eNews re IRB Review

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Over-Enrollment

HSD has posted a revised policy and guidance document on the topic of “over-enrollment.” Located on the HSD website at: http://www.washington.edu/research/hsd/docs/1251; this document provides important information about what constitutes over-enrollment and its consequences. 

Guidance on “IRB Continuing Review of Research” posted by the Office for Human Research Protections (OHRP) on November 10, 2010 states: “An investigator enrolling more subjects than the maximum number allowed under the IRB-approved protocol would represent a violation of (a) the constraints set forth by the IRB under its approval, and (b) the HHS regulatory requirement that all changes in a research activity not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subjects.” (45 CFR 46.103(b)(4)) This statement clearly indicates that over-enrollment is a type of non-compliance.

Due to the many reports of over-enrollment received at HSD, it is clear that more information and education is needed. HSD steps to clarify and inform the UW research community about over-enrollment include:

For any IRB approved research project, it is the researcher’s responsibility to ensure that the approved number of enrolled subjects (or records or specimens) has not been exceeded.  You may submit a Modification Form to request approval for an increase in subject numbers before exceeding the limit described in your initial application.

 

Over-Enrollment Q&A

What should I do if I have enrolled more subjects than approved?

Submit a “Report of Other Problems” form describing what happened and explaining how you will avoid this in the future.

Why can’t I just submit a modification to add to my numbers to match the number already enrolled?

Federal regulations do not allow the IRB to grant retroactive approval of enrollment that exceeds what was originally approved.  This includes subject numbers.

If I report it, what will happen to the data I collected from the “extra subjects?”

Data collected from “extra subjects” (those that exceed the number of subjects originally approved) cannot be retroactively approved by the IRB.  However, after reviewing your “Report of Other Problems” we will provide you with guidance on how to appropriately handle this type of non-compliance, including appropriate statements to insert in manuscripts and conference presentations.

 

Please direct any questions about the revised policy, or the topic of over-enrollment to Wendy Brown wbrown3@uw.edu.

 


 

Global Health Reviewers Launches Website

Global Health Reviewers has just launched an interactive website supporting ethics committees and institutional review boards around the world. Funded by the Bill & Melinda Gates Foundation, it seeks to support research ethics reviewers internationally by providing resources and a place to discuss issues arising when reviewing research. Registration at the site is free and provides access to:

  • Open forums to discuss case studies and issues arising when reviewing research,
  • Confidential forums to discuss specific protocols, Links to ethics committees around the world and the resources they've developed,
  • Links to guidance, regulation, reports and articles on international ethical review and research ethics,
  • a directory of free online training for reviewers,
  • and a glossary and FAQs about ethical review of research.

Global Health Reviewers is part of the Global Health Hub and reviewers can also access its companion sites discussing the science of clinical trials (www.globalhealthtrials.org) and international bioethics (www.globalhealthbioethics.org).

 


 

HSD Performance Metrics: 12th Report Posted

The 12th Report of HSD Performance Metrics (for reporting period 4/1/11 to 9/30/11) has been posted to the HSD website. Information about turn-around times and other key aspects of the IRB review process can be found in the report at http://www.washington.edu/research/hsd/docs/1335 along with reports from previous quarters.

 


 

New and Revised Documents

You may have noticed that HSD has been releasing new or revised written policy, procedure, and guidance documents at a brisk pace during the past year. This is a major effort that will continue during the coming year, due to:

  • Campus requests
  • HSD's goal of increasing transparency and knowledge about the IRB review process
  • The increased frequency of federal regulatory changes

We generally release and post all new and revised documents on the last Friday of every month.  (Due to the Thanksgiving holiday, this month we are posting at the end of the month.) We use this newsletter to alert you to those new documents. We hope you like our new format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)

**Important Note: if you downloaded the Human Subjects Review Application on the morning of 12/1/2011, please check to make sure there are eleven (11) total questions in the "Subjects" section.  An incomplete version was posted the evening of 11/30.**

 

Topic Over-Enrollment 
Document(s) REVISED policy and guidance
Description Addition of steps that occur when over-enrollment is noted in the Status Report.
Expected impact

Medium. Beginning of HSD campus outreach on subject of "over-enrollment."

Related changes

Additional questions, and new subject number reporting table in the Human Subjects Review Application, and Status Report Form

Link for more info http://www.washington.edu/research/hsd/docs/1251
Implementation date November 30, 2011

 

 

Topic Subject Numbers
Document(s) REVISED Human Subjects Review Application, Status Report form
Description

Additional questions regarding subject enrollment on the Human Subjects Review Application, and a new table on the Status Report Form for reporting subject numbers.

Expected impact

High. New questions and table expected to help reduce incidents of over-enrollment and the resulting non-compliance.

Related changes

Over-enrollment policy and guidance update

Links for more info

http://www.washington.edu/research/hsd/docs/3

http://www.washington.edu/research/hsd/docs/342

Implementation date November 30, 2011

 

 

 


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Dec 1, 2011

IN THIS ISSUE

Over-Enrollment

  Over-enrollment Q&A

Global Health Reviewers Launches Website

HSD Performance Metrics

New and Revised Documents

  IMPORTANT NOTE

  Over-enrollment

  Subject numbers

 


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