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1. Why is GW outsourcing to an external IRB?
GW and MFA want to ensure that all industry sponsored trials are reviewed carefully and in full compliance with all applicable state and federal laws. GW and MFA also want to ensure that such studies are reviewed within a reasonable time after being submitted to the IRB. Because of this, GW and the MFA began discussing the possibility of outsourcing certain IRB services to a commercial IRB in the summer of 2006.
2. What outside IRB is being considered for a contractual agreement with GW?
Western Institutional Review Board (WIRB) is the commercial institutional review board (IRB) that serves as the IRB of record for industry sponsored trials at this time. WIRB provides ethical reviews of human subjects research. It is the largest IRB in the United States, with over 200 staff members that serve over 5,000 investigators all over the world. It is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AHRPP).
3. How would this affect GW’s Federal Wide Assurance?
Using an outside IRB would not change GW’s obligations under its existing FWA. The review performed by the designated IRB, whether the GW IRB or WIRB, will meet the human subject protection requirements of GW’s OHRP-approved FWA. GW remains responsible for ensuring compliance with the IRB’s determinations and with the Terms of its OHRP-approved FWA. WIRB will follow written procedures for reporting its findings and actions to appropriate officials at GW. Relevant minutes of IRB meetings, as well as all other study related materials, will be made available to GW upon request.
4. What research activities will be eligible for review by the external IRB?
Only new industry-sponsored clinical trials are eligible to be reviewed. Types of research not eligible for review by an external IRB include, planned emergency research, xenotransplantation, gene transfer, embryonic stem cell research, investigator-initiated research (regardless of funding source) research that must be conducted under the purview of the IBC or RSC.
5. What is an “industry-sponsored” clinical trial?
- A controlled study involving human subjects, designed either to
- test drugs, devices, diagnostics, treatments, interventions or preventative measures including testing for an unapproved indication,
- evaluate the safety and effectiveness of new drugs, devices, diagnostics, treatments, interventions or preventative measures or
- collect data to increase knowledge that would lead to enhanced safety and efficacy of a drug, device, diagnostic, treatment, intervention or preventative measure, AND
- the protocols for the project is designed and written by a pharmaceutical or device sponsor or another for profit entity/company that holds the INDs/IDEs for the protocol.
6. What documents are required by the Office of Human Research prior to sending the studies
to WIRB?
To register studies in the OHR, you will need to submit a copy of the completed WIRB Initial Submission Form and GW OHR WIRB Sign-Off Sheet (hard copy or via e-mail to ohrirb@gwumc.edu)
A GW OHR IRB number will be assigned to the study and the signed GW OHR WIRB Sign-Off Sheet will be returned to you. This form is part of the required documents submitted to WIRB. WIRB will not review the study unless they receive the GW OHR WIRB Sign-Off Sheet.
7. What is the turn-around time for investigators to receive the signed GW
OHR WIRB Sign-Off Sheet?
The OHR will sign off on the GW OHR WIRB Sign-Off Sheet as soon as the terms of the payment for IRB fees have been established or when the Clinical Trial or Research Agreement (study contract) has been signed.
8. What about other research studies that are not industry sponsored clinical trials?
All other university research and all GW investigator initiated clinical trials research, regardless of funding, will continue to be reviewed by the GW IRB.
9. Is WIRB going to review “emergency use” (compassionate
use) requests and the required follow-up “emergency use” applications?
No. However, if an emergency request turns into an industry-sponsored clinical trial, then that trial can go to WIRB.
10. What about Patient Registries?
An industry-sponsored patient registry may be reviewed by WIRB if the primary goal of the registry is to collect data on long-term safety and efficacy, and if the registry will be managed by the industry sponsor rather than the GW.
11. What about the Radiation Safety for a clinical trial?
WIRB can review this aspect of the protocol.
12. What are the advantages associated with having studies reviewed by an outside IRB instead
of the GW IRB
- The “turn-around” time for review and approval may be much faster.
- Conflict of interest is eliminated since no GW affiliated individual serve as a member
of the external IRB.
