About HRPP Contact Us Dates Fact Sheets e-IRB Services Forms Guidelines Links News Public Notices Research Directory School of Medicine SOPPs Training UCSD Home Page

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. (Released 01/17/12) 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. (Released 11/2/11; Updated 12/15/11) 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. (Released 08/19/11) 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. (Release 2/17/12) 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. (Released 11/28/11) Amendment/Compliance Reminder: 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. (Released 03/08/11) 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. (Released 10/7/11) 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. (Released 08/11/11) 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. (Released 08/02/11) 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. (Released 05/17/11) 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. (Released 05/17/11) 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. (Released0 6/08/11) 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. (Released 4/1/11) 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. (Released 3/22/11) 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. (Released 2/2/11) 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. (Released 1/12/11) 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. (Released 1/4/11) 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. (Released 1/3/11) 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. (Released 3/29/11) 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. (Released 11/12/10) Updated Form: The UCSD Sample Informed Consent has been updated to reflect current wording for projects that involve radiation exposure. The updated document can be found here. (Released 11/12/10) 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. (Released 9/10/10) 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. (Released 6/30/10) 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. (Released 6/3/10) 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. (Updated 8/10/11; Released 3/25/10) 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. The updated schedule is available here. (Released 10/29/10) 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. (Released 8/26/10, updated 6/8/11) 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. (Released 10/20/10) 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. 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. (Released 5/25/10) 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. (Updated 10/2/09; Released 7/17/09) 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. (Released 10/8/09) New Procedures and Forms for Study Closure/Withdrawal: New procedures for closing/withdrawing a study can be found here. (Released 7/31/09) 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. (Released 11/2/09) 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. (Released 10/12/09) 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. (Released 3/5/09; Updated 4/2/09) Exemption from IRB Review Application: More information about projects that may be exempt from IRB review at UCSD can be found here. (Released 2/6/09) 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. (Released 12/7/09) 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. (Released 7/10/09; updated 7/15/09) 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. 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. (Released 1/26/09) 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. (Released 9/19/08) 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. (Released 9/19/08) HRPP announces new guidelines for reporting adverse events to the IRB. Investigators often engage in a popular strategy of over-reporting and relying in the IRB triage mechanisms for deciding what reports go to convened meetings. OHRP notes that because most individual adverse events (AEs) do not appear to represent unanticipated problems, the vast majority of AEs do not need to be reported to the IRB. UCSD's HRPP has revised its Standard Operating Policies and Procedures in response to recent guidance provided by OHRP, the FDA and the VA Office of Research Oversight. Guidance for Prinicipal Investigators and research staff when reporting unanticipated problems or adverse events to the IRB is provided in this fact sheet. VA Privacy and Data Security Plan. VA investigators are now required to include procedures in their Research Plans for ensuring safety and security of VA research data. Guidelines and recommendations for this VA requirement can be found here. Hybrid Consent Information Update. The VA R&D review process is currently undergoing a transition and that office has contacted researchers directly. As a result of the changes in process, studies including both UCSD and VA sites and/or investigators may be affected. Therefore, during this period, it has been determined that it may be best for researchers to continue to submit separate UCSD and VA/VMRF consents rather than use the newly proposed VA hybrid consent when submitting NEW applications for IRB review. In addition, institutional contractual agreements (such as clinical trial agreements or CTAs) may differ between institutions that can impact consent language. A review by these offices of the proposed hybrid consent is underway. Please note: should you already have an approved hybrid consent, continued use is acceptable at this time through the expiration period until further notice. Change in fee schedule for commercially sponsored clincial trials. As of September 1, 2008, there will be a change in the fee for IRB review of commercially sponsored clinical trials to reflect a flat rate of $1600 for an initial review and $1600 for each 4-year "re-submission" (treated as a "new" project by the IRB) review and $400 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. Beginning June 15, 2008--New Requirements for VA Human Studies. VA investigators have been notified by the ACOS R&D (memo dated 5/28/08) that in order to ensure that all VA-related research projects undergo R&D Committee review, the R&D Committee has required that an R&D application be initiated prior to IRB review and that a receipt of that application accompany the IRB application. A fact sheet detailing this requirement and outling the "VA Receipt of Review Request" form is available here. The VA has stated that this may appear to create additional burdens in the application and approval process for studies; however, the intent is to coordinate reviews by both the IRB and the R&D Committee and to allow processes to proceed in parallel where possible. Pediatric IRB Information. The Pediatric IRB "D" Committee was launched in May 2007. As announced, IRB submissions involving children and adolescents will be assigned to this Committee because of expertise. As the "D" Committee only meets once per month, please ensure careful review of due dates and meeting dates to avoid significant delay or any lapse in approval. (In general, no research may be conducted if a protocol has been allowed to expire.) The meeting due dates can be found here. Senate Bill 13 requires that the Health and Human Services Agency's Committee for the Protection of Human Subjects approve scientific research proposals before state agencies are permitted to disclose personal information to researchers. If the proposed research involves this type of data, this fact sheet provides background information. The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) has provided new guidance to Institutional Review Boards for the review of information provided to potential research subjects through clinical trial websites. This guidance describes the circumstances for which IRB review of clinical trial websites is both required and not required. Websites, along with print and broadcast advertisements, are commonly used by investigators and institutions to recruit research subjects. Details here... The International Committee of Medical Journal Editors (ICMJE) that represents major journals now requires that clinical trials be registered in a publicly accessible trials' registry. Details here... Effective January 1, 2005, the maximum project lifespan for IRB study numbers (protocol numbers) will be up to four review periods rather than two.  Federal regulations require Continuing Review by the IRB at intervals that will avoid lapses in approval and are not more than than 365 days post initial/continuing review approval. An online Continuing Review submission process is available via the e-IRB My Protocols at a Glance service.  Should you not have access to that e-IRB, the fillable forms are also available at http://irb.ucsd.edu/forms.shtml. Projects extending beyond the initial review period (up to 365 days) will be eligible for up to three cycles of Continuing Review.  (November 28, 2004) Revised Guidelines for Studies involving Placebo in High Risk Patients with Psychiatric Illnesses (November 4, 2004) Public Notice of UCSD researchers' plans to test a blood substitute for treatment of life-threatening injury.  Details here... (7/23/03) HIPAA (Health Insurance Portability and Accountability Act of 1996) requirements for research become effective April 14, 2003. Details here... New California law on use of State Death Records for Research effective January 1, 2003, requires IRB review of projects that will use decedent records. (1/27/2003) New procedures  for Surrogate Consent became law in California, and will affect any project that uses a "Legally Authorized Representative" signature line in its informed consent documents. (1/10/2003)  More... Final Guidelines for determining Decision-Making Capacity of study participants have been developed by a UCSD Task Force. Decisional Making Capacity assessment will be a component of many projects that employ Surrogate Consent. See details here.  (1/10/2003) An "almost paperless" online project submission and review, the "e-IRB" for new project submissions, is now available. (6/11/2002)