Form Name | Description |
---|---|
Ancillary Review Matrix
Last updated
|
6-14-23 12:22 p.m.
|
|
Assent for a Research Study
Last updated
|
5-16-23 11:47 a.m.
|
This is a template form for gaining patient assent toward a blood draw or other laboratory test used for research.
|
Certificate of Confidentiality Supplement
Last updated
|
7-31-20 5:39 p.m.
|
This form is used to aid in determining whether a study is covered by a Certificate of Confidentiality.
|
Children Supplement
Last updated
|
4-3-23 10:56 a.m.
|
Use this form to request Institutional Review Board approval to use children in a clinical research study.
|
Closure - Participating Site
Last updated
|
6-23-23 11:43 a.m.
|
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.
|
Confirmation of Limited Activity Form (CLAF)
Last updated
|
2-27-23 1:19 a.m.
|
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
|
Consent Form Template: Clinical Research
Last updated
|
5-16-23 11:57 a.m.
|
This consent form template contains sample language for consenting a clinical trial participant.
|
Consent Form Template: Minimal Risk
Last updated
|
5-16-23 11:57 a.m.
|
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
Last updated
|
5-16-23 11:57 a.m.
|
This consent form template for minimal-risk studies contains sample language for obtaining consent from a patient to participate in a clinical trial.
|
Consent Form Template: PHS
Last updated
|
5-16-23 11:58 a.m.
|
This consent form template is designed for use by Public Health Sciences researchers conducting more than minimal-risk research.
|
Consent Form Template: PHS Minimal Risk
Last updated
|
5-16-23 11:58 a.m.
|
This consent form template is designed for Public Health Sciences researchers conducting minimal-risk research.
|
Continuing Review Supplement
Last updated
|
7-19-23 11:30 a.m.
|
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.
|
Continuing Review Supplement - Participating Site
Last updated
|
5-16-23 1:45 p.m.
|
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.
|
Department of Defense (DoD) Supplement
Last updated
|
4-3-23 11:47 a.m.
|
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).
|
Device Supplement
Last updated
|
8-27-23 11:58 p.m.
|
Use this form to request the use of medical device(s) in a clinical research study.
|
Drug Supplement
Last updated
|
4-3-23 11:46 a.m.
|
Complete and attach this supplement to your submission in Hutch IRB to provide supporting information.
|
Exempt Form
Last updated
|
4-3-23 11:04 a.m.
|
Use this if you qualify for an exemption from the requirement to obtain an IRB review.
|
Expedited Review Form
Last updated
|
4-3-23 11:03 a.m.
|
This is a form for determining which research activities may qualify for expedited review by the Institutional Review Board.
|
External IRB Supplement
Last updated
|
6-23-23 11:42 a.m.
|
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.
|
Funding Verification and Activation Form
Last updated
|
2-27-23 1:19 a.m.
|
Use this form to submit study funding verification and activation to the Institutional Review Office.
|
Genomic Data Sharing Supplement
Last updated
|
4-3-23 10:58 a.m.
|
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.
|
HIPAA Authorization for the Use of Patient Information for Research
Last updated
|
8-17-23 11:06 a.m.
|
This form describes what we will do if you give your permission to share patient information about you for use in research.
|
HIPAA Supplement and Waiver of Authorization
Last updated
|
4-3-23 10:59 a.m.
|
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.
|
IRB Application
Last updated
|
9-11-23 4:01 p.m.
|
This page contains IRB Application forms that are used to apply for Institutional Review Board approval of studies.
|
IRB Authorization Agreements
Last updated
|
5-1-23 11:45 a.m.
|
Forms needed for working with outside institutions on human subject research.
|
Individual Investigator Agreement
Last updated
|
5-1-23 11:46 a.m.
|
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.
|
International Research Performance Site Assessment Supplement
Last updated
|
4-3-23 10:59 a.m.
|
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.
|
Local Context Review Form
Last updated
|
4-3-23 11:48 a.m.
|
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.
|
Model Repository Access Confidentiality Pledge
Last updated
|
10-18-17 1:05 p.m.
|
A confidentiality pledge for studies wishing to withdraw data and specimens from the Repository
|
Modification Supplement
Last updated
|
5-1-23 11:38 a.m.
|
Use this form to modify a research protocol, from research design to methods for documenting consent.
|
Modification Supplement - Participating Site
Last updated
|
5-1-23 12:05 p.m.
|
This form should be used to modify approval for a participating site outside the Fred Hutch/UW Cancer Consortium that relies on the Fred Hutchinson Cancer Center IRB.
|
Multi-Center Supplement
Last updated
|
4-3-23 11:01 a.m.
|
Use this form to list multiple study performance sites where Fred Hutch is the institutional review board, or IRB, of record.
|
NHS Funding Modification
Last updated
|
7-20-20 12:43 p.m.
|
This form is only to be used to submit funding modifications on research that has an existing Not Human Subjects (NHS) determination from the Institutional Review Office.
|
Participating Site Supplement
Last updated
|
6-30-23 9:48 a.m.
|
This form should be used to obtain approval for a participating site outside the Fred Hutch/UW Cancer Consortium that relies on Fred Hutch IRB. Submit once IRB approval for the master file has been obtained.
|
Prisoner Certification Checklist for Investigator
Last updated
|
4-3-23 11:02 a.m.
|
This form is for research studies that involve incarcerated individuals.
|
Reliance Agreement Intake Form
Last updated
|
6-27-22 11:01 a.m.
|
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.
|
Reportable New Information (RNI) Supplement
Last updated
|
6-4-23 10:43 p.m.
|
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.
|
Repository, Registry or Databank Supplement
Last updated
|
4-3-23 11:02 a.m.
|
This form is used with studies that require the use of tissue repositories, registries and databanks.
|
Research Assessment Form
Last updated
|
5-5-23 11:03 a.m.
|
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.
|
Short-Form Consent - 2018 Requirements
Last updated
|
10-19-23 10:56 p.m.
|
This short-form consent version is for use by studies approved by the IRB on or after January 21, 2019.
|
Short-Form Consent - Pre-2018 Requirements
Last updated
|
10-19-23 11:02 p.m.
|
This short consent form to participate in a research study is available in 39 languages, from Albanian to Vietnamese.
|
Short-Form Consent to Participate in a Research Study
Last updated
|
1-19-19 3:10 p.m.
|
Short-form consent forms are for use when subjects cannot read English and the study did not expect to enroll participants that speak their language.
|
Short-Form Consent to Participate in a Research Study (in 39 languages)
Last updated
|
1-20-19 1:53 p.m.
|
This short consent form to participate in a research study is available in 39 languages, from Albanian to Vietnamese.
|
Transfer of IRB Oversight
Last updated
|
4-3-23 11:03 a.m.
|
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.
|
Translation Certification Form
Last updated
|
5-1-23 12:54 p.m.
|
Every person providing translation services must complete and sign the Translation Certification Form.
|
Waiver of Consent Supplement
Last updated
|
4-3-23 10:57 a.m.
|
Use this form to request a full or partial waiver of consent for a research study.
|
Waiver of IRB Fee Request Form
Last updated
|
1-9-23 11:02 p.m.
|
All waiver of IRB fee requests must be approved by the VP of Research Administration.
|
eSubmission System Access Form
Last updated
|
2-27-23 11:37 a.m.
|
Use this form to request access to the eSubmission System.
|