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A newsletter for research & medical education September 2009

FEATURE


Research Community Busy Preparing for IRBNet Launch on September 8


"IRBNet will bring our research community fully electronic submissions, reviews, and approval documents. Researchers will be able to check on the status of their submissions as they move through the review process, and will be able to 'share' their projects with collaborators both within and external to our institution. ”

—Karen Christianson, RN, BSN, CCRP
Director, HRPP

The management of IRB, IACUC, and IBC approvals will be changing September 8 to use IRBNet, a web-based system that will greatly enhance the efficiency of the submission and approval process. According to Karen Christianson, Director of the Human Research Protection Program, "There is still much work for IRB staff to do before the launch of IRBNet. And after launch, collaboration with researchers is required for the success of the implementation and to allow full functionality of the product."


Training and Resources

Training sessions run every day throughout September in the Health Sciences Library Computer Room. In addition, HRPP staff will be available in the Library to serve as a resource to researchers. Online training materials and the training schedule are both available on the IRB eWorkplace page under "IRBNet Resources."


Data Conversion Is One of the Primary Challenges

After the current IRB Webkit becomes read-only on August 27, the IRB office will closed so that IRB and IS staff can “clean” the data

and upload into the new system as many basic study documents, such as current approved consent, protocol, and investigator’s brochure, as possible.


Researchers have responsibility for uploading these documents into the new system if they do not exist in electronic form in the current system. Items that by policy require submission within 5 days to the IRB will be granted an automatic extension.


Additional Forms and Documents To Be Submitted by Researchers

In the next step after data cleaning, researchers will need to complete 2 essential forms and may need to upload basic documents for each of their studies.  This must be completed either by:

  • the next submission for the study (amendment, continuing review, etc.)

  • December 1 if there is no activity (submissions to the IRB) prior to this date. 

It is anticipated that this will take approximately 30 – 60 minutes per study depending on the complexity of the study and the familiarity of the researcher with the system. 


Important Dates

  • August 3: IRB is closed to submissions other than follow-up on submissions already in progress, time-sensitive amendments (require prompt implementation in order to minimize risks to subjects), and continuing reviews.

  • August 27: Current IRB WebKit is closed; will be "read-only."

  • August 27 - September 8: IRB Office closed

  • September 8: IRBNet will “go-live.”

  • December1: Basic data entry into IRBNet must be completed for all projects.

Contents


Feature

News

Announcements

Events

Research Tips

Grant Awards

New Publications




Keep Us Informed
Academics @ Baystate is published monthly by the Division of Academic Affairs. Please send us your comments on this issue, ideas for future issues and news about your professional accomplishments and interests.

Sharon Glazer MPH, Editor
academics@bhs.org

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October 14, 2009->