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What Every Researcher Needs to Know

This guide has been prepared by the Research Subjects' Protection Programs Staff to assist researchers with the IRB's points of emphasis as they prepare to conduct research involving human subjects in accordance with the guidelines set forth by the University.

Each section will address regulations involved with why the review board must evaluate the issue, some information regarding how the Committeee assesses submissions, and a few examples to help researchers as they start the process.

 

 

Topics

   

Before Beginning

  • Requirements
  • Staff, Training, Costs, and Resources

Principal Investigator Responsibilities

  • Conduct
  • Resources
  • What responsibilities are Included
  • Advising

Qualifications

  • Requirements
  • Training
  • Resources

Study Design

  • Ethical and Regulatory Issues
  • Demonstrating Compliance
  • How Committee Evaluates Design

Minimizing Risk

  • Monitoring for Harm
  • Reporting UPIRTSO
  • Data Safety Monitoring Board

Conflict of Interest

  • Regulations
  • Meaning
  • How It Applies to my Application

Informed Consent Process

  • Explanation of Process
  • Requirements

Recruitment

  • Planning
  • Advertising
  • What Can Be Included

Payment

  • Principal of Incentive and Reimbursement
  • How the Committeee Evaluates
  • Method of Disbursement

Unanticipated Problems (UPIRTSOs)

  • Definitions
  • Criteria
  • Reporting
  • Adverse Events

Post-Approval Reporting

  • Continuing Review
  • Changes in Protocol
  • UPIRTSO

Data Monitoring

  • Responsibility
  • Resources

Application Preparation and Principal Investigator Designation

  • Submitting a Compete Application
  • Supporting Materials
  • Investigator Considerations

 

Subject Complaints

  • Reporting
  • Assistance

Scientific Review

  • Definition
  • Methods
  • Requirements
 

 

 
 
 
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