- With decreased administrative burden, GW OHR staff can dedicate additional resources
to quality improvement activities associated with the human subjects protections program.
13. What are the fees charged by WIRB?
WIRB charges a separate fee for each review activity: initial review, continuing review, review of modifications, and so on.
14. Who pays the WIRB fees? And are those fees negotiated as part of the contract between the
GW and the sponsor?
GW and the IRB are not responsible for paying fees associated with WIRB review activities. Researchers should arrange the payment method directly with the industry sponsor. WIRB will bill directly the sponsor or the individual identified in the WIRB application. WIRB fees are NOT negotiated in any agreements between the GW Office of Research Services and sponsors. The method of payment may be negotiated.
15. What if the sponsor refuses to pay the WIRB fees?
If the sponsor refuses to pay the billed amounts after the study has been reviewed by WIRB, the investigator will be responsible for the fees.
16. Does this affect the F&A rate on Industry-sponsored clinical trials?
No. All Industry sponsored clinical trials still must carry the standard F&A rate of 25%. This covers indirect costs of conducting the research that are incurred by the University & MFA.
17. Who will pay for mail services between the researchers and WIRB?
WIRB submissions and approvals are done electronically. Should mail services be required, researchers should negotiate this with the sponsors and include language addressing this issue in the Clinical Research Agreement. GW will not pay for the mail services between the researchers and WIRB.
18. What if my sponsor requires review by a local IRB?
WIRB is the IRB of record for industry sponsored clinical trials. The agreement between GW and WIRB anticipates that WIRB will undertake activities to allow it to assure knowledge of the GW local research context. As such, this should be sufficient to satisfy the sponsor.
19. Can I use the consent form templates on the WIRB web site?
You may use the GW approved consent guidance document which contains specific required language approved by legal counsel. WIRB has a copy of this guidance document and is aware of the GW specific required language.
20. What about HIPAA?
Use the GWUMC HIPAA forms, as applicable and include them in your application packet to WIRB. Call the OHR for additional guidance specific to HIPAA issues.
21. If I need a federal Certificate of Confidentiality, which institution signs it?
The GW Office of Health Research.
22. How can I document my completion of Human Subjects training for WIRB?
You must obtain training through the GW web-based CITI program. WIRB will verify your completion by communication with the GW OHR.
23. After receiving WIRB approval, how do I apply for changes
to the consent documents or procedures, any other modifications and amendments, or continuing review
(status reports)?
You may apply directly to WIRB, without going through the GW OHR. Use the appropriate forms and instructions that are posted on the WIRB web site.
24. Where do I send adverse event reports or reports of unanticipated problems involving
risk of harm to subjects?
Send them to WIRB, using the forms provided on the WIRB web site. If you are reporting an on-site serious adverse event that is unexpected, report this to WIRB with a copy to the GW OHR, within 24 hours.
25. If my trial is placed on hold, suspended, or terminated, should I notify the GW OHR?
Yes. The GW OHR must be notified immediately. It does not matter whether the hold, suspension, or termination was initiated by the researcher, WIRB, the sponsor, the FDA, or any other agency.
26.
If I need approval for Review Preparatory to Research (RPR), a partial waiver of research subject
authorization or a Limited Data Set (LDS) for my research, who signs these forms?
The Privacy Officer of the covered entity. GW covered entities are the MFA and the GW Hospital. The University is not a covered entity.
27. Who should subjects contact if they have concerns, questions, or complaints?
They may contact the GW Human Protections Administrator. This is stated in the research consent form contact information.
28. Who should I contact if I need to set up a Material Transfer Agreement, or a Research and
Collaboration Agreement, in order to send or receive material or biological samples to a third party?
Direct all questions to the OHRCTT (202-994-2995). .
29. Who do I contact if I have questions about WIRB, fees, forms, types of studies eligible
for WIRB review or other issues associated with the use of an external IRB?
Please direct all questions to Leody Bojanowski via e-mail @ reslab@gwumc.edu
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