Advisories
Subscribe to the IRB-Info Listserv to stay informed of changes to the UC Davis IRB Administration Website and/or policy and procedure changes of the UC Davis Institutional Review Board (IRB).
Posted May 16, 2013
Common Audit Findings
Dear Research Community,
Our office works in close collaboration with the Research Compliance and Integrity Unit and their Quality Improvement Auditor has provided us a list of common audit findings in human subjects research. We are sharing the list for educational purposes. These findings are:
Unspecified duration of study (from start to closure) and planned enrollment
Missing documents: consent and regulatory forms
Subjects consented by unapproved research personnel
Subjects consented with expired versions of the consent form
Consent form missing signatures (subject and/or researcher) and dates
Consent form missing answers/initials to the optional questions (future contact for research, specimen banking)
Human subject research continued past the IRB approved duration
Inaccurate reporting of enrollment numbers
These easily avoided situations could lead to unnecessary delays and/or suspension in research and put subjects at risk. Please protect your research subjects by appropriately training your research personnel staff and keeping your research records up to date.
For further information about researcher responsibilities, please take the time to review our Investigator Manual.
If you have any additional questions, do not hesitate to contact our IRB Staff.
Sincerely,
IRB Administration
Posted May 3, 2013
Tips for Successful Submissions
Dear Research Community,
The following tips and hints from our in-house staff will assist in speeding up review times and reduce IRB reviewer comments:
1. Within HRP-503 Protocol Template, for any items described in the sponsor’s protocol, grant, contract, or other documents submitted with the application, copy/paste the documentation into the protocol template. This should be quick and will decrease the time our reviewers take trying to locate and verify the information.
2. HRP-502 Consent Form Template contains the California Experimental Subject’s Bill of Rights, which is required for all biomedical research, on the first page. No need to submit a separate document with this information.
3. The IRB Administration no longer requires the creation of separate assent forms or letters of information for minors in research. The existing HRP-502 Consent Form Template contains the documentation for assent of minors under the section titled "Signature Block for Children." Additional information can be found in 45 CFR Part 46.408.
4. For studies containing multiple consent forms, label the different consent forms within the footer, lower left side, for ease of identification by our office (e.g. parental control group, control group, pregnant women control group, etc.).
5. Pager prefix change – If the consent form your study is utilizing contains a pager number for a contact number and was impacted by this change (from 762- to 816- ), the IRB Administration will allow you to manually cross out the incorrect pager prefix and insert the correct one until the study is up for renewal or requires modification (not related to the pager prefix change). At this time you will be required to update the pager prefix number. Please initial and date the change.
6. Place version dates within the footer, on the left side, of your documentation (e.g. protocols, consent forms, recruitment material, etc.). Version dates should not be changed unless the document itself has been updated. Please do not change the existing IRB document version dates within headers of applications or footers of forms.
7. Please do not submit Checklists or Worksheets with your submissions. These documents have been made available to you as reference material and are not reviewed by the IRB Administration.
8. Please do not submit hand written documentation. This will be rejected and a request for type-written documentation will be requested.
If you have any questions, please contact our IRB Staff.
Sincerely,
IRB Administration
Posted May 2, 2013
New Information/Form Update
Dear Research Community,
In response to community feedback, and our own quality assessment procedures, we have updated/modified the following to improve processes, procedures, and overall efficiency.
1. Updated Forms and Templates
HRP-212 Continuing Review Progress Report:
- Expanded, simplified, and clarified the "Enrollment Status" section.
*Please see the definition of enrollment under section 2
- Simplified and clarified the "Current Protocol Status" section.
- Embedded a response area to "The following questions refer to all sites involved in the protocol since the last IRB continuing review" section.
- "Brief summary of the progress of the protocol" memo has been replaced with embedded questions.
- New section, "For IRB Expired Studies Only", which addresses studies that are submitted to the IRB after their expiration date. Principal Investigators who allow their studies to expire are required to complete the HRP-214 Reportable New Information form and submit it with their renewal.
HRP-502 Consent Form Protocol:
- New standard language available for studies using a Certificate of Confidentiality.
- New 24 hour contact information language for all studies (The IRB Administration is now requiring Principal Investigators to provide participants a 24-hour contact number in the case of an emergency).
