Announcements

 

 

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 February 28, 2017

IRB Office Hours Update

In order to provide UC Davis researchers the most effective and efficient assistance possible, IRB Administration is restructuring the IRB Office Hours Program. Through the month of March, IRB representatives will be available at the regularly scheduled times and locations only if researchers have scheduled an appointment.  This change will allow IRB Administration to appropriately staff the Office Hours session. If no appointment is scheduled two hours before the start time of the Office Hours session, the session will be cancelled. Click here to schedule an appointment.

Starting April 3, the UC Davis IRB will no longer hold Office Hours but will provide consultation services upon request. Researchers can email a consultation request to IRB Administration to schedule an appointment with an experienced IRB Analyst. The consultation will be scheduled for a mutually agreed upon time and location. Click here to request a consultation.

Eligibility to act as Principal Investigator

The IRB’s policy regarding eligibility to act as Principal Investigator when research does not receive external funding has been updated. For more information please review the Principal Investigator Qualifications posted on our website.

NIH Training Requirement Reminder

The NIH now requires Good Clinical Practice training for Social and Behavioral Research that meets the definition of a clinical trial.  A new course has been developed specifically to address clinical trials using behavioral interventions and social science research. The course, titled “NIH Good Clinical Practice” is available now through the UC Davis Learning Management System. Once you are in the system, search for NIH Good Clinical Practice to access the modules.

Upcoming IRB Training Events

CRC 2.0: IRB Submissions: Commonly Seen Mistakes and Best Practices

Sacramento
Date: April 6, 2017
Time: 2:00 – 5:00 pm
Location: Medical Education Building, Room 3202

Hosted by the Clinical Trials Office, this course is designed for those knowledgeable in IRB review and will outline the most common errors in IRB submissions. Attendees will review projects from the IRB’s perspective and will learn how to screen their own projects for problems prior to submitting to the IRB. Registration through the UC Learning Management Center is required.

IRB New Submitter Training

Davis
Date: May 9, 2017
Time: 1:00 – 3:00 pm
Location: Hoagland Hall, Room 260

Designed for researchers new to human subjects research at UC Davis, this course includes an introduction to our electronic submission system, IRBNet, a description of the types of projects which require IRB review, an overview of the IRB review process, and an outline of IRB submission types and required documents. Attendees will learn guidelines for successful submissions to the IRB. Registration through the UC Learning Management Center is required.

New Class: IRB Protocol Writing Lab

Davis
Dates: May 9, 2017
Time: 3:00 – 4:30 pm
Location: Hoagland Hall, Room 260

During this hands-on protocol writing lab, you will work independently at a computer while an IRB Analyst guides you through two of the essential documents for IRB review of a new research project: HRP-503 Protocol Template and Initial Review Application. At the end of the session you should have a clear idea of the information needed to complete the application and how to submit an application for IRB Review. This class is designed to complement the IRB New Submitter Class. Registration through the UC Learning Management Center is required.


Posted January 27, 2017

UC Davis IRB Implements 10-year Approval Periods

The final revised Common Rule was published January 19, 2017. One new provision eliminates the requirement for continuing review on studies involving only minimal risk. The rule does not become effective until January, 2018, however, UC Davis IRB Administration is taking action to reduce administrative burden for researchers today, as allowed under the current regulations.

Effective immediately IRB Administration will be is issuing 10-year approval periods for studies that meet ALL of the following requirements:

  • This research involves no more than minimal risk
  • This research does not receive any federal or state government funding or funding from a private funder who requires annual review per contract
  • This research Is not subject to FDA jurisdiction
  • This research does not include prisoners as participants
  • This research is not part of an IRB reliance
  • This research is not subject to SCRO oversight
  • This research is not subject to oversight by the Research Advisory Panel of California (RAP of C)
  • This research does not involve personnel supported by federal training, center, or program grants
  • No personnel involved in the design, conduct, or reporting of this research have a related financial interest (RFI) in this study, or any existing RFIs have previously been reported and there are no changes to any previously reported RFI.

When 10 year approval is issued researchers will not need to submit an HRP 212 Continuing Review Progress Report until 45 days prior to the expiration date (10 years from approval) or at study closure, whichever comes first. Existing projects that meet the qualifications above will be granted a 10-year expiration date when we receive information from investigators that the study qualifies.

The HRP 212 FORM Continuing Review Report has been revised to allow investigators to report studies that qualify for a 10-year approval period.  This form will be uploaded to IRB Administration’s website very soon. If the study meets the criteria for 10-year approval, investigators can complete the sections at the top of the form and submit it to the IRB. If the project qualifies, the IRB will issue a new, 10 approval period without conducting continuing review. The revised HRP 212 can be submitted at any time, but it must be submitted at least 45 days before the study was originally scheduled to expire.

Please note, investigators must continue to submit all changes to research prior to implementation and reportable new information items as currently required.  In addition, investigators will receive an annual notice listing details of the research. Investigators must submit a modification if there are changes to any of the items listed in the notice.

We are currently working with our contacts at IRBNet to develop a process that will allow us to eliminate the need for entering an expiration date in the system. When the process has been established, we will no longer assign a 10-year expiration date and studies will remain approved until they are closed or approval is terminated.

When the revised Common Rule becomes effective, the IRB will further reduce the requirement for continuing review to include federally funded studies.

NIH Good Clinical Practice for Social and Behavioral Research Now Available
Effective January 1, 2017 all  NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

While CITI provides coursework in drug, device, or biologic research, a new course has been developed specifically to address clinical trials using behavioral interventions and social science research. The course, titled “NIH Good Clinical Practice” is available now through the UC Davis Learning Management System. Once you are in the system, search for NIH Good Clinical Practice to access the modules.

OHRP Releases Research Participant Website
A message from OHRP:

The Office for Human Research Protections (OHRP) is excited to announce the launch of its new public outreach website, About Research Participation! These resources are designed to help potential volunteers better understand research and ask for the information they need to decide whether to participate. This initiative broadens OHRP’s educational and outreach efforts to the general public.

The newly developed resources include a series of short videos about participating in research and a printable list of questions potential volunteers can ask researchers. Trial coordinators and research staff also could use these materials to facilitate and improve the informed consent process. No additional permission is required to use or disseminate these public resources.

We believe these materials will be a valuable resource for the research community as well as the general public. Please consider sharing this information broadly! We also welcome your feedback, and would be happy to receive comments on this initiative at OHRP-edu@hhs.gov.

A link to this website has been made available at the UC Davis IRB Research Participants website.

Updates to the HRP-503 Protocol Templates

There have been several significant changes to research oversight in the first month of 2017. To assist UC Davis researchers in assessing how these changes impact their projects, the HRP-503 Protocol Templates have been updated.

