The HIPAA privacy rule went into effect in Spring 2003 and included sweeping new regulations regarding when and by whom individually identifiable health information (PHI) can be used and disclosed. Under the rule, individual authorization to access PHI is required from every study participant, even for minimal-risk research, unless three criteria are met. However, the three criteria include non-specific language, allowing wide latitude for IRB interpretation.
The objective of this study was to elicit informed input from veterans using a deliberative democracy approach. We addressed two policy-relevant issues:
Specific Aim #1: To determine the range of informed individual and group opinions and recommendations of veterans on the optimal criteria for allowing researchers access to PHI.
Specific Aim #2: To determine the range of informed individual and group opinions and recommendations of veterans on how the current HIPAA regulations should be interpreted and implemented for minimal-risk research.
Veterans from four diverse study sites were randomly selected and invited to an all-day deliberation session. Short surveys were administered at baseline, during the deliberative session, and at follow-up. 217 veteran patients attended the all-day deliberative sessions across the four sites. They were divided into 8-10 deliberation subgroups at each site (n = 36 subgroups total). After being presented with balanced written materials and brief presentations (followed by Q&A sessions), each subgroup deliberated about considerations important when deciding whether to allow researchers access to PHI without individual authorization.
The most notable finding is that veterans were not particularly interested in limiting their input to interpretation of the HIPAA Privacy Rule for research purposes and there was not clear consensus on how the Rule should be interpreted. The majority (78%) of groups felt that a procedure that would allow VA patients to give permission to use their records for research should be put in place, with many endorsing a one-time opt-in approach. Veterans place high importance conducting minimal risk research in the VA. However, they believed that getting permission to use their record for studies was also critically or very important. The percent of veterans endorsing the need to obtain explicit permission for every study declined after deliberation (74% pre-deliberation vs. 48% post-deliberation; p<0.001). This change remained stable at follow-up 4-6 weeks later. 90% of veterans said they would be willing to give permission to VA researchers to use their medical records in a study about a serious medical condition and even more (96%) said they would be willing at the time of follow-up (p=0.04 for the difference). Participants were very engaged in the deliberations and expressed a desire to help other veterans by allowing their medical record to be used in research. Some participants were concerned that the VA was not fully disclosing how their medical records were being used in research but, at the same time, they wanted to know more about how they may have contributed to research findings.
Participants who had a higher level of trust in the VA to keep their medical records private and confidential were less likely to take the extreme position of recommending that researchers obtain authorization from every patient for each study (p=0.02) and were more willing to share their medical records (p<0.001). Veterans placed significantly higher trust in researchers at the VA than researchers associated with the Medicare program, a university, a drug company, or a health insurance company. People with higher levels of trust in each of these entities, were consistently more willing to share information with that entity (p’s<0.004).
In conclusion, veterans believe it is important to conduct medical records research in the VA but they also feel that they should have a say in whether their PHI can be used for research. A one-time opt-in approach was a popular compromise solution that arose spontaneously in many deliberation groups (e.g., “I think it is very important to ask at least once.”). Veterans said they would be less concerned about the use of their health information for research in the situation where obvious identifiers (such as name and social security number) have been removed from the information. Veterans also expressed an interested in being more engaged participants in the research enterprise. The level of trust veterans have that the VA will keep their medical records private and confidential influences their willingness to share their medical records for research and the liklihood they will recommend a more stringent consent procedure.
These results, based on deliberated empirical responses from a sample of veterans, deserve careful consideration by VHA for potential policy changes and local IRBs in implementing the HIPAA privacy rule.
- Damschroder LJ, Pritts JL, Neblo MA, Kalarickal RJ, Creswell JW, Hayward RA. Patients, privacy and trust: patients' willingness to allow researchers to access their medical records. Social science & medicine. 2007 Jan 1; 64(1):223-35.
- Damschroder LJ, Pritts JL, Neblo MA, Hayward RA. Patients' Views of Privacy and Research: Deliberative Democracy at Work. Paper presented at: Society of General Internal Medicine Southern Regional Annual Meeting; 2004 Oct 19; Atlanta, GA.