IRB-identified ethical issues in nursing research.

Ethical issues in nursing research protocols submitted to a School of Nursing institutional review board (IRB) were identified by examining the letters sent to researchers whose protocols required revision or were not-approved. Themes were extracted from the ethical issues and placed into the following categories: The informed consent document, barriers to informed consent, subject benefit, subject risk, confidentiality, and problems with specific populations. The protocols were coded by the researcher's status (student/nonstudent), type of review (expedited/full committee), vulnerability of the population (vulnerable/nonvulnerable), and the type of subject (healthy volunteer/at-risk/patient/family/provider). A total of 157 protocols were examined; of these, 45.9 per cent were approved without requiring revision. Revisions were required in 46.5 per cent of the protocols and 8.3 per cent were not-approved. Problems with the form used to document informed consent were found in 43.3 per cent. The next most commonly identified theme was "information needed" in 30.6 per cent of the protocols, followed up by "inadequate explanation of benefit" in 22.3 per cent of protocols. The nursing research protocols in this study were found to be more vulnerable to ethical problems arising from the relationship between the researcher and subject than from physical harm. It is suggested that nurses give extra care to issues of coercion, deception, and attention to problems uncovered in the research process.