eNews re IRB Review

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Signature Policy Change

A revision to the HSD Signature Policy should ease the burden of trying to obtain the sometimes elusive original ink signatures on forms. HSD now accepts signatures in digital, electronic, or stamped format, in addition to the original ink, except on the UW Confidentiality Agreement.

If the signer is unable to sign the materials, the signature may be provided by email, hand delivery, mail, or a faxed copy of the signature page. An email from the lead research indicating approval to submit the materials is also acceptable. Both methods must include a full and correct project title identical to the other submitted materials, mitigating the possible difficulty in matching them in the HSD office.

The remaining exception to this new policy is the UW Confidentiality Agreement. This form still requires the original non-delegated signature; required by state law for research that will use UW-owned records (such as medical or educational records) without the consent of the subjects.

Please read the full policy on our website at: http://www.washington.edu/research/hsd/docs/931 and see the New and Revised Documents section of this newsletter for a list of documents that have been updated.


 

Expiring Approvals in Principle

If you have an Approval in Principle (AIP) that is expiring, you will need to submit either a full IRB Application, or apply for a Limited Activities Determination (LAD).

Approval in Principle was a mechanism developed many years ago by HSD to allow new federal awards to be released before IRB approval was obtained for the research project, with the limitation that the released funds could not be used for any activities involving human subjects. HSD learned that AIP was increasingly being requested inappropriately, and that is was inconsistent with federal regulations, thus, the move to a Limited Activities Determination.

LAD criteria are more restrictive, and not all federal grants with expiring AIP status will qualify for LAD. By federal law, LAD can be granted only when human subjects activities cannot begin until significant and lengthy development work has occurred. Examples include:

  • Development of specific procedures, questionnaires, or research instruments
  • Completion of animal studies also funded by the award
  • Purification of compounds
  • Development of an assay or diagnostic test
  • Development of a device

Apply for a Limited Activities Determination, continuation, or closure using HSD's interactive PDF form available on our website: http://www.washington.edu/research/hsd/docs/1307. For more information, see the guidance document at: http://www.washington.edu/research/hsd/docs/776

IMPORTANT REMINDER: Funding agencies are not required to release funds with LAD status.  HSD has observed that NIH and NSF are increasingly reluctant to release awards unless the investigator has exempt status, or full, unconditional, IRB approval.  In short, LAD status may not be sufficient for receiving an award.

 


 

WIRB Updates the Initial Review Submission Forms

WIRB's initial review submission forms have been revised and are available for use on their website: http://www.wirb.com

You are encouraged to begin using the new format; however, use of the updated forms will not be required until March 1, 2012.  Older versions of the submission form will not be accepted after this date.

If you have any questions about WIRB forms, please contact WIRB at clientservices@wirb.com or 1-800-562-4789.

If you have any questions about the UW HSD screening process for WIRB reviewed studies, please contact Arna Elezovic at hsdinfo@uw.edu or 206-543-0639.  Information is also available on the UW HSD website: http://www.washington.edu/research/hsd/topics/Western+IRB+%28WIRB%29

 


 

New Staff at HSD

Over the past several months, HSD has been lucky enough to fill several vacant positions with a great group of people.

Heidi Thielmann is the Review Coordinator for Committee A. She will soon be receiving her doctorate from the UW Department of Sociology with a scholarly focus in Criminology.

Dean Moore is the Program Coordinator for Committees D & G. Dean previously worked for HSD as an Administrative Assistant, and has returned with a strong interest in IRB work.

Steven Moran is the Submission Intake Coordinator. Steven graduated from the UW with a BA in Political Science last June, and has worked in the Vice Provost's office as well as in the Health Promotion Research Center here at UW.

Bailey Bell is the Review Coordinator for the Minimal Risk sub-committee E/C. She previously served as a Grants and Contracts Assistant Manager for Behavioral Tech Research, Inc.

Stefan Shipman is the Compliance Administrator, and most recently worked as a Research Supervisor and Clinical Research Associate at the Polyclinic in Seattle. He is working on his master's degree at the UW in Biomedical Regulatory Affairs.

