Adverse Event Reporting
The following changes have been made in response to researcher requests and to reflect evolving federal regulatory guidance.
Timeframe for reporting
While it is important to inform the IRB of events as soon as possible, the required timeframe for submitting this form and a copy of the signed consent form is now 10 business days from the time you become aware of the event. This is a change from our old reporting timeframe of 24 hours.
- Some questions have been revised, for clarity.
- The instructions describe the new timeframe for reporting.
- The instructions also now describe a new option for emailing the form, when it is not possible to provide HSD with the required paper copies within the required 10 business days.
Over-enrollment and Subject Numbers
In order to help the UW research community comply with federal regulatory guidance regarding over-enrollment, last month HSD revised the Subject Numbers sections of the main Human Subjects Review Application and the Status Report form. (See the December eNews.)
It rapidly became clear from your feedback that the new questions created confusion about what is a Human Subject, and when does the subject/record/specimen count towards the total number of subjects.
We are quickly working to address the problem by refining the new questions and by adding a graphic element to the questions. Due to the very broad range of research activities performed at the UW, developing understandable and applicable questions can be a challenge. To illustrate (and celebrate) the breadth of the UW research mission, here are a few examples:
- Multi-site, multi-arm clinical trials of an experimental drug for children with HIV/AIDS, involving data collection from children, parents, and childrens' physicians;
- Participatory observational ("live among") ethnomusicology studies in another country;
- A study of how virtual communities develop through social media;
- A review of 60,000 exisiting medical records, to evaluate the success of different approaches to treating a medical condition.
Volunteers to help test the new format are welcome. Please email: firstname.lastname@example.org if you'd like to participate.
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. 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)
||REVISED Adverse Event Report Form
||Timeframe for reporting increased to 10 business days, question and formatting clarification.
Medium - changes will help investigators remain in compliance.
|Link for more info
||December 30, 2011
Quick Tips from HSD
Welcome to Quick Tips, a new eNews item that takes those troublesome IRB terms, and exposes them for what they really are...
I'm in a hurry, so I want to choose Expedited Review, right? Maybe not!
Expedited review is a review process defined by the federal regulations that allows for a research study to be reviewed by the IRB committee chair, or by one or more review members designated by the chair, rather than the full convened IRB. Despite its name, expedited review is not necessarily quicker than review by a full IRB committee. The most important factor for efficient review is the researcher providing complete and accurate information within the application.
Okay, so it's not necessarily quicker. What qualifies for Expedited Review?
The UW Human Subjects Division uses Expedited Review interchangeably with Minimal Risk Review because to qualify for expedited review, a study must first meet the regulatory definition of Minimal Risk: "...the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
In addition to being no more than minimal risk, all study procedures must fall into one or more of the research categories in this regulatory list: http://www.hhs.gov/ohrp/policy/expedited98.html. If the procedures do not fit into this list, the study cannot receive expedited review even if it is no more than minimal risk.
Got it, but I'm always sending in the wrong number of copies. What's up with that?
Because of differences in filing systems between the minimal risk teams and the full committee teams at HSD, new applications for expedited review should be submitted as two copies only - not the three copies required for new full-IRB applications. You should also send in two copies of modifications and status reports.
Sometimes a study under full IRB review can have expedited review of its modifications and status reports, performed by the staff of the full IRB. If your study was initially reviewed and approved by a full IRB, all modifications and status reports must be submitted in three copies. The review team will decide whether a given modification or status report requires full-IRB review or is expeditable.
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