IRB Review Process - Getting Started
New Project Submission
Are you ready to submit to the IRB? Remember to do the following:
- Review the IRB Submission Checklist
- Consult the UNM IRB Researcher Handbook
- If conducting in person research, review the COVID-19 guidance and obtain appropriate approvals, prior to submitting to the IRB
- Prepare your IRB protocol and supporting documents
- Consider using available study tools to help organize project documents
- If a student researcher, meet with your faculty advisor/PI to discuss project
- Submit your project to Department Chair or Thesis/Dissertation Chair for scientific review and approval
- Ensure all project team members have completed the annual Conflict of Interest (COI) disclosure
- Uploaded a CITI completion report (that lists module titles) for all project team members
- Review the IRBNet Submission Instructions
- Create a project in IRBNet and ensure the PI electronically signs the package
IRB Review Process
When a package is submitted using the IRBNet submission database, the submission undergoes in-take by IRB staff. If the package contains the minimum required documents as noted in the IRB Submission Checklist, it is processed and tagged for pre-review. Please note that these documents must be filled out in their entirety and signed by the necessary individuals to qualify for in-take. If the package does not contain the minimum required documents, the project is immediately withdrawn and the PI is sent an email notifying them to resubmit when all required documents are present.
Next, the submission undergoes a pre-review. An IRB analyst reviews all documents for completeness, consistency, and other regulatory and administrative requirements. If there are any issues, the analyst will publish an email using IRBNet, referred to as a Clarifications message, listing questions or recommended changes and unlock the package for response. Once all of the issues have been addressed, upload and/or replace edited documents and click "Mark Revisions Complete" at the top of the designer page, so the analyst can continue processing the submission. Please note that you have 30 days to respond to clarifications; if there is no response, the submission will be withdrawn. If you have a submission under review by the IRB, be sure to check your Spam folder regularly as IRBNet automated messages are sometimes routed to that folder.
Once pre-review is complete, the submission will be scheduled on an agenda for IRB review. The types of IRB review are described below.
After the IRB has reviewed the submission, you will be sent an automated email and a determination letter will be published in IRBNet. The possible determinations (excluding determinations related to noncompliance or reportable events) are as follows:
- Approved - begin/continue the project or proceed with the proposed changes;
- Exempt (for federally funded projects only) - begin/continue the project or proceed with the proposed changes;
- Modifications Required - specific changes must be made or more information is required before approval; If you receive a modifications required letter, you CANNOT begin the research until you respond and the response is reviewed and approved. You will create a new package for the existing project in IRBNet to upload edited documents. When you upload edited documents, create a version trail (see IRBNet Submission Instructions for more information); or
- Disapproved – the research cannot be conducted as submitted.
Types of IRB review
Activities that meet the federal definitions of “human subjects research” (HSR) or “clinical investigation involving human subjects” (FDA only) require IRB review. Activities that do not meet the definition of HSR (e.g. scholarly or journalistic activities, oral history, public surveillance, etc.) do not require IRB review. If you require a determination letter from the IRB of whether IRB review is required, you must submit documentation via IRBNet as described in the IRB Submission Checklist. HSR determinations are reviewed administratively.
Human research that is not funded by the federal government and that involves no greater than minimal risk can undergo minimal risk review. Minimal risk review is different than exempt or expedited review because it includes additional categories of research that are not included in the Federal Register (see below). This is a determination made by the IRB upon review of the project. Minimal risk review allows an individual IRB member to review and approve projects on behalf of the full IRB. Projects that qualify for minimal risk review are reviewed on a weekly basis. Although not required, the IRB may determine that these projects require continuing review or post approval monitoring, depending on the type of research and participant population.
Certain categories of federally funded HSR can be determined to be exempt from the federal regulations as long as they meet prescribed ethical criteria including the requirement for informed consent and considerations for participant privacy and confidentiality. Any significant changes to an exempt project need to be submitted to the IRB to ensure that the exempt determination still applies. Exempt determinations can only made by the OIRB or IRB. Studies that qualify for exempt review are reviewed on a weekly basis.
