Clinical research aims to improve human health, gain a better understanding of human biology, and ultimately lead to significant scientific advances. Over 409 thousand clinical trials had been registered globally as of March 2022, a significant increase from previous years. These studies are critical for developing new medications and determining their medical applications.
In response to numerous instances of patient exploitation, ethical standards and regulatory practises have evolved over time, assisting in the protection of volunteers while also preserving scientific integrity.
Role of Regulations and Ethics Codes in Clinical Research
Regulatory and ethical standards have evolved over time as a result of unfortunate instances of unethical research throughout history. The Tuskegee Syphilis Study is one of the most well-known case studies. In this unethical and deceptive study, 400 African American males in Alabama who tested positive for syphilis were given placebos. The true goal of the trial was to track the progression of syphilis, but participants were duped into believing they were receiving treatment.
The objective of clinical research is to generate a holistic perspective that improves human health or broadens understanding of human biology. Participants in clinical research help to preserve that knowledge. Testing new medications or treatments on willing patients is one way to determine their safety or effectiveness. However, clinical research has the potential to exploit patient volunteers by putting some people in danger for the benefit of others. The goal of ethical guidelines is to protect patient volunteers while also maintaining the objectivity of science.
Today’s ethical standards are largely a reaction to historical malfeasance, the most infamous of which occurred in America in Tuskegee, Alabama, during an experiment in which 400 African American men with syphilis were denied treatment in order for scientists to track the disease’s progression. In response to such studies, the twentieth century saw the development of a slew of ethical standards.
Guiding Principles of Clinical Research
Informed consent is frequently regarded as clinical research’s moral compass. In contrast, informed consent is neither required nor sufficient for moral clinical research. Seven criteria can be proposed to methodically elucidate a coherent framework for judging the ethics of clinical research studies, drawing on the fundamental philosophies underlying significant codes, declarations, and other documents relevant to human subject’s research:
- Social & Clinical Value
Every research study aims to provide an answer to a specific question. Knowing the answers to some questions will benefit society as well as current and future patients suffering from a specific illness. The research question’s answer must be significant or valuable enough to justify asking participants to accept some risk or inconvenience. In other words, the research question’s answers should contribute to our understanding of health or aid in the development of better plans for the early detection, diagnosis, and treatment of patients suffering from a specific disease. Human subjects’ risk and burden can only be justified if society benefits from the research. This necessitates revealing both positive and negative results.
- Scientific validity
The goal of a study should be to produce a clear answer to the main research question. This requires considering a variety of factors, including whether the research question can be answered, the reliability and validity of the research methods, and whether the study was designed with a specific scientific purpose in mind. Statistical plans must also be capable of analysing data and definitively testing the objective. Ineffective research is unethical because it wastes resources and jeopardises people.
- Fair Subject Selection
To answer the posed question, who must be included in the study? The primary criterion for selecting which groups and individuals to include in the study should not be vulnerability, privilege, or any other factor unrelated to the study’s goals. People should be chosen in a way that minimises risks while maximising benefits to individuals and society, according to the scientific goal. The benefits and costs of research should be shared by those who stand to benefit from it as well as those who accept the risks and obligations that come with it. Specific groups or individuals (for example, women or children) should not be denied the opportunity to participate in research unless there is a good scientific reason or a particular susceptibility to risk.
- Favourable Risk-Benefit Ratio
Clinical research is inherently uncertain about the full range of risks and benefits associated with a drug, device, or procedure being tested; otherwise, the research would be pointless. Furthermore, early-phase research, by definition, involves more risk and benefit uncertainty than later-phase research. Research risks can range from minor to severe, depending on the specifics of the study, resulting in either short-term discomfort or long-term changes. Financial, social, psychological, and physical risks (such as infection, disability, or death) are all examples of risks (for example, discrimination or stigma from participating in a certain trial). Is every effort being made to minimise the risks and discomfort experienced by research participants, maximise the potential benefits, and achieve a balance between the risks and potential rewards for both individuals and society? Clinical research volunteers frequently receive some health services and benefits in exchange for their time, but clinical research is not intended to provide medical care.
- Independent Review
To reduce potential conflicts of interest, a neutral review panel should examine the proposal and ask pertinent questions, such as: Are those conducting the trial sufficiently free of bias? Is the study taking every precaution possible to protect its participants? Is the risk-benefit ratio skewed in favour of the ethical design of the trial? In the United States, local institutional review boards (IRBs), grant organisations, and data and safety monitoring boards evaluate research projects impartially. These organisations also monitor a study’s progress.
- Informed Consent
Most people agree that in order for research to be ethical, each individual should be able to choose whether or not to participate. This is achieved through the informed consent process, in which participants (1) are fully informed of the research’s objectives, design, procedures, risks, benefits, and available solutions, (2) comprehend this information and how it relates to their own clinical situation or interests, and (3) choose whether or not to participate voluntarily.
In some cases, such as when the patient is a child, an adult with severe Alzheimer’s disease, an adult knocked out by a head injury, or a person with limited mental capacity, informed consent is not required. To ensure that the subject’s participation in the research is consistent with his or her values and interests, decision-making authority is frequently delegated to a proxy decision maker. Typically, these decisions are based on what the study participant would have done if given the option.
Respect for potential and enrolled subjects
Even if a person declines to take part in a study, they should be treated with respect before, during, and after the study. This includes the following:
- Keeping their personal information confidential and respecting their privacy.
- Respecting their right to withdraw at any time if their minds change or they decide that the research is not in their best interests.
- Keeping them informed of any new information that emerges during the research that may affect how they weigh the benefits and risks of participating.
- Monitoring their health, ensuring they receive appropriate care, and removing them from the study if they have adverse reactions, unfortunate events, or clinical status changes.
Conclusion
Regulations and ethics remain critical in ensuring clinical trials’ validity and morality. These are required to ensure that research is carried out in a way that both protects patients and advances scientific research. Many ethical issues remain to be addressed in the field of clinical research.
Concerns have been raised about stem cell research, for example, because human embryos are used to harvest stem cells. Human gene editing research also opens the door to the possibility of editing human embryos, which is another ethical concern that must be addressed in the future.