Ethics in clinical research are the set of appropriate ethics which are considered in the conduct of a clinical trial in the field of clinical research. It derives from the broader fields of medical ethics and research ethics. The major goal of the clinical research is to enhance the clinical research which develops the human health or increases the human biology understanding. Most of the population who participate in the clinical research make it likely to secure the knowledge. During the process of finding the new drug or any particular treatment it should be safe or effective. For instance, it is to test it on patient volunteers. By placing it on the people at risk of harm for the sake for good of others, clinical research has the potential to exploit patient volunteers. The key purpose of the ethical guidelines is to protect and guard the patient volunteers and preserve the integrity of science. The duty of the physician is to safeguard and promote the well-being, health, and rights of patients, which includes of those who are majorly involved in medical research. Moreover, medical research is the subject to ethical standards promoting and ensuring the respect for all human subjects and protect their rights and health.
The ethical guidelines of clinical research in various parts of the world were framed only after discovery of inhumane behavior with participants during the period of research experiments. In February 1980, Indian Council of Medical Research (ICMR), released a ‘Policy Statement on Ethical Considerations which involved a research on Human Subjects. This policy was a first statement proposing the official guidelines for the establishment of ethics committees (ECs) in all the research centers and medical colleges. Various ethical guidelines related to the clinical research were developed in the period of 20th century in response to various studies. Some of the major ethical issues in conducting the research include:
a) Beneficence- Do not harm
b) Informed consent
c) Respect for privacy
d) Respect for anonymity and confidentiality.
Some of the influential codes of regulations and ethics that guide ethical clinical research include:
- Nuremberg Code (1947)
- Belmont Report (1979)
- Declaration of Helsinki (2000)
- U.S. Common Rule (1991)
- CIOMS (2002)
Why is research ethics important?
There are various reasons to be considered is important to follow to ethical norms in research. Firstly, norms promote the aims of research, such as truth, knowledge, and avoidance of error. Most of the people are more likely to fund a research project if it can be trustable in the quality and integrity of research. Most of the people learn ethical norms at schools, colleges, home, churches or in any other social settings. They acquire their sense of right and wrong during childhood. Ethical norms are universal that one might be interested to regard them as simple commonsense. The moral development of the people occurs throughout life and human beings pass through different stages of growth as they mature.
Different professional government agencies, associations, and universities have accepted the specific rules, codes, and policies relating to research ethics. Most of the government agencies, have ethics rules for funded researchers. They include:
- National Institutes of Health (NIH)
- National Science Foundation (NSF)
- Food and Drug Administration (FDA)
- Environmental Protection Agency (EPA)
- US Department of Agriculture (USDA)
What are ethical standards?
When any particular principles are followed they promote the values such as good behavior, fairness, trust, and kindness. There is no any consistent in the set of standards for all the companies to follow, but in accordance the company has a right to enhance and develop the standards which are meaningful and applicable in their organization
Using the sources of guidance of researchers and various organizations, seven main principles have been described as guiding the conduct of ethical research which include:
- Social and clinical value
- Fair subject selection
- Scientific validity
- Favorable risk-benefit ratio
- Informed consent
- Independent review
- Respect for potential and enrolled subjects