Cooperative Research IRB Brownbag, 3/4/08

ISU Policy Cooperative research projects are those projects which involve more than one institution. The official relationship between the two institutions is not relevant. Each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with federal and institutional policies.

PI(s) at ISU who are conducting research at another institution are required to abide by ISU requirements, as well as the requirements of the other institution. The PI will need to request a letter of approval from other institution stating that the research may be conducted at the site and that those at the site agree to comply with ISU’s IRB requirement for the protection of human subjects If the other institution has an IRB, the PI may be required to seek its approval as well, or file a request to designate one of the institutions’ IRB to review the research (e.g., IRB authorization agreement).

When ISU is considered to be “engaged in research” but the PI is not associated with ISU, the PI must submit the following for review by the IRB: an application (Form A, and Forms B or C, if applicable), a letter of support from a faculty member or EAP staff member at ISU who will sponsor the project, and a letter of approval from IRB of the institution where the individual is at, unless the individual’s institution does not have an IRB. The IRB will then complete the appropriate review process, based on the nature of the research project. ISU may choose to rely on the review of the PI’s IRB, in which case both institutions would need to complete the IRB authorization agreement. When ISU is not “engaged in the research,” the unaffiliated PI needs to obtain IRB approval at his or her institution and secure permission from an ISU official (e.g., department chairperson, dean, supervisor) to conduct the study at ISU.

This begs the question: What does it mean to be “engaged in research?”

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects