RESEARCH ETHICS

In recent years, several prominent universities have come under scrutiny because of violations related to research with human subjects. Regulations at the institutional and federal level have become increasingly strict, generally in response to violations. Understanding the history of protection of human subjects in research is a very important framework for considering the ethical parameters of your own research. You also should be familiar with the purposes and functions of your local Institutional Review Board, or IRB. The material presented here includes information on the history of medical and research ethics, what an IRB is and what it does, and how to best prepare for getting your project approved by your local IRB, including issues such as appropriate informed consent. Also included are a few suggested reference books for further exploration of this topic.

Introduction to Research Ethics Presentation

A great place to start is a series of Powerpoint presentations developed by Dr. Eric Zemper (Michigan State University and the University of Michigan) which will give you an excellent overview of the history of protections of human subjects, the IRB and informed consent. Click here to open the modules.

• Module 1
• Module 2
• Module 3
• Module 4

Web links for Research Ethics

Here are some helpful web links to learn more about ethics in research and your responsibilities as an investigator.

• To link to federal legislation and regulations for research, go to http://www.apa.org/SCIENCE/research/reglaws.html
• To learn about the Health Insurance Portability and Accountability Act or HIPAA Privacy Rule, go to NIH’s web page http://privacyruleandresearch.nih.gov/
• For more insight into the processes by which IRBs review research, go to http://www.hhs.gov/ohrp/irb/irb_chapter4.htm
• For a list of federal agencies regulating research, go to http://www.apa.org/SCIENCE/research/regfeds.html
• For an in-depth discussion of why ethics matter in research, go to http://dir.niehs.nih.gov/ethics/whatisethics.htm
• For a list of bioethic resources on the web, the NIH has pulled together a useful list http://bioethics.od.nih.gov/

Books for Ethics in Research

Research Ethics

• Brody BA. The Ethics of Biomedical Research. New York: Oxford University Press, 1998.
• Levine RJ. Ethics and Regulation of Clinical Research. Baltimore, MD: Urban & Schwarzenberg, 1986.
• The Belmont Report. 1978. (A seminal document that is the basis of much of the current ethics of research.) Found at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm or click here for a PDF copy of the report. Insert “TheBelmontReport” pdf here.

Clinical Ethics

• Beauchamp TL & Childress JF. Principles of Biomedical Ethics (5th Edition). New York: Oxford University Press, 2001.
• Lo B. Resolving Ethical Dilemmas: A Guide for Clinicians (2nd Edition). Philadelphia, PA: Lippincott Williams & wilkins, 2000.

Ethics and the Business of Medicine

• Weber LJ. Business Ethics in Healthcare: Beyond Compliance. Bloomington, IN: Indiana University Press, 2001.