IRB (Institutional Review Board)
New Consent Form Requirement Effective March 7, 2012
For studies that must register on ClinicalTrials.gov
The FDA has amended the regulatory requirements for obtaining informed consent in clinical trials that must be entered into the ClinicalTrials.gov databank. If this applies to your study, you must add the following statement to the "Participation" section of your consent form:
"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time."
This requirement applies to studies submitted on or after March 7, 2012.You do not need to update consent forms for studies approved by the IRB before this date.
For more information on this change, please see the February edition of IRB Notes.If you are still unsure whether this requirement applies to your study, please contact OCTRI investigator support and integration services.
Consent form templates have been updated to include this language.
We have also eliminated the non-barcode versions of the Consent, Consent and Authorization, and Genetic Consent templates.The posted versions all contain a barcode.If you need to remove the barcode from your consent form, please refer to the new Consent Form INSTRUCTIONS document, available on the IRB Forms page, for guidance.
IRB Analyst Brown Bag Sessions
April 26, Updates from the ORIO
11:30 a.m. to 12:30 p.m.
MacDonald Auditorium
Kelly Kidner
This session will bring you all the latest information from the ORIO, including:
- Document updates -- consent templates
- Recent changes to the eIRB -- PI change, funding
May 24, OHSU/PVAMC combined review process
11:30 a.m. to 12:30 p.m.
MacDonald Auditorium
Trish Lindstrom
This session will provide information about the new simultaneous IRB review process for OHSU and the PVAMC through the eIRB. Items to be discussed may include:
- Which studies / researchers are eligible to use this process
- The eIRB combined submission process including useful information and checklist
- Timeline for review
June 28, Consent Form Writing
11:30 a.m. to 12:30 p.m.
MacDonald Auditorium
Wendy Doggett
A well-written consent form significantly increases the efficiency of IRB review. This brown bag session is designed to provide an overview of consent form writing. Handouts will be available to assist participants in the continuing pursuit of the well-written form. Topics include:
- Templates and boilerplate language
- Writing style
- Organization of procedures and risks
- Common corrections
What is Human Subject Research?
The Code of Federal regulations defines Research as:
"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]
and defines Human Subjects as:
"...living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual , or (2) identifiable private information." [45 CFR 46.102(f)(1-2)]