- Updated protocol completion instructions on page 1.
- The sections “Study-Wide Number of Subjects” and “Number of Subjects” have been condensed into one section for ease of understanding and clarification.
- The sections “Study-Wide Recruitment Methods” and “Recruitment Methods” have been condensed into one section for ease of understanding and clarification.
2. Definition of "Enrollment"
Due to confusion and misinterpretation of the term "enrollment" amongst the UC Davis research community, the UC Davis IRB Administration has decided to adopt the FDA and industry definition, as follows:
“Subjects that have been consented, met formal inclusion and exclusion criteria, and are scheduled to participate/are participating/or have participated in the research in accordance with the protocol are enrolled within a study”
Adopting this definition will provide consistency of understanding at all levels within the research community.
3. Standard Operating Procedures (SOPs)
The following SOPs have been updated:
- HRP-021 Pre Review
- HRP-024 New Information
- HRP-033 Designated Faculty Review
- HRP-034 Designated Faculty Review Conduct
- HRP-041 IRB Meeting Conduct
- HRP-043 IRB Meeting Minutes
- HRP-052 Post Review
- HRP-063 Expiration of IRB Approval
4. Exempt Studies
The IRB Administration has decided to no longer put expiration dates on studies determined to be exempt. This will only impact studies submitted for initial review and studies coming through for continuing review, going forward. Existing exempt studies with expiration dates still need to be submitted for continuing review. This decision meets all federal, state, and institutional regulations.
If you have any questions, please contact our IRB Staff.
Sincerely,
IRB Administration
Posted January 4, 2013
New/Updated Forms
Dear Research Community,
A friendly reminder that as of December 3rd, 2012 the IRB Administration is no longer accepting initial submissions on our "older" forms, please visit our website at www.research.ucdavis.edu/f/f#Forms-IRBAdmin for our newest applications and templates.
In addition, please be aware that several of our new forms have been recently modified based upon feedback from the research community. To identify a form's current version date, please look at the date in parenthesis to the right of the form title (i.e. HRP-503 – Protocol (12/26/12)). We highly recommend that you do not save copies of our forms on electronic devices, for they may be outdated the next time you utilize them.
If you have any questions, please contact our IRB Staff.
Sincerely,
IRB Administration
Posted November 30, 2012
New Forms Reminder/Updated GCP Deadline
Dear Research Community,
This email contains two announcements:
- Transition to new IRB forms
- Good Clinical Practice training deadline
1. Transition to new IRB forms
A friendly reminder that as of December 3rd, 2012 we will no longer be accepting submissions on our "older" forms, please visit our website at www.research.ucdavis.edu/f/f#Forms-IRBAdmin for our newest applications and templates. Existing approved protocols on older IRB formatted documentation will be grandfathered in, but will be required to utilize the new continuing review progress report, modification, and reportable new information forms. The IRB will reject submissions that do not utilize the new forms.
2. Good Clinical Practice training deadline
Due to feedback from the research community in regards to the new requirement that clinical trial investigators and research staff complete a Good Clinical Practice course (view original November 26th post here), the IRB Administration has decided to extend the grace period until January 1st, 2013.
If you have any questions in regards to these changes, please contact our IRB Staff.
Sincerely,
IRB Administration
Posted November 26, 2012
New Clinical Trial Research Training Requirement
Dear Research Community,
Effective December 3rd 2012, all investigators and research personnel involved in clinical trials (view NIH's definition of clinical trial) are required to receive certification for passing a Good Clinical Practice (GCP) training course, in addition to the already required research tutorials for human subjects research. GCP, created by the International Conference on Harmonisation (ICH) in 1996, is the compilation of accepted ethical and scientific standards governing clinical research that ensures the integrity of data obtained and the protection of human subject research subjects. Adherence to the principles of GCP is universally recognized as a critical requirement to the conduct of research involving human subjects.
The IRB has begun checking for GCP certification, via CITI, of investigators and research personnel on recently submitted clinical trials and advising investigators that have not yet been certified of this new requirement. After December 3rd, if GCP certification has not been obtained by the investigator or any research personnel on an initial submission for a clinical trial, approval will be withheld until certification has been confirmed. Instructions on how to take the GCP course can be found on our website accessed at http://www.research.ucdavis.edu/c/cs/hrp/res/roe.
