Behind the Research is an ongoing series to peek behind the research bench and learn more about the words and phrases that scientists use. We hope that through a better understanding of the science of disease and how clinical research works, you will be a more empowered and confident participant in your care.
In this installment of Behind the Research, we are going learn more about the institutions that play a role in the clinical research and drug approval process.
- Belmont Report: The Belmont Report is named for the Belmont Conference Center, then a part of the Smithsonian Museum, where it was written over four days in 1976, after nearly monthly discussions spanning seven years. The report was commissioned by the National Research Act, which was signed into law by President Nixon after a series of congressional hearings on research involving human subjects. This comprehensive report is a compilation of multiple individual reports written over that timespan, and it serves as a guidance to Institutional Review Boards and outlines the three guiding principles in conducting biomedical research with human subjects:
- Respect for persons: This protects the participant’s autonomy and ensures that all communication is respectful and truthful.
- Beneficence:This is the “do no harm” clause — researchers should maximize research benefits but always minimize any and all risks to the participants.
- Justice: Ensure that quality care is given to all participants and that all risks and benefits are distributed equally among all those who are affected by the condition
- FDA: The Food and Drug Administration is an agency within the Department of Health and Human Services. Its role is to determine the safety and efficacy of drugs and devices. The agency reviews clinical trial data to evaluate if the new drug or device is safe and effective enough to approve for use in the US, and it approves all language that goes on the drug label. The FDA does not run trials, design trials, or mandate how trials must be conducted. The agency also plays no role in how much the consumer pays for the drug once it is approved. The FDA solely evaluates the trials that are submitted to them to determine if the drug can be approved.
- Institutional Review Board (IRB): An Institutional Review Board is required to approve and monitor all research involving human subjects. The IRB should be composed of a diverse group of stakeholders of at least five members, and it must have at least one scientific member, one non-scientific member, and one member who is unaffiliated with the institution. The primary goal of the IRB is to ensure that the welfare, rights, and privacy of the human subjects participating in clinical research.
- Trial Sponsors: The trial sponsor is the person or group who writes and runs a clinical trial. Usually, this is the pharmaceutical company who has developed the drug. Some trials are investigator-initiated — those are the trials that a doctor at a medical institution designs and then writes grants to apply for the funding to carry out. Either way, the sponsor is the one who is responsible for the planning and execution of the trial and any regulatory issues with the FDA or IRB.
This started as an idea for a single post, but it quickly became evident that the best plan would be to aliquot the idea into multiple posts to form a series. If there’s a word, phrase, or concept that you’d like me to tackle in a future installation of our Behind the Research series, please leave a comment and I’ll add it into my queue!