Financial Interest Review Form (FIRF) Updated
Please note the Financial Interest Review Form (FIRF) has been updated. Please ensure you are using the most up-to-date version. Click here to view the Templates & Forms page.
Additional Training Sessions Added
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
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.
How a simple’Thank you’ could improve clinical trials
NATURE.COM | EDITORIAL
Read the article online at: https://www.nature.com/articles/d41586-018-07410-0?utm_
New System Information
IMPORTANT NOTICE Please click the button below to navigate to the website page that includes the most up-to-date information as well as the link to the new system. Click Here Implementation
2019 Meeting Schedule Available
The meeting schedule for all committees for the official 2019 calendar year has been uploaded. To view click here.
Upcoming OHRP Workshop on 9/7/2018
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
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
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
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
Updated the Calendar of Meetings for all committees for the calendar year 2018. Click here.