FAQs

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 “Activities Requiring IRB Review”
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.
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.
Anyone that is involved in the following needs to be on your protocol personnel tab in Streamlyne: 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 protocol personnel tab. It is the Principal Investigator’s responsibility to ensure all protocol personnel 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 that 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.
Federal human protections regulations and accreditation standards require that a scientific or scholarly validity review be conducted. The IRB has delegated this responsibility and can be conducted in one of the following ways:
  1. 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;
  2. 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); OR
  3. 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.
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.
In most cases, 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 handbook. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human research. Students should always discuss the need for IRB approval with their instructor or faculty advisor so that they can determine whether it is necessary.
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 IRB of Record to review and approve the research.

Please see the IRB Submission Checklist for a list of what documents are required. Grey highlighted documents are MANDATORY. Submissions will be withdrawn if these are not included. All documents necessary for a new protocol can be found in the Submission Forms & Templates.

We strongly encourage that initial submissions be as complete as possible upon submitting for IRB Review. Please carefully edit and proofread all application materials before submission to OIRB as incomplete and missing information will cause delays in the review process.

For student projects the faculty advisor is always listed as the principal investigator (PI) on all forms and in Streamlyne. The faculty member is the person responsible for overseeing the conduct of the research and is responsible to ensure that the project stays in compliance with federal regulation, state and local laws, and UNM policies. This includes submitting or ensuring submission of appropriate paperwork to the IRB for Continuing Review or Closure as well as appropriate handling of any complaints or concerns from participants and the IRB.
The Streamlyne IRB Researcher Manual provide instructions for using Streamlyne including logging into your account, submitting a new protocol, responding to an return to PI and submitting an amendment or renewal.  Please see the training videos page for tutorials on how to create a new protocol and creating an amendment for an approved protocol using Streamlyne. 
You can find your determination letter in Streamlyne by following the instructions in the View Approval Letter Tipsheet. IRB determination letters should be downloaded and kept with your study records.
The UNM IRB no longer requires IRB review of protocol personnel changes for approved projects. Protocol personnel will continue to be required upon initial review and CITI and Conflict of Interest (COI) will be verified accordingly. However, after initial approval of a protocol, it is the responsibility of the Principal Investigator (PI) to track changes to the protocol personnel and to verify current human research protections training and COI disclosure status for each individual. Please note that if changes to protocol personnel have occurred, you will want to update protocol personnel to the IRB with any subsequent submission. Reference the Adding and Removing Study Personnel Tipsheet for Streamlyne instructions. The UNM OIRB has developed tools to assist with this including a CITI COI Tracking instructions and a CITI-COI Tracking Log which are available in the Study Tools Library. 
All protocol personnel need to complete the CITI training every 3 years. The UNM IRB accepts the Main Campus Researchers training. Please see the CITI Instructions for more information. When submitting in Streamlyne, please be sure to check the personnel tab to ensure all protocol personnel have up to date CITI.
Educational Records (ER) are protected under FERPA and include anything held by the institution related to the student. This includes but is not limited to course grades, graded coursework, transcripts, class lists, student course schedules, health records, student financial information and student discipline files. Recorded in any way including handwriting, print, computer, media, videotape, audiotape, film, microfilm, and email.  Please reference the FERPA guidance for additional information.