IRB Archive
Leadership
Name:
Walter Kraft, MD
Position:
- Director, Jefferson Office of Human Research Protection
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
Email:
Walter.Kraft@jefferson.edu
Contact Number(s):
Below you will find an archive of documents and links that are no longer in use. You may reference these resources, but they should not be submitted with study applications. To find a listing of active IRB Forms & Templates, please visit the Active IRB Forms & Templates page.
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| OHR-1 (DOCX) | 8/24/22 | Proposal Transmittal and Approval Form |
| OHR-2 Submission Guidelines (DOCX) | 10/2/17 | Guidelines for Preparing and Submitting OHR-2 |
| OHR-2 (DOCX) | 11/11/21 | Summary of Interventional Human Subjects Research |
| OHR-2B (DOCX) | 11/11/21 | Summary of Non-Interventional Human Subjects Research |
| OHR-3 (DOCX) | 1/21/19 | Request for Waiver of Subject Authorization to Collect Protected Health Information |
| OHR-4 (DOCX) | 11/1/18 | Record/Chart Review/Computer Database Research Study |
| OHR-5 (DOCX) | 5/2015 | De-identification of protected health information certification |
| OHR-9 (DOCX) | 11/11/21 | Continuing or Final Review of Research Protocols Involving Human Subjects |
| OHR-12 (DOCX) | 8/23/19 | Amendment to Research Protocol |
| OHR-12B (DOCX) | 9/29/21 | Adding Study Personnel |
| OHR-12C (DOCX) | 9/29/21 |
Removing Study Personnel |
| OHR-15 (DOCX) | 11/1/18 | Human Biological Specimen, Tissue, and/or Genetic Research |
| OHR-18 (DOCX) | 9/4/20 | Application for Exemption from IRB Review |
| Request for Acknowledgement (DOCX) | 02/04/22 | Request for Administrative Acknowledgement of Documents |
OHR has provided the following resources to assist with changes due to
COVID-19.
| DOCUMENT | DESCRIPTION |
|---|---|
| Changes to Research Made in Response to COVID (PDF) | General announcement on changes to clinical research studies due to COVID-19 and how to report them to the IRB. |
| Changes Made to Study to Eliminate Immediate Apparent Hazard to Research Participants (DOCX) | Use this log to document changes made to eliminate immediate hazards to research participants due to COVID-19. |
| Guidance for Alternate Routes of Consent in Response to COVID-19 (PDF) | A guide to modifying the consent process for compliance with governmental and Jefferson social distancing requirements. |
| Resuming Non-Essential Clinical Research Operations (RTF) | |
| Departmental Plan for Resuming Clinical Trials (DOCX) | |
| Departmental Plan for Resuming Clinical Trials - Excel (XLSX) |
IRB Announcements
All links are PDFs, unless otherwise noted.
| DATE | DESCRIPTION |
| October 7 | Changes to the JOHRP Policies and Procedures Manual |
| DATE | DESCRIPTION |
| November 11 | Changes to Investigator Signature Options in Consent Form |
| DATE | DESCRIPTION |
| March 16 | Changes to Research Made in Response to COVID |
| DATE | DESCRIPTION |
| August 27 | IRB Reliance Website |
| April 12 | Modified Subject Injury Language |
| April 02 | REMINDER: Investigator Signature Line in Consent Forms (MCARE) |
| April 01 | IRB Announcements Transitioning from Listserv to myJeffHub |
| January 21 | Common Rule |
| January 18 | Accessing IRB Forms |
| DATE | DESCRIPTION |
| November 07 | Updates to CITI Training |
| November 01 | Burden-Reducing Provisions |
| October 17 | Changes to JeffTrial and IRB Submission Process 2 |
| June 28 | Changes to JeffTrial and IRB Submission Process |
| May 24 | Change in Procedure for Submitting IAAs |
| May 23 | Updates to IRB Fees |
| March 21 | Changes to Consent (including PA Court Ruling) |
| February 28 | Please Use Current OHR Forms for IRB Submissions |
| February 27 | Updates - Reporting SAEs and UAPs to the IRB |
| January 19 | Implementation of Revised Common Rule Delayed |
| January 10 | Annual Conflicts of Interest Reporting Process |
