Human factors research plays a critical role in the development of over-the-counter (OTC) products. By examining how people interact with technology and the environment in the context of product development, human factors research helps ensure that products are safe, effective, and easy to use for their intended populations. However, when conducting human factors research, researchers must determine whether or not Institutional Review Board (IRB) approval is necessary.
What is an IRB?
The Institutional Review Board (IRB) reviews, approves and monitors research studies involving human subjects. It plays a critical role in ensuring that the research is ethical. In accordance with regulatory requirements, and the rights and welfare of human subjects are in protection.
The IRB reviews study protocols, informed consent forms, and other documents related to the study. They ensure that the study design minimizes risks to the subjects and that the benefits outweigh the risks. IRB approval provides assurance that the study meets certain ethical standards, which increases the credibility of the research and its results.
Benefits of IRB Approval in research
- Ethical and responsible research: IRB approval ensures that the research is conducted in an ethical and responsible manner, minimizing any risks to the study participants.
- IRB approval can increase the research’s credibility and its results, indicating that the study has undergone a rigorous review and meets specific ethical standards.
- Improved research quality: Following the IRB approval process can help researchers design a study that is scientifically sound and methodologically rigorous, which can improve the quality of their research.
When is IRB Approval Necessary?
IRB approval is a critical requirement for research involving human subjects in the United States. Whether conducted or supported by the federal government or under the auspices of an institution, IRB approval ensures that research is conducted ethically and protects the rights and welfare of human subjects. Here are some key points about when IRB approval may be necessary:
- Federal regulations mandate IRB approval for research involving human subjects conducted or supported by the federal government.
- Many institutions require IRB approval for all research involving human subjects conducted under their auspices.
- Studies involving interventions, interactions, surveys, interviews, observations, and other types of data collection may require IRB approval.
Federal regulations, such as the Common Rule, require IRB approval for research involving human subjects conducted or supported by the federal government (45 CFR 46). Obtaining IRB approval is essential for conducting ethical and responsible research, protecting the rights and well-being of human subjects.
Examples of OTC Human Factors Research Requiring IRB Approval
- Usability testing involves the evaluation of a product’s ease of use and user satisfaction. If the usability testing involves human subjects and interventions such as observation, surveys, or interviews, IRB approval is necessary.
- User interface design involves the design of product interfaces that are intuitive and easy to use. If the user interface design involves human subjects and interventions such as surveys or focus groups, IRB approval may be necessary.
- Risk assessment involves the identification and evaluation of potential hazards associated with the use of a product. If the risk assessment involves human subjects and interventions such as interviews or surveys, IRB approval may be necessary.
When is IRB Approval Not Necessary?
Not all OTC human factors research studies require IRB approval. If researchers analyze existing data or test non-human use products, they may not need IRB approval.
Additionally, some human factors research studies may be considered exempt from IRB review. The United States federal regulations provide specific criteria for determining when research is exempt from IRB review. These criteria include studies that involve anonymous or de-identified data, studies that involve non-sensitive topics, and studies that do not involve any risk to participants.
The Importance of Ethical Considerations in research
Even if IRB approval is not required for a human factors research study. It is still important to consider ethical considerations when conducting the study. This includes obtaining informed consent from study participants, ensuring participant privacy and confidentiality. And minimizing any potential risks associated with the study.
Additionally, it’s crucial to ensure transparency and impartiality in conducting the study and accurately and honestly reporting the results. This guarantees ethical conduct and trustworthy and reliable findings.
Conclusion
When conducting human factors research for over-the-counter products, it is important to carefully consider whether or not IRB approval is necessary. When conducting research, researchers must follow established guidelines and procedures for obtaining IRB approval if required. Even if not , they must still consider ethical considerations to ensure the study is reliable and ethical.. By taking these steps, researchers can help ensure that over-the-counter products are safe, effective, and easy to use for their intended populations.