Based on years of experience and learning from past mistakes, strict rules are now in place to ensure clinical research participants are safe. For example, a trial must get the approval of an Institutional Review Board (IRB) before it can begin. The IRB will examine the study to ensure it is ethical and complies with all laws. They will also make sure the participants are well informed about the purpose of the study, the possible risks, and how the trial will be monitored.
One concern raised by some scholars is that paying for participation can contribute to therapeutic misconception in prospective subjects by masking the costs and burdens of participating in research, resulting in unequal distribution of benefits and burdens between better-off and worse-off people. This ethical issue also has implications for the principle of justice, which aims to ensure everyone gets a fair share of opportunities to improve health, including the right to participate in research.
To prevent these concerns, most clinical trials are closely supervised by the principal investigator and a Data and Safety Monitoring Committee of experts in the condition being studied and the treatment being tested. The committee will regularly monitor what is happening in the trial and ensure the treatment does not harm patients. If it is, the committee will stop the study.
One of the central ethical challenges posed by clinical research involves when it is permissible to expose some individuals to risks of harm for the benefit of others. The prevailing view holds that clinical research should satisfy the norms of clinical medicine, which posit that individuals are owed treatment consistent with their medical interests. Some, however, argue that a more general moral standard should apply to clinical research: researchers must be able to justify exposing participants to risk regarding its potential to uncover scientific knowledge.
Such a justification might require investigators to disclose their study’s purpose and exact methods and risks for potential participants to make informed choices about participation. Moreover, this justification might demand that investigators respect participants’ autonomy by allowing them to withdraw from the study at any time.
Before a trial can begin, however, it must be reviewed and approved by an institutional review board (IRB). IRBs are panels of scientists, doctors, and ethicists who evaluate the safety of clinical trials. IRBs ensure that participants’ rights are protected and that researchers follow strict regulations governing the trial’s conduct. In addition, these panels conduct on-site inspections of clinical trials to verify that they are being conducted in line with the FDA’s guidelines.
Informed consent is an essential aspect of conducting ethical clinical research. According to US Federal regulations, potential participants must be provided with a detailed written description of the study’s purposes and risks. Moreover, the person signing up for clinical trials must be competent to voluntarily decide and grant their consent. The informed consent process also involves a verbal discussion with the possible participants. Physicians must separate their roles as clinicians and researchers to prevent undue inducement in the form of financial compensation.
Informed consent should also include a statement that participants can terminate the study at any time. This is especially important for trials with long durations. Moreover, it is necessary to disclose the nature and source of funding for unforeseen complications that may arise during the trial.
The concept of informed consent should consider the individual’s values and goals in medical treatment, ensuring that a physician is not overly imposing their preferences on a patient. This is particularly important when a trial is designed to help patients with a chronic illness.
While the premise of informed consent is an essential part of conducting scientifically sound research, many studies need to be conducted properly. Several reports have indicated that the current systems for monitoring subject safety are inadequate. The key to improving the system is incorporating more transparency and accountability between researchers and sponsors. This includes ensuring that a trial is based on the best possible science and is ethically conducted.
When people are facing severe illness, they may feel desperate to try anything that might help. However, a system of rules exists to prevent this understandable desperation from causing harm to participants. These systems include standards of medical professionalism, requirements for pre-market safety testing by the FDA, and institutional review board oversight of research. These rules also ensure that participants have adequate time to think through the risks, burdens, and discomforts of participation before agreeing to participate in a study.
Sponsors must be careful not to give incentives that might influence a participant’s decision to join a clinical trial. They need to pay enough to cover the costs of the study, but not so much that it influences the person’s choice. This is why sponsors must be transparent about how much they pay participants. This includes stating the total payment in advertisements and on the IRB-approved consent form. Including the average payment per study site in advertisements is also good so potential participants know what they might expect to earn.
While incentive payments are problematic, most other forms of compensation do not raise concerns about undue influence. They can be ethically essential for facilitating recruitment and completion of trials, encouraging diverse participation, and acknowledging the value of volunteers’ contributions to research.