Institutional Review Board

IRB Policy Statement re Electronic Consent, Revised 5-26-21

The Seattle Children’s Institutional Review Board (IRB), in cooperation with other institutional teams (including IT and Legal) provides this policy statement and guidance (DOCX) on the use of electronic systems and processes to obtain informed consent. This information is intended for both the time that COVID impacts study procedures as well as beyond.

If you have questions about this policy statement, please email Seattle Children’s IRB.

Update 3-30-2020 – COVID-19 Seattle Children’s IRB Guidance

Seattle Children’s has instituted COVID-19 screening and increased isolation procedures for patients. Because many patients are also research participants, Seattle Children’s IRB is providing the following guidance for those studies under its oversight. Studies subject to the oversight of other IRBs (central/single IRB situations) should consult with those IRBs for guidance.

System-Wide COVID-19 Mandatory Screening: Mandatory screening procedures/questionnaires are not generally considered research procedures for your study, and therefore do not trigger the need for a study modification. These screening procedures/questionnaires do not constitute a change in the research procedures unless you choose to incorporate the data collected under the mandatory screening into your research plan. If you do wish to include data obtained from this mandatory screening in your research plan, then a modification or new study should be submitted to the IRB for review.
Changes to IRB Studies: Any changes to IRB research study procedures must be submitted to the IRB via a modification request and may not be implemented prior to review and approval by the IRB, except when necessary to eliminate apparent immediate hazards to the subject per federal regulations (Common Rule and FDA regulations). Seattle Children’s also has a responsibility to ensure the safety of its workforce. As such, interim measures to reduce immediate hazards to research participants and/or workforce members – which may involve changing study procedures prior to securing IRB approval – may be warranted to relieve an immediate hazard and to ensure consistency with Seattle Children’s policies during this time.
- Investigators are encouraged to use their judgment when considering approaches to reduce the risk to subjects and workforce. Examples could include approaches that would reduce the need for “at risk” research participants to visit Seattle Children’s facilities, such as:
  - Conducting study visits by phone rather than in-person (e.g., surveys, focus groups)
  - Permitting “out of window” study visits and/or canceling study visits if not safety-related
- Please note that this information only applies to participants already enrolled in a research study. Obtaining verbal consent instead of written consent to enroll a subject for a study that is only approved to obtain written consent would not be permissible.
- For the examples above, and any other study modifications, research teams should work with their funding and regulatory sponsors to develop appropriate plans for research participants and research procedures, in light of the current circumstances.
- Important Note: If you do make a change to eliminate immediate hazard prior to IRB review, then you must notify the IRB within 5 business days of the change via a Reportable New Information (RNI).
  - If the change will be implemented again (for one or more participants) and/or apparent immediate hazards will be sustained for a duration that would practicably allow for prior IRB review and approval, then a modification request must also be submitted.
  - “Out of window” or missed study visits are not considered a change for purposes of the above and should follow normal IRB process. Specifically, an RNI needs to be submitted to the IRB if there is a harm/risk involved.
IRB Business Continuity Plan: Seattle Children’s IRB is continuing to operate to ensure business continuity and service. We have systems in place to allow our IRB office and committee members to effectively work remotely as needed. Study teams should follow current best practices for communicating with our IRB office, specifically, using the Click IRB electronic system as the primary communication means, emailing the main IRB account when appropriate, and ensuring you leave a voicemail if you are requesting a call back.
Prioritization of IRB Submissions: In light of the COVID-19 situation, the IRB office will be automatically considering incoming new studies and modifications that involve COVID-19 or its impact on ongoing research for prioritization. A rush review request is not needed for these submissions unless there are particular circumstances you need the IRB to consider for its potential prioritization. When submitting a COVID-19 related submission, please include “COVID-19” in the study title, brief description, or modification summary so the IRB office can quickly triage such submissions.
ClinCard Changes: Due to the COVID-19 situation, the IRB understands that many study teams may need to substitute egift cards in place of ClinCard(s), in the same dollar amount as initially planned, in order to thank participants for taking part in studies. To support these changes, the IRB is taking the following actions:
- Providing this IRB Policy Statement (PDF)
- Posting this IRB Pre-Approved Participant Letter Template (PDF) (DOCX)

This policy statement and IRB pre-approved participant letter template are intended to negate the need to submit modifications to the IRB for these changes.

If you have questions about this guidance, please email Seattle Children’s IRB.

Click IRB Library Recent Updates – January 2020

Click IRB documents have been revised to reflect administrative, regulatory and policy changes. See more information about the updates.

What is the Institutional Review Board?

The Institutional Review Board (IRB) is a committee established to protect the rights and welfare of the children and families who participate in research activities conducted under the auspices of Seattle Children's and affiliated research organizations. The IRB reports to the president of Seattle Children's Research Institute. The IRB is responsible for ensuring that basic ethical principles as well as federal regulations, state law and institutional policy governing the protection of research participants are applied to research activities.

Mandatory Use of Click IRB

Most study materials must be submitted to the IRB via Click IRB. Visit the Click IRB Resources page for training Information, Quick Guides, and other resources. If you have questions, please email the IRB.

Membership

IRB members are appointed by the president of the research institute. A broad representation of pediatric specialties is found among the scientific members. In addition to the scientific members, the IRB includes non-scientists and unaffiliated members as required by federal regulation.

Additional Information

Seattle Children's holds a Federalwide Assurance: FWA# 00002443.
Seattle Children's has two IRB registration numbers: IRB00000277 and IRB00009311.
View our institutional authority page (PDF).