CPHS/OPHS Site Map
About CPHS/OPHS
- Contact Us
- About CPHS/OPHS
- Impact of Campus Budget Cuts on OPHS
- Directions
- Site Map
- Privacy Policy
- CPHS/OPHS Website Credits
- Committees and Meeting Schedules
- Federalwide Assurance and Registrations
- News
eProtocol
- Berkeley eProtocol Instructions
- Berkeley eProtocol FAQs
- Berkeley eProtocol Quick Guides
-
Investigators
- Create a New Protocol
- Add SPO Funding
- Navigating Informed Consent (video)
- Delete a Protocol
- Clone (Copy) a Protocol
- PDF and Print a Protocol
- Check Application for Completeness
- Submit a Protocol Application
- Resubmit a Returned Application
- Respond to Comments
- View Protocol Review History and Approval Letter
- Amend/Modify an Approved Protocol
- Renew (Continue) an Approved Protocol
- Close an Approved Protocol
- Report an Incident (Adverse Event or Unanticipated Problem)
- Report a Protocol Deviation/Noncompliance
- Application Tips (video)
- Reviewers (Chairs, Vice Chairs, CPHS-1 and CPHS-2 Members)
-
Investigators
- About Berkeley eProtocol
- eProtocol Login
For Researchers
- Where to Start: Decision Tree
- What Needs CPHS/OPHS Review
- Am I Conducting Human Subjects Research? questionnaire
- Outline of October 30, 2003 Discussion with Dr. Michael Carome, Associate Director, HHS-OHRP, Regarding Oral History, Qualitative Interviews, and Human Subjects Research
- Research with Coded Private Information or Biological Specimens: Worksheet to Determine Whether Human Subjects Are Involved in Research When Obtaining Existing Data/Biological Specimens
- Types of Review
- Guide to the IRB Review Process
- Human Subjects Research in an International Setting
- Committees and Meeting Schedules
- Collaborative Research
- Informed Consent
- CPHS Informed Consent Guidelines
- Informed Consent Checklist
- Informed Consent Checklist for DNA/Genetic/Genomic Testing
- Child Assent and Parent Permission
- Instructions for Use of Template/Sample Consent Forms
- Instructions for Unsigned vs. Signed Consent
- Instructions for Consent Form Reference to Media Records Release Form (New)
- Template Consent Form – Biomedical Study
- Template Consent Form – Experimentation on Self
- Template Consent Form – Experimentation on Self – Social-Behavioral Study
- Template Consent Form – Social-Behavioral Study
- Template Consent Form – Interview with Audiotaping
- Template Consent Form – Online Survey
- Template Consent for Use of Media (Photo, Audio, or Videotape) Records
- SPH Biorepository Template Language for Consent & Parent/Guardian Permission
- Instructions for Use of Template Assent and Permission Forms
- Instructions for Unsigned vs. Signed Permission and Assent
- Template Assent Form, 7–12 Year Olds - Biomedical Study
- Template Assent Form, 13–17 Year Olds - Biomedical Study
- Template Permission Form, Parent – Biomedical Study
- Template Assent Form, 7–12 Year Olds - Social-Behavioral/School-Based Study
- Template Assent Form, 13–17 Year Olds - Social-Behavioral/School-Based Study
- Template Permission Form, Parent – Social-Behavioral/School-Based Study
- Sample Assent Form – Social-Behavioral/School-Based Study [for 7–12 Year Olds]
- SPH Biorepository Template Language for Child/Minor Assent
- Education and Training
For CPHS Members
- Checklists and Worksheets
- Criteria for IRB Approval of Research
- Informed Consent Checklist
- Permissible Research with Children
- Research Involving Neonates
- Research Involving Pregnant Women or Fetuses
- Research Involving Prisoners
- Significant Risk vs. Non-significant Risk Medical Device Studies
- Waiver of Child Assent
- Waiver of One of More Elements of Informed Consent
- Waiver of Parent or Guardian Permission
- Waiver of Requirement for Documented Consent
- Waiver or Alteration of HIPAA Authorization
- Committees and Meeting Schedules
For Research Participants
- Medical Research Subjects’ Bill of Rights
- FAQs for Research Participants
- About Research Participation
Resources
- Guidance
- COVID-19 Guidance for Human Subjects Research
- CPHS Guidelines
- Amendments
- Attachment Requirements for Surveys, Questionnaires, and Interview Guides
- Attachments Check List for Exempt Applications
- Attachments Check List for Non-Exempt Applications
