HIPAA and Clinical Research

Discussion ­ Week 5C OL LA PS EHIPAA and Clinical ResearchTwo debatable issues that relate to the privacy and confidentiality of clinical research data are the use ofinformation about obtaining biological material and genetic information from clinical research subjects.There is a high potential for inappropriate use of the associated data.To prepare for this Discussion, think about the following situation:You are considering participating in a study. During the informed consent meeting, the research nursetells you that the protocol requires the team to collect samples of DNA and tissue. She also discusses theHIPAA rule with you and reassures you that your information will be entirely confidential.By Day 4, post a comprehensive response to the following:Has HIPAA made it easier or more difficult to find subjects for clinical trials? Explain.Would the HIPAA Privacy Rule make it more likely that you would participate in a study thatrequired you to provide biological material and genetic information?Would HIPAA convince you that your biological information and genetic information would beprotected?If you were asked to participate in a clinical research trial that required genetic testing, would youwant to know whether you had a genetic predisposition for a terminal disease? Why or why not?250 words and in-text citationOptional resourcesArticle: Myers, J., Frieden, T., Bherwani, K., & Henning, K. (2008). Ethics in public healthresearch: Privacy and public health at risk: Public health confidentiality in the digitalage. American Journal of Public Health, 98, 793–801. Retrievedfrom http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=ehh&AN=32130147&site=ehost­live&scope=siteThese authors argue that storing patient data electronically protects patient information moreeffectively than paper-based methods. In fact, they believe that electronically stored data can besafer from security breaches than paper records, and they support this supposition bydescribing methods for increasing the security of patient information.Article: Erlen, J. (2005). HIPAA—I mplications for research. Orthopaedic Nursing, 24(2),139–142. Retrieved fromhttp://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=rzh&AN=2005076789&site=ehost­live&scope=siteThis article answers many questions about the implications of HIPAA on clinical research,including the following: “How do the Health Insurance Portability and Accountability Act (HIPAA)regulations regarding individually identified health information and protected health informationaffect research?” The following answer to this and other questions involves how HIPAAinfluences the conduct of research. The author considers the influences HIPAA exerts onInstitutional Review Boards, subject recruitment, consent, access to data, de-identification ofdata, authorization to disclose data, and the processing, transmission, and storage of collecteddata.Article: NIH. (2004, February). Clinical research and the HIPAA privacy rule. NIHPublication Number 04-5495. Retrievedfromhttp://privacyruleandresearch.nih.gov/clin_research.asp.

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