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Ethical Considerations of Human Research

Authors:
  • University of Uyo Teaching Hospital/ University of Uyo

Abstract

Research with human subjects has a long history throughout the world. Stories abound of unethical research practices in the biomedical sciences, such as the experiments conducted by Nazi doctors and scientists on concentration camp prisoners during World War II and the Tuskegee Study of Untreated Syphilis in the Negro Male, conducted by the U.S. Public Health Service. The Ethical problems in that study included lack of informed consent, deception, withholding information, withholding available treatment, putting men and their families at risk, exploitation of a vulnerable group of subjects who would not benefit from participation. These abuses led to the creation of codes of research ethics. Key principles formulated included respect of persons, beneficence and justice which aim at safeguarding the rights of the research subjects. Researchers must continue to uphold these principles during the conduct of research in order to avoid exploiting research subjects.
Ofonime et al., Novel Science International Journal of Medical Science (2012), 1(11-12): 304-307
304
Available online at http://www.novelscience.info Online ISSN: 2278–0025
Novel Science
International Journal of
Medical Science
Ethical Considerations of Human Research
Ofonime Johnson
Department of Community Health, University of Uyo Teaching Hosptal, Uyo, Nigeria
Received 26 Oct. 2012; accepted 28April 2013
Abstract
Research with human subjects has a long history throughout the world. Stories abound of unethical research
practices in the biomedical sciences, such as the experiments conducted by Nazi doctors and scientists on
concentration camp prisoners during World War II and the Tuskegee Study of Untreated Syphilis in the Negro
Male, conducted by the U.S. Public Health Service. The Ethical problems in that study included lack of informed
consent, deception, withholding information, withholding available treatment, putting men and their families at
risk, exploitation of a vulnerable group of subjects who would not benefit from participation. These abuses led to
the creation of codes of research ethics. Key principles formulated included respect of persons, beneficence and
justice which aim at safeguarding the rights of the research subjects. Researchers must continue to uphold these
principles during the conduct of research in order to avoid exploiting research subjects.
Key Words: Human subjects, informed consent, respect of persons, beneficence and justice.
Introduction
Those who cannot remember the past are condemned to
repeat it (George Santayana, The Life of Reason,1905)
Research with human subjects has a long history
throughout the world.
Corresponding Author: Ofonime Johnson
Department of Community Health,
University of Uyo Teaching Hosptal,
Uyo,Nigeria
E-mail: drjohnsonoe@yahoo.com
Stories abound of unethical research practices in the
biomedical sciences, such as the experiments conducted
by Nazi doctors and scientists on concentration camp
prisoners during World War II and the Tuskegee Study
of Untreated Syphilis in the Negro Male, conducted by
the U.S. Public Health Service1. These abuses led to the
creation of codes of research ethics. The first code to be
created was the Nuremberg Code of 1947 which was a
response to the atrocities committed by Nazi
physicians2. Subsequently, the World Medical
Association developed a code of research ethics, known
as the Declaration of Helsinki in 1964.
In the U.S., news that researchers deceived and
withheld treatment from subjects in the Tuskegee
Study, led to the creation of the National Commission
Ofonime et al., Novel Science International Journal of Medical Science (2012), 1(11-12): 304-307
305
for the Protection of Human Subjects of Biomedical
and Behavioral Research which was charged with
establishing a code of research ethics for U.S. research
with human subjects. In 1979, the Commission issued
the Belmont Report, which outlines three key ethical
principles for conducting research with human subjects:
respect for persons, beneficence, and justice.3
Landmark social sciences studies such as Milgram's
Obedience to Authority Study, Zimbardo's Stanford
Prison Experiment, and Humphreys's Tearoom Trade
Study, made it clear that social and behavioral research
may carry risks of harm related to psychological
wellbeing, violations of autonomy and privacy, and
reputational damage.
This essay takes a close look at one of the unethically
conducted studies. It also highlights some of the codes
and the application to research with human subjects.
Definition of terms
Research: Research is defined as "a systematic
investigation designed to develop or contribute to
generalizable knowledge.”
A human subject: A human subject is a living
individual about whom an investigator conducting
research obtains data through intervention or interaction
or identifiable private information.
Ethics: Ethics is basically defined as the study of moral
principles.
