MED 255 - Responsible Conduct of Research

Session 5: Human Subjects Research and Data

Optional Reference Readings

Korenman, S. History of Rules About Research in Humans. Teaching the Responsble Conduct of Research in Humans.

A condensed outline of the ethical principles for medical research involving human subjects, as delineated by the Declaration of Helinski.

Policy Regarding Human Subject Research in the Sociobehavioral Sciences. The Penbrook. University of Pennsylvania. (2009).

Describes the University of Pennsylvania’s policy on human subjects research, with the university’s details on when a study is exempt from IRB review and the steps necessary to ensure research is harmless for the subjects.

Regulatory Changes in ANPRM. United States Department of Health and Human Services. Office for Human Research Protections.

Overview of some of the changes being considered for the ANPRM, comparing the current rule and the rationale for the changes.

Mastroianni, A., Kahn, J. (2002). Risk and Responsibility: Ethics, Grimes v. Kennedy Krieger, and Public Health Research Involving Children. Americal Journal of Public Health 92(7): 1073-1076.

Examines informed consent in the seminal court case Grimes v Kennedy Krieger Institute and implications for obligations of researchers and institutions.

Buchanan, D., Miller, F. (2006). Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: the Ethics of Public Health Research on Less Expensive, Less Effective Interventions. American Journal of Public Health 96(5): 781-787.

Argues that research, such as the Kennedy Krieger lead paint study, with the intention of developing less expensive –but also less effective – health treatments has value for society.

Sweeney, L. (2010). Privacy Issues Overlooked. Modern Healthcare, Sept. 9, 2010.

Computer scientist, mathematician, and writer Latanya Sweeney brings up the issues that arise in the adoption of electronic medical records.

US Department of Health & Human Services FAQs on Human Research - Provides answers to commonly asked questions about working with human subjects in the areas of informed consent, research with vulnerable populations such as children and prisoners, investigator responsibilities, and others.

Knoppers BM, Avard D, Cardinal G, Glass KC. Science and society: children and incompetent adults in genetic research: consent and safeguards. Nat Rev Genet. 2002;3(3):221-225.
SUNetID login required to access full text

Summarizes appropriate precautions for research involving vulnerable populations.

Walter, C. (2006) A Little Privacy, Please. Scientific American, July 2007.
Walter, C. (2006) Privacy Isn’t Dead, or At Least It Shouldn’t Be: A Q&A with Latanya Sweeney.

Outlines privacy and confidentiality issues raised by electronic medical records and databases and some proposed technical and policy solutions.