News

July 3, 2021: In preparation for the July 7 launch of Kuali IRB, two buttons now appear in the top right of our website, one for the legacy e-IRB Services and one for Kuali IRB. Please see this matrix for guidance about which system to use during the yearlong rolling transition. We have also de-activated links to the various forms for new submissions throughout our website; please do not use any copies of these forms that you might have retained locally. e-IRB Services remains active for responses, amendments, reports, continuing reviews and closures related to existing studies. Submissions for new studies will only be accepted in Kuali IRB. Please see the May 22 news item below for links to additional information about the Kuali IRB project.

June 14, 2021: As part of our customer support for the upcoming launch of Kuali IRB, we have gone live with the ServiceNow ticketing system already used by units across UC San Diego.

When you send an e-mail to our general or reliance addresses or when you leave a voicemail at our general contact number, a ticket will be automatically generated. For e-mails, you will receive a confirmation of the ticket. This confirmation does not require any action on your part.

ServiceNow does not change how you can get in touch with us, it simply helps us better route and track your questions. Our goal is not just to promptly take care of your question, but to make sure we are actively identifying patterns and getting information or solutions out to everyone who might have similar questions.

You also now have the option of opening a ticket at https://support.ucsd.edu/research without sending an email or calling us. That page will become the home for IRB-related Knowledge Base articles as we update our guidance and frequently asked questions.

May 22, 2021

Changes Are Underway — Stay Informed! We are preparing to go live with the Kuali IRB system (July 7, 2021) and to roll out other exciting changes to our program over the coming months, including a new identity as the Office of IRB Administration (OIA)! Instead of remembering to check this space and the Kuali IRB project pages, sign up now at the links below to have the updates you want delivered to your inbox:

Sign up for Kuali IRB Project Updates to stay up-to-date with the Kuali IRB rollout.
Sign up for Human Research News to stay up-to-date with policy and process changes and other occasional announcements from us.

We appreciate that you are inundated with emails. Although we will make a number of announcements on each list over the next 3 to 4 months, be assured that by the end of the year we will have deactivated the Kuali IRB list and settled into a calmer pace with the Human Research News list. Finally, if you haven't kept up with the Kuali IRB rollout don't panic! July 7 will mark the start of a yearlong transition period. Now is the time to catch up if you:

Expect to submit new projects for review this summer
Will need to renew existing projects that expire in September or October

To refresh yourself (or to get caught up), take a quick look at both the Kuali IRB Project Page and the Kuali IRB Updates distributed so far. This matrix breaks down when to use Kuali IRB and when to use the legacy e-IRB Services during the transition period. If you won't be submitting new projects or renewals until this fall (or beyond), you can learn more now or check in with us later. Information and training will continue to be available after go-live.

October 29, 2020: Please note the following regarding HRPP/IRB operating schedules in November and December. Please keep these adjustments in mind when preparing IRB submissions. As always, IRB meeting dates are available here . For information about handling urgent changes or emergency use of investigational products without IRB approval, please see the end of this message.

On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!

November 26-27: UC San Diego, including the HRPP Office, will be closed for the Thanksgiving holiday and will re-open Monday, November 30.

December 24-January 1: UC San Diego, including the HRPP Office, will be closed for winter holidays and will re-open Monday, January 4, 2021.

Note: You may implement changes to research to eliminate an apparent immediate hazard to a subject without obtaining prospective IRB approval. Changes made in those circumstances must subsequently be reported to the IRB.

You may make emergency treatment use of investigational products according to the appropriate instructions for drugs or devices (including permission from the FDA as required). Links to consent templates are included in these guidance documents. Such emergency uses must be reported to the IRB within 5 days.

May 22, 2020: For study teams preparing COVID-19-related clinical trials, please note that UC San Diego Health has established the COVID-19 Clinical Trials Review Committee (CCTRC). Clinical trials falling under the purview of the CCTRC must be approved by that committee before submission for IRB review.

Any new submission to the HRPP of an applicable clinical trial must include documentation of CCTRC review in order to continue through the IRB review process. This includes trials that will be reviewed by an external IRB (such as a commercial IRB or the IRB of a collaborating site).

The HRPP and the IRBs appreciate the urgency of COVID-19-related clinical trials and we are working with the CCTRC to coordinate our processes. This new step will improve study initiation by allowing the IRB to focus on its core responsibilities. This ultimately best serves our shared responsibility to protect UCSD patients and research subjects.

For more information about the CCTRC, its application form, and administrative contacts for questions, please visit the COVID-19 page on Pulse (AD login required), go to “Clinical Care Resources” and then expand the “Clinical Trials” section.

