UCSD Human Research Protections Program

News

May 22, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.4, 2.1, and 2.2 have been updated. Section 1.4, page 1, has been updated to include additional documents that are part of adequate documentation; pages 1 and 2 have been updated to include that deliberations will be separate for each action, approval period, and category of expedited initial/continuing review approval is provided in the meeting minutes; and page 3, update indicates that IRB records will allow for the reconstruction of the complete history of IRB records. Section 2.1, page 1 has been updated to include that in general, an unaffiliated IRB member, and an IRB member who represents the general perspective of subjects, will attend 10 of 12 IRB meetings. And section 2.2, page 2 has been updated to include IRB membership will be evaluated and adjusted to meet regulatory and organizational requirements and page 4 has been updated to address stipends provided to various IRB members. The updated SOPPs can be found on the SOPPs page .
April 11, 2017

Updated SOPP, Fact Sheet, and Form, and New Form for Exempt Studies

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP) and the Fact Sheet regarding studies that are exempt from IRB review have been updated. The updates include an updated SOPP with a definition of "existing" data and a link for an exempt sample informed consent, as well as, links to the updated Cover Sheet for Exempt Status Application and the "new" Exempt Status Facesheets. The updated SOPP, section 3.9, can be found on the SOPPs page , the updated Fact Sheet on the Fact Sheets page , and the updated forms on the Exempt Status forms page .
March 20, 2017

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 4:00 pm, Friday, March 24, 2017, to approximately 1:00 pm, Sunday, March 26, 2017. We regret any inconvenience this may cause. Please plan accordingly.
March 7, 2017

HRPP Website Down

Because of circumstances beyond our control, the HRPP website was down on Tuesday, March 7, 2017, from approximately 1:00 pm until approximately 4:30 pm. We apologize for any inconvenience this may have caused.
February 10, 2017

IRB Website not available, Saturday, February 11, 2017

Due to circumstances beyond our control, the IRB website will be unavailable from approximately 8:00 am until approximately 11:00 am, Saturday, February 11, 2017. We apologize for any inconvenience. Please plan accordingly.
January 6, 2017

Multiple Document Uploads

The HRPP website has been enhanced to allow for multiple document uploads through "e-IRB Services." In addition, the "Document Type" is now selected using a dropdown menu. Further information can be found on the document upload page via "My Protocols at a Glance."
December 5, 2016

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 9:00 am to approximately 6:00 pm on Tuesday, December 27, 2016, and Wednesday, December 28, 2016. We regret any inconvenience this may cause. Please plan accordingly.
November 28, 2016

Dear UCSD Researchers and Staff:

In a September Campus Notice, the Office of the Interim Executive Vice Chancellor-Academic Affairs and the Office of the Vice Chancellor and Chief Financial Officer notified the UC San Diego Community that UC San Diego will officially close four (4) working days in December, 2016 (26th and 27th) and January, 2017 (2nd and 3rd). The HRPP will be closed between Monday, December 26, 2016 and Tuesday, January 3, 2017, reopening Wednesday, January 4, 2017. Please keep this in mind when preparing your IRB submissions. The IRB meeting dates are available here. On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!
November 18, 2016

New Forms for Amendment Requests and Key Personnel Changes

Two new forms have been created for amending an approved study and requesting changes to key personnel associated with a study. The Amendment Request Cover Letter was created to formalize the means for providing the IRB/HRPP with sufficient information for an appropriate review of an amendment request. The Request Key Personnel Changes Only form can be used for making changes to key personnel associated with a study only where those changes do not require revision of the consent/permission/assent form(s) and/or the change is not to the PI of the study. The Amendment Request form and information about the using the form can be found here. The Request Key Personnel Changes Only form and information about using the form can be found here.
November 18, 2016

New Forms for Existing Medical Record Review Studies

New forms have been created for studies that propose to only review pre-existing medical records. These forms may only be used when a retrospective medical record review study that is reviewing pre-existing medical records is being proposed. Pre-existing means the medical records are collected prior to this research use for the purpose other than the proposed research, and the only information accessed in the medical records must be present at the time the Existing Medical Record Review (EMRR) Application Facesheets are submitted to the HRPP via the web. These forms include EMRR Application Facesheets and an EMRR Research Plan. These forms and information about using these forms can be found here.
October 31, 2016

November and December IRB Meeting Dates

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure quorum. The updated schedule is available on the IRB Meeting Dates page .
August 16, 2016

HRPP Website Unvailable

The HRPP Website including e-IRB services will not be available to researchers and staff from approximately 6:00 am until 2:00 pm, Saturday, August 20, 2016, because of circumstances beyond our control. Please plan accordingly.
May 31, 2016 (Updated June 16, 2016)
HRPP Office has Moved
The HRPP Office has moved to the Altman Clinical and Translational Research Institute (ACTRI) building. The new HRPP Office phone number is 858-246-HRPP (858-246-4777). For more updated HRPP Office contact information, please see the Contacts page .
April 4, 2016

Additional Sample Informed Consent

An additional sample informed consent has been created for adult subjects for research where Rady Children's Hospital - San Diego is a site of performance. The sample consent can be found on the Biomedical Research forms page .
March 14, 2016

Additional Sample Informed Consent Forms and Wording About Changes to Harm Clause/HIPAA Authorization

Three (3) additional sample informed consent forms for studies associated with exempt studies or studies associated with paper or online surveys have been created. In addition, wording regarding changes to the subject harm clause and HIPAA authorization indicating requests for changes cannot be honored has been provided. The sample consents for paper or online surveys can be found on the Biomedical Research forms page and SBS Research forms page . The exempt consent can be found on the Exempt Status forms page . The wording regarding changes to the harm clause and HIPAA authorization can be found on Biomedical Research forms page .
February 19, 2016

Change in Fee Schedule for Commercially-Sponsored Clinical Trials

Effective immediately, there will be a change in the fee schedule for UCSD IRB review of commercially sponsored clinical trials to reflect a flat rate of $3510 for an initial review and $3510 for each 10-year resubmission (treated as a "new" project review by the IRB) and $1300 for each annual continuing review. More information can be found on the HRPP Fact Sheet "Institutional Review Board (IRB) Fees for Commercially Sponsored Projects" located here .
January 5, 2016

Updated SOPP

The SOPP, section 3.19, Collaboration with Other UCSD Committees, has been updated to reflect the current procedures associated with the collaboration between the IRB/HRPP and the Moores Cancer Center Protocol Review and Monitoring Committee (PRMC). The updated SOPP can be found on the SOPPs page .
December 17, 2015 (Updated December 29, 2015)

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 9:00 am to approximately 6:00 pm on Monday, December 28, 2015 and Tuesday, December 29, 2015. We regret any inconvenience this may cause. Please plan accordingly.
November 23, 2015

Holiday Schedule and Closure

Dear UCSD Researchers and staff: In a September Campus Notice, the Office of the Executive Vice Chancellor-Academic Affairs and the Office of the Vice Chancellor and Chief Financial Officer, notified the UC San Diego community that UC San Diego will officially close four (4) working days in December, 2015 (28th, 29th, and 30th) and January, 2016 (1st). The HRPP will be closed between Thursday, December 24, 2015 and Sunday, January 3, 2016, reopening Monday, January 4, 2016. Please keep this in mind when preparing your IRB submissions. The IRB meeting dates are available here . On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!
November 17, 2015

