IRB Submission Requirements

What documents do I need for my project?

The UNM OIRB has developed templates that may be used by investigators to develop robust documents for IRB consideration. These templates can be found in the IRB Library.

The following are examples of documents that are typically submitted with a new study application. 

Protocol

A protocol is a document developed by the investigator to describe the project procedures and study design with respect to compliance and the ethical treatment of human research participants. 

Consent Form

A consent form is a document that contains information to be presented to the potential research participant during the consent process to help them decide whether or not to volunteer for your project. The consent form must contain basic elements of informed consent and is required for every IRB project unless a waiver is justified in the protocol.

Recruitment Materials

Recruitment materials are developed by the investigator to be used to recruit potential research participants. The following are some examples of recruitment materials:

  • Flyer/Poster
  • Print/Video/Radio Media
  • Online Advertisement
  • Email/Telephone Script

Project Instruments

Project instruments are tools that investigators will use to collect data for analysis. A general rule is that if a participant is going to see/hear it, then it needs IRB approval. The following are some examples of project instruments:

  • Surveys/Questionnaires
  • Interview Scripts/Guides
  • Focus Group Prompts
  • Devices/Technology

What documents do I need for my IRB Application?

The Office of the IRB requires several documents to be completed by the investigator. An IRB Submission Checklist has been developed by the OIRB to help investigators identify the required documents for a specific IRB Application (New Project, Continuing Review, Study Closure, Event Reporting...). This submission checklist can be found in the IRB Library.

The following are examples of documents that are typically submitted with a new project application. 

  • Application Form (with PI's signature)
  • Departmental Review (with Department Chair's signature)
  • Project Team Form
  • CITI Completion Report
  • PI's CV
  • Protocol
  • Consent Form
  • Assessment

Do the version dates on the Application Forms matter?

Yes, the OIRB has developed new IRB forms that are intended to streamline the IRB review process for the investigator and the IRB. IRB forms that have a version date older than 02/17/14 will no longer be accepted.