If you’re considering participating in a clinical research study, you may ask yourself, “How can I be sure that the trial is safe, fair, and ethical?” Fortunately, human rights and ethical standards are fundamental when it comes to conducting sound, reliable medical research. After centuries of medical experimentation, researchers have developed stringent criteria to resolve ethical issues in clinical research studies. Read on to find out more about some of the more common ethical concerns, and how researchers work to combat these every day.
Ethical Issues in Clinical Research Studies
Combating Ethical Issues with Informed Consent
The term “informed consent” refers to the requirement for researchers to fully inform trial participants of anticipated risks and benefits (if any) before they decide whether to participate in research. Participants have a right to be informed of every aspect of a trial before research begins. That includes the purpose of the research, the exact research methods, and any risks associated with the research. Only after being properly informed can a prospective trial participant give their full consent and begin the trial process. The safe, respectful treatment of participants goes hand-in-hand with informed consent. With that in mind, researchers must commit to subjects’ confidentiality. Researchers must also keep subjects informed throughout the trial process, allowing participants to withdraw at any time if issues arise.
Social and Clinical Value in Clinical Research Studies
A brief published in Perspectives in Clinical Research explains that any risk involved in a clinical research study must be justified, with the potential to uncover scientific knowledge “that warrants asking people to risk inconvenience and unknown health outcomes for the greater good.” For example, if trial participants consent to testing a new sleep aid drug and that drug leads to unusual drowsiness, researchers must have a good reason for inconveniencing participants – namely, proven scientific advancement. With this in mind, researchers must ensure that their research methods are valid, feasible, and clear, with very little chance of unduly inconveniencing participants.
Bias and Ethical Subject Selection in Clinical Research Studies
Bias in clinical research studies is an ongoing topic of discussion in research communities. Ultimately, researchers must work to combat implicit bias (having attitude towards people or associating stereotypes with them without our conscious knowledge) throughout the trial process, starting with subject recruitment and continuing through results reporting. As explained by the American Bar Association, recruiting should be based “exclusively on [the study’s] scientific goals.” Candidate selection should also involve “minimal risk and maximum benefit to individuals and society.” Finally, researchers should work to expand diversity in clinical research studies to combat participant bias in research results.
Avoiding Ethical Issues Through Independent Review
Long before a study begins, an independent review board must review the proposed research. Individuals on the board cannot have vested interest in the outcome of the study, such as financial gain. For example, if a proposed trial seeks to determine the efficacy of a new drug, that drug’s manufacturer cannot have a place on the independent review board. This board will assess the integrity of the study, ensuring that it is safe, ethical, and adequately protecting participants.
Ultimately, sound clinical research is guided by stringent ethical guidelines. These guidelines exist both to protect participants and to ensure the integrity of the study results. As a potential trial participant, if you have any questions about the ethics of an upcoming study, it is your right to ask questions, stay informed, and assess the integrity of a study for yourself before enrolling.
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.