REVIEWING THE ETHICAL ASPECTS OF A NURSING STUDY

Why is Ethics important in Research?

Research has the potential for exploitation of human subjects

participants are the means to securing research knowledge

some people are at risk of harm for the good of others (harms may outweigh benefits)
Protections and safeguards needed to prevent harm

Why is Ethics important in Research?

Research produces benefits

- but maybe unavailable/not provided.

Abuses in Research have occurred in the past

- conducted without the knowledge or consents of subjects

- Exploitation of vulnerable population

Case #1 Tuskegee Trial

Tuskegee Trial (1932-1978)

1932 US Public health Service and Tuskegee institute, Macon county, Alabama

TITLE - "Tuskegee Study of Untreated Syphilis in the Negro Male.

Objectives: study the natural progression of untreated syphilis in rural African

American men

METHODOLOGY: > 600 rural black men were enrolled; 399 with syphilis and
201 healthy black men

Case #1 Tuskegee Trial

1947 penicillin had become standard therapy for syphilis but participants withheld
penicillin, information about it, and were prevented from accessing syphilis
treatment programs

1972 Results: Of the 399 patients : only 74 of the test subjects were alive, 28
had died of syphilis, 100 were dead of related complications, 40 of their wives
had been infected and 19 of their children were born with congenital syphilis.

Case #1 Tuskegee Trial

1973, a class-action lawsuit was filed.

In 1974, a $10 million out-of-court settlement was reached.

This led to bioethics reforms in the US 1979 Belmont Report and the establishment of
the Office of Human Research Protection.

federal laws and regulations requiring Institutional Review Board for the protection of
human subjects in studies

May 16, 1997: Public apology from U.S. President Clinton (CNN);

Case #1 Tuskegee Trial

THE RESEARCH SUBJECTS:

The study was conducted without the benefit of patients' informed consent.

The men thought they were receiving free health care from the U.S. Government

The consent of the subjects for spinal taps was obtained by depicting the diagnostic
test as a "special free treatment.

The men were never told they had syphilis but they were told that they were being
treated for "bad blood", a local term for various illnesses

Case #2 Nazi Human Experimentations (1940s)

Medical experiments on prisoners (Jews, Romani et al) in concentration camps from
across Europe, by Nazi German scientists in early 1940 (WW II)

Objectives

Effect of cold, heat, chemicals on men, women and children Experiments on

twins, Head injury and Freezing experiments , Bone, muscle, and nerve
transplantation experiments, effects of phosphene gas etc

Case #2 Nazi Human Experimentations (1940s)

Unethical research objectives & methods

Any information gathered is irrelevant because prisoners were forced to participate

Outcome: Nurenberg War Crime Trials

25 German scientists taken to court, 7 acquitted, 9 imprisoned, 9 given death

sentence

Nuremberg Code of 1947: 10 principles that became the first documented code of
ethics for human research

The Nurenberg Code

1. The voluntary consent of the human subject is absolutely essential.

2. The experiment should be such as to yield fruitful results for the good of society.,
unprocurable by other methods or means of study, and not random and unnecessary in
nature.

3. The experiment should be so designed and based on the results of animal

experimentation and a knowledge of the natural history of the disease

4. conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted, where there is reason to believe that death or

disabling injury will occur

6.The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject.

8. The experiment should be conducted only by scientifically qualified persons. The

highest degree of skill and care should be required through all stages of the experiment .

9. During the course of the experiment, the human subject should be at liberty to bring
the experiment to an end

10. During the course of the experiment, the scientist in charge must be prepared to
terminate the experiment at any stage, if continuation of the experiment is likely to result
in injury, disability, or death to the experimental subject.

Historical background

Jewish Chronic Dis. Hosp. injection of live cancer cells into elderly patients

1993, Atomic energy commission ; radiation experiments to prisoners and elderly

hospitalized clients.

Why do we need Ethics in research?

to minimize the possibility of exploitation participants are not merely used but are treated
with respect while they contribute to the social good.

Basic Ethical Principles

1. Respect for Persons.

a ) treated as autonomous agents and acknowledge their autonomy, and

b) that persons with diminished autonomy are entitled to protection.

BASIC ETHICAL PRINCIPLES

1. RESPECT FOR PERSON

consider their opinions and choices

refraining from obstructing their actions unless they are clearly detrimental to others

Participants enter into the research voluntarily and with adequate information

Basic Ethical Principles

2. BENEFICENCE

Two general rules have been formulated as complementary expressions of beneficence

(1) do not harm

one should not injure one person regardless of the benefits that might come to others

(2) maximize possible benefits and minimize possible harms.

