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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 28, 2014

Prisoners in Biomedical Research

Dear Research Community,

A gentle reminder that California Penal Code (Section 3502) does not allow for the enrollment of state prisoners into biomedical research.  Our state requirement is different from the federal requirement.

A prisoner is defined as: “Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.” [45 CFR part 46.303(c)]

If a research participant is incarcerated after enrollment in biomedical research, review our Standard Operating Procedure, New Information (SOP-24), Section 5.7, for the appropriate steps to notify the IRB as soon as possible.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


 

Posted March 24, 2014

Avoid Research Personnel Changes Rejection!

Dear Research Community,

Effective April 1, 2014 we will no longer be accepting older versions of the Application for Initial Review (HRP-211) or Research Personnel List forms. New versions of these forms have been available since November 26, 2013.  You should start using the new forms immediately.   You can find more information on how to submit research personnel changes by clicking this link Advisories.

At continuing review, please check the latest RPL for the study.  If the RPL is not listed on the current HRP 211 or Research Personnel List Template, you must submit an updated list using HRP-211 Initial Application or Research Personnel List Template.

All other forms will be rejected at time of submission.

Remember – the current forms require the PI to attest that the personnel on the list have:

(1)    the correct credentials
(2)    received the required training, and
(3)    reported conflicts of interest.

Please ensure these requirements are met before you submit a new RPL.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted March 7, 2014

Human Subject Research Training

Don’t let approval of your research be delayed!

We receive many submissions that cannot be approved because the training requirements are not met.  Don’t let approval of your submission be delayed.  Complete the required training before you send your research to the IRB.  Training requirements can be found in the Investigator Manual (HRP-103).

Please note – When the PI signs the Application for Initial Review (HRP-211) and/or the Research Personnel List, he/she is attesting that he/she and all research staff have completed the required training.   When this attestation is signed, we shouldn’t be able to find instances where the training is not completed.  When we find that the training is not completed, we may need to refer the issue for possible audit.

Sincerely,

IRB Administration

 


Posted February 27, 2014

 

Clarification on Research Personnel List

Dear Research Community,

The IRB Administration would like to provide clarification on the recent enacted changes to reporting and documenting research personnel to our office. Please reference the guidance below as to when to list or not list research personnel by name and within which documents to so.

List research personnel by name within:

  • HRP-211 - Application for Initial Review

Or if you would like to use Research Personnel List Template in addition to HRP-212

Example:

Name and Title

CITI Human Subjects Training Course

NIH Protection Human Research Participants Course (PHRP)

CITI GCP Training

ACRP/SoCRA Certified

Involved in consent?

Dr. Hawkeye Pierce

X

 

X

X

Margaret Houlihan, RN

X

 

X

X

Maxwell Klinger

X

 

 

X

X

 

List research personnel by role and qualifications within:

 

Example (HRP-503 Protocol, section 24 “Resources Available”):

Nurse Practitioner: will assist the PI with subject medical examinations and charting. Has participated in previous research studies and is familiar with…..

Study Coordinator: will be directly involved with the subjects recruiting, screening, consenting, scheduling, and communicating along with the preparation and conduction of research procedures. Has previous experience in coordinating large muli-site research and familiar with UCD IRB requirements.

Modifications to the Research Personnel List:

As the individual responsible for the study, Principal Investigators are required to attest that they have verified that all research personnel, involved in the design, conduct, or reporting of the study, have completed the required human subject research training when submitting a modification to their research personnel.   In addition, the PI will attest that the individuals have reported conflicts of interest.  It is very, very important that PIs ensure that this statement is correct before signing the attestation on the form.

Protocols existing prior to the launch of attestation on February 10, 2014, will not be grandfathered and PIs will be required to submit their updated personnel list utilizing either HRP-211 Initial Application or Research Personnel List Template

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted February 7, 2014

Clarification on Reporting Adverse Events

Dear Research Community,

In our efforts to provide further clarity for reporting of adverse events, we have updated category 2 in our HRP-214 Reportable New Information form with new definitions and criteria for reporting serious, unexpected, and probably related harms.

