Module 15: Research Ethics
Upon completion of this module, the resident should be able to:
- Identify and describe the significance of key milestones in the evolution of clinical research ethics.
- Describe the meaning and practical applications of the principles of respect for persons, beneficence, and justice in clinical research.
- Describe other key criteria or requirements for the ethical conduct of clinical research, including scientific and social value, fair risk-benefit ratios, respect for subjects, etc.
An interesting public broadcast system telecast on the ethics of clinical research can be found at http://www.pbs.org/wnet/religionandethics/week848/cover.html.
The Association of Clinical Research Professionals has developed a code of ethics that may be found here: http://www.acrpnet.org/about/ethics.html.
Henry K. Beecher, MD’s landmark study, “Ethics and Clinical Research,” can be found here: http://www.scielosp.org/pdf/bwho/v79n4/v79n4a13.pdf.
The full text of the Nuremberg Code can be found here: http://www.hhs.gov/ohrp/references/nurcode.htm. The full text of the Declaration of Helsinki can be found here: http://www.scielosp.org/pdf/bwho/v79n4/v79n4a14.pdf.
Another classic statement of ethical precepts for clinical research can be found here: http://www.who.int/docstore/bulletin/pdf/2001/issue4/vol79.no.4.365-372.pdf.
An article exploring the impact of therapeutic research on informed consent from the medical oncology perspective can be found here: http://www.jco.org/cgi/reprint/17/5/1601.
The complexities of clinical research ethics are explored in a succinct article found here: http://www.cmaj.ca/cgi/reprint/158/10/1303.pdf.
Individuals involved in human subjects research funded by the National Institutes of Health must undergo education on this topic; frequently asked questions about this requirement can be found at: http://grants1.nih.gov/grants/policy/hs_educ_faq.htm.
The text of the Common Rule can be found here: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
The website of the U.S. Department of Health and Human Services Office of Human Research Protection can be found here: http://www.hhs.gov/ohrp/.
The U.S. Department of Health and Human Services Office of Human Research Protection offers a series of decision charts designed to help investigators understand the ethical dimensions and regulatory requirements of proposed studies. These charts can be found here: http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm.
A comprehensive, but layperson-focused overview of clinical trials can be found at: http://clinicaltrials.gov/ct/gui/c/w1b/screen/PrintURL?file=resources.html&JServSessionldcs_current=e7rhe2u5q5.