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  • Human Subjects Division - Quick Tips from HSD
    test This means eating and giving opinions two things at which Quick Tips excels That and sleeping but that s for another eNews issue After answering an ad in the Daily for human subjects needed to give opinions on flavors of soup we were surprised to see an HSD stamp on the consent form Turns out at the time that HSD reviewed it this study was not Exempt per the federal regulations because subjects were asked to identify pictures of vegetables on flash cards prior to the taste test The researchers wanted to know if looking at pictures of vegetables made the subjects more interested in the vegetable soups Quick Tips has some questions QT What What about Exempt Category 6 Wholesome foods involved in food quality evaluation R Unfortunately the study did not qualify at the time for this category The fact that there was a task identifying vegetable and priming prior to the tasting excluded the study from exemption QT What R Exactly We were told that because there was a task it needed Minimal Risk review instead of Exempt QT Is this study federally funded R No we re not funded at all QT What about Exempt

    Original URL path: http://www.washington.edu/research/hsd/quick_tips/?q=1628 (2014-06-24)
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  • Human Subjects Division - Quick Tips from HSD
    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 Quick Tips from HSD The Future of IRB Review Apr 1 2014 at 12 00am Are you concerned about future approval for human subjects research Twenty to thirty years in the future Will human subject regulations apply to cyborgs Zombies Will teleportation require FDA approval If you have these burning questions you are in luck HSD is pleased to announce the formation of a new IRB Committee Omega Ω Staffed entirely by precogs Committee Ω will be reviewing all future research HSD will have your approval ready before you even know what research question you are trying to answer The best part we will be able to anticipate any adverse events ensuring your experience with our Regulatory Affairs team is seamless The precogs will of course be adhering to a strict set of regulations that will be developed some time in the year 2029 These regulations include regulations on precogs Unfortunately this means that they cannot give you future research results the result of any particular grant application or the winner of any

    Original URL path: http://www.washington.edu/research/hsd/quick_tips/?q=1608 (2014-06-24)
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  • Human Subjects Division - Quick Tips from HSD
    on the Ave Hum this stout looks good a lovely coffee flavor Don t spill it on your laptop Her colleague had already ordered a liter of the day s special he d set it smack in the center of the small table leaving little room for either of their laptops which they both had open She grumbled slightly under her breath She was sure her colleague couldn t hear her over the chatter and the rumbling 70 s style guitar riffs pumping out over the sound system Right anyway like I was saying I ve got to get a Status Report into the IRB She jabbed at her keyboard trying to get the Human Subjects Division web page to refresh Isn t there any Wi Fi here She looked around the cozy room hoping to catch someone s eye Nope Her colleague pulled out his cell phone and waived it around above his head I m not picking up anything Well my wizarding friend I guess I can just use the copy that I last saved to my hard drive The research scientist sighed and swiveled in her seat this time with more determination to get someone s attention A person with notepad in hand appeared Great hi can I get a Don t do it The server interrupted What I just want a pint of Don t use that form from your hard drive Whoa what are you talking about The Status Report the Status Report Download the latest one from the HSD website That way you ll always have the latest version with all the latest information and the Intake Coordinator won t send it back and the reviewers won t email you with a bunch of questions and what kind of beer would you like The

    Original URL path: http://www.washington.edu/research/hsd/quick_tips/?q=1598 (2014-06-24)
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  • Human Subjects Division - Quick Tips from HSD
    Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here HSD Home Quick Tips from HSD 1545 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 Quick Tips from HSD An ti ci pay ay shun Dec 4 2013 at 12 00am Here at QuickTips we ve gotten used to that feeling You may remember way back in 2011 the federal Department of Health and Human Services HHS announced that they were proposing major changes to the rules regarding the protection of human research subjects aka the Common Rule The ambitious proposal titled Human Subjects Research Protections Enhancing Protections for Research Subjects and Reducing Burden Delay and Ambiguity for Investigators sought to strengthen and streamline the human subjects research protections that have been in place since 1991 But things happen and the whole proposal seems to have slipped quietly to the background The HHS department has been a bit pre occupied with other projects lately Don t worry QuickTips and the HSD newsletter will keep you up to date when any new developments occur

    Original URL path: http://www.washington.edu/research/hsd/quick_tips/?q=1545 (2014-06-24)
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  • Human Subjects Division - Quick Tips from HSD
