UCSD HRPP Standard Operating Procedures and Policies (SOPPs)

IRB Organization

Section	Title	Last Revised
2.1	Composition of IRBs	11/5/2010
2.2	Member Appointment, Compensation, and Responsibilities	2/1/2011
2.3	Orientation and Training	10/30/2008

IRB Review Procedures

Section	Title	Last Revised
3.1	Initial Screening	11/5/2010
3.2	Full IRB Review	6/24/2011
3.3	Criteria for Approval	1/3/2011
3.4	Informed Consent	4/21/2011
3.5	Emergency Use and Informed Consent	11/5/2010
3.6	Privacy and Confidentiality of Research Records	10/30/2008
3.7	Protected Populations	11/5/2010
3.7.1	Prisoners	11/5/2010
3.7.2	Students and Employees	11/5/2010
3.7.3	Pregnant Women	11/5/2010
3.7.4	Fetuses or Fetal Tissue	11/5/2010
3.7.5	Children and Adolescents	11/5/2010
3.7.6	Surrogate Consent and Impaired Decisional Capacity	11/5/2010
3.8	Financial Disclosure and Conflict of Interest	1/3/2011
3.9	Exemption from IRB Review	7/21/2011
3.10	Expedited Review	12/27/2011
3.11	Continuing Review	1/6/2011
3.12	Protocol Amendments	10/30/2008
3.13	Reporting Adverse Events and Unanticipated Problems	1/3/2011
3.14	Protocol and Regulatory Violations	10/30/2008
3.15	Radiation Exposure and Radioisotopes	12/16/2011
3.16	Banking of Specimens	10/30/2008
3.17	Advertisements and Recruiting Materials	10/30/2008
3.18	Review of Subject Complaints/Concerns/Questions	12/15/2011

Functions and Operations

Section	Title	Last Revised
4.1	IRB Meeting	10/30/2008
4.2	Categories of Action	10/30/2008

Protocol Audits and Scientific Misconduct

Section	Title	Last Revised
5.1	Protocol Audits	10/30/2008
5.2	Communications, Sanctions, Appeals, and Disciplinary Actions	11/5/2010

e-IRB Services

Section	Title	Last Revised
6.1	e-IRB Submission and Review	10/30/2008

Multi-Site Studies

Section	Title	Last Revised
7.1	Multi-Site Studies	10/30/2008

Appendix

Section	Title	Last Revised
8.1	Abbreviations	10/30/2008
8.2	Definitions	1/6/2011