Has HIPAA made it easier or more difficult to find subjects for clinical trials? Explain.

Discussion ­ Week 5
C OL LA PS E

HIPAA and Clinical Research
Two debatable issues that relate to the privacy and confidentiality of clinical research data are the use of
information 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 nurse
tells you that the protocol requires the team to collect samples of DNA and tissue. She also discusses the
HIPAA 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 that
required you to provide biological material and genetic information?

Would HIPAA convince you that your biological information and genetic information would be
protected?

If you were asked to participate in a clinical research trial that required genetic testing, would you
want to know whether you had a genetic predisposition for a terminal disease? Why or why not?

250 words and in-text citation

Optional resources
Article: Myers, J., Frieden, T., Bherwani, K., & Henning, K. (2008). Ethics in public health
research: Privacy and public health at risk: Public health confidentiality in the digital
age. American Journal of Public Health, 98, 793–801. Retrieved
from http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?

direct=true&db=ehh&AN=32130147&site=ehost­live&scope=site

These authors argue that storing patient data electronically protects patient information more
effectively than paper-based methods. In fact, they believe that electronically stored data can be
safer from security breaches than paper records, and they support this supposition by
describing 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=site

This 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 information
affect research?” The following answer to this and other questions involves how HIPAA
influences the conduct of research. The author considers the influences HIPAA exerts on
Institutional Review Boards, subject recruitment, consent, access to data, de-identification of
data, authorization to disclose data, and the processing, transmission, and storage of collected
data.
Article: NIH. (2004, February). Clinical research and the HIPAA privacy rule. NIH
Publication Number 04-5495. Retrieved
fromhttp://privacyruleandresearch.nih.gov/clin_research.asp.

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