Human Subjects Manual
Table of Contents

1. Human Subjects Policy
   
   
   1. Statement of Policy
   2. Oversight
   3. Appeals process
   
   
2. Types of Research
   
   
   1. Definition of research
   2. Research requiring review
   3. "No Risk" Research (Exemptions)
   4. "Minimal Risk" Research (Expedited)
   5. Research requiring full committee review
   
   
3. Review Procedures
   
   
   
   1. No Risk Review (Exemptions): Departmental-level review
   2. Human Subjects Review Committees
      1. General Information
         1. Structure
         2. Function
      2. Human Subjects Review Committee Application form (UW 13-11)
   3. Minimal Risk Review (Expedited): Subcommittee review
      1. General information
      2. Procedures
   4. Full Committee Review
      1. General information
      2. Procedures
   5. Emergency Review
   6. Approval in principle
   7. Modifying an approved application
      1. Types of modifications
      2. Procedures
      3. Funding sources
   8. Continuing review
      1. Types of continuing review
      2. Procedures
   
   
4. Informed Consent
   
   
   
   1. General information
   2. Documenting informed consent
   3. Elements of consent
      1. Basic requirements
      2. University of Washington Requirements
      3. Elements to be included when appropriate
      4. Elements to be included in special circumstances
   4. Types of consent
      1. Written consent
      2. Oral consent
      3. Proxy consent
      4. Waiver of consent
      5. Waiver of consent in emergency medicine research.
      6. Assent
      7. Implied consent
         
   
   
5. Adverse Events
   
   
   1. Expected Adverse Events
   2. Unexpected or more serious than expected
   
   
6. Special populations
   
   
   1. Research with minors
      1. Permission of Children and Parents or Guardians
      2. Degree of Risk Involved
      3. Special Custodial Circumstances
   2. Research with pregnant women and fetuses
   3. Research with prisoners
   4. Research with subjects who are not competent to provide consent
   5. Research with subjects with reproductive potential
      
      
7. Special Topics
   
   1. Investigational Drugs
   2. Investigational Devices
   3. Radiation exposure
   4. Administration of Alcohol or Illegal Drugs
      1. Screening
      2. Informed consent
      3. Risks
      4. Protections against post-experimental risk
      5. Additional information
   5. Research using records and stored biological specimens
      1. Using health care information with informed consent
      2. Using health care information without informed consent
   6. Confidentiality
   7. Compensation for adverse events
   8. Subject recruitment
      1. Approaching subjects to participate
      2. Advertisements
   9. Grants and Contracts
   10. Subject Compensation
   11. Deception
   12. Electrical Equipment
   13. DNA
   14. Genetic Research
   15. Research at other sites
       1. Cooperative agreements
       2. Other organizations
       3. Other countries
   16. Definition of terms
   
   
8. Forms
   
   
   
   1. UW 13-11 application form
   2. Status Report
   3. Certification of Exemption
   4. Adverse Event Report Form
   5. Sample Consent Form
      
      
9. Laws and Regulations
   
   
   1. 45 CFR 46
   2. 21 CFR 50
   3. RCW 42.48
   4. RCW 70.02
   5. The Belmont Report
   6. the University of Washington Assurance Document (also below)
   
   
10. Assurance Document

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