Federalwide Assurance

Brown University and the following research affiliates hold a Federalwide Assurance issued by the Office of Human Research Protections. The Brown IRB complies with the registration requirements for both OHRP and the FDA.

Brown University (FWA00004460)
Butler Hospital (Component: The Providence Center) FWA00000963
Rhode Island Hospital (component: Hasbro Children’s Hospital) FWA00001230
The Miriam Hospital FWA00003538
Newport Hospital FWA00003435
Bradley Hospital FWA00001129
Women & Infants Hospital FWA00000056
Kent Hospital (FWA00003210)
Gateway Healthcare FWA00022347
St. Anne’s Hospital FWA00002716
Morton Hospital FWA00022668
University Orthopedics FWA00033466

Look up FWA expiration dates

IRB Meeting Schedule

The convened IRB meets the third Thursday of each month. If your protocol is discussed at an IRB meeting then within five business days after the meeting you will receive a letter within Huron detailing the outcome of the IRB’s review of your study materials. 

The meeting dates and deadlines below apply only to research that may be greater than minimal risk and requires review by the full, convened IRB, or other situations as guided by HRPP staff (for example, policy exception requests). Unless otherwise instructed by the HRPP team, these dates and deadlines do not apply to minimal risk research, which is reviewed by HRPP staff and the IRB on a rolling basis and does not have submission deadlines.

View meeting dates and deadlines

About IRB Deadlines

The submission deadline is the date by which research materials must be submitted (by 5 p.m.) in the Huron electronic platform to be considered for review during the corresponding IRB meeting date. There is no guarantee that a submission will be reviewed at an assigned meeting.

If the HRPP staff communicates with you regarding your submission, a complete response must be received by 5 p.m. on the pre-review response deadline for the submission to be considered for the next full board meeting.

The full IRB committee meeting date is the date the IRB meets to review submissions.

Why a Submission May Not Be Assigned for Review

There are several reasons a submission may not be assigned to the next full board meeting for IRB review, including the following:

• The submission was received after the submission deadline.

• The submission did not include a review by a special area expert (e.g., cultural consultant), so that the IRB would be unable to determine if risks to subjects are reasonable in relation to anticipated benefits.

• The submission was of poor quality and/or incomplete, so that it provided insufficient information for the IRB to meet its regulatory obligations.

• The HRPP team had a high number of requests and/or questions for the principal investigator (PI) and the PI did not respond by the pre-review response deadline.

The IRB will make a determination regarding your submitted study, as one of the following options.

The length of time a study can take to be approved depends on many factors, such as the volume of submissions, the quality of the submission, the type of review required and the responsiveness of the investigator.

All correspondence from the HRPP staff or the IRB is sent to the study PI through the electronic Huron system. The study PI and PI proxy will receive an email when the HRPP/IRB takes an action on a study record. 

30-Day Response Deadline

During each stage of a submission’s review cycle (i.e. Pre-Review, IRB Review, and Post Review), PIs have 30 calendar days from the first clarification request to respond to feedback and complete that stage of review. The 30-Day Response Deadline resets with each new stage. Submissions may be discarded after 30 calendar days due to a lack of response by the PI.

When responding to HRPP/IRB questions or requests for more information, provide a written response to each request, along with any new or revised documents you are asked to submit. Do not submit any new or revised material that was not requested by the HRPP/IRB, as this will delay the review of your response. 

Be sure to address all questions or requests as thoroughly and clearly as possible to avoid additional questions. If changes to study documents are requests, use track-changes to note the revisions.