Schulman Associates Institutional Review Board (IRB)
Information For the Researcher
St. Luke’s Healthcare System and the Office of Research Administration (ORA) have established a contractual relationship with Schulman Associates IRB to oversee initial and continuing review of protocols for specific clinical trials conducted at St. Luke’s facilities.
For new study submissions, St. Luke’s ORA will serve as the liaison between Schulman and St. Luke’s investigators.
Eligibility Criteria for Submitting a New Study to Schulman
Research Studies Eligible for Submission to Schulman
The criteria for Research Studies to be eligible for Schulman review include:
- The research meets the National Institutes of Health definition of a clinical trial: “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments or devices).”
- The research is a Phase I/II/III/IV drug Research Study.
- The research is a medical device Research Study.
- The research is designed by and the protocol written by the sponsor.
- The sponsor is a pharmaceutical or medical device company.
- The sponsor holds all INDs/IDEs.
- The research has not previously been submitted to the SLHS IRB for review.
Research Studies Not Eligible for Submission to Schulman
Research Studies that are not eligible for submission to Schulman include:
- Planned emergency research.
- Embryonic stem cell research.
- Investigator initiated research.
- Research that involves a request for approval for local non-affiliated sites.
- Research that involves the use of recombinant DNA and its derivatives, such as vectors or infectious agents.
- Research that the SLHS determines that the rights and welfare of subjects would be better served by local review.
Submitting a New Study to ORA and Schulman
All new submissions to Schulman must be sent to St. Luke’s ORA. ORA will determine whether the submission is eligible for submission to Schulman and, upon confirming eligibility, will submit the new study to Schulman. Please review the Schulman IRB Submission Flow Chart for more information on the submission process.
The ORA review is required by the institution (St. Luke’s) to assure the proposed research fits the mission statement of the hospital and includes a due diligence review. This due diligence review includes evaluation and negotiation of: contracts, budgets, establishment of a billing plan, as well as an evaluation of the impacts that the research may have on St. Luke’s (the departments where the research will occur (Research Process Committee) (RPC). Once the ORA review is complete, the study is ready for submission to Schulman Associates IRB.
Email new study submission packets to ResearchSubmission@slhs.org with the subject line “Schulman Submission,” or hand-deliver to the ORA office.
Please Note: for electronic submissions, all documents must be in PDF format EXCEPT Consents. ONLY Consents must be in Word format.
The following completed materials must be submitted to ORA for internal review:
- SLHS ORA form, Application for Research Study Review by Schulman located on SLHS website;
- All Schulman required dated and signed submission forms and documents, including but not limited to conflict of interest information, curriculum vitae (“CVs”) for all investigators, and recruitment and/or study-related material to be presented to subjects;
- For research involving investigational drugs, provide the IND number;
- For research involving an investigational device, a copy of (a) the signed Investigator Agreement for protocols with an Investigational Device Exemption (“IDE”) and an FDA letter granting the IDE, OR (b) a letter from the study sponsor stating that the study is a non-significant risk device study, OR (c) a letter explaining why the investigation is exempt from the IDE requirements under 21 CFR 812.2(c);
- Protocol (and amendments, if any);
- Investigator’s Brochure, Package Insert, and/or other product safety information;
- Informed Consent Document(s) and Authorization(s) to Use and/or Disclose Protected Health Information;
- Study Budget; and
- Clinical Trial Agreement.
SLHS ORA will verify that all Schulman required forms and documents are complete and signed by the PI. If deficiencies are noted, the SLHS ORA liaison will correspond with the PI to obtain necessary information to correct deficiencies prior to submission to Schulman.
SLHS will also ensure that all regulatory reviews required for a specific study are conducted and applicable information is shared with Schulman (ex. Institutional Biosafety reviews, Radiation Committee reviews).
Additionally, SLHS will ensure that each Clinical Trial Agreement (“CTA”), Coverage Analysis and budget items, if any, and applicable ICD do not conflict with regard to subject compensation for injury and any potential financial costs to subjects. SLHS will inform Schulman, upon request, of actions taken to resolve such a conflict. If a conflict exists between the CTA, Coverage analysis or budget and the ICD, the research will not commence until the conflict is resolved in a way that is acceptable to SLHS and Schulman.
SLHS will submit all New Study Submission documents, including a Certification of Eligibility letter, electronically to Schulman on behalf of the PI. Schulman will NOT accept new study submissions from SLHS investigators that are not accompanied by the Certification of Eligibility letter.
Upon Schulman’s receipt of a new study submission from SLHS, a SiteAccess account will be established using the site contact email provided on the Schulman submission form. SiteAccess allows users to track review activities in real time as well as to download approval documents as soon as they become available.
Schulman SiteAccess technical support is available via email at SiteAccessSupport@sairb.com or via phone at (877) 216-7666.
Ongoing Review Activities
Amendments to the protocol, Administrative Changes, and requests to revise the informed consent document(s) (ICD[s]) must be submitted directly to Schulman following the guidelines provided on Schulman’s website except as noted below:
- Amendments Involving Change to Research Staff: For Amendments or ICD revisions involving changes to research staff, including, but not limited to a change of Principal Investigator, the Principal Investigator must submit such a request for change(s) to SLHS ORA designated liaison. Following pre-review by SLHS designated liaison, the PI may proceed with submission of Schulman’s required documents to Schulman.
Continuing Review and Final Reports
- Investigator Alerts: The Research Study investigator will receive e-mail alerts from Schulman regarding the need for continuing review of Schulman approved protocols.
- Submission to Schulman: Prior to expiration of Schulman IRB approval, the investigator must seek continuing review approval or close out the study by submitting a final report. For continuing review or to close the study, the investigator must submit all required documents directly to Schulman following the guidelines provided on Schulman’s website.
- Follow-up and Document Posting: Schulman will contact the investigator with any questions regarding the report. Re-approval documents will be accessible to the investigator and SLHSauthorizedliaison(s) via Schulman’s SiteAccess system.
Unanticipated Problems Involving Risks to Human Subjects or Others and Serious and/or Continuing Non-Compliance
Unanticipated Problems Involving Risks to Human Subjects or Others (“Unanticipated Problems”) must be reported to the Board within ten (10) business days of the site becoming aware of the problem. Unanticipated Problems must be reported to the IRB within 24 hours of discovery if the Unanticipated Problem involves a death. The Unanticipated Problem(s) must be reported in writing using the Unanticipated Problem Form on Schulman’s website.
The Principal Investigator must use his/her clinical judgment in determining whether an Unanticipated Problem is an event that is both unexpected/ unforeseen, whether it is related or possibly related to participation in the research and if the event suggests that the research places the subject(s) or others at greater risk of harm than was previously known or recognized. Unanticipated Problem Forms that are submitted electronically will receive an acknowledgment of receipt via e-mail.
All non-compliance issues with the Research Study protocol, applicable laws and/or regulations and/or IRB requirements that have an adverse effect on the safety or welfare of the study subject(s), and/or on the data collected, and/or are related to a breach of confidentiality must be reported to Schulman within ten (10) days of the site becoming aware of the non-compliance. Use the Non-Compliance Form located on Schulman’s website to report any non-compliance issues to Schulman.