eNews re IRB Review

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New FCOI Training Available

The online Financial Conflicts of Interest (FCOI) training is now available at http://uw.edu/research/fcoi. Starting August 24, 2012, Public Health Service (PHS) funded investigators or investigators anticipating receiving PHS funds must complete the online FCOI training prior to the expenditure of funds on any new award.


 

E-Mail Confidentiality Statement Update

In the past, we have required that in each document in which e-mail contact is solicited or suggested, the following statement is to be included: "Please note that we cannot guarantee the confidentiality of e-mail communications." As of June 4, 2012, the inclusion of the e-mail confidentiality statement is no longer a requirement. Instead, the UW IRBs have the option to request this statement as a method to mitigate risk in relation to the security of e-mail communications.

How will researchers know when the IRBs choose this option?

When data are sensitive in nature, the inclusion of this statement will most likely be requested by the IRB. Should a researcher determine that the data to be transmitted are sensitive, it is recommended that the statement be included without waiting for the IRB's assessment.

What is "sensitive data?"

The term sensitive data applies broadly to information for which access or disclosure may be assigned some degree of sensitivity, and therefore, for which some degree of protection or access restriction may be warranted. Unauthorized access to or disclosure of information in this category could result in a serious adverse effect, cause financial loss, cause damage to the reputation of the individual and loss of confidence or public standing, or constitute an unwarranted invasion of privacy.


 

Emergency Medicine Research

Effective immediately, IRB Committee A will review all new applications for research that involves the emergency exception to informed consent, aka "Emergency Medicine*" interventions. IRB Committee A has more than a decade of experience in reviewing these complex studies. Researchers should contact Lyn O'Doran, the IRB Administrator for Committee A, before they submit the IRB application for a new emergency medicine study.

How does this help researchers?

  • It will improve the consistency of IRB review, because all reviews will be done by the same IRB.
  • There is now a single point of contact in HSD to provide expert guidance and assistance in navigating this challenging regulatory process.

*This is not the same as single patient emergency uses, in which a physician wants to use an investigational drug or device for clinical reasons with a patient for whom there are no other viable options. Instead, "emergency medicine" research refers to research trials of interventions designed to assess treatments or diagnostic tests used in pre-hospital or emergency department settings.


 

CITI Updates Week of June 25th

Due to staffing shortages, response time to the hsdtrain@uw.edu e-mail will be slower than usual, and requests to manually add training completions will be delayed. Normal response times will resume on Monday, July 2nd.


 

New and Revised Documents

There are no major changes or updates to report for the month of June.


 

light bulbQuick Tips from HSD

UW-GS 7 - not just another HSD term...

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 record 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

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June 22, 2012

IN THIS ISSUE

New FCOI Training Available

E-mail Confidentiality Statement

Emergency Medicine Research

CITI Updates

New and Revised Documents

Quick Tips from HSD

 


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