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University of Washington - April 21, 2014

April 21, 2014

Mani Soma, Ph.D.
University of Washington
Office of Research
Box 351202
Seattle, WA  98195-1202

Re:   Human Research Subject Protections Under Federalwide Assurance FWA-6878

Dear Dr. Soma:

Thank you for your February 27, March 29, and August 15, 2013 reports in response to our December 17, 2012 letter regarding the Office for Human Research Protection’s (OHRP) on-site evaluation of University of Washington’s (UW) compliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).  In our letter, we made the following determinations:

A. Previously made determinations regarding human subjects protections at your institution

1) We determined that UW does not have written institutional review board (IRB) procedures that adequately describe the following activities, as required by HHS regulations at 45 CFR 46.103(a), 46.103(b)(4) and (5):

a) The procedures which the IRB will follow for determining which projects require review more often than annually.  

b) The procedures which the IRB will follow for determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review.

c) The procedures the IRB will follow for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.

Corrective Action:  
We acknowledge that UW has revised and developed written IRB procedures to address these and other requirements.  We also acknowledge that UW has undertaken an extensive campaign to educate researchers, IRB members and staff regarding the IRB written procedures.  These corrective actions adequately address these determinations and are appropriate under your FWA.

B. Additional determination regarding your institution’s system for protecting human subjects

1) Based on information provided in your February 27, 2013 report, we have determined that that the IRBs lacked sufficient information to make 45 CFR 46.111 approval decisions regarding the research studies referenced below, but nevertheless conditionally approved them, instead of deferring approval.  For additional information about when conditional approval is appropriate under the HHS regulations at 45 CFR part 46, we refer you to OHRP’s guidance document on point, found at http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html. The research studies, relevant information that was lacking, and relevant approval criteria are as follows:

a) Protocol 40018.  According to the February 9, 2011 IRB conditional approval letter for this study, the UW IRB voted to conditionally approve the study even though the IRB lacked information regarding how risks to subjects would be minimized and how the confidentiality of data would be protected.  According to this letter, the IRB requested that the investigator provide a more detailed explanation of: (i) whether and how the neuromuscular electrical stimulation procedures increase risks of complications for the subjects given that they have already been irradiated; (ii) whether subjects will have sufficient time for their skin to heal following radiation treatment before undergoing study procedures; (iii) the inclusion criteria; (iv) the “sham” procedure; (v) whether the investigator will screen subjects for allergies to honey if it is included as an ingredient of Varibar; (vi) whether there is any experience or information on the use of the device at home; and (vii) the investigator’s assessment as to whether at-home use increases risks for subjects.  The letter also asked the investigator to provide a more detailed explanation of how data will be protected at the data-coordinating institution.

b) Protocol 40980.  According to an undated IRB conditional approval letter, the UW IRB voted to conditionally approve the study even though the IRB lacked information regarding confidentiality of research data.  According to this document, the IRB requested that the investigator provide a more detailed explanation of: (i) what platform the server is running on; (ii) what measures have been taken to secure the server from remote attacks; and (iii) how secure are the desktop computers that access the server.  

c) Protocol 42364.  According to the February 29, 2012 IRB meeting minutes, the IRB voted to conditionally approve the study even though the IRB lacked information related to risks of the research and confidentiality of data.  According to the minutes, the IRB requested that the investigator provide a more detailed explanation of: (i) the procedures for collection of specially requested samples; and (ii) the investigator’s assessment of the feasibility and ethical responsibility to contact subjects since the investigator will have the ability to link subjects to results.

d) Protocol 42675.  According to the April 17, 2012 IRB meeting minutes, the IRB voted to conditionally approve the study even though the IRB lacked information related to risks of the research.  According to the minutes, the IRB requested that the investigator provide more information regarding: (i) whether there are additional risks for subjects who have the MRI and CT scans the same day and receive contrast agent for both research procedures; and (ii) whether subjects will be asked to fast for 2 hours prior to the MRI study, and if so, how long could they be asked to fast if they participate in both studies on the same day.

e) Protocol 39888B.  According to a May 2, 2012 IRB conditional approval letter, the IRB voted to conditionally approve a modification even though the IRB lacked information related to informed consent and risks of the research.  According to the minutes, the IRB asked the investigator to describe what will be included on the web site for the announcement and to clarify whether the investigator is specifically interested in prescribed medications or whether the investigator wants to know about any antacid medications a participant will be taking.  

f) Protocol 42911B.  According to a May 17, 2012 IRB conditional approval letter, the IRB voted to conditionally approve this study even though the IRB lacked information related to risks of the research.  According to the letter, the IRB asked the investigator to: (i) explain why the investigator wants to reenroll approximately 450 subjects; and (ii) provide more information regarding the investigator’s research laboratory space.  In particular, the IRB asked whether there is dedicated space for the research and how the space is set up for the research.  

g) Protocol 42812-B.  According to a May 16, 2012 IRB conditional approval letter, the IRB voted to conditionally approve this study even though the IRB lacked information related to risks of the research, informed consent, and confidentiality of data.  According to the letter, the IRB asked the investigator to: (i) describe what the additional 5 minutes of imaging will involve; (ii) how the investigator will determine whether or not a potential subject is competent to provide consent; and (iii) how data and images will be sent to the coordinating center, including information about the precautions in place to protect privacy.

Corrective Action:   
We acknowledge that the UW IRB written procedures have been revised to clarify when conditional approval may be granted.  In addition, IRB members, chairs and staff will be trained on these procedures and regulatory guidance will be given during IRB meetings for the Assistant Directors of Operations.  Finally, a new Assistant Director of Regulatory Affairs will develop a permanent and on-going quality assurance monitoring program of IRB activities, including conditional approval.  These corrective actions adequately address the determinations and are appropriate under your FWA.

We determine that the corrective actions adequately address all of the determinations, and that the concerns that we expressed in our December 17, 2012 letter are resolved.  At this time, there should be no need for further involvement by our office in this matter.  Please notify us if you identify new information which might alter this determination.

We appreciate your institution’s continued commitment to the protection of human research subjects.  

Sincerely,
 

Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland  20852
Telephone: 240-453-8132
FAX:    240-453-6909
E-mail: Kristina.Borror@hhs.gov

cc:   
Dr. Karen Moe, Human Protections Administrator, UW
Dr. Zane Brown (UW – A IRB Chair)
Dr. Jane  Hitti (UW IRB 2 – B Chair)
Ms. Elizabeth Berggren (UW – IRB 3 – C Chair)
Dr. Jeff Purcell (UW IRB 4 – D Chair)
Dr. Carl Rimmele (UW IRB 5 – G Chair)
Dr. Karen Thomas (UW IRB 7 – J Chair)
Dr. Ragnhild Bundesmann (UW IRB 9 Chair)
Dr. Margaret Hamburg, Commissioner, Food and Drug Administration
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office Science Policy, NIH