Because each department or committee reviews research studies with their own scope of interest, the timelines for ancillary reviews are independent of each other and will not delay IRB review. For example, the IRB will review your protocol even if your application to the Institutional Biosafety Committee (IBC) for blood sample collection has not yet been approved or you have not yet submitted an application to the Office of Information Technology (OIT) for a new software program.

If the IRB approves your study before an ancillary review is complete, it is the responsibility of the principal investigator (PI) to submit a modification to make any required changes to the protocol based on the outcome of an ancillary review. The IRB may not maintain an approved protocol with content disapproved by an ancillary review. You may not begin any human subjects research activities until you bring the IRB protocol into compliance with any applicable ancillary review determination. As such, PIs are encouraged to work proactively with all ancillary review departments and committees before submitting to the IRB.

Athletic Compliance Office

To ensure compliance with NCAA rules and regulations, the Brown University Athletic Compliance Office reviews research involving Brown's student-athletes when:

• research focuses on or targets this special population, or when
• the data collected may uniquely impact Brown’s student-athletes.

Ancillary review is not necessary when Brown’s student-athletes may enroll in research as part of a study’s eligibility criteria applicable to Brown’s general student body population.

All research studies must be submitted to the Athletic Compliance Office by the last day of each month to ensure they are reviewed on the second Monday of the following month. For more information, email compliance@brown.edu.

Conflict of Interest Review 

The Conflict of Interest in Research Policy applies to all researchers at Brown. Conflicts of interest in research may arise in situations in which a researcher’s personal, financial or other interests could affect, or appear to affect, the conduct of their research activities.

Having a conflict does not imply improper conduct of research; rather, conflicts of interest must be identified and managed, reduced or eliminated so that they do not threaten the integrity of scientific investigations and the public’s trust in academic research.

Conflicts of Interest in Human Subjects Research

Controller’s Office

The Controller’s Office is responsible for ensuring the proper stewardship of the University’s financial resources. The IRB relies on the Controller’s Office to determine which forms of compensation comply with federal and state laws and University policy. PIs are strongly encouraged to design their study using one of the compensation methods approved by the Controller’s Office.

If you intend to use a method of compensation that is not approved, you will need to contact accounts_payable@brown.edu for consultation and approval for its use before including the compensation in your submission for review by the Human Research Protection Program (HRPP) and IRB.

Embryonic Stem Cell Research Oversight Committee

The Embryonic Stem Cell Research Oversight (ESCRO) Committee ensures that human embryonic stem cell (hESC) research is conducted only after full consideration is given to all relevant scientific, medical, regulatory and ethical issues, including compliance with Rhode Island statutes. 

The ESCRO reviews human subjects research involving hESC when:

• the donor may be identified by researchers; 
• there is interaction or intervention with a living individual and information about such individual, or tissue from such individual, is obtained; and/or 
• there is derivation of induced pluripotent stem cells (iPSCs) from identifiable patient, volunteer or repository samples.

The ESCRO is an ad hoc committee and not a standing committee that meets routinely; therefore, it is imperative that any investigator proposing to use hESCs and/or iPSCs contact escro@brown.edu for an application well in advance of requiring approval to begin their research to allow time for a committee meeting to be called.

Embryonic Stem Cell Research Oversight Committee (ESCRO)

Export Control/Sanctions Review

Export Controls are federal laws that regulate the shipment or transfer, by whatever means, of controlled items, software, technology or services out of the U.S. These laws also restrict the release of certain information to foreign nationals here in the U.S. Export Controls could affect foreign scientists visiting Brown, international collaborations, international travel, sponsored research, international shipping, and/or international fieldwork. 

If you are conducting research activities outside the U.S., HRPP staff will forward your application to the Export Control team for a compliance review. Export Control will contact you directly if they have any questions.

Export Controls

Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) is responsible for regulating the use of biohazardous agents to ensure compliance with appropriate regulations and guidelines and safeguard the health and safety of the Brown community. If your research involves the collection or handling of human source material (e.g., blood, urine, tissue, cell lines, etc.) on the Brown campus or by Brown research personnel, you will need to submit a biological research authorization for IBC review. 

The IBC holds 11 scheduled meetings per year; an authorization must be submitted no later than one month prior to the IBC meeting date for consideration at the meeting.

Institutional Biosafety Committee (IBC)

Office of Information Technology

Brown requires all data to be categorized according to its Data Risk Classifications and appropriately protected according to the minimum security standards. Brown’s Office of Information Technology (OIT) partners with researchers to ensure these requirements are met.

In addition, OIT conducts a security review of all software used for research purposes to ensure they meet Brown’s security standards for research data. OIT keeps a software catalog of all vetted research software with assigned risk levels. OIT strongly encourages you to design your study using vetted software. PIs intending to use software not on this list are encouraged to reach out early in the process of writing a protocol to ensure there is adequate time to review any new software products.

If the data you intend to use meets the criteria for Level 3 Risk or if you propose to use a software or service that OIT has not vetted, please contact OIT for a security review. OIT will communicate with you directly to address any questions.

If you have any questions, please reach out to oit-contract-managers@brown.edu.

• Research Data Management
• OIT Data Risk Classifications
• Security of Desktop, Laptop, Mobile and Other Endpoint Devices Policy
• OIT Software Catalog

Radiation Safety Committee

The Research Agreements and Contracts team reviews, negotiates and signs incoming and outgoing data use agreements (DUAs) and material transfer agreements (MTAs) on behalf of research investigators and Brown. This review process may also engage OIT to consult on any data security management plans and terms related to data security within DUAs and with the Export Control team for certain MTAs. You should allow for additional time for these reviews, as well as the negotiation of applicable terms and conditions that may be required.

• Research Agreements and Contracts
• Date Use Agreements 
• Material Transfer Agreements

Strategic Procurement and Contracts

Strategic Procurement and Contracts (SPC) provides guidance regarding the selection of suppliers and is responsible for reviewing, negotiating and approving contracts for the purchase of goods and services, with one exception; OIT provides contract review for all information technology (IT) contracts. 

All contracts for the purchase of goods and services are processed through the Brown Contract Management System (BCM). SPC has developed a flowchart to help determine what needs to go through BCM.

Contact contractmanagerpurchasing@brown.edu with any questions about BCM or contracts for the purchase of goods or services.

• Strategic Procurement and Contracts
• IT Contract Review
• Brown Contract Management System (BCM)
• Does This Contract Go Into BCM Flowchart? (Google Doc)