Ethics in Nursing Research: Historical Background, Codes, and Participant Protections

What historical events led to the development of ethical codes in nursing research?

Nazi experiments, the Tuskegee Syphilis Study, and various unethical U.S. federal agency experiments.

What was the Tuskegee Syphilis Study?

A study from 1932 to 1972 where treatment was withheld from poor African American men with syphilis without their informed consent.

What is the Nuremberg Code?

A set of ethical guidelines developed in 1949 to prevent unethical medical research, requiring voluntary consent and ensuring participant safety.

What are the key principles of the Nuremberg Code?

Voluntary consent, risk must not outweigh benefits, researchers must be qualified, participants can withdraw, and research must be terminated if harm is likely.

What does the Declaration of Helsinki emphasize?

Informed consent, awareness of potential harm, and the necessity of written consent for research participation.

What distinguishes therapeutic research from non-therapeutic research?

Therapeutic research is expected to benefit the subject directly, while non-therapeutic research generates knowledge without direct benefit to the subject.

What was the outcome of the 2001 Johns Hopkins University asthma study?

A healthy research participant died after being given a medication.

What ethical issues arose from the 1960s Jewish Chronic Disease Hospital experiments?

Live cancer cells were injected into elderly patients without their consent.

What unethical practice occurred at the Willowbrook Institution?

Mentally handicapped children were deliberately infected with the hepatitis B virus.

What is the Belmont Report?

A report from 1979 that outlines ethical principles and guidelines for research involving human subjects.

What are the three primary ethical principles articulated in the Belmont Report?

Respect for persons, beneficence, and justice.

What ethical standards protect research study participants?

Informed consent, risk assessment, and the right to withdraw from the study.

What was the purpose of the Nuremberg Code's directive on animal experiments?

To ensure that animal experiments precede human experiments and justify the need for human research.

What does the term 'non-therapeutic research' imply?

Research that generates new knowledge but does not provide direct benefits to participants.

What was the ethical violation in the 1940s to 1990s U.S. Federal Agencies' experiments?

Radiation experiments were conducted on prisoners and elderly hospital patients without proper consent.

What is a key requirement of the Declaration of Helsinki regarding research subjects?

Subjects must be informed of the benefits and risks of the study before consenting.

What does 'beneficence' mean in the context of research ethics?

The obligation to minimize harm and maximize benefits to research participants.

What does 'justice' refer to in the Belmont Report?

The fair distribution of the benefits and burdens of research among all groups in society.

What was the ethical issue with the 1980s National Women's Hospital study?

Women with cervical carcinoma in situ were not treated to observe the disease's natural progression.

What is the significance of informed consent in research ethics?

It ensures that participants are fully aware of what the research entails and agree to participate voluntarily.

What is the primary justification for exposing healthy volunteers to potential harm in research?

There must be strong justification to gain new scientific information.

What are the three main focuses of clinical trials?

Diagnostic, therapeutic, and prophylactic procedures.

What are the three ethical principles outlined in the Belmont Report?

Beneficence, respect for human dignity, and justice.

Define beneficence in the context of research ethics.

Maximizing benefits and minimizing harm to participants.

What does respect for human dignity entail in research ethics?

Self-determination, voluntary participation, and freedom from coercion.

What is the principle of justice in research ethics?

Fair treatment and equitable distribution of benefits and burdens among participants.

What is the role of an Institutional Review Board (IRB)?

To protect human subjects and review research proposals for ethical compliance.

What are the three levels of IRB review?

Full review, expedited review, and exempt from review.

What constitutes minimal risk in research?

Risk that is not greater than that ordinarily encountered in daily life.

What is informed consent?

A process where participants sign a consent form acknowledging their understanding of the study.

What is the difference between confidentiality and anonymity in research?

Confidentiality means only authorized individuals can identify data, while anonymity means no identifying information is collected.

What are potential benefits to study participants?

Access to interventions, increased self-knowledge, and potential monetary gains.

What are some potential risks to study participants?

Physical harm, psychological distress, social risks, and loss of privacy.

What does the Office for Human Research Protections (OHRP) do?

Provides leadership in protecting the rights and welfare of research subjects.

What is research misconduct?

Includes fabrication, falsification, and plagiarism in research practices.

What is a conflict of interest (COI) in research?

Situations where personal considerations may compromise a researcher's professional judgment.

Why is open disclosure of COI important?

To ensure transparency and integrity in research reporting.

What ethical principle is demonstrated when a female patient decides whether to be intubated during an exacerbation of COPD?

Autonomy.

What type of IRB review is required for studying obesity factors in middle school students?

Expedited review.