Updated wording:

2)      Serious harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related (>50% likely; "Don't know" = <50%) to the research procedures.

a) A harm is "serious" when it meets any of the following criteria; 1.) results in death; 2.) is life-threatening (place the subject at immediate risk of death from the event as it occurred); 3.) results in inpatient hospitalization or prolongation of existing hospitalization; 4.) results in a persistent or significant disability/incapacity; 5.) results in a congenital anomaly/birth defect; 6.) based upon appropriate medical/psychological judgment, may jeopardize the subject’s health and may require medical, counseling, or surgical intervention to prevent one of the other outcomes listed in this definition; or 7.) results in criminal or civil liability or damaging of the subject’s financial standing, employability, or reputation

b) A harm is “unexpected” when its specificity or severity are inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.

c) A harm is “probably related” to the research procedures if in the opinion of the investigator, the research procedures more likely than not caused the harm.

The updated document is now available on the IRB website.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted December 16, 2013

Changes to Research Personnel List

Dear Research Community,

In our continuing efforts to streamline the IRB administration process and forms, we are no longer requiring that each individual research personnel (excluding Principal Investigator) be listed within the research protocols and consent forms. Research protocols will only require you to describe personnel by roles (e.g. coordinator, research assistant, or pharmacist) and the qualifications (e.g. training, experience, oversight) required to perform each role.  Including only the roles of the personnel and not the names will allow you to make personnel changes without having to modify the protocol.

In addition, Principal Investigators will now be required to attest that they have verified that all research personnel, involved in the design, conduct, or reporting of the study, have completed the required human subject research training. This attestation will be required at initial review and any subsequent changes to the research personnel.

These changes required revisions to the following documentation:


We believe these changes will have the following positive impacts on the research community:

    • Reduce IRB review times
    • Reduce delays in approval of research
    • Reduce modification paperwork for  research personnel changes

 

The updated documents are now available on the IRB website. After February 10, 2013 only these new forms will be accepted by our office. Existing approved protocols will be grandfathered in and will not be required to list personnel by roles within the protocol and consent forms.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted November 27, 2013

New IRB Approval Stamp

Dear Research Community,

In our continuing efforts to streamline the IRB Administration processes, we are removing the expiration date from our approval stamp. This small change aligns us with industry practice, and at the same time, reduces the UC Davis research community's administrative workload.

Here is an example of the new stamp:

IRB Approval Stamp

We believe that removing the expiration date will have the following positive impacts on the research community:

  • Reduce the chance that investigators will obtain consent from subjects with an expired consent form.
  • Reduce the number of consent form versions over the life of a study.
  • Reduce subjects' confusion about study end dates.
  • Reduce renewal paperwork required to be submitted to the IRB.

 

We will apply the stamp to consent documents only at initial approval and when a modified version is approved.  Please note that you must not use a modified informed consent document until that document has been approved and stamped with the new approval date.

Please also note that the informed consent document is the only document that receives an approval stamp.  For  more information about our document stamping policy, please view our guidance IRB Approval Document Stamping.

We will utilize the new stamp starting on December 2, 2013.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted October 14, 2013

Protocol Expiration Notification Process

Dear Research Community,

The IRB Administration recently started a new process to try to decrease the number of studies that expire.

We are now sending protocol renewal notices at intervals of 120, 90, 60, and 30 days prior to expiration of the study. We will also contact research staff by phone if we haven’t received the continuing review report within 30 days of expiration. We will stop the notifications as soon we receive the required report.

We hope that this new process will decrease the number of expired studies and also decrease the number of “restricted” investigators. You may be aware that PIs who have allowed one or more of their studies to expire are placed on a “restricted list” until they submit the required reports to either renew or close the study. When a PI is on the restricted list, the IRB will not review any submissions of new research from that PI.

Please respond to the notices as early as possible so your study does not expire and your ability to have your research reviewed is not restricted.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted October 10, 2013

IRB Updates

Dear All,

In a constant effort to reduce turnaround times and improve workflow, we are pleased to announce that we have hired three new Biomedical Committee Analysts, in addition to our new IRB Associate Director.  Two of our new Biomedical Committee Analysts, Jessica Trask, PhD, and Amanda Carioggia, started in August, and our third Biomedical Committee Analyst, Debbie Leung, started in September.  They are still onboarding and will be transitioning into their independent roles in late October/early November.  We apologize for any delays you have experienced during this time, and ask for your patience as we complete the onboarding process.  Our previous Biomedical Committee Analysts have accepted new positions within the IRB Administration, and we appreciate and look forward to their continued contributions.

