The landscape of human subjects research is evolving as artificial intelligence (AI) tools become more prevalent. Concerns arise regarding the adequacy of existing regulatory frameworks to safeguard participants in this rapidly changing environment. While AI has the potential to enhance healthcare and streamline research processes, it must be developed with stringent oversight to mitigate risks associated with data usage.
Human subjects research (HSR) involves studies conducted on living individuals, gathering data or biological samples, and it is categorized into social-behavioral-educational and biomedical fields. To initiate such research, obtaining approval from an Institutional Review Board (IRB) is mandatory. These committees are tasked with ensuring ethical standards are upheld, particularly since historical instances of research abuses have prompted the establishment of protective measures.
The Belmont Report, published in 1979, was a significant milestone in ethics, arising from public outrage over past misconduct, such as the Tuskegee Syphilis Study. It introduced key principles that continue to inform federal policies, including the Common Rule, which governs IRB operations and aims to protect the rights and welfare of research participants.