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Human Subjects Division (HSD)


eNews re: IRB Review - April 1, 2014

Apr 4, 2014 at 8:14am

Open HSD Position: Post Approval Monitor

Now Hiring

Wendy Brown, HSD's Post Approval Monitor, has retired and is currently basking in the Arizona sunshine, watching the Mariners spring training. Wendy provided many years of valuable service to the UW: at HSD, the Clinical Research Center, through the Seattle Cancer Care Alliance, and as a member of IRB Committee A. Thank you, Wendy!

If you are interested in the position, you can apply through the UW employment site, under requisition #105919 "Post Approval Monitor". Clinical research coordinators are likely to have significant relevant experience and background for this position.


Federal Certificate of Confidentiality

Reminder About Timing

Certificates of confidentiality are issued by federal agencies for research involving sensitive data, upon request by the researcher. They allow researchers to refuse to fulfill requests or subpoenas for identifiable sensitive research data.

If a Certificate is planned or required for a study, be sure to allow sufficient time for obtaining the Certificate from the federal agency before you begin contacting subjects. IRB approval cannot be granted for the parts of the study that will be covered by the Certificate until the UW IRB has received and acknowledged the Certificate from the researcher. This includes recruiting and consenting for those parts of the study. See the SOP Certificate of Confidentiality for more information.


Clinical Trials Registration at CT.gov

Reminder About How to Obtain Help

Most clinical trials are required by federal law to be registered at the public website www.ClinicalTrials.gov (sometimes referred to as "CT dot gov"). This is the responsibility of the researcher, except for industry trials and trials reviewed by the Fred Hutchinson IRB.

Richard Brzustowicz, a senior HSD administrator, is the University's primary administrator for CT.gov. He can help you with setting up accounts, re-setting passwords, and similar issues. Email him at brz@uw.edu or call him at 206-543-4464. Also, short step-by-step instruction documents are available at the HSD Clinical Trials.gov web page, where you can also find contact information for the federal staff who can help you with questions or difficulties as you navigate specific registration requirements.


Required HIPAA Training for Washington State IRB

New Option for Fulfilling this Requirement

The Washington State IRB reviews UW research that will use records or clients from certain state agencies such as the Washington State Department of Health. When the state records include Protected Health Information (PHI), the state IRB requires all members of the research team to obtain training about the federal HIPAA regulations that govern the use of PHI.

UW faculty, staff, or students who are not employees of UW Medicine cannot take UW Medicine's HIPAA training. Therefore HSD has arranged for two alternative ways to fulfill this requirement:

  • Completion of the standard CITI human subjects training (which includes HIPAA) through the CITI web portal, or
  • Completion of the stand-alone HIPAA module (titled "Health Information Privacy and Security (HIPS)") through the CITI web portal.

CITI is a national online human subjects training service. You must enter and register through the UW portal. Instructions are located on the HSD website.


2014 Update to the International Compilation of Human Research Standards

The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines that govern human subjects research in 107 countries, as well as the standards from a number of international and regional organizations. The Compilation was developed for use by researchers, IRBs, and others.

The 2014 edition is now available and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. Major changes in human subjects standards were reported for Brazil, France, Kyrgyzstan, Switzerland, Taiwan, and Turkey. Three new countries are featured in the 2014 edition: Cameroon, Mozambique, and Zambia.


Continuing Medical Education (CME) Credits for the NIH PHRS Course

Physicians who successfully complete the free online NIH course in the Protection of Human Research Subjects (PHRS) can earn up to 3 American Medical Association Physician's Recognition Award (AMA PRA) Category 1 Credits TM.

The CME Credit option is offered through a partnership with University Health Services - Professional Education Program of Virginia Commonwealth University Health System. CME-eligible individuals who want to earn these credits must follow the link to VCU's registration system after completing the training and pay a $25 fee for CME credit recording.

For more detailed information, visit the NIH PHRS training page, and click on the link to CME info. HSD has also posted information on our training pages.


HSD On YouTube

HSD now has its own YouTube channel. We are producing short (3-7 minute), focused video presentations about the IRB review of Human Subjects Research. The videos are available from the left hand navigation menu on the HSD website homepage. Click on "Training" then "HSD Training Videos", or use this direct link.

The latest video focuses on the changes to compliance and problem reporting by researchers. It outlines the new standard operating procedures regarding what does and what does not need to be reported to the IRB.

Also available on this page, a recording of  live HSD Information Sessions, videos regarding changes to the Modification Form, and a video summary of policy changes made over the last year.

Please send any questions or comments to Katy Sharrock, Training and Education Specialist, sharrock@uw.edu.



New Email Address for Reminders

HSD is now using a new email address to send the automatic reminders for Status Reports (continuing review). The new email address is uwhsdcrr@uw.edu. Please add this email address to your "safe list" to prevent reminders from ending up in your junk email box.

As a reminder, it is ultimately the researcher's responsibility to track IRB approval periods and ensure that IRB approval does not lapse. Failure to receive or notice HSD reminders does not absolve researchers of this responsibility, nor does it change the consequence of a lapsed approval. For more information, see SOP Status Report Reminders.