The Ethics of Research

Objectives
Define the meaning of code of ethics in

research Describe the historical events influenced the development of ethical code in research Discuss the importance of protection of human rights in nursing research Explain the benefits and risks involved in conduction of research studies

Introduction

The nursing research is not

only for the development of generating new knowledge and refine it but also must consider the ethical components involved in carrying out research studies.

Ethics in research refers to the

quality of research procedures with respect to their adherence to ; Professional . Legal and Social obligations to the human subjects.

 Since the nursing studies require

knowledge of studying human subjects ,the protection of human rights of will be an ethical consideration in conduction of nursing research.
There are certain Ethical actions that

investigators to take in carrying out the research.

The Ethical Actions include

Protecting the human rights of the

Research subjects Balancing benefits and risks of a study Securing informed consent Submitting the research proposal for institutional review.

Ethical Actions in Research

Protection of Human Rights Balancing benefits and Risks

Submission of Research proposal for the Inst. review

Secure Informed Consent

History
Since 1940s the ethical conduct of researchers has received increasing attention because of mistreatment of human research subjects.

Nuremberg Code 1949 The mistreatment of human subjects in some experiments led to the development of Nuremberg code. This ethical code of conduct has some general rules and specific that were developed to direct investigators to conduct research with ethical principles.

The code includes guide lines for the following

Voluntary consent Withdrawal of subjects from studies Protection of subjects from physical

and mental suffering Injury Disability or Death Balance of benefits and risks of the study.

 This code was mainly

formulated to direct the biomedical research ; but the rules in this code are essential to conduct the research in behavioral sciences such as psychology, sociology and nursing.

The two Examples of experimental studies

1.

The chronic disease hospital study The Tuskegee syphilis study

2.

1.Chronic Disease Hospital study:

This study was conducted at the Chronic disease

hospital, New York City,USA in 1960s.

Its purpose was to determine the patients

rejection response to live cancer cells.

Twenty two patients were injected with a

suspension containing live cancer cells that had been generated from human cancer tissues(Hershey & Miller ,1976).

The rights of these patients were not protected, because;

They were not informed that they were taking

part in the study. And they received live cancer cells.

In addition the study was never presented to

the research committee of the Chronic Disease hospital for review.

The physicians caring for the patients were

unaware that the study was being conducted .

 The research project was conducted

without the informed consent of the research subjects. Without institutional review, and Had the potential to cause injury , disability and death to the research subjects

Theses actions violated the Nuremberg code .

Tuskegee Syphilis Study:(1932)

The united States Public Health initiated a study of

syphilis in black males in the small rural town of Tuskegee , Alabama USA .
The study was conducted to determine the natural

course of syphilis in the adult , black, males for 40 years.

The subjects who consented to be in the study were

not informed about the purpose and procedure of the experiment. and

 Some were unaware that they were part of the experiment.

The subjects were examined periodically, but none of them received treatment for syphilis, even penicillin was determined to be an effective for the disease.

The rights of these patients were not protected & violated the Nuremberg code .

Protection of Human Rights:

There are Five Human Rights

which need to be protected while conducting research on human subjects.( American Nurses Association,1985, American Psychological association 1982)

Five Human Rights

The right to Self Determination The right to Privacy

The right to Anonymity & Confidentiality

The right to Fair Treatment
The right to Protection from Harm & Discomfort

Right To Self - Determination:

The right to self determination is based on the ethical principle of Respect for persons , which states that human beings are capable of taking decisions for their self and control their own destiny.

 There fore humans need to be treated as autonomous

agents, who have the freedom to conduct their lives as they choose without external controls ( Beauchamp & Walters ,1982) .
Prospective subjects are treated as autonomous

agents & inform them about a proposed study.

Allow them to voluntarily choose to participate or not.

Subjects have the right to terminate participation in a

study at any time without penalty.

Violation of the right to Self- Determination:

1. A Subjects right to Self-Determination is violated if he/she is forced to participate in a study. 2. Coercion occurs when overt threat of harm or excessive reward is intentionally presented by one person to an other in order to obtain compliance.
3. Some subjects are coerced to participate because they fear harm or

Example:
Some students feel forced to

participate in research to protect their grades or to prevent negative relationships with the faculty conducting research.

