Human Research Protection Program Policies and Procedures

Human Research Protection Program Policies and Procedures

Program Components and Organization
Overview of HRPP	HRPP Advisory Committee Charter
HRPP Organizational Chart	UW-Madison IRBs and HRPP Advisory Committee
HRPP Institutional Official	Components of HRPP
Office of Research Policy

Organizational Policies and Procedures
Assuring Independence of IRBs Policy	IRB Composition Policy
HRPP Resources Policy	IRB Roster Policy
Provision of Sufficient IRBs Policy	Qualifications of IRB Personnel Policy
Internal Audit of HRPP Policy	IRB Authorization Agreements Policy
HRPP Education and Training Policy	Applying State Law Policy
Communicating with HRPP Personnel Policy	Fetal Tissue Policy
Questions, Suggestions and Concerns about IRBs and HRPP Policy	UW-Madison Federalwide Assurance

Conflict of Interest
Investigator Conflict of Interest Policy	IRB Conflict of Interest Policy

IRB Meetings and Records
IRB Meetings Policy	IRB Records Maintenance Policy
IRB Minutes Policy	IRB Records Retention Policy

Protocol Review
Review by Experts Policy	Expedited Review Policy
Review of Prisoner Research Policy	Initial Review by Full IRB Policy
IRB Consultants Policy	Continuing Review by Full IRB Policy
Scientific and Scholarly Review Policy	Change of Protocol Review by Full IRB Policy
Review of Protocol Resources Policy	Five Year Renewal Policy
Defining Human Subjects Research Policy	HS IRBs Exception to Five Year Renewal Policy
Existing Datasets Policy	Risk-Benefit Analysis Policy
Coded Information and Specimens Policy	Data and Safety Monitoring Policy
Student Research Policy	Protection of Privacy and Confidential Data Policy
Exempt Research Policy	Multisite Research Policy

Participant Recruitment and Consent
Equitable Selection Policy	Informed Consent Policy
Participant Recruitment Policy	Emergency Exception to Informed Consent Policy
Research with Vulnerable Participants Policy	Monitoring Consent Policy
Research with Adults Lacking Consent Capacity Policy

Test Article Research (Drugs and Devices)
Review of Test Article Research Policy	Emergency Use of Test Articles Policy
Control of Test Articles Policy	Humanitarian Use Device Policy

Incident Reporting
Unanticipated Problem Policy	Noncompliance Policy
Suspension and Termination of Research Policy	Reporting to Federal Authorities Policy

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