March 30, 2020
For the Record – March 30, 2020
In this Issue:
- Evolving Restrictions and Requirements
- NIH CoC Application Process for non-NIH Funded Research
- SUPPLEMENT IRB Protocol, Version Updates
- Other New or Revised Documents
Evolving Restrictions and Requirements for Human Subjects Research
Researchers have received many communications from multiple sources about how their human subjects research is affected by the COVID-19 outbreak. Frequent communications have been necessary to quickly disseminate information about how rapidly-changing public health guidelines and requirements apply to the breadth and diversity of UW research. Also, the need for swift action means that the normal communication coordination is truncated or not possible. This can feel overwhelming and confusing to researchers. Here is a summary of the key communications, together with context about how they related to each other. If there are any questions about their inter-relatedness: please consult with the Office of Research through firstname.lastname@example.org.
|March 13. UW Medicine announced a temporary suspension, effective immediately, of all non-COVID-19 clinical study activity, including consenting, that requires the presence of research personnel in UW Medicine intensive care units and emergency departments.||HSD Comment. This is a location-specific halt but only for research that requires the presence of research staff AND that is not related to COVID-19. This halt is still in place.|
|March 19. The University, Office of Research, and Human Subjects Division announced a temporary halt of some human subjects research involving in-person interactions. Specific criteria were provided for identifying studies (and study procedures) that can continue. The criteria are described on HSD’s webpage COVID-19 and Human Subjects Research||HSD Comment. This is a very broad halt that applies to all UW research that does not meet the criteria for continuing. It applies to all locations, and to UW research reviewed by any IRB. This halt is still in place.|
|March 20. The University and UW Medicine announced a new COVID-19 Research Portal. UW researchers must use this portal to request access to UW Medicine patients with, at risk for, or recovered from COVID-19, their biospecimens, or their medical record information.||HSD Comment. This requirement provides management, evaluation, and coordination of requests – which are expected to be greater than can be fulfilled. It protects patients by managing the cumulative burden of multiple research projects. It will continue indefinitely.|
|March 24-26. The Office of Research widely distributed guidance about what types of “in-person research” is allowed (human, animal, other). It included updates to the existing webpage “Mitigating Impacts to Research Activities Due to COVID-19” as well as a new FAQ about research during the “Stay Home, Stay Healthy” time period, and a new Decision Tree.||HSD Comment. The Office of Research guidance does not supersede the March 19th temporary halt to some types of human subjects research, but rather is in addition to the HSD guidance. The term “in-person” in the Office of Research information refers to UW researchers, study staff, or students involved in research coming in-person to a UW facility. The term “in-person” in the HSD guidance is about in-person interactions between subjects and research staff, regardless of location.
The two sets of materials – HSD and Office of Research – are additive. Researchers should first consider whether their research meets the HSD criteria for continuing. If yes, then they should consider the Office of Research FAQ and Decision Tree to determine whether allowable human subjects research can continue that requires a UW staff, faculty, or student to go to a facility (such as UW office, clinic, or laboratory).
When the HSD criteria allow human subjects research that seems dis-allowed by the Office of Research criteria please contact the Office of Research for guidance at email@example.com.
|March 25. HSD updated the information on its COVID-19 webpage. The revision included a new section called “Information for UW Researchers Planning COVID-19 Research” and some minor refinements to the criteria for human subjects research that can continue.||HSD Comment. The criterion “Clinical trials where all in-person interactions can occur in the context of a needed clinical care visit” has been refined to: “Research for which all in-person interactions can occur in the context of a needed clinical care visit AND through interaction with only the clinical care providers the participant would see even if not participating in the research (i.e., this does not allow interactions with research staff).”|
NIH Certificate of Confidentiality Application Process for non-NIH Funded Research
Revised process for obtaining a CoC for non-NIH-funded research
All projects funded by the National Institutes of Health (NIH) automatically receive a federal Certificate of Confidentiality (CoC) as a condition of the award, but NIH has implemented a new system for issuing CoCs for non-NIH funded research (NOT-OD-20-075).
- In the updated Online Certificate of Confidentiality System, investigators are asked to provide information in short text fields and make self-certification statements rather than uploading most of the documents that were required under the old system. For example, the system no longer requires a copy of the informed consent form, the IRB approval letter, or the Institutional Assurance document. The only document that may need to be uploaded is the Drug Enforcement Authority (DEA) registration certificate, when applicable.
- To obtain the Institutional Assurance, investigators will be asked to provide contact information for an Institutional Official who has signature or other authority to submit the request. At the UW this is the Office of Sponsored Programs (OSP). Investigators should provide the general OSP email address (firstname.lastname@example.org).
Additional details about the new application process can be found at the NIH website and in the revised SOP Certificate of Confidentiality Apply, Extend, Modify. The form, REQUEST Certificate of Confidentiality Signature Cover Sheet has been retired since OSP will be required to submit directly into the system rather than signing this form to give to the research team.
SUPPLEMENT IRB Protocol, Version Updates
New form – in case researchers wonder about a new, short, form they are asked to complete
The IRB Protocol application form has been revised several times since its introduction in Spring 2016. As a result, older versions of approved IRB Protocols may not contain information needed to assess modification applications. The new SUPPLEMENT IRB Protocol, Version Updates contains all significant questions that have been added since version 1.0. This form is only accessible to HSD staff and is not posted on the HSD website. When assessing a modification request, HSD staff may send this SUPPLEMENT to researchers and ask them to complete one or more of the questions as a way of incorporating needed information into the IRB application overall.
Other New or Revised Documents
- Revised ZIPLINE SOP RNI Reporting by Researchers. Requirements for what needs to be reported to the IRB, and when, have not changed. The document has been re-formatted, re-organized, and considerably shortened.
- Revised POLICY & SOP Research Conducted without Prior IRB approval. This replaces the SOP Data Collected Without IRB Approval. It addresses some gaps in the prior document but does not contain any policy changes.
- New RELYING SITES Reporting New Information [to the UW IRB]. This new document provides guidance to non-UW sites that are relying upon the UW IRB (i.e., as a Single IRB) about what types of events and new information must be reported to the UW IRB, as well as the time frame and process for doing so.