Re: SACHRP Recommendations Regarding Informed Consent and Waiver of
Consent
Dear Secretary Sebelius:
The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons
(CNS) appreciate the opportunity to comment on the Secretary’s Advisory Committee on Human
Research Protections (SACHRP) letter dated October 9, 2012, which recommends changes to the
Department of Health and Human Services’ (HHS) Protection of Human Subjects regulation, also
known as the “Common Rule.” We support SACHRP’s proposal calling for the elimination of
irrelevant, non-research related information (e.g., standard surgical risks) from the informed consent
document. However, we remain concerned that the SACHRP has yet to directly address additional
exemptions related to quality improvement activities. This lack of guidance poses significant
uncertainty for neurosurgical practices as they endeavor to undertake meaningful quality improvement
efforts.
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