New Fact Sheet and Updated SOPP

A new Fact Sheet has been created regarding research methods courses in the Social and Behavioral Sciences. In addition, SOPP, section 3.4 Informed Consent, has been updated to include links to the UCSD short form and Experimental Subject's Bill of Rights translated into Spanish, Vietnamese, Chinese (both Simple and Traditional), Arabic, and Somali. The Fact Sheet can be found on the Fact Sheets page . The updated SOPP can be found on the SOPPs page and information regarding procedures associated with the use of the short form (also found in the SOPP) can be found at https://irb.ucsd.edu/Short-Form-Consent.shtml .
October 27, 2015

New Fact Sheet and New Cover Letter Form

A new Fact Sheet has been created regarding procedures for PI-initiated clinical trials and IND applications. In addition, a new form has been created for a Cover Letter that can be used for only making changes to "key personnel" that are associated with a study. The Fact Sheet title "Investigator Initiated Clinical Trials/IND Applications" can be found on the Fact Sheets page . More information about the Cover Letter form can be found here .
October 13, 2015

Let your voice be heard — NPRM

The US Department of Health & Human Services has announced a Notice of Proposed Rule Making (NRPM) for changes to the "Common Rule" for protection of human subjects and is requesting public comment about those changes. The public comment period for the proposed changes will be open for approximately 2 more months. For more information about the NPRM and submitting your comments, please go to the OHRP web site . The HRPP Office is also providing a Word document that includes a table of questions associated with the NPRM as well as a PDF that provides a more easily readable NPRM to allow for greater ease in providing your comments.
October 8, 2015

November and December Meeting Dates

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure quorum. The updated schedule is available on the Dates page .
August 17, 2015

Updated Fact Sheet and "Re-release" of SOPP

The Fact Sheet, Submitting an Amendment/Modification to a Research Plan (Protocol), has been updated to more specifically outline what is required when amending/modifying an approved study and when an amendment is considered incomplete and what may be done with incomplete requests. The UCSD IRB/HRPP Standard Operating Policy and Procedure, section 3.4, Informed Consent, is being "re-released" to remove redundant wording that was previously included. The re-released SOPP was previously updated to address the definition of a witness, the use of interpreter, and short form consent procedures. The updated Fact Sheet can be found on the Fact Sheets page , and the "re-released" SOPP can be found on the SOPPs page.
August 17, 2015

Updated Application Facesheets

The Biomedical Research and Social and Behavioral Sciences (SBS) Research Standard Application Facesheets have been updated to collect additional information requested by various entities including the University of California, Office of the President and other HRPP-collaborating offices. The additional information requested includes whether a study is a multicenter/multisite study, whether there is compensation for participation associated with the study, and whether international site(s) is/are associated with the study. In addition, the Biomedical Research Facesheets have been revised to include that the PRMC should be contacted if the study involves patients with cancer or are at a high risk of developing cancer during the study and changes to requested Funding information to more specifically indicate whether a study includes a commercial sponsor, which is Sponsor initiated or includes a Commercial sponsor, which is PI initiated. The updated Biomedical Research Facesheets can be found on the Biomedical Forms page and the updated SBS Research Facesheets can be found on the SBS Forms page .
July 2, 2015

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 2:00 pm, Friday, July 10, 2015 through approximately 6:00 pm Sunday, July 12, 2015. We regret any inconvenience this may cause. Please plan accordingly.
June 25, 2015

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 4:00 pm, Friday, June 26, 2015 through approximately 6:00 pm Sunday, June 28, 2015. We regret any inconvenience this may cause. Please plan accordingly.
June 12, 2015

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 4:00 pm, Friday, June 12, 2015 through approximately 6:00 pm Sunday, June 14, 2015. We regret any inconvenience this may cause. Please plan accordingly.
May 29, 2015

Updated IRB/HRPP Stamp-of-Approval

The IRB/HRPP stamp-of-approval has been updated to a smaller, more square stamp. The HRPP Office will use the updated stamp beginning June 1, 2015.
May 22, 2015

Change In Fee Schedule for Commercially-Sponsored Clinical Trials

For agreements submitted June 1, 2015 or later, there will be a change in the fee schedule for UCSD IRB review of commercially-sponsored clinical trials to reflect a flat rate of $3402 for an initial review and $3402 for each 10-year resubmission (treated as a "new" project review by the IRB) and $1260 for each annual continuing review. More information can be found on the HRPP Fact Sheet "Institutional Review Board (IRB) Fees for Commercially-Sponsored Projects" located here .
May 7, 2015 (Updated May 8, 2015)

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, the HRPP website including e-IRB services will not be accessible from approximately 4:00 pm - 6:30 pm, Friday, May 8, 2015. We regret any inconvenience this may cause. Please plan accordingly.
May 1, 2015

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 5:30 pm, Friday, May 1, 2015 through approximately 6:00 pm Sunday, May 3, 2015. We regret any inconvenience this may cause. Please plan accordingly.
April 22, 2015

Scheduled Maintenance for HRPP Website

Because of scheduled maintenance being performed on the HRPP website, e-IRB services and various documents may be slow to access and/or load or not be accessible and/or load intermittently from approximately 1:00 pm, Friday, April 24, 2015 through approximately 6:00 pm Sunday, April 26, 2015. We regret any inconvenience this may cause. Please plan accordingly.
April 10, 2015

Facesheets submission and some web site pages/files currently unavailable

The submission of Facesheets and some IRB website files/pages are currently unavailable. We are working to correct the problem and apologize for any inconvenience.
December 17, 2014 (Updated December 31, 2014)

Scheduled Maintenance for HRPP Website

The HRPP website, e-IRB services, was not available to researchers and staff from approximately 9:30 am, Monday, December 29, 2014 through approximately 12:10 pm, Wednesday, December 31, 2014. Please plan accordingly.
November 24, 2014

Holiday Schedule and Closure

Dear UCSD Researchers and staff, in an August Campus Notice, the Office of the Executive Vice Chancellor-Academic Affairs notified the UCSD community that UC San Diego "will officially close for twelve (12) days between Wednesday, December 24, 2014 and Sunday, January 4, 2015." The HRPP will reopen following this closure on Monday, January 5, 2015. Please keep this in mind when preparing your IRB submissions. The IRB meeting dates are available here . On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!
November 24, 2014

New Fact Sheet, EBP/QA/QI Projects

A new Fact Sheet has been created regarding submission and review of evidence based practice (EBP), quality assurance (QA), and quality improvement (QI) projects. The new Fact Sheet can be found on the Fact Sheets page .
October 28, 2014

Presentation by Dr. Kristina Borror, OHRP Director, Division of Compliance Oversight

On November 21, 2014, 10:00 am, Dr. Borror will be presenting a talk entitled, "Informed Consent Process - Vulnerable Population Focus" in the Goldberg Auditorium, Moores University of California Cancer Center. The talk is part of the Moores Cancer Center Clinical Research Continuing Education program. For more information, please contact Roxana Phillips at 858-822-5361 .
October 21, 2014 (Updated October 29, 2014)

