Jefferson Office of Human Research Protection
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):
* Secure links
For Research Activities
Position:
- Senior Associate Provost, Research Integrity, Conduct & Compliance
- Professor, SKMC Department of Pathology & Genomic Medicine
Contact Number(s):
IRB Forms & Submission Materials
The following forms and templates should be used as applicable when submitting to the IRB. Forms should be completed in their entirety and should be uploaded to iRIS as a PDF. Uploading word documents to iRIS may cause distortion and lead to a delay in review. Note: Password protected documents are not accepted by iRIS.
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| HIPAA Authorization (DOCX) | 4/12/19 | Authorization to use and/or disclose PHI |
| Informed Consent Template (DOCX) | 1/10/25 | Informed Consent |
| Instruction Manual for Consent Form (PDF) | 3/27/25 | Instruction Manual for the Consent Form for a Research Study |
| 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) |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| OHR-10 (DOCX) | 2/2018 | Only Use if You Do Not Have Access to the eSAEy System |
| OHR-20 (DOCX) | 8/2014 | Only Use if You Do Not Have Access to the eazUP System |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Research Protocol Template (DOC) | 11/2010 | For use with investigator-initiated trials (IIT) in addition to the OHR-2 |
| Sidney Kimmel Comprehensive Cancer Center 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 |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Monitoring Plan | 1/10/25 | Plan for monitoring by a clinical trial monitor, not a DSMB |
| DSMB Charter | 1/10/25 | Charter template for DSMB |
| DSMB Summary Report | 1/10/25 | Template for Summary Report for DSMB meetings |
| Protocol Language Suggestions for Medical Monitors and DSMB | 1/10/25 | Language to include in the protocol regarding having a Medical Monitor and DSMB |
| FORM | REVISED | DESCRIPTION |
| Unaffiliated Investigator Agreement (DOC) | 5/6/19 |
For use with investigators who have no institutional affiliation (with Jefferson or other institutions). |
| SMART Letter of Acknowledgement (DOCX) | 9/4/24 | Used for IRB reliance situations where IRB review will be ceded under the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement. Please consult the IRB Reliance webpage or email jennifer.polizzi@jefferson.edu. |
| IAA (DOCX) | 9/4/24 | Used for IRB reliance situations where IRB review will be ceded from a non-SMART IRB institution. Jefferson will serve as the IRB of Record. Please consult the IRB Reliance webpage or email jennifer.polizzi@jefferson.edu. |
| Authorization to submit to CIRB (StrokeNet) (DOC) | 8/28/24 | 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) | 8/28/24 | A template used when submitting to NEALS IRB. Please consult the IRB Reliance webpage. |
| WCG Authorization Form (DOCX) | 2/20/25 | A template used when submitting to WCG IRB. Please include in iRIS submission. |
| Advarra Authorization Form (DOC) | 2/20/25 | A template used when submitting to Advarra IRB. Please include in iRIS submission. |
| Castle IRB Authorization Form (DOCX) | 8/28/24 | A template used when submitting to Castle IRB. Please include in iRIS submission. |
| Nemours IRB Authorization Form (DOCX) | 8/28/24 | A template used by Jefferson Personnel when submitting to Nemours IRB. Please include in your Qualtrics form submission. |
| LVHN IRB Authorization Form (DOCX) | 2/18/25 | A template used when LVHN will serve as IRB of Record for a multi-site study. Please include in iRIS submission. |
| Local Context Questionnaire for Site Relying on Jefferson IRB (DOCX) | 3/18/19 | Jefferson Relying on Site Survey for Multicenter Studies |
| Statement of Work Template (DOCX) | 8/26/24 | This form is used to provide activities for a site and investigator(s). |
| Certification of Local Context (DOCX) | 9/4/24 | This form should be completed by external sites ceding IRB review to Jefferson. This form must be updated and submitted to Jefferson IRB for review during initial onboarding, late onboarding of a site(s) or continuing review |
| Overall PI Checklist (DOCX) | 9/4/24 | This checklist should be reivewed by the PI in order to review the responsibilities in assuming the role of overall PI for a study under single IRB ovesight. A signed copy should be submitted via iRIS with the amendment submission. |
| Relying PI Checklist (DOCX) | 9/4/24 | This checklist should be reivewed by the PI in order to review the responsibilities in assuming the role of relying PI for a study under single IRB ovesight. A signed copy should be submitted via iRIS with the initial submission packet. |
| 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) | 1/29/25 | Research Involving Coded or Anonymous Private Information and Biological Specimens. |
| OHR-29 (DOCX) | 11/11/21 | Review Preparatory to Research Request Form |
| Request for Data Transfer & Use Agreement (DOCX) | 01/06/24 | Use to request preparation of a data transfer & use agreement (DTUA) when a study involves sharing of data with or from entities outside of Jefferson and such sharing is not already covered in a research contract. |
| 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 |
| OHR-32 (PDF) | 10/2024 | Radiation Research Review Form |
| 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 |
| OHR-31 (DOCX) | 07/08/15 | Waiver Request for Inclusion/Exclusion Criteria |
| 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 |