Two new sections have been added to the HRP-503 General Template:

  1. gov Registration: This section provides support when determining if research requires registration on clinicaltrials.gov,
  2. Criteria for 10-year Approval: This section assists researchers in securing 10-year approval by indicating to the IRB that all of the requirements have been met.

The Criteria for 10-year Approval section will also added to the specialized HRP 503 Record/Data/Specimen Review and HRP-503 Surveys/Interviews and/or Focus Groups Templates.

The revised templates will be available on our website next week.

Upcoming IRB Training

New Submitter Training

Designed for researchers new to human subject research at UC Davis, this course includes an introduction to our electronic submission system, IRBNet, a description of the types of projects which require IRB review, an overview of the IRB review process, and an outline of IRB submission types and required documents. Attendees will learn guidelines for successful submissions to the IRB. Registration is required through the UC Learning Center.

Date: February 8, 2017,
Time: 1:00 – 3:00 pm
Location: Hoagland Hall, Room 260
Davis, CA

 

CRC 2.0: IRB Submissions: Commonly Seen Mistakes and Best Practices

Hosted by the Clinical Trials Office, this course is designed for those knowledgeable in IRB review and will outline the most common errors in IRB submissions. Attendees will review projects from the IRB’s perspective and will learn how to screen their own projects for problems prior to submitting to the IRB. Registration is required through the UC Learning Center.

Date: February 16, 2017
Time: 2:00 – 5:00 pm
Location: Medical Education Building, Room 2205
Sacramento, CA


Posted December 12, 2016
NIH GCP Training Requirement
Find attached the NIH policy statement on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.

Of note in this policy:
This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See https://grants.nih.gov/grants

This policy takes effect January 1, 2017.

How this affects you:
UC Davis researchers involved in the conduct, oversight, or management of biomedical or behavioral clinical trials receiving NIH support will be expected to complete GCP training. To fulfill this requirement UC Davis offers two courses through CITI. Choose the appropriate course based on the research you are conducting. Researchers are only required to take one GCP course. If conducting research with both drugs/biologics and devices, investigators should take the GCP course that applies to the majority of their research.

  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • GCP for Clinical Trials with Investigational Medical Devices

GCP training certification is valid for 3 years. When GCP training is due to expire, investigators may take a GCP refresher course to renew certification. There are two versions of the refresher course; researchers are only required to take one GCP refresher. Investigators should take the GCP refresher course that applies to the majority of their research.

For more information on enrolling in CITI courses visit the Required CITI Education page on our website http://research.ucdavis.edu/policiescompliance/irb-admin/outreach/citi/

CCRP Exam Update
The Certified Clinical Research Professional (CCRP) exam date at UC Davis has changed from February 16th, 2017 to February 27th, 2017. Details can be found below. For more information about SOCRA and the CCRP exam click here.

Exam Date: February 27, 2017
Time: 5:00 – 9:00 p.m.
Exam Location: UC Davis CTSC Building, Sacramento
Application Deadline: January 16, 2017


Posted November 18, 2016

IRBNet Automated Stamping

IRBNet now offers an automated document stamping process for IRB Administration use. The automated process allows for faster stamping of consent documents once they have been approved and reduces the possibility of errors in protocol numbers and approval dates found in the stamp. The new stamping process automatically converts documents from Word to PDF and applies a stamp in the lower right corner of each page.

The use of automated stamping depends on the proper formatting of documents. The automated process lacks the scale and placement tools that IRB staff have used to manually work around non-standard formatting.

To avoid problems with the new stamping process please follow these guidelines for consent documents:

  1. Set the bottom margin at 1.3”
  2. Save all pages in portrait orientation (not landscape)
  3. Submit consent documents as PDF files

HRP 502 Template Consent Form has been updated with a new bottom margin to allow adequate space for the stamp. Please use the revised template found on our website or the IRBNet Library when submitting new consent forms. When making edits to previously approved consent forms set the bottom margin to 1.3”. If you have any questions contact the IRB Education team at hs-irbeducation@ucdavis.edu.

Template Risk Language

IRB Administration has developed standard language to assist researchers in providing complete and concise descriptions of risks commonly encountered in human subjects research. It is not a requirement that researchers use this language; it is provided as guidance. The new language can be found on our Forms page under Templates.

Upcoming Events

IRB New Submitter’s Class

Designed for researchers new to human subjects research at UC Davis, this course includes an introduction to our electronic submission system, IRBNet, a description of the types of projects which require IRB review, an overview of the IRB review process, and an outline of IRB submission types and required documents. Attendees will learn guidelines for successful submissions to the IRB. Registration is required through the UC Learning Center. To register for the class log into the UC Learning Center, search for “IRB,” select the course of interest and complete the registration process.

Date: November 29, 2016
Time: 1:00 – 3:00 pm
Location: Medical Education Building
Room 2205, Sacramento

Date: February 8, 2017
Time: 1:00 – 3:00 pm
Location: Hoagland Hall
Room 260, Davis

Certified Clinical Research Professionals (CCRP) Exam

SOCRA developed the Certified Clinical Research Professional Certification program to evaluate a CRP’s knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice (E6) (ICH/GCP), ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), the United States Code of Federal Regulations (CFR) and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. This Examination does NOT test on state, provincial, Ministry of Health, local, or institutional policy. Click here for more information.

Exam Date: February 16, 2017

Time: 5:00 – 9:00 p.m.
Exam Location: UC Davis CTSC Building, Sacramento
Application Deadline: January 4, 2017


Posted November 4, 2016

IRBNet Spotlight: New Document Management Tools
IRBNet is pleased to announce our powerful new document management tools, focused on streamlining and enhancing the Designer experience for your busy study teams.  These enhancements dramatically reduce the effort required to assemble Submission Packages within the Designer.

Assemble and Manage Project Documents
The Designer has been enhanced to greatly reduce the number of clicks and navigational steps required to create, submit and manage Project Documents.  Please note:

  • Package Assembly.  From the Designer, researchers with Write or Full access may now directly attach multiple documents at one time through upload or drag and drop techniques.
  • Smart Forms.  Access and initiate Smart Forms directly from the Designer.
  • Package Description.  The package description field provides the opportunity to capture and communicate additional detail about each package.
  • Document History.  Easily add, remove, or move documents between Document Histories simply by dragging and dropping.
  • Package Navigator.  This handy tool  aids access to every submission package and document.
  • All Project Documents view.  This subtle tool eases moving from viewing documents in a package to all documents associated with a project and make it easy to locate the most current version of any project document.

Create New Packages
In addition to these enhancements, the navigation experience to create new Packages has been streamlined.  This function can now be accessed both from the new Package Navigator as well as Project Administration menu to the left of the screen.

Next Steps
Click here for a guide to the new tools. IRBNet plans to release these tools in the near future. If you would like additional information or assistance in learning the new tools, please contact the IRB Education group at hs-irbeducation@ucdavis.edu or visit our office hours. Details for office hours can be found below.