| DATE | DESCRIPTION |
| September 26 | Shinal Case and Human Research (Obtaining Consent) |
| August 04 | CITI Training Requirements for Investigators and Key Personnel |
| February 02 | OHR Welcomes Schulman Associates IRB as New Partner |
| DATE | DESCRIPTION |
| December 28 | Elimination of OHR-12C |
| December 16 | IRB Reminder Emails |
| September 01 | Suggested Methods for Using Version Date and Version Number |
| June 23 | Number of Full Review Packets Changed |
| May 31 | SAE and UAP Summary Reports |
| April 29 | Expedited IRB Submissions Are Now Paperless |
| February 18 | IRB Website Updates |
| DATE | DESCRIPTION |
| November 18 | New Essential Study Documentation Webpage |
| November 04 | New Frequently Used Documents Link on OHR Website |
| November 04 | Additional IRB Options with WIRB-Copernicus Group |
| October 22 | Welcome to the New Office of Human Research Website |
| August 31 | Quorum IRB Review Goes Live |
| May 29 | IRB Announcements Are Now Available on Our Website |
| May 27 | Amendments Changing PI |
| April 10 | Subject Initial Requirement on Consent Form Eliminated |
| February 06 | Provision of Paper Copy for IRB Submissions |
| January 09 | Password-Protected Documents in the Portal |
| January 09 | WIRB Application Process Is Now Live |
| January 07 | OHR-1 Is Now Exclusive Signature Form |
IRB Archive
| DATE | DESCRIPTION |
| January (PDF) | Final Common Rule Published, Avoiding Non-Approval, "One IRB" Initiative, Consent Signatories |
| DATE | DESCRIPTION |
| June (PDF) | 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 (PDF) | AAHRPP Site Visit; Commercial IRBs; Abington Integration; Staff Updates; Key Personnel; Policy Updates |
| DATE | DESCRIPTION |
| OHR Leadership; Vice Chair of Board 153; OHR Move; Forms & Policies; Essential Documentation Binder |
| DATE | DESCRIPTION |
| July (PDF) | FDA Inspection; Use of Independent IRBs; New Webpage; How to Submit a New Study; Reporting Unanticipated Problems |
| April (PDF) | 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 |
| DATE | DESCRIPTION |
| May (PDF) | Special Addition Introducing JeffTrial |
| February (PDF) | New & Revised Policies; IRB Turnaround Time; Current Forms |
| DATE | DESCRIPTION |
| March (DOC) | 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 |
| DATE | DESCRIPTION |
| October (DOC) | 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 (DOC) | Change In IRB Voting System; Correspondence With Investigators; Response of Investigators; Change Coming for Common Rule |
| July (DOC) | IRB Approval Letters for NIH; New Forms; Review of Serious Adverse Events (AEs) and UAPs; Initial Review of Possible Non-Compliance |
| June (DOC) | TISSUE ISSUE - Banks; Ownership; Donation; Submitting to IRB; TJU/JUH Policy |
| February (DOC) | AAHRPP Renewal; Updated IRB Policy Manual and Forms; Human Subjects Research Training and IRB Review; GCP; Compliance Corner |
| DATE | DESCRIPTION |
| August - Addendum (DOC) | Notice of Community Outreach Symposium |
| August (DOC) | Jefferson Moving to CITI Program; Instructions for Accessing CITI; AAHRPP |
| April (DOC) | ORA Budgeting Services and Medicare Coverage Analysis; Research Study Information for In-Patient Charts; Using Human Tissue in Your Research; Aware for All |
| DATE | DESCRIPTION |
| July (DOC) | 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 (DOC) | Conflicts of Interest (COI) and Subject Recruitment Incentives; IRB Fees; eSAEY; Aware for All |
| February (DOC) | AAHRPP; Role of Investigational Drug Service Pharmacist on IRB; Clinical Trials.Gov; Aware for All; Humanitarian Use Devices (HUD) |
| DATE | DESCRIPTION |
| September (DOC) | AAHRPP; Final Reports; Amendments; Forms; Fees; Resubmission of Expired Studies |
| April (DOC) | IRB Accreditation; Noncompliance; Reporting UAPs; Modifications to Protocols Before IRB Review |