JOIN > Urologists Practicing Outside of AUA Section Boundaries > Application Cycle

Module 15: Research Ethics

Upon completion of this module, the resident should be able to:

  1. Identify and describe the significance of key milestones in the evolution of clinical research ethics.
  2. Describe the meaning and practical applications of the principles of respect for persons, beneficence, and justice in clinical research.
  3. 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.

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Additional Resources


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.



Posttest / Transcript

Status
Module: 15 ETHICSMOD-15 Research Ethics Posttest Available  
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