In lieu of the CITI GCP course, investigators and research personnel who are ACRP or SoCRA certified may submit a copy of their certification. With this option, they will need to upload the documentation with each study, as it will not appear on the CITI certification spreadsheet.
GCP Training is valid for a three year period, after which time the training must be repeated. Please review our Investigator Manual, section "What training do my staff and I need to conduct Human Research" for further information.
Sincerely,
IRB Administration
Posted October 26, 2012
IRB Transition Period
Dear Research Community,
The IRB Administration would like to thank the researchers and research staff that were able to attend our training sessions this past month. During those sessions, you learned about the wonderful changes we are making and how impactful these changes are to the research community as a whole. As typical with all changes, there are bumps to be smoothed out and logistics to be fine-tuned, which can place a strain on an already burdened system. Our commitment to the research community to reduce the turnaround times for all reviews, while still ensuring compliance with the Federal Regulations, is still our number one goal, and we are determined to achieve this goal. In addition to our new SOPs, forms and templates, we will be implementing a new online electronic direct submission database system called Kuali Coeus. Please keep an eye out in the near future for the launch announcement and training schedules for this new system. In the meantime, the IRB Administration would like to thank you for your patience as we continue our transition and implementation of our new policies and procedures to obtain this goal.
The IRB Administration would also like to offer those researchers and research staff unable to attend our on-site training sessions a chance to view a recorded session. Please visit our website at http://www.research.ucdavis.edu/c/cs/hrp/out/online-videos and view the recording of a training session conducted on October 9th. In addition, you will find the presentation slides from the training session available for download.
Sincerely,
IRB Administration
Posted October 15, 2012
New IRB Forms and SOPs
Dear Research Community,
Over the last few weeks we have been meeting with you to discuss the many wonderful changes coming to the IRB Administration. One of the biggest changes that we spoke to you about was our new forms and Standard Operating Procedures (SOPs). Today is the day we make those documents available to you on our website at www.research.ucdavis.edu/c/cs/hrp. We will still accept our old forms for review and communication until December 3rd, 2012. After that, all submissions to the IRB Administration will be required to be on the new forms.
These new SOPs and forms are designed to provide UC Davis Investigators and research staff with a more efficient and customer service-oriented experience. If you have any questions in regards to the new forms or SOPs, please contact our IRB staff.
Sincerely,
IRB Administration
Posted September 13, 2012
UPDATE: IRB RESEARCH PERSONNEL TRAINING
Dear UC Davis Research Personnel:
Due to the overwhelming response to attend the IRB’s “brown bag” training session for research coordinators, nurses, and personnel, we have changed the venues for the sessions being held on October 9th and 10th to accommodate additional attendance.
The new venue locations are listed below:
No venue change:
You will only need to attend one session. Please RSVP by emailing IRBAdmin@ucdmc.ucdavis.edu.
Sincerely,
Miles McFann
IRB Administration
University of California, Davis
916.703.9156
Posted September 11, 2012
IRB RESEARCH PERSONNEL TRAINING
Dear UC Davis Research Personnel:
The Institutional Review Board (IRB) Administration cordially invites you, our current and future research coordinators, research nurses and research personnel, to attend a 60-minute IRB "brown bag" training session that will familiarize you with the recent changes to our department. At this training session we will discuss our new forms, new procedures, the benefits to the research community, what to expect during the review process, and we will answer your questions.
The repeating session will be offered on the following dates and location:
You will only need to attend one session. Space is limited, please RSVP by emailing IRBAdmin@ucdmc.ucdavis.edu.
The IRB would like to thank you for your ongoing support, especially in this time of change.
Sincerely,
IRB Administration
University of California, Davis
916.703.9156
Posted September 10, 2012
IRB RESEARCHER TRAINING
Dear UC Davis Researchers:
Following up on our campus-wide announcement in regards to the changes being made at the Institutional Review Board (IRB) Administration, we cordially invite you, our current and future Principal Investigators, to attend a mandatory 20-minute IRB training session. At these training sessions, we will discuss our new procedures, the benefits to the research community, and will answer your questions.
