IRB Updates and New Information

1.18.2017
NEW FDA/NIH Requirements for Posting Clinical Trials onto ClinicalTrials.gov:  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.

For more information, please see the links below:

12.7.2016
The 2017 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html.  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, Democratic Republic of the Congo, Dominican Republic, Guyana, and Senegal.

The listings are organized into eight categories:

  1. General Research
  2. Drugs and Devices
  3. Clinical Trial Registries
  4. Research Injury
  5. Privacy/Data Protection
  6. Human Biological Materials
  7. Genetic Research
  8. Embryos, Stem Cells, and Cloning

Many of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest.  Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.

12.1.2016
Updated the Calendar of Meetings for the GHUCCTS IRB Committee meeting date and time for the December meeting.

10.20.2016

10.19.2016
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.  For more information please see our Education page at https://ora.georgetown.edu/irb/education.

10.6.2016

9.1.2016
Updated the Calendar of Meetings for the Committee C IRB Committee meeting date in September.

7.27.2016
Updated the eRIC Website page with new information regarding access to eRIC and log-in difficulties.

7.1.2016
Updated the Calendar of Meetings for the GHUCCTS IRB Committee meeting date in July.

5.18.2016
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).

3.14.2016
Updated Calendar of Meetings for the GHUCCTS IRB Committee.

3.1.2016
Updated Calendar of Meetings for Committee D.

2.25.2016
Updated Calendar of Meetings for Committee C.

1.5.2016
Protection of Minors Policy updated.

11.13.2015
Uploaded Calendar of Meetings for Committees A, B, C, and D for the calendar year 2016. 

7.8.2015
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).

Grants applications and IRB protocols should include details of the required data sharing plan. In general, consent documents should include language that allows for the broad future sharing of genomic data.

The GDS Policy is effective beginning with proposals submitted for the January 25, 2015 due date and thereafter.  See FAQs and the NIH implementation guidelines here.

5.29.2015
Updated Calendar of Meetings for 2015 for committee C.

4.8.2015
Updated Calendar of Meetings for 2015 for committee C.

1.14.2015
Updated Calendar of Meetings for 2015 for GHUCCTS

12.17.2014
Updated Calendar of Meetings for 2015 for committee C.

12.11.2014
Uploaded December committee rosters for committees A, B, and C

12.4.2014
Uploaded Calendar of Meetings for 2015 for all committees.

10.8.2014
Updated GHUCCTS Calendar of Meetings

9.3.2014
Updated Protection of Minors Policy.