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https://www.hhs.gov/ohrp/compliance-and-reporting/determination-letters/index.html
Determination Letters and Other Correspondence. OHRP has implemented a practice to redact from compliance oversight determination letters posted on its website any sections that discuss unresolved concerns, questions, or allegations related to an ongoing investigation.
https://www.hhs.gov/ohrp/regulations-and-policy/index.html
Find a variety of OHRP policy and guidance documents to support ethical human subjects research that complies with HHS regulations. Request for Comments . Request for Comments. Submit public comments on any OHRP guidance document. Decision Charts tile . Decision Charts.Author: Office For Human Research Protections (OHRP)
https://www.doctemplates.net/letter-of-support-samples/
Letter of support samples provide important guidelines to follow for individuals, groups or organization who are requested to draft such a letter. Letter of support samples, or templates, assist the individual, organization or group in how to format a letter of support in the best possible manner, one that will ensure that the candidate is seen ...
https://www.nejm.org/doi/full/10.1056/NEJMc1308015
A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.Cited by: 67
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077328/
So I thought about my college petition, talked with colleagues who were leaders in the Association of Bioethics Program Directors, and decided that OHRP and the researchers should know that some in the bioethics community did not agree that what happened during SUPPORT justified the response from OHRP. A letter was circulated, with countless ...Cited by: 17
https://www.reliasmedia.com/articles/63377-ohrp-letters-focus-on-informed-consent-issues
Jun 01, 2013 · OHRP letters focus on informed consent issues. Thorough risk descriptions needed. The University of Alabama at Birmingham (UAB) was the most recent in a small list of institutions that received letters of determination from the Office for Human Research Protections (OHRP) of Rockville, MD, about allegations of noncompliance.
https://www.oig.hhs.gov/reports-and-publications/portfolio/oig-12-14-04.pdf
OFFICE OF INSPECTOR GENERAL ... 1 To distinguish this second letter from OHRP's initial compliance determination letter, we here refer to the later correspondence as the "clarification" or "revised" letter. 1 . ... and NIH provided OHRP with SUPPORT study documents.
https://oig.hhs.gov/oei/reports/oei-01-14-00560.pdf
OHRP sent an inquiry letter to UAB and RTI on July 18, 2011, copying the principal investigator for SUPPORT along with relevant individuals at NIH, NICHD, and the Food and Drug Administration (FDA).
https://www.thehastingscenter.org/support-update-ohrps-compliance-actions-on-hold/
In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.” Further, OHRP promises not to initiate compliance actions “in studies involving similar designs”… Read more
https://www.nejm.org/doi/full/10.1056/NEJMc1307008
A group of medical ethicists and pediatricians asks for reconsideration of the recent Office for Human Research Protections ... OHRP and SUPPORT. ... SUPPORT was conducted. This letter was ...Cited by: 71
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