The Rules of Engagement

June 2025 Issue

Author(s):

• Matt Ogrodnik, MS, CIP, OHRA Director

• Jamie Merrill, MPH, CIP, IRB Director

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• Introduction
• What is Engagement?
• What are Some Common Cases of Engagement Vs. Non-Engagement?
• Summary

Introduction

Any project that meets the definition of research with human subjects and/or that is subject to FDA regulations must be submitted to the IRB for approval or for an exemption determination prior to conducting any research activities. Projects that do not meet the definition of human subjects research, known as “Not Human Subjects Research” (NHSR) or “Non-Engagement in Human Subjects Research” (Non-Engagement), generally do not need to be submitted to the IRB*.

This is not always clear-cut, however, in multi-site research. Often, multi-site research involves both institutions that are conducting human subjects research (are “engaged”), and institutions that are not conducting human subjects research (are “not engaged”). Institutions that are “not engaged” generally do not require IRB oversight. This month’s CR TIMES Feature Article describes the criteria for engagement, and provides examples to help illustrate when IRB review is or is not required.

What is Engagement?

Both OHRP Guidance and our HRPP Policies and Procedures Section 2.4      Engagement in Research define the engagement criteria. In brief, the engagement criteria can be summarized as follows:

The institution is the prime awardee of federal funding for human subjects research activities; or the investigators will conduct the consent process with participants, or interact/intervene with participants post-consent, or receive and use/analyze individually identifiable data.

The full engagement and non-engagement criteria state:

Boston Medical Center or Boston University Medical Campus IS engaged in human subjects research if:

Boston Medical Center or Boston University Medical Campus receives a direct Federal award through a grant, contract, or cooperative agreement for human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution; or

• Boston Medical Center or Boston University Medical Campus employees or agents:
• intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures or by manipulating the environment; or
• interact for research purposes with any human subject of the research; or
• obtain the informed consent of human subjects for the research; or
• obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research. Obtaining identifiable private information or identifiable specimens includes, but is not limited to:
• observing or recording private behavior; or
• using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; or
• using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of either institution or the investigators.

Boston Medical Center or Boston University Medical Campus IS NOT engaged in human subjects research if activities involve:

• Assisting with the recruitment of subjects by:
• informing prospective subjects about the availability of the research; or
• providing prospective subjects with information about the research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects’ consent for the research or act as representatives of the investigators; or
• providing prospective subjects with information about contacting investigators for information or enrollment; or
• seeking or obtaining the prospective subjects’ permission for investigators to contact them.*
• *Submission to the IRB may be required depending on population and use/release of PHI
• Example: A BMC clinician provides patients with literature about a research study occurring at another institution, including a copy of the informed consent document, and gives the patient contact information for the external investigators.
• Obtaining coded private information or biological specimens from another institution, provided that the recipient investigators will be unable to readily ascertain the identities of the subjects to which the coded information or specimens pertain (for example, by having a written agreement prohibiting the release of the key to the code);
• Example: BU SPH Biostatistician performing analysis on a dataset without any direct identifiers and there is an agreement in place.
• Authoring a paper, journal article, or presentation describing a human subjects research study without obtaining access to identifiable private information; or
• Performing commercial or other services for investigators provided that all of the following conditions also are met:
• the services performed do not merit professional recognition or publication privileges; and
• the services performed are typically performed by those institutions for non-research purposes; and
• the institution’s employees or agents do not administer any study intervention being tested or evaluated in the study;
• Example: BMC phlebotomy employees obtain blood through a blood draw or collect urine, and provide such specimens to investigators as a service.

There are a few more listed in the policies and in OHRP guidance that do not occur as often, including:

• Accessing or using identifiable private information when visiting an institution that is engaged in the research, provided that their research activities as visitors are overseen by the IRB of the institution that is engaged in the research
• Providing clinical trial-related medical services that are dictated by the study and would typically be performed as part of routine clinical monitoring and/or follow-up of subjects enrolled at a study site by clinical trial investigators, provided certain conditions are met
• Administering the interventions being tested or evaluated in the study limited to a one-time or short-term basis, provided certain conditions are met.

What are Some Common Cases of Engagement Vs. Non-Engagement?

Questions about engagement are perhaps the most common type of inquiry received by the IRB. The below cases provide examples of when an investigator/institution is or is not engaged in research:

Scenario 1:

A BUMC researcher partners with a non-profit that helps veterans with PTSD. During a group session, the BUMC researcher obtains informed consent from the veterans and a buccal swab. However, since the study looks at changes over time, the busy BUMC researcher asks the non-profit employees to collect a buccal swab each week for a year and to consent any new participants that join the group. Is the non-profit engaged in research?

• Non-profit is engaged in human subjects research
• Non-profit is not engaged in human subjects research

In this scenario, the non-profit IS engaged in human subjects research. This is because the non-profit employees intervene for research purposes with the research participants by performing noninvasive procedures (collecting buccal swabs) and because they obtain the informed consent of human subjects for the research.