November, December, and January IRB Meeting Dates

As is customary, the schedule for the IRB meeting dates changes during the months of November, December, and January because of University holidays and the need to ensure quorum. The updated schedule is available on the Dates page.
October 10, 2014

Updated SOPPs

UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.3, 2.1, 3.10, and 3.21 have been updated. Section 1.3, Review and Updating SOPPs, was revised to reflect additional procedures for approving updated SOPPs. Section 2.1, Composition of IRBs, was revised to include updated wording regarding definition of "quorum." Section 3.10, Expedited Review, was revised to define "retrospective" and procedures associated with amending a project with a retrospective review of records. Section 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs, was revised to add procedures for using Quorum Review IRB oversight. The updated SOPPs can be found on the SOPPs page.
October 8, 2014

"New" IRB Committee

The UCSD HRPP now supports six federally registered IRBs, five Biomedical IRBs including one IRB that specializes in pediatric projects and the "new" IRB that specializes in oncology projects as well as one Social and Behavioral Sciences IRB. The meeting dates for Committees can be found on the Dates page .
September 11, 2014

Updated SOPPs and Forms

UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.9, Exemption from IRB Review; and 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs; the WIRB checklist; and the Research Plan associated with exemption category 4 have been updated. Section 3.9 has been updated to more clearly indicate that the IRB Chair and/or the IRB Chair's designee may determine whether a submitted research project meets the requirements for exemption from IRB review. Section 3.21 has been revised to reflect the addition of Copernicus Group IRB (CGIRB) oversight (specific Facesheets and checklist have been provided) and a change in the eligibility criteria for WIRB IRB oversight to include that a multicenter study is defined as 5 sites including UCSD, Phase II studies and Phase I studies that meet criteria as well as provide documentation of approval for the project from the UCSD Institutional Official. The WIRB checklist has been revised to reflect these changes. The Research Plan associated with exemption category 4 has been updated to reflect conditions required to grant waiver of individual HIPAA authorization. The updated SOPPs can be found on the SOPPs page. The updated Research Plan can be found on the Exemption forms page.
September 8, 2014

Updated SOPPs

UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.1, Responsibility and Authority; 2.2, Member Appointment, Compensation and Responsibilities; 3.10, Expedited Review; and 4.2, Categories of Action, have been updated. Section 1.1 has been updated to more clearly reflect 45 CFR 46.112 and to include procedures associated with reporting/reviewing attempted undue influence of UCSD IRB, HRPP Administration, and/or HRPP staff. Section 2.2 has been updated in regards to the appointment of an IRB Chair. Section 3.10 has been updated to reflect extended approval, up to 3 years, of minimal risk studies that meet specific criteria. Section 4.2 has been updated to include procedures for assigning a response to an approved pending letter from the Committee requesting review of the response to another Committee with the approval of the IRB Chair and HRPP Director. These updated SOPPs can be found on the SOPPs page.
June 25, 2014

Change In Fee Schedule for Commercially-Sponsored Clinical Trials

For projects submitted after July 1, 2014, there will be a change in the fee schedule for UCSD IRB review of commercially-sponsored clinical trials to reflect a flat rate of $2700 for an initial review and $2700 for each 10-year resubmission (treated as a "new" project review by the IRB) and $1000 for each annual continuing review. More information can be found on the HRPP Fact Sheet "Institutional Review Board (IRB) Fees for Commercially-Sponsored Projects" located here.
May 22, 2014

Updated CIRB Consents Boilerplate Language Approved

Updated CIRB consent/permission/assent boilerplate language has been approved by the CIRB. As noted in the approval documentation from CIRB, "The Signatory Institution Principal Investigator has the responsibility for ensuring that CIRB-approved boilerplate language is appropriately inserted into the CIRB-approved consent form(s) and institutional requirements are met." The updated, approved boilerplate language can be found here.
May 14, 2014

Updated SOPP

UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), section 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs, has been updated to reflect additional wording regarding submission of amendment documentation to ensure appropriate information is available for UCSD departments/committees including Investigational Drug Service. The updated SOPP can be found on the SOPPs page.
March 3, 2014

Life Span of Projects Increased

As of March 1, 2014, the life span of a project has been increased from 7 years (i.e., up to 6 cycles of Continuing Review after initial approval) to 10 years (i.e., up to 9 cycles of Continuing Review after initial approval). The PI is reminded that continuing review documents must be submitted to the HRPP approximately 45 days prior to the project expiration date (365 days from the initial approval /continuing review approval or as outlined in the approval letter) to ensure that there is no lapse in study approval. IRB/HRPP web pages and documents including SOPPs sections 3.11 and 3.13 have been revised to reflect the increase in life span.
February 21, 2014

IRB Website Not Available Friday, February 21, 2014

Due to circumstances beyond our control, the IRB website will be unavailable from approximately 4:00 pm until approximately 6:00 pm, Friday, February 21, 2014. We apologize for any inconvenience. Please plan accordingly.
February 3, 2014

Updated Biomedical Research Application Facesheets, Research Plan Instructions, and "New" Supplement

The Biomedical Research Application Facesheets have been revised to remove requests for information regarding the VA San Diego and to include requests for information regarding whether a project involves an infectious agent; meets criteria for an IND exemption; involves a non-significant risk or significant risk device; and to indicate the "Phase" of a clinical trial, as appropriate. The Research Plan instructions have been updated to include that if a study is requesting an IND exemption, the IND exemption supplement to the Research Plan must be completed and submitted. And a "new" supplement for IND exemption requests has been created. The updated Facesheets, instructions and the new supplement, as well as the other supplements to the Research Plan, can be found on the Biomedical Research Forms page.
January 31, 2014

Updated SOPPs

UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPPs), Sections 1.1; 1.3; 1.4; 1.5; 2.1; 2.2; 2.3; 3.1; 3.3; 3.4; 3.6; 3.7; 3.9; 3.14; 3.17; 3.18; 8.1;and 8.2 have been updated to reflect that the UCSD IRBs are no longer the San Diego VA Healthcare System IRBs of record. The updated SOPPs can be found on the SOPPs page.
November 25, 2013

Holiday Schedule and Closure

Dear UCSD Researchers and staff, in an August Campus Notice, the Office of the Executive Vice Chancellor-Academic Affairs and the Office of the Vice Chancellor-External and Business Affairs, notified the UCSD community that UC San Diego will officially close four (4) working days in December (December 23rd, 26th, 27th, and 30th). The HRPP will be closed between Saturday, December 21, 2013 and Wednesday, January 1, 2014, re-opening Thursday, January 2, 2014. Please keep this in mind when preparing your IRB submissions. The IRB meeting dates are available here . On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!
October 30, 2013

New Fact Sheet

A new Fact Sheet has been created regarding a CSUSM/UCSD agreement for review of human subject research associated with students enrolled in joint CSUSM/UCSD programs and CSUSM graduate programs conducting research at UCSD facilities. The new Fact Sheet can be found on the Fact Sheets page.
October 28, 2013

November and December Meeting Dates

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure quorum. The updated schedule is available on the Dates page .
October 14, 2013

Updated Social and Behavioral Sciences Research Consent/Permission/Assent Examples and Research Plan Instructions

