Of the many myths surrounding clinical research studies, the idea of unregulated research studies may be the most damaging. In reality, the Food and Drug Administration (FDA) heavily regulates research studies to protect participants. This regulation also ensures an accurate, unbiased result, which protects future patients and consumers. But what are the FDA clinical research study requirements, and how do they impact individual studies?
FDA clinical research study Requirements
How Does the FDA Regulate Clinical Research Studies?
First, let’s explore the basics of FDA clinical research study regulation. The FDA regulations for the conduct of clinical research studies have been in effect since the 1970s. Today, the agency manages a wide variety of regulations and guidance documents. The agency also partners on international trial guidance documents. The agency accomplishes this level of oversight thanks to a dedicated office, known as the Office of Good Clinical Practice (OGCP). This office develops ongoing clinical research study best practices, ensures consistency in agency-wide regulations, and engages in international trial regulation efforts. The office also works with other federal agencies and external stakeholders to protect research participants.
FDA Informed Consent Requirements
The FDA maintains a stringent list of clinical research study requirements, but the practice of informed consent may be the most important. Per the FDA website, informed consent is “a process used by researchers to provide potential and enrolled participants with information about a clinical study.” This information helps participants give consent; in other words, it helps them decide whether they want to participate in any given study. The informed consent process outlines a number of trial specifics, including risks, potential benefits, and alternatives associated with the study. The FDA generally requires that a participant sign an official informed consent document before joining a study. However, this document is not a binding contract. Ultimately, participants may withdraw from a study at any time.
FDA clinical research study Institutional Review Boards
The FDA also requires that any federally-supported, FDA-regulated clinical study is reviewed, approved, and monitored by an external board. These boards are known as institutional review boards, or IRBs. The FDA’s website explains that these boards typically involve doctors, researchers, and other members of the medical community. The boards may also contain members of applicable federal agencies. The boards’ responsibilities include managing general ethical boundaries, reviewing the informed consent document, and more. Ultimately, these boards exist to protect participants and consumers alike.
If you’re preparing to enroll in a clinical research study, rest assured knowing the Food and Drug Administration has your best interest at heart. FDA clinical research study requirements exist to protect trial participants while ensuring a medically sound, unbiased trial process. For more information on the FDA’s role, check out the agency’s designated clinical research study database.
Have you ever thought about participating in a clinical research study? You could be a part of history! QPS Missouri is looking for new participants. 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. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical research study.
To get started, you simply need to fill out an online application. After that, 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 frequently asked questions.