Protection of Human Rights

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THE ETHICS OF RESEARCH

(1)

Dr.Wafa Abdul Karim

Protection of Human Rights

Right to Anonymity and Confidentiality : Based on the right to privacy, the research subject has the right to anonymity and the right to assume that the data collected will be kept confidential.

Anonymity exists if the subject's identity cannot be linked, even by the researcher, with his or her individual responses. An investigator should design a study to achieve subject anonymity if possible (Sasson &

Nelson, 1971).

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

(Levine, 1981).

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 subject's identity, a violation of the right to anonymity. Breaches of confidentiality of data about religious preferences, sexual practices, income, racial prejudices, drug use, child abuse and personal attributes

(such as intelligence, honesty and courage) are serious because of,the possible social harm that the subject might experience.

Protection of Anonymity and Confidentiality : Researchers have a responsibility to protect the anonymity of subjects and the confidentiality of the data collected during the study and after the study

is completed. In data collection using questionnaires, the subject's 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' names should be kept separate from the data collection tools.

Some nurse researchers have encountered heatth 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.

Sometimes family members or close friends would like to see the data collected on specific subjects.

The confidentiality of the data collected must be maintained. Breaches of confidentiality can harm 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 she is 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 subject selection resulted from social, cultural, racial and sexual biases 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, peasants, dying persons and others who were considered "undesirable" (Reynolds, 1979).

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 subject's participation involves and what the role of the researcher will be

(American Psychological Association, 1982). While conducting a study, the researcher should respect that agreement.

If the data collection requires appointments with the subjects, the experimenter should be on time and should terminate the data collection process at an agreed upon time. The activities or procedures that the subject is to perform should not be changed without the subject's consent.

The benefits promised the subjects should be provided. For 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 and Harm : The right to protection from discomfort and harm is based on the ethical principle of beneficence.

This principle states "above all, do no harm" and indicates that members of 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 and 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 temporary discomfort,

(4) risk of permanent damage and

(5) certainty of permanent damage.

No Anticipated Effects: In some studies, there are no positive or negative effects that are expected for the subjects.

For example , studies that involve reviewing patients' records, students' files, pathology reports or other documents have no anticipated effects on the subjects.

In these types of studies, the researcher does not interact directly with the research subjects.

However, even in these situations, there is a potential risk that the subject's right to privacy might not be protected.

Temporary Discomfort : Studies that cause temporary discomfort are described as minimal risk studies, in which the discomfort encountered is similar to what the subject would experience in his or her daily life and ends with the termination of the experiment (DHHS, January 26, 1981).

Many nursing studies require the completion of questionnaires or participation in interviews, which usually involves minimal risk(s) for the subjects.

The physical discomforts might include fatigue, headache or muscle tension.

The emotional and social risks might include anxiety, embarrassment or stress associated with responding to certain questions.

The economic risks might include the time of being involved in the study or travel costs to the experimental site.

Unusual Levels of Temporary Discomfort: In studies that have unusual levels of temporary discomfort, the subjects frequently experience discomfort during the study and after the study has been terminated.

For example , subjects might experience muscle weakness, joint pain and dizziness after participating in a study that required them to be confined to bed for 7 days to determine the effects of immobility.

In these types of studies, the physical discomforts experienced are more severe, such as the deep pain experienced with the drawing of blood gases.

Studies that require subjects to experience failure,extreme fear or threats to their identity or to act in unnatural ways involve risks of unusual levels of temporary discomfort.

Risk of Permanent Damage : Subjects participating in some studies have the potential to suffer permanent damage. The potential to suffer permanent damage is more of a risk in medical research than in nursing.

For example , medical studies of new drugs and surgical procedures do have the potential to permanently damage the subjects.

However, there are topics that nurses investigate that have the potential to permanently damage subjects emotionally and socially.

Studies of sexual behavior, child abuse or drug use have significant risks for subjects.

These types of studies have the potential to cause permanent damage to a subject's personality or reputation.

Certainty of Permanent Damage: In this type of research, the subjects will encounter permanent damage.

Conducting research that will permanently damage subjects is highly questionable, regardless of the benefits that will be gained.

The benefits gained frequently benefit other patients or clients but not the subjects.

Balance Benefits And Risks In A Study

Researchers and reviewers of research must balance the potential benefits and risks in a study to promote the conduct of research ethically.

To balance benefits and risks, the researcher must project the outcome of a study and assess the potential benefits and risks based on this outcome.

Assessment of Benefits:

The benefit of knowledge to be gained from research can affect the individual subject, but, more importantly, this knowledge can have an influence on a discipline and numerous members of society.

The type of research conducted, therapeutic or nontherapeutic, affects the potential benefits for the subjects. In therapeutic nursing research, the individual subject has the potential to benefit from nursing care measures.

The benefits might include improvement in the subject's physical condition, which could facilitate emotional and social benefits.

In addition, the knowledge generated from the research might expand the subjects' and their families' understanding of their health.

Assessment of Risk : Researchers must assess the type, degree and number of risks the subjects experience or might experience by participating in a study.

Risks can be physical, emotional, social and economical in nature and can range from minimal discomfort to permanent damage.

The researcher must try to determine whether or not the potential risk(s) are likely to occur.

The risks of a study increase if the researcher fails to protect the rights of the subjects when implementing the research.

Maximizing Benefits and Minimizing Risks: After the benefits and risks have been assessed, the researcher attempts to maximize the benefits and minimize the risks by making changes in the purpose and/or procedures of the study.

If the risks cannot be eliminated or further minimized, the researcher should be able to justify their existence.

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