Researchers in low-risk clinical trials could experiment on patients without obtaining informed consent if they meet at least four conditions, the FDA proposed Tuesday in a new rulemaking notice.
The agency will grant waivers if researchers can prove:
- A trial “involves no more than minimal risk” to humans;
- The waiver won’t negatively affect patients’ health or rights;
- A trial can’t “practicably be carried out” unless a waiver is granted; and
- Patients are given study details and findings after a trial wraps up.
The proposed rules firm up a 2017 guidance that laid out the same conditions for informed consent waivers. FDA Commissioner Scott Gottlieb said the move would help sponsors conduct low-risk trials “that may be important to addressing significant public health needs without compromising the rights, safety or welfare of human subjects.”