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Human Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA
Phone:
(203) 785-4688
Fax:
(203) 785-2847
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Announcements Archive
New consent form template language for trials that qualify for registration under the FDA Amendment Act
This study has been/will be (choose whichever applies) registered in an online database for clinical trials that is run by the federal government. The purpose of this database is to allow everyone to see information on what studies are being done, and what studies have been done. The database will expand during the next year to require study results to be posted there as well. If you would like information about this study online or if you would like to see this online database you may view it at clinicaltrials.gov.
Information on the FDA Amendment Act:
For more information on the FDA Amendment Act or how to register a trial please see the YCCI website at: http://ycci.yale.edu
The HIC Request for Re-approval and Request for Termination, previously referred to as Form 5, has been separated into two new forms:
Request for Re-approval of a Protocol for Research Involving Human Subjects, Form #5R and Request to Close a Research Study Involving Human Subjects, Form #5C.
Additionally, the content of the forms have been updated to reflect new concerns in human subject protections and applicable best practices. These changes enable investigators to provide more complete and relevant information to the HIC with the hopes of facilitating the process.
Please note that the HIC will only accept Request for Reapprovals or Terminations/Closures on the old form #5 until June 15, 2007. After that date, investigators will be asked to resubmit their request(s) using the new #5R or #5C form.
As a reminder: when completing forms, always pull the form from the HIC website, rather than using a version from your file. This will ensure using the most current form, saving time for you, as well as for processing in our office. Thank you.
Announcement
UPDATED MAGNETIC RESONANCE IMAGING RISK LANGUAGE: For research involving MRI procedures, investigators are advised that the MRRC requires the use of new consent form language addressing risks. Please visit the MRRC website and click on HIC MR Risks for this information.
Announcement:
Please be advised that as of January 2, 2007 the HIC will require that all protocol amendment requests be submitted to the HIC on the "Request for Approval of Amendment" form, with the rationale for each change clearly described. Note that the HIC will continue to accept the Yale Cancer Center Protocol Review Committee (PRC) Amendment Request form in lieu of the HIC form. A descriptive rationale for changes is required on this form as well. Amendment requests that do not include a rationale for each change will be considered an incomplete submission by the HIC and returned to the investigator.
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Last modified: Tuesday, 04-Mar-2008 09:31:29 EST. (JJ)