The Charles Drew University Health Services Research Center
joins the rest of the University in its commitment to human subject protections. Because our research is conducted largely in one of the nation’s most underserved, impoverished communities, we give particular attention to protecting the interests of vulnerable populations. The Institutional Review Board at CDU includes members with diverse backgrounds in health services research, epidemiology, medical sociology, molecular biology, medicine and other disciplines. More information about CDU IRB can be found at: http://www.cdrewu.edu/irb/default.htm
The following resources are offered as suggestions for site users to increase their appreciation of the history of the IRB system in the U.S., as well as the importance of properly implementing human subjects protection policies:“Protecting Human Subjects”
is a video made available, at no charge, by the Office of Human Research Protections. The video reviews the history of the IRB system and the fundamental ethical principles that should guide the development and evaluation of research projects.
Ordering instructions can be found at: http://www.hhs.gov/ohrp/education/#materials“The Committee for the Protection of Human Subjects (CPHS)”
at Dartmouth College has made a number of useful IRB forms and other resources available for download at http://www.dartmouth.edu/%7Ecphs/tosubmit/forms“Guidance on Continuing Review.”
The federal Office of Human Research Protections (OHRP) describes requirements and recommendations on conducting "substantive and meaningful" continuing reviews of research at the following webpage:http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm
“The Belmont Report”
is a eight-page document that IRB members use to evaluate research protocols according to the principles of respect for persons, beneficence, and justice.
A copy of the Belmont Report is available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
“The Common Rule”
refers to federal regulations, first promulgated by the Department of Health and Human Services in 1981, that form the basis for the IRB system in the U.S. These regulations define the policies and procedures that an IRB must follow when evaluating research.
A pdf copy of the Common Rule is available at: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf"The Nuremberg Code"
was developed after World War II following a trial of Nazi physicians who forced prisoners to undergo horrifying procedures for research purposes. This document articulated ethical standards that have been used as a foundation for most subsequent ethical codes and federal regulations.
A copy of the Nuremberg Code is available at: http://www.bachelorsdegreeonline.com/blog/2012/the-nuremberg-code-and-its-legacy/
“Ethical Principles for Medical Research Involving Human Subjects”
was first drafted by World Medical Association (WMA) Declaration of Helsinki in 1964. This document builds on the Nuremberg Code, emphasizing the following two principles:
- The interests of research subjects should always be given a higher priority than those of society
- Every subject in clinical research should get the best known treatment.
A pdf copy of the WMA’s principals is available here: http://www.wma.net/e/policy/pdf/17c.pdfThe following book on privacy in health research, published by the National Academy Press, can be read entirely online: