Manual for Conducting Human Subject Research

Manual Table of Contents

1. Introduction
   • 1.1 HRRC's Oversee "Human Subject Research" and "Clinical Investigations"
   • 1.2 The Foundation for Human Subject Protections: The Belmont Report
   • 1.3 The UNMHSC Multiple Project Assurance and the Federal Regulations
   • 1.4 The HRRCs
2. Oversight
   • 2.1 Jurisdiction of HRRCs
   • 2.2 Authority of the HRRC's
     • 2.2.1 Reporting Relationships
     • 2.2.2 Delegation of Authority
     • 2.2.3 Inappropriate influence of the HRRCs
   • 2.3 Requirement for Departmental and Other Committee Reviews
     • 2.3.1 Department/ Scientific Review
     • 2.3.2 VA Research Committee Review
     • 2.3.3 Radiation Safety Committee, Human Uses Subcommittee
     • 2.3.4 Clinical Research Center
     • 2.3.5 Indian Health Service (IHS) IRB
   • 2.4 Scope of Authority of HRRCs
   • 2.5 Effect and Review of HRRC Approval and Disapproval Decisions
   • 2.6 Non- Compliance with Human Research Protection Program Requirements
     • 2.6.1 Definitions of Non- Compliance
     • 2.6.2 Identifying & Reporting Non-Compliance
     • 2.6.3 Evaluation of Non- Compliance by staff
     • 2.6.4 Evaluation of Non- Compliance by Director
     • 2.6.5 Evaluation of Non- Compliance by an HRRC Chair
     • 2.6.6 Review by the Convened HRRC
     • 2.6.7 Executive Committee Reviews of Non- Compliance
     • 2.6.8 Scientific Misconduct
   • 2.7 Serving as the IRB for an Unaffiliated Entity on UNMHSC Faculty Research
   • 2.8 Collaborative Research
3. HRRC Membership
   • 3.1 Regular Voting Members
     • 3.1.1 Composition
     • 3.1.2 Terms
     • 3.1.3 Appointments
   • 3.2 Alternate Voting Members
   • 3.3 Non-voting Members
   • 3.4 Consultants
   • 3.5 HRRC Chair, Executive Chair, Chair-elect
     • 3.5.1 Duties
   • 3.6 Duties of HRRC Members
   • 3.7 Notification of OPPR of Changes in HRRC Membership
   • 3.8 Conflicts of Interests in HRRC Member and Consultant Reviews
4. HRRC Meetings
   • 4.1 Committee Meetings/Deadlines
   • 4.2 Assignment of Projects for Review
   • 4.3 Assignment to and Presentation by Primary Reviewers
   • 4.4 HRRC Meeting Agenda
   • 4.5 HRRC Meeting Procedures
   • 4.6 Actions that the HRRCs May Take at Meetings
   • 4.7 HRRC Notification of Meeting Decisions
   • 4.8 Time Sensitive Protocols
   • 4.9 Appealing a HRRC decision
5. HRRC Review & Investigator Applications
   • 5.1 Exempt Research
     • 5.1.1 Existing Records or Specimens, Anonymously Recorded
     • 5.1.2 Surveys, Interviews, Public Observations, and Educational Tests
     • 5.1.3 Other Exemptions
     • 5.1.4 Applying for Exemption
   • 5.2 Expedited Review
     • 5.2.1 Categories of Research Eligible for Expedited Review
     • 5.2.2 Application for Expedited Review
   • 5.3 Full Committee Review and Application
6. Criteria for HRRC Review and Approval of Research
   • 6.1 General HRRC Review
     • 6.1.1 Risk and Benefits
     • 6.1.2 Selection of Subjects
     • 6.1.3 Issues of Privacy and Confidentiality
     • 6.1.4 The Informed Consent Process
     • 6.1.5 Additional Monitoring or Safeguards
   • 6.2 Additional Requirements for Vulnerable Populations
     • 6.2.1 Review of Research Involving "Minors" and "Children"
     • 6.2.2 Prisoners
     • 6.2.3 Fetuses, Pregnant Woman, in vitro Fertilization
     • 6.2.4 Decisionally Impaired
   • 6.3 Additional Requirements for Drug Studies
     • 6.3.1 Investigational New Drug Application
     • 6.3.2 Studies on Marketed Drugs
     • 6.3.3 Radiopharmaceuticals
   • 6.4 Additional Requirements for Device Studies
     • 6.4.1. Investigational Device Exemptions
     • 6.4.2. Significant Risk and non-significant Risk medical device Studies
     • 6.4.3 SR/NSR Studies and the HRRC: the Decision
