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Form Name Description
2018 Common Rule IRB Applications
Last updated | 12-11-18 10:31 p.m.
Six IRB forms have been updated to accommodate applications under the 2018 Requirements of the Common Rule, 45 CFR 46.
Adverse Event Reporting
Last updated | 5-26-17 10:30 a.m.
Use this form to report an adverse event to the Institutional Review Board relating to a clinical trial. An adverse event must meet the following criteria: unexpected; related to or possibly related to the research; suggests that the research places participants or others at a greater risk of physical or psychological harm than was previously known or recognized.
This form is used to report third-party allegations of noncompliance regarding human-subjects research conducted by the Hutch.
Assent for a Research Study
Last updated | 12-22-16 11:23 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 | 11-20-17 8:10 a.m.
This form is used to aid in determining whether a study is covered by a Certificate of Confidentiality.
Children Supplement
Last updated | 5-26-17 9:51 a.m.
Use this form to request Institutional Review Board approval to use children in a clinical research study.
Confirmation of Limited Activity Form
Last updated | 7-3-17 1:23 p.m.
Signing this form 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.
Consent Form Template: Clinical Research
Last updated | 12-21-17 9:44 p.m.
This consent form template contains sample language for consenting a clinical trial participant.
Consent Form Template: Minimal Risk
Last updated | 12-21-17 9:50 p.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 | 12-21-17 9:56 p.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 | 12-21-17 10:17 p.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 | 12-21-17 10:20 p.m.
This consent form template is designed for Public Health Sciences researchers conducting minimal-risk research.
Continuing Review Report
Last updated | 7-3-18 10:23 a.m.
Use this form to report the current status of clinical research and whether that status has changed since the last Continuing Review Report, or CRR, was filed. This report is intended to assist the Institutional Review Board to carry out its continuing-review responsibilities to assure the protection, rights and welfare of human subjects participating in research.
Department of Defense Supplement
Last updated | 5-26-17 9:50 a.m.
Use this form to describe research activities funded by the Department of Defense.
Device Supplement
Last updated | 5-26-17 9:51 a.m.
Use this form to request the use of medical device(s) in a clinical research study.
Emergency Use Acknowledgement Report
Last updated | 7-5-17 9:40 a.m.
“Emergency use” is defined as the use of a test article (such as an investigational drug/biologic or device) on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval for the use. The clinician is still required to obtain informed consent under these circumstances, hence the use of this form.
Exempt Checklist
Last updated | 11-16-18 2:30 p.m.
Use this if you qualify for an exemption from the requirement to obtain an IRB review.
This form is used to notify the IRB of unanticipated problems or instances of noncompliance.
This is a checklist for determining which research activities may qualify for expedited review by the Institutional Review Board.
This form is used to document the Institutional Review Board of record on a multi-center study and to report any potential conflicts of interest with Fred Hutch.
External IRB Cover Sheet - New Application
Last updated | 7-12-18 10:28 a.m.
This form is used to document the Institutional Review Board of record on a multi-center study and to report any potential conflicts of interest with Fred Hutch.
Funding Source Supplement
Last updated | 7-5-17 8:47 a.m.
Use this form to submit funding-source documentation for review by the Institutional Review Board.
Funding Verification and Activation Form
Last updated | 9-1-17 9:42 p.m.
Use this form to submit study funding verification and activation to the Institutional Review Office.
Genomic Data Sharing Supplement
Last updated | 5-26-17 9:29 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.
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 | 12-22-16 11:23 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.
Human Subjects Research Determination
Last updated | 8-28-18 4:12 p.m.
Complete this form to determine whether a proposed research activity involves human subjects under Department of Health and Human Services and Office of Human Research Protections guidance.
IRB Application for Review
Last updated | 11-16-18 2:56 p.m.
This page contains forms that are used to apply for Institutional Review Board approval of interventional and observational studies, as well as research that involves human specimens and/or data.
IRB Authorization Agreements
Last updated | 7-3-17 1:34 p.m.
Forms needed for working with outside institutions on human subject research.
Individual Investigator Agreement
Last updated | 7-3-17 1:35 p.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.
Use this template to approve IRB applications.
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.
Interpreter Certification Form
Last updated | 5-26-17 11:04 a.m.
This form is used to certify the qualifications and experience of language interpreters who work with non-English-speaking study participants.
Investigator Prisoner Certification Checklist
Last updated | 5-26-17 11:13 a.m.
This form is for research studies that involve incarcerated individuals.
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
Multi-Center Supplement
Last updated | 8-9-17 11:18 a.m.
Use this form to list multiple study performance sites where Fred Hutch is the institutional review board, or IRB, of record.
Participating Site Application
Last updated | 11-16-18 2:46 p.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.
Repository, Registry or Databank Supplement
Last updated | 5-26-17 11:13 a.m.
This form is used with studies that require the use of tissue repositories, registries and databanks.
Research Modification Form
Last updated | 11-19-17 11:59 p.m.
Use this form to modify a research protocol, from research design to methods for documenting consent.
This short consent form to participate in a research study is available in 38 languages, from Albanian to Vietnamese.
Statistical Center Supplement
Last updated | 5-26-17 12:05 p.m.
This form is only for statistical centers that are not also serving as the coordinating center of a study. This form concerns the privacy of subjects, confidentiality of data, informed consent and more.
Third-Party Safety Reporting Form
Last updated | 5-26-17 12:05 p.m.
This form is used to report problems, events and information involving risks to research study participants.
Transfer of IRB Oversight
Last updated | 7-3-17 1:37 p.m.
Translation Certification Form
Last updated | 5-26-17 9:28 a.m.
Every person providing translation services must complete and sign the Translation Certification Form.
Waiver of Consent Supplement
Last updated | 11-16-18 2:40 p.m.
Use this form to request a full or partial waiver of consent for a research study.
eSubmission System Access Form
Last updated | 12-22-16 11:24 a.m.
Use this form to request access to the eSubmission System.