Allows the healthcare facility to conduct human-subject research on patients subject to 21 C.F.R. Pt 50 and/or 45 C.F.R. Pt 46 (relating to the informed consent of human subjects).
Impact
If enacted, SB 2394 would significantly impact state laws related to the rights of patients within healthcare settings. The bill clarifies that healthcare facilities must obtain informed consent from patients before involving them in research programs that utilize human subjects. Importantly, it allows for exceptions in life-threatening situations where a patient may not be able to provide consent. This nuanced approach aims to protect patient autonomy while also considering critical medical circumstances where immediate decisions are necessary to save lives.
Summary
Senate Bill 2394 amends section 23-17-19.1 of the General Laws relating to the licensing of healthcare facilities in Rhode Island. The bill is designed to enhance the rights of patients when it comes to their treatment within healthcare facilities, particularly concerning situations where human-subject research may be conducted. It establishes clear guidelines on what constitutes patient consent and ensures that patients are informed and given a choice regarding their participation in any research protocols. This aligns with federal regulations under 21 C.F.R. Pt 50 and 45 C.F.R. Pt 46, which govern the informed consent of human subjects.
Sentiment
The sentiment around SB 2394 appears to be largely positive, particularly among healthcare advocates and ethics committees who support strengthened patient rights and autonomy. However, there might be some concerns from healthcare facilities regarding the implications of increased regulation and the potential administrative burden of ensuring compliance with the new informed consent requirements. The sentiment reflects a balance between the protection of individual rights and the operational realities faced by medical providers.
Contention
Notable points of contention regarding SB 2394 include the balance between patient autonomy and the necessity for rapid consent processes in emergency medical situations. While some stakeholders emphasize the importance of informed consent as a fundamental right, others argue that flexibility is needed in critical scenarios to facilitate timely medical intervention. This ongoing debate highlights the challenge of aligning ethical standards with practical healthcare delivery, especially when lives are at stake.
Allows the healthcare facility to conduct human-subject research on patients subject to 21 C.F.R. Pt 50 and/or 45 C.F.R. Pt 46 (relating to the informed consent of human subjects).