics, and figures.”

The policy guidance was published online on September 15 in CMAJ.

Striving for Clarity

“The consent process has, to some extent, been reduced to a formal collection of a signature on an agreement, rather than a thoughtful evaluation by potential participants of the benefits of their participation against the potential for foreseeable harms,” wrote the authors.

Beginning in 2022, members of the Canadian Critical Care Trials Group collaborated with Canadian Institutes of Health Research (CIHR) staff to develop the guidelines. Their aim was to assess the many already mandated elements of consent forms, as well as approaches taken by universities and research institutions that can make these documents more complicated. The authors analyzed studies on consent forms, met with patient and medical groups, and tested a proposed consent template. The draft guidelines were released to the public last year for comment and feedback.

The published guidelines outline the elements that consent forms should have for clinical research projects funded through CIHR, according to Longstaff. CIHR, a major sponsor of health research in Canada, spent more than $1.3 billion in the most recently completed fiscal year on grants and awards. Of this amount, about $677 million went toward investigator-initiated projects.

The guidelines and several templates have been posted on the Canadian Critical Care Trials Group website as the Pan-Canadian Core Consent Project.

Increasing the clarity of consent forms may aid efforts to broaden the pools of participants in medical studies, Longstaff told Medscape Medical News. Enrollment in trials now often skews toward people with more experience and trust in the medical organizations, often due to high levels of income and education.

“It can be very difficult to create new pathways to research participation for historically excluded groups,” said Longstaff.

‘Chasm in the Middle’

Efforts to improve consent agreements like the work of Longstaff and colleagues may help address what Brendan Leier, PhD, adjunct professor of health ethics at the University of Alberta in Edmonton, calls the “chasm in the middle” of clinical research.

Both highly educated patients who understand the potential of new therapies and medical approaches and patients with fewer resources, who may enter studies for financial reasons, are often overrepresented in studies.

“You need to have representative populations if the science is going to be legitimate [and] if you are to draw any conclusions,” said Leier, who did not participate in drafting the guidelines.

In the past, researchers could seek leeway if they failed to recruit certain populations because of logistical challenges. For example, Leier cited Inuvik, a town of approximately 3400 people located about 200 km (125 miles) north of the Arctic Circle, as a place that researchers might not consider in their work.

“Historically, there have been lots of reasons to give [researchers] a dispensation.” Leier said. “But in an age where you could literally put a heart monitor on someone who’s living in Inuvik and do telemedicine on them, why shouldn’t they be included in a trial?”

Keeping What Works

The new guidelines should not be construed to interfere with choices already made by Indigenous organizations, study teams, and communities, who may have their own preferred templates, according to the authors.

“These groups may choose to use this template; however, their right to self-governance and data sovereignty must be respected,” they wrote. “All researchers should carefully consider how the design of their studies may affect Indigenous peoples and other groups that have historically been excluded from or harmed by research.”

The new Canadian guidelines also may not be universally relevant. “We recognize that it may not meet the needs of industry sponsors and that it may not replace other negotiated streamlined consent templates that are working well in certain disease domains like cancer,” the authors wrote.

The Canadian guidelines are a welcome step toward simplifying consent forms, said James DuBois, DSc, PhD, executive director of the Bioethics Research Center at Washington University School of Medicine in St. Louis.

“But the end result is still a dense legal document that covers 75 points. It is important to have a thorough document that people can consult as interested or as needed — it fosters transparency and can answer questions,” DuBois told Medscape Medical News. “However, I think two things must supplement it. First, a good consent discussion. Second, a short, highly readable summary of the most important points.” DuBois did not participate in drafting the guidelines.

Like the authors, DuBois has worked with colleagues to develop tools for researchers to simplify the materials presented to patients considering participating in clinical research. Their materials are posted on the Consenttools.org project.

Consent in America

Revising consent forms has been challenging for research institutions in the US. A major nationwide effort took almost a decade.

In 2019, the federal government put into effect an updated version of the Common Rule, which is a policy meant to protect patients who participate in medical research.

The original Common Rule dates to 1991. Work on a major overhaul began two decades later in 2011. The US government published the updated Common Rule in 2017 and provided a 2019 start date to allow institutions time to adapt.

Among the major changes in the Common Rule was a mandate for patient consent forms to include a concise explanation at the beginning of the document of the key information that would be most important to people contemplating participation in a study.

DuBois co-authored a 2020 paper in the Journal of Clinical and Translational Science that examined how research institutions had responded to the Common Rule update. They reviewed patient consent information templates at 46 US medical institutions. They found that documents from 27 institutions (58.7%) did not contain any guidance on health communication best practices.

“In the US, the ‘Key Information’ section is supposed to achieve this, but our early review of such documents suggests it often fails,” said DuBois.

The guidelines were funded by the CIHR for the Canadian Network of COVID-19 Clinical Trials Networks. The guideline authors included researchers who were paid by CIHR. They reported having no other relevant financial relationships. Leier and DuBois reported having no relevant financial disclosures.

Kerry Dooley Young is a freelance journalist based in Washington, DC. She has reported on medical research and healthcare policy for more than 25 years.