How should privacy legislation apply to medical research?
A. Privacy legislation should be carefully crafted to allow the continuation of vital medical research. BIO recommends that the use of patient identifiable information in medical research should continue to be governed by existing regulations to protect the safety and privacy of research subjects, specifically those cited in the Code of Federal Regulations at 21 CFR 50 and 45 CFR 46. The regulatory system governing medical research in America today is both comprehensive and complex. Biotechnology and pharmaceutical research is closely regulated by the FDA. For both the public and private sectors, strict national and institutional guidelines prescribe how medical research shall be conducted. The research process is carefully monitored to ensure strict patient confidentiality. In addition to obtaining FDA or NIH review, clinical trials also must be approved by institutional review boards (IRBs), in compliance with NIH guidelines and FDA regulations, to assure patient safety and confident
Related Questions
- Has the HIPAA Privacy Rule hindered medical research by making doctors and others less willing and/or able to share with researchers information about individual patients?
- Does the website confirm to current data control, Privacy Laws and confidentiality legislation?
- How should privacy legislation apply to medical research?