     • 6.4.4 Investigator Responsibilities
     • 6.4.5 Investigator Initiated Research
   • 6.5 Compensation or Payment in Human Research Studies
     • 6.5.1 Compensation Amounts and Advertisements in Human Research Studies
     • 6.5.2 Payment for Subjects in VA Human Research Studies
   • 6.6 Additional Requirements for Research Involving Students as Subjects
7. Informed Consent Requirements
   • 7.1 Process of Informed Consent and its Exceptions
   • 7.2 Presentation
   • 7.3 Content Requirements
   • 7.4 Who May Provide Informed Consent?
     • 7.4.1 Adults & Emancipated Minors
     • 7.4.2 Assessing a Subject's Capacity to Consent and use of a Legally Authorized Representative(LAR)
     • 7.4.3 Differences & Similarities between the LAR as defined by VA Human Research Subject Regulations & New Mexico Law
     • 7.4.4 Children
   • 7.5 Modification (including Waivers) of Informed Consent Requirements
     • 7.5.1 Requirement for HRRC Approval
     • 7.5.2 Short Form Informed Consent
     • 7.5.3 Waiver of Documentation Requirement
     • 7.5.4 Waiver of Informed Consent Requirement in Minimal Risk Studies
     • 7.5.5 FDA/OHRP Waiver of Informed Consent for Acute Care Research (e.g., research with trauma, cardiac arrest, etc., victims)
     • 7.5.6 Waiver of Parental Permission in Studies Involving Children
8. Monitoring of and Investigator Requirements Regarding Research in Progress
   • 8.1 Amendments in Protocol or Informed Consent, and Application Procedure
   • 8.2 Reporting of Adverse Events and Problems
     • 8.2.1 Events Requiring Report to HRRC
     • 8.2.2 Adverse Events Report Form
     • 8.2.3 Expedited or Full Review
     • 8.2.4 Investigator Required Reporting to OHRP, UNMHSC Risk Management and Sponsoring Federal Agency
     • 8.2.5 Investigator Reporting to Sponsor
     • 8.2.6 Investigator Reporting to Subjects
   • 8.3 Additional Measures of HRRC to Monitor Active Research Projects
   • 8.4 Continuing Review
     • 8.4.1 Required Re approval of Study no less than Annually, but may be More Frequent
     • 8.4.2 Investigator Submission of Continuing Review Progress Report
     • 8.4.3 Type of Review
     • 8.4.4 Expiration of Approval Period
   • 8.5 Study Closure and Reporting
   • 8.6 Clinical Research Quality Improvement Monitoring Program
9. Use of Drugs & Devices Beyond the context of Research
   • 9.1 Emergency Use of Investigational Article
   • 9.2 Emergency Use Without Informed Consent
   • 9.3 Individual Patient Access
   • 9.4 Treatment IND/IDE
   • 9.5 Humanitarian Use Device
10. Research Records
    • 10.1 Investigator Records
    • 10.2 HRRC Records
    • 10.3 HRRC Meeting Records
    • 10.4 HRRC Member Records
11. Miscellaneous Policies
    • 11.1 Tissue or Data Repositories (Databases) for Research
    • 11.2 HRRC Subject Recruitment Guidelines
    • 11.3 Finder's fees & Bonus Payments for Recruitment
    • 11.4 State Laws and Human Research
    • 11.5 Research Involving Partners of Family Members of Study Participants
12. Available Regulations, Policies & Educational Material

 

 

• Manual for Conducting Human Subject Research

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• Table of Contents
•  1. Introduction
•  2. Oversight
•  3. HRRC Membership
•  4. HRRC Meetings
•  5. HRRC Review & Investigator Applications
•  6. Criteria for HRRC Review and Approval of Research
•  7. Informed Consent Requirements
•  8. Monitoring of and Investigator Requirements Regarding Research in Progress
•  9. Use of Drugs & Devices Beyond the context of Research
• 10. Research Records
• 11. Miscellaneous Policies
• 12. Available Regulations, Policies & educational Material
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