Misconducts in biomedical research
Several records abound of researches on human
subjects where the investigators’ primary
considerations were the outcomes of the research and
not the subjects. A common example is the Public
Health Service Syphilis Study (1932-1972). This study
was designed as a natural study of the course of syphilis
in African-Americans. The men were recruited without
their full informed consent, deliberately misinformed,
eg spinal taps were described as necessary and special
"free treatment" for "bad" blood. Even after penicillin
was found to be a safe and effective treatment for
syphilis in the 1940s, the men with syphilis were denied
antibiotics. In addition, the researchers continued to
protect the status of the study as a "natural history” and
tracked the men till 19721. Not providing penicillin may
have been responsible for 28 deaths, 100 cases of
disability, and 19 cases of congenital syphilis. The
Tuskegee syphilis study therefore used disadvantaged,
rural black men to study the untreated course of a
disease that is by no means confined to that population.
The Ethical problems in that study included:
lack of informed consent,
deception,
withholding information,
withholding available treatment,
putting men and their families at risk,
exploitation of a vulnerable group of subjects
who would not benefit from participation.
Introduction of codes of ethics in Human research
Since 1945, various codes for the proper and
responsible conduct of human research have been
adopted by different organizations. The best known are
the Nuremberg Code of 1947, the Helsinki Declaration
of 1964 (revised in 1975), and the 1971 Guidelines
(codified into Federal Regulations in 1974) issued by
the U.S. Department of Health, Education, and Welfare.
In the late 1970s the Council for International
organizations of Medical Sciences (CIOMS) and the
World Health Organization issued a proposed
international guideline for Biomedical Research
involving human subjects.4-8
Nuremberg Code
This code was written by the court during the trial of 23
Nazi doctors and scientists at the end of World War II,
for the inhumane treatment and murder of concentration
camp inmates used as research subjects. This was
condemned as a particularly flagrant injustice.
The code included the following guidance for
researchers:
Informed consent
Research on human subjects should be based on
prior animal work.
The risks should be justified by the anticipated
benefits.
Only qualified scientists should be allowed to
conduct research with human subjects.
Physical and mental suffering must be avoided.
Research in which death or disabling injury is
expected should not be conducted.
Further Development of Regulatory Process
In 1974, the National Research Act was enacted by US
congress in response to public concerns primarily over
Ofonime et al., Novel Science International Journal of Medical Science (2012), 1(11-12): 304-307
306
the syphilis study which established the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research to identify the
basic ethical principles that underlie the proper conduct
of human research and develop guidelines to ensure
compliance. The act also required the establishment of
Institutional Review Boards (IRBs). It was initially
applied at institutions receiving US Department of
Health, Education and Welfare support for human
subjects research. In 1991, 16 other federal agencies
and departments agreed to apply the regulations to the
research they fund or conduct.4-8
The Belmont Report
This was published by the National Commission in
1979. It identified 3 basic ethical principles for
conducting research with human subjects, commonly
called the Belmont Principles:
respect of persons,
beneficence
justice.
Respect for Persons
This incorporates two ethical convictions, firstly,
individuals should be treated as autonomous agents and
secondly, persons with diminished autonomy are
entitled to protection. The principle of respect for
persons thus divides into two separate moral
requirements: the requirement to acknowledge
autonomy and the requirement to protect those with
diminished autonomy. In most cases of research
involving human subjects, respect for persons demands
that subjects enter into the research voluntarily and with
adequate information and involves creating a
meaningful consent process.
Beneficence
The principle requires researchers to maximize benefits
and minimize the risks of harm.
Justice
The principle of justice gives rise to moral requirements
that there be fair procedures and outcomes in the
selection of research subjects. It requires us to design
research so that its burdens and benefits are shared
equitably. An injustice occurs when some benefit to
which a person is entitled is denied without good reason
or when some burden is imposed unduly. For example,
during the 19th and early 20th centuries the burdens of
serving as research subjects fell largely upon poor ward
patients, while the benefits of improved medical care
flowed primarily to private patients.
Applications of the general ethical principles to the
conduct of research
Ethical considerations must be given to the different
stages of research. At the stage of design, the research
studies must be scientifically sound. During subject
recruitment, it is important to obtain informed consent,
paying particular attention to the vulnerable groups.
The principle of respect for persons requires that
subjects, to the degree that they are capable, be given
the opportunity to choose what shall or shall not happen
to them. Informed consent should contain 3 elements:
information, comprehension and voluntariness. The
research should be justified on the basis of a favorable
risk/benefit assessment. This bears a close relation to
the principle of beneficence. There should be fair
procedures and outcomes in the selection of research
subjects. This is a moral requirement from the principle
of justice. It requires that researchers exhibit fairness
and not offer potentially beneficial research only to
some subjects while giving a disproportionate burden to
the less advantaged subjects. In addition, data collection
must respect the privacy and dignity of the subjects.
