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700-19-Privacy and Confidentiality

Title: Privacy and Confidentiality
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: The USU IRB assures that the privacy and confidentiality protections for all research participants are adequate.

Investigators must describe provisions to protect the privacy interests and confidentiality of data of participants in the IRB Review Form. The IRB determines whether protections are adequate.

Investigators are required to abide by HIPAA Privacy Rule, when applicable. For researchers to gain access to health information that is stored at any HIPAA covered entity, investigators must provide the covered entity with written assurances describing how the health information will be used and protected.

Purpose: The purpose of this policy is to detail requirements for research protocols regarding privacy and confidentiality.

Procedures:

  1. Procedures for Review
    1. Upon review of the IRB Review Form, the IRB determines whether the investigator’s proposal for the protection of the privacy and confidentiality of research participants is adequate. The determination is documented in the IRB Reviewer Checklist.
    2. For research subject to the HIPPA Privacy Rule, investigators may request the use of protected health information for research in the IRB Review Form. The IRB may approve the investigator’s proposal to obtain HIPAA Authorization from individuals to use their protected health information (PHI). Generally, HIPAA Authorization is obtained in conjunction with Informed Consent but may be separate. If HIPAA Authorization is not obtained from individuals, the investigator must obtain approval for one of the following:
      • alteration of (HIPAA) Authorization
      • waiver of (HIPAA) Authorization
      • use of a de-identified Data Set that contains no PHI
      • use of a Limited Data Set with an effective Data Use Agreement in place, as applicable
      • research on Decedents’ Information

    3. The determination of approval is documented in the IRB Reviewer Checklist.

Scope: This policy applies to projects/research conducted by USU constituents.

Documents and Forms:

IRB Review Forms: DBA Program, DNP Program, EdD Program, Faculty & Staff (available in Policy 700-41)