Role and impact of government regulatory agencies

Ethical Principles in Biomedical Research

Biomedical research is a field of medical research which is used to assist and support the body of knowledge that is available in the field of medicine. It is divided into two major categories. The first is the evaluation of new treatments for both their efficacy and safety in what are known as clinical trials. This kind of research contributes in the development of new forms of treatment. The second category is the preclinical research which is conducted to specifically elaborate on the knowledge available in order to develop new therapeutic strategies.

Role and impact of government regulatory agencies

Biomedical research is a highly regulated field. This is because it can directly or indirectly because of several reasons. The first is that it uses human subjects. Second is that it can cause serious harm, directly and indirectly, to the human subjects under test. National regulatory authorities have a role to supervise and monitor all biomedical research being carried out. In the U.S., this is the role of the Food and Drug Administration (FDA) which oversees the development of new drugs and forms of treatment. In Europe, there is the European Medicines Agency which does the same work as the FDA. In Japan, it is the work of the as the Ministry of Health Bosk & Vries, 2004()

There are also other agencies that deal with regulation of biomedical research. The World Medical Association is tasked with the development of ethical standards for biomedical research. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) deals with the development of rules and guidelines for developing new forms of medication such as the Good Clinical Practice (GCP). All ideas for the regulation of biomedical research are usually based on the country’s ethical code of standards. This is the reason why a certain drug or form of treatment may be acceptable in one country but not in another one Bosk & Vries, 2004()

Major principles of ethics and their application in biomedical research

There are four major principles of ethics which are generally accepted in health practice. The first principle is the principle of respect for autonomy. Respect for autonomy is whereby the patient is allowed to act in any way they would like. It means that the patient has the capacity to act in their own intention with their own understanding and without the control of any influences that would prevent them from taking a voluntary and free action. This principle is also the basis of the common health practice of informed consent. This is where the patient is supplied with as much information as possible on the procedure or treatment to be undertaken including advantages, disadvantages, alternatives, possible complications, etc. And then the patient makes their decision based on the provided information. In biomedical research, this simply means that the patient or research participant has the freedom to make their own decisions Emanuel, Wendler, Killen, & Grady, 2004()

The research participant should also be allowed to make their choice based on the principle of informed consent. The patient should be informed of the pertinent information regarding the research study being done including what the results will be used for, confidentiality, possible complications, research methodology, researcher(s), and etc. The patient will then be able to decide on whether they should join the study or not Fadare & Porteri, 2010()

The second principle is the principle of non-maleficence. This is whereby the medical practitioners are required to take actions which do not harm or injure the patient in any way either through the action of omission or commission. This is simply the avoidance of negligence and providing a high standard of care in order to avoid and minimize risks arising to the patient. Negligence, under the legal criteria, is determined by four major things. These are as below:

1. The medical professional must have a duty or role to play to the party that is affected.

2. The medical professional must be in breach of that particular duty.

3. The party that is affected must experience a kind of harm for the breach of the duty by the medical professional.

4. The harm that is experienced by the affected party must be caused by the breach of this duty by the medical professional. Emanuel et al., 2004()

The principle of non-maleficence accepts that there is a need for medical professionals to be competent and to work with due diligence. It becomes very clear that mistakes of a medical nature can occur, however, this principle states that the health care professionals have a fundamental commitment to protect the patients who they have a duty towards from any such harm Emanuel et al., 2004()

In biomedical research, this principle can be applied in that the health care professionals need to take due diligence and care to prevent any harm from happening to the patients. For example, in a clinical research, if it is realized that there is a potential complication that is occurring in the patients, the study should be stopped for a while until the source of the complication is identified and removed. Similarly, in a preclinical research, the researchers should work hard to protect any harm from arising to their patients including taking care in the carrying out of any procedures.

The third principle is the principle of beneficence. This principle simple implies that the medical practitioners should be of some benefit to the patient. They should take the necessary positive steps towards the prevention and removal of any harm or potential source of harm to the patient. These duties of the medical professionals are viewed as being self-evident and they are generally accepted as the part of the goals of medicine. These goals are applied both to the patients individually and for the good of the society as a whole. This principle of beneficence is a goal of medicine since, for example, it is a goal of medicine to achieve the good health of patients and to prevent diseases through the activities of research, vaccination and immunization Emanuel et al., 2004()

Scholars in the medicine world state that non-maleficence is a constant duty for health care professionals in general whereas beneficence is a limited duty. The medical professional has a duty to seek the benefit of their patients. However, the professional has a choice of whom they can admit to their practice which is not a strict duty. The duty becomes complex if two or more patients appeal to be treated at the same time. The professional needs to make their own criteria of urgency which they use to decide on whom to help first DuBois, 2009()

This principle can be applied in biomedical research where the researchers have a duty to ensure they benefit the research study participants. This is achieved through having the betterment of lives as one of the objectives of the study.

The last principle is the principle of justice. Justice in health care simply refers to fairness. As stated by Aristotle, fairness is ‘giving to each that which is due.’ It implies fairness in the distribution of health care professionals and supplies. Therefore, there must be some form of fairness in the allocation of scarce medical resources to the patients. In the field of medicine, it is generally accepted that the people who are equals should also qualify for equal treatment. There are certain factors that are implied in the criteria for distributive justice. This criteria is that to each person, an equal share is given according to their need, effort, contribution, merit and free-market exchanges Emanuel et al., 2004()

In biomedical research, this principle means that all subjects should be treated fairly and as equals. For example, in a clinical research, there are those participants in the control condition who receive a placebo of the drug and those in the experimental condition who receive the drug itself. All participants in the control should be treated as equals. Same goes for those participants in the experimental condition.


Biomedical research is an important field of medicine which adds to the knowledge that is available in the particular field. Since the field usually deals directly with human subjects and it is expected that there can be some harm caused to the patients, the field needs to be highly regulated and this is where the government regulatory authorities come in. Medical professionals involved in biomedical research also need to apply the four major ethical principles to make sure the research is conducted in an ethical manner.


Bosk, C.L., & Vries, R.G. d. (2004). Bureaucracies of Mass Deception: Institutional Review Boards and the Ethics of Ethnographic Research. Annals of the American Academy of Political and Social Science, 595, 249-263.

DuBois, J.M. (2009). The Biomedical Ethics Ontology Proposal: Excellent Aims, Questionable Methods. Journal of Empirical Research on Human Research Ethics: An International Journal, 4(1), 59-62.

Emanuel, E.J., Wendler, D., Killen, J., & Grady, C. (2004). What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. The Journal of Infectious Diseases, 189(5), 930-937.

Fadare, J.O., & Porteri, C. (2010). Informed Consent in Human Subject Research: A Comparison of Current International and Nigerian Guidelines. Journal of Empirical Research on Human Research Ethics: An International Journal, 5(1), 67-74.

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