MSU HRPP Manual Table of Contents - Expanded

• Section 1: MSU Agreements
  • 1-1, Federal Wide Assurance
  • 1-2, Reserved
  • 1-3, Use of Institutional Authorization Agreements
  • 1-4, Reliance on External Independent (Commercial) Institutional Review Boards
  • 1-5, Use of the National Cancer Institute Central Institutional Review Board
  • 1-6, Institutional Review Board Registration
  • 1-7, Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements

  
  

   

• Section 2: Ethical Principles, Federal, State, and Local Guidelines and Regulations
  • 2-1, Ethical Principles
  • 2-2, Federal Guidelines and Regulations
    • 2-2-A, U.S. Department of Defense
    • 2-2-B, U.S. Environmental Protection Agency
    • 2-2-C, U.S. Department of Justice
      • 2-2-C-i, Bureau of Prisons
      • 2-2-C-ii, National Institute of Justice Funded Research
    • 2-2-D, U.S. Department of Education
      • 2-2-D-i, Family Educational Rights and Privacy Act
      • 2-2-D-ii, Protection of Pupil Rights Amendment
      • 2-2-D-iii, Funding under 34 CFR 356 for Fellowships Involving Disability and Rehabilitation Research
    • 2-2-E, U.S. Department of Energy
    • 2-2-F, Reserved
      • 2-2-F-i, U.S. Department of Health and Human Services, National Institutes of Health Definition of a Clinical Trial
      • 2-2-F-ii, U.S. Department of Health and Human Services, National Institutes of Health Good Clinical Practice Training
      • 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health)
      • 2-2-F-iv, U.S. National Institutes of Health Data Management and Sharing
    • 2-2-G, Revised Common Rule Single IRB Requirement
    • 2-2-H, Certificate of Confidentiality
  • 2-3, State and Local Guidelines and Regulations
  • 2-4, International Conference on Harmonization-Good Clinical Practice (E6)(R2)
  • 2-5, Transnational Research
  • 2-6, Considerations for Data Sharing in Human Research Studies

   

• Section 3: MSU Human Research Protection Program
  • 3-1, MSU Human Research Protection Program Plan
  • 3-2, Policy Development and Approval
  • 3-3, Evaluation and Quality Improvement

   

• Section 4: Jurisdiction and Responsibilities
  • 4-1, Applicability
  • 4-2, Authority of IRBs
  • 4-3, Determination of Human Subject Research
    • 4-3-A, Clinical Case Report
  • 4-4, Institutional Official
  • 4-5, Responsibilities of the Institutional Review Boards
  • 4-6, Responsibilities of Investigators
  • 4-7, Recordkeeping for Institutional Review Board Records
    • 4-7-A, Recordkeeping for Investigators
  • 4-8, Reporting Policy
    • 4-8-A, Investigator Reporting
  • 4-9, Designation as Principal Investigator
  • 4-10, Designation as Key Project Personnel on Non-Exempt IRB Projects
  • 4-11, Applicability of the Revised Common Rule (2018 Requirements)
  • 4-12, Engagement

   

• Section 5: HRPP Organization and Structure
  • 5-1, IRB Chairs
  • 5-2, HRPP Staff
    • 5-2-A, HRPP Director
    • 5-2-B, Compliance Office
    • 5-2-C, IRB
  • 5-3, IRB Membership
  • 5-4, Additional Expertise
  • 5-5, Meetings
  • 5-6, Contact Information
  • 5-7, Reserved
  • 5-8, IRB Fees

   

• Section 6 IRB Evaluation Criteria
  • 6-1, Criteria for IRB Approval of Research
  • 6-2, Minimization of Risks
    • 6-2-A, Sound Research Design
    • 6-2-B, Adequate Resources
  • 6-3, Risk Benefit Ratio
    • 6-3-A, Incomplete Disclosure / Deception
  • 6-4, Informed Consent 
    • 6-4-A, Documentation of Informed Consent
    • 6-4-B, Waiver or Alteration of Informed Consent
    • 6-4-C, Parental Permission and Child Assent
    • 6-4-D, Waiver of Documentation of Informed Consent
    • 6-4-E, Informed Consent Exception for Screening, Recruiting, or Determining Eligibility
    • 6-4-F, Posting of Clinical Trial Consent Forms
    • 6-4-G, Electronic Consent
    • 6-4-H, Electronic Signature
  • 6-5, Selection of Subjects and Recruitment
  • 6-6, Privacy, Confidentiality, and Anonymity
    • 6-6-A, Student PID Policy
  • 6-7, Data and Safety Monitoring
  • 6-8, Special Categories of Research Subjects
    • 6-8-A, Pregnant Women, Human Fetuses and Neonates
    • 6-8-B, Prisoners
    • 6-8-C, Children
    • 6-8-D, Individuals with Diminished Capacity
    • 6-8-E, HIV and AIDS
  • 6-9, Special Considerations
    • 6-9-A, Student Classroom Research
    • 6-9-B, Graduate Student Research
    • 6-9-C, Community Based Research
    • 6-9-D. Reserved
    • 6-9-E, Emergency Research
    • 6-9-F, Multiple Research Sites When MSU is the Lead

