Research Affairs: 2018 IRB and IACUC notices

REMINDER of COI for IRB Process

Amy Casey — Wed, 21 Mar 2018 14:43:56 -0700

Conflict of Interest disclosure and training must be completed for all research personnel responsible for the design, conduct or reporting of a study prior to the study being reviewed, per federal requirements. For full board review this means a study will only be assigned to the IRB agenda once all COI requirements are met.

Revised IRB Forms

Amy Casey — Wed, 21 Mar 2018 14:40:51 -0700

The IRB forms below have been revised. Since forms and guidance may be updated at any time to reflect new regulations and IRB accreditation, be sure to download the latest versions as needed from the IRB Toolkit for Investigators to avoid delays in the approval process. Contact us at x44531 or email IRB@llu.edu if you have any comments/feedback.

- Archival/Retrospective Data Application Form

- Waiver of Consent/HIPAA Authorization

ClinicalTrials.gov studies reassigned effective April 1, 2018

Jerri McIlhagga — Wed, 21 Mar 2018 14:33:24 -0700

Effective April 1, 2018, the registration and results submission for ClinicalTrials.gov studies has been reassigned to the following departments:

PIs requiring assistance in registering cancer-related studies should contact Tami Terry at the Cancer Center: (909) 558-7117 Extension: 87117

PIs requiring assistance in registering non-cancer related studies should contact the Clinical Trials Center at: (909) 558-5830 Extension: 55830

Prior to April 1, 2018, PIs for all types of studies may still contact Jerri McIlhagga for assistance at:

(909) 558-9408 Extension: 49408 Email: jlmcilhagga@llu.edu

Coming Soon(?) Changes to the Common Rule – Impact on LLUH investigators

Sandra Figueroa — Mon, 12 Feb 2018 09:44:10 -0800

Coming Soon (?) Changes to the Common Rule – Impact on LLUH investigators

Please join us as Linda G. Halstead, MA, Director, Responsible Research Services, reviews the pending revisions to the Common Rule and how these changes may impact your research. Pre-registration is required.

The seminar will be held in the Loma Linda University Medical Center, Research Wing, A-Level Amphitheater from 12-1pm. Physicians attending this session will earn CME.

You must register to receive credit. Lunch is limited – available on a first come, first serve basis.

Please click link Register

NOTE: If you register, please make every effort to attend, or contact us in advance, should your plans change. Seating is limited and we do maintain a waiting list. That will allow us to give your “ticket” to one of your research colleagues.

Thank you for your attention. We look forward to seeing you there.

COI for IRB PROCESS EFFECTIVE IMMEDIATELY

Amy Casey — Tue, 02 Jan 2018 09:39:04 -0800

Conflict of Interest disclosure and training must be completed for all research personnel involved in the design, conduct or reporting of a study prior to the study being reviewed, per federal requirements. For full board review this means a study will only be assigned to the IRB agenda once all COI requirements are met.