Ethics and nursing research

Ethics and Nursing Research Prof Mrs Rafath Razia

Overview• Synonyms• Examples of Un-ethical Research•Development Of Ethical Codes And

Guidelines• Elements Of Informed Consent•Documentation Of Informed Consent• The Nurse Researcher As A Patient

Advocate• Clinical Trials• Vulnerable Research Subjects• Assent•Guidelines for Critiquing the Ethical

Aspects of a Study

Synonyms: beliefconductconscienceconventionethosgoodnesshonestyhonoridealimperativeintegritymoralitymoresnature

conventionalitiescriteria decency natural law moral code principles right and wrong standardsthe Golden Rule rules of conduct practicestandard

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)

Conspiracy Between US Government Leaders And The Japanese

Shearer (1982) revealed some of these horrible experiments:

• Infecting women prisoners with syphilis, having them impregnated by male prisoners, then dissecting the live babies and mothers

• Draining the blood from prisoner’s veins and substituting horse blood

• Exploding gas gangrene bombs next to prisoners tied to stakes

• Vivisecting prisoners to compile data on the human endurance of pain

The book is titled The Truth About Until 731

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)

Health Research In US

• In Los Angeles, California, between, 1989 and 1991 approximately 900 children who were mostly black of Hispanic, were given an experimental measles vaccine called EZ (“Measles Mistake,” 1996)

• The researchers never told the parents about the experiment because the vaccine was unlicensed

• Kaiser Permanente and the Centers for Disease Control and Prevention (CDC) sponsors of the study, said the drug was safe but agreed that they should have notified parents about the status of the drug

Health Research In US

• A similar situation occurred in 1991 at the Standing Rock Sioux Reservation in the Dakotas (“Parents Say Government Quiet,” 1996)

• A group of American Indian children were given a vaccine for hepatitis A

• Parents were never told their children were part of a research project and that the vaccine had not been approved at that time

• The study was sponsored by the CDC and the Indian Health Services

Health Research In US• In 2005 it was revealed that government funded researchers

tested experimental AIDS drugs on hundreds of foster children without providing these children with an independent advocate (Solomon, 2005)

• These children, who were mostly poor or from minority groups, received cutting-edge treatments at the government’s expenses

• In some cases, their lives were extended

• However, many children experienced side effects, such as rashes, vomiting, and sharp drops in infection-fighting blood cells

• They had no advocate to weigh the advantages and disadvantages of their participation in research

Development Of Ethical Codes And Guidelines

• The biblical Ten Commandments are an example of a code of conduct that has endured through the centuries

• 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 society

3. Research must be based on animal experiments, if possible

4. Researcher must try to avoid Injury to research subjects

5. Researcher must be qualified to conduct research

6. 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

General Guidelines For Research• The U.S. Department of Health,

Education and Welfare (HEW) (now the Department of Health and Human Services, DHHS) published general guidelines for research in 1981

• The federal government guidelines resulted in the creation of institutional review boards (IRBs)

• These review boards are given various names

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

Major Elements Of Informed Consent• Subject selection process is

described

Major Elements Of Informed Consent• Purpose of study is described

Major Elements Of Informed Consent• Study procedures are

discussed

Major Elements Of Informed Consent• Potential risks are described.

Major Elements Of Informed Consent• Potential benefits are

described

Major Elements Of Informed Consent• Compensation, if any, is

discussed

Major Elements Of Informed Consent• Alternative procedures, if

any, are disclosed

Major Elements Of Informed Consent• Anonymity or confidentiality

is assured

Major Elements Of Informed Consent• Right to refuse to participate

or two withdraw from study without penalty is assured

Major Elements Of Informed Consent• Offer to answer all questions

is made

Major Elements Of Informed Consent• 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

Clinical trials

•Clinical trials are research studies conducted to evaluate new treatments, new drugs, and new or improved medical equipment

•Nurses should be able to answer patients’ questions about research studies, particularly clinical trials (Habel, 2005)

Vulnerable Research Subjects

• Certain special groups of people are considered particularly vulnerable research subjects because they are either unable to give informed consent or because the likelihood of coercion to participate is strong

• Special precautions must be taken to ensure that the study has a low risk potential for these vulnerable people

Vulnerable Research Subjects

These groups include:

• Children • Geriatric clients • Prisoners • People with AIDS• Homeless • Unconscious • Sedated patients

Assent

• When children are younger than 7 years, parental consent is sufficient

• If a child is older than 7 years, not only must the parent consent to the child’s participation but the child must also agree to be in the study by giving assent to participate in a study

• Assent means that an underage child or adolescent freely chooses to participate in a study

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 Study

6. 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?

Reference

•Nieswiadomy, Rose Mary. Foundations of Nursing Research, Prentice Hall New Delhi, 2009.

Thanks