eNews re IRB Review

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Important Considerations

What is considered support for a research project?

The IRB should be informed of all support, on the initial IRB application, or in the "Add Funding" section of the Modification form.  Support includes any grant, contract, gift, item, or other type of financial support that helps facilitate or pay for any part of the research. Contact hsdinfo@uw.edu if you need advice on whether to list a type of support on an IRB application. Here are two examples that are frequently overlooked but that should be described on IRB applications:

  • "Generic" salary support for faculty members, residents, or trainees that is not tied to a specific project but that provides time for activities such as data analysis and manuscript preparation.  Examples: salary from a training grant, or from a career development award.
  • Items for the research, such as a gift or donation of: drugs, a device, equipment, or printed materials.

Do you need prospective IRB approval to drop an approved research procedure or group of subjects from your project?

Yes. Changes to an IRB approved research project should be reviewed and approved in advance by the IRB, except when necessary to eliminate apparent immediate hazards to subjects. Many changes that involve eliminating a procedure or research group are eligible for "minimal risk" review and therefore don't require the review of a full IRB committee. Contact hsdinfo@uw.edu or any IRB administrator if you need advice.

Data protection: what do you need to do?

There is no "one size fits all" answer to this question.  There are many ways for researchers to protect the security and confidentiality of the data they collect. Researchers should propose the protection measures they feel are appropriate to the research, the nature of the data, and the possible risks of harm to the subjects. It is important to be thoughtful about this issue because the protection measures, when approved by the IRB, are then required.  Failure to implement or maintain them is considered non-compliance.  Future editions of this newsletter will describe some new tools and practical tips for protecting your data.  In the meantime, feel free to consult hsdinfo@uw.edu or any IRB administrator if you need advice.

 


 

Updates to the Consent Form Template

At the request of the National Institutes of Health (NIH), we are removing the sentence in our consent template language about Certificates of Confidentiality that states we may voluntarily disclose research data to:

someone who is accused of a crime, if he or she believes that our research records could be used for defense

Question: Do existing, already-approved, consent forms that have this sentence need to be revised?

Answer: No. If NIH granted a Certificate for a consent form that has this sentence, it may be left as is.

REMINDER: as of August 2011, you may no longer use language in the Consent Form that states you are applying for a Certificate of Confidentiality. You should obtain the Certificate of Confidentiality before you begin consenting subjects, and the consent form should state that you have a Certificate of Confidentiality.

 


 

Correction to Description of Training Requirements

The document on HSD's website that describes the UW's policy on human subjects training requirements has been revised to:

  • Correct an inaccuracy about UW researchers collaborating with other institutions, and
  • Provide information about UW researchers whose projects are reviewed by a non-UW IRB (such as WIRB or the "Hutch" IRB).

See sections 1.3 and 1.4 for the changes in "Training for Researchers, Research Staff and Consultants in the Protections of Human Research Subjects" at http://www.washington.edu/research/hsd/docs/827

 


 

New and Revised Documents

You may have noticed that HSD has been releasing new or revised written policy, procedure, and guidance documents at a brisk pace during the past year. 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 new format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)

 

Topic Certificate of Confidentiality
Document(s) REVISED Consent Form Sample Template
Description Language removed from the Certificate of Confidentiality information in the Confidentiality section stating that research information will voluntarily be given to: "someone who is accused of a crime, if he or she believes that our research records could be used for defense"
Expected impact

Minor

Related changes

None

Link for more information

http://www.washington.edu/research/hsd/docs/555

Article within this eNews

Implementation date February 24, 2012

 

Topic Signature Policy Revisions
Document(s) REVISED Modification Form
Description Signature policy for changing PIs has been revised so that an original ink signature of the former PI is no longer required
Expected impact

Medium - relieve burden of obtaining original ink signatures from former PI

Related changes

None

Link for more info http://www.washington.edu/research/hsd/docs/325
Implementation date February 24, 2012

 

Topic Training in the Protection of Human Research Subjects
Document(s) REVISED Training for Researchers, Research Staff, and Consultants in the Protection of Human Research Subjects (PHRS)
Description Corrections made to training requirements for UW researchers who are collaborating with other institutions; added information for UW researchers whose research is reviewed by a non-UW IRB
Expected impact

Medium

Related changes

None

Link for more info

http://www.washington.edu/research/hsd/docs/827

Article within this eNews

Implementation date March 7, 2012

 

Topic Update from Word to PDF forms
Document(s) Seattle Biomed Request: Defer Review to Seattle Biomed (Western IRB), Conditional Approval Response Form
Description Both documents have been convertedfrom Word to PDF format, for ease of completion
Expected impact

Low

Related changes

None

Link for more info

http://www.washington.edu/research/hsd/docs/963

http://www.washington.edu/research/hsd/docs/321

Implementation date February 24, 2012

 


 

light bulbQuick Tips from HSD

Welcome to Quick Tips, a new eNews feature that reveals the true meaning of some of those confusing IRB terms!

Student Research?

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 out 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 starting 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 part 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 studied 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 honors theses, masters theses 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...

 


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March 16, 2012

IN THIS ISSUE

Important Considerations

   What is considered support?

   Prospective IRB approval?

   Data protection?

Updates to the Consent Form Template

Correction to Description of Training Requirements

New and Revised Documents

   Confidentiality Agreement

   Signature Policy

   Training

   Word to PDF

Quick Tips from HSD

 


Help from HSD

We're here to help and want to hear from you.

General Information & Assistance
hsdinfo@uw.edu

Training Information & Requests
hsdtrain@uw.edu

Forms Assistance, Troubleshooting & Suggestions
hsdforms@uw.edu

Website Assistance, Troubleshooting & Suggestions
hsdweb@uw.edu

Verification of
Training Completion