April 29, 2020: A clarfication memo is available addressing questions and concerns about how the IRB database calculates and displays expiration dates and how approval and expiration are explained in IRB procedures and approval letters, all further complicated by the 2019 leap year. Despite the confusion, the UCSD IRB does conduct continuing reviews at intervals required by regulation.

This memo can be provided to sponsors or attached as a Note to File. We apologize for the inconvenience and confusion.

April 14, 2020: New forms have been created for studies that only propose the secondary use of data, records, or biospecimens. Secondary Use means the data/records/biospecimens to be used are/were initially collected for a purpose other than the proposed research. These forms are to be used regardless of the expected level of review. They replace both the Exempt Category 4 and Existing Medical Record Review forms. The new forms can be found here .

April 14, 2020: The HRPP/IRB will no longer acknowledge the submission of a completed “Cover Letter for Request Change/Modification to an Approved Study – Key Personnel Changes Only” form. Submitting the form or a copy of the signed delegation log with additions/removals highlighted will be considered sufficient to inform the IRB/HRPP of key personnel changes associated with the study. The HRPP database will be updated as soon as possible following the submission of the form/log. More information can be found here.

March 13, 2020 (Updated March 18, 2020): The latest guidance information, updated March 18, 2020, regarding Coronavirus (COVID-19), the UCSD IRB, and human research studies can be found at https://irb.ucsd.edu/IRB-COVID-19-Guidance.pdf . Additional updates, as needed, will be posted on this website.

January 6, 2020: Principal Investigators that have started new federally supported multisite projects since January 21, 2019 or are planning new proposals for such projects should especially be aware of the new requirement regarding single IRB (sIRB) review. More information about this requirement can be found here . For additional assistance, please contact the HRPP Office at irbrely@ucsd.edu .

December 6, 2019: 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 12:00 noon, Friday, December 20, 2019, to approximately 12:00 noon on Tuesday, December 24, 2019. We regret any inconvenience this may cause. Please plan accordingly.

November 15, 2019: Please note the following regarding HRPP/IRB operating schedules in November and December. Please keep these adjustments in mind when preparing IRB submissions. As always, IRB meeting dates are available here. For information about handling urgent changes or emergency use of investigational products without IRB approval, please see the end of this message.

On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!

November 18-20: Several members of the HRPP team are attending the annual conference for IRB professionals. Although emails, calls and submissions continue to be handled, you may experience delays during and immediately after this period. We appreciate your understanding and support for this important educational opportunity.

November 28-29: UC San Diego, including the HRPP Office, will be closed for the Thanksgiving holiday and will re-open Monday, December 2.

December 23-January 1: UC San Diego, including the HRPP Office, will be closed for winter holidays and will re-open Thursday, January 2, 2020.

Note: You may implement changes to research to eliminate an apparent immediate hazard to a subject without obtaining prospective IRB approval. Changes made in those circumstances must subsequently be reported to the IRB.

You may make emergency treatment use of investigational products according to the appropriate instructions for drugs or devices (including permission from the FDA as required). Links to consent templates are included in these guidance documents. Such emergency uses must be reported to the IRB within 5 days.

June 21, 2019: HRPP is making available an updated FWA statement letter. In addition to updating information, the letter now covers both UCSD and RCHSD and also addresses several common sponsor requests. This new content is intended to help UCSD and RCHSD PIs and Study Teams negotiate with sponsors about the standard HIPAA authorization for research or the standard consent language about treatment and compensation for injuries. To access the new letter, please see the About HRPP web page or click here .

January 19, 2019: On January 21, 2019, a number of changes to the Federal Policy for the Protection of Human Subjects (aka the Common Rule) are scheduled to take effect. At this time, the UCSD IRBs and HRPP will only apply these changes to federally supported research that will receive initial IRB approval or initial certification of exemptions on or after January 21, 2019. Additional information for these changes can be found here and specifically for changes associated with the consent process, see here.

December 6, 2018: UC San Diego, including the HRPP Office, will be closed starting Monday, December 24, 2018 and will re-open Wednesday, January 2, 2019. Please keep this in mind when preparing your IRB submissions. As always, upcoming IRB meeting dates are available here . On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!

Note: You may implement changes to research to eliminate an apparent immediate hazard to a subject without obtaining prospective IRB approval. Changes made in those circumstances must subsequently be reported to the IRB.

You may make emergency treatment use of investigational products according to the appropriate instructions for drugs or devices (including permission from the FDA as required). Links to consent templates are included in these guidance documents. Such emergency uses must be reported to the IRB within 5 days.

October 26, 2018: 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.

September 26, 2018: Shared ACTRI resources, including e-IRB Services, are experiencing intermittent network connection problems. If you are unable to connect, please wait 15 minutes and try again. IT staff are working to correct the issues and we apologize for any inconvenience.

