Ethical issues that arise in the average rheumatology practice and in clinical research are often straightforward. The AMA Code of Medical Ethics and the Office Practice and Procedures Manual offer useful information.1 In research, the Protocol and Investigators Agreement spells out who you can enroll and how the trial must be conducted. But still—even when you’re doing everything correctly and listening to the inner voice that separates right from wrong, situations come up that you could never foresee.
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Explore This IssueJuly 2016
We are a clinical practice and research center located in a major U.S. city. Many of us have been here for years. We have seen the amount of administrative tasks required to conduct a clinical trial more than quadruple and the length of a consent form grow from six pages to 30 or more. Paper documents have been replaced by electronic data capture, accompanied by a perplexing number of vendors and clinical research organizations (CROs) that oversee aspects of the trial, each with its own required training, passwords and (unhelpful) help desks. So we have it all covered, right?
In the middle of April 2016, we were presented by one of our CROs with a form for the principle investigator (PI) to sign: the Ethics and Compliance Acknowledgement and Certification Form that referred to a website where the Ethics Policy, a Global Code of Conduct and an Anti-Corruption Compliance Policy were listed. Our PI was to certify that he had read, understood and would comply with the documents during the conduct of the trial. Helpful, right? The study started in 2013, and this request arrived during the close-out visit in 2016.
Wait, you want me to sign what?
A patient who has been in a clinical trial before is offered enrollment in another study. There is a long, clearly written consent form, and a copy of it is given to the patient to take home to read.
“This is your working copy. If you like to read with a highlighter or write questions on the form, go ahead. Your doctor will review it with you at the screening examination if you decide to go ahead with it.”
The patient returns two weeks later, having discussed the consent form with her primary physician. She is accompanied by a family member, who is a nurse. The patient reports they have all discussed how the study will work. The patient, her daughter, the PI and study coordinator have a one-hour meeting discussing the study. The patient reports that she understands everything, has no questions and can tell the PI the difference between the blinded treatment arms. The consent is signed, and the screening visit is completed. Two weeks later, all results are in, and the patient returns to be randomized. But just before she is assigned to a treatment group, the patient says, “I do not want to do it if I get the pill, so make sure that I get the shot.”