Human Subjects & Approval

• What is the Human Subjects Committee?
• Who needs Human Subjects Approval?
• Where to begin?
• Human Subjects Training Module
  • Training FAQ
• What do I need to submit?
  • ORahs (Office of Research Application for the use of Human Subjects)
  • Human Subjects Application (ORahs) tutorials
  • Signature Page
  • Other Human Subjects Forms

  How do I renew my protocol?

  Deadlines

Human Subjects Forms

Human Subjects Committee Policies and Procedures

Any reference to 112f or 112x forms in the following information sheets predate ORahs (Office of Research Application for the use of Human Subjects). ORahs is the only application for Human Subjects use. The information is still correct as it applies to ORahs.

Information Sheets

• Definitions

Informed Consent

• Required Procedures for Obtaining Consent from Human Subjects Used In Research
• Waiver of the Requirements for Obtaining Informed Consent
• Basic Elements of Informed Consent
• Waiver of Requirements for Basic Elements
• Documentation of Informed Consent
• Waiver of Documentation
• Consent Forms
• Oral Consent
• Tips on Informed Consent

Applicability and Exemptions

• Applicability of Review Requirements
• Implementing Procedures for Exemptions
• Exemption Criteria

Expedited Review

• Expedited Review Policy
• Application for Expedited Review of Research
• Disposition of Applications for Expedited Review
• Criteria for Expedited Review of Research

Communication with the UCSB HSC

• Disapprovals, Conditions and Requirements for Modification
• Other Communications
• Procedures
• Address and Telephone Number

Minimum Requirements for Screening/Monitoring

• Experiments Involving Human Subjects In Exercise
• Experiments Involving Exposure to Foreign Substances
• Experiments Involving Work to Exhaustion
• Experiments Involving Invasive Techniques
• Adverse Post-Experimental Consequences

Basic Ethical Principles

• Regulations and Policy Regarding Basic Ethical Principles
• The Belmont Report (A Summary)

Additional Protections for Children

• Claim of Exemption
• Informed Consent
• Documentation of Informed Consent
• Risk/Benefit Ratio
• Wards

Recommendations from the Alzheimer's Association

• Additional Protections for the Cognitively Impaired
  

Policy on the Use of Human Subjects

• UCSB Research Circular D.2
• University of California Policy on Protection of Human Subjects
• 45 Code of Federal Regulations 46
• Belmont Report
• Human Subjects Brochure
• HIPPA
  • HIPPA Forms
• Public Records Research (SB 1614)
• Stem Cell Research (SB 253 Ch 789)