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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review, March 8, 2013

Mar 13, 2013 at 11:29am

Financial Disclosure in FDA-Regulated Research

New Guidance: "Financial Disclosure by Clinical Investigators"

Effective: February 26, 2013

The Food and Drug Administration (FDA) has published the final version of its guidance on financial disclosure by investigators. The guidance was developed in response to a 2009 report from the Office of the Inspector General that criticized the practices of investigators, clinical trial sponsors, and the FDA on this issue. Find out what this means for researchers by reading the full article here.

 

Children in FDA-Regulated Research

New Regulations

Effective: March 28, 2013

The Food and Drug Administration (FDA) has amended its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products.

The new regulations are called Subpart D of the regulations of 21 CFR 50. This will have little or no impact on UW research, as the new FDA rules are almost identical to the other major set of federal rules about children in research. Read more in our eNews.

 

WIRB Fee Schedule Change: Effective 1/7/13

WIRB has changes its fee scheduled effective January 7, 2013.  See the revised fee schedule here.

Please note that an additional one-time fee of $1,500 must be paid to the Human Subjects Division. The Office of Sponsored Programs and the Clinical Research Budget and Billing Office will add this to the study budget when it is developed.

 

Semi-Annual Metrics

HSD is decreasing the publication rate of its metrics from quarterly to semi-annually. Read the details here.

 

Quick Tips from HSD

Modifications Happen.  Read the full article here, or browse to the Quick Tips tab on our home page.