UCDMC Campus
Date: Every Tuesday
Time: 12 pm to 1 pm
Medical Education Building
Computer Lab 2106

UCD Campus
Date: Every Wednesday
Time: 12 pm to 1 pm
Mrak Hall
Room 61


Posted September 29, 2016

Educational Opportunities for UC Davis Researchers

With each new academic year the IRB sees new investigators conducting human subjects research at UC Davis. IRB Administration provides support and education to UC Davis researchers with classroom training, weekly office hours, a comprehensive website, and a dedicated education phone line and email account. Below we’ve outlined ways you can learn more about human subjects protections and IRB review at UC Davis.

New Submitter’s Training
Dates: October 5, 2016, February 8, 2017, May 9, 2017
Time: 1:00-3:00 pm
Location: Hoagland Hall, Room 136, Davis, CA

Designed for those new to human subjects research at UC Davis, this course covers the types of projects which require IRB review, an overview of the IRB review process, an outline of IRB submission types and required documents, and an introduction to our electronic submission system, IRBNet. Attendees will learn guidelines for successful submissions to the IRB. Registration is required through the UC Learning Management System. Click here for more information.

CRC 2.0: IRB Submissions: Commonly seen mistakes and best practices
Dates: February 16, 2017, April 6, 2107
Time: 2:00-5:00 pm
Location: Medical Education Building, Room 2205, Sacramento, CA

Hosted by the Clinical Trials Office, this course is designed for those knowledgeable in IRB review and will outline the most common errors in IRB submissions. Attendees will review projects from the IRB’s perspective and will learn how to screen their own projects for problems prior to submitting to the IRB. Registration is required through the UC Learning Management System.

IRB Office Hours
Dates: Tuesdays
Time: 12:00-1:00 pm
Location: Medical Education Building, Room 2106, Sacramento, CA

Dates: Wednesdays
Time: 12:00-1:00 pm
Location: Mrak Hall, Room 61, Davis, CA

IRB Administration’s weekly office hours are an opportunity to seek one-on-one help with your project. An IRB analyst is available to answer your questions about human subjects research and IRB submissions. Appointments are appreciated, but walk-ins are welcome. To make an appointment contact the IRB Education Team.

IRB Administration Website
Not sure where to start with your human subjects research questions? Our website provides comprehensive information about human subjects protections and IRB review at UC Davis. You can find guidance on topics ranging from “Does my project need review by the IRB?”  to “Collaborative research at UC Davis” and “Study closure submission process” and everything in between. Visit http://research.ucdavis.edu/irbadmin for more information.

IRB News Emails
When the IRB wants to highlight important news that may impact you we send out an IRB News email. You received this message because you have subscribed to IRB News. If you know someone who is new to UC Davis and could benefit from IRB News, they can subscribe by clicking here.

IRB Education Team
If you’ve looked high and low and still need more information, contact the IRB Education Team. We have a phone line and email account monitored by experienced staff here to help you.

Email: hs-irbeducation@ucdavis.edu
Phone: 916.703.9158

Posted June 9, 2016

Announcing our Improved IRB Website with New Content!

After eight months of hard work, we are delighted to announce the launch of our new website on June 7, 2016. The site is available and the URL is http://research.ucdavis.edu/policiescompliance/irb-admin.

Our goal with this improved website is to provide our research community an easier way to locate information about the IRB, our submission process, and the federal, state and institutional regulations and policies that govern human subject research. New content has been added including such topics as:

This is your website and we hope you find it offers easy access to the information you need. We welcome your feedback so that we can continue to improve the performance and content of our website. To provide feedback, please contact our Outreach, Training and Education Group at hs-irbeducation@ucdavis.edu.

Articles of Interest

Botched French Drug Trial Followed Rules But Lacked ‘Common Sense’

France’s social affairs inspectorate said in report released May 21 that while the trial was legal, Bial and Biotrial made mistakes. Study participants were given a drug dose that was too high, the companies delayed alerting authorities, and Biotrial did not react quickly enough after the first participant got sick, the report said…..for the full article go here


Posted May 10, 2016

Form Changes: The Continuing Review Progress Report (HRP-212)

To improve efficiency in routing studies for review and address problems reported by the research community we’ve made the following enhancements to HRP-212 Continuing Review Form:

  • Included additional instructions for reporting vulnerable population enrollment numbers
  • Updated “Protocol Status” list with more detailed list of possible statuses
  • Reduced the number of questions pertaining to Related Financial Interest

We hope the result will address concerns raised by researchers and improve usability of the form.

Introducing the Continuing Review Committee

As a pilot program, we created the Continuing Review Committee to be dedicated to only review continuing review submissions for clinical/biomedical studies that are greater than minimal risk and have no modifications (except research personnel changes). This successful program has help reduce initial review turnaround times by allowing more initial review studies to be assigned to committee review quicker than in the past. The Continuing Review Committee meets federal regulations in its design and consists of members Committee A, Committee B and in-house reviewers that meets averagely once a month. For more information about the Continuing Review Committee contact our Education Group at hs-irbeducation@ucdavis.edu.

IRB Office Hours

Need additional guidance or assistance with your IRBNet submission? Or, need to speak to us about your research? The IRB Administration’s IRB experts will be available every Tuesday (UCDMC Campus) and Wednesday (UCD Campus) at noon to provide one-on-one hands on help. You can make an appointment or just stop by. For more information about IRB Office Hours and location please visit our website at here.

Survey Opportunity: IRB Wants to Hear What You Have to Say!

The UC Davis IRB Administration would like feedback from the research community it serves on how we are doing. Please take a few minutes of your time and visit our survey at:

http://ucdavis.co1.qualtrics.com/SE/?SID=SV_6R922AhaROJa6Z7 (copy/paste link into browser)

OR

On our website at:

http://research.ucdavis.edu/policiescompliance/irb-admin/feedback-form/

You may skip any questions you do not wish to answer.  If you start the survey and find you do not wish to participate, simply exit the survey. We will receive your responses only if you click the “forward arrows” button at the bottom right corner of the screen.

If you are an IRB Committee member, please respond from the perspective of an IRB customer.

If you have any questions or concerns, please contact the UC Davis IRB Training and Education Group at HS-IRBeducation@ucdavis.edu.

Upcoming Events:

SoCRA Northern California Chapter Meeting

May 19, 2016 at 12 pm:

Best Practices in Clinical Trial Start Up

Presented by:

Kate Marusina, PhD, MBA

Manager, Clinical Trials Resource Group

&

Tracy Hysong

Project Manager/Budget Negotiations

Location:

University of California, Davis

Clinical Translational Science Center (CTSC)

2921 Stockton Blvd, Suite 1400, Room 1444

Sacramento, CA 95817

Parking and Entrance at rear of building

 (Directions)

Objectives:

Introduce Clinical Trials Resource Group

Describe Start Up tools: process map, feasibility questionnaire, difficulty estimator, Microsoft project,  templates

Describe Budget tools: internal template, negotiation with the sponsors

Put it all together!

