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News For November 12, 2007
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Current Government Rules Making Health Research Hard in Human Studies (Interview with Dr. Norman Fost, MD, MPH)
Current Government Rules Making Health Research Hard in Human Studies (Interview with Dr. Norman Fost, MD, MPH)

(November 13, 2007 - Insidermedicine) Health information privacy rules negatively impact the way health research is conducted, often making research more time-consuming and costly, say experts in a report published in the Journal of the American Medical Association.

Here is some information about the rules protecting patient information:
•    The Health Insurance Portability and Accountability Act – or HIPAA – Privacy Rule was implemented in 2003 to strike a balance between protecting the privacy of patient health information and allowing it to be used legitimately for the advancement of society
•    The Privacy Rule is complicated and the rules vary depending on the type of research being conducted, and some scientists abandon their projects due to delays  and fear of “getting caught” for minor infractions
•    Many researchers have expressed concerns that the Privacy Rule has negatively affected the way biomedical research is conducted

In the present study, researchers surveyed more than 1,500 scientists to determine how the Privacy Rule has influenced research on human subjects in the US.

Approximately two-thirds of clinical scientists surveyed reported that the Privacy Rule made research more difficult. Almost 40% said that research costs were increased as a result of the rule and half indicated that research took longer to complete. Only one-quarter believed that the rule had enhanced patient privacy.

Based on the results of the survey, it is clear that changes need to be made to allow scientists more leeway to conduct research while at the same time protecting patient privacy and confidentiality. This will likely require input from government agencies, institutions, researchers, certifying agencies, and research participants.

If you are asked to participate in a research study, you are entitled to assurances that your privacy will be protected in the study. That information must be in everyday language that you can understand. Make sure you know the exact terms of the study before you consent to participate.

For Insidermedicine in Depth, I'm Dr. Susan Sharma.

 
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