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.
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
Why can’t I just
submit a modification to add to my numbers to match the number already
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 firstname.lastname@example.org.
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
- 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
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. (email@example.com)
**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.**
||REVISED policy and guidance
Addition of steps that occur when over-enrollment is noted in the Status Report.
Medium. Beginning of HSD campus outreach on subject of "over-enrollment."
Additional questions, and new subject number reporting table in the Human Subjects Review Application, and Status Report Form
|Link for more info
||November 30, 2011
||REVISED Human Subjects Review Application, Status Report form
Additional questions regarding subject enrollment on the Human Subjects Review Application, and a new table on the Status Report Form for reporting subject numbers.
High. New questions and table expected to help reduce incidents of over-enrollment and the resulting non-compliance.
Over-enrollment policy and guidance update
|Links for more info
||November 30, 2011
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