The Privacy Rule (HIPAA) as it Relates to Clinical Research
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.
- August 2003 Complete Privacy, Security, and Enforcement (Procedural) Regulations Text (45 CFR Parts 160 and 164) http://www.hhs.gov/ocr/combinedregtext.pdf/, Sponsor: DHHS Office for Civil Rights, Accessed: 23 January 2006.
- Code of Federal Regulations Title 45 Part 46 http://www.hhs.gov/ohrp/humansubiects/guidance/45cfr46.htm/. Sponsor: DHHS Office for Human Research Protections, Accessed: 23 January 2006.
- Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update, Appendix E: Significant Differences in FDA and HHS Regulations http://www.fda.gov/oc/ohrt/irbs/appendixe.html/, Sponsor: FDA, Accessed 23 January 2006.
- Code of Federal Regulations Title 21 Part 56 http://www.cfsan.fda.gov/~lrd/cfr56.html/, Sponsor: FDA, Accessed 23 January 2006.
- HIPAA Privacy Rule — Information for Researchers http://privacyruleandresearch.nih.gov/, Sponsor: NIH, Accessed 23 January 2006.
- Privacy Boards and the HIPAA Privacy Rule http://privacvruleandresearch.nih.gov/pdf/privacy_boards_hipaa_privacy_rule,pdf/, Sponsor: NIH, Accessed 23 January 2006.
- Research Repositories, Databases and the HIPAA Privacy Rule http://privacyruleandresearch.nih.gov/research_repositories.asp/. Sponsor: NIH, Accessed 23 January 2006.
- Institutional Review Boards and the HIPAA Privacy Rule http://privacyruleandresearch.nih.gov/pdf/IRB_Factsheet.pdf/, Sponsor: NIH, Accessed 23 January 2006.
- Guidance on Research Involving Coded Private Information or Biological Specimens, August 10, 2004 http://www.hhs.gov/ohrp/humansubiects/guidance/cdebiol.pdf/. Sponsor: DHHS Office for Human Research Protections, Accessed 23 January 2006.
- The Privacy Rule (HIPAA) as it Relates to Clinical Research
- Book Title
- Cancer Clinical Trials: Proactive Strategies
- pp 199-207
- Print ISBN
- Online ISBN
- Series Title
- Cancer Treatment and Research
- Series Volume
- Series ISSN
- Springer US
- Copyright Holder
- Springer Science+Business Media, LLC
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