Clinical research is vital to the delivery of health care. Clinical research is how scientists come up with novel treatments, cures, and preventive measures to help stop the disease from spreading. Furthermore, clinical research guarantees that when these therapies are released, they have been demonstrated to be safe and effective, with any potential adverse effects reported.
Clinical research is distinguished not just by scientific rigor but also by adherence to ethical guidelines. The current COVID-19 crisis emphasizes this point: while clinical researchers are aware of the need for treatments and vaccines, they also feel obligated to follow ethical protocols, ensuring that their data is accurate and transparent and that any treatments are thoroughly tested before being released.
What Is Clinical Research and How Does It Work?
Clinical research, as defined by the National Institutes of Health (NIH), is medical research that involves testing new treatments and therapies on humans. Clinical trials, according to the FDA, are research investigations that assign one or more interventions to human participants in order to determine the impact of the interventions on biological and behavioral health outcomes.
Clinical research’s ultimate purpose is to further medical knowledge and enhance patient care. Clinical research must be undertaken purposefully through systematic study and data collecting in order for the findings to be valid and useful. The Food and Drug Administration (FDA) in the United States defines the various forms of clinical research as follows:
- New drugs, psychotherapy approaches, medical equipment, surgical and therapeutic techniques, and other intervention innovations are all studied in treatment research.
- Prevention research focuses on using medicine, vitamins, immunizations, and lifestyle modifications to prevent diseases from developing or returning.
- Diagnostic research aims to provide effective methods for identifying problems and providing doctors and clinicians with prediction criteria for detecting diseases in patients.
- The purpose of genetic studies is to better understand the link between genes and disease in order to improve disease prediction and estimate the likelihood of an individual developing a given disease.
- Epidemiological studies aim to uncover risk factors and protective variables for diseases in specific groups in order to spot patterns, causes, and ways to control them.
- As the National Institute on Aging notes, clinical studies are sometimes known as observational studies. Clinical studies study people in everyday situations in order to categorize volunteers based on their characteristics and track changes over time. The findings of these researches frequently lead to the development of additional clinical trials.
Ethics in Clinical Research: How Important Is It?
For numerous reasons, clinical research ethics are stressed. Ethical measures preserve the safety of patients who consent to participate in clinical trials as well as the integrity of the study results. Furthermore, ethical guidelines serve to ensure that volunteers are not abused or treated unfairly by the study team.
According to the Hastings Center, a bioethics research institute, government regulations require that all proposed clinical trials be approved by an institutional review board to guarantee that the experiments are ethical and that the rights of participants are protected.
Clinical trials raise ethical concerns about whether participants are sufficiently told about the trials’ dangers and the chance that they will not personally benefit from the research.
Clinical researchers’ work is guided by other key ideas in addition to these ethical norms. The following are some noteworthy examples:
- Assuring that testing is meticulous and adheres to all clinical procedures.
- Verifying the results’ scientific validity
- Choosing clinical trial participants in a fair and non-prejudiced manner
- Before giving their consent, all volunteers should be fully informed about the trial and its risks.
Ethical Issues in Clinical Research
Despite the fact that these abuses appear to be a thing of the past, clinical researchers are nevertheless confronted with serious ethical challenges. To prevent such misdeeds, federal regulations require that any research involving a human participant be examined and authorized by an institutional review board (IRB) both before and during the study. Physician-researchers, statisticians, and community advocates might all be on the committee.
All research volunteers must give their informed consent to participate, which includes disclosure of information about the study’s processes and goals, with a few exceptions. According to the Hastings Center, the subject of informed consent is a source of great disagreement and debate among medical research groups.
1. Populations at Risk
According to the FDA’s research approval requirements, research involving vulnerable populations must take into account their particular characteristics and the impact their research may have as a result of these traits. Children, criminals, pregnant women, physically and mentally challenged people, and those who are economically or educationally disadvantaged are all vulnerable populations.
2. Compensation (Monetary)
Another ethical issue for researchers is the amount of money they should pay their subjects. Many programs just reimburse participants for their out-of-pocket expenses, but some patient advocates believe that compensation should go beyond that, motivating clinical trial participation.
Paying clinical research participants raises ethical questions about the undue influence and coercive effect of offering money in exchange for accepting the risk of catching a disease or being injured in some other way by the research procedure. The journal BMC Medical Ethics describes a study in Malawi that paid participants $10 per study visit.
The lack of criteria for determining appropriate compensation called into question the ethics of the pharmaceutical companies that funded the research and stood to profit handsomely from the items under test.
3. Recruiting Patients
The most time-consuming part of clinical studies is usually patient recruitment. Researchers are constantly looking for more efficient ways to find volunteers while maintaining clinical quality. However, an entire industry has sprung up to assist researchers in finding patients for these studies.
Antidote, for example, is one of 15 clinical trial recruitment organizations that connects medical researchers with patients who are interested in participating in clinical studies.
According to Contemporary Clinical Studies Communication, researchers may compete for patients who match the criteria for their proposed trials. Patients’ best interests and well-being must take precedence over all other research concerns, including the need to tell patients about all of their alternatives, as well as all risks and advantages.