Archive: IRB Updates and News
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Updated Radiation Safety Committee Forms
OCTOBER 5, 2017
The Radiation Safety Committee (RSC) Forms have been updated.Category: IRB Updates and News
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New FDA/NIH Requirements for Posting Clinical Trials onto ClinicalTrials.gov
JANUARY 18, 2017
Effective January 18, 2017, according to new FDA and/or NIH requirements, your trial must adhere to the new additional requirements regarding registration and reporting of clinical trial results via ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine (NLM). Studies initiated prior to January 18, 2017, must still comply with existing registration and reporting requirements.Category: IRB Updates and News
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International Compilation of Human Research Standards 2017 Edition Released
DECEMBER 7, 2016
The 2017 edition of the International Compilation of Human Research Standards has been released and is now available online. The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 126 countries, as well as standards issued by a number of international and regional organizations. The updated edition includes hundreds of updates from the previous year. Six new countries are included in the 2017 edition: Benin, Bermuda, the Democratic Republic of the Congo, Dominican Republic, Guyana, and Senegal.Category: IRB Updates and News
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GHUCCTS December Meeting Date and Time Updated
DECEMBER 1, 2016
Updated the Calendar of Meetings for the GHUCCTS IRB Committee meeting date and time for the December 2016 meeting.Category: IRB Updates and News
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2017 Calendar of Meetings Available for All Committees
OCTOBER 20, 2016
Uploaded the Calendar of Meetings for IRB Committees A, B, C, and D for the calendar year 2017.
Uploaded the Calendar of Meetings for the GHUCCTS IRB Committee for the calendar year 2017.Category: IRB Updates and News
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New Education Opportunity: Luminaries Lecture Series
OCTOBER 19, 2016
The Office of Human Research Protections (OHRP) is offering a new lecture series titled the “Luminaries Lecture Series”. The series is intended to be of broad interest to investigators and IRB professionals, as well as anyone involved in human subjects research.Category: IRB Updates and News
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New Information Available for eRIC Log-in Issues
JULY 27, 2016
Updated the eRIC Website page with new information regarding access to eRIC and log-in difficulties.Category: IRB Updates and News
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ICF Templates Updated
MAY 18, 2016
Updated the Georgetown University Clinical Trials Office telephone number in the Georgetown University Biomedical Consent Form Template (pg. 7) and the Joint MHRI-GU Consent Form Template (pg. 9).Category: IRB Updates and News
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Protection of Minors Policy Update
JANUARY 5, 2016
The Protection of Minors Policy was updated.Category: IRB Updates and News
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New NIH Genomic Data Sharing Policy
JULY 8, 2015
NIH Genomic Data Sharing Policy (GDS Policy) applies to all NIH-funded research (e.g., grants, contracts, intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as future use of the data. The policy includes the NIH’s expectations and requirements for the broad sharing of genomic data. The Policy applies to contracts and all grant types, with few exceptions (T-types, K12s, and Fs, for example). The GDS Policy is effective beginning with proposals submitted for the January 25, 2015 due date and thereafter.Category: IRB Updates and News