Ethical Issues In Research

9/8/21, 7)49 PMEthical Considerations in Nursing Research

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Ethical Considerations in Nursing Research

Ethical Considerations in Nursing Research

Objectives:

After reviewing this lesson the student will be able to:

Describe briefly what is meant by "ethical" research. Discuss some of the unethical studies documented in the historical record. Trace the development of ethical codes and guidelines. Describe briefly three important ethical principles. recommended by the Belmont Report. Identify the elements of informed consent. Appreciate the role of institutional review board Describe the procedures researchers must follow in order to ensure confidentiality for research participants.

Basic Ethical Principles Ethics refers to question of what one should do.... What one person considers to be good or right may be considered bad or wrong by another person Ethics are principles for guiding decision making and reconciling conflicting values.

Morality is similar to ethics and many use the term interchangeably. Morality refers to

personal standards of what is right and wrong in conduct, character, or attitude.

9/8/21, 7)49 PMEthical Considerations in Nursing Research

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Bioethics is a way of understanding and examining what is "right" and what is "wrong" in biomedical research and practice. Research involving human subjects poses complex ethical issues.

What is the difference between an ethical and unethical action?

Ethical Unethical

Leads to good consequences. Leads to bad consequences.

Takes in consideration the freedom to make choices.

Does no take in consideration personal decision making.

In accord with an ethical principle.

Violates an ethical principle

Elements of Ethical Research Protecting human rights: with research involving human participants the

risks and costs must be balanced against the potential benefits. Understanding informed consent:prospective participants must be given adequate information on both the possible risks and the potential benefits of their involvement to allow them to make informed decisions Understanding institutional review of research: a committee responsible for reviewing and overseeing human subjects research. An IRB may also be called a research ethics committee (REC) or research ethics board (REB).

Balancing benefits and risks in a study: with research involving human subjects the risks and costs must be balanced against the potential benefits.

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Test Your Knowledge

Historical Cases in Unethical Research But what ethics has to do with research?

There have been historical eases of unethical research that have contributed to how we conduct research with participants today. These studies led to the creation of the Belmont Report and the Institutional Review Board (IRB) which were formed to protect human subjects involved in research.

Nazi medical experiments WWII (1939 - 1945)

During World War II, a number of German physicians conducted painful and often deadly experiments on thousands of concentration camp prisoners without their consent.

Tuskegee Syphilis Study (1932-1972)

The Tuskegee Syphilis Study, carried out in Macon, Alabama, from 1932 to 1972 in one of the most economically disadvantaged parts of the U.S., Researchers in this study deceived a group of 399 black male syphilitics into participating in a study with no therapeutic value. These "volunteers" were not treated as patients, but rather as experimental subjects, or walking cadavers. Even after the development of penicillin, the Tuskegee group was denied effective treatment. Despite regularly published scholarly articles, forty years passed before there was any protest in the medical community. The aftereffects of the study, along with the suffering of its victims, include a series of congressional investigations, the drafting of medical ethics guidelines, and the establishment of independent review boards.

The Willowbrook Study (1963-1966) The Willowbrook Study involved a group of children diagnosed with mental retardation, who lived at the Willowbrook State Hospital in Staten Island, New York. These innocent children were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected

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individuals and later subjects received injections of more purified virus preparations. Parents were forced to give permission for their child in order to gain their child's admission to the institution.

Regulatory Ethical Codes and Guidelines Resulting from Unethical Research

Nuremberg Code (1948) One of the first internationally recognized efforts to establish ethical standards Developed after the Nazi atrocities were made public in the Nuremberg trials.

Declaration of Helsinki (1964)

Adopted in 1964 by the World Medical Association then later revised in 2000. "Concern for the interests of the subject must always prevail over the interests of science and society."

ANA code-human rights guidelines for nurses American Nurses Association Position Statement

"Respect for the inherent worth, dignity, and human rights of every individual is a fundamental principle that underlies all nursing practice. "Nurses take into account the needs and values of all persons in all professional relationships" (American Nurses Association [ANA], 2001, p. 7).

Belmont Report-made by the National commission for the protection of Human Subjects of Biomedical and Behavioral Research (1978)

Created in wake of outcry over Tuskegee Syphilis study. Every person has the right to determine what shall happen to him or her – participation must be voluntary. Special consideration and protection is extended to "vulnerable" subjects such as children, persons with cognitive disabilities, prisoners, and institutionalized persons

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Ethical Principles of the Belmont Report

Principle of Respect for Persons Individuals should be treated as autonomous agent. Forms the foundation of participant's right to informed consent, privacy, & confidentiality Self-determination (participation and withdrawing) Right to be free from pressure or coercion Full disclosure, no deception. Voluntary consent. Must have information to make informed choices (risks vs benefits) Persons with diminished autonomy have special protections.

Beneficence Nonmaleficence - the duty to not inflict harm Beneficence - the duty to promote good Freedom from exploitation Researcher's responsibility to minimize risk & maximize benefits to participants High anticipated benefit may balance high risks

Justice Fair treatment (even if choose not to participate). Participants have the right to fair and equitable treatment before, during, or after the research study. Respect for cultural and other forms of human diversity Fair and nondiscriminatory selection of participants with shared risks and benefits. Right to privacy Anonymity Confidentiality Protection of participants from incompetence and access to research treatments are expectations of the justice principle

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Random selection of participants avoids potential bias and unfairness in sample selection

Methods of Protecting Human Subjects Informed Consent Institutional Review Boards

How IRB Protect Human Participants in Research

What is informed consent?

Essential information for consent Comprehension of consent information Competence to give consent Voluntary consent

Vulnerable Participants Children, the elderly, and the mentally ill may be incapable of understanding information that would enable them to make and informed decision about the research study. When conducting studies that involve any of these individuals the researcher is require to take especial consideration to protect them.

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Function of the IRB Reviewing research to ensure:

–Risks are minimized

–Risks are reasonable vs. benefits –Selection is equitable –Informed Consent is obtained

–Data and Safety are protected/monitored –Privacy and confidentiality are upheld –Vulnerable population protections are enhanced

Other Ethical Issues :Plagiarism Plagiarism is taking another's work and passing it off as your own.

Plagarism is copying text word for word from a book or article and pretends to be the author.

Plagiarism is buying an already written paper on the web. What can I do to avoid plagiarism? Provide references for any tables, graphs, numbers, text that are cited in your manuscript. Use quotation marks around all words copied from a source.

Paraphrase an author's words by stating his or her ideas in your own words with your own phrasing.