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Policies and Procedures

Here are the Federalwide Assurance for the LBNL Human Subjects Protection Program, the LBNL Human Subjects Committee (IRB) charter, implementation guidelines for the charter, and a list of the responsibilities for membership in the HSC. The following HSC policies and procedures may be useful for those questioning how to proceed in a certain matter. Call that Human and Animal Regulatory Committees (HARC) offices at 510/486-5399, or email us at harc@lbl.gov with any questions.

Policies applying to protocols submitted after 1/21/2019

  1. Criteria for the Approval of Human Subjects Research
  2. Energy/Environmental research and IRB review requirements
  3. Full or Initial Review Process
  4. Expedited Protocol Review Process
  5. Exempt Protocol Review Process
  6. Continuing Review, or Renewal Process
  7. Changing, Amending, Modifying an Approved Protocol
  8. Treatment and Compensation for Research-Related Injury
  9. Dealing with Adverse Events
  10. Using radioactive drugs

Note: a few policies still apply to protocols submitted before 1/21/2019:

Criteria for Approval

Full or Initial Review

Expedited Review