Principal Investigator Policy
HSC UNM Investigators
For the HSC Human Research Protections Office (HRPO), a Principal Investigator 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 special exception:
- Should be sent on behalf of the individual with an approval and endorsement from the department chair (if applicable)
- An assurance that the department will assume responsibility for the conduct of the research project
- Sent to the Operations Director of the HRPO. The Vice President for Translational Research will review the request.
If you are a VA Investigator, you need to have joint appointment with UNM and the VA to qualify as a UNM Investigator. If you do not have a joint appointment, you will need to contact the VA research office. They will assist you in submitting a memo from Dr. Thomas Byrd to our office.
UNM Main Campus
Investigators
Applicants to the Main Campus IRB must be
- Investigators with faculty appointments who plan on conducting human subject's research under the auspices of an academic department, research center, institute or other administrative unit.
- Tenured, tenure-track and salaried faculty or research staff with letters of academic title may sponsor and serve as the responsible faculty member such as in the case of student research or research conducted by part-time faculty or visiting scholars from other institutions.
Research staff at centers and institutes or at other program offices may also submit applications to the IRB with approval of the respective Director who will supervise the project in lieu of a faculty member. In all cases, the responsible faculty member or the unit Director must assure compliance with human research protections and IRB requirements.
Non-UNM Affiliated 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 and is conducted in accordance with Section 2.7 of our manual "Serving as the IRB for an Unaffiliated Entity"
Request for PI status should be sent on behalf of the individual to the Operations Director of the HRPO. The Vice President for Translational research will review the request. Upon approval, any non-UNM affiliated principal investigator must sign and submit to the HRPO an Unaffiliated Investigator Agreement.
However, if the non-UNM affiliated investigator is conducting research under their own institution's FWA and that institution has designated UNM HRRC or Main Campus IRB as their IRB, a valid IRB Authorization Agreement must also be in place between the two institutions.
Non-UNM investigators agree to pay any and all penalties assessed against UNM or its faculty should the federal Office for Human Research Protections (OHRP), or any other entity finds that any of the researcher's actions failed to comply with 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 investigators.
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.
- That the application/study has been 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 submitting the application to the HRPO.
- Comply with all components of the UNM HRPO or applicable FWAs, all policies and procedures of the UNM HRPO, and all policies and procedures of the UNM Conflicts of Interest Committee as well as all applicable laws and regulations and subject safety.
- That if severing their relationship with the University will be expected to appoint an eligible person to assume full responsibility for all aspects of their research. That person must be approved by the HRPO.
- To pay the HRPO protocol review fees, as applicable.