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Human Subjects in Research

About the Human Subject Committee of Lawrence (HSCL)

Forms
HSCL and HIPAA forms

Tutorials
The Human Subjects Protection tutorial for all human subjects, and the HIPAA tutorial

Policies and procedures
HSCL and HIPAA FAQs, printable handbook and tutorial documents

The HSCL handbook

  1. The institutional authority under which the IRB is established and empowered

    • Policy
    • Procedure

  2. Definition of the purpose of the HSCL

    • The university's assurance
    • Criteria for approval levels
    • Bases for HSCL application evaluation
    • HSCL Policy on Experiments Involving Deception of Subjects

  3. Principles that govern the HSCL in assuring that the rights and welfare of subjects are protected

  4. Authority of the HSCL

    • What types of studies must be reviewed
    • No risk research
    • Minimal risk research
    • Research requiring full committee review
    • Criteria for HSCL approval of research
    • Lotteries or Drawings
    • Internet research
    • Genetic research
    • Progress reports
    • Suspension or termination of approval
    • Processing of Complaints and Allegations Against PIs
    • Restrictions on a study

  5. HSCL's relationship to the institution

    • Chain of Reporting
    • Responsibility and Charge of the HSCL
    • Education of Investigators
    • Communication with researchers
    • Communication with other institutions
    • Communication with Regulatory agencies

  6. Membership of the HSCL

    • Description of membership
    • Qualifications of members
    • Provisions for replacing members
    • Members whose expertise is with special populations
    • Alternate members

  7. Management of the HSCL

    • The Faculty Chair
    • HSCL members
    • Training of HSCL chair and members
    • Compensation of HSCL members
    • Liability coverage for HSCL members
    • Use of consultants
    • Secretarial/administrative support staff (duties)
    • Resources

  8. Functions of the HSCL

  9. Operations of the HSCL

    • Research Application and Review
    • Full Board Review
    • Disapproved/Not Approved Projects
    • Requirements for researcher response
    • Continuing Review

  10. Use of Personal Health Information under the Health Insurance Portability and Accountability Act (HIPAA)

Other resources

Questions? Please contact:
David Hann
785-864-7429 | dhann@ku.edu
Coordinator | Human Subjects Committee of Lawrence (HSCL)

— or —

Mary Denning
785-864-7385 | mdenning@ku.edu
Associate Coordinator |Human Subjects Committee of Lawrence (HSCL)