Policies and Procedures

_{Human Research Protection Program} 

The Villanova HRPP Plan (click on grey button below to download) was developed to ensure the rights, safety and welfare of all subjects recruited or enrolled in research projects, regardless of funding source. A direct link to Federal regulations is also provided (blue button).

Reference Materials

Researcher Specific Documents

• PI Roles and Responsibilities
• HRP 090 - Informed Consent Process for Research
• HRP 091 - Written Documentation of Consent

The documents linked in the sections below are technical in nature and are designed for use by IRB members and ORP staff. They are available as reference for researchers preparing applications for IRB review and navigating the IRB submission process if desired, however more 'user-friendly' materials are available on the Education and Training webpage.

SOPs - IRB and ORP Procedures

• HRP 001 - Definitions
• HRP 013 - LARs, Children, and Guardians
• HRP 021 - Pre-Review
• HRP 024 - New Information
• HRP 025 - Investigations
• HRP 026 - Suspension or Termination of IRB Approval
• HRP 040 - IRB Meeting Preparation
• HRP 041 - IRB Meeting Conduct
• HRP 043 - IRB Meeting Minutes
• HRP 050 - Conflicting Interest of IRB Members
• HRP 051 - Consultation
• HRP 052 - Post Review
• HRP 060 - Annual Evaluations of the HRPP
• HRP 063 - Expiration of IRB Approval
• HRP 070 - IRB Records
• HRP 071 - Standard Operating Procedures
• HRP 072 - IRB Records Retention
• HRP 080 - IRB Formation and Registration
• HRP 082 - IRB Membership Addition
• HRP 083 - IRB Membership Removal
• HRP 084 - IRB Meeting Scheduling and Notification
• Organizational Approver Protocol Certification 
• Organizational Approver Selection
• Appeals to IRB Action 

Checklists

• HRP 410 - Waiver or Alteration of Consent Process 
• HRP 411 - Waiver of Written Documentation of Consent
• HRP 412 - Pregnant Women
• HRP 415 - Prisoners
• HRP 416 - Children
• HRP 417 - Cognitively Impaired Adults

Worksheets

• HRP 308 - Pre-Review
• HRP 310 - Human Research Determination
• HRP 311 - Engagement Determination
• HRP 312 - Exemption Determination
• HRP 313 - Expedited Review
• HRP 314 - Criteria for Approval
• HRP 315 - Advertisements
• HRP 316 - Payments
• HRP 317 - Short Form of Consent Documentation
• HRP 319 - Limited IRB Review and Broad Consent
• HRP 320 - Scientific and Scholarly Review
• HRP 321 - Review of Information Items
• HRP 326 - Performance Evaluation for IRB Chairs
• HRP 327 - Performance Evaluation for IRB Members
• HRP 328 - Annual Performance Evaluation Criteria for IRB Staff
• HRP 330 - HIPAA Authorization
• HRP 333 - Certificate of Confidentiality
• HRP 832 - Considerations for Ceding IRB Review
• HRP 833 - Considerations for Serving as the sIRB