Protection of Human Research Subjects
One of the requirements of study approval by the IRB is the completion of human subjects training by all personnel working on a research project, including those projects deemed to be exempt under 45.CFR.46.101. “All personnel” is defined as those individuals responsible for the design and conduct of the research, data analysis or project reporting. This includes investigators, clinical coordinators, those administering informed consent or surveys, laboratory staff and students. Subcontractor personnel and consultants, as well as those outside individuals operating under VCOM’s FWA, must also comply with this educational requirement. VCOM requires a refresher course to be taken every three years.
VCOM utilizes Collaborative Institutional Training Initiative (CITI) as its training program. The required training program includes, but is not limited to, history and ethical principles, informed consent, regulation and review process, vulnerable population research and conflicts of interest in research. VCOM provides access to the training course through CITI’s interactive online modules.
To begin the process, you must register on the CITI site and choose VCOM from the drop-down menu of participating institutions. A PowerPoint presentation is available below that walks through the registration process as well as how to find your required course and how to start each module.
A completion report / certification for all study personnel is required as part of the IRB application submission. An IRB submission will not be considered complete until a training certification is received for all personnel involved.
Financial Conflicts of Interest in Research
Based upon the revised federal regulations, VCOM personnel who conduct extramural research must take online education modules on financial conflict of interest. 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. However, VCOM is applying this standard to all research regardless of funding source. 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, VCOM investigators are required to take an on-line module through CITI. This course is required to be taken once every four years. 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 (https://www.citiprogram.org/) and choose “Add a Course or Update Learner Groups” under your VCOM Learner Tools. The VCOM 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.
IRB Member Education
IRB committee members and IRB staff are also required to be up to date on human subjects research training. 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. Information on training requirements can be found in the IRB policies.
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. 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’s Guidance and Resources webpage). However, RCR training is available as an option for all VCOM students, faculty and staff, and VCOM students are especially encouraged to take advantage of the online training program VCOM has available.
VCOM 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 here and log in. 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 “Add a course or update learner groups.” Question 6 covers the RCR courses; please pick the course that most closely matches your area of research: Biomedical or Social and Behavioral. For further information, please contact the VCOM IRB Coordinator.
If you are interested in the HHS’s Office of Research Integrity’s (ORI) Introduction to the Responsible Conduct of Research, you can view the book here, or you may download a PDF version of the book here (7,2MB). Links to additional modules, books and other resources are available on ORI’s General Resources page.
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) 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: http://www.hhs.gov/ohrp/education/training/ded_video.html
OHRP YouTube Playlist: http://www.youtube.com/view_play_list?p=5965CB14C2506914
All of the links below will open a YouTube webpage with the specified video.
- Nuts and Bolts of 45.CFR.46 (1 hour, 6 minutes)
- Investigator Obligations Under 45.CFR.46 (40 minutes)
- General Informed Consent Requirements (18 minutes)
- Research Involving Vulnerable Populations (28 minutes)
- Research Use of Human Biological Specimens and Other Private Information (23 minutes)
- Biobanking: Consent, Privacy and Data Sharing in the Age of the Genome (1 hour, 3 minutes)
Additionally, the National Institute of Mental Health has a video discussing the required elements in an informed consent document for a clinical research protocol. This video is intended for use by novice clinical investigators and clinical research staff: The Elements of a Successful Informed Consent (24 minutes)