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<h2>Module 6: Biomedical Ethics</h2> <p>This module will go into the study of ethical, social, and legal issues that arise in biomedicine and biomedical research. Specifically, medical ethics focuses on issues in health care; research ethics, which focuses issues in the conduct of research; environmental ethics, which focuses on issues pertaining to the relationship between human activities and the environment, and public health ethics, which addresses ethical issues in public health.</p> <h3>Learning Objectives</h3> <ol> <li>Identify & explain the basic principles that govern Human Subjects research</li> <li>Identify the types of information that must be provided to get approval from an Institutional Review Board (IRB)</li> <li>Explain what is and is not Protected Health Information (PHI)</li> <li>Enumerate the 5 situations when a Health Care Providing Entity can disclose PHI to an investigator for the purpose of research</li> <li>Explain what is meant by the de-identification of research data and give examples of identifying data</li> <li>Identify U.S. regulatory policies that address requirements related to animal use in research</li> <li>Explain investigator responsibilities related to use of animals for research</li> </ol> <h3>Readings and Resources</h3> <p><strong>Required</strong></p> <p>Goldenberg, Aaron J. et al. 2015. “IRB practices and policies regarding the secondary research use of biospecimens.” BMC Medical Ethics 16(32): 1-8. <a href="https://doi.org/10.1186/s12910-015-0020-1" rel="nofollow">https://doi.org/10.1186/s12910-015-0020-1</a> </p> <p>Oscar A. Zarate, et al. 2012. “Balancing Benefits and Risks of Immortal Data: Participants’ Views of Open Consent in the Personal Genome Project.” Public Health Genomics 15(2): 106-114. <a href="https://dx.doi.org/10.1159%2F000334718" rel="nofollow">https://dx.doi.org/10.1159%2F000334718</a></p> <p>Page, Stacey A., Kiran Pohar Manhas, and Daniel A. Muruve. 2016. “A survey of patient perspectives on the research use of health information and biospecimens.” BMC Medical Ethics 17(48): 1-9. <a href="http://dx.doi.org/10.1186/s12910-016-0130-4" rel="nofollow">http://dx.doi.org/10.1186/s12910-016-0130-4</a> </p> <p>U.S. Department of Health and Human Services. Guidance regarding methods for the de-identification of protected health information in accordance with the HIPAA privacy rule <a href="http://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html" rel="nofollow">http://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html</a></p> <p><strong>Supplemental</strong></p> <p>Aufderheide, Patricia. 2016. “Does this have to go through the IRB?” The Chronicle of Higher Education August 18. <a href="http://www.chronicle.com/article/Does-This-Have-to-Go/237476" rel="nofollow">http://www.chronicle.com/article/Does-This-Have-to-Go/237476</a> </p> <p>Polonetsky, Jules, Omer Tene, and Kelsey Finch. 2016. “PII, cookies, and de-ID: Shades of gray.” Privacy Tech Blog April 25. <a href="https://iapp.org/news/a/pii-cookies-and-de-id-shades-of-gray" rel="nofollow">https://iapp.org/news/a/pii-cookies-and-de-id-shades-of-gray</a> </p> <p>Office for Human Research Protections. Protection of Human Subjects. Code of Federal Regulations 45 § 46 <a href="http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46" rel="nofollow">http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46</a></p> <p>Mittelstadt, Brent Daniel and Floridi, Luciano (Eds.). 2016. The Ethics of Biomedical Big Data. Springer International Publishing Switzerland. ISBN-13: 978-3-319-33523-0</p>
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