HRPP Policies

Duke Medicine Human Research Protection Program

Policies and Procedures

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• 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  (Revised Policy Posted on 6-15-2012) 
• 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  (Revised Policy Posted on 12-10-2011)
• Corrective Actions Declared by the DUSOM Conflict of Interest Committee  (Revised Policy Posted on 7-11-2012)

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  (Revised Policy Posted on 12-10-2011)
• 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 7-11-2012)
• Case Reports
• Conduct of a Convened IRB Meeting  (Revised Policy Posted on 7-26-2011) 
• Continuing Review  (Revised Policy Posted on 12-11-2011)
• Declarations of Concordance
• Determining the Frequency of Continuing Review
• Determining Which Studies Need Verification from Sources Other than the Investigator
• Emergency Use  (Revised Policy Posted on 12-11-2011)
• Expedited Review  (Revised Policy Posted on 12-11-2011)
• Institutional Oversight of Human Research
• IRB Fees
• IRB Interaction with Compliance Offices  (Revised Policy Posted on 12-11-2011)
• IRB Membership, Voting and Quorum  (Revised Policy Posted on 12-11-2011)
• IRB Minutes   (Revised Policy Posted on 1-13-2012)
• IRB Processing of Modifications   (Revised Policy Posted on 12-11-2011)
• Legal Counsel Opinion Policy 
• Nomination of New IRB Members and Evaluation of Members  (Revised Policy Posted on 12-11-2011)
• Quality Improvement (QI) Activities vs. Research  (Revised Policy Posted on 4-30-2013)
• Research for Which Review by the DUHS HRPP Is Required (includes policy on V.A. research)  (Revised Policy Posted on 7-27-2012)
• Retention of IRB Records and Research Records  (Revised Policy Posted on 4-18-2011) 
• Review and Approval by Other (Specialty) Committees  (Revised Policy Posted on 12-11-2011)
• Review and Processing of Problems, Complaints, Concerns, and Questions from Research Subjects  (Revised Policy Posted on 12-11-2011)
• Role of the Institutional Official (IO)
• Use of Consultants in IRB Review
• Veterans Administration (V.A.) Research Involving Human Subjects

Databases/Repositories and Retrospective Research Including Specimens

• Data Use Agreements (See the Attachments at the end of the policy)
• Research Databases, Specimen Repositories and Contact Lists (Revised Policy Posted on 7-9-2010)
• Research Using Coded Specimens or Coded Private Information
• Use of Existing Data or Specimens in Retrospective Research

Use of Duke Data by Former Students & Employees

• External Use of Duke Data by Former Students & Employees  (NEW -- Posted on 3-11-2013)

Conduct of Research

• Administration of a Study Drug or Study Procedure by a Research Participant's Local Physician ("Agents" policy) 
• Autopsy Authorizations
• Blood Drawing for Human Subject Research  (Revised Policy Posted on 12-13-2012) 
• Certificates of Confidentiality
• Compensation and Payment for Research Participation
• Contraceptive Use
• Department of Defense (DoD)-Sponsored Research: Requirements  (Revised Policy Posted on 6-5-2011)
• Department of Education-Sponsored Research:  Requirements 
• Determining if Research is Subject to or Exempt from the Privacy Rule (HIPAA)
• Duke Trainees (Medical Students & Others) Engaged in Research Involving Human Subjects at a Site Other Than Within DUHS (Revised Policy Posted on 4-17-2013) 
• HIPAA as it Relates to Research
• Injury Compensation for Research Participants
• International Research 
• Investigator Concerns  (Revised Policy Posted on 12-11-2011)
• Pregnancy Testing  (Revised Policy Posted on 1-14-2013)
• Reliance on the IRB of Another Institution, Organization, or an Independent IRB (Revised Policy Posted on 5-4-2011)
• Required Education on Protection of Human Subjects
• Research by Faculty or Staff Away From Duke  (Revised Policy Posted on 12-11-2011)
• Research Involving Multiple Sites  (Revised Policy Posted on 7-11-2012) 
• Research Involving the Use of Thalidomide, Lenalidomide or Analogs Thereof
• Tissue/Specimens that May Be Excluded from Routine Submission to Surgical Pathology and the PATHOLOGY TISSUE/SPECIMEN EXEMPTION LIST (behind the Duke firewall)

• Use of Gadolinium-Based Contrast Agents in Research
• Who May Serve as a Principal Investigator in the DUHS HRPP  (Updated Policy Posted on 7-12-2011) 

Research Involving Drugs, Devices or Biologics

• Humanitarian Use Devices and Their Review (Revised Policy Posted on 12-09-2010)
• In Vitro Diagnostic Device Studies - FDA Enforcement Discretion 
• Research Involving Drugs, Biologics or Devices (Revised Policy Posted on 12-11-2011)
• Responsibilities of an Investigator Who Is Also a Sponsor  (Revised Policy Posted on 12-11-2011)
• 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  (Revised Policy Posted on 12-11-2011)
• Determination of Risk in Studies Involving Children  (Revised Policy Posted on 5-31-2011)
• 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 (Revised Policy Posted on 7-19-2011)
• Reporting of Protocol Deviations/Violations

Regulatory Compliance

• Expiration of IRB Approval and Closing Reports (Revised Policy Posted on 2-2-2011) 
• Holds, Suspensions and Terminations  (Revised Policy Posted on 5-31-2011)
• Noncompliance Policy  (Revised Policy Posted on 5-20-2011)
• Reporting IRB Findings to DUHS Officials and Federal Regulatory Agencies

State Law Considerations

• Mandatory State Reporting Requirements
• State Law as it Relates to Research