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).
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):
About Multi-site Research - Working with Other IRBs
IRB Reliance (or “single IRB review”) is a legal arrangement that allows one IRB to review a study that is occurring at multiple sites or to review a single-site study that involves personnel from multiple institutions. Opportunities for single IRB review are established by entering into formal IRB reliance agreements.
Investigators that would like to initiate a multi-site study consolidated under single IRB review, where Jefferson will serve as IRB of record, should submit via the the IRB of Record Request Form. If a study team would like to initiate a multi-site study consolidated under single IRB review, where TJU will cede review to another academic institution or IRB (other than WCG, Advarra, NCI-CIRB, or Castle, StrokeNet, or Neals Consortium), please submit the Request to Cede Review Form.
After submission, you will receive communication from a JOHRP Analyst within 24-48 hours. Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB.
Federalwide Assurances
Several Federalwide Assurances are maintained by JOHRP covering locations within the Jefferson Enterprise, along with affiliate locations. If you have questions or concerns about FWAs, please contact our office for assistance.
Reliance Forms & Agreement Templates
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Local Context Questionnaire for Site Relying on Jefferson IRB (DOCX) | 03/18/19 | Survey for sites relying on Jefferson in Multicenter Studies |
| Statement of Work Template (DOCX) | 08/06/24 | 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. This is for informational purposes only. You do not need to upload this with your iRIS submission. |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| SMART LOA (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 of Record Authorization Form (DOCX) | 2/18/25 | A template used when LVHN will serve as IRB of Record for a multi-site study between Jefferson and LVHN. Please include in iRIS submission. |
| Jefferson-LVHN Jefferson Authorization Form (DOCX) | 5/20/25 | A template used when Jeffesron will serve as IRB of Record for a multi-site study between Jefferson and LVHN. Please include in iRIS submission. |
Commercial IRBs
The Jefferson Office of Human Research Protection now has service agreements with several independent, commercial IRBs: Advarra IRB and WIRB-Copernicus Group (WCG).
These agreements allow Jefferson investigators to apply directly to the commercial IRB to join an existing study that has already received IRB approval. Currently, this option is open for select industry-sponsored phase 1, 2, 3, and 4 clinical trials.
JOHRP will make the final decision on a study-by-study basis as to whether it will permit an investigator to apply to the commercial IRB.
Step 1: Create the Submission in iRIS
- Create a New Study Application in iRIS.
- In Section 5.0, indicate who will serve as the IRB of Record.
- In Section 6.0, be sure to include the sponsor.
- Upload the following documents:
- Authorization Agreement with your submission.
- The authorizations can be found on the Forms Page under Agreement Templates.
- ICF to be submitted (can be working draft)
- Ancillary approval(s) or parallel review memo(s).
- Authorization Agreement with your submission.
- Route submission for review.
- Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator.
- If you are not able to route for signature within iRIS, you may attach an iRIS Signature Page with the required signoffs.
- A JOHRP Analyst will review your submission and sign the Authorization Agreement.
Step 2: Return Approval Documents
Upon receipt of the Approval Letter from the commercial IRB, please return to iRIS and upload the letter to the stipulation in order for Jefferson IRB to update the local study record.
Step 3: Post-Approval Maintenance
- The PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study.
- The PI and study team are required to submit continuing review and closure notices via the External IRB – Annual Update and Closure form in iRIS.
If you have questions at any time throughout this process, please reach out to Steven Muller, Steven.Muller@jefferson.edu or Lauren Boccardo, Lauren.Boccardo@jefferson.edu.
Advarra IRB
Advarra is the new name for the company created through the merger of Schulman, Chesapeake, and Quorum IRBs. For assistance with legacy studies previously approved by these IRBs, please use the Advarra contact information.
General Submission Questions
Katie Gaiek
585-417-7891
Katie.Gaiek@advarra.com
Study-Specific Questions
Denise De La Sierra
386-222-3034
Denise.DeLaSierra@advarra.com
- Advarra IRB website
- CIRBI (online submission system)
- CIRBI Registration (PDF)
- Submitting an Initial Review in CIRBI (PDF)
WCG IRB
Jefferson’s Institution # for WCG is 83645.
WCG Contact
Christopher Gennai, CIP
Account Manager, Institutions
360-252-2460
360-252-2498 fax
CGennai@wirb.com
Research with Collaborative Partners
Jefferson Office of Human Research Protection (JOHRP) and Lehigh Valley Health Network (LVHN) Office of Research Integrity are working to integrate IRB offices and electronic platforms. Until this transition is complete, users will submit to their respective areas of the enterprise. If collaboaration occurs between legacy Jefferson and LVHN sites, please follow the guidance below.
Initial Submission - New Study
- Prior to submitting your new study application request for Jefferson to serve as the IRB of Record in iRIS, please submit a request via the Jefferson IRB of Record - LVHN Personnel Intake Form.