- Certificate of Confidentiality
- Child Assent and Parent Permission
- Children in Research
- Classroom Observations with Media Recording
- Clinical Laboratory Testing in Human Subjects Research
- Compensation of Research Subjects
- Data Security Guidelines Matrix
- Deception and Incomplete Disclosure in Research
- Deviations and Noncompliances
- Electrical and/or Magnetic Brain Stimulation in Research
- Engagement in Human Subjects Research
- Exempt Research
- FDA-Regulated Research
- FDA-Regulated Research: Decision Trees for Investigational Device Studies
- Genetic/Genomic Research
- HIPAA and Human Subjects Research
- Informed Consent
- International Research
- International Research Checklist
- Internet-Based Research
- Legally Authorized Representative
- Magnetic Resonance Imaging (MRI) in Research
- Mandated Reporting for Suspected Child, Elder, or Dependent Adult Abuse or Neglect
- Mechanical Turk for Online Research
- Pregnant Women, Fetuses and Neonates
- Prisoners as Research Participants
- Recruitment
- Reliance Agreements for Non-UC Collaborations
- Secondary Analysis of Existing Data
- Subject Pools, Recruitment Registries and Databases
- Suicidal Ideation
- Suicidal Ideation Decision Tree
- Unanticipated Problems and Adverse Events
- Undergraduate Research, Part 1: Ethical Issues in Student-Initiated Research Activities with Human Participants
- Undergraduate Research, Part 2: Guidance on Designing Student-Initiated Research Activities
- UC Polices and Guidance
- Glossary of Terms
- 2018 Common Rule (45 CFR 46)
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Frequently Asked Questions
- General Frequently Asked Questions
- Exempt Category 70
- Family Educational Rights and Privacy Act (FERPA)
- General Data Protection Regulation (GDPR)
- HIPAA Authorization Form
- Incomplete Disclosure and Deception in Research
- Informed Consent in Exempt Level Research
- Maintenance and Stewardship of Research Data
- Massive Open Online Courses (MOOCs)
- Non-Affiliates and Outside Collaborations
- Public or Private Data
- Secondary Subjects
- Secondary Use of Existing Data
- Ten-Year Approvals
- CPHS Policies and Procedures
- Policies and Procedures Maintenance
- Training and Education for IRB Members and OPHS Staff
- Training and Education for Investigators
- Management of OPHS Staff
- IRB Member Conflict of Interest
- Signatory Authority, Signatory Authority (2019)
- Data Security
- Data Security Guidelines and Matrix
- IRB Reliance
- Composition of the IRB
- IRB Membership
- Duties of IRB Members
- Research Protocol Submission Requirements
- Determination of Exemption, Determination of Exemption (2019)
- IRB Meeting Administration, IRB Meeting Administration (2019)
- Record Retention and Disposition
- Initial Review
- Expedited Review, Expedited Review (2019)
- Continuing Review, Continuing Review (2019)
- Amendment Review
- Monitoring Ongoing Research, Monitoring Ongoing Research (2019)
- Categories of Action, Categories of Action (2019)
- Unanticipated Problems and Adverse Event Reporting
- Suspension and Termination of Human Subjects Research
- Protocol Deviations and Noncompliances
- Grant-Protocol Review
- Pregnant Women, Fetuses and Neonates
- Prisoners
- Children
- Intrainstitutional Communication, Intrainstitutional Communication (2019)
- General Requirements and Documentation, General Requirements and Documentation (2019)
- Waivers of Informed Consent, Waivers of Informed Consent (2019)
- Assent and Parent/Guardian Permission, Assent and Parent/Guardian Permission (2019)
- Review for Purposes of Verification
- Federalwide Assurance and Registrations
- CPHS/OPHS Annual Report
- UC Berkeley Human Research News
- Governing Policies and Regulations
- Health Insurance Portability and Accountability Act (HIPAA)
- HIPAA PHI: List of 18 Identifiers and Definition of PHI
- What is and is not Protected Health Information (PHI) in Research Settings
- UC Research Authorization for Release and Use of Personal Health Information and Personally Unidentified Study Data (for individual subjects) - PDF or Word
- Health Insurance Portability and Accountability Act (HIPAA)
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