Policies and Procedures

Human Research Protection Program

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.

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

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

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

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.

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Status Reports for IRB Files (Policy 2.28)

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

Training (Policy 2.20)
Requirements and ongoing educational opportunities.

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

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