- Please specify the LVHN personnel who will be added to the study.
- After submission, you will receive communication from Jefferson IRB within 24-48 hours.
- Once you receive confirmation from the IRB, you may proceed with submiting the new study application in iRIS.
- Submit a new protocol in iRIS.
- Be sure to select LVHN staff in Section 3.0. If LVHN staff are not present, please email Steven Muller.
LVHN Investigators Joining an Existing Jefferson Study
- Prior to submitting a personnel change for a study where Jefferson serves as the IRB of Record in iRIS, please submit a request via the Jefferson IRB of Record - LVHN Personnel Intake Form.
- Please specify the LVHN personnel who will be added to the study.
- After submission, you will receive communication from Jefferson IRB within 24-48 hours.
- Once you receive confirmation from the IRB, you may proceed with submiting a personnel change in iRIS.
- Submit a Personnel change form.
- Be sure to select LVHN staff in Section 3.0. If LVHN staff are not present, please email Steven Muller.
- If you have questions during this process, please email Steven Muller and Lauren Boccardo.
Start Up of a New Study
Instructions for Jefferson Sub-Investigator:
- Submit a request via the LVHN IRB of Record - Jefferson Personnel Intake Form.
- Within 24-48 hours, you will receive confirmation from Jefferson IRB that you may proceed with any activities required by LVHN IRB to initiate participation in the study.
Instructions for overall LVHN PI:
- LVHN Departmental Scientific Review
- LVHN NORI Feasibility (On the Feasibility Assessment Form, Section 5, please list Thomas Jefferson as the employer for any Thomas Jefferson study team member. )
- LVHN IRB Review
- Indicate “Single Site” in Question #4- What kind of study is this
- Indicate “No” in Question #5- “Will an external IRB act as the IRB of record for this study.”
- Indicate “Yes” in Question #6- “Will your IRB act as a single IRB of record for other participating sites?”
- Add “Thomas Jefferson” as a Research Location under the “Local Research Locations Page”, as applicable.
Addition or Removal of Jefferson Staff to an Existing LVHN Study
Instructions for Jefferson Sub-Investigator:
- Submit a request via the LVHN IRB of Record - Jefferson Personnel Intake Form.
- Within 24-48 hours, you will receive confirmation from Jefferson IRB that you may proceed with any activities required by LVHN IRB to initiate participation in the study.
Instructions for overall LVHN PI:
Follow the standard LVHN process for Adding an External Study Team Member in the eIRB system.
- Upload a Word Document with the Jefferson Investigator(s) name, contact information, role and responsibilities under Local Study Team Members > External team member information:.
If you have questions at any time throughout this process, please reach out to IRB_Office@Jefferson.edu.
Purpose
Jefferson and Nemours IRB’s have entered into a Master Reliance Agreement to facilitate more efficient review of research when studies involve only Nemours sites and patients. This Master Reliance Agreement process may only be used if all of the following conditions are met:
- There are no research activities to occur at Jefferson
- No Jefferson patients will be enrolled in the study
- No Jefferson patient data will be used in the study
- There is no data-sharing between Jefferson and Nemours
If one of the conditions are not met, please view the Academic & Other External IRBs area to determine if a reliance request is appropriate.
Step 1: Download & Complete the Authorization to Submit Form
Step 2: Complete a Cede Request via AirTable
Step 3: Wait for Correspondence
A JOHRP Analyst will review the request and respond to the Jefferson Investigator within 24-48 hours (excluding weekends and major holidays). Please ensure CITI training is up-to-date to avoid delays in processing.
Jefferson Office of Human Research Protection (JOHRP) and WIlls Eye Hospital have an established Memorandum of Understanding (MOU) to streamline and enhance collaborative research between our organizations. This agreement establishes a framework for cooperation, allowing researchers from both organizations to engage in research with reduced administrative burden. The MOU facilitates the use of a single IRB review process when applicable and ensures regulatory alignment to expedite study approvals. If you are engaging in research with Wills Eye, please review the following instructions.
Step 1: Pre-Review Request via Smart Form
- Prior to submitting a request for Jefferson to serve as the IRB of Record in iRIS, please submit a request via the Reliance Intake Form.
- After submission, you will receive communication from Jefferson IRB within 24-48 hours.
- Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB.
Step 2: Initial Submission in IRIS
- Submit protocol for review in iRIS as a single-site study (Jefferson Enterprise Sites Only).
- Please be sure to select No for multi-site study and Yes to inidcate the master application will be revised to indicate the study is multi-site in a subsequent amendment.
Step 3: Submission of an Amendment
- After the inital study approval is provided, the study team may submit an Amendment to Study Protocol in iRIS to add additional participating sites.
- Please note: No protocol or main consent modifications may be included in this site addition amendment.
