MISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM. Collaborative Research and Performance Sites (01-23) Approved

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1 MISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM Collaborative Research and Performance Sites (01-23) Approved Policy It is the policy of the MSU HRPP that all human subjects research in which MSU is engaged and/or which is conducted at an MSU location must be approved by an IRB. Materials OHRP Guidance: Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement Guidance on Engagement of Institutions in Human Subjects Research IRB Knowledge of Local Research Context Sample IRB Authorization Agreement ( FDA Information Sheets: Non-Local IRB Review MSU Policy HRM Outside Employment IIA Approval Request Form Individual Investigator Agreement IRB Reviewer Comment Form for Local Context Review Definition Unaffiliated Investigator (UI) Non-MSU affiliated individual Procedure 1. Unaffiliated Investigator (UI) proposing to conduct human subjects research (HSR) at an MSU location without collaboration of an MSU Investigator When an Unaffiliated Investigator proposes to conduct HSR at an MSU location, the UI must contact the HRPP staff for a determination as to whether MSU is engaged in the HSR. An unaffiliated investigator is one who does not have an official association with MSU. This determination is required if MSU will release prospective subjects information to the non-msu investigator, or provide prospective subjects with information regarding the research. Such a determination is not required for researchers who will directly contact MSU-affiliated individuals regarding the availability of research without physically visiting an MSU location (e.g., contact by phone, mail, or only). a. MSU not engaged in HSR If it is determined by the HRPP staff that MSU is not engaged in HSR, the activity will be allowed to commence after the approval of the appropriate MSU Dean, Director, or Department Head (D/D/D). The UI may be required to submit documentation of IRB and D/D/D approval to the MSU HRPP. The MSU HRPP reserves the right to review any materials associated with the research to ensure compliance with this policy. However, the MSU HRPP will not serve as IRB of Record for research in which MSU is not engaged. b. MSU engaged in HSR If it is determined by the HRPP staff that MSU is engaged in HSR, the UI will be required to have an MSU faculty or staff member who agrees to serve as Principal Investigator at MSU to oversee the research conducted at the MSU location. The UI must have IRB approval from an IRB listed on an OHRP- Collaborative Research and Performance Sites Page 1 of 5

2 approved Federalwide Assurance (FWA). The activities of the MSU Investigator will be reviewed via normal procedures of the MSU HRPP. 2. MSU Investigator collaborating with an Unaffiliated Investigator to conduct HSR at an MSU or non-msu location When an MSU investigator proposes to collaborate with an UI to conduct human subjects research, the MSU investigator must describe activities of the UI in the IRB application so that the MSU HRPP staff may make a determination as to whether the UI is engaged in human subjects research. a. Unaffiliated Investigator not engaged in HSR If the MSU HRPP staff determine the UI is not engaged in human subjects research, HRPP approval will not be required of the UI. However, if the UI is associated with an institution with its own IRB, the MSU HRPP staff may suggest or require the UI to confer with the IRB of that institution, and may require documentation of that decision. b. Unaffiliated Investigator engaged in HSR If the MSU HRPP staff determine the UI is engaged in human subjects research, the UI must have the project approved or determined to be exempt by an IRB. In cases of federally-funded, non-exempt human subjects research, the research must be reviewed and approved by an IRB designated on an FWA. i. If the UI belongs to an institution with an FWA, it will be expected that the covered institution will provide IRB review of the project by an IRB designated on its FWA. However, other arrangements may be made for IRB review, including petition of the MSU HRPP to serve as IRB of Record for the UI as described below. ii. If the UI belongs to an institution with an IRB but lacks an FWA, the MSU HRPP will request the approval of that institution s IRB but may require other arrangements for HRPP review of the project, such as the MSU HRPP serving as IRB of Record. iii. If the UI does not belong to an institution with either an FWA or an IRB, or is acting as an independent consultant apart from any such affiliation, other arrangements must be made for IRB review, such as the MSU HRPP serving as IRB of Record. In instances where an UI is acting as an independent consultant or otherwise separate from an institution with which he or she normally has an affiliation, the MSU HRPP must receive documentation on that institution s letterhead from the IRB or other appropriate office that the individual is in fact unaffiliated with said institution for the given project. Whenever the MSU HRPP is petitioned to serve as the IRB of Record for an UI, such an arrangement will be made at the discretion of the appropriate officials as described below. In such cases, either the IRB Authorization Agreement (IAA) or Individual Investigator Agreement (IIA) must be executed to formalize the arrangement. Collaborative Research and Performance Sites Page 2 of 5

