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  • Human Subjects Division - Topics
    or Data Use Non Identifiable and self determination WORKSHEET Human Subjects Research Exempt There are six federally defined categories of research that qualify for exempt status HSD determines whether the research activity qualifies for exempt status Although exempt means that the research is not subject to IRB review investigators still have the responsibility to conduct their research ethically Form APPLICATION Determination Exempt Status Word Expedited Minimal Risk Expedited Review is a review process defined by the federal regulations It allows 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 In addition to meeting the regulatory definition of Minimal Risk all 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 a category in this list the study cannot receive expedited review even if it is not more than minimal risk As defined by the federal regulations Minimal Risk means that 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 Despite its name expedited review is not necessarily quicker than review by a full IRB committee The key to an efficient review is a complete and accurate application Form and Instructions APPLICATION Human Subjects Review 13 11 Full Board or Subcommittee Human Subjects Review Application Instructions Full Board Committee Convened IRB Research with human subjects that doesn t qualify for an Exempt determination or Expedited Minimal Risk review is assigned to a full board The UW has seven IRBs some review biomedical research

    Original URL path: http://www.washington.edu/research/hsd/topics/Apply+for+Review (2014-06-24)
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  • Human Subjects Division - Topics
    HSD Contact HSD Directions to HSD Topics Modify or Renew an Application How do you modify or renew a study Modification Changing Your Research Changes to your research require prior IRB approval A Modification Form describing the proposed changes must be submitted and approved before the changes can be implemented Examples of changes made with a modification form Add or remove research team members Change the consent form Add or remove populations Modifications to applications that have been reviewed by a full IRB receive full IRB review when the change is substantive and may increase risks to subjects who participate in the research When changes are minor and will not increase risks to subjects the modification may receive expedited review by a sub group of the IRB Modifications to applications that have been reviewed by a sub committee receive sub committee review unless they make the activity ineligible for expedited review Form APPLICATION Modification Approved Project NOTE Research that has been determined to be Exempt cannot be modified See the SOP Exempt Determination for more information Continuing Review Renewal via Status Report Form Once it is approved by the IRB your application must be reviewed at least annually Submit a

    Original URL path: http://www.washington.edu/research/hsd/topics/Modify+or+Renew+an+Application (2014-06-24)
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  • Human Subjects Division - Topics
    Research Related Problems SOP Reporting by Researchers Report Problems and New Information The table below includes a summary of problems and information that require reporting to HSD and the IRB as well as the time frame for reporting and which form to use Information events and problems that are not research related do not need to be reported Minor non compliance only needs to be reported if it consists of an event or information listed in the table and does not otherwise need to be reported When the components of the research are distributed across more than one institution or site reporting requirements may differ depending upon the IRB review arrangements For a more detailed description of HSDs reporting requirements definitions guidance and examples of what to report and what not to report see SOP Reporting by Researchers If you need help deciding what to report and what form to use call HSD at 206 543 0098 and ask for a member of the Regulatory Affairs Team Information or Event When to report Form to use Medical Problem Report within 24 hours REPORT Problems Submit by e mail as instructed on the form Problem reports are reviewed according to SOP Management of Research Related Problems Breach or possible breach of confidentiality or privacy Inappropriate access of protected health information PHI Unanticipated Problem Report within 10 business days Unanticipated medical device effect Serious non compliance Continuing non compliance Emergency deviation from IRB approved procedures See also SOP Modifications Continuation of research after IRB approval has lapsed See also SOP Continuing Review Complaint of a subject that cannot be resolved by the study team See also SOP Research Inquiries Audit inspection or safety related inquiry by a federal agency New information that has implications for the risks of the research e g

    Original URL path: http://www.washington.edu/research/hsd/topics/Report+Problems+and+New+Information (2014-06-24)
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  • Human Subjects Division - Topics
    When and How Can a Study Be Closed Closing an IRB Application If all research related activities with human subjects have been completed and all data collection and analysis of identifiable private information described in the IRB approved research plan have been finished then the human subjects aspect of the research study has been completed When a human subjects research study has been completed investigators are no longer required to obtain continuing review and approval of that study by the IRB UW researchers should submit a Status Report Form and select CLOSE IRB Application on the first page of the form under Submission Reason Once an application has been closed investigators should keep the data they collected including identifiable private data as consistent with the IRB approved research plan If the data have been de identified use of the data for analysis and publication may continue after the application has been closed However if the data have not been de identified the data may not be used after the application has been closed Investigators should continue to honor any confidentiality protections of the data as well as any other commitments that were agreed to as part of the approved research

    Original URL path: http://www.washington.edu/research/hsd/topics/When+and+How+Can+a+Study+be+Closed (2014-06-24)
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  • Human Subjects Division - Announcements
    delays in the IRB review of new applications Modifications or Status Reports Thank you to the many many faculty members and HSD staff who served on or supported IRB Committee C Flexibility Initiative Introduction HSD is pleased to announce the launching of our Flexibility Initiative Its purpose is to identify areas of flexibility in IRB review that can reduce workload for researchers and or IRBs and that can be implemented without diminishing human subject protections The flexibility projects we will implement during the next year have been identified as best practices by a national group called the Flexibility Coalition The Flexibility Coalition is an informal grass roots organization that consists of IRB managers that are interested in achieving a more flexible approach to the increasingly burdensome requirements for human subjects research HSD is one of more than 75 members The federal IRB oversight agencies and accrediting organizations agree with the Flexibility Coalition s approach and suggestions We plan to adopt some highly visible changes that will dramatically affect minimal risk research that is not federally funded The first Flexibility Project is now complete and was implemented on May 30 see news item below Stay tuned for additional Flexibility news as a regular feature of this newsletter Flexibility Project Exempt Category 7 Implemented May 30 2014 HSD s first Flexibility Project is the implementation of a new category of Exempt research called Category 7 The qualifications are the same as for Category 2 Exempt status except that Category 7 Allows the use of tasks games priming and physical actions by a subject and It is limited to research that is not federally supported HSD believes that a significant number of studies will now qualify for Exempt status rather than requiring an IRB application and Minimal Risk review See the SOP Exempt

