HS-IRBs News - May 2009
Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 6, May 2009
Thanks to everyone who responded to the survey regarding preferences for training materials and in-person training opportunities for the ARROW system. We had a tremendous response to the survey and your feedback has been very valuable in helping us develop a training plan for ARROW. As a result of your input, expect to see training materials that include text accompanied by static screen shots as well as online demos without narration. We hope to offer in-person training in small group settings to allow ample time for questions and demonstrations.
As development of ARROW continues, we want to begin introducing some features of the system as well as some administrative changes that the new system will bring.
- Email notifications and downloadable correspondence: ARROW will email study teams to let them know immediately when IRB correspondence is ready. Study teams will then be able to log into the system and view or download IRB correspondence. Consent documents also will be available for download from ARROW.
- Automatic checking of human subjects training: When study teams submit an application in ARROW, the system will automatically check to ensure that human subjects training has been completed for all key personnel listed on a study, as required by campus policy.
- A single application for all types of new studies and projects: ARROW will have just 1 application for all new studies and projects. The new initial review application will include questions for exemption, emergency uses, HUDs, protocol development activities (PDA), and others. The new form uses branching logic to ensure that study teams only see the questions that apply to their type of research or application.
Information regarding new fee structure
The HS-IRBs implemented a new fee structure in July 2008. All studies submitted prior to July 1, 2008 fall under our previous fee structure, and all studies submitted after July 1, 2008 fall under the current fee structure. Please note that the IRB office typically can’t determine whether or not fees apply to specific studies over the phone given the number of factors taken into account. If you have general questions about the fee structure, please contact the IRB office. Otherwise, a good starting place is our website, which includes information about the fee structures. Visit for more IRB Fee Policy information.
WIRB brown bag update
You are invited to two upcoming Western IRB (WIRB) brown bags:
- Please join an educational session on: WIRB Changes, How to Do Them, being held May 27, 2009 from 1pm to 3pm in the HSLC room 1325. Presentation on the various processes used for WIRB changes. Topics covered will be types of changes, what documents need to be prepared, who do I send what to, and what will receive an invoice. Question and answer section will be offered after presentation. The session has been scheduled for two hours to cover all questions.
- A Western IRB Open Forum discussion will be held June 4, 2009 from 10 am to 12(noon) in the HSLC room 1306. Forum will be moderated by Colette Wagner, Commercial IRB Specialist. Please bring your questions about WIRB processes or documents to discuss amongst your peers. Opening topic will be how to complete site section in the application. Western IRB Manager of Institutions, Elaine Azarenko-Weakley will be available via conference call to discuss how sites are fill out in the application with those who attend.
Updated IDB process
The Health Sciences IRBs have revised their guidelines for the submission of revised Investigational Drug Brochures (IDBs) after initial approval of a study. Revised IDBs should be submitted at continuing review unless they result in a change to the protocol or consent form or result in the provision of information to subjects. If you have any questions about the new guidelines, please contact us.
Questions? We're Here to Help!
Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.
- For urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
- For general IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email email@example.com. These are the quickest ways to get help with general questions.
- For assistance with ARROW or technical questions, email firstname.lastname@example.org.
- To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- To receive updates about WIRB, please sign up for the WIRB listsserv by emailing firstname.lastname@example.org with a request to be put on the list.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.