http://www.imarcresearch.com/blog/bid/275520/Informed-Consent-Still-an-Issue-in-the-21st-Century?goback=%2Egde_763127_member_221961615
Informed Consent
Sandra Maddock's blog on informed consent issues in the 21st century.
Informed Consent: Still an Issue in the 21st Centuryimarcresearch.com
The issue at the University of Minnesota along with other recent events reminds us that informed consent monitoring is still strongly needed today.
Informed consent is arguably the most important aspect of patient protection in clinical research. The informed consent process is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial. Unfortunately, informed consent remains an issue today. In fact, the FDA has sent out many warning letters regarding informed consent over the last few years.
The history of clinical research includes some very dark events, many of which include issues with informed consent. Here are a couple of the worst atrocities and the responses to them:
- From 1939-1945, the Nazis conducted many horrific experiments on Jews and other prisoners that often resulted in permanent disability, disfigurement, or death. These subjects did not give consent, and they had no choice but to participate.
- In 1947, the Nuremberg Code was developed, and it specified that any clinical research subject must provide voluntary consent.
- From 1932-1972, the U.S. Public Health Service conducted a study on the progression of untreated syphilis in poor African-American men in Tuskegee, Alabama. These men were never told they had syphilis and were not treated for it even though Penicillin was validated as a cure in 1940.
- In 1979, the federal government published the Belmont Report. The report included the ethical principle, respect for persons, which allows human subjects informed consent and truth about the research.....
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