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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.

Although this new guidance has no effect on the IRB application or review process, it will have a significant effect on researchers when they submit materials to the FDA for proposed research studies. This guidance is intended to help investigators interpret and comply with the FDA financial disclosure regulations at 21 CFR 54. The disclosure requirements extend to compensation and financial interests existing during a study and for one year after the completion of a study. The guidance uses a question and answer form to address practical issues associated with disclosure.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

 


 

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 21 CFR 50. The announcement, the regulations, and a lengthy discussion of the regulations were published in the Federal Register on February 26, 2013 (volume 78, pages 12937-12951). The new regulations finalize an interim rule published by the FDA in 2001.

What does this mean for UW investigators?

This will have little or no impact on UW research, because the new FDA rules are almost identical to the other major set of federal rules about children in research. Those other rules are 45 CFR 46, from the federal Department of Health and Human Services (HHS). The HHS rules have had a Subpart D about children for many years. The UW IRB has applied the HHS rules about children in research to all UW research. Therefore, the new FDA rules will have little or no impact at the UW.

The e-CFR website is a useful way to find the regulations: http://www.ecfr.gov/cgi-bin/ECFR?page=browse Select “Title 21 Food and Drugs”. Then select “Parts 1-99”, then Part 50. Subpart D is at the end of Part 50.

 


 

WIRB Fee Schedule Change: Effective 1/7/13

Western Institutional Review Board (WIRB) has changed its fee schedules effective January 7, 2013. The revised fees are posted to the HSD website at http://www.washington.edu/research/hsd/docs/1615

All services provided on or after January 7, 2013, will be billed at the new rates.

Contact WIRB’s Client Services Department at 360-252-2500 or 1-800-562-4789 if you have any questions.

Please note 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. You can read the policy document regarding this fee at: http://www.washington.edu/research/hsd/docs/1102

 


 

Semi-Annual Metrics

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

For more than four years, HSD has published detailed quarterly data about the HSD and IRB review processes, including turn-around-time, and work load. These metrics have led to increased transparency, as well as the ability to identify inefficiencies and bottlenecks on our processes.

Producing the metrics requires a significant amount of work. As we have observed little variation from quarter to quarter, we have decided to reduce the number of reports per year. This will free up time we can use to develop other metrics and infra-structure (including more time on our electronic application system project). We have also noted that our peer institutions generally report metrics on an annual basis (if at all).

See all of the metrics reports on the HSD website: http://www.washington.edu/research/hsd/topics/Key+Performance+Metrics

 


 

light bulbQuick Tips from HSD

Modifications Happen

If Quick Tips were to produce a line of IRB bumper stickers, this one might sell like hotcakes.

Every researcher knows that the initial research procedures don't always work out exactly as planned. And to facilitate the needed changes we have the Modification Form to help you explain the changes to the IRB.

But don’t forget, just because you’ve sent your modification request to HSD doesn’t mean that it’s been approved! Wait to hear back from us before you change anything. (Unless the changes are necessary to eliminate immediate serious risks to the subjects, of course.)

Maybe a better bumper sticker would be:

Modification Approved at IRB

Even if it doesn't fit on your car, it's still the way to go!

 


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March 8, 2013

IN THIS ISSUE

Financial Disclosure in FDA-Regulated Research

Children in FDA-Regulated Research

WIRB Fees

Quick Tips from HSD

 


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