home

News Release: ORI/OHRP Release Interactive Training Video

New interactive video aims to better protect research subjects and reduce research misconduct in clinical and social research

The U.S. Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) today released “The Research Clinic,” a web-based, interactive training video aimed at teaching clinical and social researchers how to better protect research subjects and avoid instances of research misconduct.

The new video allows the viewer to 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 four characters include:

  • A principal investigator (PI), a busy oncologist who must strike a balance between 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. 

--------------------------------------------------------------

View "The Research Clinic"
http://ori.hhs.gov/TheResearchClinic

--------------------------------------------------------------

The viewer is presented with various scenarios, and for each scenario, the viewer is asked to respond by choosing a course of action, each of which leads to a different outcome. Ultimately, the video can be used to teach researchers how to avoid committing acts of research misconduct or violating the 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 the falsification, fabrication or plagiarism of data by different members of the research team.  When serious violations of human subject protections occur, 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 that research misconduct in clinical research may be underreported because review of clinical research data often focuses on issues other than falsification, fabrication or plagiarism of data,” 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, MD, OHRP director.

“The Research Clinic” is available free of charge on the ORI and OHRP websites. In 2011, ORI released a similar product focusing on biomedical research, entitled “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.

--------------------------------------------------------------

View "The Research Clinic"
http://ori.hhs.gov/TheResearchClinic

--------------------------------------------------------------


Source URL: https://ori.hhs.gov/content/news-release-oriohrp-release-interactive-training-video