Frequently Asked Questions
The UNM Office of the IRB has two tools available to help you determine whether your project requires IRB review – “Decision Tree to Determine IRB Review” and “When do activities need IRB Review” (add links to guidance documents). Also, detailed information is available on the "What is HSR?" page.
My research is not federally funded. Do the federal regulations governing research still apply to it?
It depends. UNM IRB has created ethical standards for the conduct of all human research, regardless of funding, that are very similar to the federal criteria for approval of research. The federal regulations are considered a “floor” for the ethical conduct of human research and our nationally accredited human research protections program (HRPP) has established robust criteria for review of all human research conducted by or affiliated with the University of New Mexico. For more information about IRB review, please see our “Policies” located in the IRB Library.
Researchers should plan on a minimum of 30 business days for the review process (from the time of submission until a determination is made by the IRB). Please carefully edit and proofread all application materials before submission to OIRB as incomplete and missing information will cause delays in the project application review process.
Expedited does not mean "quick". Expedited review refers to a process of review for certain research that falls within categories established by federal regulations. If a protocol meets the specific qualifications for Expedited review (as determined by the IRB), it will not require review by the fully convened IRB. Instead, the proposed research may be reviewed and approved by a single IRB member. Please note that Expedited research still undergoes robust review and a minimum of 30 business days should be anticipated.
Yes, amendments that require approval include (but are not limited to) changes in Principal Investigator (PI), inclusion/exclusion criteria for participants, research sites, recruitment strategies, informed consent process or documentation, assessment tools, testing procedures, confidentiality measures, and/or privacy safeguards for participants. Conducting a study with unapproved changes is a violation of policy and could result in a finding of noncompliance.
No. Final approval by the IRB is necessary before any recruitment or enrollment procedures may begin.
Anyone that is involved in the following needs to be on your Project Team Form: informed consent discussions, direct interaction with study participants including recruitment activities, data collection, and analysis of identifiable data. If you are a student research conducting research under the guidance of a dissertation or thesis committee, only people on the committee involved in the above activities need to be on the Project Team Form. It is the Principal Investigator’s responsibility to ensure all project team members have completed human research protections training (within the past 3 years) and have submitted and disclosed potential conflicts of interest to the UNM Conflict of Interest Office.
UNM has two IRB offices, one the serves the Main and Branch Campuses (UNM Office of the IRB or OIRB) and one that serves the Health Sciences Center (Human Research Protections Office or HRPO). You should submit your project to the IRB based on the Principal Investigator’s primary appointment (i.e. main campus researchers submit to OIRB, north campus researchers submit to HRPO). The associated IRB Director will determine whether a deferral to another IRB is appropriate.
What is the Scientific Review (previously called “Department Review”) required by the IRB and who performs that function?
Previously, the “department review” was conducted by the PI’s Department Chair or designee. The requirement for scientific review of new projects submitted to the IRB can be in one of the following ways:
- Review by the department chair/center director/designee in which the Principal Investigator (PI) is administratively located for purposes of leading or supervising the research (same as previous policy);
- For graduate student thesis or dissertation research, review by the student’s dissertation or master’s thesis committee chair (if allowed by the department – please check with your department chair);
- For externally funded research, documented (scored) peer review. A copy of the notification of peer review by funder must be submitted as a supporting document.
Please contact the OIRB (505-277-2644) with any questions.
All submissions to the IRB receive a thorough preliminary review by OIRB staff before getting reviewed by the IRB. As part of this “pre-review”, OIRB staff may ask you to make changes or provide additional information. If you have specific questions about your submission (such as when it is appropriate to request a waiver of documentation of consent), you can schedule a consultation with an OIRB staff person by completing the online Consultation Request Form. Note that packages that are not submitted cannot be viewed in IRBNet by the OIRB.
Yes. Human research projects conducted by UNM undergraduate and graduate students need IRB approval, if the project fits the definitions of "research" and "human participants" as described in the researcher portal. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.
If my research qualifies as exempt, does this mean that I do not have to submit a protocol for review?
No. The Federal Regulations do make certain categories of research exempt from the regulations. However, UNM policy does not allow researchers to self-exempt their human participant research projects. Instead, determining if a project meets exemption criteria is an administrative review process handled by OIRB staff.
I will be collaborating with another institution. Do I need to submit to UNM’s IRB and the other institution?
If you are UNM faculty or staff, or a UNM student, and you are the person primarily responsible for the conduct of the study, you must get UNM IRB approval to conduct your research regardless of where the research takes place. Researchers should contact the OIRB whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.