Behind the Scenes at OHRP: Protecting Human Research Subjects
An international scholar, Kemnique Ramnath underwent a big culture shift in 2006 when she moved to the United States from Holmes Rock, Grand Bahama, the Bahamas, to complete her college education.
She received a master’s degree from the Department of Health Services Administration at the University of Maryland, College Park, and looked for fellowships with on-the-job training. A relative mentioned the Oak Ridge Institute for Science and Education (ORISE), telling her about colleagues who had gone through ORISE fellowships as part of their career paths.
Now, as an ORISE fellow, Ramnath is in the office that oversees all human subjects research funded by the U.S. Department of Health and Human Services (HHS).
Ramnath’s program is in the Office for Human Research Protections (OHRP) in Rockville, Maryland. Specifically, her work is with the Division of Compliance Oversight. At OHRP’s discretion, this division investigates written substantive indications of noncompliance with HHS regulations. Ramnath has participated in a number of investigations as a part of her fellowship.
Any institution engaged in nonexempt human subjects research conducted or supported by HHS must submit written assurance of compliance to OHRP. Other federal agencies that have adopted the “Common Rule” HHS regulations can rely on OHRP assurance for their human subjects research. There are approximately 13,347 institutions (9,891 domestic and 3,456 international) that have oversight agreements with the OHRP. It is up to OHRP, an office of about 20 individuals, to ensure compliance from all HHS-supported research both nationally and internationally.
Ramnath’s research and participation in DCO’s activities have led to a coauthored journal article that examines data from more than 6,500 incident reports from institutions to OHRP and the actions taken by these institutions to address problems related to research, with a discussion of best practices for institutions. The division is working on another publication that will analyze data from OHRP findings on institutions’ human protections programs.
She enjoys participating in site visits to various research institutions, reading the wide variety of protocols and learning about research. The opportunity to attend conferences held by Public Responsibility in Medicine and Research gives her exposure to a vast network of research professionals, and the visits have allowed her to become familiar with many different types of research. Additionally, Ramnath has learned how the human research protections programs of various institutions operate, along with how those regulations are interpreted by the community at large.
“I’ve learned that no policy or guidance document is written in a vacuum, but has to be looked at by various stakeholders, including other federal agencies, department leaders and the general public. Countless revisions have to be made before an agreement or any semblance of consensus can be achieved,” said Ramnath.
Her advice to anyone interested in an ORISE fellowship is to do as much research as possible about the program or office you are considering and identify a few areas of research interest. Reach out to other ORISE fellows, and find out about the type of research they do.
“Focus on the bigger picture of the work that you’re doing and try not to get caught up in the daily activities and minutiae. Always remember what the mission is of the program you’re participating in,” said Ramnath.
She is impressed with the ORISE fellowship experience and definitely recommends ORISE programs as an amazing opportunity to work with professionals, conduct impactful research, and learn about your field. The experience has led her to collaborate with people from diverse backgrounds, and she is grateful for new friendships she has made.
“As I plan to further develop my career in the public health field and through what I’ve learned in this fellowship, I believe I would like to continue working in human subjects’ research. It is my expectation to continue to apply my knowledge to the advancement of research in underserved communities, mental health issues, and minority health disparities. I feel confident that I will be joining a community of researchers and professionals who are committed to the protection of the rights, welfare and well-being of subjects involved in research.”