Brown University Institutional Review Board (IRB)

What is the IRB?

What is the Human Research Protection Program (HRPP)?

Regulatory Criteria for Human Research Protections

Federalwide Assurance (FWA)

What is the IRB?

The IRB is a diverse body of Brown faculty researchers, physicians, staff and unaffiliated community members appointed by Brown’s Vice President for Research and charged with reviewing human subject research protocols to uphold two broad standards

  • To ensure that participants are not placed at undue risk; and

  • ​To ensure that participants give informed consent to their participation free of coercion or undue influence

To this end, projects that meet the regulatory definition of human subject research must be reviewed and approved by the IRB prior to initiation.

For additional information about the Brown IRB, click here.

Structure

Brown University has one IRB that receives approximately 500 submissions annually. These submissions include new protocol applications, modification requests, continuing review forms and other required reporting forms. The IRB meets monthly on the third Thursday of the month.  Its members are appointed by Brown’s Institutional Official, Jill Pipher, Ph.D., Vice President for Research.

The Brown University IRB consists of primary voting members, alternate members, and a prisoner representative member who reviews research involving prisoners. Board membership consists of a faculty Chair and co-Chair, multiple scientists (and clinicians) representing many of the departments/schools from which the IRB receives submissions, and non-scientists and unaffiliated members, as required by federal regulation.  The IRB consults with cultural and scientific experts when reviewing protocols in cases where expertise is not adequately represented by regular membership on the committee.

If you are interested in joining the IRB as a voting member or serving as a cultural consultant for protocol reviews, please contact us!

IRB Review

Brown’s IRB reviews research that involves human participants to determine whether the research meets the approval criteria as defined by the federal regulations.  This review and approval must occur before the research takes place. Based on the level of risk, the research will either

  • Be reviewed by a designated individual IRB member (known as “expedited review” for minimal risk research)

  • Be reviewed by the full committee (greater than minimal risk research) at a monthly convened meeting of the IRB

Brown encourages the use of reliance agreements, also known as IAAs (IRB Authorization Agreements), for multi-site research studies to minimize duplicate review by multiple IRBs.  If you are interested in pursuing an IAA, please contact the HRPP office or make a note in your protocol submission that you would like us to contact another institution’s IRB to negotiate an agreement.

Learn more about IRBs and research ethics by completing the Basic CITI Training Course.

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What is the Human Research Protection Program (HRPP)?

The HRPP is the administrative office dedicated to facilitating the submission, review and approval of IRB protocols and providing individual assistance to researchers whenever needed to support their human subject research.  Click here to see all of the HRPP resources and services available to researchers.

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Regulatory Criteria for Human Research Protections

The IRB’s foundation and primary charge are supported in the Code of Federal Regulations. These regulations include, but are not limited to, the following:

Office for Human Research Protections (OHRP)
45 CFR 46 - Protection of Human Subjects

U.S. Food and Drug Administration (FDA)
21 CFR 50  -  Protection of Human Subjects
21 CFR 54  -  Financial Disclosure by Clinical Investigators
21 CFR 56  -  Institutional Review Boards
21 CFR 312 - Investigational New Drug Application
21 CFR 812 - Investigational Device Exemptions

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Federalwide Assurance (FWA)

Brown University holds a Federalwide Assurance, number 00004460, with the Office for Human Research Protection (OHRP) in the Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and Brown University and is renegotiated at regular intervals.

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