Absolute confidentiality is also key at the stage of data
management9.
Conclusion
The key principles of respect for persons, beneficence
and justice therefore aim at safeguarding the rights of
the research subjects. Researchers must continue to
uphold these moral principles during the conduct of
research in order to avoid exploiting research subjects.
While adding to the body of knowledge through
research, it is absolutely necessary to be mindful of the
process and treat the research subjects with all the
dignity they deserve.
References
1. Thomas S B. and Quinn, S C. “The Tuskegee
Syphilis Study, 1932-1972: Implications for
HIV Education and AIDS Risk Programs in the
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Black Community,” Am J. of Pub Health. 1991;
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2. U.S. National Institutes of Health. "Nuremberg
Code". Retrieved on June 20, 2012.
3. Sims, Jennifer . "A Brief Review of the
Belmont Report". Dimensions of Critical Care
Nursing,2010, 29 (4): 173–174.
4. Weindling, Paul. "The Origins of Informed
Consent: The International Scientific
Commission on Medical War Crimes, and the
Nuremberg Code". Bulletin of the History of
Medicine,2001, 75 (1): 37–71.
5. National Commission for the Protection of
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http://ohsr.od.nih.gov/guidelines/belmont.html.
Retrieved 2008-03-11.
6. "Trials of War Criminals before the Nuremberg
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ResearchGate has not been able to resolve any citations for this publication.
Article
Full-text available
The Tuskegee study of untreated syphilis in the Negro male is the longest nontherapeutic experiment on human beings in medical history. The strategies used to recruit and retain participants were quite similar to those being advocated for HIV/AIDS prevention programs today. Almost 60 years after the study began, there remains a trail of distrust and suspicion that hampers HIV education efforts in Black communities. The AIDS epidemic has exposed the Tuskegee study as a historical marker for the legitimate discontent of Blacks with the public health system. The belief that AIDS is a form of genocide is rooted in a social context in which Black Americans, faced with persistent inequality, believe in conspiracy theories about Whites against Blacks. These theories range from the belief that the government promotes drug abuse in Black communities to the belief that HIV is a manmade weapon of racial warfare. An open and honest discussion of the Tuskegee Syphilis Study can facilitate the process of rebuilding trust between the Black community and public health authorities. This dialogue can contribute to the development of HIV education programs that are scientifically sound, culturally sensitive, and ethnically acceptable.
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The Nuremberg Code has generally been seen as arising from the Nuremberg Medical Trial. This paper examines developments prior to the Trial, involving the physiologist Andrew Conway Ivy and an inter-Allied Scientific Commission on Medical War Crimes. The paper traces the formulation of the concept of a medical war crime by the physiologist John West Thompson, as part of the background to Ivy's code on human experiments of 1 August 1946. It evaluates subsequent responses by the American Medical Association, and by other war crimes experts, notably Leo Alexander, who developed Ivy's conceptual framework. Ivy's interaction with the judges at Nuremberg alerted them to the importance of formulating ethical guidelines for clinical research.
  • Jennifer Sims
Sims, Jennifer. "A Brief Review of the Belmont Report". Dimensions of Critical Care Nursing,2010, 29 (4): 173–174.
The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research"". Regulations and Ethical Guidelines
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. ""The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research"". Regulations and Ethical Guidelines. National Institutes of Health, April 18, 1979.
Laying ethical foundations for clinical research" (pdf) Bulletin of the World Health Organization
  • J Harkness
  • S Lederer
  • D Wikler
Harkness, J.; Lederer, S.; Wikler, D. "Laying ethical foundations for clinical research" (pdf). Bulletin of the World Health Organization, 2001; 79 (4): 365–366. PMC 2566394. PMID 11357216. http://www.who.int/docstore/bulletin/pdf/2001/i ssue4/vol79.no.4.365-372.pdf.edit 8. Council for International Organizations of Medical Sciences (COIMS): International Ethical Guidelines for Biomedical Research involving Human Subjects. Prepared by CIOMS in Collaboration with WHO,Geneva, 1993.
Ethical issues in health and social science research
  • Araoye Mo
Araoye MO. "Ethical issues in health and social science research": Research Methodology with Statistics for Health and Social Sciences, Nigeria, Nathadex, 2003,11-20.
  • Black Community
Black Community," Am J. of Pub Health. 1991; 81: 1503.