General FAQ
Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. If you have questions about whether your project is research, please email the IRB inbox.
Case reports that constitute Human Research require IRB review. The “HRP-101-HUMAN RESEARCH PROTECTION PROGRAM PLAN” (available in the Click Library) defines the activities that this institution considers to be “Human Research.” An algorithm for determining whether an activity is Human Research can be found in the “HRP-310-WORKSHEET - Human Research Determination” located in the Click Document Library. Use that document for guidance as to whether an activity meets the definition of Human Research, keeping in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research subject to IRB oversight.
- Please note that case reports involving 3 or fewer patients will often not meet the definition of Human Research.
- Questions about the requirements related to obtaining permission for case reports? Please reach out to the Privacy Office.
You are responsible not to conduct Human Research without prior IRB review and approval. If you have questions about whether an activity is Human Research, contact the IRB Office. Further, it is best practice and strongly encouraged to seek in writing IRB review of such activities because such determinations are often difficult to accurately make and the individual who does not seek IRB review bears the risk of any resulting noncompliance as well as ramifications from publishers. To obtain a written determination from the IRB, submit your request in Click IRB using the HRP-503C protocol template in the Click Library.
For exempt categories, please see HRP-312-Worksheet - Exemption Determination in the Click Library. Submit your study in Click IRB using protocol template HRP-503B-PROTOCOL EXEMPT.
Yes. The use of medical records, clinical databases (paper, electronic or any form) for research purposes requires IRB review.
Researchers can help improve turnaround time by submitting complete, consistent study materials and addressing all requests from the IRB in a timely manner.
No. Research participants are not to be approached until the IRB has given final approval to the study submission.
No. The IRB must review and approve any materials you plan to use before you begin recruiting individuals. This includes advertisements that appear in the newspaper, on radio or television or on the Internet, and flyers.
Yes. Refer to the Investigator Manual in the Click Library for more information.
Refer the Investigator Manual in the Click Library for complete guidance.
If you wish to make changes to your study (including projects determined to not constitute research or human subjects research, or where it was determined Seattle Children’s is not engaged, etc.), you will need to submit a modification request in Click to update the IRB with the changes you are making. Refer to the Investigator Manual in the Click Library for more information.
Adverse events that fall under one or more Report of New Information (RNI) categories must be submitted to the IRB for review. Refer to the Investigator Manual in the Click Library for the list of RNI categories and additional information.
Complete and submit the Continuing Review SmartForm in Click IRB with the relevant boxes checked and attach all relevant documents. Refer to the “Continuing Review Submission” Reference Guide on the IRB website for more information.
A Federalwide Assurance (FWA) is an agreement between Seattle Children’s and the Office for Human Research Protections (OHRP), which acts on behalf of the Secretary of the U.S. Department of Health and Human Services. The agreement provides written assurance that Seattle Children’s will comply with the basic ethical principles and the federal laws and regulations as well as state and local laws regarding the protection of human subjects in research. Seattle Children’s FWA number is FWA00002443.
For studies approved prior to January 21, 2019, the federal funding agency expects the IRB to review the federal funding proposal for consistency with the research study materials. Before funds are awarded, the federal agency requires certification of review and approval from the IRB. Studies approved on or after January 21, 2019 no longer have the requirement for the IRB to review the funding proposal.
All certification requests must be submitted to the IRB inbox. The submission should include:
- The completed HRP-2142 Genomic Data Sharing (GDS) Certification Request Form
- Completed NIH certification form(s)
- All template versions of the consent forms signed by subjects whose data will be submitted to the repository.
After reviewing the submission, the IRB will provide its recommendations to the Institutional Official (IO) about what data can be certified. After the IO’s review, the IRB will send the IO’s signed certification for NIH to the PI.
NIH issued a notice on November 1, 2018, that all genomic summary results (GSR) submitted to an NIH repository like dbGaP will be unrestricted access, and that existing controlled-access GSR data may be converted to unrestricted access on May 1, 2019. GSR are the output of analyses of genomic data across the many individuals included within a specific study’s dataset.
Controlled-access means that an investigator requesting the data will have prior NIH committee review before the data is released. Unrestricted access means that there is no prior NIH committee review. The notice also explained that individual-level data will continue to be controlled-access.
There is an exception to have GSR be controlled-access if it is from a “sensitive” study. A “sensitive” study includes studies with a population:
- From isolated geographic regions, or
- With rare traits, or
- With potentially stigmatizing traits
A new NIH certification from a “sensitive” study should explain how the study meets the “sensitive” criteria. Investigators who already submitted data and believe their study could meet the “sensitive” criteria should contact the IRB to discuss submitting an updated NIH certification.