| To Register SMDM Homepage | |
|
|
|
||||
Purpose: The HIPAA Privacy Rule went into effect April 2003, giving IRBs only vague guidelines about when researchers can access medical records without permission from patients. Patients' opinions on this issue are essential but difficult to obtain because the topic requires considerable understanding of privacy violation risks and knowledge of minimal risk research. We used a novel mixed-methods approach to provide deliberated responses to this complex policy question.
Methods: We used a deliberative democratic approach, coupled with baseline and follow-up phone surveys, to obtain recommendations about optimal criteria for allowing researchers access to medical records without permission from patients. A representative sample of veterans, drawn from two rural and two urban geographically dispersed regions, was invited to participate in an all-day deliberation session and baseline and follow-up phone surveys. 231 veterans participated in the sessions and were randomly assigned to deliberation subgroups of 4-7 people each. An additional 295 veterans participated in the phone surveys alone, as a comparison group.
Results: The majority of groups and individuals thought that researchers should ask patients at least once before using their medical records for research. Whether veterans trust that researchers will keep their medical information confidential depends on who is conducting the study. Over 80% of veterans trust that the VA will ensure confidentiality of their medical information always or most of the time and said they would be willing to allow VA researchers access to their medical records compared to only about 40% who held these views related to pharmaceutical company researchers. Veterans who participated in the all-day deliberation became more willing (p=0.008) to allow VA researchers access to their medical records after having done the deliberation, while veterans who did not attend the session were no more willing (p=0.53) at the time of the follow-up survey. 90% of veterans felt the deliberation process was fair and 94% felt they were listened to. One veteran said that "with more exposure and thought, my decisions are more in line with my moral values."
Conclusion: Veterans want a say in how their medical records are used in research. Deliberative methods appear be an effective way to obtain informed recommendations from patients for complex and value-laden policy issues in a way that traditional focus groups and large-scale surveys cannot.
See more of Oral Concurrent Session A - Patient and Physician Behavior/Preferences 2
See more of The 26th Annual Meeting of the Society for Medical Decision Making (October 17-20, 2004)