Understanding IRB Approval for Nursing Research

Conducting research is a privilege that comes with strict ethical responsibilities. When humans are the subjects of study, ethical oversight is non-negotiable. The Institutional Review Board (IRB) exists to protect the rights, welfare, and privacy of human research participants. For nursing students working on DNP projects or theses, navigating the IRB submission process can be a daunting administrative hurdle. However, it is a critical step in ensuring your work meets federal regulations and ethical standards. This guide demystifies the IRB process, from protocol development to final approval.

The Role and Composition of the IRB

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities. It has the authority to approve, require modifications in, or disapprove research.

According to the U.S. Department of Health & Human Services (HHS), an IRB must consist of at least five members with varying backgrounds to promote complete and adequate review. This typically includes scientists, non-scientists, and at least one member not affiliated with the institution (a community member) to ensure an unbiased perspective on participant safety.

Ethical Foundation: The Belmont Report

All IRB decisions are based on three core ethical principles outlined in the Belmont Report (1979), which was created in response to historical ethical breaches like the Tuskegee Syphilis Study.

• Respect for Persons: Individuals should be treated as autonomous agents. Those with diminished autonomy (e.g., children, prisoners, cognitively impaired) are entitled to protection. This is the basis for Informed Consent.
• Beneficence: “Do no harm.” Researchers must maximize possible benefits and minimize possible risks. The IRB weighs the risk/benefit ratio heavily.
• Justice: Fairness in distribution. Who ought to receive the benefits of research and bear its burdens? Researchers must ensure equitable selection of subjects and avoid exploiting vulnerable populations.

Levels of IRB Review

Not all studies require the same level of scrutiny. The level is determined by the magnitude of risk to the participants.

1. Exempt Review

Risk: Less than minimal risk. The study falls into one of 8 specific categories established by federal regulations.
Common Examples: Research conducted in established educational settings (e.g., nursing classrooms), surveys where subjects cannot be identified, or retrospective chart reviews using pre-existing, de-identified data.
Note: “Exempt” does not mean you don’t apply. It means you submit an application, and the IRB officially determines it does not require ongoing annual review.

2. Expedited Review

Risk: No more than minimal risk (harm anticipated is not greater than that encountered in daily life).
Common Examples: Collection of biospecimens by noninvasive means (e.g., saliva, hair), recording data from subjects 18 years or older using noninvasive procedures (e.g., weight, sensors, blood pressure), or minor changes to previously approved research.
Process: Reviewed by the IRB chair or a designated experienced member, rather than the full convened board, speeding up the timeline.

3. Full Board Review

Risk: Greater than minimal risk.
Common Examples: Studies involving vulnerable populations (children, prisoners, pregnant women), sensitive topics (illegal behavior, sexual history, substance abuse), or invasive procedures/experimental drugs.
Process: Reviewed by the entire convened committee during a scheduled meeting. This process takes the longest and often requires revisions.

Quality Improvement (QI) vs. Research

Many DNP projects are QI, not research. Distinguishing the two is a critical first step.

• Research: A systematic investigation designed to develop or contribute to generalizable knowledge (i.e., results applicable beyond your specific setting). Requires IRB review.
• Quality Improvement (QI): Systematic, data-guided activities designed to bring about immediate improvements in local health care delivery. The intent is to improve a specific process, not to generate new theory.
  Requirement: Often requires an “IRB Determination Letter” or “Non-Research Determination” rather than full approval, but you must verify with your institution.

For help distinguishing your project type, see our EBP Paper Services.

Informed Consent Process

Consent is a process of dialogue, not just a form to be signed.

• Elements: Statement that the study is research, purpose, duration, procedures, foreseeable risks, benefits, confidentiality measures, compensation (if any), contact info, and a statement that participation is voluntary.
• Readability: Forms must be written in lay language (typically 6th-8th grade reading level) to ensuring understanding.
• Assent: For minors (children), you obtain “Assent” (their agreement) in addition to parental permission.
• Waiver of Documentation: For minimal risk studies like anonymous online surveys, the IRB may waive the requirement for a signature to protect anonymity.

Common Rejection Reasons

Vague Methodology: Unclear recruitment strategies (how exactly will you find people?) or data collection steps.
Coercion: Recruitment materials that imply participation is required for care or offer excessive compensation.
Data Security: Failing to explain how data (PHI) will be stored (e.g., password-protected laptop, encrypted server) and when it will be destroyed.
Inconsistency: Discrepancies between the protocol document and the consent form.

FAQs on IRB

Conclusion

IRB approval is the ethical gatekeeper of research. By understanding the principles of protection and the levels of review, nursing students can navigate this process with confidence, ensuring their work respects the dignity and safety of all participants while contributing valuable knowledge to the profession.