   

• Section 7: Clinical Research Compliance
  • 7-1, Research Involving Investigational Drugs and Devices
  • 7-2, Significant Risk and Nonsignificant Risk Medical Devices
  • 7-3, Emergency Use of Investigational Drugs and Devices
  • 7-4, Charging for Investigational Drugs
  • 7-5, Investigational Use with Approved Drugs
  • 7-6, Health Insurance Portability and Accountability Act Compliance in Human Research
    • 7-6-A, Individual Authorization
    • 7-6-B, Alteration or Waiver of Individual Authorization
    • 7-6-C, Review Preparatory to Research
    • 7-6-D, De-Identification
  • 7-7, Humanitarian Use Device
  • 7-8, Clinical Research Billing Compliance
    • 7-8-A, Clinical Research Billing Compliance Coverage Analysis
  • 7-9, ClinicalTrials.gov Requirements
    • 7-9-A, ClinicalTrials.gov Requirements: General Requirements under 42 CFR 11
    • 7-9-B, ClinicalTrials.gov Requirements: Applicable Clinical Trials under 42 CFR 11
    • 7-9-C, ClinicalTrials.gov Requirements: Required Updates under 42 CFR 11
    • 7-9-D, ClinicalTrials.gov Requirements: Voluntary Registration and/or Results Reporting under 42 CFR 11
    • 7-9-E, ClinicalTrials.gov Requirements: National Institutes of Health
• Section 8: Types of IRB Review
  • 8-1, Exemptions
  • 8-2, Expedited Review Procedure
  • 8-3, Committee Review Procedure
  • 8-4, Request for 45 CFR 46.118 Designation
  • 8-5, Initial Review
  • 8-6, Modifications to an Approved Research Study
  • 8-7, Renewed Approval
  • 8-8, Flexibility Initiative
    • 8-8-A, Exemption Category 97
    • 8-8-B, Exemption Category 98
    • 8-8-C, Two Year Approvals
  • 8-9, Closure
  • 8-10, Site Visits
  • 8-11, External IRB Submissions
    • 8-11-A, External IRB Submissions Involving Henry Ford Health Employed Principal Investigators
  • 8-12, MSU as IRB of Record for Other Institutions

   

   

• Section 9: Urgent Situations
  • 9-1, Unanticipated Problems Involving Risks to Subjects or Others
  • 9-2, Noncompliance
  • 9-3, Termination or Suspension of IRB Approval
  • 9-4, Subject Complaints
  • 9-5, Unapproved Change in Protocol
  • 9-6, Undue Influence on IRB
  • 9-7, Withdrawal of Subject
  • 9-8, Protocol Deviations or Violations

   

• Section 10: Conflict of Interest
  10-1, Conflict of Interest
• Section 11: Education and Outreach
  • 11-1, Education
    • 11-1-A, Investigators and Research Staff
    • 11-1-B, IRB Member Education
    • 11-1-C, HRPP Staff Education
  • 11-2, Outreach and Engagement

   

• Section 12: Guidance
  • 12-1, Quality Assurance, Improvement, and Program Evaluation
  • 12-2, Storage and Handling of Investigational Drugs and Devices
  • 12-3, Advertisements
  • 12-4, Consent Form Guidelines
  • 12-5, Use of Anonymous and De-identified Data
  • 12-6, Pregnancy Testing When Research Involves Non-Contrast MRI of the Head
  • 12-7, Investigational Drug Accountability for Study Drugs
  • 12-8, Guidance on Exempt Category 4
  • 12-9, Guidance for the New Informed Consent Requirement for a Concise and Focused Presentation of Key Information
  • 12-10, U.S. Department of Defense Requirements: U.S. Air Force
  • 12-11, U.S. Department of Defense Requirements: U.S. Navy

   

   

• Section 14: Appendices
  14-26, Fees for For-Profit Sponsors