Does My Project Need IRB Review?

PREPARATION

SUBMISSION

INTAKE PROCESS

REVIEW QUEUE

REVIEW PROCESS

AFTER APPROVAL

STUDY CLOSURE

FAQs

REVIEW LIFECYCLE

Protocol Lifecycle

DO YOU NEED IRB REVIEW?

Refer to the guidance and helpful information on the HRPP Does My Project Need IRB Review? and Forms and Templates webpages.

There are many ways to get in contact with HRPP for assistance on making this determination. See ways to contact HRPP in the FAQs section of this page, HRPP/IRB Home Page webpage, or the Contact the HRPP webpage

Preparation

Your study meets the definition of human subjects research and you would like to submit to Brown’s IRB/HRPP.

  • Step 1: Review the HRPP Principal Investigator (PI) Eligibility & Advisor Qualifications webpage to ensure you meet Brown’s PI eligibility requirements.
     
  • Step 2: Are you new faculty coming to Brown? Review the OVPR PI Transitions – Incoming Faculty webpage to about the recommendations and requirements for transferring awards, submitting new proposals before your arrival, transferring data and/or materials, conducting human subjects research, export controls, and conflict of interest.
     
  • Step 3: Are you new to human subjects research at Brown? Sign up for a one-on-one New Investigator/Research Staff Onboarding Session to learn about the IRB/HRPP website, forms, processes, and policies.
     
  • Step 4: Refer the HRPP Education Instructions and FAQs webpage and complete all the human subjects research education applicable to your study.
     
  • Step 5: Review the HRPP Ancillary Reviews webpage to consider if any other department or committee at Brown may need to review your study, as this could impact how long it takes before you may begin research activities.
     
  • Step 6: Review the HRPP Collaborative Research webpage if your study will be conducted at any location other than Brown (domestic or foreign) and/or with non-Brown investigators. Your study may require a reliance agreement, which could impact how long it takes before you may begin research activities.
     
  • Step 7: Refer to the HRPP homepage for Review Times and Full Board Meeting Dates & Submission Deadlines. Review Times display the latest submission under review by the IRB/HRPP. These dates are updated each Friday. The Full Board Meeting & Deadline Dates list the IRB’s monthly meetings, the protocol submission deadlines, and pre-review response deadlines. These dates and deadlines are only applicable to greater than minimal risk research or other situations recommended by HRPP staff. There are no submission deadlines for minimal risk research.
     
  • Step 8: See submission instructions on the HRPP Forms and Templates webpage for submission instructions; applications; appendices for vulnerable populations, drugs, devices, PHI, international research; consent/assent templates and HIPAA Authorization template; revision request forms; and progress report, closure form, and reportable event form.
     
  • Step 9: Review the IRB Guidance & Policies webpage to ensure IRB’s applicable established guidance and policies are incorporated into your study appropriately.
Submission

See submission instructions on the HRPP Forms and Templates webpage.

What is the “Single Submission Policy”? For an accurate sequential review of your study and its associated submissions (e.g. amendments, progress reports, etc.), the IRB/HRPP only accepts one submission per study at a time.

If you have any questions there are many ways to get in contact with. See ways to contact HRPP in the FAQs section of this page, HRPP/IRB Home Page, or the Contact the HRPP webpage.


What happens during the intake process?

During the intake process, the HRPP checks for five main elements in a submission:

  1. The submission is human subjects research and requires IRB/HRPP review.
  2. The principal investigator is eligible to conduct research at Brown University.
  3. The principal investigator has completed CITI training.
  4. The application is fully filled out and completed.
  5. All study materials are attached (appendices, consent/assent forms, recruitment, study measures, interview guides, survey questions, etc.)

When and what can you expect from HRPP to indicate your submission went through the intake process and has been added to the queue?

  • You will receive an email from the HRPP either:
    • Listing any of the five main elements that are missing that must be addressed before the submission may be added to the IRB/HRPP queue for review.
    • Confirmation that the submission was added to the IRB/HRPP queue for review.
      • A submission is only added to the queue for review once you receive a confirmation email.

REVIEW QUEUE

Review dates can be found on the IRB/HRPP Home Page. The submission remains in the queue until assigned for review.

NOTE: Review dates reflect the date a submission was entered into the queue by HRPP staff, not the date a submission was emailed to HRPP. Look for the date on your confirmation email confirming your submission was entered into the queue for review.


What is the holistic review process? The IRB/HRPP will conduct a holistic review of your active study with each submission as part of the post-approval monitoring process to ensure it remains in compliance with current federal regulations, Brown policies, and IRB position statements.

What is the “One Application Policy”? All new studies will receive stamped, IRB/HRPP Approved Documents upon approval. The stamped document must be retained in your study records.

What is the 45 Day Review Policy? If a submission is not in approvable condition within 45 calendar days of the first feedback email sent by HRPP, then the submission may be withdrawn.

 

Minimal Risk Research (Exempt/Expedited) - new or modification

  1. HRPP will reach out by email with feedback that needs to be addressed prior to IRB review, if required. This is intended to assist with a streamlined IRB/HRPP process by attending to issues that may delay IRB/HRPP approval.
  2. Once the research team addresses feedback, the HRPP pre-reviewer may have follow up feedback based on the responses.
    • This process may repeat depending how much new information is shared by the research team, how many complex questions need to be addressed, etc.
  3. Once all pre-review feedback is addressed, an IRB member or HRPP staff member provides a final review of the submission.
    • The IRB member or HRPP staff member may provide additional feedback that needs to be addressed by the research team prior to approval.
  4. Once all IRB/HRPP feedback is addressed and there are no regulatory concerns, the research team will receive an IRB/HRPP Approval memo by email.

