Quick Tips from HSD

Quick Tips from HSD

• 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or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt" according to the draft guidance released by OHRP (Office for Human Research Protections) and the FDA (Food and Drug Administration) on August 19, 2011.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 need to state for how long the data will be linked to the identities of the subjects.

  The IRB also wants to make sure that you don't make any promises in your consent form documents that you cannot keep - such as, "We are going to shred this consent form as soon as the study is over." Consent forms also have a retention schedule.  For example, consent forms for biomedical treatment or intervention studies need to be retained for 30 years after the close of the study.

  Don't hesitate to contact Records Management for more information: urc@uw.edu, or visit their website.  They have lots of great advice, a cool instructional video, and order numbers for those Office Depot boxes you might need!

  Some of the Human Subjects related documents that have official records retention schedules are:

  • Certificate of Exemption (now referred to as: Exempt Status Determination)
  • Clinical Trials Phase I-IV Research Data - Investigator
  • Consent Forms for Research - Biomedical Treatment or Intervention
  • Consent Forms for Research - Adults
  • Consent Forms for Research - Minors
  • Data Collection Form
  • Human Subjects Review Committee Applications - Approved
  • Human Subjects Review Committee Applications - Denied
  • Human Subjects Review Committee Applications - Withdrawn
  • Registry Consent Forms
  • Repository Consent Forms
  • Research Data - Biomedical Treatment or Intervention (Drug, Device or Surgical Procedure/Intervention)
  • Research Data - Drug Development
  • Research Data - Non-Biomedical Treatment or Intervention (Non Drug, Device or Surgical Procedure/Intervention)
  • Research Data - Sponsor Required Contractual Obligation
  • Research Data - Exempt from Human Subjects Review

• Exempt?

  Apr 13, 2012 at 12:00am

  Exempt is another one of those terms that has a different meaning in connection with human subjects research than you might expect. (Recall how "expedited" doesn't mean quicker in the IRB world.)

  It is often thought that "exempt" means that the research activity does not involve human subjects. This is not the case. Exempt, in regulatory speak, means that the activity involves human subjects, however, because it is no more than minimal risk and fits into one or more of the six specific categories of research defined by the federal Office of Human Research Protections or OHRP (affectionately pronounced "O-Harp") it is "exempt from the regulations." An exempt determination is a specific determination that is made only by the Human Subjects Division (HSD). Take a look at either the regulations themselves, or HSD's well written and easy to read Exempt Status Request Guidance document to learn more about the six categories.

  While you're reading that guidance, Quick Tips is going to consult the Exempt Magic Eight Ball to clear up some misconceptions about Exempt Research:

  Can I use deception in Exempt research, as long as the risk is minimal and I debrief the participants afterwards?

  "My reply is no." Deception studies that intentionally provide misleading or false information are not eligible for Exempt status. One example: Participants complete a quiz and are falsely told that they did poorly, regardless of performance.

  Does a determination of "Exempt" mean that I have IRB approval?

  "Outlook not so good." Exemption is a determination by the staff of HSD that the research is exempt from review by the IRB. However, keep in mind that researchers still have a responsibility to protect the rights and welfare of their subjects, and are expected to conduct their research in accordance with ethical principles, as well as state and local institutional policy.

  Exempt means it's not Human Subjects Research, right?

  "My sources say no." If a research project involves humans (see the definition of a human subject on the HSD website) it is still human subjects research, even if it is minimal risk, and falls under one of the six categories of exemption.

  I've heard that I can determine whether my research is exempt.

  "Don't count on it." The staff of the Human Subjects Division are the only individuals authorized at the UW to determine whether the research activity is exempt from federal regulations. The UW applies the federal regulations and guidance about exemption to all human subjects research, regardless of funding, or funding source.

  So, if my research is "exempt," I don't have to do anything?

  "Very doubtful." You must complete the form "Initial Application: Exempt Status Request" either in Word or PDF. Then, send it to the HSD office to request a determination of "Exempt." Think of "Exempt" as a status that is determined by HSD, according to the specific federal regulations governing human subjects protections. The everyday usage of the word exempt does not really apply.

  Hmm, the Exempt Magic Eight Ball is on a negative streak today. Let's refrain from asking it about the lottery.

• Student Research?

  Mar 16, 2012 at 12:00am

  In our February issue, Quick Tips discussed student research projects involving human subjects that do not need to go through the HSD/IRB process.  Now we'll talk about student research that DOES need HSD/IRB review.

  A student researcher recently visited HSD Quick Tips with a timely request.  She waved around an inch-thick document while she tried to catch her breath.

          "Help! This is my master's thesis proposal.  My best friend is in my department and she told me that she didn't need to go through the HSD/IRB process for her thesis project.  So I thought I didn't have to either.  But my faculty advisor just told me that he thinks I do need IRB review."

        "Now I'm really worried, and I'm so confused!  He told me I have to figure it out before I present my proposal to my thesis committee tomorrow!"

        "Don't worry," Quick Tips replied, "we can figure it our right now.  There are just a few key things involved.  Why don't you start by giving me an overview of your project?"

  The student began describing her intent to administer surveys to parents of third grade students at a local school in an effort to show that reading to their children each night raises their overall achievement scores.  Then she started describing the statistical methods she planned to use...

        "That's fine, thanks." Quick Tips interrupted. "The key issue for most student projects is the intent of the project.  Specifically, are the results intended to be generalizable?  Almost all thesis and dissertation projects are intended to be generalizable.  I bet your friend's project was one of the rare exceptions."

  The federal and University definition of human subjects research is based on a couple of key concepts.  one of them is that the project is "designed to develop or contribute to generalizable knowledge." This is quite different from what we talked about last month, where the student was practicing skills as apart of a class project, research practicum, or internship.  The student does need to submit an application to HSD for review and approval when a student is not just practicing skills, but is actually designing and implementing a research project with the intent to apply the results more broadly beyond the individuals studies or beyond a specific time and/or location, such as to other settings, circumstances, or categories.  This includes almost all independent undergraduate research projects and honor theses, masters these and doctoral dissertations, because they are almost always intended to contribute to generalizable knowledge.

  HSD and/or the IRB will review the application and:

  • Approve it (though some changes may be required first), or
  • Determine that the project is "exempt" from the regulations, or
  • Determine that it is not human subjects research based on the complete definition.

  The student researcher was right to come to HSD with her question.  Now let's hope she convinced her committee members about those statistical methods...

• Classroom Research Project?

  Feb 21, 2012 at 12:00am

  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 than 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 studies or beyond a specific time and/or locations, 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 hwy 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.

• Expedited Review

  Jan 10, 2012 at 12:00am

  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.