LBH IRB Guide #20: Department Guidelines for Residency Research Programs Page 1 of 2

DEPARTMENTOFRESEARCH

LBH IRB Guide #20: Department Guidelines for Residency Research Programs Page 1 of 2

Version 2, 07-02-10

Institutional Review Board

Guidelines for Department Residency Research Programs

Guidelines

Research is a required activity for most LifeBridge Health (LBH) SinaiHospitalresidency 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: beforeany 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.

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 Page 1 of 2

Version 2, 07-02-10