ETHICS IN NURSING

RESEARCH

IMPORTANCE OF ETHICS IN NURSING RESEARCH• Protect the vulnerable group & other study participants

from harmful effects of the experimental interventions.• Participants are safeguarded from exploitation

researchers.• Establish risk – benefit ratio for the study subjects • Ensure the fullest respect, dignity, privacy, disclose of

information & fair treatment for study subjects.• Build the capability of subjects to accept or reject

participation in study & to have access to informed or written consent for participation in research

Post World War II Research- Ethics?• How long does it take for

body parts to freeze when people are kept naked outdoors in subfreezing temperatures? • What signs and symptoms

are seen when people are kept in tanks of ice water for 3 hours? • These questions were

asked by so-called researchers in Germany in the early 1940s

• They were trying to determine the most effective means of treating German Air Force pilots who had been exposed to cold conditions • The so-called subjects for

these experiments were prisoners in the German concentration camps

Post World War II Research- Ethics?

• During 1942 and 1943, prisoners’ wounds were deliberately infected with bacteria• Infection was aggravated by the

forcing of wood shavings and ground glass into the wounds• Sulfanilamide was then given to

these prisoners to determine the effectiveness of this drug • Some subjects died and others

suffered serious injury

• Many nurses participated in these unethical experiments; others found ways to avoid participation, such as becoming pregnant or asking for transfers to other assignments (Bonifazi, 2004)

Post World War II Research- Ethics?

• Between June and September 1944, photographs and body measurements were taken of 112 Jewish prisoners • Then they were killed, and

their skeletons were defleshed.

• One purpose of this study was to determine if photographs from live human beings could be used to predict skeletal size

• The skeleton collection was to be displayed at the Reich University of Strasbourg (Nuremberg Military Tribunals, 1949)

Examples Of Research Carried Out In US• One of the most widely known unethical studies

was started in Macon County, Alabama, in 1932 by the U.S. Public Health Service. • The study was titled “Tuskegee Study of Untreated

Syphilis in the Negro Male”• Of the 600 black male subjects, 399 had syphilis • The subjects with active disease were given no

treatment.

• They were given free medical exams, free meals, and burial expenses (Centers for Disease Control and Prevention, 2006). • Even after penicillin was accepted as the treatment

of choice for syphilis in 1945, subjects were still given no treatment. • This unethical study became common knowledge

40 years after it was begun • On May 16, 1997, President Bill Clinton made a

public apology on behalf of the nation

Ethics?

• It is common knowledge that smallpox is no

longer a threat to the world.

• Few people remember, or even know, that

Edward Jenner deliberately exposed an 8-

years-old child to cowpox to try out his new

vaccine for smallpox (Hayter, 1979).

Health Research In US• In July 1963 doctors at the Jewish Chronic

Disease Hospital in Brooklyn, New York, injected live, cancer cells into 22 elderly patients

• The study was designed to measure patients’ ability to reject foreign cells

• The patients were told that they were being given skin tests (Katz, 1972)

Development Of Ethical Codes And Guidelines

• The present ethical standards used in nursing research, and in research conducted by other disciplines, are based on the guidelines developed after World War-II

• The 1947 Nuremberg Code resulted from the revelations of unethical human behavior that occurred during the war

Nuremberg Code

This code is concerned with several criteria for research including the following.

1. Researcher must inform subjects about the study

2. Research must be for the good of society3. Research must be based on animal

experiments, if possible4. Researcher must try to avoid Injury to

research subjects5. Researcher must be qualified to conduct

research6. Subjects or the researcher can stop the

study if problems occur

The Belmont Report

• In 1978 The National Commission for the protection of Human Subjects of Biomedical and Behavioral Research was formed

• The goals of this commission were to: (a) identify basic ethical principles that should guide the

conduct of research involving human subjects and (b) develop guidelines based on principles that had been

identified.

The Belmont Report

• The report published by this commission in 1979 was titled “The Belmont Report” • Three basic principles related to research

subjects were identified

1. Respect for Persons – research subjects should have autonomy and self determination

2. Beneficence – research subjects should be protected from harm

3. Justice – research subjects should receive fair treatment

Principle of beneficence• Establishing the positive risk benefit ratio, where

the risk of the research should never exceed expected benefits for people from knowledge generated by the research activity. • A potential risk of the research study must be

carefully assessed & participants are protected from any harmful effect of research activity

• In addition to physical harm, study subjects are also protected from expected adverse psychological consequences caused by research study. • For example, psychological or emotional distress

caused from self-discloser, introspection, fear of the unknown, or interacting with a stranger.

• Research must be conducted by a scientifically qualified expert to avoid undue discomfort or distress to study participants.• Participants must be provided with maximum

physical, psychological, social & religious comfort & undue disturbance & time utilization of the subjects should be avoided

Principle of respect of human dignity• This principle of the ethics emphasizes on the

freedom of choice, where participants have right to accept or reject to be a part of the research study.• Participants have full right to question the

researcher for any additional information or clarification of doubts.• Participants have right to quit from the study at any

stage of the research study

Principle of justice• This ethical principle directs the researchers to

abide by the participant’s right of fair treatment & maintenance of privacy.• The fair & non discriminatory selection of the

participants such as any risk & benefits will be equally shared by study participants. • Participant’s selection should be based on research

requirement & not convenience, gullibility or compromised position of certain types of people.

Research Guidelines For Nurses• In 1968 the American Nurses Association Research and Studies

Commission published a set of guidelines for nursing research

• These guidelines were revised in 1975 and 1985 and are titled Human Rights Guidelines for Nurses in Clinical and Other Research• The American Nurses Association published another set of

guidelines in 1995 • This document is titled Ethical Guidelines in the Conduct,

Dissemination, and Implementation of Nursing Research (Silva, 1995)

Elements Of Informed Consent

• The principal means for ensuring that the rights of research subjects are protected is through informed consent

• Informed consent concern subjects’ participation in research in which they have full understanding of the study before the study begins

Major Elements Of Informed Consent• Researcher is identified and credentials presented• Subject selection process is described• Purpose of study is described• Study procedures are discussed• Potential risks are described.• Potential benefits are described• Compensation, if any, is discussed

• Alternative procedures, if any, are disclosed• Anonymity or confidentiality is assured• Right to refuse to participate or two withdraw

from study without penalty is assured• Offer to answer all questions is made• Means of obtaining study results is presented

Documentation Of Informed Consent• The researcher must document that informed consent

was obtained.

The Nurse Researcher As A Patient Advocate• The nurse researcher has the responsibility to

protect the privacy and the dignity of the people involved in the research

• The researcher has an obligation to refrain from conducting such research study involving undue physical risks, psychological risks, or both

• The nurse researcher must assume responsibility for study conditions

Guidelines for Critiquing the Ethical Aspects of a Study1. Was the study approved by an Institutional Review

Board (IRB)?2. Was informed consent obtained from the subjects?3. Is there information about provisions for anonymity or

confidentiality?4. Were vulnerable subjects used?5. Does it appear that subjects might have been coerced

into acting as subjects?

Guidelines for Critiquing the Ethical Aspects of a Study6. Is it evident that the benefits of participation

in the study outweighed the risks involved?7. Were subjects provided the opportunity to

ask questions about the study and told how to contact the researcher if other questions arose?

8. Were the subjects told how they could get the results of the study?