- Be sure to complete all parts of Section 5.0 Selecting IRB of Record.
- Upload the following documents to the submission:
- Addendum to IRB Authorization Agreement with Wills Eye Hospital
- Statement of Work
- Certification of Local Context
- Protocol
- ICFs (if applicable)
- Route the submission for signatures.
- Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator.
- If you are not able to route for signature within iRIS, you must attach an iRIS Signature Page with the required signoffs.
- The Amendment will be reviewed and the study team will be notified of updates via iRIS.
- An approval outcome will be issued in iRIS.
- Please Note: The Jefferson Prinical Investigator and study team are responsible for providing the relying site will all IRB-approved materials.
Step 1: Submit a Request to Cede Review
- Prior to submitting a request for Jefferson to cede to Wills Eye IRB in iRIS, please submit a request via the Reliance Cede Request Form. This will allow us to assess if reliance is appropriate.
- After submission, you will receive communication from a JOHRP Analyst within 24-48 hours regarding the status of your request.
- Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB.
Step 2: Create the Submission in iRIS
- Create a New Study Application in iRIS.
- In Section 5.0, indicate Wills Eye will serve as the IRB of Record.
- In Section 6.0, be sure to include the sponsor.
- Upload the following documents:
- Addendum to IRB Authorization Agreement with Wills Eye Hospital
- Statement of Work
- ICF(s) (if applicable)
- Protocol
- Route submission for review.
- Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator.
- If you are not able to route for signature within iRIS, you may attach an iRIS Signature Page with the required signoffs.
- A JOHRP Analyst will review your submission and sign the Authorization Agreement.
Step 3: Return Approval Documents
Upon receipt of the Approval Letter from Wills Eye IRB, please return to iRIS and upload the letter to the stipulation in order for Jefferson IRB to update the local study record.
- Note: Research may not commence until JOHRP receives the approval letter from Wills Eye IRB and issues a study activation letter.
Step 4: Post-Approval Maintenance
- The PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study.
- The PI and study team are required to submit continuing review and closure notices via the External IRB – Annual Update and Closure form in iRIS.
If you have questions at any time throughout this process, please reach out to Steven Muller or Lauren Boccardo.
Academic & Other External IRBs
The SMART IRB Agreement is a national master agreement that allows institutions to avoid having to negotiate individual IRB authorization agreements per study or group of studies. Participating institutions may cede review of human subjects research to any other participating institution's IRB under this agreement.
Step 1: Pre-Review Request via Airtable Form
- Prior to submitting a request for Jefferson to serve as the IRB of Record in iRIS, please submit a request via the Reliance Intake Form.
- After submission, you will receive communication from Jefferson IRB within 24-48 hours.
- Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB.
Step 2: Initial Submission in IRIS
- Submit protocol for review in iRIS as a single-site study (Jefferson Enterprise Sites Only).
- Please be sure to select No for multi-site study and Yes to inidcate the master application will be revised to indicate the study is multi-site in a subsequent amendment.
Step 3: Submission of an Amendment
- After the initial study approval is provided, the study team may submit an Amendment to Study Protocol in iRIS to add additional participating sites.
- Please note: No protocol or main consent modifications may be included in this site addition amendment.
- Be sure to complete all parts of Section 5.0 Selecting IRB of Record.
- Upload the following documents to the submission:
- Reliance Agreement (if paper-based)
- Statement of Work (for each non-Jefferson participating site)
- Certification of Local Context
- Local Context Survey
- Only required if recruitment/consent are part of the study.
- Protocol
- External site-specific consent (if applicable)
- All Ancillary Review Approvals
- Route the submission for signatures.
- Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator.
- If you are not able to route for signature within iRIS, you must attach an iRIS Signature Page with the required signoffs.
- The Amendment will be reviewed and the study team will be notified of updates via iRIS.
- An approval outcome will be issued in iRIS.
- Please Note: The Jefferson Prinical Investigator and study team are responsible for providing the relying site will all IRB-approved materials.
Step 3: Post-Approval Study Maintenance
- The PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study.
- The PI and study team are required to submit including, but not limited to, all protocol changes, annual continuing review, and a final report to the Jefferson IRB. Approval letters should be distributed to relying sites, as applicable.
Step 1: Pre-Review Request via Airtable Form
- Prior to submitting a request for Jefferson to cede review to another institution or IRB (other than WCG, Advarra, NCI-CIRB, Castle IRB, StrokeNet, or Neals Consortium) in iRIS, please submit a request via the Reliance Cede Request Form.
- After submission, you will receive communication from a JOHRP Analyst within 24-48 hours regarding the status of your request.
- Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB.
Step 2: Submit Initial Submission in iRIS
- Create a New Study Application in iRIS
- Be sure to complete all parts of Section 5.0 Selecting IRB of Record.
