External Research with Carroll College Community Members
Following are the policies and procedures for external principal investigators (PIs) to engage the Carroll College community on campus in research activities involving human subjects.
1.0 General Description:
1.1 In accordance with federal and institutional regulations, prior to project initiation, the IRB must approve any activity in which a Carroll College community member is engaged in research involving human subjects. If the principal investigator is an external principal investigator, the investigator must follow the outlined procedures for working with Carroll College community members as human subjects. No official of Carroll College may approve the initiation of research involving human subjects if the research has not been reviewed by the IRB [45 CFR 46.112].
2.0 Definitions:
2.1 Principal Investigator means an investigator that accepts overall responsibility for the research activity.
2.2 External Principal Investigator means a principal investigator who is not a current Carroll College community member.
2.3 Carroll College community members are any current students, faculty, or staff members of Carroll College.
2.4 Engagement means an institution’s officers, employees, agents, and/or students, for the purposes of a research project, obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.
3.0 Responsibility:
3.1 It is the responsibility of Carroll College community members when approached by an external principal investigator wishing to recruit Carroll College community members on campus or using campus provided communication to inform them of the institutional policy and direct them to Carroll College IRB.
3.2 The Carroll College IRB will review all inquiries from an external principal investigator regarding the recruitment of human subjects or human subject data from Carroll College.
3.3 The Carroll College institutional authority may withdraw his or her institutional approval of the research project at Carroll College, at any time. If this occurs, the IRB must be notified in writing.
4.0 Procedure:
4.1 Where to make an inquiry:
The Carroll College IRB will receive all inquiries from an external principal investigator regarding the recruitment of Carroll College community members. The IRB Chair will request to see the research protocol and any letters of approval from outside institutions. The IRB Chair, in consultation with the IRB, will use this information to make a determination if Carroll College is engaged in the research project.
4.2 When Carroll College is engaged in the research project:
If the Carroll College IRB determines that Carroll College is engaged in the research project, the Carroll College IRB will determine the IRB of Record on a case by case basis, either 1) entering into a joint review arrangement with the other institution, 2) relying on the review of another qualified IRB, or 3) reviewing the protocol [45 CFR 46.114].
The Carroll College IRB will advise, in writing, the external investigator on the appropriate submission process, including any additional requirements. Recruitment of Carroll College community members as human subjects must comply with the recruitment process reviewed by the Carroll College IRB.
If institutional approval is required by the IRB of Record, this approval should be granted by the Carroll College Vice President for Academic Affairs.
4.3 When Carroll College is not engaged in the research project:
If the Carroll College IRB determines that Carroll College is not engaged in the research project, the Carroll College IRB does not have the authority to approve or reject the research project. However, the IRB may advise the Carroll College the Vice President for Academic Affairs on his/her decision to grant institutional approval. If the Carroll College Vice President for Academic Affairs grants an external PI institutional approval to conduct research in which Carroll College is not an engaged institution, the external PI may recruit Carroll College community members as human subjects through appropriate channels approved by the Carroll College Vice President for Academic Affairs.