Researchers engaging in human subjects research generally need IRB approval. This includes studies involving interaction with individuals, or the use of their identifiable private information. While some activities like quality improvement projects, oral histories, or certain types of program evaluations might be exempt, it's crucial to consult with your institution's IRB to determine whether your project requires review. Ultimately, the IRB is responsible for ensuring ethical research practices and protecting the rights and welfare of human participants, so seeking their guidance is paramount.
The blog post "Who exactly needs to get approval from an Institutional Review Board (IRB)?" delves into the intricacies of determining when research necessitates review and approval by an Institutional Review Board (IRB). It commences by elucidating the fundamental purpose of IRBs, which is to safeguard the rights and welfare of human subjects participating in research activities. This protection encompasses a broad spectrum of ethical considerations, including ensuring informed consent, minimizing risks, and maintaining confidentiality.
The author then meticulously dissects the criteria that trigger the requirement for IRB review. A crucial factor is whether the activity in question qualifies as "research" as defined by federal regulations. This definition hinges on two key elements: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The post emphasizes the importance of understanding the nuanced meaning of "generalizable knowledge," explaining that it refers to information intended to be shared broadly and applied beyond the specific research context. Activities intended for internal use or quality improvement, lacking the intent to disseminate findings widely, may not fall under this definition and therefore might not necessitate IRB review.
Furthermore, the post clarifies that research involving "human subjects" also triggers the need for IRB oversight. A "human subject" is defined as a living individual about whom an investigator conducting research obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information. The post elaborates on the concept of "intervention" and "interaction," providing examples such as administering surveys, conducting interviews, or observing behavior. It also explicates the meaning of "identifiable private information," clarifying that it refers to information that can be readily linked back to a specific individual and includes a range of data, including medical records, educational records, and financial information.
The author further emphasizes that even if an activity meets the definition of research involving human subjects, certain exemptions may apply. These exemptions are carefully delineated in federal regulations and encompass specific categories of research deemed to pose minimal risk to participants. The post highlights the importance of consulting with the relevant IRB to determine whether an exemption is applicable. It also cautions that institutions may have their own policies and procedures regarding IRB review that go beyond federal requirements. Therefore, researchers are strongly encouraged to engage with their institution's IRB early in the research process to ensure compliance with all applicable regulations and policies. The post concludes by reiterating the crucial role of IRBs in upholding ethical research practices and protecting the well-being of human research participants.
Summary of Comments ( 73 )
https://news.ycombinator.com/item?id=43038395
HN commenters largely discuss the overreach and bureaucracy of IRBs, particularly for low-risk research. Many share anecdotes of seemingly unnecessary IRB hurdles for projects involving publicly available data or simple surveys. Some question the efficacy of IRBs in actually protecting participants, suggesting they're more focused on liability protection for institutions. A few commenters point out the chilling effect excessive IRB requirements can have on valuable research, especially for independent researchers and smaller institutions lacking dedicated IRB staff. Others offer advice on navigating the IRB process, including pre-registering studies and seeking out institutions with more streamlined procedures. The general sentiment is that IRB review is important for ethically sensitive research but the current system is often overly burdensome and needs reform.
The Hacker News post discussing who needs IRB approval has a robust discussion with several compelling comments.
Several commenters discuss the nuances of IRB review, particularly regarding the definition of "human subjects research." One commenter highlights that the regulations focus on "generalizable knowledge," meaning if the research isn't intended to create new knowledge that can be applied more broadly, it likely doesn't require IRB review. They provide the example of internal quality assurance projects within a company, which generally wouldn't need IRB oversight. This point sparks further discussion about the blurry line between product development and research, with another commenter suggesting that companies often disguise product testing as internal quality assurance to avoid IRB scrutiny.
Another key discussion thread revolves around the practical implications of IRB review, especially for smaller entities and independent researchers. Commenters point out the significant costs and administrative burden associated with the process, potentially hindering valuable research. One commenter mentions the chilling effect this can have on exploring new ideas, arguing that the IRB process is often too rigid and inflexible for rapidly evolving fields.
The issue of informed consent also receives attention. One commenter shares an anecdote about difficulty obtaining proper informed consent from vulnerable populations, illustrating the practical challenges of adhering to ethical guidelines. Another commenter raises concerns about the potential for coercion in research settings, emphasizing the importance of ensuring truly voluntary participation.
There's a brief but interesting exchange about the international variation in IRB regulations, with one commenter noting that the US system is particularly stringent.
Finally, some commenters express frustration with the perceived overreach of IRBs, arguing that they sometimes hinder innovation and impede progress in certain fields. They suggest that a more streamlined and risk-based approach might be more effective.
In summary, the comment section offers a multi-faceted view of IRB approval, touching upon the definition of human subjects research, the practical challenges of IRB review, the ethical considerations of informed consent, international variations in regulations, and the potential for overreach. The commenters' diverse perspectives and real-world experiences contribute to a nuanced understanding of this complex issue.