US · guidance
CMS SOM App. U, Tag R177
(2) Protection of human research subjects (45 CFR part 46)
Interpretive Guidelines: §403.738(a)(2)
The RNHCI must also ensure compliance with federal, state and local laws, which should
include policies and procedures to protect the patient. The fundamental principle of
human subjects protection is to ensure that any patient receiving services at the RNHCI
are not subjected to involuntary research, meaning without their informed consent.
The Office for Human Research Protections (OHRP) provides leadership in the
protection of the rights, welfare, and wellbeing of human subjects involved in research
conducted or supported by the U.S. Department of Health and Human Services (HHS).
OHRP is part of the Office of the Assistant Secretary for Health in the Office of the
Secretary of HHS. Additional information may be found at https://www.hhs.gov/ohrp/.
Survey Procedures:
• Ask the RNHCI management to describe their processes for protecting patients
against human research studies.
• Verify the organization has a policy for this protection.
History
Rev. 239; Issued: 04-24-26; Effective: 04-24-26; Implementation: 04-24-26
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
6f58e0b47fcf1dd7488478a71b0b605decb483e20c8a24ab01e8f68ef7914139
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