1 CEU available to SoCRA members

Certificates of Attendance will be provided to those who attend


Posted March 17, 2016

Survey Opportunity: IRB Wants to Hear What You Have to Say!

The UC Davis IRB Administration would like feedback from the research community it serves on how we are doing. Please take a few minutes of your time and visit our survey at:

http://ucdavis.co1.qualtrics.com/SE/?SID=SV_6R922AhaROJa6Z7 (copy/paste link into browser)

OR

On our website at:

http://research.ucdavis.edu/policiescompliance/irb-admin/feedback-form/

You may skip any questions you do not wish to answer.  If you start the survey and find you do not wish to participate, simply exit the survey. We will receive your responses only if you click the “forward arrows” button at the bottom right corner of the screen.

If you are an IRB Committee member, please respond from the perspective of an IRB customer.

If you have any questions or concerns, please contact the UC Davis IRB Training and Education team at HS-IRBeducation@ucdavis.edu. Do not reply to this email with your concerns or questions.


 

Posted February 18, 2016

Research Personnel Changes to be Reported at Continuing Review

On March 14th, 2016 the UC Davis IRB Administration will be breaking with tradition, but not any federal, state, local, or institutional law and/or regulation. The IRB is adjusting its requirement for reporting changes to research personnel lists. Going forward, please report all research personnel changes in submissions for continuing review. It is no longer necessary to submit a separate modification for each change in research personnel during a study; you can add and remove research personnel without submission of a new research personnel list (RPL) between initial and continuing reviews.

When onboarding new research personnel, Principle Investigators (PI) are still required to follow all federal, state, and local laws and regulations, as well as UC Davis policies and procedures. PI’s are required to:

  • Verify the personnel are qualified to do the protocol procedures
  • Train the personnel on the protocol and procedures
  • Verify personnel are up-to-date on training in human subjects research
  • Report any conflict of interests among research personnel to the UCD Conflict of Interest Committee and the IRB.

Updated Standard Operating Procedures, Templates, Forms, Worksheets and Checklist will be made available on our IRB website prior to the March 14th, 2016 effective date.

Please Note: changes to the PI and/or Co-PI do not fall under this new process.  A modification must be submitted to the IRB prior to updating the PI and/or Co-PI of a protocol.

Please do not hesitate to contact the IRB Education Group with any questions at HS-IRBeducation@ucdavis.edu. Do not reply to this email with your concerns or questions.

IRB Feedback Survey

The UC Davis IRB Administration would like to hear back from the research community it serves on how we are doing. Please take a few minutes of your time and visit our survey at:

http://ucdavis.co1.qualtrics.com/SE/?SID=SV_6R922AhaROJa6Z7 (copy/paste link into browser)

OR

On our website at:

http://research.ucdavis.edu/policiescompliance/irb-admin/feedback-form/

You may skip any questions you do not wish to answer.  If you start the survey and find you do not wish to participate, simply exit the survey. We will receive your responses only if you click the “forward arrows” button at the bottom right corner of the screen.

If you are an IRB Committee member, please respond from the perspective of an IRB customer.

If you have any questions or concerns, please contact the UC Davis IRB Training and Education team at HS-IRBeducation@ucdavis.edu. Do not reply to this email with your concerns or questions.

Updated Forms and Templates

The following minor changes have been made to the IRB documents listed below:

HRP-214 Reportable New Information:

  • Number 10: updated to reflect only requests and/or inquiries from a federal agency to be reported.
    • Old language: “Audit, inspection, or inquiry by a federal agency or other entity and any resulting reports (e.g., FDA Form 483)”
    • New language: “Inquiry by a federal agency and any reports (e.g., FDA Form 483).”
  • Number 11: updated to include audit reports and clarify language.
    • Old language: “Ancillary approvals (e.g. CoC, SCRO) that do not result in a protocol revision, Data Safety Reports that include a recommendation to terminate or modify a study and written reports of study monitors with reportable events that have not yet been reported. “
    • New language: “Ancillary approvals (e.g. CoC, SCRO) that do not result in a protocol revision; written reports by study monitors and auditors that include reportable events that have not yet been reported; Data Safety Reports that include a recommendation to terminate or modify a study.”

HRP-212 Continuing Review Progress Report: added the underlined language to question ” Have subjects experienced any harms (unexpected or increased frequency and/or severity of expected) probably related to the research procedures.” The language was added to align with federal regulations serious adverse events reporting requirements.

HRP-213 Modification:  removed the language “Point-by-point response (For a response to modifications to secure approval, deferral, or disapproval)”, as this form is no longer needed to respond to requests for revisions and/or a Letter of Action issued by the UC Davis IRB administration. Please note that the IRB requires a “PI Response Memo” providing a point-by-point response for any response to modifications to secure approval, deferral, or disapproval. These instructions are located within the form letters sent to the PI upon review by a convened board (i.e. full board review).

If you have any questions or concerns, please contact the UC Davis IRB Training and Education team at HS-IRBeducation@ucdavis.edu. Do not reply to this email with your concerns or questions.

Upcoming Events:

San Francisco Bay Area SoCRA Chapter Meeting

Thursday, March 10th, 2016 12 – 1pm

Medicare Coverage Analysis

Presented by:

Karen Mottola, MA, CHRC, CPC, CRCC
Research Compliance Officer, Sutter Health Systems Office

This presentation will be available via webinar at UC Davis

Location:

University of California, Davis Medical Center

Medical Education Building

4610 X St, Room 2205

Sacramento, CA, 95817

 


 

Posted February 18, 2016

Great News for Researchers Using Online Web Services

Qualtrics Research Suite is now available to all UC Davis faculty, staff, and students through a campus-wide license.

Qualtrics is a web-based survey-tool similar to Survey Monkey and Survey Gizmo, but with advanced features designed for research in social sciences, marketing, and institutional analysis.

Some of the advance features include:

  • Advanced logic, randomization, survey distribution, and panel management features needed for research in social sciences, institutional analysis, marketing, and other fields;
  • Analysis and reporting tools such as conjoint analysis, cross tabulation, graphical reporting, and downloading of data for external analysis in common formats including SPSS, CSV, XML, and more;
  • Robust collaboration that enables flexible sharing of surveys, responses, analyses, reports, question libraries, etc. both with other UC Davis users and with external collaborators;
  • A web API that enables integrating Qualtrics directly into your applications.

With campus-wide access, we believe that Qualtrics will be a valuable tool for research, teaching, and administration.