- Upload the following documents to the submission:
- Reliance Agreement (if paper-based)
- Statement of Work (for Jefferson investigators)
- Protocol
- Jefferson-specific Consent From
- Note: Required if obtaining consent
- You may use the OHR-8 Jeffeson Template or external site template. Please ensure all required language in the Cost, Injury, HIPAA, and MCARE sections are included.
- Local Context Survey
- Note: If Required by IRB of Record
- Route the submission for signatures.
- Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator.
- If you are not able to route for signature within iRIS, you must attach an iRIS Signature Page with the required signoffs.
- The Reliance Team will review the submission and work with the study team to ensure the study receives approval.
- The IRB will request that the study team upload the fully executed reliance agreement, Jefferson site addition approval letter, and final approved consent form from the External IRB prior to issuing study activation.
Step 3: Post-Approval Study Maintenance
- The PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study.
- The PI and study team are required to submit continuing review and closure notices via the External IRB – Annual Update and Closure form in iRIS.
SMART IRB Reliance Agreements
The SMART IRB Agreement is a national master agreement that allows institutions to avoid having to negotiate individual IRB authorization agreements per study or group of studies. Participating institutions may cede review of human subjects research to any other participating institution’s IRB under this agreement.
Check the Participating Institutions List to see if your collaborator’s institution is a member of SMART IRB.
FAQ's about Multi-Site Research
A reliance agreement is signed by two or more institutions that normally would be required to conduct their own IRB review. The reliance agreement allows for one IRB to conduct the review that fulfills federal requirements about human subjects protection. The other institutions "rely" on the reviewing IRB, thus streamlining the approval process. Even when relying on another IRB, all institutions must comply with applicable state laws and institutional policies.
- When the Jefferson IRB is being asked to serve as the reviewing IRB for a multicenter study.
- When Jefferson personnel plan to participate in research covered by another IRB.
- When Jefferson investigators plan to conduct research at non-Jefferson locations and personnel from the non-Jefferson location will be part of the study team, or
- When non-Jefferson personnel come to Jefferson to participate in our research.
Yes, in many cases Jefferson is able to serve as the single IRB. The IRB will evaluate the investigator’s plan to oversee the study and assist the investigator in making arrangements for review of the non-Jefferson sites.
When requesting oversight by an outside IRB, investigators must always start with a permission from their home institution.
Every institution is responsible for research conducted by its own personnel, regardless of where the research occurs. When Jefferson personnel conduct human subjects research, the institution has two options:
- Review the research through the Jefferson IRB, or
- Arrange reliance on another qualified IRB
Jefferson personnel may not conduct human subjects research until approval has been obtained through one of the above options and all institutional requirements have been met.
Our current IRB reliance arrangements include:
- SMART IRB (a network of 500+ academic institutions, hospitals, and institutes)
- NCI CIRB
- Advarra
- WIRB-Copernicus Group
- NIH Strokenet
Even when an external IRB reviews and oversees a project, there are other institutional requirements that must be addressed. These include requirements for investigator training, conflict of interest review, HIPAA, data security, SKCCC PRC, radiation safety, management of grants and contracts, and compliance with state laws. These additional requirements are categorized as “local context” issues that are evaluated at the time the study is proposed.
Investigators using an external IRB remain responsible to update the IRB when key events occur. The IRB must be aware of:
- Changes to study personnel
- Annual review report
- Updates on conflict of interest disclosures
- Injury to a Jefferson subject
- Protocol deviations that could impact safety or data integrity
Please request a single review as early as possible, in the planning stages of your project.
- For new studies, the PI should pursue this step before the grant submission (if applicable) or before submitting the protocol to any IRB for review.
- When a new site or external collaborator is added to a study that is already approved at Jefferson, please contact the IRB office as soon as the site or collaborator is identified. The Jefferson IRB office can work with the other organization to see if they will rely on our review.
All research proposals are submitted through iRIS. You will create a new study application and indicate in section 5.0 who the IRB of record will be.
In general, any institution located in the United States that is engaged in cooperative (involving more than one institution), federally funded research (where each site will conduct the same protocol) must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. Please see the policy for additional information.
If preparing a grant proposing that Jefferson IRB serve as the reviewing IRB, contact the IRB at least four weeks before the proposal is due, to ensure the IRB is willing to serve. Similarly, if the grant will require that Jefferson rely on an external IRB, contact the IRB In plenty of time to receive a response prior to the grant deadline.
You should submit these documents to the Jefferson IRB for review. The Jefferson IRB will update its tracking system to reflect the new approval period. You will submit an External IRB - Annual Update and Closure.
You should first submit a closure request to the IRB of record for review and approval, according to their submission procedures. Once the IRB of record has closed the study, you should submit a copy of the closure letter to the Jefferson IRB by submitting an External IRB - Annual Update and Closure. Be sure to select that you are using the form to submit a Final Report in section 1.2.