Office of Human Research
Leadership
Positions:
- Director, Office of Human Research
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
Email:
Walter.Kraft@jefferson.edu
Contact Number(s):
For Research Activities
Positions:
- Senior Associate Provost, Research Conduct & Compliance
- Professor, SKMC Department of Pathology, Anatomy & Cell Biology
Contact Number(s):
IRB Forms & Submission Materials
With the new iRIS system, many of the following forms are legacy and/or for reference only.
Guidance Documents for IRB Submission
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| First Steps - Intro to an IRB Submission (PDF) | 1/21/19 | Help for those new to the IRB submission process |
| Making IRB Submissions in the Portal (PDF) | 9/17/14 | Portal Instruction Guide |
| New IRB Submission Checklist (DOCX) | 1/20/20 | Checklist of required forms to be included with new submissions |
| Overview of IRB Submissions for New Studies (DOCX) | 11/1/18 | Table of forms required for new submissions |
| Training Slides for Submitting in the IRB Portal (PDF) | 7/23/20 | Instruction Slides |
Standard IRB Forms
| 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-10 (DOCX) | 2/2018 | Only Use if You Do Not Have Access to the eSAEy System |
| 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 |
| OHR-20 (DOCX) | 8/2014 | Only Use if You Do Not Have Access to the eazUP System |
Consent Templates
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| HIPAA Authorization (DOCX) | 4/12/19 | Authorization to use and/or disclose PHI |
| OHR-8 (DOCX) | 12/7/21 | Informed Consent |
| OHR-8B (DOCX) | 11/11/21 | Surrogate Consent |
| OHR-8D (DOCX) | 12/7/21 | Addendum to Consent Form |
| OHR-8F (DOCX) | 7/2006 | Subject Recruitment Letter |
| OHR-8H (DOCX) | 1/20/20 | Verbal Consent With Optional Use of Disclosure of PHI |
| OHR-8K (DOCX) | 2/27/19 | Consent Form Template for NCI CIRB Studies Only |
| OHR-8S (English) (PDF) | 11/4/19 | Short Form Consent (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Albanian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Arabic) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Bengali) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Cambodian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Chinese-Simple) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Chinese - Traditional) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Farsi) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (French) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Greek) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Gujarati) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Haitian Creole) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Hindi) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Indonesian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Italian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Korean) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Polish) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Portuguese - Brazilian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Russian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Spanish) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Vietnamese) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| Cooperative Consent Form Addendum (DOC) | Consent form addendum for institutions participating in a study at TJU through a cooperative agreement |
Protocol Templates
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Research Protocol Template (DOC) | 11/2010 | For use with investigator-initiated trials (IIT) in addition to the OHR-2 |
| SKCC Protocol Templates | For use with investigator-initiated trials (IIT) involving cancer in addition to the OHR-2 | |
| TransCelerate Biopharma Inc. Protocol Template | Use link to access the Basic Word Edition Template and Guidelines |
Agreement Templates
If your study involves sharing data with entities outside of Jefferson and the sharing of data is not already covered in your research contract, please contact Doreen Kornrumpf in the Office of Legal Affairs for assistance with preparation of a data use agreement (DUA).
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Unaffiliated Investigator Agreement (DOC) | 5/6/19 |
For use with investigators who have no institutional affiliation (with Jefferson or other institutions). |
| IRB Reliance Agreement (DOCX) | 8/4/20 | Used for IRB reliance situations where another IRB agreement does not take precedence (i.e., Smart IRB, Master, or Network agreement). Please consult the IRB Reliance webpage. |
| Authorization to submit to CIRB (StrokeNet) (DOC) | 8/3/20 | A template used when submitting to University of Cincinnati IRB for StrokeNet studies. Please consult the IRB Reliance webpage. |
| Authorization to submit to NEALS IRB (DOC) | 8/3/20 | A template used when submitting to NEALS IRB. Please consult the IRB Reliance webpage. |
| WCG Authorization Form (DOCX) | 10/27/22 | A template used when submitting to WCG IRB. Please include in iRIS submission. |
| Advarra Authorization Form (DOC) | 10/27/22 | A template used when submitting to Advarra IRB. Please include in iRIS submission. |
| Castle IRB Authroization Form (DOCX) | 2/6/22 | A template used when submitting to Castle IRB. Please include in iRIS submission. |
Data & Tissue Request Forms
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| NIH Biospecimen Decision Chart (PDF) | 6/25/19 | Used to Assist the Researcher in Determining Whether the OHR-19 Criteria Apply |
| OHR-17 (DOCX) | 11/11/21 | Certification for Use of PHI of Decedents for Research |
| OHR-19 (DOCX) | 8/23/19 | Research Involving Coded or Anonymous Private Information and Biological Specimens |
| OHR-22 (DOCX) | 7/8/15 | Collection of Discarded Tissue |
| OHR-29 (DOCX) | 11/11/21 | Review Preparatory to Research Request Form |
Regulatory Checklists
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| OHR-25 (DOCX) | 11/1/18 | Device Worksheet |
| OHR-26 (DOCX) | 5/2012 | Research Involving Children |
| OHR-27 (DOCX) | 5/2011 | Research Involving Pregnant Women, Fetuses, and Neonates |
| OHR-28 (DOC) | 5/2011 | In Vitro Diagnostic Device Research |
Miscellaneous Forms
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| iRIS Access Request for non-Jefferson personnel (DOCX) | 09/20/22 | iRIS Access Request for unaffiliated individuals |
| Signature Form for Study Application for iRIS | 08/24/22 | Form to obtain signatures for Chairs/Supervisors and Business Administrators without access to iRIS |
| Request for Acknowledgement (DOCX) | 02/04/22 | Request for Administrative Acknowledgement of Documents |
| OHR-31 (DOCX) | 07/08/15 | Waiver Request for Inclusion/Exclusion Criteria |
| OHR-32 (DOCX) | 08/24/22 | Radiation Research Review Form |
| OHR-33 (DOCX) | 11/01/18 | IRB Approved Protocols and External Funding |
| OHR-34 (DOCX) | 12/14/22 | Research Not Requiring IRB Review: A Checklist |
| OHR-35 (DOCX) | 02/2020 | Checklist for Undergraduate Research Study |
| OHR-36 (DOCX) | 03/06/19 | Quality Improvement vs Human Research Decision Tool |
| OHR-37 (DOCX) | 05/22/20 | Checklist for International Research |
| OHR-38 (DOCX) | 05/22/20 | Subcontractor Checklist: Safeguarding and Protecting Children |
| Radiology Research Feasibility Assessment | 10/07/16 | Online Form to Be Completed When a Study Needs Radiology Approval Prior to IRB Submission |
| Local Context Questionnaire for Site Relying on Jefferson IRB (DOCX) | 03/18/19 | Jefferson Relying on Site Survey for Multicenter Studies |
| TJU SMART IRB Acknowledgement Template (DOCX) | 03/18/19 | Acknowledgement of Site Agreement to Cede IRB Review and Reviewing IRB to Provide Oversight |
IRB Submission Portals
The IRB Submission Portals can only be accessed on the Jefferson network, except for the external IRB Portal site.