To access the UC Davis Qualtrics license log in at this address with your UC Davis credentials:

https://ucdavis.qualtrics.com/

To learn more about this service offering, including important links to institutional policies governing human subjects research, mass communications, and data security, please visit the entry for Qualtrics in the UC Davis IT service catalog:

http://itcatalog.ucdavis.edu/service/qualtrics-research-suite-online-surveys

Mechanical Turk Update

The University of California, Office of the President (UCOP) announced yesterday that the online service Mechanical Turk is acceptable to when conducting human subjects research if the data collected is non-sensitive. This information was provided to all UC IRB Administration Directors on February 16, 2016. Implementation of this announcement may vary with each UC IRB Administration.

UC Davis IRB Administration will not allow the use of Mechanical Turk if the data collected could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation, or is covered by HIPAA.

Prior to using and agreeing to Mechanical Turk terms and agreements, please contact UCD Contracting Service.

Please contact the UCD IRB Administration Education Group at 916-703-9158 or hs-irbeducation@ucdavis.edu with any IRB related questions.

IRBNet Quick Tips:

  • Should I request the IRB unlock the package?

The IRB can unlock your current submitted package for editing/revising only when a determination has not been made on the submitted package. Reasons for researchers to request a package to be unlocked can be as follows:

  • Missing documentation
  • New documentation
  • Errors in documentation
  • Wrong documentation

 We often get requests to unlock a package so the researcher can submit a continuing review, modification, reportable new information or closure. These must be submitted as a new package.

To submit a new package to the IRB follow these steps:

  1. Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. Click “Project History
  4. Click “Create New Package
  5. Click “Designer” and update documents, as appropriate
  6. Edit other project information, as appropriate
  7. Collect necessary signatures
  8. Click “Submit this Package” and complete the subsequent steps

DON’T FORGET TO CLICK SUBMIT!

The IRB cannot review your submission until you have

completed the steps to submit the package.

 

  • Stacking Documents

“Stacking” is a convenient tool which allows you to quickly view the version history of one document in one simple click of the button.  Not “stacking” documents causes delays in reviews and frustration for all parties involved. Thus, “stacking” is an important step to complete when submitting to the IRB.

To “stack” new documents on top of older versions:

  1. In the Designer, scroll the “Documents from Previous Packages” Section
  2. Click the pencil icon next to the document you wish to update
  3. Click “Choose File
  4. Locate the file you wish to upload and click “Open
  5. If appropriate, update the Description field
  6. Click “Update
  7. The new version of the document is now “stacked” on top of the previous version of the document. Click the stack of papers icon to view a list of all versions of the document.
  8. Stack like documents; tracked-changes versions should be stacked on previously reviewed tracked-changes versions, while clean versions should be stacked on previously reviewed clean versions.

Posted February 2, 2016

Amazon’s Mechanical Turk and Third Party Online Vendors

Important News for Researchers Using Online Web Services

From cloud hosting (e.g. Amazon Web Services) to online surveys (e.g. Survey Monkey) to smartphone applications (e.g.  Apple: ResearchKit) the use of online web services is continually growing and so is their use in human subject research. With that growth comes the complication of online terms and conditions that can cause more harm than good for UCD and researchers.  Faculty, student, or staff wishing to use online web services, for research or not, should check with UCD Contracting Services prior to agreeing to any contracts and/or online terms and conditions. Their website also provides a list of online web services that have been “pre-approved” by UCD for use. UC Davis is working to obtain a contract with another survey vendor, Qualtrics. More information on this vendor should be coming soon.

University of California, Office of the President has stated that the use of Amazon’s Mechanical Turk for research is not permissible.  The two most poignant reasons for UCOP’s ban on the use of Mechanical Turk is due to the site not providing adequate privacy provisions and Mechanical Turk’s claim to co-own all data transmitted on their site. In response, the UCD IRB Administration will no longer approve initial application submissions in which Mechanical Turk is used.  Existing IRB approve protocols, that are utilizing Mechanical Turk, will be grandfathered and not be required to change to another online web service.


 

Posted December 21, 2015

IRBNet’s Online Initial Review Application (New Project)

As of January 1, 2016 all New Projects must contain (at minimum) the following:

  1. Online Initial Review Application
  2. A sponsor protocol OR an abbreviated HRP 503 Protocol (see next article)
  3. HRP 226 Administrative Approval Form
  4. Electronic signature of the Principal Investigator

Many studies will require additional documents such as a consent form and other documents provided to participants.  When the electronic Initial Review Application form is completed, a “Form Complete” page will appear, and this page will include a list of additional documents required for the study. This list will be based on the information you entered on the electronic application.

IRB Administration will soon be removing the following from IRBNet’s Forms and Templates section as well as the IRB Administration’s Forms Page, as these documents have been replaced by an online form or by an abbreviated version of the previous document described in the section below.

  • HRP 211 Application for Initial Review
  • HRP-503 Protocol Template Standard
  • HRP-503 Protocol Template Research Involving Retrospective/Prospective Data Specimen Review
  • HRP-503 Protocol Template Research Involving Surveys/Questionnaires/Interviews and/or Focus Groups
  • Qualifying Clinical Trials Form

Abbreviated HRP-503 Protocol Templates

IRB Administration has developed abbreviated versions of the HRP 503 Protocol Template  to be used in conjunction with the online Initial Review Application when there is no sponsor protocol. These templates have been tailored to eliminate redundancy and provide standardized answers whenever possible. IRB Administration’s goal is collect all information necessary to ensure compliance and protect the rights and welfare of human subjects and reduce the need to request additional information from  researchers.

Three abbreviated protocol templates have been created; one for general use and two for specific types of research.  You only need to submit one Protocol with your New Project and should select the template most appropriate for your research.

  • HRP-503 Protocol Template *Use with online Initial Review Application Form
  • HRP-503 Record/Data/Specimen Review Template *Use with online Initial Review Application Form
  • HRP-503 Surveys/Interviews and/or Focus Groups Review Template *Use with online Initial Review Application Form

Introducing UC Davis IRBNet Demonstration Videos

IRB Administration has created several IRBNet demonstration videos covering a range of topics. The videos are specific to the UC Davis IRBNet submission process and provide step-by-step guidance for UC Davis Researchers.  Click a here to view the videos.

  • Create New Project (Initial Review of a New Study)
  • Create New Package (Response to a Letter of Action, Modification, Continuing Review or Reportable New Information)
  • Package Unlocked, Project Mail Response
  • Sharing a Project
  • Electronic Signature
  • Stacking Documents

IRBNet Tip:

Corresponding with the IRB Administration

During the review process you may need to send and/or reply to a correspondence from IRB Administration. You must use the Project Mail feature within IRBNet for all communications related to your project. You can access this feature by logging into IRBNet, clicking the project title, and clicking “Send Project Mail.”

If you need to send correspondence to the IRB Administration and you are unsure who to contact, please send the message to Royce Yokoi only and he will forward your message to the appropriate person. Do not select all IRB Administration staff, as this selection will delay responses to your inquiry.


