News & announcements from the RSPP

SOP Update

The Aurora IRB SOPs are currently being reviewed as part of the re-accreditation application process. Individual SOPs will be posted on the IRB web site as each document is approved by the IRB Steering Committee. If you need access to a particular SOP, please call the Aurora IRB office to check on the status of the policy and whether any substantive revisions are pending.

FDA issues revised guidance document on protecting device and drug research subjects

The FDA has issued a series of revised guidance documents to assist institutional review boards (IRBs) and clinical investigators in fulfilling their responsibilities to protect human subjects participating in clinical trials regulated by FDA. The five revised guidance documents are part of the agency's Information Sheet Guidance Initiative, through which the FDA plans to rescind information sheets that are obsolete, revise and reissue information sheet guidance that address current issues, and develop new guidance documents, as needed. The process of revising and reissuing all 40 existing documents may take several years to complete. View the revised documents. Updated guidance documents are indicated by a date of 2006, highlighted in red.

Attention physician investigators and clinical research coordinators working with investigational cardiac devices at Aurora St. Luke's Medical Center

The mandatory research compliance training for year 3 of St. Luke's Settlement Agreement will begin later in the month of January 2007. You are encouraged to send your email address to Gail Buenger, Vice-President Project Management for Aurora Health Care to help simplify the process.

The plan this year is to conduct the training 100% online. Having your email address will speed up and simplify this process. You can also call Gail at (414) 649-5599. Once again, individuals will have 30-days to complete the training. Anyone not complete by the due date will be suspended from cardiac device research privileges at St. Luke's until such time as the training is complete. Thank you.

Aurora Health Care participates in the NCI CIRB Initiative

Aurora Health Care is now participating in the National Cancer Institute's (NCI) Central IRB (CIRB) Initiative. As a participating organization, Aurora physicians who take part in Cooperative Group phase III adult oncology clinical trials may request to enroll their patients into CIRB-approved protocols. Learn more about the NCI CIRB Initiative.

Mandatory IRB Registration

On July 6, 2004, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) published a joint proposed rule in the Federal Register (v. 69 no. 128) regarding the mandatory registration of Institutional Review Boards (IRBs) that review federally-funded research or research conducted under the jurisdiction of FDA.

Sponsor memo available regarding Aurora's AE reporting policy

The RSPP office has prepared two memos that can be downloaded and provided to sponsors outlining the AE reporting policy of the Aurora IRB. These memos can be found under our RSPP Guidance Documents.

Emergency use of unapproved drugs and devices

Memos from Gail Buenger, JD, Vice President Project Management and the Chairs of the Aurora IRBs.

Brown Bag Sessions regarding new IRB policies and procedures

Listen to the audio taped discussions about the new policies and procedures guiding human subject research at Aurora Health Care. The information contained in these audio tapes reflects the current practice of the Aurora Research Subject Protection Program (RSPP), but may be revised in the future to meet changes in human subject protection requirements.

Session

Date

Listen/Download

Updates to the IRB Standard Operating Procedures related to Re-Accreditation 1/21/2011 MP3
 
"Lost" in Protocol Compliance? Return to the island and get clues on IRB reporting requirements! 3/19/10 MP3
 
Quality Assurance at Aurora: A Partnership between the IRB and Clinical Research Professionals to Improve Human Subject Research 2/20/09 MP3
 
Improving the Quality of IRB Submissions 1/30/09 MP3
 
Aurora IRB Update: AAHRPP Accreditation and Forms, "Reporting of Unanticipated Problems" 4/18/08 MP3
 
Aurora IRB Update: AAHRPP Accreditation and Forms, "The New Submission Form" 4/4/08 MP3
 
Aurora IRB Update: AAHRPP Accreditation and Forms 3/19/08 MP3
 
Regulatory Documents and Compliance in the Conduct of Clinical trials 5/18/07 MP3
 
After the Clinical trial Visit: Understanding Billing and Compliance Processes for Clinical Research Studies 4/20/07 MP3
 
IRB Top 3: New Guidance Documents and FYIs 3/16/07 MP3
 
The PI and You! The secrets of being a successful research coordinator 8/18/06 MP3
 
Compliance Updates for Coordinators 7/21/06 MP3
 
Informed Consent Reading and Understanding Are Not the Same 4/21/06 MP3
 
Successful Grant Writing is NOT Just the Luck of the Irish 3/17/06 MP3
 
The New Informed Consent Template 2/17/06 MP3
 
Study Coordinator Questions and Comments 11/3/05 MP3
 
Non-English speaking subjects and Recruitment: Study Coordinator Experiences 9/29/05 MP3
 
Conflicts of Interest and Protocol Violations 11/17/04 MP3
 
Review of the new SOPs and Questions about IRB Forms 9/30/04 MP3
 
Adverse Events 8/31/04 MP3
 
Continuing Reviews 7/22/04 MP3
 
St. Luke's session 3/31/04 MP3
 
Aurora Sinai session 3/29/03 MP3

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