How is it determined if research is considered "Human Subject Research" and needs to be reviewed by the IRB?
- Is the activity a systematic investigation designed to develop or contribute to generable knowledge?
- Does the research involve obtaining information about living individuals?
- Does the research involve intervention or interaction with the individuals? If No, is the information identifiable? If yes, is the information private?
- Is the human subject research conducted or supported by HHS or is it covered by the UNM OHRP approved assurance created under 45 CFR 46.103?
If at the end of each of the questions the answer is "yes", then the project is considered "human subjects research". Remember, only the IRB can provide an investigator with an official determination that shows that the research was carefully reviewed.
My research is not federally funded. Do the federal regulations governing research still apply to it?
Yes, UNM has elected to apply the protections of the federal regulations (45 CFR 46) to all of our human subject research regardless of its source support (or lack thereof).
How long does it take for approval?
Investigators are responsible for allowing a minimum of 30 business days for the review process (from the time pre-review is completed 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.
I need my protocol approved right away. Can it be "expedited"?
Expedited doesn't necessarily 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 full Institutional Review Board. Instead, the proposed research may be reviewed and approved by a single IRB member. Please note that Expedited research still undergoes complete review and a minimum of 30 business days is required (from the time of submission until a determination is made by the IRB).
Do I need to report changes to my protocol to the IRB?
Yes, modifications that require approval include (but not limited to) changes in Principal Investigator (PI), study team members, inclusion/exclusion criteria for subjects, sites of study, recruitment strategy, consent and authorization process, informed consent documentation, survey/interview/focus group questions, testing procedures, confidentiality measures, and/or safeguards for participants. Conducting a study with unapproved changes invalidates the approval status!
May I begin recruitment of subjects while approval of my protocol is pending?
No. Final approval by UNM's Main Campus IRB is necessary before any recruitment or enrollment procedures may begin.
Who should be on my Project Team Form?
Anyone that is involved in activities with the participants in the context of you research needs to be on your Project Team Form. This would include consenting, data collection, analysis of indetifiable data, project monitoring, and some recruitment activities. If you are a student research conducting research under the guidnace of a committee (e.g. disertation committee), not all people on the committee need to be on the Project Team Form, unless they are involved in the previously mentioned activities.