Memo: Enhancing Participant Privacy and Confidentiality

Recent federal actions and proposals have raised new concerns about privacy among Boston University researchers and research participants. During this time of transition, the BU Charles River Campus Institutional Review Board (IRB) encourages researchers to proactively review their study materials, methods, and procedures to enhance the rights and welfare of research participants. The following tools are available to support you in safeguarding participant privacy.

1. Consider de-identification of the study data. If it is no longer necessary to retain the identifiers linking a research participant to study data, consider de-identifying the research data (for example, if coding and transcription is complete for a study that involves video and/or audio recordings, consider deleting the recordings if allowed by the approved IRB application or discuss with your designated IRB analyst.

2. Consider if the collection of signatures during the informed consent process is necessary for the research.

• Exempt-reviewed studies: If a study will be, or has been, reviewed under Exempt procedures, signed consent is not required under the federal regulations or institutional policies. If the study sponsor, site of the research or others involved in the research do not require the collection of signatures and you wish to remove the collection of signatures from an ongoing study, reach out to your designated IRB analyst to discuss.
• Expedited/Full Board-reviewed studies: The federal regulations stipulate that informed consent must be documented by a written informed consent form (ICF) that is signed, however, many studies conducted by researchers on the Charles River Campus qualify for a Waiver of Documentation of Consent. Refer to section 4.11 of the IRB’s Policy and Procedures Manual for more information.  If you wish to remove the collection of signatures, which may be the only identifiable piece of information tying a research participant to the researcher, contact your designated IRB analyst to discuss.

3. Review the data security procedures outlined in your IRB application and ensure it meets BU’s current data security standards. Researchers are encouraged to review the wide range of services BU’s IS&T Department provides to help strengthen the security of research data.

4. For sponsored studies: Review the terms for data sharing in the sponsor agreement and confirm congruence with the IRB application and ICF. It is important for research participants to understand how their research data will be used and shared.

5. If data will be shared outside of BU, determine if a Data Use Agreement is useful or required. As a general matter:

• if BU is sharing a limited data set or a fully identifiable data set, a DUA is required and the terms must be consistent with the protocol and the informed consent form;
• if BU is receiving a limited data set or identifiable data, a DUA is required;
• if BU is sharing or receiving a fully de-identified data set, a DUA is recommended but not required unless the provider of the data set requires a DUA.  When sharing a de-identified data set, data sharing must be consistent with the protocol and the consent form.

If one or more of these scenarios applies to a research project, researchers can complete and submit a DUA Request Form found here.

6. Finally, consider methodological changes to the research that may further enhance the confidentiality of data and privacy of research subjects. See the IRB guidance here to learn more about submitting revisions to ongoing studies.

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