Philadelphia University + Thomas Jefferson University

IRB Newsletter Archive

2017

Date Description
January Final Common Rule Published, Avoiding Non-Approval, "One IRB" Initiative, Consent Signatories

2016

Date Description
June AAHRPP Site Visit, New Frequency of IRB Meetings, Commercial IRBs, Community IRB Members Wanted, eSAEy and eazUP Updates, Staff Updates, Policy Updates, Portal 2.0 Coming Soon
January AAHRPP Site Visit; Commercial IRBs; Abington Integration; Staff Updates; Key Personnel; Policy Updates

2015

Date Description

April

OHR Leadership; Vice Chair of Board 153; OHR Move; Forms & Policies; Essential Documentation Binder

2014

Date Description
July FDA Inspection; Use of Independent IRBs; New Webpage; How to Submit a New Study; Reporting Unanticipated Problems
April New Amended Policies and Forms; Policay GA120 Reporting and Reviewing Unanticipated Problems Involving Risks to Subjects; Continuing Reviews and Amendments, Guidance G619 Use of Radioactive Materials in Clinical Trials; Electronic IRB Submissions; Tips for Using the Portal; Emailing IRB Approval Materials

2013

Date Description
May Special Addition introducing JeffTrial
February New & Revised Policies, IRB Turnaround Time, Current Forms

2012

Date Description
March Conflict of Interest Disclosure, Collaboration with Commercial Entities-Tissue Studies, Quality Improvement Audits, Electronic IRB Submissions, How to Use the Portal, Recruitment of Subjects, Determinations by the IRB-Approved and Not Approved

2011

Date Description
October Renewal of Full Accreditation by AAHRPP, Changes to IRB Training Requirements, DHSP Website Update, IRB Stamp for Approved Ancillary Study Materials, Reporting SAEs and UAPs
September   Change In IRB Voting System, Correspondence with Investigators, Response of Investigators, Change Coming for Common Rule
July IRB Approval Letters for NIH, New Forms, Review of Serious Adverse Events (AEs) and UAPs, Initial Review of Possible Non-Compliance
June TISSUE ISSUE - Banks, Ownership, Donation, Submitting to IRB, TJU/JUH Policy
February AAHRPP Renewal, Updated IRB Policy Manual and Forms, Human Subjects Research Training and IRB Review, GCP, Compliance Corner

2010

Date Description
August - addendum Notice of Community Outreach Symposium
August Jefferson Moving to CITI Program, Instructions for Accessing CITI, AAHRPP,
April ORA Budgeting Services and Medicare Coverage Analysis, Research Study Information for In-Patient Charts, Using Human Tissue in Your Research, Aware for All

2009

Date Description
July IRB Timelines, Preparation of Submissions, Protocol Exceptions, Deviations and Violations/OHR-20, Submission of Amendments, New FDA Requirements for IRB Registration, Re-Consenting Research Subjects, New and Modified Forms
May Conflicts of Interest (COI) and Subject Recruitment Incentives, IRB Fees, eSAEY, Aware for All
February AAHRPP, Role of Investigational Drug Service Pharmacist on IRB, Clinical Trials.Gov, Aware for All, Humanitarian Use Devices (HUD)

2008

Date Description
September AAHRPP, Final Reports, Amendments, Forms, Fees, Resubmission of Expired Studies
April IRB Accreditation, Noncompliance, Reporting UAPs, Modifications to protocols before IRB Review