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When a manuscript describing human subject research arrives at a journal’s editorial desk, one of the things the editor will look for is whether the study was reviewed and approved by an Institutional Review Board (IRB). IRBs are important for safeguarding ethical standards in human subject research across US institutions. Let us explore the functions, regulatory framework, and impact of IRBs on research publishing.
What Are Institutional Review Boards (IRBs)?
Legal Framework Governing IRBs
IRB Approval and the Publication Pipeline
Best Practices and Tips for Researchers and Authors
What Are Institutional Review Boards (IRBs)?
IRBs are administrative bodies designated to review and oversee research involving human subjects, ensuring the protection of participants’ rights, safety, and welfare. In the US, IRBs are established under US federal regulations enforced by the Food and Drug Administration (FDA) to review, approve, and monitor research involving human subjects. They evaluate protocols before any data collection begins and can disapprove studies based on risk-benefit assessments.1 Every institution receiving federal funding for research must have an IRB or must operate under a formal agreement with another institution’s board.
An IRB typically comprises at least five members with diverse backgrounds: scientists, non-scientists, ethicists, and at least one community member who is not affiliated with the institution. This structure ensures that protocols are evaluated from scientific, ethical, legal, and community standpoints.
IRBs: A Historical Background
The Tuskegee Syphilis Study and Nazi medical experiments are landmark unethical cases that drove the creation of IRBs.2 The Tuskegee Syphilis Study, which ran from 1932 to 1972, denied treatment to Black men with syphilis in order to study the disease’s progression. In fact, they were coerced, with false promises, into joining the study. The National Research Act of 1974, passed in the wake of public outrage over Tuskegee, mandated the creation of review mechanisms for federally funded human subject research. The Belmont Report of 19793 further codified the principles of respect for persons, beneficence, and justice, which IRBs are charged with upholding today.
Legal Framework Governing IRBs
US IRBs operate under federal regulations such as the Common Rule (45 CFR 46), FDA rules (21 CFR 50 and 56), and Office for Human Research Protections (OHRP) oversight. Under these regulations, IRB review is mandated for all federally funded or FDA-regulated human subject research.
The salient criteria for approval include minimizing risks, ensuring equitable subject selection, obtaining informed consent, and protecting confidentiality, especially for vulnerable populations. Institutions must register IRBs with the Department of Health and Human Services (HHS). Non-compliance runs the risk of funding cuts or legal penalties.
Scope of IRB Oversight
In the US, IRBs oversee human subject research ethics. The term “human subject research” refers to any systematic investigation designed to develop or contribute to generalizable knowledge that involves obtaining information or biospecimens from living individuals through intervention or interaction, or obtaining, using, studying, analyzing, or generating identifiable private information or biospecimens.
Not all human subject research requires the same level of scrutiny, however. IRBs categorize studies into three review tracks: exempt, expedited, and full board review.
- Exempt studies involve minimal risk, e.g., certain educational research or analysis of publicly available data.
- Expedited review covers research with no more than minimal risk, e.g., surveys, interviews, and collection of blood samples from healthy volunteers.
- Full board review is reserved for research that poses greater than minimal risk; involves vulnerable populations such as children, prisoners, or cognitively impaired individuals; or raises significant ethical questions.
It is worth noting that even studies initially deemed exempt must often obtain a formal determination from the IRB. The researcher’s own assessment is not sufficient; the board must make the designation.
IRB Approval and the Publication Pipeline
The connection between IRBs and research publishing has grown stronger and clearer over the past few decades. Major journals and publishers, including those affiliated with the International Committee of Medical Journal Editors (ICMJE), Committee on Publication Ethics (COPE), and the World Association of Medical Editors (WAME), now require authors to disclose IRB status as a condition of submission.
In practical terms, this means authors must include a statement in their Methods section identifying the IRB that approved the study, the protocol number, and the date of approval. Many journals also require documentation that all participants provided informed consent, or a statement explaining why informed consent was waived while confirming that the IRB approved such a waiver.
Best Practices and Tips for Researchers and Authors
Despite the centrality of IRB compliance to research publishing, manuscripts often arrive at journals with incomplete, incorrect, or missing documentation.
- Retroactive approval is perhaps the most common problem. Investigators sometimes complete a study, collecting data, analyzing results, etc., before realizing they needed IRB review! Researchers must obtain approval before data collection begins.
- Next, international and multi-site research can cause some confusion. A study conducted at multiple institutions may require approval from each institution’s own IRB, or the lead site’s IRB may serve as the single IRB under a formal agreement. When research is conducted outside the US, authors must explain what ethical oversight mechanism was in place, often citing the Declaration of Helsinki as a guiding framework. Many US journals will accept international ethics board approvals if they demonstrate standards equivalent to US requirements.
- Secondary data analysis presents another gray area. Researchers using existing datasets (e.g., institutional records, large national surveys, or biobanks) may assume their work is automatically exempt because they are not collecting new data. However, if the data are identifiable, or if the secondary analysis represents a new direction not covered by the original consent, a new IRB approval might be needed. Authors should always obtain a written exemption from their IRB rather than assuming and self-certifying exemption.
A few practical insights can prevent delays and rejections.
- First, it is essential to remember to engage the IRB at the study design stage, not after data collection.
- Second, all documentation, i.e., approval letters, protocol amendments, consent forms, continuing review approvals, must be kept organized and accessible. Did you know that journal editors and funders may request these documents years after a study ends?
- Third, when writing the Methods section, authors should be specific and transparent about IRB status. State the full name of the approving institution, the protocol or IRB number, and confirmation that the study was conducted in line with relevant regulations and ethical principles.
Remember: IRB regulations and journal policies are not static. The topic of human subject research oversight continues to evolve, and researchers bear the responsibility for staying informed and up to date. Journals, editors, and reviewers rely on IRB approval as a credibility signal, and readers rely on it to maintain public trust. While standards might shift, researchers who treat ethics as an integral part of their work rather than a procedural hurdle will be better positioned to meet them.
References
1. Office of Research Integrity. ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects — IRBs. U.S. Department of Health and Human Services. https://ori.hhs.gov/content/chapter-3-The-Protection-of-Human-Subjects-IRBs (accessed 23 February 2026).
2. Pressel DM. Nuremberg and Tuskegee: lessons for contemporary American medicine. J Natl Med Assoc. 2003;95(12):1216–1225.
3. Nagai H, Nakazawa E, Akabayashi A. The creation of the Belmont Report and its effect on ethical principles: a historical study. Monash Bioeth Rev. 2022 40(2):157–170. doi: 10.1007/s40592-022-00165-5.
