Effect of HIPAA Privacy Rule on Health Research


Anecdotes and small studies have suggested that the HIPAA Privacy Rule and its procedural requirements have hampered research without meaningfully protecting the privacy of health information. The Institute of Medicine (IOM) commissioned a series of studies to examine the impact of the HIPAA Privacy Rule on health research. The Cancer Research Network, which is a multi-site collaboration involving members of the HMO Research Network (HMORN) was identified as one of the study settings in which to examine the effects of HIPAA.

##Study Aim

The aim of this project was to assess researchers’ and IRB administrators’ perspectives on the HIPAA Privacy Rule as it pertains to their research and their involvement in multi-site studies, including direct impact on one or more of the researchers’ own studies, steps taken to mitigate the impact of the HIPAA Privacy Rule provisions, and extent to which the IRB administrators and researchers held converging viewpoints on the impact of the HIPAA Privacy Rule.


Three different data collection strategies were employed:

1. Web-based survey of investigators in the Cancer Research Network

2. Follow-up telephone survey for investigators who report having a study affected by the HIPAA Privacy Rule Regulations

3. Mailed survey of IRB Administrators at the 15 HMORN sites


To our knowledge, this is the first study that has concurrently examined the views of IRBs and researchers at the same site. In addition, this study afforded an opportunity to both assess the interpretation of the HIPAA Privacy Rule at different institutions who collaborate frequently, and examine the impact of this Rule on multi-site studies.

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