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
Updated Reliance Process
Attention research community: the reliance process at Jefferson has been updated to greatly improve the experience. Please use the links below to submit via the revised process flows for IRB of Record or Cede Requests. This will allow us to streamline your request and determine if engaging in a reliance agreement is the appropriate process.
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.
Reliance Submission Guidance
Below is general submission guidance for studies that utilize a single IRB. If you have questions or concerns, please reach out to a reliance team member. Find contact information: Contact JOHRP & Staff.
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. A signed copy should be submitted via iRIS with the initial submission packet. |
| 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 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. |
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).
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.
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.