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Indicator: 1
[Output]
Measurements in/of Recommendations Made
Relationships: Department of Health and Human Services - Narrower_Than
Other Information:
Secretary's Advisory Committee on Human Research Protections
| Type |
Target |
Actual |
| StartDate |
2010-10-01 |
2010-10-01 |
| EndDate |
2011-09-30 |
2011-09-30 |
| Number |
n/a |
281 |
| Description |
Unspecified |
These recommendations were provided to the Secretary of HHS in a series of communications from SACHRP to the Secretary through
the Assistant Secretary for Health. These letters outlined the committee's interpretation and conclusions on issues associated
with HHS regulations for the protection of human subjects at 45 CFR 46, including but not limited to research involving children,
prisoners, pregnant women, individuals with impaired decision-making, and areas within subpart A, known as the Common Rule,
involving continuing review, expedited review and training requirements for individuals involved in the review, oversight,
or conduct of human subjects research. In FY 2011 SACHRP issued an extensive set of FAQs on the topic of informed consent
and the use of biospecimens in research, as well as a series of recommendations in response to the Office of Civil Rights'
HIPAA/HITECH NPRM on Accounting of Disclosures and Access Reports. SACHRP also responded to the President's Commission for
the Study of Bioethical Issues' Request for Comments on Human Subjects Protections in Scientific Studies, and the HHS ANPRM
entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity
for Investigators.
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