This policy defines the scope of research that is reviewed by the Tufts Institutional Review Boards (Tufts Health Sciences IRB and Tufts SBER IRB). Along with the Tufts PI Eligibility Policy, it clarifies who may submit to Tufts IRBs, particularly when investigators conduct research on behalf of organizations other than Tufts.

To Whom Does This Policy Apply

Employees, faculty, staff, students, contractors, and volunteers, among others, who are conducting human subjects research on behalf of Tufts Medicine (Tufts Medical Center, MelroseWakefield Healthcare, Lowell General Hospital) or Tufts University fall under the jurisdiction of the Tufts IRBs. These individuals are referred to collectively as “members of Tufts Work Force,” regardless of whether or not the individual is receiving compensation or a stipend.

When Tufts IRB Review is Required

The following are the categories of human subjects research that must be reviewed by the Tufts Health Sciences IRB:

1. The research is performed as part of an individual’s employment responsibilities.
2. The research is conducted by a member of Tufts Work Force during Tufts work/education/volunteer time or with Tufts resources/money/space.
3. The research is being performed as part of a Tufts course or training program.

While it is clear that research conducted by Tufts Medicine or Tufts University requires review by the Tufts IRBs, it may be less obvious that, if members of the Tufts Work Force perform research at other institutions—internationally, in the community, or in their private practices—on behalf of Tufts, they must also receive approval by the Tufts IRBs.

The following are some less obvious examples of when review by a Tufts IRB may be required:

1. A member of the Tufts Work Force conducts research at a school, day care center, company, community center, or another healthcare facility.
2. The research is performed as part of an individual’s academic requirements at Tufts.
3. A Work Force member receives a grant/subcontract through Tufts, but proposes to conduct the research at another location.
4. Tufts data or samples are provided to external researchers for use at an offsite location.
5. A member of the Tufts Work Force obtains an appointment at another site in order to conduct research at that location and is listed as a co-investigator on the protocol submitted at the other institution.
6. A member of the Tufts Work Force consults on the design of a research protocol to be conducted elsewhere and also participates in data analysis.

In some cases, arrangements can be made to rely on another IRB. However, the research must be disclosed to the IRB office staff, who will help determine whether the extent of the involvement of members of Tufts Work Force constitutes engagement in human subject research and whether reliance agreements can be utilized. When there is a question as to whether review by Tufts IRBs may be necessary, or whether a reliance agreement may be possible, consultation with the other organizations may also be required to help make this determination. If a reliance agreement is used, it must be in writing. The Tufts IRB reviewing the study will notify the PI if and when the agreement has been executed. Research activities may not be conducted prior to this official notification.

When Research Is NOT Eligible for Review by Tufts

Some human subjects research projects may not be eligible for review by Tufts IRBs, although activities may be conducted by members of the Tufts Work Force. This occurs when a member of the Tufts Work Force is conducting human subjects research on behalf of another organization for which he/she works or volunteers or for which he/she is completing education requirements, unrelated to their duties as a member of the Tufts Work Force. Examples may include when an individual is performing research for their own private practice or company, conducting research on behalf of another organization (e.g. affiliation with a not-for-profit; faculty with a joint appointment), or conducting research to fulfill education requirements that are not associated with Tufts academic requirements.

When there is a question as to whether a member of Tufts Work Force is conducting research on behalf of Tufts, and whether the Tufts IRBs are the appropriate body to review the project, the Investigator should bring this to the attention of the IRB administrative office. The IRB will consult with the appropriate Institutional Official to make this determination.