Ethicists at the Johns Hopkins Berman Institute of Bioethics collaborated with the University of Malaya in Kuala Lumpur to develop a new master’s program in health research ethics.

“When we were developing the curriculum and seeking to rigorously evaluate the program, we were unable to find an existing framework delineating the competencies our graduates should have,” says Sean Tackett, MD, MPH, an associate professor of medicine at Johns Hopkins.

Tackett and colleagues created a framework to define expected outcomes for participants and programs.1 The first graduates of the MOHRE (Master of Health Research Ethics Program) initiative are working in research ethics committees, government, and academia. The second cohort of students is nearing the end of the program. A third cohort will begin in the fall. “Without a clear statement of the outcomes expected of advanced degree programs in research ethics, it is challenging to measure a program’s effectiveness and if there is a favorable return on investment in supporting these programs,” Tackett says.

Tackett’s team was surprised that despite ongoing efforts to develop research ethics programs over many years in the United States and internationally, there was no published competency framework to follow. “We were also surprised that there wasn’t a standard approach to creating competencies in this context,” he adds.

This, despite the fact competencies have been used for education in business, medicine, and elsewhere for more than 50 years. In hospital settings, “our work could be useful to bioethicists where research is being conducted, perhaps if they serve on institutional review boards or are involved with developing hospital policies related to research,” says Jeremy Sugarman, MD, MPH, MA, deputy director for medicine at the Johns Hopkins Berman Institute of Bioethics. For example, IRBs might want to assess whether its members have the necessary competencies to conduct meaningful ethics oversight of research.

Biomedical and behavioral scientists need awareness of ethical, legal, and social implications that come up in day-to-day research environments, says Camille Nebeker, EdD, MS, the director of the Research Center for Optimal Digital Ethics Health (ReCODE Health) at the University of California, San Diego. Nebeker suggests courses cover bias, research subject protections, mentor/mentee roles, collaboration, authorship, and data management. IRBs should increase awareness of human research protection ethics by pointing out if research protocols are ethically problematic in some way.

Additionally, IRBs should connect regulatory requirements with the ethical principles of The Belmont Report, a summary of basic ethical principles for research involving human subjects.2 “This is one way an IRB could educate in tandem with the role of regulatory compliance,” Nebeker offers. Finally, IRBs should involve ethicists, whether that means providing guidance on a specific question or considering ethical issues for all phases of a study. “ReCODE Health provides ethics consultation and education and conducts research focusing on digital health research ethics,” Nebeker reports.

If research ethics training is inadequate, “it raises both ethical and legal concerns,” says Stephanie Solomon Cargill, PhD, MSPH, associate professor of healthcare ethics at Saint Louis University.

The highly regulated research environment includes many requirements for training, documentation, and surveillance. “If researchers and clinicians are unaware of these expectations, they are likely to violate them and incur penalties,” Cargill cautions. IRBs should play a key role in research ethics education, says Cargill, “since IRBs sit at the junction between ethics and compliance.”

Research ethicists sometimes provide this education. “But unless they are aware of how their content intersects with the IRB practices at their institution, researchers and clinicians may be led astray,” Cargill notes.

Concurrently, IRBs’ educational focus is more on compliance than ethics. “Thus, IRBs should not be the sole provider of ethics education, at risk of reducing the ethical questions of research to the technical questions of compliance,” Cargill says.

Ethicists can determine how researchers can assess for coercion and power dynamics, mitigate vulnerabilities in patient populations, and inform diverse patient populations adequately of what they are asked to do and why. “Without research ethics training, many people tend to conflate the practices of clinical care and research, to the detriment of both,” Cargill says.

REFERENCES

  1. Tackett S, Sugarman J, Ng CJ, et al. Developing a competency framework for health research ethics education and training. J Med Ethics 2021 Apr 2;medethics-2021-107237. doi: 10.1136/medethics-2021-107237. [Online ahead of print].
  2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. April 18, 1979.