Designed to test the safety and efficacy of medical treatments in humans, research studies play an important role in the development of new drugs and medical devices. If you aren’t familiar with the standards behind clinical research, you might question their ethics. So, let’s explore the protocols and procedures that underpin these studies. What makes clinical research ethical?
What Makes Clinical Research Ethical?
The Benefits Must Justify the Risks
A clinical research study must have social or scientific significance. The following is one of the key principles of ICH-GCP: “Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.” Clinical research may only be justified if the risks to participants are minimized, the benefits to participants are enhanced, and the benefits to participants and society are proportionate to or outweigh the risks (source).
research studies are carefully designed to protect the rights of the participants. Before human participants are even involved, the researchers conduct extensive preclinical research. This begins in the laboratory, where researchers identify promising interventions that have the potential to become safe, effective treatments. Then, they test these treatments using animal models to evaluate their safety and effectiveness. This initial research helps researchers fine-tune treatments before they reach research studies.
The U.S. government requires that all research studies be approved by an institutional review board (IRB) at the Food and Drug Administration (FDA) before they begin to ensure they are ethical and protect participants’ rights. In addition, research studies must be reviewed and approved periodically throughout the study.
To begin this process, researchers send an Investigational New Drug (IND) application to the FDA, where it will be analyzed by an IRB composed of physician-investigators, statisticians, community advocates, and others. These committees determine whether trials are ethically acceptable and whether the rights of the participants are adequately protected. According to ICH-GCP, research studies must be “scientifically sound, and described in a clear, detailed protocol.”
Fair Subject Selection
clinical research study teams must specify specific inclusion and exclusion criteria and create a strategy for recruiting participants. Fair subject selection is critical. Vulnerable or “convenient” populations must not be unfairly targeted for potentially risky research, and powerful or privileged populations must not be favored for potentially beneficial research. In addition, researchers must ensure that the selection of participants will not cause biased or inaccurate results.
Federal regulations require that participants give their informed consent before they may take part in clinical research. To meet this requirement, researchers must disclose certain study information to potential participants so that they have sufficient knowledge of the research and can make an informed, voluntary decision to participate. This knowledge should include the study’s purpose, procedures, risks, benefits, alternatives, requirements, and other pertinent information. It should also take into account the participant’s language, education, familiarity with the research, and cultural values. In addition to providing written information, clinical research teams also provide potential participants with opportunities for discussion. Once participants are fully informed, they are asked to sign a written consent document. This is an integral component of all clinical research.
Trained Medical Professionals
Each member of the clinical research study team must be well trained and qualified to perform the tasks assigned to them. This helps ensure that participants receive medical care from professionals with the knowledge and experience necessary to make informed decisions. ICH-GCP states, “The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician.”
Respect for Participants
All clinical research participants should be treated with respect and dignity. According to ICH-GCP, “The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.” This respect begins the moment the participant is enrolled, extends throughout their participation, and continues after the trial ends.
As we mentioned above, the clinical research study team must maximize benefits and minimize possible harms for participants. Researchers also have a responsibility to monitor the well-being of participants and to protect their privacy and confidentiality. Finally, all study participants have the right to withdraw from the trial at any time and for any reason.
What makes clinical research ethical? Clearly, many critical components are involved: preclinical research, FDA approval, informed consent, respect for participants, and more.
Are you interested in participating in clinical research? To explore the possibility, check out QPS Missouri if you live in the southwest Missouri region. 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. 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 FAQs.