Importance of Ethics in Clinical Research | MMS University

Importance of Ethics in Clinical Research

Overview

Clinical Research follows experimentation on Human subjects, bearing in mind the sole purpose of finding a new drug or a drug better than the existing one, to cure an illness. These experiments may expose the test subjects to a high risk factor. In order to minimize the risk and safeguard the credibility of the participant, ethical practice, during all the phases of the experiment, is mandatory. Therefore, there is a need for an Ethics Committee at every research center to ensure that ethics is a practice and a discipline in all aspects of the research.

Why Ethics?

During The Second World War, there were numerous tests performed on the prisoners of war, without their consent. These tests often resulted in the death of the subject or left them barely alive! An ante mortem dissection was performed on the subjects who survived, to study the changes within their body as a result of the tests. The inhumane act by the Nazi Doctors back then, took the whole world by shock and led to the formulation of “The Nuremberg Code” (First International Code for Ethics in Clinical Research), to lay down guidelines for research activities involving human subjects.

Today, drugs developed through unethical practices would be rejected by the Food and Drug Administration (FDA) on thorough investigation of the path taken to develop the same. Even the slightest sign of malpractice raises red flags and the process of getting the FDA to sign off becomes more challenging. As a result, years spent on the development of that particular drug would be considered futile and the research center would incur a great loss with respect to Time and Money. To avoid such huge losses, an institute experimenting on human subjects should follow the norms laid by some influential codes of ethics like The Nuremberg Code (1947), Belmont Report (1979), Declaration of Helsinki (2000), and others.

How are Ethics monitored during trials? – Ethics Committee (EC)

The need for EC was stated or agreed on in The Declaration of Helsinki (1964).

In India, The Indian Council of Medical Research (ICMR) released a Policy statement in the year 1980, laying guidelines for every medical college and research center to establish an Ethics Committee (EC). The Committee should have 5-15 members, comprising of at least one Medical Scientist (Pharmacologist), one Clinician, a Legal Expert, a Social Scientist and a representative from the community and the head of the community should preferably an outsider.

Starting from questioning the need for the drug to be developed down to the last phase of administering the drugs to a larger group, EC shall always be a check point at each and every stage, and upon its consent shall things proceed further.

Roles and Responsibilities of EC

  • Review the need for the drug before the start of the research.
  • Review the scientific design and the conduct of the research.
  • Ensure that the participant has complete knowledge on the process and the adverse effects expected in case of any, all of which should be presented in the form of a document known as the Patient/Participant Information Sheet. In case the participant is vulnerable, a legal guardian’s consent is mandatory.
  • Data confidentiality of the subject must be maintained.
  • Informed Consent, where the Informed Consent Form (ICF) should be written in a vernacular language and signed or thumb printed by the participant.
  • Risk to benefit ratio must be analyzed at every stage taking into account, the documented test sample results.
  • Plans for Post Trial Access and Compensations.

In case of absence of an EC or guidelines on how to go about in a clinical experiment,

  • The chances of the developing countries being targeted for subjects would be high, considering their lack of education and the economic status.
  • People who are incapable of voicing out their interests fall prey to such experiments, with absolutely no benefits in terms of health or needs.
  • The subjects may presume that they are under a medication benefiting from it, but in turn would be under an experimental treatment.
  • In case of adverse affects that occur on consuming experimental drugs, their treatment may not be ensured, the effects may not be recorded, compensations in case of extreme situations may not be assured.
  • The chances of science being demeaned would be high, following improper documentation of experimental data or wrong usage of advancement in technology.
  • Loss in Time and Money.

Upon stating the ethical considerations involved in Research on Human Subjects in their 1980 Policy, the Indian Council of Medical Research (ICMR) finalized the Ethical Guidelines for Biomedical Research on Human Subjects,” which was revised in 2006 to accommodate 12 general principles for any biomedical research to follow/abide by.

  • Principle of essentiality
  • Principles of voluntariness, informed consent and community agreement.
  • Principle of non-exploitation
  • Principle of privacy and confidentiality
  • Principle of precaution and risk minimization
  • Principle of professional competence
  • Principle of accountability and transparency
  • Principle of the maximization of the public interest and distributive justice
  • Principle of institutional arrangements
  • Principle of public domain
  • Principle of totality of responsibility
  • Principle of compliance

Career Opportunity

Ethics are important in all departments within a Clinical Research Center. Ethical choices take place against a backdrop of uncertainty. Just as a patient’s diagnosis is perceived through years of experience and judgment, so does ethical awareness. People in charge of documentation such as Medical Writers, Scientists and in some cases professionals from other disciplines such as Clinical Programming and others, should be aware of ethical aspects of carrying out an experiments on human subjects.

For one to be a member of the EC via a medical field, one has to start as a practitioner in a Clinical Research Center. The opportunities are vast considering the fact that every Research Center and Medical College should have an EC. The growth in the field of medical science and technology has in turn increased the number of Clinical Research Centers over the years, and the Drug development sectors would continue to grow along with it.

If you are reading this and are interested in developing your skill set so that you may enter the pharmaceutical industry as a practitioner, it is important to note that today, most companies look to hire candidates who have some advanced levels of knowledge about the industry characteristics in general, and some specific levels of expertise in certain areas. As a result, most recruiters look for candidates who have gone the extra mile and acquired additional knowledge as a result of going through relevant courses.

In addition to one’s core education degrees, having specialized expertise through certificate courses could be a powerful yet cost effective way of standing out among peers while being considered for a job in the life sciences industry.

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MMS University (www.mmsuniversity.com) is among the top ranked online universities in the world that provides the perfect launch pad for prospective Medical Writers, SAS Clinical Programmers, Pharmacovigilance professionals and other life sciences industry aspirants who are interested in learning from practicing experts. MMS University offers exhaustive ‘Assessment based Certification’ courses in Medical Writing, SAS Clinical Programming, Trial Disclosures and Pharmacovigilance which are designed to provide enhanced credibility to prospective Clinical Research professionals in their search for employment opportunities, career growth options and freelance work.

To know more, visit us at www.mmsuniversity.com today.

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