"Enhancing communication between the IRBs at MSU and Researchers"

Online Submission of Renewals and Revisions

We are excited to announce that the MSU IRB online application system will soon include renewal and revision applications! Currently, only initial applications may be submitted online. The online submission of renewal and revision applications will help streamline the IRB process for investigators, automatically completing some of the basic project information on renewal and revision applications, such as the IRB#, review category, title, and the contact information for the responsible project investigator. Similar to the initial application system, the renewal and revision system allows investigators to start, save and access drafts, submit applications online, and email attachments. The online submission of renewals and revisions is another step towards a “paperless” IRB application process.

 

The enhanced online application system also provides a more detailed IRB project history for investigators, listing all IRB applications (e.g., initial, renewal, revision) that have been submitted for each IRB project. After logging in, an investigator may view specific information related to each application on a particular IRB project, such as the dates when the application was started, submitted, and approved, and IRB reviewer comments. In the future, a copy of the completed renewal or revision application will also be available for all renewals or revisions submitted through the online application system.

 

The online renewal and revision applications also include an “electronic” signature for the Responsible Project Investigator (PI), eliminating the need for a signed application form.  While any investigator who is listed on the project may begin or work on a renewal or revision application, only the Responsible PI will be able to submit the application. When the application is ready to submit, the Responsible PI would log in, read the signature language, check a box, and submit the application.

 

The tentative date for the launch of the updated system is Wednesday, August 29, 2007. The update to the system will cause the current system to be down for several hours on the evening of Tuesday, August 28, 2007. Please note that this will affect the online application system and the MSU IRB Tutorial.

 

After the launch, all new renewals and revisions should be submitted using the online system. However, during the transition period, we will accept hard copies of renewals and revisions until November 1, 2007. After November 1, all renewals and revisions must be submitted using the online system, and mailed or emailed copies will not be accepted.

 

Workshops on “How to Submit a Renewal or Revision IRB Application” will be scheduled for the fall semester. These one-hour workshops will be held in a computer lab where attendees will get an interactive overview of the IRB submission and review process for renewals and revisions (for approved expedited and full board review projects). Sessions will include a hands-on demonstration of how to use the new online application system. Registration is required, and registration forms will soon be available at http://www.humanresearch.msu.edu/workshops.html .

 

Updated Human Research Website
We are excited to announce the launch of enhancements to the human research web site! The enhanced web site, www.humanresearch.msu.edu, has a new look, with additional navigational links and features. New resources, such as consent templates, individualized web pages for each IRB (BIRB, CRIRB, SIRB), search functionality, and an IRB staff directory, are now available to investigators. The updated website also includes a revised and expanded frequently asked questions page, a feedback form where investigators may submit suggestions or concerns, and an upcoming events calendar.

 

Consent Templates Posted

Now available on the enhanced human research web site are consent templates, created to assist researchers in developing their consent document. There currently are two consent templates available, one for biomedical research and one for social science / behavioral / education research. Please note that the consent templates are designed for expedited and full board research projects, and a template for exempt research is in the process of being developed.

 

The templates include the elements of consent required by the federal regulations, as well as text that may be used to help develop a consent form. These templates give various possibilities for many types of research, and not all of the statements are relevant for all projects. The templates are provided as a guide to help researchers, and are not required. It is important to note that IRB members may still request changes to the consent document, even if the consent template is used.  

 

CRIRB Initial Application Online

CRIRB initial applications may now be submitted through the MSU IRB Online Application System. Previously, only BIRB and SIRB initial applications could be submitted through this system. We are in the process of transitioning all new CRIRB initial applications to the online system. Therefore, all new CRIRB initial applications should be submitted using the online application system and should no longer be submitted by mail or email.

 

Update to CRIRB Email Address

Also, please update your CRIRB email address. All email correspondence for CRIRB should be sent to irb@msu.edu. The old CRIRB email, crirb@msu.edu, is in the process of being phased out and will no longer be used.

 

Other Upcoming Educational Events

• Wednesday, September 5, 2007 - How to Submit an Initial IRB Application Workshop, 9:00 A.M. – 11:00 A.M. at 12 Olds Hall  (registration required, forms available at the human research web site)
• Tuesday, September 11, 2007– IRB Seminar Series, “Special Circumstances in Informed Consent: Waivers and Proxy Consent”, 12:00 P.M. – 1:15 P.M.  at C214 Wells Hall (no registration needed)
• Friday, September 14, 2007- How to Submit an Initial IRB Application Workshop, 9:00 A.M. – 11:00 A.M. at 12 Olds Hall  (registration required, forms available at the human research web site)
• Monday, September 24, 2007- How to Submit an Initial IRB Application Workshop, 1:00 P.M. – 3:00 P.M. at 12 Olds Hall  (registration required, forms available at the human research web site)
• Friday, October 19, 2007– 2007 Fall IRB Conference, 8:30 A.M. – 4:30 P.M. at MSU Union (registration is required and will open at the beginning of September)
• Dates for the How to Submit a Renewal or Revision IRB Application Workshop will be posted to the human research web site soon!

Thanks for your help and support in the protection of human subjects,

Peter

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
Peter Vasilenko PhD
Director, Human Research Protection Program
Office of Regulatory Affairs

Michigan State University
202 Olds Hall
East Lansing, Michigan 48824
Phone 517-355-2180
Fax     517-432-4503

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