The Social and Behavioral Sciences (SBS) Research consent/permission/adolescent assent examples have been updated to include wording regarding reporting rules associated with child and elder abuse. The SBS Research Plan Application instructions have been updated to reflect this information as well (item 15). The updated examples and instructions can be found on the SBS Forms page.
October 14, 2013

Updated SOPP

Section 3.14, Protocol and Regulatory Violations and Exceptions, has been revised to provide definitions for Serious Non-compliance and Ongoing Non-compliance. The SOPP has also been updated to request additional information regarding previous protocol exceptions. The updated SOPP can be found on the SOPPs page.
October 1, 2013

New Fact Sheet, Oral History/Journalism Projects

A new Fact Sheet has been created regarding review of oral history/journalism projects. The new Fact Sheet can be found on the Fact Sheets page.
October 1, 2013

Updated Biomedical Research Consent/Permission/Assent Examples

The Biomedical Research consent/permission/assent examples have been updated to reflect wording regarding reporting rules and GINA/CALGINA. In addition, the provided Cost language should be used for all studies that involve billable events not only cancer studies. The updated examples can be found on the Biomedical forms page.
October 1, 2013

Updated Biomedical Research Application Research Plan Instructions

The Biomedical Research Application Research Plan instructions have been updated to add wording regarding a) procedures preparatory to research (item 11); waiver of assent (item 12); randomization and Standard of Care procedures (item 14); reporting rules (item 16); and provision of sponsor determination regarding IND/IDE (item 25). The updated Research Plan instructions can be found on the Biomedical forms page .
October 1, 2013

Updated SOPPs

Section 3.17, Advertisements, Recruiting Materials, and Procedures, and Procedures Preparatory to Research, has been updated to include wording regarding procedures preparatory to research. Section 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs, has been updated to more clearly describe OCTA and OCAA procedures as well as NCI CIRB and procedures preparatory to research. Section 4.2, Categories of Action, has been updated to more clearly describe procedures when the IRB requests the PI's response be reviewed by a convened IRB. Section 8.2, Definitions, has been updated to revise the definition for "Generalizable Knowledge" and "Systematic Investigation." The updated SOPPs can be found on the SOPPs page.
October 1, 2013

Scheduled Maintenance for HRPP Website

The HRPP website including e-IRB services will not be available to researchers and staff from approximately 7:00 am through approximately 7:00 pm, Thursday, December 26, 2013, and Friday, December 27, 2013. No uploading of document(s) or entering of information should occur during this time. Though it may appear the system will allow these functions to occur, any uploads or data entered will most likely be lost in the transition. Unfortunately, we will not be able to track lost documentation.
September 23, 2013

Updated HIPAA Authorization

As of September 23, 2013, newly enrolled participants who need to sign a HIPAA authorization must "opt-in" to allow the use of their PHI for optional sub-studies and future secondary use of PHI. The HIPAA authorization has been updated to include a checkbox to indicate the participant has agreed to this use. The updated HIPAA authorization should be used for all participants who require completing a HIPPA authorization and can be found on the Biomedical Forms page .
July 30, 2013

Updated IRB/HRPP Stamp-of-Approval

The IRB/HRPP stamp-of-approval has been updated to remove the Geisel Library logo replacing it with the current UC San Diego logo. The HRPP Office will use the updated stamp beginning August 1, 2013.
July 30, 2013

Updated SOPPs

Section 1.4, Documentation and Records Retention, and Section 3.2, Full IRB Review, have been updated to more clearly indicate how the IRB will be informed and advised of expedited actions including approval of research that is contingent on specific minor conditions that have occurred since the last IRB meeting. Section 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs, has been updated to more clearly note that projects that involve research-related radiologic procedures are not eligible for WIRB IRB oversight unless the procedures prescribe by the protocol are within the uses in the approved labeling of the radiologic device(s) and are used for standard of care procedures. The WIRB Facesheets have also been updated to reflect this revisions. The updated SOPPs can be found on the SOPPs page.
July 23, 2013

Updated Consent and Permission Samples

The UCSD Adult consent, and UCSD and RCHSD Parent permission samples have been updated to include revised "Cost" wording for cancer studies that involve billable events. The updated documents can be found on the Biomedical Forms page .
July 19, 2013

Updated SOPPs

Section 2.2, Member Appointment, Compensation, and Responsibilities, has been updated to reflect the duration of the IRB Chair's appointment. Section 3.14, Protocol and Regulatory Violations and Exceptions, has been updated to reflect procedures for a protocol exception to enroll an individual subject. Section 3.17, Advertisement, Recruiting Materials, and Procedures, has been updated to reflect procedures of using lotteries, raffles, and/or drawings to recruit or retain participants. The updated SOPPs can be found on the SOPPs page.
July 19, 2013

Updated Form and Fact Sheet

The Social and Behavioral Sciences Research Application Facesheets have been updated to include space to print the name of the Department Chair and the Faculty Advisor. The Fact Sheet, Submitting Advertisements/Recruitment Materials Related to a Research Plan (Protocol), has been revised to reflect procedures for using lotteries, raffles, and/or drawings to recruit or retain participants. The updated Facesheets can be found on the Social and Behavioral Sciences Forms page . The updated Fact Sheet can be found on the Fact Sheets page .
June 27, 2013

Scheduled Maintenance for HRPP Website

The HRPP website including e-IRB services will not be available to researchers and staff from 4:00 pm through approximately 7:00 pm, Friday June 28, 2013. No uploading of documents or entering of information should occur during this time. Though it may appear the system will allow these functions to occur, any uploads or data entered will most likely be lost in the transition. Unfortunately, we will not be able to track lost documentation. Therefore, we ask that you not use e-IRB services during this time. Please plan accordingly.
June 24, 2013

UC IRB Reliance Registry/UC MOU

A UCSD Investigator may apply for reliance on another UC campus or Lawrence Berkeley National Laboratory for IRB review or vice versa by means of a UC Memorandum of Understanding (MOU) agreement. The types of research covered by this agreement include human subjects as defined by federal and state statutes and regulations that is determined to be exempt or is eligible for IRB review and that a) will be a collaborative research effort between one or more of the UC campuses or Berkeley Lab; b) involves obtaining individually identifiable data or samples from one or more UC campuses or Berkeley Lab on which one or more other UC campuses or Berkeley Lab will conduct analyses; or c) involves obtaining samples that are not identifiable for research subject to oversight by the Food and Drug Administration (FDA). More information can be found at https://irb.ucsd.edu/UC-MOU.shtml .
May 31, 2013 (Updated June 13, 2013)

Additional Scheduled Maintenance for HRPP Website

The HRPP website including e-IRB services will not be available to researchers and staff from 7:00 am through approximately 4:00 pm, Saturday, June 15, 2013. No uploading of documents or entering of information should occur during this time. Though it may appear the system will allow these functions to occur, any uploads or data entered will most likely be lost in the transition. Unfortunately, we will not be able to track lost documentation. Therefore, we ask that you not use e-IRB services during this time. Please plan accordingly.
May 10, 2013

Updated Forms, "New" Consent Sample, and "New" Fact Sheet

The Biomedical and Social and Behavioral Application Facesheets have been updated. The updates include minor changes to Section 5, Funding, Funding Mechanisms regarding through whom study contracts are done. The "new" consent sample is for pregnant partner studies. And the "new" Fact Sheet provides information regarding timeframes for postapproval reporting of events, deviations, violations, incidents, updated study information, etc. The updated forms and new sample can be found on the Biomedical Forms page and Social and Behavioral Forms page . The new Fact Sheet can be found on the Fact Sheets page .
April 30, 2013

