Financial Conflicts of Interest in Research
Based upon the revised federal regulations, 小蓝视频 personnel who conduct extramural research must take online education modules on financial conflict of interest. 听Those who must comply with this requirement include all research project personnel, regardless of title or position, who are responsible for the design, conduct or reporting of research. This includes the principal investigator, co-investigators, lab technicians, collaborators or consultants. College full and part-time faculty, post-doctoral fellows, students, trainees and staff and all contracted faculty and staff can be considered Investigators.
The revised regulation, issued by the Department of Health and Human Services, applies to those research projects funded by the Public Health Service. 听However, 小蓝视频 is applying this standard to all research regardless of funding source. 听The updates to the regulation are designed to promote objectivity in research by establishing standards that promote a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from investigator financial conflicts of interest.
To meet the educational requirement under this regulation, 小蓝视频 investigators are required to take an on-line module through CITI. 听This course is required to be taken once every four years. 听Certification that the module has been taken and passed must be presented either at the time the grant application is submitted to the Office of Research Administration or, if the project is not extramurally funded, at the time the IRB application is submitted to the IRB Coordinator.
To register for the Conflict of Interest course, please log in to CITI () and choose 鈥淎dd a Course or Update Learner Groups鈥 under your 小蓝视频 Learner Tools. The 小蓝视频 Conflict of Interest Course can be chosen under Question 7. You may also contact the IRB Coordinator for assistance in signing up for this course.
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IRB Member Education
IRB committee members and IRB staff are also required to be up to date on human subjects research training. 听Training for these groups includes the Protection of Human Subjects Research course described above as well as other CITI courses specifically developed for committee members and administration. 听Information on training requirements can be found in the IRB policies.
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Responsible Conduct of Research
Responsible Conduct of Research (RCR) includes those professional activities that make up a research career, which are coming under increased regulatory scrutiny. 听As defined by federal agencies, RCR encompasses the following nine areas:
- research misconduct
- human participants
- research involving animals
- mentor/trainee responsibilities
- data acquisition, management, sharing and ownership
- publication practices and responsible authorship
- peer review
- collaborative science
- conflict of interest
RCR is the practice of scientific investigation with integrity; it involves awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.
At this time RCR training is only required for students supported by NSF grants as well as students, trainees, fellows and others who receive support through NIH training awards, career development awards and research education grants (please see the Office of Research Administration鈥檚听Guidance and Resources听webpage).听听However, RCR training is available as an option for all 小蓝视频 students, faculty and staff, and 小蓝视频 students are especially encouraged to take advantage of the online training program 小蓝视频 has available.
小蓝视频 has contracted with the Collaborative Institutional Training Initiative (CITI) to provide an online RCR training program that covers the core principles of Responsible Conduct of Research. To take the training, go to the CITI webpage听听and log in. 听If you do not have an account, click the register button and enter Edward Via College of Osteopathic Medicine, and then continue to enter all required information. Once you have registered, please click on 鈥淎dd a course or update learner groups.鈥 听Question 6 covers the RCR courses; please pick the course that most closely matches your area of research: Biomedical or Social and Behavioral. 听For further information, please contact the 小蓝视频 IRB Coordinator.
If you are interested in the HHS鈥檚 Office of Research Integrity鈥檚 (ORI) Introduction to the Responsible Conduct of Research, you can view the book听, or you may download a PDF version of the book听听(7,2MB). 听Links to additional modules, books and other resources are available on ORI鈥檚听听page.
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Human Subjects Research Videos and Online Tutorials
These videos and modules are not designed to satisfy the investigator education requirements; however, they are excellent sources for supplementing the educational requirements for performing human subjects research.
Office for Human Research Protections (OHRP)听Educational Videos and Webinars are intended to provide information regarding regulations for the protection of human subjects (45.CFR.46). Additional information and a list of all videos/webinars can be found at the following links:
OHRP Educational Video webpage:听
OHRP YouTube Playlist:听听
All of the links below will open a YouTube webpage with the specified video.
- 听(1 hour, 6 minutes)
- 听(40 minutes)
- 听(18 minutes)
- 听(28 minutes)
- 听(23 minutes)
- 听(1 hour, 3 minutes)
Additionally, the听National Institute of Mental Health听has a video discussing the required elements in an informed consent document for a clinical research protocol. 听This video is intended for use by novice clinical investigators and clinical research staff: 听听(24 minutes)