DEPARTMENT OF RESEARCH
Institutional Review Board
Guidelines for Department Residency Research Programs
Guidelines
Research is a required activity for most LifeBridge Health (LBH) Sinai Hospital residency training
programs. All research activity, whether it occurs on-site at a LBH facility or at a program-associated
off-site facility requires LBH Institutional Review Board (IRB) evaluation. Some resident research
activities may not require IRB approval and oversight, although the status of each project (e.g.,
exempt from IRB review, qualifies for expedited review, or requires full board review) can only be
determined by the chairman of the IRB or by one of his designees.
The LBH IRB recommends that all departments sponsoring residency training programs with either a
voluntary or required research training component consider incorporating the following guidelines into
their training programs:
1. Develop and monitor a mentoring program. Senior faculty/investigators should be encouraged
to provide guidance and training for new or research-naive colleagues.
2. Faculty sponsors of resident research should have experience in the research topic. Although
desirable, research experience is not mandatory for this mentoring role. In this situation,
residents should be encouraged to create a co-mentor program involving at least two faculty
members who can provide the appropriate clinical and research guidance.
3. Faculty sponsors and research program advisors must complete the Collaborative Institutional
Training Initiative (CITI) Program for the Protection of Human Research Subjects (see:
http://www.citiprogram.org/default.asp?language=english) before any research may begin.
4. All residents planning any kind of research involving human subjects or human subject-derived
data must complete the CITI training program before any research activity can commence.
All residency programs should consider making completion of the CITI training program a
requirement regardless of resident research activity.
5. Departments should require documentation (LBH IRB approval letter and CITI Certificate of
Completion) from the resident prior to accepting any research project, paper, or presentation
submitted or made to satisfy a residency program requirement.
6. Departments should verify that the resident and mentor have submitted documentation of
studies being conducted at a different facility to the LBH IRB for approval.
7. Departments should consider maintaining a record of all residents electing or required to do
research for their program, and to provide that information to the Research Office annually.
8. Departments should initiate resident research projects during the first year of their residency
program, providing more time for their completion.
LBH IRB Guide #20: Department Guidelines for Residency Research Programs
Version 2, 07-02-10
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9.
Faculty, residents, and staff should be reminded that failure to comply with local, state, and
federal regulations governing human subjects research could have a significant negative
impact on themselves, the residency program, the department, and LBH.
LBH IRB Guide #20: Department Guidelines for Residency Research Programs
Version 2, 07-02-10
Page 2 of 2