Research Participant Study Data

• Background
• Types of Research Findings
• Federal Guidelines
• Institutional Review Board responsibilities
• Research Participant Rights
• California Information Practices Act and Patient Access to Health Records Act
• PHI versus RHI
• Unvalidated or Investigational Tests
• IRB Considerations

Background

This guidance explains how to get your findings from research studies if you wish, when findings may be withheld, or how to state that you do not wish to receive them. The guidance includes:

• Types of research findings
• Federal guidelines that apply
• Responsibilities of the Institutional Review Board that oversees research

Types of Research Findings

Federal Guidelines

The informed consent form tells you if and when you may receive your findings as part of the study. This follows federal guidelines. Check your consent form for details.

Institutional Review Board responsibilities

The Institutional Review Board (IRB):

• Does not have access to your research results
• Must approve the consent form language that covers how research results will be managed

Research Participant Rights

If your research findings are part of your medical record, you can access that information. Patients can request access to their Protected Health Information (PHI). This rule is in both the:

• Health Insurance Portability and Accountability Act of 1996 (HIPAA, or the Privacy Rule)  
• 21st Century Cures Act (the Cures Act) 

If research results are part of a person's medical record, they can access their data. There are some exceptions in the Privacy Rule and Cures Act.

One exception is PHI created or collected by a researcher in clinical research. The Privacy Rule and the Cures Act allow for pausing access to this PHI during the study. This rule applies only if the participant agrees to it in their consent. The research team must let the participant know that they have PHI access after the study is over.

California Information Practices Act and Patient Access to Health Records Act

Two other Acts give research participants in California access to their records. The Acts are:

• California Information Practices Act (CIPA), and
• Patient Access to Health Records Act (PAHRA)

CIPA sets rules for accessing study records. If sharing could harm a participant, the study can deny access. But if the participant gives written consent, the study can share their records with a chosen medical professional (Cal. Civ. Code Sec. 1798.40(f)). 

PHI versus RHI

The Privacy Rule and Cures Act apply to access to PHI in the EMR. RHI does not appear in a participant’s EMR. This means researchers don’t have to share findings with participants during or after the study. Research results may be shared after the study ends, unless the participant has agreed on the consent form that results won’t be shared.

Unvalidated or Investigational Tests

The Clinical Laboratory Improvement Amendments of 1988 Program (CLIA) These standards ensure that patient test results are accurate and reliable. All CLIA-certified labs must follow these rules. Researchers can share lab results with patients only if the tests are done at a CLIA-certified lab.

IRB Considerations

The IRB considers whether some research results should not be shared out of concern for participant safety. The IRB will address such questions as:

1. How will participant or others use the data? The IRB may choose not to allow it to be shared to prevent misuse. For example, a participant’s clinical care provider might use investigational test results for clinical treatment when it's unnecessary or could be harmful.

2. How do researchers evaluate what data can be shared? A key factor is whether the study team has the right expertise to provide guidance to participants.

Note: This guidance has benefited from the University of Washington’s extensive guidance regarding the return of individual results.