Posted November 30, 2015

IRBNet’s Initial Review Application

IRBNet has an efficient way of submitting new applications to the IRB using a “Smart Form” online application.  This electronic form is an efficient, user friendly way to submit an application that replaces all of the following:

  • HRP-211 Application for Initial Review
  • HRP-215 Research Personnel
  • HRP-503 Protocol Template  when a sponsor protocol is submitted, and
  • Project Information Worksheet.

In other words, you do not need to submit any of the above if you complete and submit an online application.

The online application is easy to complete because the form will ask questions based on answers to previous questions.  So, it will not ask for information that is not applicable to your submission.

Effective January 1st, 2016, all initial review applications submitted will be required to utilize the IRBNet online Initial Review Application form. To learn more about the benefits of the online Initial Review Application form and IRBNet, please visit our website here.

IRBNet Tip:

What is “stacking” and why is it so important?

“Stacking” is uploading a new version of a document within the same file that a current previously reviewed version exists.  Stacking is similar to filing new versions of documents in an electronic folder in chronological order with the most recent version on top.  IRBNet is an electronic database that is compliant with federal regulations.  Regulators will look at documents in IRBNet to insure the IRB and investigators have communicated when required and all documents (and versions of documents) required by regulations are maintained.   Stacking provides “version control” functionality that ensures the requirements are satisfied.

Please be sure to stack all documents, if applicable, appropriately prior to submitting the package to the IRB for review.  IRB will request that you correct your submission if the documents are not stacked appropriately.  To stack documents follow these quick and easy steps:

  1. Click the pencil icon next to the document you wish to update
  2. Click “Choose File
  3. Locate the file you wish to upload and click “Open
  4. If appropriate, update the Description field
  5. Click “Update
  6. The new version of the document is now “stacked” on top of the previous version of the document. Click the stack of papers icon IRBNet Stack Icon  to view a list of all versions of the document.
  7. Stack like documents; tracked-changes versions should be stacked on previously reviewed tracked-changes versions, while clean versions should be stacked on previously reviewed clean versions.

To learn more about stacking and more, please visit our website here.


Posted October 31, 2015

IRBNet Rollout – FINAL NOTICE

November 2, 2015 is the IRBNet Transition Deadline

As of November 2, 2015 all submissions to the IRB must be made through IRBNet. The IRB Administration will no longer accept any submissions via eDocuments and IRB accounts will be removed from the eDocuments system. If you have not prepared for the transition, please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/ to learn how to register an IRBNet account, access training resources, and request the release of your existing IRB studies.

One-on-One IRBNet Support

Need assistance with your IRBNet submission? The IRB Education Team will be available every Tuesday at noon to provide one-on-one assistance; you ca make an appointment or just stop by. For more information about IRBNet Lab hours and locations please visit our website athttp://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/#IRBNet Training.


Posted October 21, 2015

IRBNet Lab Available

10 Days until IRBNet Completely Replaces eDocuments

Starting November 2, 2015 all IRB submissions must be made through IRBNet. The IRB Administration will no longer accept any submissions via eDocuments and IRB accounts will be removed from the eDocuments system. If you have not prepared for the transition, please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/ to learn how to register an IRBNet account, access training resources, and request the release of your existing IRB studies.

*NEW* IRBNet Lab Hours

Need additional guidance or assistance with your IRBNet submission? The IRB Administration’s IRBNet experts will be available every Tuesday at noon to provide one-on-one hands on help. You can make an appointment or just stop by. For more information about IRBNet Lab hours and location please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/#IRBNet Training

*NEW* Protocol Template for Surveys/ Interviews/Focus Groups

We now have a protocol template (HRP-503) specifically for research involving interviews, surveys, and focus groups. This new template is designed to collect all of the information the IRB needs to make a determination. Our goal is to reduce the review time for these studies by eliminating the need to contact researchers requesting additional information.  We encourage you to use this template for all research involving surveys, interviews and/or focus groups. To download the template, please visit our site at http://research.ucdavis.edu/policiescompliance/irb-admin/irb-forms/.

SoCRA Chapter Meeting Thursday, October 22, 2015

Time:   12:00 PM – 1:00 PM

Location:    UC Davis Medical Center Education Building Room 3204

4610 X Street, Sacramento, CA 95817 http://www.ucdmc.ucdavis.edu/healthconsumers/calendar/Education_Building_map.html

Topic: HIPAA Privacy Rule

Speaker:   Sharalyn Reed, JD, MPH, CHC, Deputy Compliance Office, UC Davis Health

Program Objectives:   At the conclusion of the program, attendees should be able to:

  1. Explain how the Rule affects investigators’ ability to conduct research
  2. Explain the requirements that must be met before an individual’s protected health information can be accessed for research purposes
  3. Explain the rights individuals have to access, amend and amend their medical record
  4. Explain the institution’s requirement for accounting for disclosures

For more Information, contact:

Daniel Redline, BA, CCRP, CIP (Chair)

redline4research@gmail.com

Lori Ried, RN, CCRP (Vice Chair)

riedl@sutterhealth.org

Cindy Gates, JD, RN, CIP (Outreach & Education Officer)

cmgates@ucdavis.edu

Cost: Free – All SoCRA members and nonmembers are welcome.

SOCRA Members receive 1.0 continuing education unit for attending.

Remote attendance is available through WebEx if there are at least 2 SoCRA members at the Remote Site. Please email Liza Reys, Chair of the SF Bay Area Chapter, at LReys@sjm.com for details.


Posted October 12, 2015

IRBNet Final Phase Nov. 2

Important: On November 2 eDocs will no longer be available and you must use IRBNet for all submissions.

After several months of phased implementation the final deadline to transition to IRBNet is nearly here.  Soon IRBNet will be fully launched to UC Davis and we will wave goodbye to the eDocuments System. Starting November 2, 2015 all IRB submissions must be made through IRBNet. The IRB Administration will no longer accept any submissions via eDocuments and IRB accounts will be removed from the eDocuments system. If you have not prepared for the transition, please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/ to learn how to register an IRBNet account and request the release of your existing IRB studies.

*NEW* IRB Office Hours

The IRB Administration is now  hosting lunchtime office hours to answer your questions about human subjects research, IRB requirements and submission processes. You can make an appointment or just stop by. For information on dates, times, and location please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/#IRBNet Training

*NEW* IRBNet Quick Tip

As you know, the UC Davis IRB can only have quick turnaround times if we know a researcher has uploaded new or revised documents into IRBNet.. To be sure our office receives the proper notification, please click on the “mark revisions complete” link in the top left hand corner of the Designer page once the documents have been updated. This changes the red unlock symbol to a green lock and notifies us you have completed revisions.

