Revised HRPP/IRB Policies & Checklists

The following policies were revised (see list below within each policy type/category).  We also have checklists that have been revised as well that are listed at the end. Furthermore, we have attached this list as a word document so you can print out as needed (listed at the very end of this announcement).

Policy Type: Compliance (the following policies were revised)

  • Expiration of IRB Approval and Closing Reports
  • Holds, Suspensions and Terminations
  • Non-Compliance
  • Reporting to DUHS Officials and Federal Agencies

Policy Type: Conduct of Research (the following policies were revised)

  • Compensation for Participation in Research
  • Department of Defense (DoD) Research
  • Department of Education Research
  • External IRBs
  • External Research by Duke Trainees
  • External Use of Duke Data by Former Students & Employees
  • HIPAA as It Relates to Research
  • HIPAA Exemption
  • International Research
  • Investigator/Study Team Concerns
  • Local Physician Participation
  • Multiple Site Research
  • Principal Investigator Qualifications
  • Re-Opening a Closed Study
  • Reliance by External Sites on the DUHS IRB

Policy Type: Conflict of Interest (the following policies were revised)

  • Conflict of Interest for IRB Members
  • Corrective Actions for COI

Policy Type: Consent (the following policies were revised)

  • Appropriate Study Personnel to Conduct the Consent Process
  • Consent and Its Documentation
  • Consent Monitoring
  • Legally Authorized Representative (LAR)
  • Short Form Consent
  • Undergraduates Conducting the Consent Process
  • Waiver of Documentation of Consent

Policy Type: Database, Repository, & Retrospective Research (the following policies were revised)

  • Research Databases, Specimen Repositories, and Contact Lists
  • Research Using Coded Private Information or Biospecimens

Policy Type: Drugs, Devices & Biologics (the following policies were revised)

  • Humanitarian Use Devices
  • In Vitro Diagnostic Devices
  • Investigator Who Is Also a Sponsor
  • Research Involving Devices
  • Research Involving Drugs or Biologics
  • Significant Risk vs Non-Significant Risk Device Studies

Policy Type: Recruitment (the following policies were revised)

  • Advertisement
  • Recruiting Students and Employees
  • Recruitment of Other Providers' Patients (No Cold Calling Policy)

Policy Type: Reporting to the IRB (the following policies were revised)

  • Protocol Deviations/Violations
  • Unanticipated Problems

Policy Type: Review by the IRB (the following policies were revised)

  • Amendments
  • Case Reports
  • Conduct of an IRB Meeting
  • Consultants in IRB Review
  • Continuing Review
  • Continuing Review Frequency
  • Data and Safety Monitoring
  • Emergency Use
  • Expedited Review
  • Interaction with Compliance Offices by the IRB
  • Key Personnel Qualifications
  • Legal Counsel Opinion
  • Membership, Voting and Quorum for the IRB
  • Minutes of the IRB Meetings
  • Modifications Processing Procedure
  • Nomination and Evaluation of IRB Members
  • Planned Research in an Emergency Setting
  • Quality Improvement (QI) vs. Research (Policy and Checklist)
  • Research for Which Review by the DUHS HRPP Is Required
  • Retention of Records
  • Scientific Validity of a Research Protocol
  • Specialty Committee Review
  • Subject Problems, Complaints, Concerns and Questions
  • Undue Influence Upon the IRB
  • Verification of Studies
  • Waiver for a Single Person

Policy Type: State Law Considerations (the following policies were revised)

  • Mandatory State Reporting Requirements
  • State Law for Research

Policy Type: Vulnerable Populations (the following policies were revised)

  • Children Who Are Wards of the State
  • Children’s Research
  • Decision Making Capacity in Adults
  • Pregnant Women, Fetuses, and Neonates
  • Prisoners

Checklists

Form Type: Principal Investigator Checklists (the following checklists were revised)

  • Humanitarian Use Device Checklist
  • IDE Checklist
  • IND Checklist

Form Type: IRB Reviewer Checklists (the following checklists were revised)

  • Checklist on Adequate Provisions for Soliciting the Permission of Parents or Guardians and Checklist on Adequate Provisions for Soliciting the Assent of Children
  • Children: Checklist for Review of Research Involving Children
  • DOD-Supported Research Checklist
  • Humanitarian Use Device Checklist
  • IDE Checklist
  • IND Checklist
  • Pregnant Women: Checklist for Research Involving Pregnant Women or Fetuses
  • Prisoners: Checklist for Research Involving Prisoners

 

Share