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Welcome to the IRB Homepage. Please note that the news bulletin posted here is always the most recent, but there are more news items on the News page that may be important to you.

6/20/2019 - 9/5/2019 - Weekly IRB Office Hours

Location: 3800 Spruce Street, First Floor, Suite 151E

Date: Every Thursday starting this week, 10am – 12pm (except July 4^th)

Directions: Click Here

 

7/5/2019 - IRB Submission Procedure & Guidance updates:

REPORTABLE EVENT FORM AND GUIDANCE UPDATE

A new reportable event form has been posted- https://irb.upenn.edu/forms and our guidance has been updated.

THE FORM:

• The new form combines medical and non-medical events eliminating the need to choose the correct form. There is now only one form for all types of events.
• The new form includes detailed guidance and clarifications for appropriate reporting of an event
• Please note that the screening questions built into HSERA when creating reportable events have not changed and are still applicable to our current guidance, definitions and submission criteria.

THE GUIDANCE:

• In alignment with recent revisions to the Continuing Review procedures which (became required on June 3, 2019), the guidance regarding reportable events provided on the IRB website has been revised for clarity
• Reportable event guidance along with the form is posted at the following webpage which is also linked directly in the form in several locations: https://irb.upenn.edu/reportable-event

The new form should be utilized by all research teams as soon as possible instead of previous versions. The IRB may return your submission or require substantial clarification via email upon receipt of a submission that does not utilize the new form after August 1, 2019.

Research teams are encouraged to thoroughly review the reporting criteria, definitions and timelines prior to reaching out with any questions about submitting. Questions related to the new event form and guidance should be sent to the IRB POBox: irb@pobox.upenn.edu

MODIFICATION FORM UPDATES

A new Modification form has been posted- https://irb.upenn.edu/forms. Updates to the form include:

• Clarification to the requirements for modification submission (Summary of changes and rationale for changes must be included)
• Addition of new question for research involving products or agents. This question aims to clarify whether the modification includes a change to investigational agents as well as identification of IDS or hospital pharmacy support. These changes aim to improve IDS involvement and communications in active research.
• Clarification that changes to personnel and conflicts of interest must be reflected on the Personnel page of HSERA.

The IRB may return any submissions created after August 1, 2019 that do not utilize the new form.

Questions related to the new modification form should be sent to the IRB POBox: irb@pobox.upenn.edu

ICF TEMPLATE UPDATES

In relation to the revisions to the common rule pertaining to informed consent and the requirement for a concise summary, the IRB wishes to clarify that concise summaries should be incorporated into any full-length main consent document on page 1– not a separate document

To support this format, new consent templates for Biomedical and Social Behavioral research have been posted on the Forms and Templates page- https://irb.upenn.edu/forms. These new templates incorporate the concise summary information on page 1 of each template while also referencing and linking the existing concise summary guidance document that was released earlier this year.

The concise summary guidance document indicating the “Do’s” and “Don’ts” of writing concise summaries is still available and should be referenced while drafting new consent forms. That document is available here under Required Elements of Consent

Questions related to utilizing the new ICF templates or drafting a concise summary should be sent to the IRB POBox: irb@pobox.upenn.edu

HSERA UPDATE TO DISPLAY EXPIRATION DATES

On Wednesday May 15, HSERA was updated to begin displaying expiration dates in the “Create: Continuing Review” As well as “Submission History” pages that are utilized by research personnel. The column displaying the expiration date can be clicked to sort by date. Additionally, the page now includes new filter fields to narrow the list of studies displayed by the expiration date of the study. The initial roll out is limited to studies with the most common IRB Approval statuses. However, we are working with ISC to expand this function to apply to all IRB determinations that would require an expiration date (Approved-Relying IRB, Approved CHOP-Penn, Approved Contract pending, etc). Future updates to this function will be announced in a bulletin once they are applied.

We hope this update to HSERA functionality will be useful to the research community for study maintenance including management of expirations and timely submission of continuing reviews or closures.

Any technical questions related to using HSERA (unrelated to the research being submitted) should be sent to the HSERA Help desk : hsera_help@lists.upenn.edu

NEW GUIDANCE FOR INITIAL APPLICATIONS

A new guidance document has been posted on the IRB website under Guidance Documents for Initial Submissions at - https://irb.upenn.edu/initial . This document provides detailed information for investigators about the criteria for IRB approval and tips for appropriately communicating information about your study to meet those criteria.

Questions about drafting initial applications should be directed to staff members identified in our directory for Initial submissions based on risk level (minimal risk or greater than minimal risk): https://irb.upenn.edu/Help