The Lankenau Institute for Medical Research
1. Follow-Up from AAHRPP Site Visit on September 23-24, 2015
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) site visit occurred on September 23-24, 2015. Thank you to all who participated and made the site visit a success. The Human Research Protection Program at Main Line Health should receive initial accreditation by the end of 2015 or early 2016!
As a result of the AAHRPP recommendations, the following changes have been made:
1.) MLH Transmittal Form and Clinical Trial Budget Submission templates have been updated. Please begin using with all new protocol submissions effective immediately.
2.) The requirements for IRB Submissions/Applications have been updated for New Protocol Submissions. Please review and begin using the new requirements effective immediately.
3.) The “Questions/Contact Information” section (page 4) of the Informed Consent Form Preparation Guide has been revised to the following:
“In addition, if you have any problems, concerns and questions as a research subject, contact Albert A. Keshgegian, M.D., Ph.D., Chairman, Main Line Hospitals Institutional Review Board at 484-476-3552 or Anne Marie Hobson, J.D., Director, Regulatory Affairs at 484-476-2692 to speak to someone independent of the research team. (If the study is to be done at Bryn Mawr, insert Dr. Guy Bernstein, Vice Chair, Bryn Mawr Hospital IRB at 610-525-2515”.)”
We are aware that this will require changes to study documents for research studies throughout Main Line Health. To make this transition as easy as possible, follow the guidelines below for updating your informed consent effective December 1, 2015:
For all New Research studies, the updated contact information is required at time of submission for IRB review.
For research studies which are a.) actively enrolling or b.) closed to accrual with patients receiving treatment: All Requests for Continuing Reviews and Amendments the revised contact information in the informed consent is required at time of submission for IRB review.
The revised Informed Consent Form Preparation Guide is available here.
4.) The Compensation for Medical Treatment section (pages 3-4) in the Informed Consent Form Preparation Guide has been revised and a new section has been added titled “Consistency of Informed Consent with Sponsor Written Agreement (contract or funding agreement)” to indicate the new requirement for the provisions for medical care or other care or services for research-related injury language in the consent document is consistent with written agreement from a sponsor. These changes are effective immediately.
The revised Informed Consent Form Preparation Guide is available here:
1. IACUC – Updated IACUC Policy and Procedure Manual
The IACUC Policy and Procedure Manual has been updated. A detailed summary of changes will be provided via email to all Principal Investigators. Please review the revised policies and begin adopting the changes immediately. Contact the Office of Research Affairs if you do not have the password to access the manual. The manual is located here.
Office of Research Affairs (ORA)
for Medical Research
100 Lancaster Avenue
Wynnewood, PA 19096