Basic Ethical Principles

3. JUSTICE.

- "fairness in distribution of burden and benefits" or "what is deserved."

- An injustice occurs when some benefit to which a person is entitled is denied without good
reason or when some burden is imposed unduly.
- that equals ought to be treated equally.

Basis/formulation of which burdens and benefits should be distributed.

(1) to each person an equal share,

(2) to each person according to individual need,
(3) to each person according to individual effort,
(4) to each person according to societal contribution,
(5) to each person according to merit.

SEVEN ETHICAL REQUIREMENTS THAT PROVIDE A SYSTEMATIC AND

COHERENT FRAMEWORK FOR DETERMINING WHETHER CLINICAL
RESEARCH IS ETHICAL
1. Scientific Value
2. Scientific validity
3. Fair subject selection
4. Favorable risk-benefit ratio
5. Independent review

6. Informed consent
7. Respect for Enrolled subjects
Emmanual E. What makes Clinical research Ethical. JAMA may 24/31 2000 Vol 283 No
20
1. SOCIAL OR SCIENTIFIC VALUE

To be ethical, clinical research must be valuable.

Enhancement of health or knowledge must be derived from the research

Evaluation of a treatment, intervention or theory that will improve health and well being
or increase knowledge

2. SCIENTIFIC VALIDITY

To be ethical, valuable research must be conducted in a methodologically rigorous

manner.

Use of accepted scientific principles and methods, including statistical techniques to

produce reliable and valid data

- poorly designed or conducted research can produce unreliable or invalid results

- it may expose subjects to risks or inconvenience to no purpose
3. FAIR SUBJECT SELECTION

encompasses decision on:

- who will be included.

- inclusion and exclusion criteria
- strategy for recruitment
- that stigmatized and vulnerable individuals are not targeted for risky research and the rich and
the socially powerful not favored for potentially beneficial research

Vulnerable Subjects

Children

Persons under discipline (soldiers, army, police)

Laboratory assistants

Medical students

Ethnic minorities

Persons in nursing homes

Those mentally incapacitated (poor understanding)

Persons with incurable diseases or in emergency situations

Those economically disadvantaged (unemployed, impoverished, homeless, nomads,

refugees)

4. FAVORABLE RISK-BENEFIT RATIO

3 condition

1. potential risks to individual subjects are minimized

2. the potential benefits to individual subjects are enhanced

3. the potential are proportionate to or outweighs the risks.

Emmanual E. What makes Clinical research Ethical. JAMA may 24/31 2000 Vol 283

No 20
5. INDEPENDENT REVIEW

Undergoes ethics review

- important for social accountability

-assures members of the society that people enrolled in trials will be treated ethically and not
benefit from the misuse of other human beings.
6. INFORMED CONSENT

Provision of information:

> purpose

> procedures

> potential risk, benefits and alternatives

so that the individual understands this information and can make a voluntary decision
whether to enroll and continue to participate

7. RESPECT FOR POTENTIAL AND ENROLLED SUBJCTS

Respect for subjects by

a) permitting withdrawal from the research

b) protecting privacy through confidentiality
c) informing subjects of newly discovered risks or benefits
d) informing subjects of results of clinical research
e) maintaining welfare of subjects
Emmanual E. What makes Clinical research Ethical. JAMA may 24/31 2000
Vol 283 No 20

Procedures for Protecting Study Participants

Risk-benefit assessments
Informed consent
Confidentiality procedures
Debriefings and referrals
Treatment of vulnerable groups
Institutional Review Boards and external reviews

RISKS- BENEFITS ASSESSMENT

Major Potential Benefits

Access to intervention

Comfort for being able to catharsize

Escape from normal routine/excitement of being part of study

Monetary or material gain

Major potential risks

1. Physical harm, unanticipated s/e

2. Physical discomfort, fatigue, boredom

3. Psychological/emotional distress

4. Social risks: stigma, loss of status

5. Loss of privacy

6. Loss of time
7. Monetary costs ( transpo, child care, time from work)

TIPS TO ADDRESSING ETHICAL ISSUES

1. Self evaluation of procedures to evaluate adherence to ethical requirements

2. Have study evaluated by ERB or other formal committee