IRO News

Current eNewsletter

November 2009 (volume 18)  pdf

Archived eNewsletters

October 2009 (volume 17)   pdf

September 2009 (volume 16)   pdf

June 2009  pdf

April 2009  pdf

Revised Forms and Policies

January 14, 2008

Several forms and policies were revised.  [all IRB forms] [all IRB policies]

Some revised forms and a new forms page

August 24, 2007

We have made minor revisions to 6 IRB forms and 2 policies. [all IRB forms] [all IRB policies]

Revised third party safety reports

March 23, 2007

There are now two different forms: one for AEs that meet the expedited reporting requirements, and one for AEs that do not. [more information and forms]

Revised not-human-subjects flowchart

March 23, 2007

Updated Flow Chart to Determine Not Human Subjects Research or Human Subjects Research. [flowchart] [more info]

IACUC Regional Education Conference on June 11 in Seattle

March 19, 2007

Conference link added to IACUC training page.

Human Subjects Training: May Lecture Rescheduled

March 5, 2007

The "basic" human subjects training lecture on May 24 has been rescheduled to May 14. [full schedule and registration]

Human Subjects Training: Expanded Requirements

February 14, 2007

Human subjects training is now required for investigators and staff involved in the design, conduct, or reporting of human subjects research conducted at FHCRC or through the Cancer Consortium. Training must be completed every 3 years. [more information and courses]

IRB consent review checklist updated

February 9, 2007

The IRB now only requires the PI to be listed on consent forms. [link to checklist]

Research not Involving Human Subjects

October 23, 2006

Some research involving deidentified data or specimens may be considered not to involve human subjects. For more information, see the FAQ at http://centernet.fhcrc.org/depts/iro/irb/not-human-subjects-f/index.html.

IRB Forms Revised

October 23, 2006

To more accurately capture the information needed for IRB review, the new application for full review and continuation review report have been revised.

Revisions to the new application for full review include:

• New feature: if a section does not apply to your study, you can skip the questions
• New section: adverse events
• Expanded sections: non-English-speaking subjects, multicenter studies, use of data, HIPAA, confidentiality, radiation, IBC
• New appendices: Repository, Registry, or Databank Form; Cancer Surveillance System (CSS) Case Subject Recruitment Method Form; Coordinating Center Operations Form
• Biostatistician’s signature is no longer needed
• Questions about conflict of interest have been moved to the Protocol Disposition Form

Revisions to the continuation review report include:

• New feature: you can skip some questions (depending on type of study)
• New sections: vulnerable populations, repository/registry/databank, radiation, gene therapy, summary of progress
• Expanded or updated sections: funding, gender/ethnicity, multicenter studies, FDA, conflict of interest, adverse events

Although the new forms are preferred, the IRB will continue to accept the old forms until January 1, 2007. After that, IRB staff will return the application and request resubmission using the revised forms.

IRO Web Pages Reorganized

October 16, 2006

In response to requests to make IRB and IACUC information easier to find, the IRO web pages have been reorganized.

The starting point for useful information is still centernet.fhcrc.org/depts/iro. Direct links to forms, policies, and other materials mean users can find information with fewer clicks of the mouse.

Comments, suggestions, and corrections are welcome. Contact web editor Cindy Hirano at chirano@fhcrc.org.