Laura Busch is the Minimal Risk sub-committee E/G Administrator. She will soon be receiving her doctorate from the UW Department of Communication with a focus on digital media, social activism, and the framing of political messages.

Hillary Long is the Office Assistant 3 and most recently worked at the UW Bothell Library assisting in Image Collections, Reserves, and Access Services. Her bachelor's degree is from UWB in Interdisciplinary Arts & Sciences with a focus in Art History.

Alison Loechl is the Program Coordinator for Committee K. Alison comes to HSD from the UW Department of Surgery where she worked with various research studies as an assistant and student intern.  She recently received her bachelor's degree in Public Health and Anthropology from the UW.

Welcome to HSD!


 

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. (hsdforms@uw.edu)

 

Topic Signature Policy Document Revisions
Document(s) Human Subjects Review Committee Application and separate instructions, Status Report Form, Use of Non-Identifiable Specimens or Data, Repository Application, Limited Activities Determination, Initial Application: Exempt Status Request
Description Instructions on the application forms have been modified to reflect the new signature policy
Expected impact

Medium - relieve burden of obtaining original ink signature

Related changes

Signature Policy has been revised

Implementation date January 27, 2012, all changes were posted

 

Topic Signature Policy
Document(s) REVISED Signature Policy
Description Signature policy has been revised to accept signature in digital, electronic, or stamped format in addition to the original ink
Expected impact

Medium - relieve burden of obtaining original ink signatures

Related changes

Instructions on relevant application forms have been revised

Link for more info http://www.washington.edu/research/hsd/docs/931
Implementation date Policy was implemented on December 30, 2011 and posted on January 27, 2012

 

Topic Federalwide Assurance
Document(s) REVISED IRB Authorization Agreement, Individual Investigator Agreement
Description
  • Minor reformatting to streamline the agreements
  • Deletion of the statement that faxed or scanned copies are not accepted, (they are accepted)
  • On the IRB Authorization Agreement, elimination of the statement that UW IRBs must be listed on the Relying Institution's FWA, which was incorrect (per OHRP guidance)
Expected impact

Minor

Related changes

None

Link for more info Please contact Arna Elezovic at elezovic@uw.edu with questions
Implementation date February 21, 2012

 


 

light bulbQuick 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...

Classroom Research Project?

Dear HSD Quick Tips,

I recently took a research methods class in which we were broken up into groups, asked to choose a population, then design and conduct interviews with these people. We then had a big presentation at the end of the quarter.

Why didn't our instructor have us submit anything to the HSD office? I thought you were supposed to look at all human subjects research?

Sincerely,

Student Researcher

 

Dear Student Researcher,

Your instructor was right. Your project didn't need to come to our office. The key is the term "human subjects research."

HSD (and the Institutional Review Boards it supports) is responsible for reviewing research with human subjects as defined by federal regulations. These regulations (45 CFR 46.102) define research as a "systematic investigation, including research development, testing, and evaluation, designed to contribute to generalizable knowledge."  "Designed to contribute to generalizable knowledge" means that the project is designed to produce results that can be validly applied more broadly beyond the individuals studied or beyond a specific time and/or location, such as to other settings, circumstances, or categories.

As you can see, this says nothing about publishing or presenting.  A project can be designed to contribute to generalizable knowledge, and thus constitute research, even if the results are never published.  At the same time, many things are published (biographies, for example) that aren't designed to be generalizable.

The purpose of your class project (and other projects such as practica and internships) was not so much to add to the larger body of general knowledge, but to teach you about research methods, and give you the opportunity to practice these skills. In other words, your class projects did not meet the federal definition of the kind of research that requires review. That's why they did not need to come to our office.

Your instructor should still work with you to ensure that your projects adhere to the ethical standards of your field, and to relevant laws and regulations.

Next time, we'll visit when student research DOES need to come to HSD.

 


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Feb 21, 2012

IN THIS ISSUE

Signature Policy Change

Expiring Approvals in Principle

WIRB

New Staff at HSD

New and Revised Documents

   Signature Policy

   Federalwide Assurance

Quick Tips from HSD

 


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