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Reporting Requirements Graphic
Guidance on Counting Subjects - 2024
Reportable Events Policy - 2023
Informed Consent Form Template - 2023
Treatment and Compensation for Research-Related Injury - 2023
NEW FORM to submit use of Coded or De-identified human data/specimens for Not Human Subjects Research determination - 2023
Template Language for Exempt Study Disclosures - April 2022
Call the HARC office at 510-486-6005, or email us at [email protected] with any questions.
Review Policies applying to protocols submitted after 1/21/2019
- Criteria for the Approval of Human Subjects Research (Regulatory Language)
- Energy/Environmental research and IRB review requirements
- Full or Initial Review Process
- Expedited Protocol Review Process
- Exempt Protocol Review Process
- Continuing Review, or Renewal Process
- Changes to an Approved Protocol
- Treatment and Compensation for Research-Related Injury
- HSC Reporting Requirements
- Using radioactive drugs
Note: a few policies still apply to protocols submitted before 1/21/2019:
Other Guidelines/Policies/Forms for human research:
Translation Attestation Form 2022
Guidelines for Compensation of Subjects 2021
NHSR Determination Guidance 2021
Online surveys and fraudulent responses
Privacy regulations for the state of California & the European Union
Federalwide Assurance for the Human Subjects Committee
