IRB Updates and News

  • Additional Training Sessions Added
    December 19, 2018

    Additional training sessions for the new system have been added.  These sessions will take place via Zoom Conference on 12/20/2018.  See the following link for more details: https://georgetown.box.com/s/ewd7ltr5mk9i5o5acuyflvxti983fgq2.

  • ‘Go Live’ of the New IRB System
    November 29, 2018

    As announced in previous communications, the University is launching a new Georgetown-MedStar IRB system.  As of today, Thursday, November 29, the new system is ‘live’ and available for all IRB submissions and actions. The link to the new system as well as additional information regarding the system can be found at https://ora.georgetown.edu/georgetownmedstarirbsystem.    

    As a reminder, ongoing training sessions are planned at various locations on both the Medical Center and Main Campuses. Specific dates, times and locations can be found on the training schedule, as posted on the website noted above.   Additionally, please make sure to review the important dates also found on this website.

  • Featured Story: How a simple ‘thank you’ could improve clinical trials
    November 13, 2018

    NATURE.COM | EDITORIAL
    Read the article online at:  https://www.nature.com/articles/d41586-018-07410-0?utm_
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  • New System Information
    October 29, 2018
  • 2019 Meeting Schedule Available
    October 26, 2018

    The meeting schedule for all committees for the official 2019 calendar year has been uploaded.  To view click here.

  • Upcoming OHRP Workshop on Informed Consent on 9/7/2018
    August 30, 2018

    OHRP Exploratory Workshop: Meeting New Challenges in Informed Consent in Clinical Research
    When: Livestream on Friday, September 7, 2018, 8:00 a.m. – 4:45 p.m. ED

    The OHRP Exploratory Workshop is a new initiative to provide a forum for intellectual exchange within the research community on important issues related to human subjects protections. The workshop will bring together experts from diverse perspectives to discuss challenges for informed consent and innovative ways to address them. It is anticipated that panel discussions will involve only invited speakers and moderators.  No registration is required.

    For more information click here or click on the title of the update. 

  • New Education Opportunity: OHRP Exploratory Workshops
    August 29, 2018

    The Office for Human Research Protection (OHRP) announces a new OHRP Exploratory Workshop Initiative. The rapidly changing landscape of biomedical and health-related behavioral research continues to present diverse challenges for adequately reviewing and appropriately regulating research to best protect human research subjects. Charged with the mission of providing leadership in the protection of the rights, welfare, and well-being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) endeavors to keep abreast of these challenges with the long-term goal of analyzing emerging ethical and regulatory issues and developing meaningful policy guidance.

    OHRP’s Division of Education and Development (DED) promotes education and outreach on the protection of human subjects in research. DED created the OHRP Exploratory Workshop to provide a platform for collegial intellectual exchanges within the research community to promote exploration of a topic of interest that hinges on the Federal regulations on human subjects protection. Speakers are asked to present their perspectives and discuss concerns, controversies, and potential solutions. OHRP considers constructive communication a vital first step towards finding common ground and creating pragmatic workable solutions.

    To view the current Exploratory Workshops available, visit: https://www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop.

  • International Compilation of Human Research Standards 2018 Edition Released
    December 5, 2017

    The 2018 edition of the International Compilation of Human Research Standards has been released and is now available on OHRP’s website at: 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 130 countries, as well as standards issued by a number of international and regional organizations.  Most of the listings provide hyperlinks to the source document. These laws, regulations, and guidelines are classified into nine categories:

    1.  General, i.e., applicable to most or all types of human subjects research
    2.  Drugs and Devices
    3.  Clinical Trial Registries
    4.  Research Injury
    5.  Social-Behavioral Research
    6.  Privacy/Data Protection
    7.  Human Biological Materials
    8.  Genetic
    9.  Embryos, Stem Cells, and Cloning

     

    Disclaimer: Though this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new laws, regulations, and guidelines are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to international human subject research protections. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities.

  • 2018 Calendar of Meetings Available for All Committees
    November 7, 2017

    Updated the Calendar of Meetings for all committees for the calendar year 2018.  Click here.

  • Updated Radiation Safety Committee Forms
    October 5, 2017

    The Radiation Safety Committee (RSC) Forms have been updated.  Click Here.

  • 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.

    For more information, please see the links below:

    New FDA/NIH Requirements Information Sheet
    Clinical Trials Registration

  • 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: 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.

  • 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.  Click here.

  • 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.  Click here.
    - Uploaded the Calendar of Meetings for the GHUCCTS IRB Committee for the calendar year 2017.  Click here.

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

  • 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.  Click here.

  • 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).  Click here.

  • Protection of Minors Policy Update
    January 5, 2016

    The Protection of Minors Policy was updated.  Click here.

  • 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).

    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.

  • Protection of Minors Policy Update
    September 3, 2014

    The Protection of Minors Policy was updated.  Click here.