Examples of exempt studies include online surveys, classroom curriculum evaluations, interviews on non-sensitive topics, review of existing academic, medical or other records without recording identifiers, etc. See SOP 302 “Exempt Review” for a complete list of exemption categories. Note that the IRB may still require informed consent procedures for studies that are determined to be exempt.
Certain federally funded research that involves no greater than minimal risk and only includes procedures listed in the Federal Register expedited review categories can undergo expedited review. This is a determination made by the IRB upon review of the study. Expedited review procedures allow an individual IRB member to review and approve projects on behalf of the full IRB. Studies that qualify for expedited review are reviewed on a weekly basis. Some full board, greater than minimal risk studies may qualify for expedited review once the study is limited to data analysis or if no participants have been enrolled in the study.
Examples of expedited categories include blood draws, recorded interviews and focus groups, studies that access identifiable health or educational records, studies collecting biological specimens by noninvasive means, etc.
Studies that do not qualify for exempt or expedited review and/or present greater than minimal risk to participants must be reviewed at a fully convened IRB meeting. The full board meets once per month. The OIRB website lists monthly submission deadlines for each meeting agenda. A majority of the board including at least one non-scientific member must be present at the meeting in order for quorum to be established. If protocols include research with children or prisoners, then an IRB member with that expertise must be present in full board meetings that review such research protocols.
Examples of full board studies include research in prisons, studies administering drugs or alcohol, research involving invasive interventions (e.g. biopsies, tDCS), or intervention research involving high risk or vulnerable populations.
Minor changes to approved projects and study closures are reviewed administratively by OIRB staff. Submissions that qualify for administrative review are done on a daily, first come first serve basis.
Administrative changes include but are not limited to:
- changes to contact information or formatting in approved documents;
- changes to project timeline or project team;
- new or revised recruitment advertisements or scripts if similar to already approved recruitment materials;
- increase or decrease in enrollment numbers in minimal risk projects;
- submission of letters of support (but not addition of sites);
- submission of project or consent documents translated into a foreign language and the required translation certificate(s).
Research that is greater than minimal risk must be reviewed by the full convened IRB no less than once per year. Minimal risk research may or may not require continuing review. If the IRB approval has an expiration date, a Continuing Review Application and applicable paperwork as outlined in the IRB Submission Checklist must be submitted no later than 30 days prior to the expiration date to allow adequate time for IRB review. Researchers may update project team members and CITI trainings at the time of continuing review. IRBNet sends automated email reminders of continuing review at 60- and 30-days prior to expiration of IRB approval. Continuing reviews are submitted as new packages within the existing IRBNet project. Please note continuing review and amendments may not be submitted at the same time.
Prior to implementing a change to a study, an amendment must be submitted to and approved by the IRB. Examples include adding or revising questionnaires or other study procedures, changing a study location or participant inclusion/exclusion criteria, changing recruitment and/or compensation procedures, etc. An Amendment Application must be completed and submitted along with any new or revised documents (using track changes and version trails). An amendment is submitted as a new package within the existing IRBNet project. For further guidance, please see the IRBNet submission instructions.
Projects that are not subject to continuing review will receive an administrative check-in. As part of this process, the PI and student investigator, if applicable, are emailed a link to a survey asking questions about the status of the project. This email is sent based on the anticipated project end date identified in the IRB approved protocol. Depending on the responses to the survey, the project will either be extended for the period indicated or will be administratively closed by the OIRB. Exceptions are made on a case-by-case basis. Failure to respond to the administrative check-in request will result in a process hold on future submissions.
The PI and/or the IRB may close approved protocols under certain circumstances. The PI is responsible for promptly closing out an IRB approved project when:
- all research activities including analysis of identifiable data and reporting are complete;
- the PI never initiated the study;
- participant enrollment is closed, all data collection is complete and the only remaining activity is analysis of de-identified data with no identifying links or codes;
- the PI plans to leave the University and intends to continue the research activities at another institution;
- a student researcher leaves the University without notifying the IRB.
The study cannot be closed if the study:
- is still collecting data from participants;
- is analyzing identifiable data (including data with codes or links to identifiers).
To submit a closure request, the PI or student researcher will submit a Closure Application and other documents as outlined in the IRB Submission Checklist as a new package within the existing IRBNet project. Closures are reviewed administratively.