Eastern Colorado Health Care System
VA Investigator Agreement
COMIRB # ______Study Title: ______
Principal Investigator: ______VA Investigator: ______
1. As the VA Investigator conducting human subject’s research, I understand that I have the ultimate responsibility for employing sound study design, minimizing risk to the subjects, conducting and/or supervising personally the study, including recruitment and selection of study participants, and to do so in a fair, equitable, non-coercive, and ethical manner, protecting the rights and welfare
of the human subjects.
2. I will ensure the protocol is carried out in full compliance with all Federal, VHA, state, and local regulations, as well as Good Clinical Practice guidelines, as defined by the FDA. I also agree to strictly adhere to any stipulations imposed by the appropriate IRB of record either the Colorado Multiple Institutional Review Board (COMIRB) or the VA Central IRB (VA CIRB); the VA Subcommittee on Research Safety (SRS); and the VA Research & Development (R&D) Committee.
3. I agree to conduct the study in accordance with the relevant, current protocol that has been approved by the IRB, the SRS, and the R&D Committee. I will only make changes in a protocol after notifying the sponsor (if any) and obtaining the approval of the IRB and R&D Committee, except when necessary to eliminate apparent immediate hazards and protect the safety, rights, or welfare of subjects (in which case the IRB and R&D Committee must then be notified at once). If the amendment addresses an issue related to biosafety, radiation safety, or devices, the SRS must also review and approve the amendment prior to R&D Committee approval.
4. I agree to ensure the protection of every research subject. I will ensure the adequacy of both the informed consent document and the informed consent process, regardless of which members of the research team are authorized to actually obtain and document consent. I will respond promptly to participants’ questions and/or complaints. I will notify subjects of new information that may become available during the course of the study that may affect the subjects’ decision to remain enrolled in the study.
5. For studies involving drugs or devices, I have read and understand the information in the investigator’s drug or device brochure, including potential side effects and risks of the drug or device. I agree to inform any subjects or any persons used as controls that the drugs or devices are being used for investigational purposes. I will ensure that the requirements relating to obtaining informed consent, as well as those requirements set by the IRB, the SRS, and R&D Committee are met. I also agree to report to the sponsor adverse experiences and unanticipated problems that occur in the course of the investigation in accordance with Federal regulations.
6. If I file an IND or an IDE, I understand I am also considered the Sponsor and as such carry all of the FDA regulatory responsibilities
and reporting obligations of both the Investigator and the Sponsor as described in the FDA regulations, which includes a monitoring
plan approved by the IRB, the SRS, and the R&D Committee.
7. I agree to ensure that all associates, colleagues, and employees assisting in the recruitment +/or conduct of the study under the auspices of the VA are informed about their obligations in meeting all VA commitments, that all have taken an approved human subjects protection training program and all annual VA required research training. I will notify the VA Research Office of any new staff (i.e., to confirm appointment, credentialing, and training, including HR processing and Employee Health screening) and departing research staff.
8. I agree to maintain complete and accurate research records and to make those records available for inspection in accordance with Federal, state and local regulations. If I leave the VA facility, I understand the original research records must be retained at this institution.
9. I ensure that I will submit this project for initial review and continuing review for approval by the IRB, the SRS, and the R&D Committee within one year of the initial review, or sooner if determined by the IRB and R&D Committee, according to the degree of risk.
10. I agree to comply with the VHA regulations for storage and/or banking of Human Biological Specimens.
11. I understand that the potential for conflict of interest exists when any financial arrangement, situation or action affects or is
perceived to exert inappropriate influence on the design, review, conduct, results, or reporting of research activities or findings.
Therefore, if participation in this project presents any real or potential financial or non-financial conflict of interest, i.e., personal or private, for myself or any of my research staff I will notify the VA ACOS/R&D. I agree that any subsequent financial or non-financial, real or potential conflict of interest arising after initial application must also be reported promptly to the VA ACOS/R&D.
12. I agree to report promptly to the IRB, the VA Research Office (who will then notify the other appropriate subcommittee(s)
and R&D Committee), and the Sponsor, when applicable, any and all changes in the research activity including but not limited to,
modifications to the protocol or informed consent, changes in study personnel, protocol deviations, expiration of approvals, conflict of interest, Safety and DSMB reports, all unanticipated problems involving risk to human subjects or others during the course of the
investigation, and project closure.
13. I agree to the best of my knowledge that all VA sensitive information associated with this research study is now or in the process of being used, stored, and secured in accordance with applicable VA and VHA policies and guidance.
My signature certifies my agreement to adhere to the above statements.
Signature of VA Investigator: ______Date: ______
The VA Investigator is the VA’s responsible investigator who must have a VA appointment, either compensated or without
compensation (WOC), and serves as the PI for the VA. The VA Investigator is responsible for VA-specific adverse reactions, clinical
emergencies related to research, financial issues, and other VA-related concerns. In some cases, the VA Investigator may not be the
same as the Principal Investigator. This is a division of responsibility negotiated by the investigators themselves. Rev.11-11-11