The effect of new regulations on access to medical records for research purposes is currently unclear, however, some speculate that patient consent will be required for all record reviews. We conducted a Women’s Heath Study from October, 1998 to April, 1999 which provided an opportunity to assess the effect of requiring patient consent on study results. The 566 primary care patients participating in the study were asked for permission to review their medical records. A total of 443 (78.3%) women provided consent and 123 (21.7%) women refused. Analysis of survey responses found that the primary patient characteristic associated with providing medical record access was race/ethnicity. Over 80% of White women and Latinas provided consent versus 64.5% of African-American women (p-value<0.001). This difference remained significant when the comparison was adjusted for age, education, and perceived economic hardship using logistic regression. Providing consent was not associated with socioeconomic status, mental health or partner violence. Physician characteristics associated with women providing access to their medical records included a sense of trusting her physician (p=0.018) and feeling free to talk about private thoughts with her physician (p=0.03). These findings suggest two important biases that may emerge in studies using medical records when patient consent is required, the under-representation of African-American women and the under-representation of women who have poor relationships with their physicians. Because the quality of patient-physician relationships is associated with adherence to medical regimens, health outcomes and utilization of services, requiring patient consent for record review may introduce bias into many studies.
Learning Objectives: At the conclusion of the session, the participate will be able to: 1. Describe the new confidentiality regulations related to medical record access. 2. Identify health outcomes studies most likely to be biased if informed consent is needed for record review.
Keywords: Medical Care, Research Ethics
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
Disclosure not received
Relationship: Not Received.