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.
An article that appeared in the Minneapolis Star Tribune, “Drug Study Recruiting at U of M Questioned”, reported that researchers conducting a pharmaceutical study at the University of Minnesota improperly consented mentally ill patients. According to the article, an ethics professor at the university, Carl Elliott, “says he has obtained consent documents for two separate schizophrenic patients that appear to be exact copies — not just in the subjects’ apparent replies, but in the positions of the lettering on the pages.” The professor goes on to say, “it is improbable that separate patients would provide identical responses to the questionnaire, which includes open-ended questions about the risks and requirements of clinical research. And that, he said, raises questions about whether the university was really examining patients to determine their ability to consent to research.”
Clinical monitors can look-out for errors and misconduct by closely examining informed consent forms and processes. Here are just some of the many items that are monitored during periodic study visits:
- Ensure the form contains all necessary criteria as required by FDA regulations, protocol requirements, and IRB policies
- Ensure the form is properly signed and dated by the subject
- Ensure the subject reads and signs the correct version of the form
- Ensure a Legally Authorized Representative or witness signs and dates the form when necessary
- Ensure the investigative site has a well-defined informed consent procedure
- Ensure the consenter is properly trained
- Ensure a consent discussion has taken place in which the subject as time to ask questions
- Ensure the consent process is completed before study procedures are initiated
This issue at the University of Minnesota along with other recent events reminds us that informed consent monitoring is still strongly needed today. What are your thoughts on this issue? What else can monitors do to ensure subjects are consented properly? What can be done to prevent violations in the future?
Photo Credit: Alex E. Proimos