Our new IRB Associate Director, Cindy Gates, JD, RN, CIP, started in September.  She spent 11 years at Western IRB (WIRB), holding senior leadership positions as the VP of Regulatory Affairs and VP of Operations.  She has a strong track record of operational improvements and reducing turnaround times.  We believe that we are now well-positioned to meet and exceed the expectations of the research community and sponsors.

We also submitted our AAHRPP application for institutional accreditation in June 2013, and are currently submitting responses to our Step 1 application review.  We are expecting a site visit sometime after January 2014, and before May 2014.

In addition, we continue to work on our new KC IRB system, and are currently evaluating programming and implementation timelines.

We are constantly developing new ways to better serve your needs, and appreciate your continued patience while we get our new staff up to speed.

Very sincerely,

Dan

Daniel Redline, BA, CCRP, CIP
Director, IRB Administration
University of California, Davis

 


Posted October 9, 2013

2014 Full Board Committee Meeting Dates

Dear Research Community,

The IRB has posted the 2014 Full Board committee meeting dates to our website. We have also posted our new guidelines on how submissions will be assigned to these committees. This information can be located at http://www.research.ucdavis.edu/c/cs/hrp/res/irb-mtg.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,


IRB Administration

 


Posted July 18, 2013

CITI Website Unavailable 07/29 – 07/31 Due to System Upgrades

Dear Research Community,

Starting Monday July 29th at 8 a.m. Pacific Daylight Time, the online human subject research education program website, known as CITI, will be unavailable for approximately two to three days to complete a major software upgrade.

The UCD IRB Administration will generate its normal "CITI and GCP Certified" list on the morning of July 29th to capture all current certified UCD/UCDHS research personnel prior to shutdown. This list will be available on our website at http://www.research.ucdavis.edu/c/cs/hrp/res/roe.

Please have all research personnel complete any and all necessary training modules prior to the shutdown of the CITI website that may delay the approval of your protocols during this time.

During the software upgrade of the website neither the UCD IRB Administration nor CITI will have access to the website.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted July 04, 2013

New FWA and IORG Expiration Dates

Dear Research Community,

We have updated our Federalwide Assurance (FWA) and IRB Organization (IORG) registrations to include the recent changes within the UC Davis IRB Administration.  As such, we wanted you to be aware of the new expiration dates for both:

 

FWA #00004557 is approved until June 13, 2018

IORG #0000251 is approved until July 2, 2016

 

For more information about FWAs and IORGs, please visit OHRP.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

 


Posted June 06, 2013

Open Positions within the IRB

Dear Research Community,

Due to two upcoming internal promotions, and a continued focus on reducing turnaround times, the IRB Administration is looking for three Biomedical (Clinical) Committee Analysts to join our team.  Please forward this announcement to others who may be interested:

Positions: IRB Biomedical (Clinical) Committee Analysts

Brief Description: Under general supervision of the Associate Director of the IRB Administration, efficiently manage IRB committee(s); review policies, processes and protocols and provide guidance and analytical support to the IRB, Office of Research, departments and campus units and external organizations/clients. Conduct analysis of large quantities of information and provide policy interpretation, guidance and recommend solutions in resolving time sensitive protocol issues.

For Full Consideration Apply By:  6/18/2013
Requisition Number:  03009908
Payroll Title:  Analyst II
Position Number:  02014267
Department:  IRB ADMINISTRATION – 061811
Number of positions: 3
Salary Range: $19.06 -$34.30/Hr.

Quick Link To This Position:   https://www.employment.ucdavis.edu/applicants/jsp/shared/position

Please feel free to contact OR HR at orhr-help@ucdavis.edu if you have any questions or need additional information.

Sincerely,

IRB Administration

 


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).

HRP-503 Protocol Template:

    • 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:

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