    over her shoulder What are you reading He asked as his coffee cup started dripping over the pages She sighed shaking the paper trying to rid it of the coffee before it soaked in too much I m just going over my UW IRB application She thumbed through the sheets of paper I want to make sure that I ve got all the right attachments The elevator finally arrived The researcher and her colleague stepped in The elevator was full of people and a large food trolley I m very excited about starting this new oncology study she continued I ve just joined the Cancer Consortium and they offer some great support services She waived her application back and forth to dry off the spilled coffee Oh no A voice piped up from somewhere at the back of the elevator After some shuffling the voice continued from behind the food trolley Don t apply to the UW IRB What the heck the research scientist scanned the crowded elevator looking for the source of the voice This is happening far too often she mumbled under her breath The elevator lurched to a stop on the 3rd floor and more people pushed on Read the application cover page Most UW cancer related studies go to the Fred Hutch Cancer Consortium IRB instead of the UW IRB The researcher twisted around trying to pinpoint the location of the voice You re not seriously hiding behind a food trolley are you Give me a break the voice squeaked back It s hard to be mysterious and deliver timely advice in an elevator That mysterious voice is right you know It says right here Do not complete this form if you are member of the Cancer Consortium The colleague tapped the cover sheet a few

    Original URL path: http://www.washington.edu/research/hsd/quick_tips/?q=1529 (2014-06-24)
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  • Human Subjects Division - Quick Tips from HSD
    behind the newspaper Thank you The researcher smiled but before she could turn fully around the stranger was out the open shuttle door and gone Oh well said her colleague You ll always have the Health Sciences Express Exempt Status Changes Aug 8 2013 at 12 00am I can t seem to get my subjects to answer the survey questions honestly The research scientist sighed as she sipped her rapidly cooling latte Three of them are clearly trying to give me the answers they think I want to hear and one is thoroughly combative She traced her finger around a coffee stain on the table How about changing the survey questions Her colleague was always giving unwanted advice No She sighed again I ve been through these questions backwards and forwards this is just a classic example of demand characteristics I need to use deception so they don t know what I m trying to evaluate but the study is otherwise Exempt I didn t want to do anything that was going to mean going through the full fledged IRB review process The research scientist rested her elbows on the table and placed her chin in her hands thinking of all the paperwork and of the lost funding for the coordinators who used to handle all the details Psst she hears a breathy whisper from behind At first she thinks it s the milk steamer at the espresso counter Hey ahem A louder cough and a nudge finally force her out of her paperwork fog Yes she turns around Haven t you read the latest HSD eNews A slightly accusatory voice pipes up from behind an enormous laptop Well I was going to If you had then you d know that HSD just changed its policy regarding the automatic exclusion of studies that use deception from the Exempt Status The unseen speaker continued Now studies using deception or concealment may qualify for Exempt Status when all applicable Exempt criteria are met and when the deception or incomplete disclosure is necessary to ensure valid results What The research scientist s colleague exclaimed Is that true Or are you deceiving us right now No squeaked the voice from behind the laptop As long as the deception isn t being used to get subjects to do something that they wouldn t do if the information was fully disclosed to them and as long as the deception creates no more than minimal risk of physical or emotional distress The research scientist smiled Where did you get all this wonderful information Just read that new Standard Operating Procedure about Exempt Determination The unseen speaker quickly slammed the laptop shut and hurried out the back door Who was that elusive person anyway The research scientist turned back to her colleague and sipped the last foamy bits of her coffee Now the smiley face the barista made in the crema seemed appropriate It sounds like you should definitely be reading that eNews Her colleague exclaimed Sigh More unwanted advice Exculpatory Language Apr 30 2013 at 12 00am By regularly reading Quick Tips you waive your right to ask HSD any questions Now what kind of statement is that It s exculpatory And per the federal regulations this kind of language should not be included in consent forms See 45 CFR 46 116 Exculpatory language in a consent form is language which has the general effect of freeing or appearing to free an individual or an entity from malpractice negligence blame fault or guilt according to the draft guidance released by OHRP Office for Human Research Protections and the FDA Food and Drug Administration on August 19 2011 In particular it is not allowable to use statements that appear to limit or waive the University s liability or the subject s ability to make claims against the University for negative experiences associated with the research Here s an example from an actual consent form I hereby hold harmless and release and forever discharge the UW from all claims demands and causes of action which I my heirs representatives executor administrators or any other persons acting on my behalf or on behalf of my estate have or may have by reason of this authorization Needless to say Quick Tips red pencil was called into action on this one The regulations allow an interesting exception to this rule it is acceptable to ask subjects to waive their right to property rights and any profits eventually created because of the research or future use of their biological specimens For example this statement I voluntarily and freely donate any and all blood and tissue samples to the UW and hereby relinquish all property rights title and interest I may have in those samples So don t worry you can keep sending your questions to HSD But also keep reading Quick Tips We ll never use exculpatory language again Encryption Mar 29 2013 at 12 00am Back when Quick Tips was in grad school we had an entire file box of research data stolen from the backseat of our Pacer Luckily it had been encrypted and nobody without the super secret Cracker Jack decoder ring could figure out what was there Here in the 21st