Researcher Responsibilities

My project received IRB Approval, does this mean I am done with IRB?

Congratulations on receiving IRB Approval. Depending on the IRB's determination of your project, you may need to continue to work with the OIRB and the IRB. Here are your responsibilities as an investigator:

  • Design and implement ethical research, consistent with three ethical principles delineated in The Belmont Report
  • Comply with all applicable Federal Regulations impacting the protection of human subjects
  • Ensure that all research involving human subjects is submitted to and approved by the Institutional Review Board
  • Comply with all applicable IRB policies, procedures, decisions, conditions, and requirements
  • Implement research as approved and obtain prior IRB approval for changes
  • Obtain informed consent and assent in accord with Federal Regulations and as approved by the IRB
  • Document informed consent and assent in accord with Federal Regulations and as approved by the IRB
  • Report progress of approved research to the IRB as often and in the manner prescribed by the IRB
  • Report to the IRB any injuries, adverse events, or other unanticipated problems involving risks to subjects to others
  • If applicable, retain signed consent documents and IRB research records for at least three years past completion of the research activity

Do I need to read my IRB Approval Letter?

Yes. The IRB Approval Letter contains the following important information:

  • Your project is APPROVED and research may BEGIN
  • FOLLOW and USE the documents that have been approved by the IRB
  • The IRB determines the requirements or waivers to OBTAIN & DOCUMENT INFORMED CONSENT
  • The IRB's approval may have an EXPIRATION DATE
  • Submit paperwork for CHANGES, EVENT REPORTING, CONTINUING REVIEWS, and CLOSURES when appropriate

Can I change my project without IRB review and approval?

No. All changes to be made to an IRB Approved project must be reviewed and approved by the UNM IRB prior to implementing the changes.

Changes may include the following:

  • Change IRB Approved project information (project procedures/design, methods, logistics, data procedures, participant enrollment, etc.)
  • Change to IRB Approved project documents (protocol, consent, recruitment, study instruments, etc.)
  • Change to IRB Approved project team
  • Change to IRB Approved Principal Investigator of Record

It is the responsibility of the investigator to submit an Amendment submission that describes and justifies the requested changes to be reviewed by the IRB AND implement these changes after the IRB approves the Amendment. This request must be received as a complete submission by the Office of the IRB as soon as possible to provide enough time for OIRB processing and IRB review.

Does my project's expiration date matter?

Yes. An ‘active’ Expedited or Full Board project that has been approved by the UNM IRB requires continuing review to maintain compliance. A  project is considered ‘active’ when project activities meet the any of the following criteria:

  • Collection of participant data through project interactions or interventions will begin or is in process; or
  • Long-term follow-up of participants will begin or is in process; or
  • Data analysis of individually identifiable data will begin or is in process.

It is the responsibility of the investigator to submit a complete Continuing Review submission to the Office of the IRB no later than 30 days from the project’s expiration date to provide enough time for OIRB processing and IRB review prior to the project’s expiration date.

When can I close my project to the IRB?

An ‘in-active’ project that has been approved by the UNM IRB requires closure review to maintain compliance. A  project is considered ‘in-active’ when project activities meet the all of the following criteria:

  • Project enrollment never began or is complete; and
  • Collection of participant data through project interactions or interventions never began or is complete; and
  • Participant involvement in project related interactions or interventions never began or is complete; and
  • Long-term follow-up of participants never began or is complete; and
  • Data analysis of:
    • individually identifiable data never began or is complete; or
    • de-identified data continue locally; identity of all participants are not or cannot be readily ascertained by the investigator or associated with the data.
  • Current status of project data are:
    • de-identified; identity of all participants are not or cannot be readily ascertained by the investigator or associated with the data.
    • identifiable per UNM IRB approved protocol.

It is the responsibility of the investigator to submit a complete Closure submission to the Office of the IRB no later than 30 days from the project’s expiration date to provide enough time for OIRB processing and IRB review prior to the project’s expiration date.