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All of the Institutional Review Board policy and procedure files are available on this page. Signed copies are on file at Fred Hutch.


Office of the Director Policy on Human Research Protection Program (HRPP)
Statement of overarching principles and guidelines for human subjects research at Fred Hutch.


Approval Date Guidelines and Turnaround Times (Policy 1.8)
Guidelines on the turnaround time for Institutional Review Office, or IRO, staff to process and provide approval documents.

* Approval Date Guidelines and Turnaround Times

Closure and Re-open Policy (Policy 2.9)
Describes how IRO closes and reopens research studies.

* Closure and Re-open Policy

Communications Policy (Policy 2.21)
Expectations for communications with IRB stakeholders.

* Communications Policy

Continuing Review Policy (Policy 2.2)
Details about when and how often continuing review of approved human research studies must occur.

* Continuing Review Policy

Control and Distribution of Policies and Supporting Documents (Policy 1.1)
Describes how the Fred Hutch IRO creates and maintains written policies and supporting documents.

* Control and Distribution of Policies and Supporting Documents

Database PIRO (Policy 2.22)
Describes the purpose and use of internally developed software for IRO information and process management.

* Database PIRO

Determining when Activities are Research Involving Human Research Participants (Policy 1.14)
Guidelines for establishing which activities are clinical investigations that involve human subjects.

* Determining when Activities are Research lnvolving Human Research Participants

Emergency Use of an Investigational Drug or Device (Policy 2.4)
Guidelines for emergency drug or device use when there is not sufficient time to gain IRB approval.

* Emergency Use of an Investigational Drug or Device

Federal-wide Assurance (Policy 1.2)
Principles concerning compliance with Federal-wide Assurance with the Office for Human Research Protections.

* Federal-wide Assurance

Funding Source Document Review (Policy 2.18)
Assuring there are adequate resources to conduct proposed research activities.

* Funding Source Document Review

Identification and Use of Legally Authorized Representatives (Policy 2.25)
Principles for obtaining legally effective informed consent from legally authorized representatives.

* Identification and Use of Legally Authorized Representatives

Informed Consent (Policy 2.11)
Obtaining legally effective informed consent from research participants or their representatives.

* Informed Consent

Investigational New Drugs (IND), Biologics and Investigational Device Exemptions (IDE) (Policy 1.13)
This policy outlines the IRB's process and reporting criteria for studies that involve investigational new drugs or devices.

* Investigational New Drugs (IND), Biologics and Investigational Device Exemptions (IDE)

IRB Committee Structure (Policy 1.3)
Composition of IRBs to ensure the protection of research participants.

* IRB Committee Structure

IRB Member Conflict of Interest (Policy 1.5)
Avoiding financial conflicts to assure research participants are adequately protected.

* IRB Member Conflict of Interest

IRB Reliance Agreements (Policy 2.24)
Mechanisms for delegating IRB review authority in multi-site research.

* IRB Reliance Agreements

IRB Requirements for Reporting to Institutional and External Officials (Policy 2.8)
Guidelines for reporting unanticipated problems, noncompliance or changes in IRB approval.

* IRB Requirements for Reporting to Institutional and External Officials

IRB Review of Genomic Data Sharing Studies (Policy 2.27)
Consideration of requests to allow broad sharing of data from genome-wide association studies.

* IRB Review of Genomic Data Sharing Studies

IRO Website Policy (Policy 2.23)
Principles for maintaining the IRO's online presence and relevancy.

* IRO Website Policy

Maintenance and Retention of IRB Documents (Policy 2.17)
Guidelines for how the IRB manages research records and materials.

* Maintenance and Retention of IRB Documents

Meeting and Meeting Records (Policy 1.6)
Procedures related to IRB meetings, schedules, materials and agendas.

* Meeting and Meeting Records

Modification to Ongoing Activities (Policy 2.5)
Review and approval of proposed changes to an approved research study.

* Modification to Ongoing Activities

Monitoring of Institutional Review Board, IRB Operations, and Research Studies (Policy 2.16)
Assessing the effectiveness of the Fred Hutch Human Subjects Protection Program.

* Monitoring of Institutional Review Board, IRB Operations, and Research Studies

Multi-Center Study Coordination – IRB Review and Oversight (Policy 2.14)
Responsibility for the management of IRB approval for multiple performance sites.

* Multi-Center Study Coordination —IRB Review and Oversight

New Application (Policy 2.1)
Submitting applications and receiving approvals prior to initiating research activities.

* New Application

Noncompliance (Policy 1.9)
Principles governing prompt reporting of noncompliance.

* Noncompliance

Privacy and Confidentiality (Policy 2.12)
Conducting research in a manner that protects participants' personal information.

* Privacy and Confidentiality

Recruitment and Compensation (Policy 2.0)
Review of materials and methods used to recruit and compensate study participants.

* Recruitment and Compensation

Reporting Obligations for PIs (Policy 1.11)
Requirements of principal investigators for reporting adverse events, unanticipated problems, noncompliance and other matters.

* Reporting Obligations for PIs

Research Involving Department of Defense (DoD) Components (Policy 2.26)
Compliance with the additional requirements in the Fred Hutch Department of Defense addendum.

* Research Involving Department of Defense (DoD) Components

Research Involving Special Populations (Policy 2.15)
Special procedures with respect to the inclusion of special and vulnerable populations, such as children or individuals with impaired decision-making capacity, in research studies.

* Research lnvolving Special Populations

Research Participant Inquiries (Policy 2.10)
Providing ways to ask questions and express concerns about research studies.

* Research Participant lnquiries

Risks to Research Participants (Policy 1.7)
The use of sound research principles to minimize risks.

* Risks to Research Participants

Staff Structure (Policy 1.4)
Selection and evaluation process for IRO staff who coordinate human-subjects review.

* Staff Structure

Status Reports for IRB Files (Policy 2.28)

* Status Reports for IRB Files

Suspension or Termination of IRB Approval (Policy 1.10)
Principles and process for suspending or terminating research activities.

* Suspension or Termination of IRB Approval

Training (Policy 2.20)
Requirements and ongoing educational opportunities.

* Training

Unanticipated Problems Involving Risks to Subjects or Others (Policy 2.6)
Requirements for reporting certain problems, events and information.

* Unanticipated Problems Involving Risks to Subjects or Others

Use of interpreter Services and Translated Documents (Policy 2.13)
Review and approval of all documents translated or interpreted from English to another language.

* Use of interpreter Services and Translated Documents