To learn more about ways to save your time with IRBNet visit our FAQ section of our IRBNet website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet.


 

Posted September 9, 2015

Urgent IRBNet News

Have You Created an IRBNet Account Yet?

If not, you will soon be unable to submit to the IRB. For step-by-step account-creation instructions click here.

Have You Requested Access to Your Existing Studies Yet?

If not, time is running out. After September 14 all Continuing Review submissions must be made through IRBNet.

You must email the IRB Education Team and request that your studies are released. Do not create a new project when submitting for an existing study.  For more information about requesting access to your existing studies click here.

Once the study release is complete you will see your protocols when you log into IRBNet. You and your research team will use IRBNet for all future IRB submissions.

IRBNet training is available via online and/or in classroom. Classes are being held weekly every Wednesday. For more information about IRBNet training, please visit our website here.

Ten Reasons to Create your IRBNet Account Now:

  1. All submissions must be through IRBNet beginning November 2.
  1. It takes less than 5 Minutes to create an account.
  1. The IRBNet online Initial Application Smart Form is the fastest and easiest way to create a new study.
  1. You can access your IRBNet account to upload, sign and view documents wherever there is Internet.
  1. IRBNet is a repository for all of your IRB documents.
  1. You never have to find the investigator to obtain a signature. Wherever there is Internet, the PI can sign.

4.   You can track the review process in real time.

  1. You can sync your CITI account with IRBNet so you will know when training is required.
  1. Submitting through IRBNet speeds up the review process.
  1. Submitting through IRBNet reduces the workload for everyone!

IRBNet TIPS

Project Status View: Submission Manager Enhancement

On the top of the My Projects table, to the left to the “Collapse by Project” link, you will find the new “Project Status View” link.  Clicking this link will reveal the most recent Project Expiration Date and Project Status for each submission. This information will be displayed for all submissions shown.  Uses include:

  • Prioritize Continuing Review submissions according to Expiration Date.
  • Combine “Project Status View” with “Collapse By Project” to view projects according to Project Status.

Tagging Your Projects

Use Tags  to organize your projects, track tasks and status, and share important information with other users. When you tag a project you can choose if you want to keep the Tag personal (only you can see it) or if you want to share the Tag so it can also be seen by others (note that you can only share your Tags if you have Full or Write access to the project). For example:

  • Add a Tag to remind your PI to sign the new package waiting for submission
  • Add a Tag to remind your PI of the IRB administrative due dates for renewals
  • Add a Tag to identify protocols that are Clinical Trials
  • Add a Tag to identify sponsored protocols

Replying to IRBNet Messages

Messages sent from IRBNet are being forwarded to the email address on file in your account profile.  Please keep in mind to reply to this message you need to log into IRBNet and use the “Send Project Mail” feature to respond.  DO NOT REPLY DIRECTLY TO THE EMAIL. This is the only way IRBNet will be able to capture and archive communication between the researcher and IRB.

Note: Federal regulations require that all communication between researchers and the IRB, in regards to a specific protocol under review, be kept on file with the protocol. This requirement applies to the IRB and the researcher. IRBNet was designed to do this for both parties by storing the communications in one location that all have access to. This feature only works if it is used properly by both parties.

 


 

Posted August 19, 2015

IRBNet Stage 1 Launch a Go!

You’ve trained on IRBNet. You’ve activated your IRBNet account. You’ve integrated your CITI account. Now you’re ready to use this awesome new online electronic database. As of August 17th all initial review submissions are required to be submitted via IRBNet. Initial applications submitted through eDocuments will be rejected with instructions on how to setup an IRBNet account. At this time, we are not requiring researchers to use IRBNet’s Online Initial Review Application  (although we think you’ll find it much easier to use than the old HRP-211 Application for Initial Review).  For the time being, we are still accepting HRP-211 Application for Initial Review, with supporting documentation, when submitted via IRBNet. To improve on IRBNet’s functionality as a “one stop shop” electronic database for submitters we have added our forms and templates into IRBNet’s Library. The following documents are now located within the “Forms and Templates” section of IRBNet:

  • Form: HRP-211 Application For Initial Review
  • Template: HRP-502 Informed Consent
  • Template: HRP-503 Protocol
  • Template: HRP-503 Research Involving Record/Data/Specimens Review
  • Template: HRP-504 Letter For School Permission To Conduct Research

Be prepared for the next stages:

  • Stage 2: September 14 – You will need to submit all continuing review submissions through IRBNet.
  • Stage 3: November2 – You will need to submit all submissions through IRBNet.

ONGOING: ALL PRINCIPAL INVESTIGATORS, CO-PRINCIPAL INVESTIGATORS, AND PRIMARY CONTACT PERSONNEL ARE REQURIED TO CREATE AN IRBNET ACCOUNT FOR RELEASE OF EXISTING STUDIES

IRBNet Training Available Online or in Classroom

Learn more about IRBNet by taking an online course and/or reserve a seat in a classroom. For more information about IRBNet training, please visit our website here.

For further information about IRBNet, please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet.


Posted August 5, 2015

New Submission Requirements Starting August 17th

Out with the old, in with the new! As you may recall from last month’s announcement, the IRB Administration has successfully field tested IRBNet in preparation for its release to the research community. We are now ready to roll IRBNet out in stages to the community to smooth the transition between systems. The stages will occur as follows:

  • Stage I: August 17 You will need to submit all initial review submissions through IRBNet.

 

  • Stage 2: September 14You will need to submit all continuing review submissions through IRBNet.

 

  • Stage 3: November 2 You will need to submit all submissions through IRBNet.

For those not familiar with IRBNet, here is a brief summary:  IRBNet is a researcher-facing database that contains a robust set of electronic tools supporting the management, submission, review and oversight of research protocols. Some of the many features include an online initial application, electronic document management, web-based protocol sharing and collaboration, automatic notifications, electronic submissions and reviews, integrated training and credential management, and important audit capabilities including electronic revision histories, electronic signatures and event tracking.

IRBNet training is available via online and/or in classroom. For more information about IRBNet training, please visit our website here.

For general information about IRBNet, please visit our website at http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet.

 

 

More information on Exemption Category 4 and Medical Record Review

Last month, we reported that we would start applying exemption Category 4, research involving the use of existing data, to protocols that involve retrospective medical review as the primary activity.  To qualify for this exemption, the following must be true:

“Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects

In layman terms, when you record data from the medical record you cannot record any individually identifiable information. In addition, you cannot use a coding system to link the information back to an identifier for future reference. In other words, the recorded data must be completely anonymous. However, limited data sets are considered “not individually identifiable” and qualify for this exemption.  See our HIPAA Guidance webpage for additional information on what is considered identifiable data.

