Office of Human Research

Leadership

Positions:
  • Director, Office of Human Research
  • Director, Clinical Research Unit
  • Professor, SKMC Department of Pharmacology & Experimental Therapeutics
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.

Title Placeholder

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

FORM REVISED DESCRIPTION
HIPAA Authorization (DOCX) 4/12/19 Authorization to use and/or disclose PHI
Informed Consent Template (DOCX) 1/23/24 Informed Consent
Instruction Manual for Consent Form (PDF) 11/15/23 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
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

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).
SMART LOA (DOCX) 9/18/23 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.
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) 11/15/23 A template used when submitting to WCG IRB. Please include in iRIS submission.
Advarra Authorization Form (DOC) 11/15/23 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.

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-29 (DOCX) 11/11/21 Review Preparatory to Research Request Form
     

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

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