Research ethics concerns how knowledge is pursued while respecting the people involved. An institutional review board, or IRB, reviews covered human-subject research under applicable rules. In the United States, the HHS regulations in 45 CFR part 46 are an important framework, but applicability depends on the activity and its regulatory context. Not every activity called research requires the same form of review.
This page describes general distinctions, not a determination for a proposed project. Institutions may apply additional policies, and other legal or regulatory requirements may be relevant.
Ethical questions come before paperwork
The Belmont Report identifies respect for persons, beneficence, and justice as foundational principles. In practical terms, investigators should consider voluntary participation, understanding, possible harms and benefits, and fair selection of participants.
For nurses, these questions can arise in interviews about work as well as in intervention studies. A project without physical procedures can still raise concerns about privacy, distress, or the consequences of disclosure. A consent form alone does not resolve every ethical issue.
Determine the review route
Under the revised HHS Common Rule, research and human subject are defined terms. The rule also contains exemptions, and certain exemptions involve limited IRB review. Expedited review is a review procedure for eligible research; it is not the same as exemption or permission to start immediately.
Use the institution's research-protection process to obtain and document the applicable determination before beginning activities that depend on it. Provide the actual purpose, methods, participants, data, and funding or oversight context. A project title such as “evaluation” cannot establish its status.
An illustrative workplace study
Imagine a nurse proposes interviews about staff experiences raising safety concerns. Even if no patient information is collected, the plan should address whether supervisors know who participates, how recordings are stored, how quotations could identify a person or unit, and whether declining could appear to affect employment.
These are hypothetical planning questions, not a finding about a particular employer. They illustrate why recruitment and confidentiality require attention in workplace research. A small unit can make a person recognizable even when a name is removed.
Understand what approval covers
For covered research, IRB approval criteria address matters including minimized and reasonable risks, equitable selection, consent, and privacy protections where appropriate. Approval is tied to the reviewed activity and its conditions; it is not a general endorsement of every later change or conclusion.
Keep the approved documents and determination accessible to the team. Follow the applicable process for changes, concerns, and unexpected problems. If the project's purpose or data use changes, ask whether its determination also needs reconsideration.
See quality improvement versus research for a common classification issue.
For a teaching case, consider the separate issue of patient privacy in nursing education.
Sources
- HHS OHRP: The Belmont Report (accessed 2026-11-11).
- eCFR: 45 CFR 46.102, Definitions (accessed 2026-11-11).
- eCFR: 45 CFR 46.104, Exempt research (accessed 2026-11-11).
- eCFR: 45 CFR 46.110, Expedited review (accessed 2026-11-11).
- eCFR: 45 CFR 46.111, Criteria for IRB approval (accessed 2026-11-11).