We will be offering this training over the course of the first week of October at the following sites and times. The sessions will begin on the hour every hour and you can attend at any time during the hours listed. You will only need to attend one time:
The IRB would like to thank you for ongoing support, especially in this time of change.
Sincerely,
IRB Administration
University of California, Davis
916.703.9156
Posted June 1, 2012
CHANGE IN UC COLLABORATIVE RESEARCH PROCESS
As of June 1, 2012, UC Davis is transitioning to a new online UC IRB Reliance Registry hosted by the UC Office of the President. This new system applies for all studies covered by the Memorandum of Understanding (MOU) between the UC Campuses. The MOU allows a UC collaborative research study to be reviewed by a single UC IRB, rather than requiring IRB review at two or more UC campuses where the research will take place.
Paper versions of the Notice of Intent to Rely will no longer be accepted. All new requests must be submitted via the online Reliance Registry, prior to protocol submission to the Reviewing IRB.
Existing collaborative arrangements must be entered into the new online Registry at the time of protocol renewal or amendment.
Further details and instructions may be found on the IRB Administration / UC IRB Reliance Registry for UC Collaborative Research page.
Posted May 16, 2012
IRB Updates
Dear Colleagues,
This email contains two announcements:
- New approval stamping procedures
- eDocs submissions
1. New approval stamping procedures
Effective immediately the IRB Administration will only be stamping subject consent forms with current approval dates upon completion of initial/renewal or modification review. This change is in accordance with federal regulations and guidance.
2. eDocs submissions
The instructions for eDocs submissions have been revised. Please submit documents as individual attachments in Word or PDF format. We no longer accept a single large document of multiple materials, as our new internal system has improved capacity and document management capability. PDF Packaging of the submission so that each document remains as a separate file within the package is acceptable.
As a friendly reminder, there are two notifications when using the eDocs system: (1) notification that the system received your submission, and (2) an email that your documents were picked up. If you do not receive a notification after 3 business days that the documents have been picked up, please contact the IRB Administration.
Please take the time to review the updated instructions as this will facilitate in reducing delays in processing.
Sincerely,
The IRB Administration Team
Posted April 24, 2012
Revised IRB Forms
Dear Colleagues:
This announcement involves the following IRB Forms:
1. Application (all review types)
2. Description of Study (all review types)
3. Multi-Center or Multi-Site Research Supplemental Form
Effective today, the Multi-Site Supplemental is no longer required. The Description of Study has been updated to include one question that should be completed only if UC Davis is the lead site for multi-site research.
Sincerely,
IRB Administration Team
Posted April 20, 2012
New Contact Information and Transition plan for the IRB
Dear Research Community:
As many of you know and have experienced, the IRB office supporting Human Research Protection at UC Davis has been experiencing significant transitional and resource challenges. To provide immediate support of the IRB, the Office of the Vice Chancellor for Research has secured resources from Huron Consulting Group to provide leadership, stabilization support and a substantive review of the IRB over the next few months.
The Huron team brings considerable experience in human subject protection compliance and is working quickly to formulate both a short term and long term plan to reduce protocol backlogs while the Office of Research moves forward on recruitments to fill vacancies on the IRB staff.
Lynn Smith will be providing on-site leadership and day-to-day support for the IRB. She can be reached at: lesmith@huronconsultinggroup.com or by phone at 312-714-6514.
Additional team members from Huron include:
David Goldstein (protocol review and support)
Jeff Cooper, MD (regulatory support, IRB structural and compliance review and system solutions)
Stuart Horowitz (overall responsibility for the project team)
Additionally, you can contact Cindy Kiel directly with your IRB support concerns and needs. Cindy would also like to receive nominations from faculty who are willing to serve on one of the IRB committees. Human subjects protection is a vital compliance program that requires both administrative support and faculty service to be successful. Please consider meeting your academic service commitments through volunteering for service on the IRB.
Thank you for your patience and support during this challenging transitional time.
Cindy Kiel
Executive Associate Vice Chancellor for Research
University of California, Davis
1850 Research Park Dr. Ste 300
Davis CA 95618
Ph: (530) 754-7944
e-mail: cmkiel@ucdavis.edu
