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• NEW/REVISED HRPP Policies and Procedures
• IRB Global Reliance Agreements
• Zoom Replacing IRB Office Drop-In Hours

NEW/REVISED HRPP Policies and Procedures

Principal Investigators and their study teams should note these updates (see https://www.bumc.bu.edu/ohra/hrpp-policies/).

Additional information on the highlighted changes are provided below the full list:

Revisions approved 9/16/26

• Section 2.5.4, 6.6.2.1.5.2, 6.6.3.2, 6.6.3.3, 6.6.5.2, 10.2.1.5, 11.3.8, 11.3.9.1, 11.5: Standardizing the reporting and response timeframe used throughout the HRPP Policies and Procedures from “7 days” to “7 calendar days”

• Section 7.2.2.6.5 and 8.1.3.4: Removing references to requiring a full consent meeting all required elements when the screening involves obtaining PHI directly from subjects

• Section 7.2.2.11: Revising to account for the roll-out of the new BU third-party payment system, which requires collection of SSN/ITIN and bank account information for any amount of subject payment

• Section 7.3.3: Revising language to reflect move to concurrent ancillary department sign-off and IRB review

• Section 10.2.4.2.1.2 and 10.2.4.2.2.2: Clarifying that studies can qualify for exemption even if they mix and match from equivalent protections exempt categories and Common Rule exempt categories (provided the activities fit only in these two sets of exempt categories)

1) Section 7.2.2.6.5 and 8.1.3.4: Full consent used to be required whenever screening involved collecting PHI directly from potential subjects unless the IRB granted a waiver of HIPAA authorization, even for a simple questionnaire.  Full consent is now only required whenever screening includes an actual clinical procedure (e.g., a blood draw, imaging study, or similar). Screening that doesn’t involve a clinical procedure can now use the shorter “Brief Screening Agreement” in all scenarios. The “Screening Questions Full Consent Template” has been removed from the IRB template website.

2) Section 7.2.2.11: BU’s new third-party payment platform Candex requires subjects to provide an SSN/ITIN and bank account information to receive any payment, regardless of the amount. Studies using this platform will need to collect this information for all paid subjects, not just those expected to reach the $2,000 IRS reporting threshold. Studies with payments expected to stay below the $2,000 IRS reporting threshold must offer subjects a gift card as an alternative so they aren't required to provide this information in order to receive payment. Above the $2,000 threshold, the SSN/ITIN is required for IRS reporting regardless of payment method.
The Payment section language in all IRB non-exempt consent form templates have also been updated to account for the use of Candex.

3) Section 7.3.3: Initial new studies used to require that all special routing signoffs be completed  (e.g., to Radiology, Pharmacy, or another ancillary department; full list here) before the submission could reach the IRB’s review queue, which could add significant time to the front end of the review process. Under the revised policy, ancillary special routing sign-offs and IRB review will happen concurrently:  the study enters the IRB review queue right away following sign-off from the Principal Investigator and Department Chair, instead of sitting in a holding pattern until all ancillary sign-offs are collected. PIs should still expect to hear from assigned departments separately and to respond to any concerns they raise, but the IRB clock now starts sooner.

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IRB Global Reliance Agreements

The Boston Medical Center (BMC)/Boston University Medical Campus (BUMC) IRB and the Boston University Charles River Campus (CRC) IRB have put in place global reliance agreements to streamline multisite collaboration across CRC, BMC and BUMC. These agreements, now in effect:

• automatically apply to qualifying minimal‑risk collaborative research; and

• simplify cross-campus collaboration by requiring only one submission, to the reviewing IRB, with no per-study reliance paperwork.

Read this April 2026 Feature Article from the Clinical Research Times Newsletter for more information.

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Zoom Replacing IRB Office Drop-In Hours

Due to the increased shift to using remote meeting technology, the IRB is discontinuing its once-a-week in-person drop-in office hours in order to expand its availability and service through Zoom meetings.  Please contact the IRB by email at medirb@bu.edu to request a Zoom meeting with an IRB representative, and provide these details so that the IRB can pre-assess your needs:  type of research study (and INSPIR study # if available); your questions; and your availability dates and times.

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