Scenario 2:

A collaborator at Tufts asks a BMC pathologist to review slides of tissue to assess the level of inflammation taken before and after exposure to a novel anti-inflammatory drug being tested in a federally-funded, IRB-approved research study. The slides are de-identified, and only labeled with a unique code (with the master-code held only by Tufts) and the institutions have executed the appropriate agreements.

• BMC is engaged in human subjects research  
• BMC is not engaged in human subjects research

In this scenario, BMC is NOT engaged in human subjects research. This is because the BMC pathologist is obtaining coded, non-identifiable tissue slides from another institution involved in the research; and BMC and the holder of the key (Tufts) have entered into an agreement prohibiting the release of the key to the BMC employees or agents under any circumstances.

Scenario 3:

BU SPH has a subcontract with Tufts for a clinical trial. The Scope of Work describes BU SPH’s activities as:  Designing the protocol; receiving non-identifiable, coded data for an analyses; providing expertise on interpretation of aggregate results; contributing to writing and publishing the manuscript as study authors.

• BU SPH is engaged in human subjects research
• BU SPH is not engaged in human subjects research

In this scenario, BU SPH is NOT engaged in human subjects research, as they are NOT the prime awardee, and are not conducting the consent process, nor interacting with participants, nor receiving individually identifiable data.

Scenario 4:

A BU-CRC student is joining a BUSPH study team in order to help support the conduct of a focus group study. This BU-CRC student is excited about the opportunity as she will both gain experience in research and also will be obtaining academic credit for her work on the project. She will be helping to facilitate the focus groups.

• BU-CRC is engaged in the research
• BU-CRC is not engaged in the research

In this scenario, BU-CRC IS engaged in the research. This is because the student is acting as an agent of BU-CRC (since she is obtaining academic credit for her work), and because she will be interacting with participants for research purposes when facilitating the focus groups. For more information about determining when BU-CRC students/faculty/staff are engaged, and corresponding next steps, see here: How to add BU CRC Students, Faculty, or Employees to your study

Scenario 5:

A BMC PI is collaborating under a subaward on a multi-site clinical trial that is  evaluating a new research-only type of cognitive behavioral therapy (CBT). Subjects will be identified and consented at UMass Chan Medical School, and the UMass team will randomize subjects to one of two study arms; (1) usual care + CBT, or (2) usual care alone. For subjects randomized to the usual care + CBT arm, BMC co-investigators will administer the CBT at regular study visits using a telehealth platform hosted by UMass.

• BMC is engaged in human subjects research
• BMC is not engaged in human subjects research

In this scenario, BMC IS engaged in human subjects research because the BMC co-investigators will interact with the study participants for research purposes by delivering the research-related CBT intervention.

Scenario 6:

A BMC PI recently learned that she is the prime awardee of a new R01. This grant will fund study activities in South Africa conducted by collaborators at the University of Witwatersrand (Wits). The Wits IRB will review and provide IRB oversight for the local South African study team. Subjects will be enrolled and consented by Wits study staff. Blood will be drawn at 5 timepoints, and subjects will also fill out questionnaires. De-identified blood samples and de-identified questionnaires will be shipped from South Africa to the BMC PI in the USA for analysis.

• BMC is engaged in human subjects research
• BMC is not engaged in human subjects research

In this scenario, BMC IS engaged in human subjects research. Even though BMC investigators are not interacting with participants nor receiving individually identifiable data, BMC is the prime awardee of the federal grant that is funding the human subjects activities.

Scenario 7:

A BMC PI is collaborating with MGB on a clinical trial. The BMC MD co-investigators will identify eligible patients from their clinical practice by screening medical records and introducing the study to them at a clinical visit by providing flyers. If the patient is interested in learning more, the BMC co-investigators will ask them to sign a HIPAA authorization to permit disclosure of their contact information to MGB. MGB will then reach out directly to the patients to discuss the study; and for those interested, MGB investigators will conduct the consent process and all follow-up activities, with no data going back to BMC.

• BMC is engaged in human subjects research
• BMC is not engaged in human subjects research

In this scenario, BMC is NOT engaged because the BMC investigators are only facilitating recruitment, and are not conducting the consent process nor participating in any further activities or data analyses. Please note, however, that this scenario does require IRB review, as the IRB needs to grant the waiver of HIPAA authorization for pre-screening and also help prepare the authorization.

Summary

The IRB fields many questions about whether an investigator is engaged or not engaged in human subjects research. This is a vital question since the engagement determination often guides whether an investigator or institution requires IRB oversight. The following summarized criteria for engagement will allow you to make this determination the majority of the time:

• The institution is the prime awardee of federal funding for human subjects research activities; or
• The investigators will conduct the consent process with participants, or will interact/intervene with participants post-consent, or will receive and use/analyze individually identifiable data.

Please never hesitate to reach out to the IRB at medirb@bu.edu to discuss this determination, as this will have a significant impact on the subsequent IRB review process.