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Research ethics is beyond the protection of human participants

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Anyone conducting research involving humans is encouraged to adopt these ethical principles (National Cancer Institute - Unsplash)

By: Prof. Dr. Mohammad Tariqur Rahman

Ethics Committee or Institutional review boards (IRB) are meant to scrutinize if a proposed research is planned to be conducted following ethical guidelines.

Prof. Dr. Mohammad Tariqur Rahman

Formally ethical scrutiny started with the Nuremberg Military Tribunal’s decision (1946-1949) – popularly known as the Nuremberg Code – consists of ten aspects of permissible medical experimentation on humans. According to the codes, humane experimentation must “satisfy moral, ethical, and legal aspects” and benefit society.

Later at the 8th World Medical Association General Assembly held in 1964 a Declaration of Helsinki was adopted. The amended version of the declaration comprises ethical principles for medical research involving humans, including research on identifiable human material and data.

While the Declaration primarily addressed physicians, anyone conducting research involving humans is encouraged to adopt these principles. Albeit the principles of the declaration are straightforward. However, the reality of its practical application is not. Hence the theoretical and practical boundaries of ethical, moral, and legal scrutiny remain subjective.

Even the legal aspects may vary from one country to another. Research on genetically modified organisms and human cloning are the best examples that are not equally “legal” in all countries.

At the same time, how the moral and ethical boundary is determined may vary from different views namely deontological, utilitarian, or moral scrutiny.

From a deontological perspective, an action is either ethical or not ethical without exception. A utilitarian view is based on the balance of the consequences and benefits for a community, society, or nation. However, a sceptical or relativist view (moral scrutiny) stands on standards that are not universal but relative to a particular culture and time.

Surely, the views to determine the ethical or moral boundary of research are not limited to the above three views. In fact, it may raise an enduring debate to resolve the very fundamental question – if the ethical or moral aspects can be used interchangeably – in preparing guidelines to conduct and conclude a research. Or whether those ethical and moral aspects are limited to research dealing with humans and animals only.

The debate may also bring a topic as trivial as if humans who are pivotal in providing data in research should be considered and regarded as “subjects” or “participants”. Then it may go beyond the scope of how to deal with them during the research.

The current ethical and moral principles ensure every possible protection of the participants in the research. However, it rarely looks beyond the boundaries of the participants.

Credit sharing among the co-researchers is often ignored which in the end may give rise to ethical dilemmas too. At least seldom, if not more often, principal researchers all of a sudden add more researchers to the team without consulting the rest of the group. In case a research is pursued by a student for an academic degree, a new co-supervisor pops up even after finalization of the research design or conducting most of the experiments. Often their participation is neither required nor justified.

Undoubtedly, the credibility of a researcher of a given research project is part of the evaluation of IRB. Then monitoring how, when, and why a new co-researcher could join an ongoing project should be evaluated too.

It is not unlikely that adding more coresearchers or co-supervisors could be justified within the legal aspects of the ethical boundary. However, from a moral perspective taking credit for what someone does not deserve will remain between the lines of the ethical principles that appear in black and white.

In academia, research output in the form of publications is set as their performance indicator and evaluated in awarding the degree. Sadly, result fabrication and other forms of research misconduct marred thousands of research publications fated in retraction. Both students and supervisors were found guilty of such research misconduct.

Indeed, it is beyond the scope of the current IRB evaluation process to monitor research misconduct and is mostly addressed by the relevant authority dealing with integrity. However, it is not beyond the scope of the IRB evaluation of a research proposal to ask for a pledge from the researchers that they will conduct and conclude the research by upholding the ethical and moral spirit.

If it is not meant to eliminate any potential research misconduct, the pledge would remind the researchers that the ethical and moral compass in research is not limited to the protection of human participants.

……

The author is the Associate Dean (Continuing Education), Faculty of Dentistry, and Associate Member, UM LEAD, Universiti Malaya, Kuala Lumpur, Malaysia. He may be reached at tarique@um.edu.my

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