The Privacy Rule (HIPAA) as it Relates to Clinical Research

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4. Conclusion

The Privacy Rule has increased the complexity of life for an investigator engaged in research with human subjects. However, contrary to the fears of many and the claims of some, the Privacy Rule need not stifle such research. By understanding all of the regulations that govern research with human subjects, including the Common Rule, FDA regulations and the Privacy Rule, investigators are able to perform scientifically sound and ethical research. The IRB with which the investigator works can be a valuable resource to guide the research team as the study is designed and submitted for approval.