Policies and Procedures

All Institutional Review Board policy and procedure files are available on this page.

Office of the Director Policy on Human Research Protection Program (HRPP)

Statement of overarching principles and guidelines for human subjects research at Fred Hutch.

Human Research Protection Program

Investigator Manual (HRP-103)

HRP-103 - Investigator Manual

Approval Date Guidelines and Turnaround Times (Policy 1.8)

Guidelines on calculation of IRB approval dates, stamping of approved documents, and IRB/IRO turnaround times.

Approval Date Guidelines and Turnaround Times

Closure and Re-open Policy (Policy 2.9)

Describes procedures for requesting closure on an IRB file and how IRO closes lapsed studies.

Closure and Re-open Policy

Communications Policy (Policy 2.21)

Expectations for communications with IRB stakeholders.

Communications Policy

Conflicting Interests of IRB Members (HRP-050)

Describes how to determine whether an IRB member holds a conflicting interest on a study under review and the process after a conflicting interest has been identified.

HRP-050 - SOP - Conflicting Interests of IRB Members

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

Determining when Activities are Research or Human Research (Policy 1.14)

Guidelines for establishing which activities are research, which research involves human subjects, and when Fred Hutch is engaged in research.

Determining when Activities are Research or Human Research

Emergency Use or Compassionate 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) and for compassionate and expanded access uses.

Emergency Use or Compassionate Use of an Investigational Drug or Device

Federal-wide Assurance (Policy 1.2)

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

Federal-wide Assurance

Funding Source Document Review (Policy 2.18)

Review of funding sources to assure there are adequate resources to conduct proposed research activities; also addresses certification of IRB approval and confirmation of limited activity requests.

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; also addresses remote consent, electronic consent (e-consent), consent waivers, re-consent, observation of the consent process, and special populations.

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 Reliance Agreements (Policy 2.24)

Mechanisms for serving as the single IRB (sIRB) and 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, as well as guidelines for reporting to AAHRPP.

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.

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, agendas, minutes, and result letters.

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 participating sites.

Multi-Center Study Coordination —IRB Review and Oversight

New Application (Policy 2.1)

Submitting applications and receiving approvals prior to initiating research activities; addresses review levels.

New Application

Noncompliance (Policy 1.9)

Principles governing prompt reporting and review of noncompliance.

Noncompliance

Privacy and Confidentiality (Policy 2.12)

Conducting research in a manner that protects participants' personal information; addresses privacy, confidentiality, Certificates of Confidentiality, HIPAA, etc.

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 for principal investigators to report adverse events, unanticipated problems, noncompliance and other matters and for IRO to report to AAHRPP.

Reporting Obligations for PIs

Research Involving Department of Defense (DoD) Components (Policy 2.26)

Compliance with additional requirements for research supported by the Department of Defense or any of its components.

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)

Ensuring participants and others have mechanisms 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 reviews.

Staff Structure

Status Reports for IRB Files (Policy 2.28)

Process for annual reminders for non-Exempt human subjects research that is not subject to Continuing Review requirements.

Status Reports for IRB Files

Suspension or Termination of IRB Approval (Policy 1.10)

Principles and process for suspending or terminating research activities; also addresses other actions the IRB may take in response to noncompliance events.

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)