Do all of my investigators have to participate in Human Research Protection Training to be eligible to participate in this trial?
Yes. After January 1, 2007, no application will be processed if all of the investigators listed have not received Human Research Protection Training. It’s easier to add that investigator to the trial after they have completed their training.
What if I’m missing one or two documents at submission? Can I still submit my application?
Yes. Please call the IRB office to notify them of the documents that will be missing. There are 2 ½ weeks between the IRB deadline and the IRB meeting. You will be required to have the missing documents to the office before the meeting. An approval letter will not be issued until all of the documents have been received into the IRB office.
What documents are required to be submitted with the application?
In addition to the completed application, you will be required to submit:
- Copy of the protocol
- Copy of the revised site specific Patient Informed Consent form
- Investigator’s Drug Brochure (included with drug studies)
- Instructions For Use manual (included with device studies)
- Signed and dated Financial Disclosures
- Billing and Allocation Sheet
- Site Sponsor Information Sheet
- Proof of Human Research Protection Training (if not previously filed with the IRC office)
- Signed and Dated copy of CV (only submitted once per calendar year) and
- Any recruitment materials, posters, instruction tools, education tools (CD’s & DVD’s), any website addresses, or any materials given or presented to potential or participating subjects.
What if my potential participants are non-English speaking subjects?
Your Patient Informed Consent form will be required to be in the language of the potential participant. If a sponsor provides you with non-English materials, you will be required to submit both versions of the material (English vs. non-English) to Interpreter Services here at Mercy. They will provide you with a letter to submit with your application to the IRB. During the consenting process, we suggest that you use Interpreter Services.
Can I submit a signed copy of the sponsor’s Financial Disclosure instead of having the investigators sign the one provided in the Application Packet?
No. At the present time CHI (Catholic Health Initiatives) requires that each investigator listed on the application sign the provided financial disclosure. One Financial Disclosure should be signed for every application submitted to the IRB office.
Am I required to have a co-investigator sign the application?
No. This area of signature is provided only in the case of an emergency. An example would be if it is the last day for submission and the Primary Investigator was out of town. A co-investigator could sign for him.
What is the Site Sponsor Information Sheet for?
From this sheet comes the information needed to invoice the sponsor company for IRB review fees. These fees are for review of the submitted trial. The fees are not for approvals and the sponsor company will be invoiced whether the trial is approved or not. Trials that are sponsored through the NIH, investigator-initiated or are part of a grant are not invoiced. Trials that are registries or Phase IV trials are invoiced $500. All other sponsored trials are invoiced $2,000.
Any study invoice that is not paid within 60 days will be placed on Administrative Hold. This means that the IRB will not place any further items (amendments, annual reports, etc.) on their agenda for that trial until the invoice is paid. The site and sponsor will both be notified on any trial being placed on Administrative Hold.