Western Institutional Review Board (WIRB®)

Options for IRB Review of Clinical Trials

The FDA Warning Letter issued to Wayne State University in April, 2010 has led to questions from some of our sponsors of clinical trials. The most frequent requests are for information about the details of the IRB review of their particular protocols, or about the university's corrective actions and responses to the FDA. Most sponsors have been satisfied with the information we have provided to them. The contact for these communications with sponsors is Gayle Kusch, Director of the Responsible Conduct of Research at WSU (gayle.kusch@wayne.edu). She can be reached by phone at 313-577-9064.

If the answers that we provide do not satisfy a sponsor’s concerns, then an additional option can be considered. WSU has arranged to use WIRB^® for some clinical trials under these special circumstances until the warning letter has been lifted. WIRB^® is an independent central IRB located in Olympia, Washington. WSU has implemented processes to (1) review requests to use WIRB^® and, (2) manage protocol submissions to WIRB^®^.

Please note: Revised WIRB^® initial review submission forms will be available for use on November 1, 2010. To ensure that you submit your application on the correct form, please download a new form from WIRB for every application.

FAQs
1. What WSU studies are eligible for WIRB^® submission?
2. If WIRB^® will be the IRB for my study, why must I go through the Research Compliance Office?
3. How much money should be budgeted for WIRB^® studies?
4. How does the process work?
5. How can I obtain assistance with the WIRB^® submission?
6. WIRB^® - WSU Clinical Trials Consent Form Template

1. What WSU studies are eligible for WIRB^® submission?

Studies may be considered for submission to WIRB^® if they are industry-sponsored clinical trials and the sponsor has notified the investigator that they intend to hold the study until the Warning is lifted.

2. If WIRB^®will be the IRB for my study, why must I go through Research Compliance?

WIRB^® provides ethical review, which is only one part of clinical trial oversight. Certain regulatory responsibilities still remain the responsibility of WSU. These responsibilities include:

Ensuring adequate personnel training in Protection of Human Subjects and Good Clinical Practice.
Maintaining a compliance oversight role locally.
Ensuring that site specific requirements are in place.

3. How much money should be budgeted for WIRB® studies?

Make sure you include WIRB’s fees as direct charges in your budget, and plan enough funds to cover amendments, continuing reviews, and other actions during the life of the study. Please see WIRB^® Fee Schedule. Contact Sponsored Programs for additional assistance regarding budgeting fees.

4. How does the process work?

The Division of Research recognizes that the process of starting a clinical research study has many components that often need to occur simultaneously. However, to ensure the process runs efficiently, please follow the steps below as closely as possible:

Download WSU/WIRB^® Cover Sheet and Review Authorization Form

Submit the Wayne State University required items indicated on the form’s checklist by e-mailing them to wirb@wayne.edu

Download the WIRB® initial review submission form (Click here to get WIRB^® forms) and prepare the WIRB^® submission materials indicated on the checklist.

Use WIRB^® - WSU Clinical Trials Consent form template when preparing consent document. Follow the template provided, tailoring the procedures and language to that of your study. Remember, keep the language simple.

E-mail the WIRB^® submission materials along with the WSU/WIRB^® Cover Sheet and Review Authorization form to the Research Compliance Office at: wirb@wayne.edu

Obtain a signed copy of the WSU/WIRB^® Cover Sheet and Review Authorization form after review by Research Compliance. Research Compliance Office will email you a signed copy when it is approved.

Submit the WIRB^® submission materials and signed Authorization form to WIRB^® via your mechanism of choice (mail, email, or online submission). Note: WIRB^® will not review your submission without the WSU/WIRB^®Cover Sheet and Review Authorization form signed by an authorized signatory from the Research Compliance Office.

Notify your Proposal and Contract Administrator in Sponsored Programs once you receive a WIRB^® approval letter; your account cannot be set up without this approval letter.

5. How can I obtain assistance with the WIRB^® submission?

You can visit the WIRB^® web site in order to learn more about WIRB® and download their submission forms. You may also contact WIRB^® at: 800-562-4789 or via e-mail at wirb@wirb.com. Additionally, the Office of Research Compliance at WSU has designated a staff member to assist you with the WIRB^® submission: please contact the Office at 577-9064 to arrange for help or training.

6. WIRB^® - WSU Clinical Trials Consent Form Template

When submitting clinical trials research studies, please follow the template provided here. You may tailor the procedures and language to follow your study specifics, but remember to keep the language simple.

If you have additional questions, you may contact the Research Compliance Office at (313) 577-9064.