If you hear “clinical trial” and think of a study looking at a cure for a disease, the National Institutes of Health (NIH) wants you to think again.
NIH is in the process of enhancing “the accountability and transparency of clinical research” through a number of new initiatives that impact researchers. At the heart of these changes is its broad definition of a "clinical trial."
Beginning in 2017, the NIH started enforcing new requirements for researchers conducting what it calls a clinical trial, and effective Jan. 25, all researchers must know whether their research falls under NIH’s definition of a clinical trial in order to apply for funding. NIH’s definition of a clinical trial breaks from the traditional understanding to include both basic biomedical research and basic social and behavioral research.
“This is a major shift in our thinking,” according to Katie Bode-Lang, director of education and quality management in Penn State's Office for Research Protections (ORP). “In the past, we wouldn’t have thought of a study looking at something like the success of a new teaching technique as a clinical trial, but now the NIH could call it one.”
The Office for Research Protections is assisting researchers in determining whether their studies meet NIH’s definition of a clinical trial and is also helping them fulfill the requirements for clinical trials. At the College of Medicine, the Research Quality Assurance program is helping investigators.
NIH has stirred controversy in the research community because many have suggested that NIH’s definition is too broad, especially for those conducting basic science and social/behavioral research. Many have expressed concerns that the new policies will increase researcher burden: Those conducting NIH clinical trials are required to register and report results on ClinicalTrials.gov, and study staff must take additional training. However, if researchers impacted by the change do not select a funding opportunity that supports clinical trials when they apply to NIH, their grant will be rejected without review.
“We’re aware that people might not want their study be considered a clinical trial because of the extra responsibilities, but we also don’t want researchers to risk not getting funded,” says Bode-Lang. In addition to consulting with researchers, the ORP has a website specific to clinical trials and will be hosting a 15-minute overview session related to the changes on Jan. 16. The office also oversees compliance for ClinicalTrials.gov requirements.
In 2017, Penn State received more than $126 million in funding from the Department of Health and Human Services, which includes NIH.
For more information, contact the ORP Quality Management Team ORP-QM@psu.edu, 814-865-1775. If primary affiliation is with the College of Medicine, contact Research Quality Assurance at clinicaltrials.gov@pennstatehealth.psu.edu or Nicole Matthews at 717-531-8521 ext. 287544.