eNews re IRB Review

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This edition of our e-News is much longer than usual, due to the larger-than-usual number of improvements and clarifications we are implementing. If you have any questions about anything you read in this newsletter, please send an email to hsdinfo@uw.edu

 

Use of the UW IRB

New Policy

UW researchers develop innovative relationships and affiliations with other organizations at a rapid pace. This has resulted in some confusion about who is eligible to use the UW IRB for review of human subjects research. For example, it has not been clear when the UW IRB will review research that is performed at Northwest Medical center or Valley General Medical facilities.

A new policy now describes the eligibility criteria for using the UW IRB. The policy incorporated feedback from numerous campus sources, including:

  • The Associate Deans for Research at the UW Schools and Colleges that do most of the UW human subjects research;
  • Several faculty governance and advisory groups;
  • The Office of Research; and
  • Several UW compliance offices.

Note that this policy addresses the question of "Who is allowed to use the UW IRB?" but does not address the separate question of "When is UW IRB review required?"

 


 

Revisions to the Most Commonly Used Forms

New Questions

The most commonly used IRB forms now have some new questions.The new questions are described below. Forms received after July 1, 2012 will not be reviewed by the IRB unless these questions are answered. The revised forms include:

Other documents that needed additional small but related changes are listed as usual in the regular "New and Revised Documents" section.

New Questions: Lead Researcher Affiliation and Position

Change:
The first page now requires more information about the institutional affiliation and position/appointment of the lead researcher.

Rationale:
This information is required to:

  • Improve tracking and identification of UW research
  • Ensure that the UW IRB is used only when the research is eligible for UW IRB review (see the news item above, "Use of the UW IRB").

New Questions: Use of Anesthesia

Change:
Section B (Procedures) of the main IRB application and Section B (Procedures) in the Modification form now include some questions about whether the research:

  • Involves certain research procedures that may occur during or just prior to clinical care involving the use of general anesthesia of the patient/subject; and
  • If yes, the name and affiliation of the anesthesiologist that was consulted (if the lead researcher is not an anesthesiologist).

Rational:
This information is required to:

  • Promote the safe conduct and oversight of research procedures that occur while or just before a patient/subject is undergoing clinical procedures involving general anesthesia; and
  • Ensure that all members of the surgical team are aware of certain research procedures that may occur in connection with clinical care involving general anesthesia

Impact on IRB process:
Research involving the procedures described in these questions cannot be approved by the IRB until the researcher (if not an anesthesiologist) has consulted with an anesthesiologist or has an anesthesiologist on the research team.

numbers New Questions: Subject Numbers

Change:
Sections of IRB forms that ask about the number of subjects in the research have been significantly revised.

Why do we ask about subject numbers?
The answer may influence:

  • Whether or not the IRB approves the study (risk/benefit ratio; feasibility)
  • Whether or not the IRB imposes any conditions or requirements
  • The duration of the IRB approval period (e.g. 6 months versus 1 year)
  • Whether the IRB continues to re-approve the study (sufficient progress to justify risk)

Why revise our application questions? What are the problems we want to address?

  • Widespread misunderstanding among researchers
  • Widespread over-enrollment resulting in non-compliance
  • Inconsistent questions across forms
  • Disproportionate time required to "screen" this aspect of Status Reports

Criteria for revised questions

  • Provide the IRB with the information it needs, in a clear format
  • Increased clarity for researchers (i.e. they understand the questions)
  • Feasibility for researchers (i.e. they are able to answer the questions)
  • Consistency across forms
  • Make sense for almost all research designs and methods
  • Provide a specific number (when possible) so that compliance is easily accomplished and assessed

Which number is being approved for compliance purposes?
The number of individuals/specimens/records who will have completed the study.  Why?

  • All studies have a completion point
  • Completion is meaningful to researchers and the success of the research
  • Completion is typically easy to define, and to tally for a given study
  • Completion includes subjects' exposure to risks and benefits

 


 

New Metrics

We published our first quarterly Performance Metrics Report just over three years ago. We've just released Report 14, for the period October 1, 2011 through March 31, 2012.

In honor of this three-year milestone, we've added several additional metrics and figures:

  • Figures showing the distribution of turn-around times for approval of exempt, Minimal Risk, and Full IRB new applications. We have received many requests for this information, and are happy to now begin providing it.
  • Modification turnaround times – i.e., the time it takes to review and approve Modifications.
  • The types, and frequency, of Modifications.