Updated Biomedical Research Samples

The Biomedical Research adult consent, the parent consent, and the adolescent assent samples have been updated. The samples have been updated to include wording that should be used when a project involves randomization and/or standard of care procedures. The updated wording is in the "What will happen..." and "What risks are associated..." sections of the consents/assent. The updated samples can be found on the Biomedical Research forms page .
April 16, 2013

New SOPP

A new SOPP has been created, section 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs. This SOPP provides information regarding the procedures for requesting oversight of specific UCSD research studies by non-UCSD IRBs, such as Western IRB and the National Cancer Institute Central IRB. The new SOPP can be found on the SOPPs page .
March 28, 2013 (Updated April 5, 2013)

Updated Scheduled Maintenance for HRPP Website

The HRPP website including e-IRB services will not be available to researchers and staff from 12:01 am through approximately 12:15 pm, Friday, April 5, 2013. No uploading of documents or entering of information should occur during this time. Though it may appear the system will allow these functions to occur, any uploads or data entered will most likely be lost in the transition. Unfortunately, we will not be able to track lost documentation. Therefore, we ask that you not use e-IRB services during this time. Please plan accordingly.
March 18, 2013

One-on-One Advising Sessions

The HRPP is introducing 15-minute, One-on-One advising sessions. These sessions will be done once a month and are designed for investigators, study staff, and students conducting research involving human subjects to obtain guidance from HRPP staff. For more information, please see the Training page .
March 1, 2013

Updated Fact Sheets

The Fact Sheets regarding advertisements/recruitment materials and amendments/modifications have been updated. The advertisements/recruitment materials Fact Sheet has been updated to reflect the updated SOPP, section 3.17. The amendment/modification Fact Sheet has been updated to more clearly indicate what documents/procedures are associated with submitting an amendment/modification including that the cover letter provided with the submission must be sent over the PI's signature. The updated Fact Sheets can be found on the Fact Sheets page .
March 1, 2013

New and Updated SOPPs

A new SOPP has been added, section 3.20, Confidentiality of Collected Specimens or Data. In addition, section 3.17, Advertisements, Recruitment Materials, and Procedures; and section 4.2, Categories of Action, have been updated. Section 3.20 includes guidelines and standards for maintaining confidentiality of specimens and data collected in a research study. Section 3.17 has been updated to include limits to information provided in advertisement/recruitment material and that lotteries, raffles, and/or drawing may not be used as these procedures provide inequitable compensation for subjects. Section 4.2 has been updated to provide additional procedures associated with deferred projects. The new and updated SOPPs can be found on the SOPPs page .
March 1, 2013

Updated Forms

The Biomedical Research and Social and Behvioral Sciences Continuing Review Facepages and Biomedical Research application Facesheets have been updated. The Facepages have been updated to include a request for additional information in Section 3, Study Participant Status, regarding the number of participants currently approved for enrollment by a UCSD IRB. This information is being requested in response to guidelines published by ORHP and FDA regarding continuing review evaluation of research progress including whether "enrollment is consistent with the planned number of subjects described in the IRB-approved protocol " and that a "marked difference between actual and expected rates of enrollment may indicate a problem with the research project that requires further evaluation including whether the research project is likely to provide sufficient data to answer the scientific question(s) being posed." The Facesheets have been updated to include "Yes/No" boxes to indicate whether a study involves event(s)procedure(s) billable to sponsor/insurance/subject (for more information contact the Office of Coverage Analysis Administration), and whether a study involves a partial waiver of individual HIPAA authorization. The updated forms can be found on the Forms page.
February 1, 2013

Updated SOPPs

The SOPPs, sections 1.1, 1.3, 1.5, 3.2, and 3.11, have been updated. In addtion, a new SOPP has been added, section 3.19. Section 1.1, Responsibility and Authority, has been updated to address projects that are exempt from IRB review and those involving an "outside" IRB that are associated with a Review/Rely agreement. Section 1.3, Review and Updating of SOPPs, has been updated to more clearly address the timing of review of SOPPs, the documentation of revised SOPPs and when SOPPs become effective. Section 1.5, UCSD Institutional Policies, has been updated to include that a copy of all responses to audits/letters of warning must be sent to the HRPP Office prior to or immediately following being sent to the regulatory agencies. Section 3.2, Full IRB Review, has been updated to more clearly indicate the focus of the Primary and Secondary Reviewer's review of Rapid-cycle projects. Section 3.11, Continuing Revew, has been updated to reflect that there can be six continuing review approvals before a project must be "re-submitted" for "full" review. And the new SOPP, section 3.19, Collaboration with other UCSD Committees, addesses procedures associated wth collaboration with the PRMC, HERC, the IRC, the ESCRO Committee and UCSD IRBs. The updated and new SOPPs can be found on the SOPPs page.
December 28, 2012

Simplified Procedures for Uploading Document Files

The procedures for uploading document files using e-IRB services has been simplified to remove one step. When uploading files, the selection of the file format is no longer required. In addition, ".DOCX," ".PPTX," and ".XLSX" files can now be uploaded.
December 20, 2012 (Updated December 27, 2012)

Scheduled Maintenance for HRPP Website

The HRPP website including e-IRB services will not be available to researchers and staff from Wednesday, December 26, 2012, 8:00 am through Friday, December 28, 2012, at approximately 8:00 am. No uploading of documents or entering of information should occur during this time. Though it may appear the system will allow these functions to occur, any uploads or data entered will most likely be lost in the transition. Unfortunately, we will not be able to track lost documentation. Therefore, we ask that you not use e-IRB services during this time. Please plan accordingly.
November 28, 2012
Secondary Use of Existing Data/Specimens Requires IRB Approval or Certificate of Exemption Reminder
Investigators and study staff are reminded that the secondary use of existing data/specimens including review of existing medical records, student records, accessing computer databases that have been produced from previous studies, etc., requires IRB approval or Certification of Exemption from IRB review. For more information about this, please see the HRPP Fact Sheet, Research Involving the Use of Existing Data/Specimens .
November 26, 2012

Holiday Schedule and Closure

Dear UCSD/VA Researchers and staff: In an August Campus Notice, the Office of the Executive Vice Chancellor-Academic Affairs and the Office of the Vice Chancellor-External and Business Affairs, notified the UCSD community that UC San Diego will officially close three (3) working days in December (December 26th, 27th and 28th). The HRPP will be closed between Saturday, December 22, 2012 and Tuesday, January 1, 2013, re-opening Wednesday, January 2, 2013. Please keep this in mind when preparing your IRB submissions. The IRB meeting dates are available here . On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays
November 2, 2012

IMPORTANT -- November and December Meeting Dates

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure quorum. The updated schedule is available on the Dates page
September 14, 2012

