eNews re IRB Review

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Many HSD Changes Coming Soon!

HSD will be implementing many policy, procedure, and form changes in the next six months. Many are planned improvements that are near completion. Other changes are required because of two recent federal audits of the UW IRB.

This end-of-the-month newsletter is our single most important way to communicate changes. We work hard to make it short, useful, and readable.  We post it on our home page http://www.washington.edu/research/hsd/ (announcements tab at the bottom), or you can subscribe directly by sending an email to hsdinfo@uw.edu.



Minimal Risk Delays

HSD has many new staff, particularly among the Minimal Risk teams. Unfortunately, this has occured at the time of year when we have the highest volume of Minimal Risk applications.

Turnaround time for many (but not all) Minimal Risk reviews is significantly longer right now.  We greatly appreciate your patience while we continue hiring and training the new staff for this important area of our office.



Use of Synthetic Nucleic Acid Molecules with Humans

Effective: March 2, 2013

New NIH policy: Review by the UW Institutional Biosafety Committee (IBC) has always been required for studies involving recombinant DNA molecules.  A new NIH policy now requires IBC review for all studies involving the deliberate transfer into humans of synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any of the following criteria:

  • Contain more than 100 nucleotides; or
  • Possess biological properties that enable integration into the genome; or
  • Have the potential to replicate in a cell; or
  • Can be translated or transcribed.

HSD changes: HSD has added a single question about this issue to the following three forms:

Impact on the IRB application and review process: minimal. The new question is a yes/no question. There is a follow-up question for "yes" answers, asking for IBC review status (i.e., pending, or approved). Pending IBC approval will not delay the IRB review process. The purpose of the new question is to (1) remind researchers about this requirement; and (2) inform the IRB about whether to expect a modification of the consent form, with revisions recommended by the IBC.



"Smart Form" Version of the Modification Form

The Modification form is HSD's longest and most complicated form. For most modifications, researchers need to complete only one or two sections - which means they need to print many unnecessary pages, or manually delete the many unused sections.

HSD is converting this form to a "smart" PDF form. This means that the form will guide the researcher through the process of completing the form, including the use of "branching" that shows the researcher only those questions that are appropriate for the situation.  For example: if the researcher selects "add new source of funding" at the beginning of the form, s/he will see only the questions related to that topic. None of the other question will be visible, nor will they be printed.

The content will also be improved in the two sections that researchers find most confusing:

  • Changing researchers and research staff
  • Changing research sites and locations

This long-awaited improvement will be announced and implemented in the coming months.

If you are interested in helping HSD test this form, please contact hsdforms@uw.edu as soon as possible.



Human Subjects Protection Training

Did you know that the UW HSD doesn't require all researchers to obtain training in the protection of human subjects?

We highly recommend that each researcher working with human subjects have a basic training course in this topic, but we do not require it. The only requirements that you have to follow for training in the protection of human subjects are those of your study’s funding agency.

For example, the National Institutes of Health require that senior/key personnel on an NIH-funded study pass a basic course in the protection of human subjects.

The UW HSD and our IRBs do have the authority, however, to require training of researchers if there are concerns about compliance or the ethical and safe conduct of the research.



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 Synthetic Nucleic Acid Molecules
Document(s) Human Subjects Review Application (13-11), UW/WIRB Cover Sheet, UW/CC-IRB Coversheet
Description New YES/NO question added regarding approval from the UW Institutional Biosafety Committee (IBC) for recombinant/synthetic DNA human gene transfer or vaccines.
Expected impact Low
Related changes None
Link for more information See the article in this eNews, and the forms themselves, linked above.
Implementation date

March 29, 2013 (effective March 2, 2013)



light bulbQuick Tips from HSD

Back when Quick Tips was in grad school, we had an entire file box of research data stolen from the backseat of our Pacer. decoder ring 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 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:

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.


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March 29, 2013


Many Changes Coming Soon!

Minimal Risk Delays

Synthetic Nucleic Acid Molecules

Modification Form Update

Training Reminder

New and Revised Documents

Quick Tips from HSD


Help from HSD

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