Ethical Matters in Epidemiological Studies

Ethics are the principles of right and wrong that are acceptable to a group of people or an individual. It is a system of standards that governs the morality and acceptability of any medical research involving human or animal subjects. Generally, a committee known as ethical committee (ethical panel) is set up or appointed to look into ethical issues arising from any anticipated medical research. The ethical panel gives or declines approval for the conduct of the study. Ethical clearance is usually obtained from the ethical committee before carrying out the study. The implementation of any epidemiological study is usually governed by some ethical standards in order to ensure compliance to their proper implementation, and to reduce any untoward effect of the study to the environment and the general population. Ethical matters involve policies, actions and investigations that are just or unjust.

Prior to the starting of any epidemiological research, written or informed consent is usually obtained (when the study has to do with human subjects), and in the case of medical research involving animal subjects, ethical issues arising in the study must be properly reviewed and ethical clearance approved for the study by the ethical panel. Ethical principles ensure that researchers protect their subject’s confidentiality, their human rights and that the truthfulness of the study is not influenced for any personal reasons. According to the World Medical Association (WMA) Declaration of Helsinki in the 59th General Assembly of the WMA in Seoul, October 2008, all medical research (epidemiological study inclusive) involving human subjects or any identifiable human material must follow and abide by some laid down ethical principles. Some of the excerpts from this declaration (which are ethical principles governing all medical research) of the 59th General Assembly of the WMA in Seoul, October 2008 that governs are as follows:

  • Researchers must protect the life, dignity, health, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects.
  • The welfare of animals used for scientific research must be respected.
  • Research involving human subjects must confirm to generally accepted standards, and it must also be based on thorough knowledge of the scientific literature, laboratory experimentation and other relevant source of information to the study.
  • Research involving sick human subjects or healthy volunteers must be thoroughly supervised by a competent health professional or physician.
  • Researchers must be well trained and possess the required qualifications for the task.
  • The research should be carried out in such a way that there will be less untoward effects (if any) to the environment.
  • The design of the research must be well-explained in the research proposal, and it must contain a statement of the ethical consideration involved.
  • The research proposal must be duly submitted to an ethical committee for consideration, comments, guidance and approval before the research study begins.
  • An anticipated study must stop if and only when it is discovered in the course of the study that the risks involved far outweigh the potential benefits of the study.
  • Written consent from voluntary subjects or sick patients in the study must not be obtained under duress.
  • If the volunteers in the study are incompetent to provide consent, researchers must seek consent from legally authorized agencies before proceeding with the study. This also applies to patients who may be unconscious to provide a written consent to the execution of the study.
  • The well being of human subjects in any medical research must take superiority over all other interests in the study.
  • Publications of the results from the study must be carried out without any manipulation of the resulting data. Researchers must adhere to generally acceptable standards for ethical reporting, and the sources of funding, conflicting interests and institution (s) where the study was carried out should be clearly stated in the publication.

References

Schneider M.J (2011). Introduction to Public Health. Third edition. Jones and Bartlett Publishers, Sudbury, Massachusetts, USA.

Stedman’s medical dictionary, 27th edition. Philadelphia: Lippincott, Williams and Wilkins.

Songer T (2005). Study designs in epidemiologic research. Supercourse, (http://www.pitt.edu/~super1/lecture/lec19101/index.htm) (Accesed May 2103).

Singleton P and Sainsbury D (1995). Dictionary of microbiology and molecular biology, 3d ed. New York: John Wiley and Sons.

Taylor LH, Latham SM, Woolhouse ME (2001). Risk factors for disease emergence. Philos Trans R Soc Lond B Biol Sci, 356:983–989.

Salyers A.A and Whitt D.D (2001). Microbiology: diversity, disease, and the environment. Fitzgerald Science Press Inc. Maryland, USA.

Rothman K.J, Greenland S and Lash T.L (2011). Modern Epidemiology. Third edition. Lippincott Williams and Wilkins, Philadelphia, PA, USA.

Rothman K.J and Greenland S (1998). Modern epidemiology, 2nd edition. Philadelphia: Lippincott-Raven.

Porta M (2008). A dictionary of epidemiology. 5th edition. New York: Oxford University Press.

Patrick R. Murray, Ellen Jo Baron, James H. Jorgensen, Marie Louise Landry, Michael A. Pfaller (2007). Manual of Clinical Microbiology, 9th ed.: American Society for Microbiology.

Nelson K.E and Williams C (2013). Infectious Disease Epidemiology: Theory and Practice. Third edition. Jones and Bartleh Learning.

Mandell G.L., Bennett J.E and Dolin R (2000). Principles and practice of infectious diseases, 5th edition. New York: Churchill Livingstone.

Merill R.M (2012). Introduction to Epidemiology. Sixth edition. Jones and Bartleh Learning,

Molyneux, D.H., D.R. Hopkins, and N. Zagaria (2004) Disease eradication, elimination and control: the need for accurate and consistent usage. Trends Parasitol, 20(8):347-51.

MacMahon   B.,   Trichopoulos   D (1996). Epidemiology Principles and Methods.   2nd ed. Boston, MA: Little, Brown and Company. USA.

Aschengrau A and Seage G.R (2013). Essentials of Epidemiology in Public Health. Third edition. Jones and Bartleh Learning,

Aschengrau, A., & G. R. Seage III. (2009). Essentials of Epidemiology in Public Health.  Boston:  Jones and Bartlett Publishers.

 

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