Updated SOPP and Biomedical Application Instructions

The SOPP, section 3.4, Informed Consent, and the Biomedical Application Instructions, items 16, Privacy and Confidentiality Considerations Including Data Access and Managment, and 25, Investigational Drug Fact Sheet and IND/IDE Holder, have been updated. The SOPP has been updated regarding consenting potential subjects who physically cannot talk or write (pages 4-5) and using electronic signature for obtaining written consent (page 9). The Instructions, item 16, have been updated to request additional information regarding protecting confidentilality of procedures and results associated with adolescents and provide a link for more information regarding minor consent in California (page 9). Item 25 has been updated to note that dispensing and administration of a test article must be done in accordance with all State and Federal regulations as well as UCSD Health System policies and provides a link to the UCSD policy (page 14). The updated SOPP can be found on the SOPPs page, and the updated Instructions can be found on the Biomedical Forms. The SOPP, section 3.4, Informed Consent, and the Biomedical Application Instructions, items 16, Privacy and Confidentiality Considerations Including Data Access and Managment, and 25, Investigational Drug Fact Sheet and IND/IDE Holder, have been updated. The SOPP has been updated regarding consenting potential subjects who physically cannot talk or write (pages 4-5) and using electronic signature for obtaining written consent (page 9). The Instructions, item 16, have been updated to request additional information regarding protecting confidentilality of procedures and results associated with adolescents and provide a link for more information regarding minor consent in California (page 9). Item 25 has been updated to note that dispensing and administration of a test article must be done in accordance with all State and Federal regulations as well as UCSD Health System policies and provides a link to the UCSD policy (page 14). The updated SOPP can be found on the SOPPs page, and the updated Instructions can be found on the Biomedical Forms page.
August 29, 2012

Scheduled Maintenance for e-IRB Services

The HRPP website including e-IRB services will not be available to researchers and staff on Friday, September 7, 2012, from about 2:30 pm until about 6:30 pm. No uploading or entering of information should take place during this time. Though it may appear the system will allow these functions to occur, any uploads or data entered will most likely be lost. Unfortunately, the HRPP Office will not be able to track lost documentation. Therefore, please do not use e-IRB services during this time period. Please plan accordingly
August 24, 2012

Updated SOPPs

The SOPPs, sections 3.14; 3.15; and 4.2 have been updated. Section 3.14, Protocol and Regulatory Violations, has been updated to include that minor violations may be reported to the IRB at the time of continuing review and major violations must be reported within 10 working days of awareness of event. Examples of major and minor violations are also provided. Section 3.15, Radiation Exposure and Radioisotopes, has been updated to include that projects, including their amendments, involving radiation exposure at UCSD and VASHSD facilities will be referred for review by the radiation safety committees of UCSD and VASHSD, as appropriate to the site where the research will be conducted. Section 4.2, Categories of Action, has been updated to include that a response will require review by a convened IRB if the response substantively alters/affects risk/benefit to subject; equitable and non-coercive selection/recruitment of subject; privacy and confidentiality; process and documentation of consent/assent; and/or additional safeguards for vulnerable subjects. These updated SOPPs can be found on the SOPPs page.
August 24, 2012
Submitting Documents to the IRB/HRPP Reminder
The IRB/HRPP does not accept study-related documents by e-mail. All documents must be uploaded to the appropriate project number through "My Protocols at a Glance" using e-IRB services on the HRPP website or may be provided hard copy only if the document requires the signature of the PI, Department Chair and/or Submitter. Or if a copy of the stamped, approved consent/assent that is currently in use is being provided for Continuing Review. If the PI has appropriate means to convert each document into a PDF, such as a document scanner, then each document can be submitted via the web.
July 31, 2012

Updated Fact Sheet and Form

The fact sheet regarding Human Subject Protection Training has been updated to indicate what projects may be subjected to should the PI and key personnel not complete required human subject training as well as that completion reports no longer need to be submitted to the IRB/HRPP unless requested. In addition, the Social and Behavioral studies Continuing Review Facepages have been revised to include that the PI's signature also certifies that the PI and key personnel have completed the appropriate CITI training. This certification is already a part of the Biomedical Research Facepages. The updated fact sheet can be found on the Fact Sheet page and the updated form can be found on the Social and Behavioral Research Continuing Review Forms page.
July 23, 2012

Updated SOPPs, Forms, and Q & A from IRB Townhall

The Spanish version of the UC systemwide HIPAA authorization has been updated to provide a more current version of this translated document. In addition, SOPP, section 3.9, Exemption from IRB Review, has been revised to remove the exclusion criteria regarding review of medical records. And a document providing questions and answers from the recent IRB townhall meeting is now available. The updated Spanish version of the HIPAA authorization can be on the Biomedical Forms page, the updated SOPP can be found on the SOPPs page, and the Q & A document can be found here.
July 2, 2012

Updated VA Forms

The VA sample informed consent and VA-specific HIPAA authorization forms have been updated. The consent form has been updated to correct the phone number of the VA Regional Counsel. The authorization revisions include revision to the copy page, protocol, and PI name to the footer and added definitions of "used" and "disclosed." These updated forms can be found on the Biomedical Research Forms page.
June 6, 2012

Updated and New Examples

The consent examples for both Biomedical and Social and Behavioral studies have been updated. In addition, "new" examples of parent consent and adolescent and child assents for both Biomedical and Social and Behavioral studies are also now available. The updated and new examples can be found on the Forms page.
May 11, 2012

Updated SOPP

SOPP, section 4.2, Categories of Action, has been updated to more specifically define the four categories of action an IRB can take when reviewing research, and the procedures regarding the review of responses to Committee requests. These procedures include that if the response alters/affects risk/benefit to subject; equitable and non-coercive selection/recruitment of subject; privacy and confidentiality; process and documentation of consent/assent; and/or additional safeguards for vulnerable subjects, the response will be placed on an agenda for review at the next appropriate IRB meeting. This SOPP can be found on the SOPPs page.
April 23, 2012

Updated Forms and SOPP

The Narrative Summary of Progress to Date for both Biomedical and Social and Behavioral studies has been revised include a separate section to more clearly provide a summary of any subject complaints since the last IRB review. In addition, SOPP, section 3.4, Informed Consent, page 5, has been updated to include ClinicalTrial.gov wording required by the FDA for applicable trials. The revised forms can be found on the Forms page. The updated SOPP can be found on the SOPPs page . More information about the required FDA wording can be found here .
March 27, 2012

Updated Form

The Biomedical Standard Application Facesheets have been revised to include an additional Yes/No checkbox to indicate whether the study will recruit potential participants using ResearchMatch. The updated form is available on the Forms page.
February 17, 2012

IRB/HRPP Website

The IRB/HRPP website is experiencing some intermittent connection problems. We are currently working on solutions to these problems and apologize for any inconvenience this may cause. Thank you for your patience
February 17, 2012

IRB/HRPP Website

The IRB/HRPP website is experiencing some intermittent connection problems. We are currently working on solutions to these problems and apologize for any inconvenience this may cause. Thank you for your patience.
February 3, 2012

Updated SOPP

SOPP, section 3.10, Expedited Review, has been updated to include additional information regarding expedited review of sponsor provided annual reports and DMC/DSMB reports. This SOPP can be found on the SOPP page.
January 31, 2012

Updated SOPP

SOPP, section 3.2, Full IRB Review, has been updated to include procedures for rapid-cycle review of adult Cancer Cooperative group trials reviewed by the National Cancer Institute (NCI) Central Institutional Review Board (CIRB). This SOPP can be found on the SOPP page.
January 17, 2012

