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Related Experiment Videos

IRB-identified ethical issues in nursing research.

D P Olsen1, D Mahrenholz

  • 1Yale University School of Nursing, New Haven, CT 06536-0740, USA.

Journal of Professional Nursing : Official Journal of the American Association of Colleges of Nursing
|June 22, 2000
PubMed
Summary

Nursing research protocols frequently require revisions due to ethical concerns, particularly regarding informed consent and subject benefit. Ensuring clear communication and addressing potential coercion are crucial for ethical nursing research.

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Area of Science:

  • Nursing Research Ethics
  • Institutional Review Board (IRB) Protocols
  • Human Subject Protection

Background:

  • Ethical considerations are paramount in nursing research to protect participants.
  • Institutional Review Boards (IRBs) play a critical role in reviewing research protocols for ethical compliance.
  • Previous studies have highlighted various ethical challenges in research, but specific trends in nursing protocols warrant detailed examination.

Purpose of the Study:

  • To identify and categorize ethical issues in nursing research protocols submitted to a School of Nursing IRB.
  • To analyze the types of revisions required and reasons for non-approval of nursing research protocols.
  • To determine the prevalence of specific ethical themes, such as informed consent, subject benefit, and confidentiality.

Main Methods:

Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

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  • A retrospective review of 157 nursing research protocols submitted to an IRB was conducted.
  • Letters sent to researchers regarding protocol revisions or non-approvals were analyzed to extract ethical themes.
  • Protocols were coded based on researcher status, review type, population vulnerability, and subject type.

Main Results:

  • 45.9% of protocols were approved without revision, while 46.5% required revisions and 8.3% were not approved.
  • Problems with the informed consent document were identified in 43.3% of protocols.
  • Key ethical issues included inadequate information for informed consent (30.6%) and insufficient explanation of potential benefits (22.3%).

Conclusions:

  • Nursing research protocols are more susceptible to ethical problems related to researcher-subject relationships than physical harm.
  • Emphasis should be placed on improving the clarity and completeness of informed consent processes.
  • Nurses must exercise heightened vigilance regarding coercion, deception, and ethical issues that emerge during the research process.