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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 5/26/2026

    • Section 2.5.2.1: Adding an exception to the indemnification signature for collaborative research between CRC and BUMC

    • Section 2.5.2.2: Clarifying that a cede review submission is not required for BUMC->CRC collaborative research covered by the global reliance agreement

    • Section 2.5.2.3: Establishing a new section to describe the existence of the global reliance agreements between BMC, BUMC, and CRC

    • Section 7.2.2.2: Adding an additional special routing question for studies that use, develop, or test artificial intelligence (AI), machine learning (ML), or large language models (LLMs) at any point in the research

    • Section 7.2.2.12.6: Clarifying the submission requirements for subjects with limited English proficiency to distinguish between anticipated and unanticipated languages. Principal Investigators must identify languages in which they anticipate enrollment so the IRB can determine whether full translation is required, but are not required to specify languages for unanticipated short form use

    • Section 7.2.2.18: Noting that the standard cede review submission is not required for BUMC→CRC studies covered by the global reliance agreement

    • Section 8.4.5.2: Simplifying the short form consent documentation workflow by removing the requirement for a separate attestation form and removing the requirement for a separate signature page to be attached to the English narrative. Adding a usage cap of three uses of the short form per language per study before full translation is required, with a risk-based distinction. Streamlining the language approval process so that all languages for which the IRB maintains a pre-translated short form are pre-approved for use, with the ability for the IRB to exclude specific languages when enrollment of subjects speaking those languages is anticipated. Adding a cover page with instructions for the research team to each short form consent document

    • Section 8.4.5.3: Clarifying the witness requirements when using the short form to explicitly state that the witness must be fluent in both languages

    • Section 10.1.2: Updating the continuing review language to reference the 3-use threshold and greater than minimal risk translation requirement established in Section 8.4.5.2

  1. Section 2.5.2.2, 2.5.2.3, and 7.2.2.18: These sections have been updated to reflect the new global reliance agreements between BMC, BUMC, and BU-CRC. For detailed information on how these agreements aim to improve cross-campus research collaboration, please see the April 2026 Feature Article entitled: Streamlining Cross-Campus Research: New Global Reliance Agreements for BMC/BUMC & CRC Faculty and Staff - Apr 2026

  2. Section 7.2.2.2: The Initial Review Submission form has been updated to add a new question:

Does your study use, develop, or test artificial intelligence (AI), machine learning (ML), or large language models (LLMs) at any point in the research?

This includes:

  • Generative AI tools (ChatGPT, Claude, Gemini, Copilot, etc.)
  • Predictive models, classifiers, or risk scores
  • Natural language processing of clinical notes, transcripts, or messages
  • Image or signal analysis tools (radiology, pathology, ECG, voice)
  • AI used by the study team to assist with recruitment, consent, data collection, coding, or analysis - even if AI is not the focus of the research

NOTE: If you are not sure whether your study uses AI, select Yes. The IRB and BMC Research IT will help determine whether further review is needed.

This question is used to facilitate special routing, when applicable. Please contact the IRB at medirb@bu.edu if you have any questions about how to answer this question.

  1. Section 8.4.5.2:  These updates include substantive changes to the use of the short form consent process. The HRPP is working hard to operationalize these changes, and additional details will be communicated to the research community prior to implementation. Investigators should continue to follow their current IRB-approved processes for use of the short form consent until the INSPIR application and updated short form template are updated and posted.

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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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