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| SERIES ON ETHICS |
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| Year : 2011 | Volume
: 1
| Issue : 2 | Page : 54-56 |
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Ethics and clinical research
Jharna Mandal1, Ajay Halder2, Subhash Chandra Parija1
1 Department of Microbiology, JIPMER, Puducherry, India
2 Department of Gynaecology, Christian Medical College, Vellore, India
| Date of Web Publication | 31-Oct-2011 |
Correspondence Address:
Subhash Chandra Parija
Department of Microbiology, JIPMER, Puducherry
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2229-5070.86925
How to cite this article:
Mandal J, Halder A, Parija SC. Ethics and clinical research. Trop Parasitol 2011;1:54-6 |
"I can do no other than be reverent before everything that is called life. I can do no other than to have compassion for all that is called life. That is the beginning and the foundation of all ethics. Ethics is nothing else than reverence for life." -Albert Schweitzer.
Research has been defined as a diligent and systematic inquiry or investigation into a subject in order to discover or revise facts, theories, and applications. It is a planned activity to test a hypothesis leading to certain measurable outcomes and conclusions which will in turn contribute/offer changes to the existing knowledge in that particular field. [1] Once we understand how research works, we will be able to absorb the information obtained during the course of conducting the research and from the research itself, and translate that knowledge into effective therapy, diagnosis, etc. The whole and sole intention is primarily to do "good"; it also implies that if one cannot do any good, one should not do any harm also. This is the essence of ethical conduct.
A well-designed study with a valid question/hypothesis to test undoubtedly forms the basis of a good research. Unfortunately, the stimulus for research has shifted from pursuit of knowledge to pursuit of fame and fortune, the latter being the most often encountered. [2]
Henry K. Beecher identified unethical practices in research conducted in renowned universities and published them in one of the world's leading journals. [3],[4] In this paper titled "Ethics and clinical research," he revealed that poor treatment of human subjects was committed even after the Nuremberg code was developed. Though published nearly 5 decades ago, it is still upheld as the most influential paper ever written about experimentation involving human subjects. This article has since played a significant role in laying the foundation for today's ethical guidelines and review committees, including a fully informed consent from research subjects. [4] Recruiting participants with little or no info, without consent or with coercion; creating info where it did not exist or changing it to suit a purpose; taking undeserved credit from a colleague or denying deserved credit to a colleague or even gifting undeserved authorship to a colleague; these and other kinds of unwholesome behaviors are no rarities. [2]
Biomedical research using human beings as subjects is a highly debatable topic to deal with. Advancements being made in the field of health sciences have necessitated the increase in the requirements for human experimentation. Undeniably, this fact holds true and so is the fact that which seems unacceptable is that we put at stake the lives of a few for the welfare of an entire population. The latter can be answered; thus, human experimentation cannot be stopped but it can be made ideal. When it comes under the purview of actual research, various organizations have been purposefully instituted to scrutinize the proceedings and conduct of the research. [5] On May 20, 1747, aboard the HMS Salisbury, James Lind, a surgeon in the Royal Navy, saw the sailors suffering from scurvy. Though Lind noted a dramatic treatment effect from citrus fruit consumption, his findings were largely ignored for decades, leading to uncounted and unnecessary deaths, and highlighting the importance of combining clinical research with clinical implementation. Lind's experiments are regarded as perhaps the first modern clinical trial. The James Lind Library ( www.jameslindlibrary.org ), created in the honor of Sir James Lind, which aims to improve public and professional general knowledge about fair tests of treatments in healthcare and their history, is one such online site which can be easily accessed. [6] "Ethical Guidelines for Biomedical Research on Human Subjects," issued by the Indian Council of Medical Research, ensures protection for subjects involved in research activities in the country. [7] From a clinician's point of view, Good Clinical Practice (GCP) is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting, and documentation of the studies involving human subjects. [8] With the assistance of certain regional committees, the WHO has initiated a program called SIDCER to strengthen ethical review throughout the world. [9]
An independent body (a review board or a committee, institutional, regional, national, or supranational), also called the Independent Ethics Committees (IEC), constituted of medical professionals and nonmedical members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a research and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the research protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to IECs may differ among countries, but should allow the committee to act in agreement with GCP and the universal principles of ethics as mentioned below. [7]
 Ethical Principles Involved in Conducting Research Involving Human Subjects | |  |
Principles of essentiality
It refer to the fact that the research entailing the use of human subjects is considered to be absolutely essential. The proposed research should have been duly scrutinized by an appropriate and responsible group/organization and who, after careful consideration, come to the conclusion that the said research is necessary in view of the benefits it has to offer to humankind.
