Oncology consent forms: failure to disclose off-site treatment availability.
Year: 2008
Type: article
Abstract: II % <!iany research studies investigate new uses of medications that are commercially available.' For example, cancer researchers often conduct studies to determine whether chemotherapy agent approved by the Food and Drug Administration (FDA) to treat one type of cancer is also effective at treating different type of cancer. The importance of such studies has been growing, as drop has taken place recently in the number of new drugs being studied in clinical trials and receiving FDA approval.2 These types of studies also provide valuable information about the safety and effica cy of FDA-approved drugs that are prescribed off-label, i.e., prescribed for condition that is not covered by the FDA approval. According to some estimates, the rate of off-label prescribing ranges from about 40% for adults to go% for children.3 Since clinical studies of new uses of commercially available treatments play an important role in health care research, it is important that these studies be con ducted with appropriate adherence to ethical and regula tory standards. Some of the most important of these rules relate to informed consent. Federal regulations, in addition to applicable ethical standards, require that potential research subjects receive relevant information in order to make informed choices about whether to enroll in clinical trials.4 More specifically, potential sub jects are supposed to be given a disclosure of appropri ate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.5 The alter native courses of treatment may include standard thera pies, as well as those under investigation in clinical trials. People often decide to participate in clinical trials pre cisely because they want access to the new treatments being tested in research studies.6 Yet what are prospec tive subjects told about alternative courses of treatment? Are they being told what they need to know to make an intelligent choice about whether to enroll in the study? To help answer these questions, we collected and evalu ated sample of consent documents for oncology clini cal trials.
Source: PubMed
Authors: David B Resnik, Shyamal Peddada, Jason Altilio, Nancy Wang, Jerry Menikoff
Institution: National Institute of Environmental Health Sciences
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W1583251663