Survey polls indicate that both concerns over risks and lack of awareness of medical research studies are deterrents to individuals participating in medical research trials. For individuals who might hesitate to sign up for a clinical trial because of a perceived risk, the role of the Institutional Review Board (IRB) should be understood. The FDA has authority over all clinical trials in the United States, including those funded by the US Department of Health and Human Services as well as those wholly funded by industry or private parties. To ensure the highest quality trial results are achieved, the FDA has established institutional review boards to monitor the structure, conduct, and reporting of medical research studies.
IRB’s are comprised of at least five members including doctors, scientists, and laypeople. Before a trial can begin, an IRB must review the specific procedures that trial will follow. These procedures must be approved before any testing can begin. To help ensure that medical research studies are carried out with the highest level of patient protection possible, the IRB evaluates which individuals should be included/or excluded from the tests. The Boards also assess the demographic and geographic areas from which participants are selected. This evaluation helps ensure that only the most appropriate individuals are selected which, in turn, guarantees the highest quality research data. The IRB also checks the informed consent form required from each participant to ensure all applicable laws have been followed.
Once the medical research studies are underway, the FDA performs periodic inspections of the study site, all methods, and each researcher working on the project. These inspections help protect the welfare and rights of all participants as well as the quality and integrity of the research data being collected. Also, other involved parties such as other government agencies, private groups, or industry sponsors may also evaluate various aspects a medical research trial. Every evaluation, regardless of the groups carrying it out, is designed to help maintain the highest level of quality with regards to participant welfare and rights and to produce the highest quality and most useful research data for the medical community. Medical research trial participants can rest comfortably knowing each step of the process is under continual review.
DM Clinical Research conducts a wide range of medical research studies including tests for advancements in managing and controlling rheumatoid arthritis, COPD, meningitis, C Diff, and Type II diabetes. We have enrolled more than 4,000 patients in over 253 successful studies. If you feel you may qualify for one of our medical research trials, please give us a call and speak with one of our professional staff. Participants receive, free of charge, all doctor visits, lab tests, medications, and compensation for their time and travel in most cases. Call today at 281-517-4550.