Institutional Review Office

*UPDATES*

Institutional Review Office

May 2010 Newsletter (volume 21)  [pdf]

Institutional Review Board (IRB)

In preparation for our upcoming renewal of the Center's human subject protection program accreditation by AAHRPP, the IRO has updated the following forms to reflect changes in regulatory requirements and to clarify certain questions:

• Application for Review
• Continuation Review Report
• HIPAA Supplement
• Coordinating Center/Operations Center Supplement

The updated forms will be available for use on June 01 2010.  We will accept the prior versions of these forms for new applications and continuing renewals received in our office until September 1, 2010. 

Application for Review

Please note Section 4.1 of the Waiver of Consent was changed. You now have  the option to check whether a portion of the research or participants for a study is waived as well as all aspects of the study are waived regarding the consent.

Continuation Review Report (CRR)

The updated form is shorter! !    A number of questions were eliminated or revised, and more yes/no style check boxes were incorporated to make the form easier (and hopefully faster) to complete.

A NEW PROCESS:  Effective June 1, 2010, there will be a process change for FHCRC coordinating centers that manage multi-center studies.  Coordinating centers will no longer be required to submit “IRB Certification of Approval” documents for the performance sites you manage at various times throughout the year.  Submission of the local IRB approval documents for all coordinated sites will now only be required at the time of the multi-center study’s CRR.  The Coordinating Center/Operations Center Supplement and CRR forms have been updated to reflect this process change.

We hope it will be easier for coordinating centers to providing documents to the IRO in one batch rather than piece meal throughout the year.

HIPAA Supplement

          The “Note” on page 2 was updated to provide clearer instructions. 

Coordinating Center/Operations Center Supplement

As described in the changes to the CRR, this supplement was updated to prompt investigators to submit IRB approval documents from performance sites at the time of CRR rather than throughout the year. 

This supplement only needs to be submitted with New Applications, CRRs, and when a new performance site is added to the study.

Institutionl Animal Care and Use Committee (IACUC)

The following forms were updated:  Training Confirmation Form and Monoclonal Antibody or Polyclonal Anti-Sera Production Application Form.

Effective April 1, 2009.  At the time of 3 year renewal applications, investigators are required to submit copies of all funding source document(s) supporting their research activities for IACUC review.