Human Research Protection Program Policies and Procedures

Human Research Protection Program Policies

Protocol Preparation and IRB Review
Conflict of Interest	Investigator Qualifications and Training
Investigator Conflict of Interest Policy	HRPP Education and Training Policy
IRB Conflict of Interest Policy	Principal Investigator Status Policy
Consent	Student Research Policy
Emergency Exception to Informed Consent Policy	IRB Jurisdiction and Expertise
Informed Consent Policy	Expertise of IRBs Policy
Research with Adults Lacking Consent Capacity Policy	IRB Composition Policy
Research with Vulnerable Participants Policy	IRB Consultants Policy
Defining Human Subjects Research	IRB Roster Policy
Defining Human Subjects Research Policy	Prisoner Research Policy
Coded Information and Specimens Policy	Social & Behavioral Science Genetic Research Policy
Existing Datasets Policy	IRB Review Criteria
Fetal Tissue Policy	Data and Safety Monitoring Policy
Student Research Policy	Privacy and Confidentiality Policy
Drug and Device (Test Article) Research	Review of Protocol Resources Policy
Control of Test Articles Policy	Risk-Benefit Analysis Policy
Emergency Use of Test Articles Policy	Research with Vulnerable Participants Policy
Humanitarian Use Device Policy	Scientific and Scholarly Review Policy
Review of Test Article Research Policy	Multisite Research
Exempt, Expedited and Full Review	IRB Authorization Agreements Policy
Exempt Research Policy	Multisite Research Policy
Expedited Review Policy	Noncompliance and Unanticpated Problems
Initial Review by Full IRB Policy	Noncompliance Policy
Change of Protocol Review by Full IRB Policy	Reporting to Federal Authorities Policy
Continuing Review by Full IRB Policy	Suspension and Termination of Research Policy
Five Year Renewal Policy (ED & SBSIRBs)	Unanticipated Problem Policy
Exception to Five Year Renewal Policy (HS IRBs)	Participant Selection and Recruitment
Federal Assurances and State Laws	Equitable Selection Policy
Applying State Law Policy	Participant Recruitment Policy
UW-Madison Federalwide Assurance	Research with Adults Lacking Consent Capacity Policy
	Research with Vulnerable Participants Policy

IRB Meetings and Records
IRB Meetings Policy	IRB Records Maintenance Policy
IRB Minutes Policy	IRB Records Retention Policy
Program Components and Organization
Components of HRPP	Organizational Charts
HRPP Advisory Committee Charter	Overview of HRPP
Institutional Official	UW-Madison IRBs and HRPP Advisory Committee
Office of Research Policy
Quality Assurance/Improvement Policies
Assuring Independence of IRBs Policy	Monitoring Consent Policy
HRPP Publication and Communication Policy
Internal Audit of HRPP Policy	Questions, Suggestions and Concerns about IRBs and HRPP Policy
Staffing and Resources Policies
HRPP Resources Policy	Qualifications of IRB Personnel Policy
Provision of Sufficient IRBs Policy

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The Graduate School

Human Research Protection Program Policies

Protocol Preparation and IRB Review

IRB Meetings and Records

Program Components and Organization

Quality Assurance/Improvement Policies

Staffing and Resources Policies