Century we have much better tools to encrypt our research data UW Medicine IT has a few great web pages outlining how you can easily encrypt Microsoft Office files and with a little more effort encrypt your emails and your mobile devices The IRB loves to hear how researchers are protecting their data and would rather not hear that no one can get to it because it s behind an unused filing cabinet in the back room that s been closed off for years and only the janitor has the key Simply follow these great steps and you ll be on your way to becoming an encryption wiz Email Encryption Mobile Device Encryption File Encryption Thanks UW Medicine IT Now let s see how much we can get for the decoder ring on e Bay Maybe we ll throw in the Pacer Modifications Happen Mar 13 2013 at 12 00am If Quick Tips were to produce a line of IRB bumper stickers this one might sell like hotcakes Every researcher knows that the initial research procedures don t always work out exactly as planned And to facilitate the needed changes we have the Modification Form to help you explain the changes to the IRB But don t forget just because you ve sent your modification request to HSD doesn t mean that it s been approved Wait to hear back from us before you change anything Unless the changes are necessary to eliminate immediate serious risks to the subjects of course Maybe a better bumper sticker would be Even if it doesn t fit on your car it s still the way to go Dropping a Research Procedure Feb 1 2013 at 12 00am Dear Quick Tips I received IRB approval 4 months ago for my dissertation research I m studying stress and study habits in Introductory Psych students One part of my research involved having the students take a survey at the beginning and end of the quarter I ought to be a subject in my own study I ve tried everything but I just can t get seem to get the SurveyMonkey website to show the survey correctly So I m giving up on the survey part of my study Rather than bother your office with a Modification I m going to just drop the survey Sincerely Sad SurveyMonkey Dear Sad Please DO send us a Modification We really need to prospectively review and approve the removal of ANY research procedure or group of subjects except when necessary to eliminate apparent immediate hazards to subjects I can tell that dropping the survey will benefit you and your stress levels but our review needs to look at whether the removal changes the risk benefit analysis of your research Best Quick Tips Washington State IRB Jan 3 2013 at 12 00am The UW IRB is the only IRB for me Go Huskies Hmm not so fast Quick Tips knows that the University of Washington is like a city with just about every service imaginable including Quick Tips home the UW s Institutional Review Board IRB If there was a comfy cot Quick Tips might never leave the UW Tower But there are some research activities that need to be reviewed by a different IRB instead of the UW IRB The Washington State IRB WSIRB reviews research activities that are Sponsored by the Washington State Department of Social Health Services DSHS Department of Health DOH or Department of Labor Industry L I Conducted by an employee of agent of DSHS DOH or L I Using any DSHS or DOH property or facility Using DSHS DOH or L I non public information to identify or contact human research subjects or prospective subjects or Using non public identifiable records or specimens from DSHS DOH or L I The University of Washington has a cooperative agreement with the WSIRB where we rely on their IRB review of research that involves any of their records properties facilities employees or agents If the funding is coming through the UW but the research involves one of the above agencies the review should be performed by the WSIRB instead of the UW IRB Examples of DSHS records include Medicaid Child welfare foster care CAMIS Temporary Assistance for Needy Families TANIF Examples of DOH records include Trauma registry WSTR Cancer registry WSCR Birth records If you want to interview mothers of special needs children under the age of five link birth records to the state cancer registry to evaluate childbearing after a cancer diagnosis or use DUI assessments from a DSHS contractor to study severity of alcohol abuse all these things would be under the jurisdiction of the WSIRB When you submit an IRB application to WSIRB don t forget to use their forms not the UW forms and don t forget to include WSIRB s Appendix E form which requires a signature from HSD This authorizes WSIRB to do the review instead of the UW IRB Questions Email hsdinfo uw edu So get off campus and visit WSIRB on the web at http www1 dshs wa gov rda hrrs default shtm How to use the new form Use of Identifiable Biological Specimens Data Nov 30 2012 at 12 00am HSD has officially released the new form and guidance the Use of Identifiable Biological Specimens Data The form and guidance pertain to using identifiable data and or specimens for research This application replaces the Medical Records Review form Last eNews we talked about when to use the new form this time let s look at how to use the PDF smart form The PDF is intended to guide you through the questions hiding the questions that you don t need to answer and revealing follow up questions that you do This will save everyone time in skipping over empty boxes and maybe save a few trees along the way Quick Tips is well aware that in some cases the form is used as a communication tool between research coordinators and researchers to fine tune their application and make sure all the questions are answered appropriately Word may have an advantage in Track Changes but PDF can accept comments The comment tools will take you back to the days when you turned in a paper and got it back full of red pen and sticky notes Or maybe that was just me Here s how you do it Flatten the document by selecting Print and changing the printer to Adobe PDF You will want to save this flattened version with a different name if you are not done with the original form as flattening is just like printing it to a piece of paper The fields will no longer be editable You will now be able to make all kinds of comments on the form using the commenting