Additional FDA-required consent wording

Additional wording regarding a statement informing participants about the ClinicalTrial.gov trial registry for applicable clinical trials must be included in the consent of applicable trials initiated on or after March 7, 2012. For more information, please see the FAQ, Frequently Asked Questions--FDA Final Rule: Clinical Trials.gov Consent Wording.
January 17, 2012

Updated and new SOPPs

SOPP, section 3.15, Radition Exposure and Radioisotopes, has been updated to include that HERC approval may be obtained before, during, or after application to the IRB; the IRB has final approval of the wording regarding human subject radiation exposure in the consent/assent document(s); and wording regarding review documentation provided to the IRB by HERC. In addition, a new SOPP has been created, section 3.18, Review of Subject Complaints/Concerns/Questions. This section provided procedures for both the PI and the IRB/HRPP when a Subject has a complaint, concern, or question. These SOPPs can be found on the SOPP page.
November 28, 2011

Change In Fee Schedule For Commercially-Sponsored Clinical Trials

For projects submitted after January 1, 2012, there will be a change in the fee schedule for IRB review of commercially-sponsored clinical trials to reflect a flat rate of $2150 for an initual review and $2150 for each 7-year resubmission review (treated as a "new" projecct by the IRB) and $500 for each annual continuing review. For more information about this, please see the HRPP Fact Sheet "Institutional Review Board (IRB) Fees for Commercially-Sponsored Projects" located here.
November 2, 2011 (Updated December 15, 2011)

The HRPP has moved

The HRPP Office has moved to the first floor of the "new" East Campus Office Building (ECOB). For our updated contact information, please see the Contact Us page.
October 7, 2011

Important--November and December 2011 Meeting Date Changes

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure meeting quorum. The udated schedule is available on the Dates page.
August 19, 2011

FAQ-Common Qs

Ever wanted to know what "Expedited Review" means? Do you know what the specific requirements for font and font size for consent/assent and recruitment documents are? What do all those red boxes on the application Facesheets mean? Answers to these and other questions can be found on an HRPP FAQ available here.
August 11, 2011

Updated Forms

The Application Facesheets for both Biomedical and Social and Behavioral studies have been revised to include an additional Yes/No checkbox to indicate whether the study will recruit non-English speaking individuals. Also, the Biomedical Research Plan instructions, item 10, and the "Supplement to Application Plan for Research Involving Pregnant Women, Neonates, and/or Human Placenta or Fetal Material" have been updated to more clearly address the involvement of women of child-bearing potential in VA studies. In addition, the VA 10-1086 form, items 12 and 14, has been updated, as well as the VA HIPAA Authorization with an additioinal paragraph on page 2, to include wording regarding privacy/confidentiality and coding/storage of specimens. These updated forms and documents are available on the Forms page.
August 2, 2011

Updated SOPP

Section 3.9 of the UCSD HRPP Standard Operating Policies and Procedures has been revised. Revisions to the updated SOPP include that research that does not qualify for IRB exemption at UCSD includes research that requires review by the UCSD Embryonic Stem Cell Research Oversight (ESCRO) Committee. The revised SOPP can be found on the SOPPs page.
June 8, 2011

Fix for Problems with Internet Explorer and the HRPP Website

If you are having problems opening pages/submitting documents on the HRPP web site, please see these instructions.
May 17, 2011

Updated Forms

The Biomedical Research Plan application and instructions have been updated. Revisions include a request for no more than one paragraph for the lay language summary/synopsis; addition of a supplement form for studies involving pregnant women, neonate, and/or human placenta and fetal material; and clarification to requested information regarding the background and signficance and preliminary studies. A document outlining revisions made to the Research Plan has been created. In addition, the VA 10-1086 form has been updated. These updated forms and document are available on the Forms page.
May 17, 2011

Updated SOPP

Section 3.4 of the UCSD HRPP Standard Operating Policies and Procedures has been revised. Revisions to the updated SOPP include that a witness signature is not required unless requested by the IRB such as when using short form consent procedures; clarification of procedures and documents required for using short form consent; and clarification of procedures for obtaining consent from individuals who cannot read or speak English or who are illeterate. The revised SOPP can be found found on the SOPPs page.
April 1, 2011

Updated Forms

The Biomedical Continuing Review Facepages; Biomedical Narrative Summary of Progress; Biomedical Study Closure/Withdrawal Facepages; VA 10-1086 Form; and VA-specific HIPAA authorization have been updated to comply with updated VA handbooks and guidelines. These updated forms can be found on the Forms page.
March 29, 2011

IRB Web Site Not Available

Sunday, April 3, 2011, from approximately 12:00 noon to 6:00 pm, maintenance will be done on the building in which the HRPP Office is located. While the maitenance is being done, the IRB web site will not be available. We apologize for any inconvenience this may cause. Please plan accordingly.
March 22, 2011

New HRPP Office Hours

The HRPP Office will now be open from 7:30 a.m to 4:00 pm. The Experimental Subject's Bill of Rights, both the English and Spanish versions, have been updated to reflect this change and are available on the Forms page.
March 8, 2011

Amendment/Compliance Reminde

The Department of Health and Human Services has notified UCSD that at least one UCSD IRB-approved research protocol was out of compliance with IRB-approved procedures. We remind all faculty and research staff that federal rules require IRB review and approval of all proposed changes in reseach activity prior to initiation of such change, except when necessary to eliminate apparent immediate hazard to subjects. Conducting research procedures without IRB approval can negatively impact the rights, welfare, and safety of human subjects who participate in research at this Institution. Any modification to an approved protocol must be reviewed and approved by the IRB prior to implementing the change, regardless of the nature of the modification. It is strongly recommended that faculty responsible for ongoing human subject research at UCSD discuss this requirement with your research staff and conduct periodic audits of your approved protocols to ensure compliance. Instances of non-adherence to IRB-approved protocols must be rectified and reported to the IRB immediately. Please remember, research compliance is a shared responsibility
February 2, 2011

Revised SOPP

Section 2.2 of the UCSD HRPP Standard Operating Procedures and Polices (SOPP) has been revised. This revised SOPP can be found on the SOPPs page.
January 12, 2011

Revised SOPPs

Sections 1.1, 1.4, 2.1, 2.2, 3.1, 3.2, 3.3, 3.5, 3.7, 3.8, 3.9, 3.10, 3.11, 3.13, 5.2 and 8.2 of the UCSD HRPP Standard Operating Procedures and Policies (SOPPs) have been revised. These revised SOPPs can be found on the SOPPs page
January 4, 2011

Updated Forms

The Research Plan and the Instructions for the Research Plan and Narrative Summary of Progress for both Biomedical and Social and Behavioral studies; the Supplement for Research Involving Prisoners; and the Investigational Drug Fact Sheet have been updated to provide information now required to comply with Federal and accreditation guidelines. Because substantial changes have been made to the Biomedical Research Plan and Instructions, a document outlining these changes has been created. This document and these updated forms can be obtained on the Forms page
January 3, 2011

