Division of Research

HRPP/IRB Review Process

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HRPP/IRB Review Process

Brown’s Human Research Protection Program (HRPP) team and Institutional Review Board (IRB) review a study according to federal regulations and by following the three basic principles laid out in the Belmont Report — Respect for Persons, Beneficence and Justice — and their corresponding applications — Informed Consent, Assessment of Risks and Benefits and Selection of Subjects.

After reviewing the application and its supporting materials, HRPP staff or IRB members may offer feedback and request revisions. When the investigator responds, reviewers evaluate the project again to see whether their feedback and requests have been adequately addressed.

To fully protect subjects, HRPP/IRB reviewers must approve a study before investigators start any work with humans, their information or their biospecimens. The HRPP/IRB cannot approve a study or its activities after it has begun or after it is finished.

Types of HRPP/IRB Review

Research projects that are determined to fit the federal definition of human subjects research are evaluated through one of three types of review — Exempt Review, Expedited IRB (Non-Committee) Review or Convened IRB (Committee) Review — according to a study’s research activities, the potential risk to human subjects, and the federal guidelines that define the categories of research.

Learn the Types of HRPP/IRB Review

Convened IRB (Committee) Review Process

The convened IRB meets the third Thursday of each month. The IRB will discuss protocols and make a decision on whether to approve a protocol via a majority vote of a quorum of board members.

If your protocol is discussed at an IRB meeting then within five business days after the meeting you will receive a letter from the HRPP detailing the outcome of the IRB’s review of your study materials.

IRB Review Determinations

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

If the IRB approves a study it means there are no changes required and research may proceed consistent with federal regulations, state and local laws and University policy.

The IRB may require minor, specific, nonsubstantial modifications for a study in order to approve the research. Once the IRB receives the required changes, the IRB chair or another board member will verify that the appropriate additions or corrections were made and will either approve the study or send it to the convened IRB for further review.

The convened IRB may defer a study for further review at a future date when it cannot fully evaluate the research under review, weigh the risks and benefits and make the determinations required for approval. The IRB may require substantial modifications to the study and/or informed consent documents, or require the investigator to submit clarifications or additional materials before the next review.

The convened IRB may disapprove a study or proposed study changes when the criteria for IRB approval are not met and the convened IRB agrees that a determination of approval cannot be made, even with substantive clarifications or modifications to the study.

The convened IRB may include this determination as part of an approval of research. Continuing review of research may be conducted using Expedited procedures when the study is not conducted under an investigational new drug application or investigational device exemption where Expedited categories 2 through 8 do not apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

HRPP/IRB Review Timelines

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. If a submission is not in an approvable condition within 45 calendar days of the first correspondence requesting clarification from the HRPP/IRB, then the submission may be discarded.

Responding to HRPP/IRB Clarification Requests

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.