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Institutional Review Boards (IRBs) assess the ethics and safety of research studies involving human subjects, such as behavioral studies or clinical trials for new drugs or medical devices. Health and Human Services oversees about 2,300 U.S.-based IRBs through routine or for-cause inspections to ass…
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Institutional Review Boards (IRBs) assess the ethics and safety of research studies involving human subjects, such as behavioral studies or clinical trials for new drugs or medical devices. Health and Human Services oversees about 2,300 U.S.-based IRBs through routine or for-cause inspections to assess if they are following federal laws when reviewing research. But few IRBs are inspected. For example, one HHS agency aims to do just 3-4 routine inspections each year. Also, HHS agencies haven't examined how many inspections are needed or if inspections could be changed to further reduce risks to human subjects (2023). More than 130 countries and international organizations have developed independent committees to approve or deny research that involves human subjects (Capili & Anastasi, 2024).
For many researchers conducting successful research is the most rewarding thing to do. But what happens when the research does not meet the IRB standards due to being biased, the truth is that many researchers find themselves facing such issues which are easy to occur when proposing a research theory. There are many things that can impact and affect the research, one can be the limited amount of information on the chosen topic, methodology and sample size. Often waiting for the review and approval from the IRB can be challenging. Four challenges identified (1) Community partners not being recognized as research partners (2) Cultural competence, language of consent forms, and literacy level of partners; (3) IRBs apply formulaic approaches to CEnR; & (4) Extensive delays in IRB preparation and approval potentially stifle the relationships with community partners (Onakomaiya et al, 2023).
In conclusion, getting research published and approved by the IRB is a tedious procedure. It requires understanding and knowledge of possible setbacks that can occur in the process of achieving the sought-out research. While these inefficiencies are an inevitable part of the research process, understanding common pitfalls can limit those hindrances (Shaffer & Huecker, 2025). Recommendations included (1) Training IRBs to understand CEnR principles to streamline and increase the flexibility of the IRB review process; (2) Identifying influential community stakeholders who can provide support for the study; and (3) Disseminating human subjects research training that is accessible to all community investigators to satisfy IRB concerns. The IRBs can benefit from more training in CEnR requirements and methodologies (Onakomaiya et al, 2023).
References
(2023, January 17). Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness. U.S. Government Accountability Office. [**https://www.gao.gov/products/gao-23-104721**](https://www.gao.gov/products/gao-23-104721)
Capili, B., & Anastasi, J. K. (2024). Ethical Research and the Institutional Review Board: An Introduction. The American journal of nursing, 124(3), 50–54. [**https://doi.org/10.1097/01.NAJ.0001008420.28033.e8**](https://doi.org/10.1097/01.NAJ.0001008420.28033.e8)
Onakomaiya, D., Pan, J., Roberts, T., Tan, H., Nadkarni, S., Godina, M., Park, J., Fraser, M., Kwon, S. C., Schoenthaler, A., & Islam, N. (2023). Challenges and recommendations to improve institutional review boards' review of community-engaged research proposals: A scoping review. Journal of clinical and translational science, 7(1), e93 **.** [**https://doi.org/10.1017/cts.2023.516**](https://doi.org/10.1017/cts.2023.516)
Shreffler J, Huecker MR. Common Pitfalls In the Research Process. [Updated 2023 Mar 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: [**https://www.ncbi.nlm.nih.gov/books/NBK568780/**](https://www.ncbi.nlm.nih.gov/books/NBK568780/)
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