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:
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:
- General Research
- Drugs and Devices
- Clinical Trial Registries
- Research Injury
- Privacy/Data Protection
- Human Biological Materials
- Genetic Research
- 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.
- 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.
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.
- Updated the Calendar of Meetings for the GHUCCTS IRB Committee meeting date and time for the October meeting.
- Updated the Calendar of Meetings for the Committee C IRB Committee meeting time and location for the October meeting.
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).
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.
Updated GHUCCTS Calendar of Meetings