An individuals right to self - determination is violated ;

when he or she becomes a research subject

without realizing it. Some times researchers exposed the subjects to experimental treatments.

without their knowledge. some other

researchers use covert methods of data collection. in which data are collected without the knowledge of subjects.

The use of deception in for

research purpose. Research can also violate a subjects right to selfdetermination. Deception is the actual misinforming of subjects for research purpose.

Example:
when you administer some treatment

to others who professional actors to convince the research subjects to show the treatment is effective the researcher is deceiving the subjects that the treatment is true and effective and to include them in study. which may harm them later to the collapse of their life.

 Use of placebos on

professional actors to treat the symptoms of a patient in an experimental studies to determine the effectiveness in relieving the symptoms

Persons with diminished autonomy:

Some people may have diminished autonomy

because of legal or mental incompetence or terminal illness or confine to an institution.

These persons require additional protection of

their rights to self determination because they decreased ability or inability to give informed consent. Terminally ill patients.etc.

Example: Mentally retarded people, Prisoners ,

Legally and mentally incompetent subjects:

Children , (minors) ,the mentally ill

patients and unconscious patients are legally and mentally incompetent to give their consent.
These individuals lack ability to

comprehend information given about the study and to make decisions regarding to participate or withdraw from the study.

When can you include such subjects in the research?

If the use of these persons as

research subjects is considered more ethical .

If the research is therapeutic

where the subjects have the potential to benefit from the experimental process

 Terminally ILL subjects

In conducting research on terminally ill subjects the investigator should determine ;

Who will benefit from the research?

Is it ethical to conduct research on who

will not be able to get benefitted from the study?

Disadvantages:
Some researchers believe that The potential risks for these subjects will increase with minimal benefits or none. The dying subjects condition could affect the study results. Can lead the researcher to misinterpret the results of the study ( watson1982)

Some researchers support conducting research on terminally ill subject for the following reasons: To generate necessary knowledge. Some subjects are very much willing to participate in the study as they believe it is a way for them to contribute to society before they die. Some subjects believe that the experimental process of research may benefit them .

Subjects confined to Institutions:

These subjects autonomy is diminished

because they are confined to settings that are externally controlled by health care personnel and because their level of health is altered. Many nursing studies involve hospitalized patients who have some diminished autonomy.

 Some hospitalized patients feel obligated to be

research subjects because they want to assist a particular nurse or physician with his or her research. Others feel coerced to participate ,because they fear that care will be adversely affected if they refuse. Nurses conducting research with hospitalized patients must make every effort to protect these subjects from feelings of coercion.

Right To Privacy:
Privacy is the freedom an individual has to determine the

time ,extent and general circumstances under which private information will be shared with or with held from others.

Private information include;

Ones attitudes, Beliefs , Behaviors, Opinions and Records.

The research subjects

privacy is protected if the subjects are informed and consents to participate in a study and voluntarily shares private in formation with a researcher.(Hater,1979)

Invasion of privacy: An invasion of privacy occurs when private information is shared without an individuals knowledge or against his or her will.

 Dangers: It might cause;

Loss of Dignity Friendship . Employment

Other damaging consequences are:

Feelings of anxiety Guilt Embarrassment Or Shame.

 Research subjects experience an invasion of privacy most frequently during data collection process.
Some researchers develop questionnaires that request private information such as ; What is the intelligence of your father or mother

Were you an abused child?etc

What type of family planning methods do you follow?

 Other researcher gather information from

subjects without their knowledge ;

by taping conversations, Observing through one way mirrors, and using hidden cameras and micro phones. Tapping telephone conversations,etc. In these situations , the subjects had no knowledge that their words an actions were

being shared with the researcher, which is an invasion of their privacy.

