When Carleton College plans to participate in collaborative (multi-site) research studies where there is an intention to contribute to generalizable knowledge, IRB application is usually required.

The federal regulation on "Cooperative Research" states:

Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or Agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. (45 CFR 46.114)

Examples:

• The ongoing cooperative Institutions Research Program sponsored by HERI, the Higher Education Research Institute (offices at UCLA)
• An occasional survey of student use of alcohol, part of an ongoing study managed by a research group at Harvard.

For all such studies initiated elsewhere but involving Carleton, the IRB asks that the relevant administrative office on campus (Institutional Research, in most cases) submit to the IRB chair the following information in advance and then follow Carleton's procedure on Cooperative Research outlined below:

1. Basic information about the study itself--its title, the sponsoring institution or organization, target subjects at Carleton, and the kinds of information to be gathered.
2. Written assurance that the project has been reviewed, or that an ongoing project is being annually reviewed by a qualified, listed IRB at another institution. If this cannot be provided, then the Carleton IRB will conduct a review.
3. A brief discussion of likely benefits to the college and to the subjects.
4. A brief discussion of any invconviniences or risks to the subject pool at Carleton.
5. Written assurance that subjects at carleton will be told clearly that they are not required to participate, may decline to participate at any point, and may decline to answer specific questions without penalty.

To implement the federal regulation above, the IRB at Carleton has developed the following procedures for cooperative (multi-institutional) research:

1. If the project has already been reviewed by a qualified IRB at another institution, then the applicant should submit the application from that institution and the IRB's finding to the Carleton IRB. We need this information to determine whether the review was done in a way that meets Carleton's responsibilities for "safeguarding the rights and welfare of human subjects and for complying with" the federal policy."

2. However, it will not be necessary to submit the full application and IRB finding from another institution in the case of established national studies that are ongoing, such as the HENRI Faculty survey. In those cases, the local administrator of the project should send a letter to the chair of the IRB affirming that the project is being regularly reviewed by a qualified IRB at another institution. If in doubt, the local administrator should contact the IRB chair to discuss how much documentation will be needed.

3. If the project has not been reviewed elsewhere, then the Carleton IRB will conduct its own review in the usual way.