 

Exempt Status Request Guidance: Additions

The Exempt Status Request Guidance has been updated to include descriptions and definitions of "task" and "deception". These definitions will help clarify when research cannot be exempt from the regulations.

DECEPTION

Research that involves any manner of deception cannot receive a determination of exempt status.  If the researcher plan to withhold information about the real purpose of the research, or give subjects false information about some aspect of the research, the subject's consent is not fully informed.  A determination of "exempt" is thus not permissible.

TASK

Under exempt Category 2: Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behavior, the definitions of "survey" and "interview" specifically state that neither of these items can include task completion or role play if they are to be considered exempt from the regulations.

The definition of task has been added for clarification.

Task is defined as a piece of work to be done or undertaken. Possible examples include:

  • Asking subjects to physically manipulate an object
  • Asking subjects to play a game
  • Asking subjects to complete a specific physical action

Some educational tests (cognitive, diagnostic, aptitude, achievement) sometimes involve task completion. The inclusion of tasks under these types of tests is permissible and may still qualify for exempt review.


 

New ClinicalTrials.gov Contact

Effective immediately, the University's institutional liaison and contact point with ClinicalTrials.gov is Stefan Shipman.  Stefan is the Compliance Administrator for the Human Subjects Division. Stefan can be reached at shipmans@uw.edu or 206-543-9218.

Registering clinical trials at ClinicalTrials.gov has been a requirement since September, 2007. Registration is required for most FDA regulated studies and NIH funded trials.  The International Committee of Medical Journal Editors (ICJME) also requires that clinical trials be posted.

 


 

New and Revised Documents

You may have noticed that HSD has been releasing new or revised policy, procedure, and guidance documents at a brisk pace. 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 format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)

 

Topic Use of the UW IRB
Document(s) NEW Use of the UW IRB
Description Describes who is eligible to use the UW IRB to review their human subjects research project
Expected impact

Medium - will clarify the requirements for using the UW IRB

Related changes

Front page of all major applications have been changed to ask for additional information about researcher affiliation

Link for more information http://www.washington.edu/research/hsd/docs/1363
Article within this eNews
Implementation date May 25, 2012

 

Topic Contact for ClinicalTrials.gov
Document(s) REVISED ClinicalTrials.gov - Instructions for Responsible Party and Releasing a Study Record; Instructions for Updating a Study Records Every 6 Months; Instructions for Registering Your Trials; Q&A for Registering Studies; Transferring a Study Record from NIH to the UW Investigator; Results Registration
Description All policies, procedures and guidance documents related to contact information for CT.gov have been updated to provide the name of the new contact person
Expected impact Low
Related changes None
Link for more info

http://www.washington.edu/research/hsd/docs/1319
http://www.washington.edu/research/hsd/docs/1112
http://www.washington.edu/research/hsd/doc/1113
http://www.washington.edu/research/hsd/docs/1111
http://www.washington.edu/research/hsd/docs/1000
http://www.washington.edu/research/hsd/docs/753
Article within this eNews

Implementation date May 25, 2012

 

Topic Subject Numbers
Document(s) REVISED Consent Form Template Standard
Description Added wording to consent form template for drug studies: "state how many people will be in the study. This number should be the same as the number that has been approved by the IRB."
Expected impact Minor
Related changes See "New Questions: Subject Numbers" in this eNews
Link for more info

http://www.washington.edu/research/hsd/docs/555
Article within this eNews

Implementation date May 25, 2012

 

Topic Limited Activities Determination
Document(s) REVISED Limited Activities Determination
Description In addition to the changes mentioned for lead researcher affiliation, the format of this document has been slightly re-arranged for ease of data entry
Expected impact Minor
Related changes See "New Questions: Lead Researcher Affiliation and Position" in this eNews
Link for more info

http://www.washington.edu/research/hsd/docs/1307
Article within this eNews

Implementation date May 25, 2012

 

 

Topic Exempt Determination
Document(s) REVISED Exempt Status Request Guidance
Description Addition of section on "deception" and definition of "task"
Expected impact Medium - clarify when research cannot qualify for a determination of "exempt"
Related changes None
Link for more info http://www.washington.edu/research/hsd/docs/1206
Article within this eNews
Implementation date May 21, 2012

 


 

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May 29, 2012

IN THIS ISSUE

Use of the UW IRB

Revisions to Common Forms

New Metrics

Exempt Guidance

New CT.gov Contact

New and Revised Documents

   Use of the UW IRB

   Contact for ClinicalTrials.gov

   Consent Form Template

   Limited Activities Determination

   Exempt Status Determination

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