NOTE: Once the review begins direct all review related questions/emails/phone calls to the assigned HRPP pre-reviewer and no longer include the main IRB inbox on correspondence.

 

Greater than Minimal Risk Research (Full Board) - new or modification

There is one Full Board meeting a month. The submission deadlines for review at each meeting and meeting dates are available on the HRPP/IRB Home Page.

  1. Once added to the review queue, Full Board submissions are assigned to a HRPP pre-reviewer, so they are ready for review at that month’s Full Board meeting.
  2. HRPP staff confirm the submission requires Full Board review.
  3. HRPP then provides a pre-review of the submission and will reach out by email with feedback that needs to be addressed prior to the pre-review response deadline. If the HRPP pre-review feedback is not sufficiently addressed prior to the response deadline, the submission may not be reviewed at the Full Board meeting. If all pre-review comments are addressed, the submission is assigned to the Full Board meeting agenda.
  4. The Friday before the meeting the Board receives all materials for their review.
  5. A determination is provided at the Full Board meeting.
    • It is recommended that the PI be available during the meeting in case the Board has any questions that need clarification by the PI. This is not a requirement.
  6. HRPP will communicate by email with the PI on the Board’s determination after the meeting.

Potential determinations and next steps:

  • Approved (No changes are required):
    • The research team will receive an approval memo by email.
  • Contingently approved (Minor, specific, non-substantial changes are required):
    • The research team will be informed by email after the meeting, and then receive a contingent approval memo with the Board’s requests up to a week later.
      • The PI is then responsible for addressing all requests in the memo.
      • Once all non-substantial changes and questions are sufficiently addressed, the research team will receive an approval memo from HRPP by email shortly after.
  • Deferred (Substantial modifications and/or additional information are required):
    • The research team will be informed by email after the meeting, and then receive a memo with the Board’s requests up to a week later.
      • The PI is then responsible for providing responses and changes to the material requested within the timeline outlined on the memo, if the PI intends to re-submit and receive IRB approval for the study
      • Once all substantial changes are addressed, the submission will be reviewed again at the closest Full Board meeting and given a new determination. Depending on the new determination, please see above for more information.

NOTE: Once review begins direct all review related questions/emails/phone calls to the assigned HRPP pre-reviewer and no longer include the main IRB inbox on correspondence.

After Approval

After you receive IRB/HRPP approval, you may begin any research activities not being held up by ancillary reviews. If you need to make changes to the approved study you should to submit a Revision Request prior to implementing any changes, and the review cycle will start again.

Study closure

Refer to the HRPP Forms & Templates webpage for the Study Closure Form when your study is complete, all information has been anonymized, and you are ready to close it.

Are you an investigator leaving Brown and your study is not ready for closure? Review the OVPR PI Transitions – Outgoing Faculty webpage to about the recommendations and requirements for transferring subawards, equipment, data, materials, research, licenses, etc. before you leave Brown.

See the Research Data Management Offboarding Checklist and webpage for Brown University policies surrounding closing a research study here at Brown.

 

FREQUENTLY ASKED QUESTIONS (FAQ)

What if I don’t know if my project requires IRB/HRPP review?

How long does it take for my study to receive IRB/HRPP approval or acceptance?

What if I submitted my study to [email protected] and haven’t received a response?

Will I be able to submit a study and not respond or address HRPP/IRB feedback?

What if I have sponsored funding that may impact when I need to receive IRB/HRPP approval or acceptance by?

How can I get in contact with HRPP/IRB with any questions or concerns?

 

What if I don’t know if my project requires HRPP/IRB review?

If you don’t know whether review is necessary, the HRPP webpage contains resources about whether a study is human subjects research and self-determination tools.

If after reviewing this information you are still questioning whether review is necessary, then reach out to HRPP prior to completing an application. We are happy to help!

How long does it take for my study to receive IRB/HRPP approval or acceptance?

Review times are available on our HRPP/IRB Home Page and turnaround times are available on our QA/QI webpage. Turnaround times strongly depend on how quickly the research team can respond to feedback/requests from HRPP/IRB.

Once a submission has received a pre-review, the PI has 45 calendar days to bring the submission to approvable status or it will be withdrawn by HRPP. Once withdrawn the PI should incorporate HRPP feedback and resubmit if they still require approval.

What if I submitted my study to [email protected] and haven’t received a response?

If you do not receive a response from HRPP once you submitted to [email protected] within 5-7 business days, please contact HRPP again by email or phone.

Will I be able to submit a study and not respond or address HRPP/IRB feedback?

It is the PI’s responsibility to read emails and respond to feedback provided by HRPP. We do not follow up with PI’s during intake, but do follow up during HRPP/IRB reviews.

Once a submission has received a pre-review, the PI has 45 calendar days to bring the submission to approvable status or it will be withdrawn by HRPP. Once withdrawn the PI should incorporate HRPP feedback and resubmit if they still require approval.

It is the PI’s responsibility to inform HRPP if they have any response delays during the review process.

What if I have sponsored funding that may impact when I need to receive IRB/HRPP approval or acceptance by?

Inform HRPP if you have any sponsored funding deadlines for receiving IRB/HRPP approval or acceptance. It is recommended you mention this deadline in your submission email with documentation, so that HRPP can properly prioritize the review. Also, include “Priority Protocol: Funding” in the email subject line.

How can I get in contact with HRPP/IRB with any questions or concerns?


We have many ways to contact us: email, phone, Zoom, TEA Time, Meeting Requests. Contacts and links below. Just reach out, we are happy to help!

General Email: [email protected] 

General Phone: (401) 863-3050

Contact Webpage

TEA Time (Open Hours) Sign up

Meeting Request Sign up