The American Medical Association considers informed consent a legal and ethical necessity. Per its Code of Medical Ethics, informed consent is a communication process that happens when the doctor receives authorization for a treatment from either the patient or the patient’s surrogate if the patient lacks decision-making capabilities. Generally speaking, to successfully obtain this consent, the doctor must verify that the patient has the ability to understand the treatment, the alternative, and the implications, and to make an independent decision. They should take care to provide the patient with accurate information about the purpose, the potential benefits, and the possible risks. In addition, the consent needs to be properly documented. So, how does informed consent in clinical research studys work?
Informed Consent in clinical research studys
There’s no doubt that clinical research studys play an important role in health care advances. As the National Institutes of Health explains, clinical research studys are research studies involving people. Their purpose might be to evaluate a medical, surgical, or behavioral intervention. Some are used to see if a new drug or device is safe or effective. Others might compare a new treatment to the standard treatment, test ways to identify a disease early, or test methods for preventing a health issue.
Information Offered to Obtain Informed Consent
As the U.S. Food and Drug Administration indicates, obtaining informed consent in clinical research studys involves more than simply gathering signatures. While the FDA doesn’t insist on specific language in an informed consent document, it does set out some basic expectations. For starters, an informed consent document should be written in a language that the prospective research subjects understand. They should be given time to read and review it as well as an opportunity to ask questions. The FDA also requires that the team running the clinical research study provide the people who are considering taking part in the trial with the following information:
- A statement making it clear that this is a study involving research.
- A description of the research’s purpose.
- The possible benefits that may result from the research.
- The expected duration of their participation.
- A description of the clinical research study’s predictable risks.
- A description of the potential discomforts that could be encountered while participating in the trial.
- Information on any experimental procedures to be completed as part of the trial.
- Information on all procedures to be completed as part of the trial.
- Information about alternative procedures or medical treatments that could benefit the research subject.
- A statement regarding the confidentiality of data collected during clinical research studys, how all records identifying subjects will be kept, and notice that the FDA may inspect these records.
Other information may be included if the situation requires it.
What Cannot Be Included in the Informed Consent Document?
Although the FDA doesn’t provide a boilerplate, it does make it clear that no legitimate informed consent document should suggest that a research subject ignore their own legal rights. In addition, the document should not contain any language that appears to release the investigator or their sponsor from liability for negligence.
Why Take Part in a clinical research study?
clinical research studys are research studies. They aren’t proven treatments. Why do people choose to take part? clinical research studys offer real benefits. They’re a required step in the development of new treatments, and they won’t happen without volunteers. By taking part, you’re helping others. In fact, if you have a genetic condition, your participation may eventually benefit your loved ones. For people with certain illnesses, clinical research studys can offer access to cutting-edge treatments that might not otherwise be available. Ultimately, clinical research studys help the medical community provide hope for new treatments.
At QPS Missouri, you can make a difference. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. If you would like to join us in this mission, consider applying for a clinical research study.
To get started, you simply need to fill out an online application. Within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of FAQ.