Life Span of Projects Increased

As of January 1, 2011, the life span of a project has been increased from 4 years (i.e., up to 3 cycles of Continuing Review after initial approval) to 7 years (i.e., up to 6 cycles of Continuing Review after initial approval). The PI is reminded that continuing review documents must be submitted to the HRPP approximately 45 days prior to the project expiration date (365 days from the initial approval or as outlined in the approval letter) to ensure that there is no lapse in study approval.
November 12, 2010

New "DoD/DON-funded Research" fact sheet:

A fact sheet regarding projects with funding support from DoD/DON including policy for review and information required for review can be found here.
November 12, 2010

Updated Form

he UCSD Sample Informed Consent has been updated to reflect current wording for projects that involve radiation exposure. The updated document can be found here.
October 29, 2010

IMPORTANT--November and December 2010 Meeting Date Changes

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure meeting quorum.
October 20, 2010

IRB Web Site Not Available

Satuday, October 23, 2010, from 3:00 pm to approximately 9:00 pm, maintenance will be done to the building in which the HRPP Office is located. During the time of this maintenance, the IRB web site will not be available. We apologize for any inconvenience this may cause. Please plan accordingly.
October 7, 2010

Web Site Not Available

Sunday, October 10, 2010, from 5:00 am to approximately 8:00 pm, Administrative Computing & Telecommunications (ACT) will be upgrading the network and telephone services in the buildings where the HRPP Office is housed. During the upgrade, the IRB web site will not be available. We apologize for any inconvenience this may cause. Please plan accordingly.
September 10, 2010

Updated Forms

The Standard Facesheets as well as the Continuing Review Facepages and Study Closure Facepage for both Biomedical and Social and Behavorial Studies have been updated. In addition, a Fact Sheet noting the major changes to the Facesheets has also been provided. These updated forms can be obtained on the Forms page.
August 26, 2010 (Updated June 8, 2011)

Fix for problems with Internet Explorer and the IRB web site

If you are having problems opening some pages on the IRB web site, please see these instructions.
June 30, 2010

Submission due dates no longer used

The HRPP will no longer use "submission due dates" in association with the review of materials submitted. More information can be obtained here.
June 3, 2010

Updated VA 10-1086 form

An updated version of the VA San Diego Healthcare System 10-1086 form (VA consent form) is now available along with a "tips sheet" about completing the form. These documents can be found here and here and on the Forms page.
May 25, 2010

SDSU/UCSD Agreement for Joint Faculty Protocol Review

When faculty from both SDSU and UCSD jointly conduct a research study involving human subjects, the study must receive approval from each institution's Institutional Review Board in advance of initiating research. We are pleased to announce that an agreement is in place for a cooperative review of research protocols involving SDSU/UCSD faculty. More information about the agreement and procedures for submitting an application can be found here.
March 25, 2010 (Updated August 10, 2011)

HRPP Push-2-Paperless (P-2-P)

The HRPP is proud to announce the HRPP P-2-P. As of July 14, 2010, the HRPP Office, with a few specific exceptions, will not accept hard copy documents. For more information, please see the P-2-P FAQ that is available here.
December 7, 2009

Power Outage

Due to circumstances beyond our control, the building where the IRB server is located had a power outage today from approximately 4:20 pm to 5:35 pm on Monday, December 7, 2009. We regret any inconvenience this may have caused.
November 2, 2009

Updated Forms

The Biomedical Standard Facesheets, the Continuing Review Facepages, the Continuing Review Narrative Summary of Progress; and the Study Closure/Withdrawal Facepages and Narrative Summary of Progress at Study Closure for both Biomedical and Social and Behavioral studies have been updated to collect additional information requested by OHRP; FDA; the University of California, Office of the President; and HRPP-collaborating offices. The additional information requested on the Facesheets includes whether a study is associated with an FDA-regulated product(s), who holds the IND, and more specific information regarding study funding support. The additional information requested on the Facepages and Narratives is regarding Adverse Events of any type. The updated forms can be found here.
October 12, 2009

New Social and Behavioral Sciences Project "Standard" Application Available

For more information about submitting the complete application electronically, please see the instructions provided here and on the application face sheet that can be obtained here.
October 8, 2009

Furlough Plan May Cause Delays

Because of the UC Systemwide furlough plan that is currently in effect, there may be delays in review/response of documents submitted to the HRPP. The HRPP has initiated a plan to prioritize submissions to ensure participant safety and well being and best serve our investigators. We apologize for any delays the furlough plan may cause and appreciate your understanding and support during these challenging times.
July 31, 2009

New Procedures and Forms for Study Closure/Withdrawal

New procedures for closing/withdrawing a study can be found here.
July 17, 2009 (Updated October 2, 2009)

Updated--New UCSD HRPP Human Subject Protection Training Required

For more information, please see the fact sheet, "Introduction of New Training for Human Research Protections Collaborative Institutional Training Initiative (CITI) Programs" available here.
July 15, 2009

As a reminder

please ensure that complete continuing review materials are submitted approximately 45 days prior to expiration (check the most recent approval letter) to avoid any lapse in approval or the need to submit a NEW application should the study's approval expire. Also, if there is no lapse in approval, a study may receive up to 4 IRB reviews. A study may undergo an Initial and 3 Continuing Reviews. Please check the status of the study carefully before submitting Continuing Review materials.
July 10, 2009 (Updated July 15, 2009)

New Regulations Regarding IRB Registration

The FDA and OHRP have recently added new regulations regarding registration of IRBs. More information about these new regulations can be obtained here.
March 5, 2009 (Updated April 2, 2009)

New "Medical Device" Fact Sheet

A new fact sheet regarding projects associated with medical devices including policy for review and information required for review can be found here.
February 6, 2009

Exemption from IRB Review Application

More information about projects that may be exempt from IRB review at UCSD can be found here.
January 26, 2009

Updated Form and Fact Sheet

The form, Continuing Review Narrative Summary of Progress to Date, has been updated to include an additional section to report adverse events (non-URPs) at this site to the IRB. This updated form can be found here . In addition, the fact sheet, Submitting an Amendment/Modification to a Research Plan (Protocol), has been updated including a more specfic description of information required in association with an amendment request. The updated fact sheet can be found here .
September 19, 2008

SDSU/UCSD Agreement for Joint Doctoral Program Research Review

The students enrolled in a SDSU/UCSD Joint Doctoral Program (JDP) who plan to involve human subjects in research are required to obtain approval from both the SDSU and UCSD Institutional Review Boards in advance of initiating research. We are pleased to announce that an agreement between SDSU and UCSD is now in place allowing for a cooperative review of research protocols involving SDSU/UCSD JDP students. Under this agreement, one campus will serve as the "reviewing" IRB and the other as the "relying" IRB. More information about this agreement and application submitting procedures can be found here .
September 19, 2008

Pre-screening of all "new" applications

As of September 24, 2008, the HRPP will be pre-screening all new applications submitted for review. This pre-screening is designed to comply with federal rules by ensuring the documentation necessary for an accurate and thorough review of the application is obtained prior to the IRB review. As noted in a prior announcement, incomplete applications will not be placed on an IRB meeting agenda. HRPP staff will notify PIs of incomplete submissions and provide information regarding missing documentation. When an application is found to be complete, it will be assigned to the next appropriate IRB meeting. It is important to note that incomplete applications cannot attain final approval by the IRB. A copy of the IRB pre-screening form can be found here .
Contact the Human Research Protections Program Office