September 14, 2018: Because of circumstances beyond our control, the ability to connect to the HRPP website was down from approximately 5:00 pm - 8:10 pm, Friday, September 14, 2018. We regret any inconvenience this may have caused.

July 19, 2018: The U.S. Office for Human Research Protections has announced a further 6-month delay of the Revised Common Rule. The changes are now expected to take effect on January 21, 2019. At this time the UCSD IRB/HRPP is reviewing its plans for implementing the changes. Please continue to monitor our website for upcoming announcements.

July 9, 2018: The 2018 Human Research Training Symposium: Navigating the Clinical Trial Process is rapidly coming up. The symposium will be held from 8 am until 12:30 pm on July 11 at Atkinson Hall - Qualcomm Institute. It's an opportunity to hear from and interact with the various units involved in the clinical trial life cycle. If you haven't yet registered, please do so with this Registration Form . Additional updates and details, such as shuttle schedules, are available by signing up for the listserv at http://mailman.ucsd.edu/mailman/listinfo/ctri-hrts-l . We look forward to seeing you there!

June 1, 2018: 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 3:00 pm, Friday, June 8, 2018, to approximately 12:00 noon on Saturday, June 9, 2018. We regret any inconvenience this may cause. Please plan accordingly.

May 9, 2018: A new Fact Sheet has been created titled, Expanded Access - Investigational Device . The updated Fact Sheet is titled, Investigator Initiated Clinical Trials/IND Applications . The new and the updated Fact Sheet provide updated information regarding expanded access investigational treatment including single patient treatment in both non-emergency and emergency situations. The Fact Sheets also provide links to sample treatment consent/permission/assent documents. The new and updated Fact Sheets can also be found on the Fact Sheets page .

April 26, 2018: Due to circumstances beyond our control, 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 5:00 pm to approximately 8:00 pm on Friday, April 27, 2018. We regret any inconvenience this may cause. Please plan accordingly.

April 24, 2018: Due to circumstances beyond our control, 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 7:00 pm to approximately 11:00 pm on Tuesday, April 24, 2018. We regret any inconvenience this may cause. Please plan accordingly.

March 19, 2018 (Updated May 4, 2018): The HRPP has made modifications for protocol review to improve efficiency. Please note there are "Rapid-Cycle Review" procedures available for Phase 2b, 3, and 4 industry-sponsored clinical trials. Also, non-federally funded research in the Expedited Category may receive a 3-year initial review approval. Additional changes include broader eligibility for non-federally funded Exempt Category research. The Amendment Request Cover Letter form , which has been available and demonstrated to improve communication with the HRPP Office, will be required for amendment submissions in April or submissions may be considered incomplete. For more information about Rapid-Cycle Review, please see SOPP, section 3.2 , page 6. A checklist for Rapid-Cycle Review can be found here . For more information about the 3-year initial review approval, please see SOPP, section 3.10 , page 3. A checklist for 3-year initial review approval can be found here . For more information about the broader eligibility for exempt category research, please see SOPP, section 3.9 , page 2. Also, longer approval periods for studies reviewed by a convened IRB will result from making the initial approval date based upon the "last touch" date rather the date of the first Committee review. In addition, there is a new Fact Sheet for NIH Issuing Certificates of Confidentiality (see Fact Sheets webpage and here ). And there is an additional FAQ, number 16, that addresses pregnant partners/pregnant participants (please see FAQs webpage ).

February 6, 2018: Two new Fact Sheets have been created. One Fact Sheet is regarding the NIH definition of a clinical trial. The other Fact Sheet is regarding the return of research and/or incidental findings. The Biomedical Facesheets have been updated to include an indication whether a study involves dual use research of concern (DURC) agents (more information about DURC agents can be found here ). The new Fact Sheets can be found on the Fact Sheets page. and the updated Facesheets can be found on the Biomedical Research Forms page. .

February 2, 2018 (Updated February 5, 2018): Due to circumstances beyond our control, the IRB website will be unavailable from approximately 5:00 pm until approximately 7:00 pm, Tuesday, February 6, 2018. We apologize for any inconvenience. Please plan accordingly.

January 29, 2018: There is still time to register for the February 27 and 28, 2018 Research Community Forum hosted by the Office for Human Research Protections (OHRP) and UC San Diego. The Forum is entitled, "Rethinking What's Ethical...Impact of New Technologies & Innovative Care." For more information, please see here.

January 10, 2018: Because of circumstances beyond our control, the ability to connect to the HRPP website was down from approximately 12:15 pm -3:15 pm, Wednesday, January 10, 2018. The cause appears to have been an outage at the SDSC datacenter. More information about the outage can be found here or here . We regret any inconvenience this may have caused.

