Summer 2014 - Vaccines

Interactive Video Aims to Reduce Research Misconduct

Earlier this year, the U.S. Department of Health and Human Services Office of Research Integrity (ORI) and Office for Human Research Protections (OHRP) released a web-based training video known as “The Research Clinic” to help teach clinical and social researchers how to better protect research subjects and avoid research misconduct. The video allows viewers to take on the role of one of four characters and then determine the outcome of the storyline by selecting decision-making choices for each character. The characters include a principal investigator (PI) who must balance between doing what he thinks is best for his patients and his research; a clinical research coordinator who is pressured by the PI to falsify data and violate study protocols; a research assistant who has trouble following research protocols and obtaining informed consent; and an institutional review board (IRB) chair who must ensure that research subjects and the integrity of the research enterprise are protected while dealing with a culture resistant to change. Viewers are presented with various scenarios in which they are asked to select from among different courses of action, each of which results in a unique outcome.

The video was made as a result of findings from both ORI and OHRP. ORI reported that one-third of its research misconduct findings were related to falsification, fabrication and plagiarism of data by research team members. And, every year, OHRP receives more than 400 complaints alleging violations of regulations that were enacted to protect human subjects. Violations include the enrollment of ineligible subjects, failure to obtain or properly document informed consent, and the conduct of research without the review and approval by the IRB.

The video is available for free at ori.hhs.gov/TheResearchClinic.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.