Right to anonymity and Confidentiality:

Based on the right to privacy ,the research subjects

have right to anonymity and right to assume that the data collected will be kept confidential. Anonymity exists if the subjects identity cannot be linked , even by the researcher , with his or her individual responses. An investigator should design a study to achieve subjects anonymity if possible. ( Sasson & Nelso1971)

Confidentiality
Confidentiality is the management of

private information. This means that if a subject shares private information ,the researcher must refrain from sharing that information without the authorization of the subject.(levine1981)
Breach of confidentiality:

Breach of confidentiality:
A breach of confidentiality occurs when

a researcher by accident or direct action allows an unauthorized person to gain access to raw data of a study. This breach of confidentiality could lead to the identification of the subjects identity , a violation of the right to anonymity.

 Breaches of confidentiality of data

Breaches of confidentiality of data

about religious preferences, sexual practices , income, racial or caste prejudices , drug use, child abuse, and personal attributes such as intelligence , honesty, courage , are serious because of the possible social harm..

Protection of anonymity and Confidentiality:

Researchers have the responsibility to

protect the anonymity of the subjects and the Confidentiality of the data collected during the study and after the study is completed. In data collection using questionnaires ,the subjects identity frequently does not need to be known by the researcher.

 The questionnaires can have code

numbers or letters on them rather than any information that will reveal the identity of the subject.
When it is necessary for researchers to

collect data from subjects more than one time .the subjects would have to be identified by name . However the subjects name to be kept separately from the data collection tool.

 Some nurse researchers have

encountered health care professionals who believe that they should have access to information about the patients in the hospital and will request to see the data collected. some times family members like to see the data. The confidentiality of the data collected must be maintained.

Breaches of confidentiality

can harm the subjects psychologically and socially as well as destroy the trust that the subject had in the researcher..

Right to Fair Treatment:

The right to fair treatment is based on the ethical principle of justice. This principle states that each person should be treated fairly and that the person should receive what he or due or owed .(Beauchamp & Walters ,1982)
In research the selection of subjects and their

treatment during the course of a study should be fair.

Fair selection of subjects:

In the past , injustice in subjects

selection resulted from social, cultural, racial, and sexual bias in society. For many years research was conducted on categories of individuals who were thought to be especially suitable as research subjects

 The poor,
charity patients, prisoners,

slaves,
dying patients and others who were considered undesirable. Researchers treated these subjects carelessly and had little regard for the harm and

discomfort they experienced.

Fair treatment of subjects During the course of the study:

Researchers and subjects should have a specific agreement about

what the subjects participation involves and what the role of the researcher will be.( American Psychology association 1982)

While conducting a study , the researcher should ; Respect the agreement.

If the data collection requires

appointments with the subjects , the experimenter should be on time &

should terminate the data collection

process at agreed upon time.

 The activities or procedures that the

subject is to perform should not be changed without the subjects consent. The benefits promised should be provided. Example: If subjects are promised a copy of the study findings , they should receive those findings soon after the study is completed.

Right to protection from discomfort & Harm:

Right to protection from discomfort & Harm is based on the ethical principle of beneficence. This principle states above all , do no harm and indicates that members of the society should take an active role in preventing discomfort and harm and promoting good in the world around them ( Frankena, 1973).

Discomfort and harm can be ; Physiological

Emotional Social

Economical in nature.

Reynolds 1972 identified five categories of studies based on levels of discomfort and harm.

1. No anticipated effects
2. Temporary discomfort

3. Unusual levels of discomfort

4. Risk of permanent damage

5. Certainty of permanent damage

No anticipated effects:
In some studies there are no positive or negative effects that are

expected for the subjects;

Example; studies that involve reviewing of patient records , students files ,

pathology reports or
other documents have no anticipated effects on the subjects . In these studies the researcher doesnt interact directly with

subjects. however , even in these situations , there is a potential risk that the subjects right to privacy might not be protected.

Temporary discomfort:
Studies that cause temporary

discomfort are described as minimal risk studies .. The discomfort encountered is similar to what the subject would experience in his or her daily life and ends with the termination of the experiments.

 Many nursing studies require the completion of

questionnaires or participation in interviews , which usually involves minimal risks for the subjects. The physical discomfort include fatigue, headache, or muscle tension, The emotional and social risks might be anxiety, embarrasenment, or stress associated with responding to questions. The economic risks may be the time of being involved in the study or travel costs to the experimental site.

Unusual levels of temporary discomfort: