WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software to support clinical research, has announced the publication of an innovative Ethics Tool Kit in the Journal of Medical Ethics. Developed by the Multi-Regional Clinical Trials (MRCT) Center of Harvard and Brigham and Women's Hospital working group, the toolkit was co-written by 20 experts in clinical research, including WCG Chief Medical Officer and President of Consulting Services Lindsay McNair, M.D., MPH, MSB, and WCG Chief Compliance Officer David Forster, JD, MA, CIP.

"We are extremely proud of Dr. McNair's and Mr. Forster's contributions to this important project. They embody WCG's commitment to upholding the highest ethical standards in clinical research. Professionals responsible for writing protocols will benefit immensely from access to this new tool kit," said WCG Chairman and Chief Executive Officer Donald A. Deieso, Ph.D.   

Entitled, "Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees," the MRCT paper describes 11 Essential Elements that should be considered for inclusion in a dedicated ethics section in a clinical research protocol.

"We recommend including a dedicated ethics section in every protocol because it will help ethics teams to proactively articulate ethical considerations associated with the protocol. That step should improve the dialog between ethics committees and clinical research teams, and among the research team members themselves," said McNair.

"Those discussions will enhance consistency and transparency between clinical trial protocols and ethical committee reviews, and may in turn expedite the review process by anticipating the concerns of those reviewers," said Forster.

The 11 Essential Elements cover the following topics: addressing a relevant question, choice of control and standard of care, choice of study design, choice of subject population, potential benefits and harms, informed consent, community engagement, return of research results and incidental findings, post-trial access, payment for participation and study-related injury.

The MRCT Center working group examined 100 clinical trial protocols that had been reviewed and approved by ethics committees. They were all multicenter intervention trials (medical, social/behavioral or device) in which at least one site was outside of the U.S. They also all involved greater than minimal risk. Informed consent forms were also reviewed if they were available. These current clinical trial protocols were evaluated to determine whether the Essential Elements were included and if they were discussed directly from an ethics perspective.

While the first Essential Element—addressing a relevant question—was included in 96% of protocols, the other elements were included much less frequently. For example, community engagement and post-trial access were featured in only nine percent and 22% of protocols, respectively. However, the community engagement aspect may not apply to all protocols and post-trial access is considered an emerging issue. Of more concern was the lack of discussion about potential benefits and harms in 24% of protocols, and about the challenges in informed consent in 44% of protocols. While the researchers may have thought through these topics, they were not clearly articulated in the protocol. 

The MRCT Center has also collaborated with colleagues at the Global Health Network at Oxford University, England to make the Ethics Tool Kit more accessible for researchers in low- and middle-income countries. They created an online course which teaches the Essential Elements through a series of 11 modules. They are available at https://globalhealthtrainingcentre.tghn.org/essential-elements-ethics.

The MRCT Center was founded in 2009 to improve the design, conduct and oversight of multi-regional clinical trials, focusing on trials conducted in emerging economies and the developing world. The MRCT Center seeks to establish common, explicit, feasible and ethical standards for conduct of transnational clinical research.