December 22, 2017 (Updated January 18, 2018): An Interim Final Rule (IFR) has been announced that delays the effective date and general compliance date for the Final Rule to July 19, 2018. Additional information about the IFR can be found here . As noted previously, the Final Rule compliance and effective date was January 19, 2018, and the Final Rule was only effective for federally supported/conducted studies initially approved on or after that date. Researchers should continue to monitor and review the HRPP website to learn of "new" information regarding the IFR and changes in policies and procedures as they become operational.

December 18, 2017: 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 4:00 pm on Wednesday, December 27, 2017; Thursday, December 28, 2017; and Friday, December 29, 2017. We regret any inconvenience this may cause. Please plan accordingly.

December 2, 2017: In an October Campus Notice, the Office of the Executive Vice Chancellor-Academic Affairs and the Office of the Vice Chancellor and Office of the Vice Chancellor & Chief Financial Officer notified the UC San Diego Community that UC San Diego will officially close for seven (7) days during the 2017 holiday season. The HRPP will be closed between Monday, December 25, 2017 and Tuesday, January 2, 2018, reopening Wednesday, January 3, 2018. 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 31, 2017: The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.5 and 3.12 have been updated. Section 1.5, page 1, has been updated to revise wording regarding who can be a PI on a study. Section 3.12, page 2, has been updated to reflect the use of the Amendment Request Cover Letter form and the Cover Letter for Request Change/Modification - Key Personnel Change Only form. The updated SOPPs can be obtained on the SOPPs page

October 20, 2017: 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 .

September 11, 2017: The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.8 and 8.2 have been updated. Section 3.8 has been updated including wording regarding conflict of interest and who may serve as an IRB member (page 1). And section 8.2 has been updated to provide the definition of "Enrolled" and clarify the definition of "Generalizable Knowledge" (page 3). The updated SOPPs can be found on the SOPPs page.

July 17, 2017: Due to circumstances beyond our control, 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 to approximately 5:00 pm on Tuesday, July 18, 2017. We regret any inconvenience this may cause. Please plan accordingly.

June 26, 2017: The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.16, 3.17, 3.20, 4.2, and 5.2 have been updated. Section 3.16, page 4, has been updated to clarify wording regarding reuse and storage of data/specimens and agreements. Section 3.17, page 2 has added two additional items that cannot be part of advertisements. Section 3.20, page 3, has been updated include wording regarding data collection and participant withdrawal. Section 4.2, page 2, has been updated to include addition information regarding disapproval and page 4 has been updated to include additional information regarding review of response to a disapproved study. And section 5.2, page 1, has been updated to define suspension and termination and page 4 has been updated to include additional information regarding informing current participants and a termination or suspension. The updated SOPPs can be found on the SOPPs page .

June 14, 2017: The Biomedical Standard Application Facesheets have been updated. Specifically, the Project Title section has been updated to allow for the specific collection of the Sponsor's protocol number, if such a number is associated with the study. In addition, the Project Characteristics section has been updated to include an indication for the involvement of DURC agents. As noted on the form, for more information about DURC agents, please contact EH&S . The updated form can be obtained on the Biomedical Forms page and/or directly here.

June 13, 2017: The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.2, 3.10 and 3.13 have been updated. Section 3.2, page 1 has been updated to reflect "Convened" rather than "Full" IRB review, and page 14, the header has changed from "Approval and Documentation" to "Review and Documentation." Section 3.10, page 5, has been updated regarding review of modification required to secure approval. And section 3.13, page 2, has been updated to include two additional events that meet the definition of a UPR, that all UPRs will be reviewed by a convened IRB, and clarified that the UPR will be presented to the IRB by the Primary Discussant; page 3 updated to reflect "10-year" timing for resubmission and page 4 has been updated to clarify that FDA clinical trials, the review will be of participants enrolled at sites under the direct purview of the UC San Diego IRB. The updated SOPPs can be found on the SOPPs page .

June 7, 2017 (Updated June 13, 2017): Due to circumstances beyond our control, 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 to approximately 10:00 pm on Friday, June 16, 2017. We regret any inconvenience this may cause. Please plan accordingly.

May 22, 2017: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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): 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: 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: 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: 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: 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): 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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): 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: 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: 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: 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): 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: 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: 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: 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): 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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): 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: 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: 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: 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): 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: 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: 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: 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: 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: 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: 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): 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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 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: 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: 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: 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: 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: If you are having problems opening pages/submitting documents on the HRPP web site, please see these instructions.

May 17, 2011: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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): If you are having problems opening some pages on the IRB web site, please see these instructions.

June 30, 2010: 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: 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: 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): 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: 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: 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: 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: 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 for closing/withdrawing a study can be found here.

July 17, 2009 (Updated October 2, 2009): 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: 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): 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): 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: More information about projects that may be exempt from IRB review at UCSD can be found here.

January 26, 2009: 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: 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: 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 .