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CITI MODULES -
BEGINNING JANUARY 1, 2009 - New Requirements for Human Subjects Protection Certification
HRPP Policies
DUHS Human Research Protection Program
Policies and Procedures
Recruitment, Ascertainment and Advertising
Advertisement of Research Studies
Processing Payments to Research Participants
Recruitment of Other People's Patients
Recruitment of Students and Employees
Review of an Investigator's Request for a Waiver of Selected Inclusion/Exclusion Criteria for a Single Person
Informed Consent
Consent Monitoring
Informed Consent and Its Documentation
IRB Approval Stamp on Consent Forms
Research Involving Non-English-Speaking Subjects
Use of the Legally Authorized Representative in Research
Use of the Short Form Consent Document
Waiver of Documentation of Consent
Conflict of Interest (COI)
Conflict of Interest Pertaining to DUHS IRB Members and Consultants
Corrective Actions Declared by the DUSOM Conflict of Interest Committee
Telephone Scripts/Research via Telephone, Mail or e-Mail
Suggested Format and Content for Telephone Scripts
Use of Questionnaires by Telephone or Mail
IRB Review
Allegations of Undue Influence Upon the DUHS IRB
Amendments to IRB-Approved Studies
Assessing the Data and Safety Monitoring Plan
Assessing the Scientific or Scholarly Validity of a Research Protocol
Assuring Key Personnel Qualifications
(Revised Policy Posted on 9-4-2009)
Case Reports
Conduct of a Convened IRB Meeting
Continuing Review
Declarations of Concordance
Determining the Frequency of Continuing Review
Determining Which Studies Need Verification from Sources Other than the Investigator
Emergency Use
Expedited Review
Institutional Oversight of Human Research
IRB Fees
IRB Interaction with Compliance Offices
IRB Membership, Voting and Quorum
IRB Minutes
IRB Processing of Modifications
Nomination of New IRB Members and Evaluation of Members
Quality Improvement (QI) Activities vs. Research
Research for Which Review by the DUHS HRPP Is Required (includes policy on V.A. research)
Retention of IRB Records and Research Records
Review and Approval by Other (Specialty) Committees
Review and Processing of Problems, Complaints, Concerns, and Questions from Research Subjects
Role of the Institutional Official (IO)
Use of Consultants in IRB Review
Veterans Administration (V.A.) Research Involving Human Subjects
Databases/Repositories & Retrospective Research Including Specimens
Research Databases and Specimen Repositories
Research Using Coded Specimens or Coded Private Information
Use of Existing Data or Specimens in Retrospective Research
Conduct of Research
Administration of a Study Drug or Study Procedure by a Research Participant's Local Physician (coming soon)
Autopsy Authorizations
Blood Drawing for Human Subject Research
Certificates of Confidentiality
Compensation and Payment for Research Participation
Contraceptive Use
Determining if Research is Subject to or Exempt from the Privacy Rule (HIPAA)
DUHS Commitment to Uphold Ethical Standards and Practices in Research
Duke Trainees (Medical Students & Others) Engaged in Research Involving Human Subjects at a Site Other Than Within DUHS
HIPAA as it Relates to Research
Injury Compensation for Research Participants
Investigator Concerns
Pregnancy Testing
(Revised Policy Posted on 5-8-2009)
Reliance on the IRB of Another Institution, Organization, or an Independent IRB
Required Education on Protection of Human Subjects
Research by Faculty or Staff Away From Duke
Research Involving Multiple Sites
Research Involving the Use of Thalidomide, Lenalidomide or Analogs Thereof
Tissue/
Specimens that May Be Excluded from Routine Submission to Surgical Pathology
(behind the Duke firewall)
Use of External Sites for Specific Study-Related Activities
Use of Gadolinium-Based Contrast Agents in Research
Who May Serve as a Principal Investigator in the DUHS HRPP
Research Involving Drugs, Devices or Biologics
Humanitarian Use Devices and Their Review
In Vitro Diagnostic Device Studies - FDA Enforcement Discretion
Research Involving Drugs, Biologics or Devices
Responsibilities of an Investigator Who Is Also a Sponsor
Significant Risk/Non-Significant Risk Device Determinations by the IRB
Use of Pharmacy Investigational Drug Service (IDS)
Vulnerable Populations in Research
Assessment of Decision Making Capacity in Adult Research Participants
Determination of Risk in Studies Involving Children
Research Involving Children
Research Involving Children Who are Wards of the State
Research Involving Pregnant Women
Research Involving Prisoners
Reporting to the IRB
Prompt Reporting of Unanticipated Problems
Reporting of Protocol Deviations/Violations
Regulatory Compliance
Expiration of IRB Approval and Closing Reports
Holds, Suspensions and Terminations
Noncompliance Policy
Reporting IRB Findings to DUHS Officials and Federal Regulatory Agencies
State Law Considerations
Mandatory State Reporting Requirements
State Law as it Relates to Research
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