Category Archives: IRB

Eligibility Screening Questions May Require Informed Consent and/or HIPAA Authorization

Whether done over the phone, online, or in person, collecting identifiable private information for study screening purposes requires informed consent (and HIPAA authorization, if applicable). This consent/authorization can be much shorter than for the form for the study itself and the IRB can waive the requirement for a signature, if needed. The IRB has a […]

Also posted in ORA | Tagged | Comments closed

Requests to rely on Central IRBs

Emory looks at several considerations when deciding if we can cede review to an external IRB. Currently we rely on one commercial IRB – Western IRB or WIRB – for industry-sponsored Phase IIb-IV drug/device studies. We will not rely on any other commercial IRBs. We often enter into study-specific reliance agreements when the relying institution’s […]

Also posted in ORA | Tagged | Comments closed

Updated Clinical Trials Consent Template

The Emory Biomedical, Grady, Children’s Healthcare of Atlanta, and Saint Joseph’s Hospital of Atlanta Consent/HIPAA templates have been updated. The new version date for all documents is 4-15-2016. Changes to the template include: A clarification to the guidance comments regarding medical records, Additional language for Cost Option 1 regarding what subjects may be liable for […]

Also posted in OCR, ORA, OSP, OTT | Comments closed

Emory IRB Membership Drive

Do you wish the IRB could review clinical studies more quickly? Are you frustrated when your study cannot be placed on an earlier meeting? Do you wonder what on earth we do and why we ask for all of those changes? Are you interested in research ethics and how they are applied at Emory? If […]

Posted in IRB | Comments closed

Imminent Changes to Federal Regulations

The Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule has been released! The proposed changes to the regulations will have significant impact on the conduct and oversight of human subjects research, if passed. For example, completely deidentified biospecimens may become covered by the Common Rule, and their use in research will require […]

Also posted in ORA | Comments closed

Emory IRB Membership Drive!

Do you wish the IRB could review clinical studies more quickly? Are you frustrated when your study cannot be placed on an earlier meeting? Then please consider volunteering to join the IRB! We can only get studies reviewed if we have members with adequate expertise in attendance at our meetings. Some studies need to be […]

Also posted in ORA | Comments closed

Upcoming Emory IRB Webinars!

The IRB presents a new webinar on the second Thursday of every month during the academic calendar year.  The presentations start at 12 pm and typically last about 30 minutes. Following the live presentation, the recording of the webinar and Q&A session will be archived for easy access. Every webinar has its own survey to […]

Also posted in Announcements, ORA | Comments closed

eIRB System Updated and Improved

The eIRB system underwent a needed update on  November 6th. This update was Phase 1 of a project to improve login and account creation, and to update departments and user accounts in eIRB. Specifically, you will observe these changes: The login screen looks different, and more like the login screens for other Emory systems, such […]

Posted in IRB | Comments closed

IRB Holiday Meeting Schedule

The IRB will have compressed meeting schedules in both November and December to accommodate the holidays. Study teams are encouraged to get potential full board submissions to the IRB promptly to avoid any delays. The final meeting in November will be on 11/18, and the final meeting in December will be on 12/16. From the […]

Also posted in ORA | Comments closed

Reminder Regarding IRB and IACUC approvals

Written By: Larry Iten, Rebecca Rousselle, Holly Sommers Office of Research Administration As most investigators know very well, federal awarding agencies, including the National Institutes of Health (NIH), require that grantee institutions verify the status of Institutional Review Board (IRB) approval for any grant involving human subjects research and Institutional Animal Care and Use Committee […]

Also posted in IACUC | Comments closed