## Module 6: Biomedical Ethics ## 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. ### Learning Objectives ### 1. Identify & explain the basic principles that govern Human Subjects research 2. Identify the types of information that must be provided to get approval from an Institutional Review Board (IRB) 3. Explain what is and is not Protected Health Information (PHI) 4. Enumerate the 5 situations when a Health Care Providing Entity can disclose PHI to an investigator for the purpose of research 5. Explain what is meant by the de-identification of research data and give examples of identifying data 6. Identify U.S. regulatory policies that address requirements related to animal use in research 7. Explain investigator responsibilities related to use of animals for research ### Readings and Resources ### **Required** Goldenberg, Aaron J. et al. 2015. “IRB practices and policies regarding the secondary research use of biospecimens.” BMC Medical Ethics 16(32): 1-8. https://doi.org/10.1186/s12910-015-0020-1 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. https://dx.doi.org/10.1159%2F000334718 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. http://dx.doi.org/10.1186/s12910-016-0130-4 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 http://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html **Supplemental** Aufderheide, Patricia. 2016. “Does this have to go through the IRB?” The Chronicle of Higher Education August 18. http://www.chronicle.com/article/Does-This-Have-to-Go/237476 Polonetsky, Jules, Omer Tene, and Kelsey Finch. 2016. “PII, cookies, and de-ID: Shades of gray.” Privacy Tech Blog April 25. https://iapp.org/news/a/pii-cookies-and-de-id-shades-of-gray Office for Human Research Protections. Protection of Human Subjects. Code of Federal Regulations 45 § 46 http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46 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