Principles of voluntariness, informed consent, and community agreement
Study subjects are made completely aware of the research study, the impact, and risk/s entailed. Also, the research subjects retain the right to enroll into a study and then abstain from further participation in it irrespective of any obligation.
Principles of privacy and confidentiality
All records and identity of the human subjects of the research or experiment should be maintained with complete confidentiality. No details should be disclosed without the consent of the subject concerned or someone authorized on their behalf.
Principles of precaution and risk minimization
The study design and the conduct of research should be such that the subjects involved are put to the minimum risk, suffer from no irreversible adverse effects, and, generally, benefit from and by the research or experiment.
Principles of accountability and transparency
The research or experiment should be conducted in a fair, honest, impartial, and transparent manner. All relevant facts or any conflicts of interest should be disclosed. Also, full and complete records of the data arising from the research and notes should be maintained for a considerable period of time which may be retrievable for any post-research monitoring, evaluation of the research, or conducting further research. The complete identity of the researcher should be disclosed to the subjects before the commencement of the study.
Human research is conducted with or without people, or their data or tissues, with the sole intention to do good. Selection of the participants should be based on the Helsinki guidelines. The recently published epitaph titled "The immortal life of Henrietta Lacks" brings to us what we know today as violation of the rights of the subject, as her cancerous tissues were taken without her or her family members' knowledge. [10] Practitioners of science today, world over owe an apology to such human souls and it is time to redeem our pledge to serve all forms of life with respect.
The WHO has raised concerns over the clinical trials conducted following the Letrozole mishap. Breach of the principles of ethics has brought clinical trials under the spotlight. A recent survey of more than 200 health researchers concluded that a quarter of clinical trials conducted in developing countries do not undergo ethical review. [9],[11] The trend of outsourcing clinical trials to developing countries has sparked concerns about unscrupulous biotech and drug firms exploiting the healthy, in the hope of earning some cash, and the sick, who hope to get free treatment. There have been several voices of concern regarding the use of paid volunteers as human subjects for conducting research. How far are we justified?
Any research involving human subjects should be conducted in accordance with the ethical principles contained in the Declaration of Helsinki and should respect three basic principles, namely justice, respect for persons, beneficence (to maximize benefits and to minimize harms and wrongs), and nonmaleficence (to do no harm).
Is it the moral responsibility of only organizations like the ICMR or the WHO to scrutinize the research activities? Are we as researchers not bound by something higher above everything mortal, i.e., our own conscience? It is time we give it a deeper thought.
| References | | |
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| 2. | Nanivadekar AS. Ethics of clinical research. Indian J Pharmacol 2004;36:275-6.
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| 3. | Beecher HK. Ethics and clinical research. N Engl J Med 1966;274:1354-60.
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| 6. | Chalmers I, Milne I, Tröhler U, Vandenbroucke J, Morabia A, Tait G, et al. The James Lind Library: Explaining and illustrating the evolution of fair tests of medical treatments. J R Coll Physicians Edinb 2008;38:259-64.
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| 7. | Statement of general principles on ethical considerations involving human participants. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical Research; 2010. p. 2-8.
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| 8. | Agarwal SP. Goodclinical practice guidelines for clinical research in India. Available from: http://www.cdsco.nic.in/html/GCP.htm. [Last accessed on 2011 May 16].
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| 9. | Fleck F. Clinical trials without ethical review under the spotlight. Bull World Health Organ 2004;82:314.
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| 10. | Skloot R. The Immortal life of Henrietta Lacks. New York: Crown Publishers; 2010.
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| 11. | Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: A perspective from developing country researchers. J Med Ethics 2004;30:68-72.
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