tools If you have the full version of Adobe Acrobat you could even experiment with shared reviews collaborating live and track reviews See the Adobe website for more information http www adobe com products acrobat html Before you say Hey is this just some Adobe endorsement know that Quick Tips finds somethings about PDF frustrating as well That s why we ll also be putting our a Word version of the Use of Identifiable Biological Specimens Data form So check it out and send Quick Tips an email if you find new and exciting ways to collaborate with PDF We d love to share them with the research community When to use the new form Use of Identifiable Biological Specimens Data Oct 11 2012 at 12 00am HSD recently posted the beta test version of the new form and guidance the Use of Identifiable Biological Specimens Data The form and guidance pertain to using identifiable data and or specimens for research This application will replace the Medical Records Review form It seems like a good time to explore when to use this form Let s see if Quick Tips can answer some questions What s the difference between the regular Human Subjects Application and the Use of Identifiable Biological Specimens Data form The form addresses research which does not include direct interaction with people therefore the form does not address recruitment or consent So it follows that you will always need to complete a Waiver Request Consent or Consent Requirements form along with this one and when appropriate a Waiver Request HIPAA Authorization See part 8 of the guidance for more detailed information So why not just fill out the regular form and state that I m not interacting with subjects The regular form asks questions that are irrelevant to research involving only analysis of specimens and or data and may drive you a bit nuts When would I use this form Examples include medical records protected health information PHI employment data study records pathology specimens data and or specimens from a repository What do you mean by identifiable In brief according to federal regulations it means that the identity of an individual is or may be readily 1 ascertained by the investigator or any other member of the study team or 2 associated with the information Quick Tips recommends reading the Use of Identifiable Biological Specimens Data Guidance for more detailed information Okay I m convinced this new form sounds great When wouldn t I use it Well if you are going to interact or intervene with subjects in any way or if you plan to follow up with subjects whose data are being reviewed you would complete the Human Subjects Review Application If your data is anonymous or coded and no one involved with the current research will have access to the key to the code it may be appropriate to fill out the Use of Non Identifiable Biological Specimens Data form if you need a determination that IRB review is not required If you are creating a registry or repository don t use this form Also if you plan to obtain information not in records at this time this form may not be appropriate In those instances it would be best to check with HSD before you complete the application Quick Tips did okay I wouldn t trust Quick Tips with my identifiable data but if you have any other questions about this form that aren t answered in the form itself or the guidance please email hsdinfo uw edu or call the Human Subjects Division at 543 0098 Registry and Repository Aug 12 2012 at 12 00am Have you ever wondered why HSD refers to a collection of data sometimes as a Registry and sometimes as a Repository A registry refers to a list of names and contact information of people who are willing to be contacted about research related to a specific topic A registry might include information that would assist in selecting candidates appropriate to recruit for a specific study A repository is a collection of data samples or both made available to researchers for analyses intended to answer various research questions A repository could also be used for recruitment purposes IF the subjects whose data are in the repository have given permission for that specific purpose However a repository does not intrinsically or automatically provide for recruitment into other studies A dual use must be specified in the Repository Application More information is available on our website UW GS 7 not just another HSD term Jun 22 2012 at 12 00am The IRB and the Human Subjects Division have all sorts of advice guidance and directives on how to handle your human subjects data while you are conducting your research but there is another UW department that is concerned about what you are doing with all those records and paperwork once the study is closed UW Records Management Take a quick trip through the retention schedule for research documents at http f2 washington edu fm recmgt retentionschedules gs general uwgs7 and you ll see that there is an entire records retention schedule just for records associated with research grants and contracts UW GS 7 These retention schedules are established by Washington State Law RCW 40 14 Records Retention and Research Data Keep in mind that for different types of research data there are different retention schedules For example research data from a study that was determined to be Exempt needs to be kept for 6 years after the close of the study Other types of data may need to be kept longer Up to 30 years for some Records Retention and the Consent Form The key to developing an accurate retention statement for the consent form is to state how long the data will remain identifiable There are no requirements to state how long the data will actually be kept but you do

    Original URL path: http://www.washington.edu/research/hsd/quick_tips/ (2014-06-24)
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  • Human Subjects Division - Syndicated
    and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD HSD Syndicated What is RSS View video RSS in Plain English View a text transcript of the video Video by www commoncraft com RSS is a family of Web feed formats used to publish frequently updated works such as blog entries news headlines audio and video in a standardized format An RSS document which is called a feed web

