Policies and Procedures

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.

Closure and Re-open Policy (Policy 2.9)
Describes procedures for requesting closure on an IRB file and how IRO closes lapsed studies.

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

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.

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 research, which research involves human subjects, and when Fred Hutch is engaged in 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.

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

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.

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

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

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.

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, agendas, minutes, and result letters.

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 participating sites.

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

Noncompliance (Policy 1.9)
Principles governing prompt reporting and review of 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.

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

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 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)
Ensuring participants and others have mechanisms 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 reviews.

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.

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.