UCSD Human Resource Protections Program

Standard Operating Policies and Procedures (SOPPs)

The current version of the UCSD Human Research Protections Program Standard Operating Policies and Procedures (SOPPs) has been "revised" to provide these policies and procedures separately rather than as one guideline. Superseded versions of the SOPPs can be found at the bottom of this page.

General Administration

Section Title Last Revised
1.1 Responsibility and Authority 4/30/2014
1.2 HRPP Program Organization 10/30/2008
1.3 Review and Updating of SOPP 9/18/2014
1.4 Documentation and Records Retention 10/29/2013
1.5 UCSD Institutional Policies 10/29/2013

IRB Organization

Section Title Last Revised
2.1 Composition of IRBs 9/18/2014
2.2 Member Appointment, Compensation, and Responsibilities 5/29/2014
2.3 Orientation and Training 10/29/2013

IRB Review Procedures

Section Title Last Revised
3.1 Initial 10/29/2013
3.2 Full IRB Review 6/28/2013
3.3 Criteria for Approval 10/29/2013
3.4 Informed Consent 3/30/2015
3.5 Emergency Use and Informed Consent 11/5/2010
3.6 Privacy and Confidentiality of Research Records 10/29/2013
3.7 Protected Populations 10/29/2013
3.7.1 Prisoners 10/29/2013
3.7.2 Students and Employees 10/29/2013
3.7.3 Pregnant Women 10/29/2013
3.7.4 Fetuses or Fetal Tissue 10/29/2013
3.7.5 Children and Adolescents 10/29/2013
3.7.6 Surrogate Consent and Impaired Decisional Capacity 10/29/2013
3.8 Financial Disclosure and Conflict of Interest 1/3/2011
3.9 Exemption from IRB Review 6/24/2014
3.10 Expedited Review 9/17/2014
3.11 Continuing Review 3/3/2014
3.12 Protocol Amendments 10/30/2008
3.13 Reporting Adverse Events and Unanticipated Problems 3/3/2014
3.14 Protocol and Regulatory Violations 10/29/2013
3.15 Radiation Exposure and Radioisotopes 7/26/2012
3.16 Banking of Specimens 10/30/2008
3.17 Advertisements, Recruiting Materials, and Procedures and Procedures Preparatory to Research 8/30/2013
3.18 Review of Subject Complaints/Concerns/Questions 10/29/2013
3.19 Collaboration with Other UCSD Committees 11/20/2012
3.20 Confidentiality of Collected Specimens or Data 1/29/2013
3.21 IRB Oversight by Non-UCSD "Centralized" IRBs 9/18/2014

Functions and Operations

Section Title Last Revised
4.1 IRB Meeting 10/30/2008
4.2 Categories of Action 5/29/2014

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 10/29/2013
8.2 Definitions 10/29/2013

Superseded SOPPs and Human Research Guidelines

UCSD Human Research Protections Program Standard Operating Policies and Procedures (150 pages - 838K PDF) 10/30/2008
UCSD Human Research Protections Program Standard Operating Policies and Procedures (134 pages - 545K PDF) 1/30/2008
UCSD Human Research Protections Program Standard Operating Policies and Procedures (125 pages - 511K PDF) 2/15/2007
UCSD Human Research Protections Program Standard Operating Policies and Procedures (124 pages - 450K PDF) 5/28/2004
Human Research Guidelines 1999
Contact the Human Research Protections Program Office