    Original URL path: http://www.washington.edu/research/hsd/syndicated/ (2014-06-24)
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  • Human Subjects Division - Questions and Answers
    be completed and signed by the collaborating institution The FWA form does not need a signature by anyone at the University of Washington Step by step instructions provided by the OHRP web site should be followed by the institution completing this form The FWA form Section 5 Designation of Institution Review Boards IRBs requests that the institution designate IRB s for review of research under their Assurance The institution may list the University of Washington IRB s and other IRBs if and as appropriate How long does the IRB review process take Multiple factors affect the time required for IRB review They include type of application level of review e g exempt minimal risk full committee complexity of the study involvement of other compliance offices or institutions quality and completeness of the application when first submitted We encourage researchers to plan for sufficient time for review based on the research and their particular situation Here are some general recommendations based on HSD s current workload Allocate adequate preparation time before submission in most cases a minimum of two weeks to one month For full IRB review plan for at least 12 to 16 weeks for the review and approval process For Minimal Risk review plan for at least 6 to 8 weeks For Exempt review plan for at least 2 to 3 weeks How long is approval valid Approval is generally valid for one year from the date of Committee approval If I am a student do I have to participate if it is a class or program requirement Yes and no Please see OHRP guidance on this issue May the investigator pre sign the consent form Except in very specific circumstances approved on a case by case basis by reviewing Committee or subcommittee consent forms should not be pre signed What are some good questions to ask before deciding to participate What are some good questions to ask before deciding to participate Where will the research take place How do I get there How long will it last How much of my time will it take What exactly will happen to me in the research What are the potential risks How likely are they to occur Is participating in the study likely to benefit me Will the study benefit others Are there other options such as alternative procedures or treatments besides the ones being studied How do the alternatives compare with this study How will my privacy be protected Can anyone find out that I am participating in this study Will I have to pay for any of the study procedures or treatments If so how much Will my insurance pay When I am in the study will the researchers work with my regular caregiver or doctor or teacher What if I am harmed by the study Will I be paid for participating in the study What if I drop out of the study before it s over Whom do I call if I have questions or problems What are the requirements for authorization when researchers wish to access patient information The HIPAA regulations use the term authorization to describe the process through which a patient allows researchers to access protected health information PHI The information must include a description of the information to be used for research purposes who may use or disclose the information who may receive the information purpose of the use or disclosure expiration date or event if the information will be kept indefinitely the authorization states that there is no expiration date individual s signature and date right to revoke authorization right to refuse to sign authorization if this happens the individual may be excluded from the research and any treatment associated with the research if relevant that the research subject s access rights are to be suspended while the clinical trial is in progress and that the right to access PHI will be reinstated at the conclusion of the clinical trial Blanket authorizations for research to be conducted in the future are not permitted Each new use requires a specific authorization What happens if I have an emergency A person who has an emergency during a study should immediately notify the treating doctor and or available research staff Personal care should always be available even when the emergency may not be related to the treatment being given What if I am doing my research in another place or country University of Washington researchers who are conducting research with human subjects that is funded by or conducted by the Department of Health and Human Services and who are engaged in research at sites that are not UW affiliated sites must have an assurance of compliance with the HHS regulations for the protection of human subjects Please see the topic Federalwide Assurance for information on how to obtain this assurance What if I want to stop participating in the research study You are free to stop participating in a research study or to withdraw at any time and for any reason Your withdrawal will not affect other services you may be getting or are entitled to in the institution If possible you should talk with the research staff investigators about why you wish to stop participating as this will help them to better understand what you have experienced and the reason s for your decision What is a Federalwide Assurance FWA Under the Department of Health and Human Services DHHS human subjects protection regulations at 45 C F R 46 103 every institution engaged in human subjects research that is funded or conducted by DHHS must obtain an Assurance Of Compliance approved by the Office for Human Research Protections OHRP This Assurance Of Compliance when granted is called a Federalwide Assurance Both awardee institutions and collaborating performance site institutions must file Assurances The awardee is responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP approved Assurance prior to their initiation of the research What is an IRB and who are

    Original URL path: http://www.washington.edu/research/hsd/qa/ (2014-06-24)
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