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Institutional Review Board
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About IRB

Applying to the IRB

IRB Forms

Guidance for Research

IRB Process and Reporting

Consent Process and Forms

Training and Education

Related Links
Office of the Vice President for Research

 
 
Office of the Vice President for Research
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What Every Researcher Needs to Know

Qualifications

 

Additional Topics

 

Conflict of Interest

Study Design

Post-Approval Reporting

Minimizing Risk

Payment

Recruitment

Before Beginning

Application Preparation and Principal Investigator Designation

Informed Consent Process

Subject Complaints

Qualifications

Unanticipated Problems (UPIRTSOs)

Principal Investigator Responsibilities

Data Monitoring

Scientific Review

Qualifications

Required Backgrounds

As a researcher you and your staff must be qualified by training and experience for research. It is important to understand that the responsibility for the welfare of participants resides on you, the researcher, even though participants may have given consent. You and your staff must have the necessary backgrounds to comply with application regulations such as:

  • Those concerning IRB review
  • Informed consent requirements
  • Reporting requirements
  • Maintenance of records, keep a complete file during and 3 years after research ends
  • Retention of records
  • Supervision of research conduct
  • Apply relevant professional standards that are applicable to your research

You and your research staff should understand when activities are subject to IRB review.

All activities meeting the definition of research, irrespective of funding, must be proposed to the IRB.  RSPP staff then uses the following definitions to determine if review is required.

Policy 102A

This information will help determine if the proposed research activity involves human subjects and if the activity is research. Call the IRB at 612-626-5654 for guidance.

Training

Training in human subject protection at the University of Minnesota opportunities:

UMN Policy on Code of Conduct

Resources

IRB Web site on training and education

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