Human Research Review Committee
(HRRC-IRB)
Supported by the
Human Research Protections Office
| HRPO Home > Principal Investigator Policy |
Principal Investigator Policy
UNM INVESTIGATORS
For review of an application by the Human Research Protections Office (HRPO), the Principal Investigator as listed on the application must meet one of the following criteria:
-
Is a contract (paid) UNM faculty member
-
Is a salaried UNM staff member and has a Letter of Academic Title in a UNM department
In special instances, other members of the university community may request permission to serve as Principal Investigator.
Requests for PI status should be sent on behalf of the individual with 1) an approval and endorsement from the relevant department chair (if applicable) and 2) an assurance that the department will assume responsibility for the conduct of the research project. Request should be sent to the Operations Director of the Human Research Protections Office. The Vice President for Translational Research will review the request for exceptions to the PI policy.
NON-UNM AFFILIATED INVESTIGATORS
The HRPO does not routinely provide IRB review for studies conducted by non-UNM investigators. Researchers in the community may request permission to serve as Principal Investigator for an HRPO research application when there is a clear collaborative arrangement with UNM.
Request for PI status should be sent on behalf of the individual to the Operations Director of the Human Research Protections Office. The Vice President for Translational Research will review the request for exceptions to the PI policy.
Upon approval by the Vice President for Translational Research, any non-UNM affiliated principal investigator must sign and submit to the HRPO an Unaffiliated Investigator Agreement, except in the case where the non-UNM affiliated investigator is conducting research under his or her own institution’s FWA and that institution has designated UNMHSC HRPO as their IRB. In the latter case, a valid IRB Authorization Agreement must also be in place between the two institutions.
Non-UNM affiliated investigators agree to pay any and all money penalties assessed against UNM or its faculty should the Office for Human Research Protection (OHRP), or any other federal, state, or local agency or office find that any of the researcher's actions failed to comply with OHRP or other relevant laws or regulations. Non-UNM affiliated investigators agree to pay all reasonable costs associated with an HRPO requested audit of relevant research records as a result of concerns about subject safety or noncompliance. If research is conducted at UNM, all use of facilities will be fully compensated by the non-UNM affiliated investigator.
ALL INVESTIGATORS
In all cases, the PI must have an active role in the research. The submission to the HRPO must detail the role the PI will have in the research project.
The PI agrees to be responsible for the research being conducted in full compliance with both federal and University regulations and with all components of the applicable Federal Wide Assurance (FWA) for the protection of human subjects in research and all other applicable requirements, including federal billing requirements.
The research protocol is given thorough and substantive scientific review by the PI's department (or other authorized scientific review committee) and the department chair (or other authorized signatory) has provided written approval for the project prior to submission to the HRPO.
The principal investigator formally agrees to comply with all components of the UNMHSC or applicable FWA, all policies and procedures of the UNMHSC HRPO, and all policies and procedures of the UNM Conflict of Interest Committee as well as all applicable laws and regulations. Regardless of where the research is conducted, the UNM HRPO may audit to ensure consistency with representations made to the HRPO, compliance with regulations and subject safety.
In order to retain the services of the HRPO for previously approved, still active research studies, Principal Investigators who sever their qualified relationship with the University will be expected to appoint an eligible person to assume full responsibility for all aspects of their research, as detailed above. This person must be approved by the HRPO.
If a faculty member leaves the University without having made satisfactory arrangements for the involvement in and oversight of his or her research by an eligible Principal Investigator, all active studies of the departing faculty member will be closed by the HRPO upon the recognized departure of that faculty member. All arrangements for assigning a new Principal Investigator will be subject to prior HRPO approval.
The Principal Investigator agrees to pay the HRPO protocol review fee, as applicable.
| Home | School of Medicine | UNM | HSC |