Research Policies and Procedures
Institutional policies and procedures for research are overseen by the Director of Research Programs in the Office of the Provost. The Institute follows the Harvard Medical School policies on integrity in science.
1. Faculty Research
All research studies in which an IHP faculty member is the principal (lead) investigator must be reviewed by the Institutional Review Board (IRB) of Spaulding Rehabilitation Hospital. The Spaulding IRB must also be notified if an IHP faculty member is a co-investigator in a research study that is reviewed by another IRB, including another IRB within Partners.
2. Student Research
All student research projects must be carried out under the direct supervision of at least one IHP faculty member. Except in special circumstances (see Exception to Spaulding IRB Review for Student Projects below), all student research projects must be approved by the Institutional Review Board (IRB) of Spaulding Rehabilitation Hospital, or a designated Partners IRB (see IRB Procedures). The supervising faculty member(s) must be listed on the IRB application as an investigator and the application must be reviewed and signed by the faculty member(s) prior to submission for Spaulding IRB review. Decisions about whether studies qualify for exemption from IRB review can not be made by IHP faculty or students. Such decisions can only be made by the Spaulding IRB.
Exception to Spaulding IRB review for student projects: Students involved in non-federally funded studies taking place outside of Partners (including outside of the IHP), at an institution with its own IRB, do not have to also submit an application to the Spaulding IRB. In such cases the students will need to provide documentation to the Provost’s Office that the project was approved by the IHP faculty supervisor, as well as documentation of the IRB process and approvals from the reviewing institution.
3. Use of Institute Students/Employees as Research Subjects (adapted from the Harvard Medical School policy)
Recruitment of MGH Institute students: For the mutual protection of the student, investigator, and the Institute, any protocol in which MGH Institute students are recruited must be submitted to the Provost’s Office for review and approval before submission to the IRB.
Recruitment of employees/students in investigator’s department: Studies of volunteers who are directly supervised by the investigator(s) or who are the investigator's students should be avoided and will usually be disapproved by the IRB. In this setting, there are confidentiality problems and issues of coercion or obligation (either real or perceived) which are best avoided entirely. It is acceptable to advertise for volunteers in approved areas in the investigator's department or within the Institute (following IRB and Institute guidelines) and allow individuals in the department who are not directly supervised by the investigator(s) to participate in research studies.
4. IRB Procedures
New applications and continuing review forms are available from the Spaulding Research Administration intranet website. Please note that this website can only be accessed from a Partners computer. Policies and guidance on human subjects research topics can be found at the Partners Human Research Committee website.
Submit completed forms to the Spaulding IRB office electronically. All signed originals should be mailed to the Spaulding IRB office. Applications will not be processed until both the electronic and hardcopy have been received. The contact person at Spaulding IRB is Catherine Sutherland.
5. Collaborative IRB Training Initiative (CITI)
All faculty researchers and students including Principal Investigators / Co-PIs and named key staff (including anyone who comes in contact with subjects or identifiable study data or information) must complete human subject research training. This training must be renewed every three years. The IRB will require documentation that the training has been completed before approval of projects can be obtained. The Institute currently subscribes via MGH Research Administration to the CITI online program.