Human Research Protection Program

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BloodCenter of Wisconsin

Human Subject Research Projects

Introduction    |    eBridge    |    Training

Transfer an Existing BCW Project    |    Open a New Project    |    Contacts    |    Resources

Introduction

In January 2014, BloodCenter of Wisconsin contracted with Medical College of Wisconsin (MCW) for IRB services.  This move was made to provide access to greater IRB resources in terms of regulatory compliance and expertise, IRB staffing and services, and electronic protocol management.  MCW’s AAHRPP accreditation assures government regulators and industry sponsors of our commitment to the protection of research participants.  This move brings us one step closer to IRB consistency across campus institutions and is intended to help meet the growing needs of BloodCenter researchers.

eBridge

The MCW/FH IRB uses an electronic IRB application system called eBridge. In order to enter a protocol into eBridge, investigators must be registered in eBridge. Please contact the eBridge Help Desk for questions regarding registration.

Additional details on registration can be found in the Job Aid for BCW eBridge Registration.

Training

Human Research Protections training (required)

All individuals involved in the design, conduct or review of human subject research that is reviewed by MCW/FH IRB must obtain CITI certification.

BCW's current requirement of NIH training will be accepted if training has been completed within 3 years prior to May 1, 2014. CITI training will be required to be completed 3 years after the date of NIH training.

Banking training (required)

If your project involves banking (storing data/specimens long term for use in a yet unknown research project), Banking training will be required prior to submission of the project. An individual meeting can be set up with Dr. David Clark to assess whether your collection of data or biospecimens qualify as a bank. Contact the IRB Office at 414-955-8422 to set up this meeting.

Banking Training is also offered quarterly through the Human Research Series Module B.

eBridge Navigation (optional/strongly recommended)

Both classroom and online training is offered. These courses are helpful for those who are new to eBridge and have not submitted projects to MCW/FH IRB. You can sign-up and view the different training options here.

IRB submissions (optional/strongly recommended)

Various training and educational opportunities are offered by the MCW/FH IRB office. The content of these sessions vary and serve to provide more detailed information about specific IRB submission questions. This training would be helpful for those who are new to eBridge and have not submitted projects to MCW/FH IRB.

Transferring an existing BCW IRB approved project

Projects that currently are approved by BCW's IRB will need to be transferred to MCW/FH IRB oversight. Transferring the submission will be coordinated with the expiration date of your project. You will begin the process of transferring your project by submitting a 'Conversion CPR' application no later than 60 days prior to your projects expiration. This table indicates when currently approved BCW projects can begin working in eBridge to complete the Conversion process.

"Shells" of these existing studies have been created in eBridge. The PI and Primary Contact (study coordinator) will have access to this submission. To begin the Conversion:

1) Log into eBridge

2) In the Study Staff Home Page, select the Human Projects tab

3) Click on the Name of the project you'd like to begin working on

4) In the Study Workspace of that project, select the Start Conversion button (located on left side of screen). This submission will include completion of a CPR (Continuing Progress Report) and New Study application. The project must be submitted to MCW/FH IRB 60 days prior to expiration.

Additional details on this process can be found in the Job Aid for BCW Conversion.

Training on this process will be offered by the MCW/FH IRB office on:

  • Tuesday, April 22, 2014, 12-1:30pm at the BRI, Ziegler B Conference Room
  • Additional sessions will be scheduled as needed at a later date

Opening a New Project with the MCW/FH IRB

Beginning May 1, 2014, all new Human Research projects require an application to be submitted to the MCW/FH IRB through the eBridge system. This includes projects that may be eligible for exempt or expedited review, projects that require Full Committee review and projects that may be considered Non-Human Subject Research.

To open a new project:

1) Log into eBridge

2) From the Study Staff Home Page, click New Human Research Project

From here the IRB SmartForm application will open. Please complete all questions in the order they are presented as the form will conditionally display follow-up questions based on answers to previous questions.

For questions on how to complete certain sections of the application, please see Instructions for Completion of the PRO SmartForm.

If the project requires consent, please use one of the MCW/FH IRB Consent Form Templates.

Safety Committee Reviews:

Radiation Safety

1) If any project activities involving irradiators, CT, x-rays, DEXA scans, Fluoroscopy, and/or unsealed radioactive materials will be conducted at MCW/FH, the project must be reviewed by MCW Radiation Safety;

2) If none of the activities listed above will be conducted at MCW/FH and all study staff are from BCW, the investigator may upload a letter from the BCW Radiation Safety Officer

Institutional BioSafety Committee (IBC)

1) All studies needing IBC review will be reviewed by the MCW IBC

Contacts

For general questions on the transfer of BCW studies to MCW/FH IRB, please contact Kristin Bastian, AnnMarie Eve, or Marcia Iverson.

Other Useful Resources

MCW/FH IRB Policies and Procedures

IRB Forms

IRB Consent form templates

MCW/FH QI Program

 

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Page Updated 04/17/2014