IRB Forms

This worksheet shows other regulatory or institutional reviews that may be required for the research taking place at a Cancer Consortium institution. These are called “ancillary” reviews because they are additional requirements beyond IRB review.

This is a template form for gaining patient assent toward a blood draw or other laboratory test used for research.

Use this form to request Institutional Review Board approval to use children in a clinical research study.

This form is to be used for a Participating Site outside the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium when the site is relying on the Fred Hutch IRB.

Signing the Confirmation of Limited Activity Form (CLAF) certifies that only activities that are clearly severable and independent from activities that involve human or animal subjects may be conducted under a specific grant award until the project has received approvals, and approvals have been submitted and accepted by the agency as appropriate. LAF

This consent form template contains sample language for consenting a clinical trial participant.

Consent to donate extra tissue samples for research during a planned clinical evaluation for blood or marrow stem cell transplantation.

Consent Form Template: Minimal Risk Studies

This consent form template is designed for use by Public Health Sciences researchers conducting more than minimal-risk research.

This consent form template is designed for Public Health Sciences researchers conducting minimal-risk research.

Fred Hutch IRB Policy 2.11 Informed Consent (Appendix A) presumes that the Principal Investigator, MD sub‑investigators, and attending physicians with the requisite health care provider credentials will obtain informed consent, especially for high-risk interventional trials. For lower risk trials, the policy outlines other roles that are presumptively qualified to conduct consent discussions. 

Use this form to report the current status of research and whether that status has changed since the last Continuing Review was filed. This report is intended to assist the Institutional Review Board in carrying out its continuing review responsibilities to ensure the protection, rights and welfare of human subjects participating in research.

This form is to be used for a Participating Site outside the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium when the site is relying on the Fred Hutch IRB.

Complete this form and attach it in Hutch IRB if the research involves funding, facilities, data, or personnel from the Department of Defense (DoD) or one of its component entities (e.g., Dept. of Army, DARPA).

Use this form to request the use of medical device(s) in a clinical research study.

Complete and attach this supplement to your submission in Hutch IRB to provide supporting information.

Use this if you qualify for an exemption from the requirement to obtain an IRB review.

This is a form for determining which research activities may qualify for expedited review by the Institutional Review Board.

This form is used in conjunction with Hutch IRB to request authorization to rely on an external IRB. If Fred Hutch is engaged in the research, use this form to request authorization from the Fred Hutch IRO to rely on an external IRB.

Use this form to submit study funding verification and activation to the Institutional Review Office.

This supplement should be completed for studies involving the proposed submission of genotype and phenotype or other genetic data (referred to here as "genomic data" or "dataset") into genomic repositories created to share genetic information within the wider research community for research purposes.

This form describes what we will do if you give your permission to share patient information about you for use in research.

This form should be completed to determine whether your study is eligible for a HIPAA authorization waiver, which would allow the Institutional Review Board to approve access to and use of protected health information under certain circumstances.

This page contains IRB Application forms that are used to apply for Institutional Review Board approval of studies.

Forms needed for working with outside institutions on human subject research.

Signing this agreement confirms that an investigator has reviewed “The Bellmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research” (or other internationally recognized equivalent) and understands and accepts the responsibility to comply with the standards and requirements stipulated therein to protect the rights and welfare of human subjects involved in research, among other human-subjects requirements.

Use this if a performance site is located outside the United States.This information will assist the IRB in its review of the unique ethical considerations that may apply to the study being conducted at a foreign performance site.

This form is used to provide local context review for research activities for Fred Hutch Institutional Review Board (IRB) serving as the single IRB for your institution.

A confidentiality pledge for studies wishing to withdraw data and specimens from the Repository

Use this form to modify a research protocol, from research design to methods for documenting consent.

This form should be used to modify approval for a participating site outside the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium that relies on the Fred Hutchinson Cancer Center IRB.

Use this form to list multiple study performance sites where Fred Hutch is the institutional review board, or IRB, of record.

This form should be used to obtain approval for a participating site outside the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium that relies on Fred Hutch IRB. Submit once IRB approval for the master file has been obtained.

This form is for research studies that involve incarcerated individuals.

If Fred Hutch has been requested to serve as the IRB for sites outside the Cancer Consortium, please complete Sections 1-3. If Fred Hutch has been asked to rely on an external IRB, please complete Sections 1-2 and Section 4.

This supplement, along with an RNI submission in Hutch IRB, is used to report new information, such as a noncompliance event or an unanticipated problem involving risks to subjects or others, about an approved study or active research to the IRB.

This form is used with studies that require the use of tissue repositories, registries and databanks.

The intent of this form is to help the person most familiar with the planning and development of a project to decide whether the project is research or not.

A form to use when transferring IRB oversight from another institution to Fred Hutch. A supplement to determine what needs to be submitted with the Transfer of IRB Oversight form.

Every person providing translation services must complete and sign the Translation Certification Form.

Use this form to request a full or partial waiver of consent for a research study.

All waiver of IRB fee requests must be approved by the VP of Research Administration.

Use this form to request access to the eSubmission System.