First-time clinical research participants often ask the same question: Are clinical studies safe? Today’s clinical studies are tightly regulated, closely monitored, and governed by principles of informed consent that ensure transparency with participants. Read on to find out more about the many safeguards currently in place to protect clinical research study participants.
Are Clinical Research Studies Safe?
Clinical Research Studies Are Regulated
As a first-time participant, you may wonder who governs clinical research studies. Are they designed by drug companies? Doctors? Someone else? Regardless of who orchestrates the study, all clinical researchers are required to follow strict rules to ensure participant safety. These rules are enforced by the federal government, in addition to other trial-specific review organizations. The latter includes an Institutional Review Board, or IRB. These boards are made up of doctors, scientists, and other laypeople who are independent from the study and are dedicated to protecting participants throughout the process. Every clinical research study in the United States must garner the approval of an IRB. Many research studies are also supervised by a Data and Safety Monitoring Committee, which periodically examines study results. If this committee finds that a trial has the potential to harm participants, the study must be halted immediately. These are just a few examples of organizations whose purpose is to monitor the safety of clinical research studies.
Clinical Research Studies Are Based on Informed Consent
clinical research study participants must undergo an informed consent process prior to taking part in any study procedures. During this process, participants are told what to expect and informed of known potential risks, side effects, and benefits, if any. Participants are required to review all of the applicable information before consenting to participate in a clinical research study. At this point, participants can decide whether or not they want to take part in the particular clinical research study. Of course, participants can withdraw at any point after registering for a study. The informed consent document in no way represents a “contract” or promise to finish a trial on behalf of the individual.
The vast majority of clinical research studies have excellent safety records. This is largely because, as mentioned above, Data and Safety Monitoring Committees are typically assigned to monitor clinical research study progress and review any serious adverse events or statistical concerns. Throughout the trial, a number of statisticians will measure the treatment’s efficacy and side effects. If a treatment is found to be ineffective, potentially dangerous, or overly uncomfortable for participants, the committee will stop the trial in its tracks.
Every clinical research study conducted in the United States involves careful review, informed consent, and safety procedures meant to protect participants.
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 more than 1,500 FDA-regulated studies, paying out nearly $50 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.