    Original URL path: http://www.washington.edu/research/hsd/announcements/?q=1627 (2014-06-24)
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  • Human Subjects Division - Announcements
    new Minimal Risk review coordinator This is being accomplished by re distributing staff and vacant positions within HSD One of the social behavioral IRBs will be discontinued as of June 30 and the staff associated with that IRB will joining Minimal Risk teams Next month s e Newsletter will have more information about theses changes We expect the transition to be smooth and to require no extra work for those researchers whose studies will eventually be transferred from the discontinued IRB to another social behavioral IRB WIRB Related Documents and Tools HSD previously announced the availability of two significantly revised Standard Operating Procedure SOP documents that consolidated the dozens of previous outdated documents about sending industry trials to Western IRB WIRB for IRB review Brecken Cardinal HSD s Clinical Trials Administrator has now completed revising or developing the suite of documents and tools about using WIRB for IRB review Note the inclusion of two new items below We hope that this suite of documents will greatly assist study coordinators and their principal investigators The completed suite includes SOP WIRB Review Research Procedures Implemented 2 28 14 SOP WIRB Review HSD Procedures Implemented 2 28 14 UW WIRB FAQs and Frequent Errors NEW 3 28 14 UW WIRB Initial Submission High Level Process Diagram Revision 2 28 14 UW WIRB Initial Submission Detail Level Process Diagram NEW 3 28 14 REQUEST AUTHORIZATION UW WIRB Revision 2 28 14 TEMPLATE Consent Form UW WIRB Revision 4 25 14 TEMPLATE Consent Form UW WIRB Clinical Pharmacology Unit CPU Revision 4 25 14 WIRB Fee Schedule 2014 Revision 2 14 14 WIRB Clinical Pharmacology Unit Fee Schedule Revision 5 10 13 WIRB Clinical Pharmacology Unit Services Brochure Revision 5 10 13 Feel free to contact Brecken with questions or comments through hsdinfo uw edu

    Original URL path: http://www.washington.edu/research/hsd/announcements/?q=1622 (2014-06-24)
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  • Human Subjects Division - Announcements
    the Certificate from the researcher This includes recruiting and consenting for those parts of the study See the SOP Certificate of Confidentiality for more information Clinical Trials Registration at CT gov Reminder About How to Obtain Help Most clinical trials are required by federal law to be registered at the public website www ClinicalTrials gov sometimes referred to as CT dot gov This is the responsibility of the researcher except for industry trials and trials reviewed by the Fred Hutchinson IRB Richard Brzustowicz a senior HSD administrator is the University s primary administrator for CT gov He can help you with setting up accounts re setting passwords and similar issues Email him at brz uw edu or call him at 206 543 4464 Also short step by step instruction documents are available at the HSD Clinical Trials gov web page where you can also find contact information for the federal staff who can help you with questions or difficulties as you navigate specific registration requirements Required HIPAA Training for Washington State IRB New Option for Fulfilling this Requirement The Washington State IRB reviews UW research that will use records or clients from certain state agencies such as the Washington State Department of Health When the state records include Protected Health Information PHI the state IRB requires all members of the research team to obtain training about the federal HIPAA regulations that govern the use of PHI UW faculty staff or students who are not employees of UW Medicine cannot take UW Medicine s HIPAA training Therefore HSD has arranged for two alternative ways to fulfill this requirement Completion of the standard CITI human subjects training which includes HIPAA through the CITI web portal or Completion of the stand alone HIPAA module titled Health Information Privacy and Security HIPS through the CITI web portal CITI is a national online human subjects training service You must enter and register through the UW portal Instructions are located on the HSD website 2014 Update to the International Compilation of Human Research Standards The International Compilation of Human Research Standards is a listing of over 1 000 laws regulations and guidelines that govern human subjects research in 107 countries as well as the standards from a number of international and regional organizations The Compilation was developed for use by researchers IRBs and others The 2014 edition is now available and can be accessed in both Word and PDF formats http www hhs gov ohrp international index html Major changes in human subjects standards were reported for Brazil France Kyrgyzstan Switzerland Taiwan and Turkey Three new countries are featured in the 2014 edition Cameroon Mozambique and Zambia Continuing Medical Education CME Credits for the NIH PHRS Course Physicians who successfully complete the free online NIH course in the Protection of Human Research Subjects PHRS can earn up to 3 American Medical Association Physician s Recognition Award AMA PRA Category 1 Credits TM The CME Credit option is offered through a partnership with University Health Services Professional

    Original URL path: http://www.washington.edu/research/hsd/announcements/?q=1607 (2014-06-24)
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  • Human Subjects Division - Announcements
    Grants gov Submission Guide Researcher s Guide You are here HSD Home Announcements 1602 HSD Home Training Training HSD Training Videos Training Options to Meet Requirements Verification Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Announcements Subscriptions About HSD s RSS Feeds Journal of Empirical Research on Human Research Ethics Subscribe Unsubscribe e News from HSD IRB UW Ranked 25

    Original URL path: http://www.washington.edu/research/hsd/announcements/?q=1602 (2014-06-24)
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