New video aims to reduce misconduct in clinical trials research
The Research Clinic, a Web-based interactive training video aimed at teaching clinical and social researchers how to better protect research subjects and avoid research misconduct, was released today by the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) and Office for Human Research Protections (OHRP).
The video lets the viewer assume the role of one of four characters and determine the outcome of the storyline by selecting decision-making choices for each playable character. The characters are:
- A principal investigator (PI), a busy oncologist who must balance doing what he thinks is best for his patients and his research;
- A clinical research coordinator, an overworked nurse who works for a PI who pressures her to falsify data and violate study protocols;
- A research assistant who has difficulties obtaining informed consent and following research protocols; and
- An Institutional Review Board (IRB) chair who is tasked with ensuring that research subjects and the integrity of the research enterprise are protected while dealing with a culture resistant to change.
The viewer is presented with various scenarios. For each scenario, the viewer is asked to choose from among courses of action, each of which leads to a different outcome. The video can be used to teach researchers how to avoid research misconduct and violating regulations enacted to protect human subjects in research studies.
About one-third of ORI’s research misconduct findings relate to clinical research studies. The unique pressures in a clinical research setting may lead to falsification, fabrication or plagiarism of data by members of a research team. When serious violations of human subject protections occur, it is possible that falsification and fabrication of data may go unidentified. The video highlights scenarios to help identify research misconduct in the clinical setting and provides solutions to help researchers avoid such missteps.
“We suspect research misconduct in clinical research may be underreported because review of clinical research data often focuses on issues other than falsification, fabrication or plagiarism,” said Don Wright, MD, MPH, ORI acting director.
Every year, OHRP receives about 400 reports alleging violations of regulations enacted to protect human subjects who participate in research studies. Examples of violations include the enrollment of ineligible subjects who may be harmed by research interventions, failure to obtain or to properly document informed consent, and the conduct of research without IRB review and approval.
“This training video has the potential to greatly reduce compliance violations by providing an engaging method to teach researchers how to properly protect the people who generously volunteer to participate in clinical trials,” said Jerry Menikoff, M.D., OHRP director.
The Research Clinic is available free on the ORI and OHRP websites. In 2011, ORI released a similar product focusing on biomedical research, The Lab: Avoiding Research Misconduct. Since its release, The Lab has been integrated into research training programs at many universities and research institutions. ORI and OHRP anticipate that The Research Clinic will have the same success with research hospitals and other clinical research organizations.
This March 31, 2014 post has been reprinted from the HHS website at http://www.hhs.gov/news/press/2014pres/03/20140331a.html.