CPHS-Related Links
- California Information Practices Act, Civil Code, Section 1798.24 (SB 13)
- FDA Regulations
- FDA Web Site
- HIPAA Privacy Rule
- Common Rule
- Office for Human Research Protections (OHRP)
- Public Responsibility in Medicine & Research and Applied Research Ethics National Association (Prim&R and ARENA)
Contact CPHS at:
400 R Street, Suite 369
Sacramento, CA 95811-6213
Phone: (916) 326-3660
Fax: (916) 322-2512
E-mail: cphs-mail@oshpd.ca.gov
Committee for the Protection of Human Subjects
Instructions for Researchers
The Instructions For Researchers manual (pdf) contains the following information. (For the fill-in forms, please see the Forms page).
I. Basic Information
II. Mission and Purpose
III. Authority and Scope
IV. Categories of Research
- What is Research?
- Distinguishing Public Health Practice from Research
- Exempt Research
- Research under HIPAA
V. Submission of Documents
- General Guidelines
- New Projects
- Continuing Projects
- Periodic Review
- Review for Changes
- Completed Projects
- Withdrawn Projects
- Determination of Research Status
- Exempt Research
- Death Data File Projects
- HIPAA Waiver or Alteration of Authorization
- California Information Practices Act Review, (SB13)*
VI. CPHS Processes of Review
- New Projects
- Continuing Projects
- Primary Reviewer System
- Expedited Review
- HIPAA Review
- Death Data Files
- California Information Practices Act Review, (SB13)*
- Convened Meetings
- Committee Actions
VII. Notification and Appeal
VIII. Adverse Events
Appendices
- Appendix I. Research Project Protocol Requirements
- Appendix II. Informed Consent and Assent
- Appendix III. Participant's Bill of Rights for Medical Research (English & Spanish)
- Appendix IV. Participant's Bill of Rights for Non-Medical Research (English & Spanish)
- Appendix V. Research Protocol Requirements for Projects Involving Death Data Files without Human Subject Content
- Appendix VI. Research Protocol Requirements for California Information Practices Act Review, (SB13)*
- Appendix VII. Template Departmental Letter of Support for California Information Practices Act Review, (SB13)*
- Appendix VIII. Guidance for using Small Numbers or Small Cells
*Recent additions