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; for example, see the Conditional Approval item below.

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.

 


 

NEW POLICY Release of Certain Types of Funding

Effective May 1, 2013

Impact on researchers: Easier and faster access to funding for certain types of funding awards.

New policy: Recent federal clarification makes it possible for us to expand the types of grants that are eligible for a LAD determination. This is great news for researchers, because the LAD form is short, easy to complete, and quick for HSD to review. The specific changes are:

  1. New name: Delayed Onset Human Research (DOHR).
  2. We know that name changes can be annoying,but the National Institutes of Health (NIH) recently started using the label "Delayed Onset Human Research" for this type of determination. Using the same label as NIH should ease the use of this mechanism for releasing funds.

  3. Expanded to additional funding sources:
  4. The LAD was limited to research that required significant development work prior to involvement of human subjects. Now, researchers can obtain a DOHR determination (and thereby obtain access to funds right away) for these additional types of awards: (a) award mechanisms whose only human subjects research is funding for small projects or trainees that will be selected and funded by the awardee; and (b) clinical research networks or consortia that will create protocols over the course of the award.

  5. Expanded to additional types of awards:

    The LAD was limited to federal funding administered through OSP. The DOHR has been expanded to include funding from non-federal entities administered through OSP (except when specifically not allowed by the award conditions).

The DOHR application process is the same as the LAD process: complete the short, simple form; HSD makes a quick determination; HSD sends the researcher a memo to be submitted to OSP and then to the funding agency.

For more information about opening the "dohr" to your funds, read the DOHR Procedure and see the DOHR form.

 


 

HSD Office Closed for Training

The HSD office will be closed so that HSD staff may attend an all-day training session on May 20, 2013. The reception desk will still be open for the Office of Sponsored Programs, and can accept submissions for HSD and the IRBs, but nothing will be processed on that day. If you are aware of any impending deadlines, please take our office closure into account, and plan ahead.

 


 

WIRB Related Changes

To make things clearer and easier for researchers, we have:

  • Posted a consent template for any UW researchers who are using WIRB's Clinical Pharmacology Unit (CPU). This is a special service unit that requires pre-arrangement with WIRB and that "fast tracks" many elements of the WIRB review process. It is especially useful for industry Phase I clinical trials. Using this WIRB-approved template is part of the service.
  • Revised the UW/WIRB Cover Sheet:
    • Eliminated some of the previously-required attachments;
    • Added two short questions to help speed HSD's review;
    • Revised the information about Confidentiality Agreements to make it clear that they are submitted after WIRB approval, not with the Cover Sheet.

 


 

Conditional Approval: An Audit Issue

A recent federal audit of the UW IRB found that the IRBs were inappropriately granting Conditional Approval to studies that should instead have been Deferred. Regulations allow Conditional Approval to be granted when the IRB has determined that the regulatory criteria for IRB approval has been met, based on the assumption that specific conditions will be met by the researcher and subsequently verified. The conditions can be: (1) to make specified changes; (2) confirm specific assumptions or understandings; and/or (3) provide information or documents. HSD has been carefully analyzing the federal guidance on Conditional Approval, and is providing additional education to HSD staff and IRB members.

What does this audit finding mean to you, the researcher? Does it mean that fewer studies will be Conditionally Approved and more studies will be Deferred?

HSD is paying very careful attention to the specific nature of IRB issues and how they are describe in review letters. You can definitely expect to more statements like, "Please confirm the IRB's understanding that..." While our need to address this audit finding may result in some studies being Deferred that might have been Conditionally Approved if reviewed before the audit, we expect that our new approach will also result in Conditional Approval of some studies that might have been unnecessarily Deferred prior to the audit. We will share our "pre and post audit" metrics analysis when we have a bit more post-audit data.

 


 

light bulbQuick Tips from HSD

Exculpatory Language

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.

 


 

New and Revised Documents

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 welcome feedback and suggestions. (hsdforms@uw.edu)

 

Topic Delayed Onset Human Research Determination
Document(s) REVISED: Delayed Onset Human Research Determination Form, Delayed Onset Human Research Standard Operating Procedure
Description Expanded the "Limited Activities Determination" to addtional funding sources, and changed the form name to "Delayed Onset Human Research (DOHR) Determination".
Expected impact Medium
Related changes None
Link for more information See the article in this eNews, and the forms themselves, linked above.
Implementation date

Posted: April 26, 2013, Implemented: May 1, 2013

 

Topic Use of the UW IRB
Document(s) REVISED: Use of the UW IRB
Description Expanded the list of institutions with which UW has a formal institution-wide agreement.
Expected impact Low
Related changes None
Link for more information http://www.washington.edu/research/hsd/docs/1363
Implementation date

May 1, 2013

 

Topic WIRB
Document(s) REVISED: UW/WIRB Coversheet, ADDED: Consent template for CPU (Clinical Pharmacology Unit)
Description Clarification of the UW/WIRB Coversheet; useful new consent template for use with industry Phase I clinical trials.
Expected impact Medium
Related changes Appropriate SOP documents also updated.
Link for more information See documents linked above, as well as the article in this eNews.
Implementation date

April 26, 2013

 


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April 30, 2013

IN THIS ISSUE

Many Changes Coming Soon!

Release of Certain Types of Funding

HSD Office Closed for Training

WIRB Related Changes

Conditional Approval

Quick Tips from HSD

New and Revised Documents

 


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