How to Submit a Protocol to the IRB

Please follow these steps if you need help with submitting a research protocol or study-related material. 

1. Submit your request via JIRA: https://sagebionetworks.jira.com/projects/SG/issues. 

2. A Governance lead will be assigned to your project. They will follow-up with you on your project and provide you with a checklist of the required items you will need to provide for the IRB submission.  

3. The governance lead will review all of the submissions items to determine if they are ready to be submitted to the IRB. 

4. The governance lead will finalize the submission and submit it to the IRB.

5. Forward any emails related to the IRB to your governance lead during or after the submission. 

Possible elements depending on the type of submission (mHealth, data sharing, dream challenges, etc):

For an initial protocol submission you may need some or all of the following sections depending on the project, data, and research questions:

• Research Protocol*, containing the following sections:

  • Rationale and Background

  • Principal Investigator (s) and Key Personnel

  • Research Question and Objective (s)

  • Research Methods

  • If collecting data from living participants include:

    • Eligibility Criteria for participants

    • Data Collection 

  • Data Management, Privacy & Security

  • Publication References (if applicable)

• Informed Consent

• Study Materials/Instruments (i.e. surveys, questionnaires, activities, etc.). 

• Outreach/Engagement Materials (i.e. website copy, emails to participants, flyers, newsletters, Privacy Policy, etc.) 

• Updated Biosketch/CV for the Principal Investigator (s)*

• Reliance or Institutional Review Board (IRB) Authorization Agreement (if applicable)*

• PI signature page (WIRB form)

For an amendment/revision to an already IRB-approved protocol, you may need the following items, if applicable:

• Rationale for the amendment and/or addition of new materials

• Revised Protocol (redlined and clean versions)

• New/updated materials (i.e. emails to participants, website copy, survey/questionnaires, etc.)  

*Governance lead can provide templates

Do’s and Don’ts

Do: Ask questions at the very start of a project and ask for help as needed for the duration of the project.

Do: Start early! IRB review can take up to 2-3 weeks so plan accordingly.

Do: Review the submission items for content, grammar, and typos.

Don’t: Send out anything to research participants without consulting a Governance team member.

Further References

1. Decisional Tool for Determining Human Subject Research

2. Decisional Tree for Determining IRB Exemption