3 In instances in which an UI is affiliated with a FWA-holding institution as described in 1.b.i. above, but officials of both institutions agree for the MSU HRPP to serve as IRB of Record, the IRB Authorization Agreement must be executed. The arrangement must be approved by a subcommittee of the Convened IRB and the MSU Institutional Official. The subcommittee will consist of the Chair, Vice Chair, IRB Officer and another member of the IRB named by the Chair. At least three members of the subcommittee must participate to conduct business. If the subcommittee cannot come to a unanimous decision, it will be referred to the CIRB. The institution relying on the review of the MSU HRPP must update its FWA with OHRP to list the MSU IRB. In instances in which an UI is not affiliated with a FWA-holding institution as described in 1.b.ii. or 1.b.iii. above, the Individual Investigator Agreement (IIA) must be executed for the MSU HRPP to serve as IRB of Record. Use of the Individual Investigator Agreement must comply with OHRP Guidance titled Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement. To petition the MSU HRPP to serve as IRB of Record for an UI, the MSU Investigator must submit the IIA Approval Request Form. For exempt projects, the IIA Approval Request Form will be reviewed by the IRB Officer. For projects undergoing Expedited or Convened IRB Review, the IIA Approval Request Form will be reviewed by a subcommittee of the Convened IRB. The subcommittee will consist of the Chair, Vice Chair, IRB Officer and another member of the IRB named by the Chair. At least three members of the subcommittee must participate to conduct business. If the subcommittee cannot come to a unanimous decision, it will be referred to the CIRB. If the IIA Approval Request Form is approved, the MSU Investigator must also submit an Individual Investigator Agreement for each UI. The IIA must be signed by the Institutional Official or designee prior to the UI s conduct of any HSR. Each individual investigator must also be listed on the IRB application or added via a Personnel Modification form. When an individual investigator will no longer be engaged in study activities, they should be removed via submission of the Personnel Modification form. In either case, when the MSU HRPP is to serve as IRB of Record, unaffiliated investigators must satisfy the requirements for human subjects protections training. c. In addition to those circumstances described above, the MSU HRPP will in certain circumstances agree to defer to another IRB designated on an FWA in regard to the activities of an MSU Investigator engaged in HSR. Such an arrangement may be considered, for example, when the project is conducted primarily by investigators at the other institution with minimal involvement of the MSU Investigator. In such a case, the agreement to defer to another IRB may be made with the approval of the IRB Chair and the MSU Institutional Official, with a subsequent report made to the Convened IRB for informational purposes. However, the IRB Chair may defer the decision to the Convened IRB. When the MSU HRPP enters into an IRB Authorization Agreement to rely on another Collaborative Research and Performance Sites Page 3 of 5

4 institution s IRB, MSU s FWA must be updated with OHRP to list the reviewing institution s IRB. 3. MSU Investigator engaged in HSR at a non-msu location Whenever an MSU Investigator conducts HSR at a non-msu location, the MSU Investigator must include with the HRPP application the External Site Form which provides information necessary to ensure the protection of human research participants and required communication between the MSU HRPP and other sites. Additionally, the form must be accompanied by a letter or of permission from an appropriate entity addressing the items outlined in the supplemental form. If the site has an IRB, this permission must come from the IRB. If the institution is engaged in research as described in item 2 above, the IRB approval letter will suffice as the permission letter. These requirements only apply if the research is to be physically conducted on site at the non-msu location. For example, an organization providing information to prospective research participants does not necessitate a written permission letter if that is the extent of their involvement. If a school is to be involved, the permission letter must come from an administrator at the Principal or Vice/Assistant-Principal level, or from the school district s Superintendent in accordance with the school s policies. The MSU HRPP will accept the letter or of permission as indication of compliance with the school s policies. (Note: It is the policy of the Starkville School District that the permission letter for research conducted in their schools must come from the Superintendent s office.) 4. MSU affiliate engaged in HSR as part of outside employment or practice of profession (including consulting) When an MSU affiliate engages in outside employment to conduct HSR, such an arrangement will not engage MSU in research. In accordance with MSU Policy HRM Outside Employment, employees desiring to engage in outside employment must execute Form Application for Permission to Engage in Employment (Practice of Profession, Consulting or Business) Outside of Mississippi State University. When engaging in outside employment to conduct HSR, the MSU employee must disclose this arrangement to the MSU HRPP. The fully executed Form signed by all applicable parties must be submitted to the MSU HRPP to document such an arrangement so that MSU HRPP approval is not required. MSU employees engaging in outside employment will not ordinarily be covered by the MSU HRPP for associated HSR activities and will have to make other arrangements for HRPP approval of their activities. The MSU employee may petition the MSU HRPP to cover those activities, but such an arrangement will be made only with the approval of the Convened IRB and the MSU Institutional Official. 5. MSU Investigator proposing to conduct human subjects research internationally, or domestically with non-english speaking subjects and/or subjects from a foreign culture In addition to other requirements of this policy regarding UIs and non-msu locations for HSR, when HSR is to be conducted internationally, or conducted domestically with non- English speaking participants and/or participants from a foreign culture (to include American Indian reservations), the HRPP must have knowledge of the local research context in accordance with OHRP Guidance titled IRB Knowledge of Local Research Context. Collaborative Research and Performance Sites Page 4 of 5

5 The HRPP must either have members with the appropriate knowledge or obtain consultation from individuals with appropriate knowledge of the local research context. The appropriate individual must have personal knowledge of the local research context, such knowledge having been obtained through extended, direct experience with the research institution, its subject populations, and/or its surrounding community. It is preferable to obtain a local context review from an IRB listed on an FWA at an institution located geographically near the site of the research. However, if this is not a possibility, the review may be conducted by a consultant to the HRPP. When a consultant performs the review, the form titled MSU HRPP Reviewer Comment Form for Local Context Review should be used to guide and document the review of the research project for local context considerations. For Convened IRB Review, if the local context review is provided in writing, it must be included in the meeting packet for IRB members in advance of the meeting in accordance with the Convened IRB Review of Research Standard Operating Procedure. 6. Any other circumstances regarding MSU affiliates and/or MSU locations associated with the conduct of human subjects research not described here-in will be considered on their own merits by the IRB Chair and/or IRB Officer and action taken as deemed appropriate. Reviewed IRB Chair Date IRB Officer Date Collaborative Research and Performance Sites Page 5 of 5