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Regulatory and Administrative Rules
The Office of Human Research Protections (OHRP) is a subsidiary of the US
Department of Health and Human Services (HHS). Their main purpose is to provide
guidance on ethical and regulatory issues in biomedical and behavioral research and
protecting human subjects in research. They offer compliance and reporting with
regard to regulatory oversight and reports of incidents. OHRP is also the registering
body of IRBs [ 18 ].
The Federal Drug Administration (FDA) and HHS define an IRB as an “appro-
priately constituted group that has been formally designated to review and monitor
biomedical research involving human subjects” [ 19 ]. Under FDA regulations, IRBs
have the authority to approve, modify, monitor, or outright reject research projects
if they are deemed dangerous for patients. The IRB is the regulatory body that most
residents/students will submit research proposals to before conducting their
research. From anecdotal experience, the IRB is also the research organization that
may provide them with the most frustrations in the research process. IRBs are often
local as part of the medical school or academic institution. One city can have mul-
tiple IRBs located at collaborating institutions and hospitals which can either have
an agreement that an approval at one is honored at all or each collaborating institu-
tion where the research will take place requires a separate IRB review and approval,
greatly increasing the work required in the submission process and can delay the
start of a research project. At some institutions, especially with regard to multicenter
clinical trials, a central IRB can be utilized for research review.
Besides IRB review, some institutions may require additional administration
sign-offs from department chairs, associate deans for research, medical student
affairs, or other departments prior to starting any research. Depending on the type of
research project, these administrative webs can be difficult to navigate without sig-
nificant time and effort to assure all the necessary parties have been notified. Any
animal studies require review by the institutional IACUC committee with extensive
detail required by the investigator to identify every detail of research details involv-
ing animals.
Formal Research Training and Certifications
Prior to conducting any research, all IRBs and IACUCs require some form of certi-
fication and/or training. IACUC certification at the least requires animal handlers’
training conducted through the institution where the research will be conducted.
IRBs require completion of a certification course on at least human subject research
that lasts for a 2–3-year term, after which renewal courses are completed to keep up
the certifications. With research becoming more of a requirement than an option,
most institutions instruct residents and students to complete or renew (if expiring
shortly) their research training at the start of their school and residency programs.
The overwhelming majority of research training is conducted through the
Collaborative Institutional Training Initiative (CITI Program) founded in March
2000 [ 20 ]. Institutions register with the CITI Program and choose which modules
and courses they want made available to their researchers; these courses include but
D.I. Dynda et al.