December 29, 2021
For the Record – December 29, 2021: New HSD Director; COVID; Guidance
- New HSD Director
- COVID Surge and the Omicron Variant
- Finding HSD Guidance
- Updated Cooperative Agreement with WSIRB
- New Review Option for NHLBI Data Sets
- SCCA Proton Therapy Center
- Revised DoD Documents
- Updated Campus Policies
New HSD Director
Beginning January 15, 2022
We are pleased to announce Jason Malone as the new HSD Director, effective January 15, 2022. Since 2015, Jason has been the HSD Assistant Director for Regulatory Affairs, overseeing the compliance and post-approval monitoring programs. Prior to HSD he spent nine years as the Clinical Compliance Officer for the UW Institute of Translational Health Sciences where he ran the compliance programs for the pediatric and adult Clinical Research Centers as well as the Data and Safety Monitoring program. Before his career at the UW, Jason spent six years at Quorum Review IRB (now Advarra) where he was responsible at various times for overseeing their nationwide site monitoring program, IRB Administration, Regulatory Compliance, and Customer Relations. Jason has a master’s degree from the UW in Public Administration, and a Certificate in Global Health.
COVID Surge and Omicron Variant
No changes to human subjects research requirements
There are currently no changes to human subjects research requirements or limitations because of the higher contagiousness of the coronavirus Omicron variant and the developing surge in COVID infections. However, the situation is being closely monitored and changes may be made with little notice. Check the HSD COVID webpage for any changes that may occur.
Check this UW coronavirus website for current information about UW and state requirements, COVID testing, facts, and resources, including links to any campus-wide communications such as this December 21, 2021 message to UW staff and personnel about most classes meeting online for the first week of winter quarter.
Finding Guidance on the HSD Website
HSD continues to move, consolidate, and re-format all of its Word-based guidance documents to webpages in a single Guidance section of the HSD website. The new Department of Defense guidance (see announcement below) can be found there. Content from the Word document GUIDANCE Department of Justice has been moved to a new webpage. In addition, all guidance may still be accessed using the HSD Policies, Procedures, and Guidance search button in the lower right part of the HSD homepage.
Advantages of web-based guidance:
- A single guidance page makes it easier and faster to find specific topics
- HTML webpage formats provide more organizational options (e.g., hide/show features; hyperlinks), which improves the readability and usefulness of information
- Webpages provide more accessible information for visually-impaired users
Updated Cooperative Agreement with Washington State IRB
15-year old agreement updated
15-year old agreement updated. Improves logistics for HSD. No process changes for researchers. New expanded webpage.
UW and the Washington State IRB (WSIRB) have updated their longstanding cooperative agreement. The updated agreement significantly clarifies the roles of each institution when WSIRB conducts review on behalf of UW and when both institutions are reviewing the same research project. Additionally, the agreement addresses the addition of several state agencies to WSIRB’s oversight over the past few years and allows flexibility for the addition of future agencies.
The updated agreement will address some longstanding logistics issues for HSD which will improve the speed of authorizing studies for review by the WSIRB. Otherwise, there will be little to no process changes impacting researchers. UW researchers must still obtain WSIRB review when required.
Reminder: Due to state agency requirements, UW research projects involving most WA State agencies must be reviewed by the WSIRB. This review is required even when all of the activities involving human subjects are being carried out by UW researchers or when the UW or another IRB is serving as the single IRB under the federal single IRB mandate. WSIRB review may also be required in some cases when a WA State agency provides funding for a research project.
See HSD’s new, expanded webpage about WA State agencies and the WSIRB for more details.
New IRB Review Option for Researchers Using NHLBI Data Sets
UW researchers performing secondary analysis of NHLBI data sets with a data use limitation of “IRB Approval Required” may obtain IRB review from either UW IRB or the newly established NHLBI Clinical Data Science Institutional Review Board (CDS-IRB).
Many NHLBI data sets available to the scientific community have a restriction that secondary uses of the data must receive prior approval by an IRB, even though their use may not be considered human subjects research under the Common Rule. The potential risks associated with secondary analyses are not necessarily the same as the risks associated with primary human subjects research, and there is little extant guidance for IRB/ethical review of proposed secondary analyses.
The CDS-IRB was established to specifically address ethical issues that may arise in the course of secondary analyses, and it has developed an ethics framework and principles to ensure consistent, comprehensive reviews specific to secondary research. The CDS-IRB members are from diverse backgrounds including clinical, ethical, and legal specialties.
Additionally, the CDS-IRB is an opportunity for the NHLBI to systematically understand the evolution and range of requests to conduct secondary analyses, recognize emerging trends, and periodically explore with the research community ways to enhance data stewardship.
There is no cost to researchers for the use of the CDS-IRB, and, because the use of these datasets is not considered human subjects research under the Common Rule, UW researchers may bypass HSD’s standard authorization process for seeking review from an external IRB and may apply directly to the CDS-IRB using its forms and processes. In other words, you do not have to tell HSD that you are applying to the CDS-IRB and do not have to provide HSD with copies of approvals or any other outcome documents.
HSD gladly supports this initiative to address the unique ethical considerations for this type of research and encourages researchers to make use of this new resource.
SCCA Proton Therapy Center now under the UW-SCCA Cooperative Agreement
The SCCA Proton Therapy Center located at the UWMC-Northwest campus has been added to the SCCA’s Federalwide Assurance. This means that the UW’s cooperative agreement with SCCA now covers UW-led research activities taking place at the center.
UW researchers obtaining UW IRB review for research taking place at the center should:
- Indicate that it is a multi-site or collaborative study in the Zipline SmartForm question 4.
- Select “SCCA Proton Therapy Center” under the Local Research Locations SmartForm in Zipline to indicate that activities are taking place there.
- Upload a completed Multi-site Supplement to provide additional information about the site activities.
No additional authorization is required from SCCA in order for UW to review the application.
Revised Department of Defense Documents
The SUPPLEMENT Department of Defense form has been revised because of significant changes in the Department of Defense (DoD) human subjects regulations. This form is submitted with IRB applications for research involving any DoD component (funding, facilities, investigators, participants). Although it is longer than the previous version, it consists almost entirely of simple checkboxes and requires few text-based answers.
The new GUIDANCE Department of Defense webpage was created to help researchers understand and navigate the many unique DoD requirements for human subjects research.
The revised WORKSHEET Department of Defense may be of interest to researchers because it describes the DoD requirements and issues that must be addressed by the Institutional Review Board (IRB).
UW Procurement Services and UW Medicine/UW Dentistry Policies
The IRB Protocol form and HSD webpages have been updated to help researchers remain compliant with the policies of other UW departments.
UW Procurement Services Amazon Mechanical Turk (MTurk) Policy
The IRB Protocol form question about subject payment and the MTurk FAQ in HSD’s GUIDANCE Subject Payment have been updated to remind researchers that per UW Procurement Services, no UW employee, family member, or student directly involved in the research may participate in MTurk tasks for that research project.
Recruitment of UW Medicine or UW Dentistry Residents and Fellows
A question has been added to the IRB Protocol form asking whether these individuals will be intentionally recruited as subjects. If yes, researchers must provide some additional specific information. In addition, researchers should inform UW HR Labor Relations prior to beginning the study at email@example.com.