Human subjects for research, Ethics of Medical Research

Sunday Asuke

Community Medicine, Bingham University

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8/18/2021

Outline

• Reasons for research
• Definition of ethics
• Some violation of human research subjects
• Some declarations – Nuremberg, Helsinki
• Major principles of ethics
• IRB
• Informed Consent

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Introduction/ Reason for research

• Understand Disease
• Validate New Therapies
• Understand Physiological Processes
• Study Human Behavior
• Evaluate Curricular Changes
• Evaluate New Teaching Methods

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Definition of Ethics

• Ethics: The discipline of dealing with what is good and bad, with moral duty and obligation
• A set of moral principles or values
• The principle of conduct governing an individual or group
• Webster’s Ninth New Collegiate Dictionary

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Definition of Ethics - 2

• The domain of ethics deals with moral duty and obligation, involving actions that are subject to being judged as good or bad, right or wrong
• Ethics are also principles of right and wrong that are accepted by an individual or a social group, or a system of principles governing morality and acceptable conduct.

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Tuskegee Syphilis Study 1932-72 Alabama

• A research project conducted by the U.S. Public Health Service.
• Six hundred low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years.
• Free medical examinations were given; however, subjects were not told about their disease.
• Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment.
• Many subjects died of syphilis during the study.

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Other Major Violations to Human Research Subjects

• 1963 -- Brooklyn - Jewish Chronic Diseases Hospital: Cancer cells were injected into debilitated elderly patients to see if they would immunologically reject the cells.
• 1972 - Willowbrook State Hospital in New York: Retarded children were deliberately infected with viral hepatitis to study its natural history.

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TROVAN TRIAL IN KANO, NIGERIA Kano

• Trovan (Trovafloxacin) clinical trials in 1996 in kano Nigeria, on pediatric age group, during the worst ever meningococcal meningitis.
• Pfizer never obtained ethical clearance
• Pfizer did not obtain informed consent, 11 children died
• Pfizer left the town after conducting the study despite the fact that the epidemic was still ongoing
• Pfizer later agreed to a $175,000 each to 4 families in out of court settlement in 2009

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The Nuremberg Code �(Post World War II)

• Requires voluntary consent
• Experiments must be rational
• Experiments must be based on animal studies and knowledge of the disease
• Experiments should avoid suffering
• No experiment should involve excessive risks, except in those studies where physical experimental physicians also serve as subjects

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The Declaration of Helsinki�World Medical Association�(1964, 1975, 1983, 1989, 1996, 2002)

• “The well-being of the subject should take precedence over the interests of science and society”
• Consent should be in writing
• Use caution if participant is in dependent relationship with researcher
• Limited use of placebo, especially if treatment is available
• Greater access to benefit once research is concluded

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The Belmont Report (The U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978)

• Ethical Principles and Guidelines for the Protection of Human Subjects of Research:
• Respect for persons
• Beneficence
• Justice

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��The Four Principles of Ethics �

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1 - Autonomy (Respect for the person) �2 - Beneficence (Do Good) �3 - Non-malfeasance (Do No Harm) �4 - Justice

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Basic Principles of Research on Human Subjects (1)

• Respect for persons
• Choices of autonomous individuals should be respected
• People incapable of making their own choices should be protected
• Voluntary subjects need adequate information for decision-making

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Basic Principles of Research on Human Subjects (2)

• Beneficence
• Participation in research is associated with a favorable balance of potential benefits and harms
• Maximize possible benefits, minimize potential harm

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Basic Principles of Research on Human Subjects (3)

• Justice
• Participation in research is associated with a favorable balance of potential benefits and harms
• Should not exploit or exclude vulnerable individuals who may benefit without good reason

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Basic Principles of Research on Human Subjects (4)

• Non-malfeasance (Do No Harm)
• This is similar to the principal of beneficence or “do no harm.” Researchers must protect participants from harm and maximize their well-being.

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Types of Risks and Benefits

• Risks or harms and benefits may be physical (pain or injury), psychological, social, economic, or legal.
• Risks or benefits of research may apply to individual participants, families, groups or organizations, communities, or nations.
• Risks and benefits to the research participant usually carry the most weight.

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Institutional Review Board (IRB)

• Also known as an Independent Ethics Committee (IEC) or Ethical Review Board (ERB).
• It is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects .

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Institutional Review Boards

• Makeup of IRB
• At least 5 members
• Male/Female
• Professionals/laypersons
• External “non-affiliated” member
• Must represent community
• Lay person must be at meeting for reviews

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Institutional Review Boards

• IRB’S must be guided by principles outlined in Belmont Report:
• Respect for persons: respect for patient autonomy
• Beneficence: maximize benefits and minimize harm
• Justice: Equitable distribution of research burdens and benefits

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IRB Approval

• To be approved:
• Risks must be minimized by sound research design
• Risks must be reasonable in relation to benefits
• Selection of subjects must be equitable
• Informed consent will be sought from each subject

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IRB Approval-2

To be approved-continued:

• Informed consent will be appropriately documented
• When appropriate, research plan must ensure continued safety of subjects
• Where appropriate, provisions made to protect privacy of subjects and data
• When working with subjects vulnerable to coercion, must consider added safeguards

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Informed Consent

• Consent must address critical elements or points outlined by Federal Law
• Consent signed by subject or legal representative and investigator
• Subject must be given copy of consent
• No exculpatory language may be used in the written consent

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Basic Elements of Consent

• Explanation of purpose and duration
• Description of risks
• Description of benefits
• Disclosure of alternatives to participation

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Basic Elements of Consent-2

• Explanation of Confidentiality of Records
• Who to contact regarding patient rights
• For research with more than minimal risks, comment on compensation and care for injury
• Right to withdraw without prejudice
• Statement regarding unforeseen risks, especially to unborn child

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Additional Elements for Consent

• Statement that investigator may terminate patient participation
• Information regarding any costs
• Statement regarding consequences of withdrawing-especially for drug studies
• Number of subjects in study

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Special Populations-Children

• Special Considerations
• Children are persons who have not attained the legal age for consent to treatments or procedures involved in research
• Research not involving greater than minimal risk may be approved:
• With assent of the child and permission of parents

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Special Populations-Children-2

• Special Considerations
• Research involving greater than minimal risk and the prospect of direct benefit to the child may be approved:
• If the risk is justified by the anticipated benefit
• The relation of the benefit to risk is at least as favorable to subjects as the alternative approaches
• With assent of the child and permission of parents

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Special Populations-Children-3

• Special Considerations
• Assent of the child
• Usually verbal-confirmed by parents
• “Assent” can usually be provided by children over six years of age-but varies based on maturity and psychological state
• Failure to object, absent affirmative agreement, should not be construed as assent

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THANK YOU FOR LISTENING

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