ETHICS IN RESEARCH
Professor Lisa High
University of Windsor
Why Ethical Guidelines?
 Face many ethical dilemmas in practice
 Vulnerable participants or patients or clients
 To protect people receiving health care and the interventions
and treatment regimes in the system
 To protect the public from harm
Historical Events
Need to discuss “unethical studies” – led to the development of
Ethical Codes and Regulations
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Nazi Medical Experiments
Tuskegee Syphilis Study
Willowbrook Study
Jewish Chronic Disease Hospital Study
Nazi Medical Experiments
 1933 to 1945 – unethical activities implemented by the
Third Reich in Europe
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Programs included:
Sterilization
Euthanasia
numerous experiments to produce a pop’n of pure Germans
& Aryans
Tuskegee Syphilis Study
 1932 – US Public Health Service initiated a study of syphilis in
black men in the small rural town of Tuskegee, Alabama
 Cont’d for 40 years (to1962)
 To determine the course of syphilis in the adult black male
 2 groups: n = 400 untreated syphilis (treatment group) n = 200
without syphilis (control group)
 Consent – participants not informed about the purpose and
procedures
 Deliberate steps to keep subjects from receiving treatment
 No effort to stop the study
Willowbrook Study
 mid 1950’s to early 1970’s – research on hepatitis at an
institution for the mentally retarded
 Subjects – children – deliberately infected with Hepatitis virus
 20 year study – closed
 Research cont’d – to new admits
 Parents were forced to give permission for their child in order
to gain their child’s admission to the institution
 Published findings
 Investigators denied vs. acquired while in the institution
 Cont’d into the early 70’s
Jewish Chronic Disease Hospital
Study
 In 1960’s – purpose to determine the patients’ rejection
responses to live cancer cells
 N = 22 – injected with a suspension containing live cancer
cells that had been generated from human cancer tissue
 Rights of patients not protected, not informed, study was
never presented to the research committee of the Jewish
Hospital
What Happened?
 NUMERBURG CODE
 DECLARATTION OF HELSINKI
 CODE OF ETHICS
Nuremburg Code
 1st internationally recognized set of ethical standards
 Developed post-Nazi atrocities were made public during the
Nuremburg trials
Declaration of Helsinki
 Provided:
(a) Greater care should be exercised to protect subjects from
harm in non-therapeutic research
(b) Strong, independent justification is required for exposing
a healthy volunteer to substantial risk of harm just to gain
new scientific info
(c) The investigator must protect the life and health of the
research subject
- 1964 – World Medical Assembly
Code of Ethics
 Most disciplines have established
- Canadian Nurses Association (1983) - “Ethical Guidelines
for Nurses in Research Involving Human Participants”
- 2002 guidelines revised
- Health Canada – “Tri County Policy Statement: Ethical
Conduct for Research Involving Humans”
- Joint – MRC (Medical Research Canada), NSERC and
SSHRC
- Eight guiding principles of ethics
- Research Ethic Review Board (REB)
Ethical Guidelines
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Principle of Respect for Human Dignity
cardinal rule
Right to self determination and right for full disclosure
Humans are autonomous agents capable of controlling their
own activities
Principle of Respect For Human
Dignity
 Right to Self-Determination and Right to Full Disclosure
 Is based on the principle of respect
 Humans capable of self-determination & controlling their
own destiny
 Autonomy – voluntarily participate & withdrawal
no coercion
full disclosure
no deception
voluntary consent
Persons with diminished autonomy: who?
Principle of Respect For Human
Dignity
 Free and Informed Consent
 Informed consent – participants have adequate information
comprehend the research
power of free choice
enable voluntary participation
Consent Forms – what should a consent include?
Implied Consent – define?
Process Consent – what does that mean?
Issues Relating to the Principle of
Respect
Full Disclosure: 2 biases
(1) Bias resulting from distorted information
(2) Bias resulting from failure to recruit a good sample
Techniques used:
(1) Covert data collection/concealment
(2) Deception
(both problematic from an ethical standpoint – why?)
Issues Relating to the Principle of
Respect
Vulnerable Populations
Define:
Examples:
Principle of Respect for Privacy and
Confidentiality
 Right to Privacy and the Right to Confidentiality
 The right an individual has to determine the time, extent,
and general circumstances under which private information
will be shared with or withheld from others
 Invasion of privacy – occurs when – private information is
shared without an individuals knowledge or against his/her
will
Principle of Respect for Privacy and
Confidentiality
 Anonymity – exists only if the subjects identity cannot be
linked even by the researcher
 Based on the right to privacy, subject has the right to
anonymity and the right to assume that the data collected
will be kept confidential
 Confidentiality – is the researcher’s management of private
information shared by the subject
 Identification numbers
Principle of Respect for Justice and
Inclusiveness
 Justice – fairness and equity
 Ethics review process have fair methods, standards, and
procedures
 Distributive justice – no one within the pop’s should be
unfairly burdened with the demands of the research
 Fair Treatment includes – see list on page 83
Principle of Balancing Harms and Benefits
 Based on the principle of beneficence
 One should do good and above all do no harm
 Freedom from harm, freedom from exploitation, risk-benefit
ratio
 Risk-benefit ratio:
 consider how comfortable you would feel having family
members participate in the study
 Would be comfortable
 Benefit to society and the nursing profession
Maximizing Benefits & Minimizing
Harms
 Principle of “Beneficence” – imposes a duty to benefit others
and in research ethics a duty to maximize benefits
 To produce benefits to society as a whole, subjects
themselves, other individuals in society, advancement of
knowledge
 Principle of “Nonmaleficence” – the duty to avoid, prevent, or
minimize harm to others
 Participants not subject to unecessary risks of harms –
terminate, no consequences if the participant withdraws
 Debriefing sessions can be used
 Freedom from exploitation
Guidelines to Critiquing the Ethical
Aspect of a Study
 Review Box – 4-2 on page 88 (1st edition)
 Review Box – 5-2 on page 103 (2nd edition)