Institutional Review Board
Frequently Asked Questions About Research at Seattle Children's
For exempt categories, please see HRP-312 in the Click Library. Submit your study in Click IRB using protocol template HRP-503B. See also HRP-502E if applicable.back to top
Yes. The use of medical records, clinical databases (paper, electronic or any form) for research purposes requires IRB review.back to top
Researchers can help move the IRB process quickly by preparing applications that are complete. Consistency within the submission documents is also very important.back to top
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.
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. View the Investigator Manual for more information.back to top
Under federal regulation the IRB is responsible for receiving and reviewing information about adverse events experienced by research participants. See the Investigator Manual for additional information.back to top
A Federalwide Assurance (FWA) is an agreement between Seattle Children’s Hospital 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 the hospital 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. The hospital’s FWA number is FWA00002443.back to top
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.
In almost all cases, informed consent must be obtained from the research participants or their legally authorized representative (s) before participation in research begins.
It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legally authorized representative (s) understands the information.
In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, usually indicated by the participant’s or their legally authorized representative (s) on the written consent document.
The IRB may approve a waiver of consent or documentation of consent in limited circumstances.
See the Investigator Manual and protocol documents HRP-90 and HRP-91 for more information.
Federal regulations require that there are adequate provisions made for soliciting the assent of children when they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent. Usually children who are age seven and older are asked to sign an assent form, and adolescents age 13 and older sign the consent form. Both forms should be written at an appropriate reading level.
Because children have not yet attained legal age to provide consent, the parent or legal guardian is also asked to give permission for participation when a child is asked to take part in research.
For new research, it is recommended to arrange a consult with the IRB to discuss how the certification process affects the study protocol and consent form.
For existing research, a new certification request 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 request(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.
What is a “sensitive” study for NIH genomic data certification and how does it affect my NIH repository submission?
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
- 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.