Please be aware, approval of research for retrospective chart review will cover only records that already exist at the time of initial submission to the IRB. If you believe that you might need to later revise your study to obtain information from medical records that will be completed in the future (but are existing at the time of the revision), you should consider including the procedures in the initial submission and obtaining prospective consent from those patients about whom medical record data will be generated.  We are unlikely to approve modifications to studies that keep extending the data range of records to be reviewed unless the modification includes a plan to obtain consent and authorization from the patients.  UC Davis IRB is committed to follow the ethical principle of Respect for Persons, which means we will obtain prospective consent and HIPAA authorization from subjects if we contemplate the need to use their information for research purposes.

If you have any questions about this topic, please contact our Outreach, Training and Education team.

 

OHRP Education Workshop, October 14th

OHRP is hosting an education workshop for research investigators and coordinators relatively new to human subjects research.

The Office for Human Research Protections (OHRP) co-hosts with

The Office of Extramural Research (OER) at the National Institutes of Health

A one-day pre-seminar workshop

“Getting through Human Research Reviews with Skill”

On Wednesday October 14, 2015

At the 2015 NIH Regional Seminar, Hilton San Diego Bayfront in San Diego, California

This workshop aims to provide participants with the skill and knowledge necessary to have their NIH grant applications and research protocols pass reviews for human research protections. It will focus on clarifying confusions and providing participants with practical tips and solutions to problems and difficulty commonly encountered during such reviews.

This activity has been approved for 5.75 AMA PRA Category 1 Credit™

REGISTER NOW at http://regionalseminars.od.nih.gov/sandiego2015/sessions/00a/ if you answer YES to any of the following questions:

  • Do you feel quite baffled by the different requirements on human research protections and wondered how you could get ahead of the process?
  • Are you sometimes confused when a research using data collected from human participants is considered ‘human subjects research’ and when it is not?
  • Have you ever felt frustrated with being told that you had not included adequate protections for human participants, when you had already spent hours working on the proposal?

Posted July 10, 2015

Changes to reduce administrative burden

The UC Davis IRB is always looking for ways to reduce administrative burden on researchers, IRB Members and IRB Staff.  We are pleased to announce several changes in our procedures that should have this effect.

(1)  Exemption Category 7

First, we have created a new Exemption Category for some minimal risk studies that do not quite fit within the categories existing under the regulations.

“Exempt Studies” are studies that are not covered by the regulations found in the Common Rule.  Exempt studies do not require continuing IRB oversight, so you need have limited contact with the IRB after approval.  In fact, the only time you need to contact the IRB about an exemption is to obtain the exemption determination before study start and to submit protocol revisions so we can determine if the changes cause the study to no longer qualify for exemption.   You do not have to send updated research personal lists for exempt studies.

Exemption Category 7 is available only for studies that are not funded or supported by the federal government.  The study must also involve only minimal risk and must not include any physically invasive interactions.  Exemption 7 includes studies that are not federally funded or supported and are limited to activities such as:

  • Reading/writing/drawing tasks.
  • Physical activities such as walking, sitting, or manipulating an object.
  • Computer tasks and/or Internet searches
  • Talking and/or listening to words, then making selections, or “think-aloud” exercises.
  • Viewing media
  • Role-playing.
  • Completing a specific physical or mental action (“imagining”).
  • Passive monitoring of space (environment) with sensors.
  • Playing a game.
  • Height/weight measurements.

To obtain an exemption determination, please submit the usual documents to the IRB (HRP 211 Application for Initial Review; HRP 226 Administrative Approvals; and HRP 503 Protocol Template or Protocol Template for Research Involving Record/Data Review.  If your study includes interactions or interventions with participants, you will need to submit consent language that includes:

  • A statement that the project is research;
  • A description of the procedures;
  • A statement that participation is voluntary; and
  • The PI’s name, association with UC Davis and contact information.

We will begin to immediately apply the criteria for Exemption 7 to new initial applications.  Current approved protocols may qualify for Exemption 7, which will be determined at next renewal.

(3) Extended application of Exemption Category 4

In the past, the IRB has not included research that involves retrospective review of medical records as exempt under Category 4, research involving the use of existing data. Instead, we elevated the review requirements to the expedited review level, which involves additional administrative burden on behalf of the investigator and the IRB.

We recently researched how other IRBs apply this exemption when retrospective medical record review is the primary activity, and found that this exemption is routinely applied. We will now include these types of studies under this exemption.  We will waive the requirements for HIPAA Authorization for this type of research whenever the requirements for the wavier are met.

Please be aware, approval of research for retrospective chart review will cover only records that already exist at the time of initial submission to the IRB. If you believe that you might need to later revise your study to obtain information from medical records that will be completed in the future (but are existing at the time of the revision), you should consider including the procedures in the initial submission and obtaining prospective consent from those patients about whom medical record data will be generated.  UC Davis IRB is committed to follow the ethical principle of Respect for Persons, which means we will obtain prospective consent and HIPAA authorization from subjects if we contemplate the need to use their information for research purposes.

(3) Revised Deviation Reporting Timelines

Next, to reduce administration burden, the IRB has revised the policy for reporting deviations from the protocol, regulations and IRB requirements.  In the past, investigators were required to report deviations within five business days of learning about the deviation.  The procedure has been revised to allow for a ten-day deadline for these reports.  This revision is documented in our FORM: HRP-214 Report of New Information.

Please note that reports of new risk information must be reported within five business days.  Risk information includes serious adverse events that are both unexpected and related to the study, revised investigator brochures with new or revised risk information, sponsor letters to investigators advising of new risks, etc.

HIPAA Accounting for Disclosures

The Federal Privacy Rule (HIPAA) requires University of California, Davis Health (UCDHS) to maintain records of access to protected health information (PHI) for research activities (1) preparatory to research,  (2) through a waiver of authorization; and (3) involving decedent’ PHI. UCDHS must provide information about those disclosures upon request of the patient or their legally authorized representative. All such access must be documented by accessing the Tracking and Disclosure database.

Recording a disclosure of access to patient records may be documented in one of two ways:

(1)  Quick Disclosure Activity in EMR – Please see P&P 2446 for instructions or contact research compliance for a quick demonstration at: complianceresearch@ucdmc.ucdavis.edu

(2)  Disclosure Tracking Database:  https://disclose.ucdmc.ucdavis.edu/ or by typing “disclose” into the UCDMC intranet web browser.

For more information, go to http://www.ucdmc.ucdavis.edu/compliance/guidance/research/researchprivacy.html. Alternatively, questions/training on HIPAA accounting, please contact the Compliance Program at complianceresearch@ucdmc.ucdavis.edu.

IRBNet Update and Training Opportunities

Back in April, we announced the testing of our new electronic database system, IRBNet, and offered in-person training for departments/divisions willing to take the first step into IRBNet. Testing has been completed successfully and we would like to thank the individuals in the 18 departments/divisions for volunteering and their valuable feedback.

We are now in final preparation for launching IRBNet to the research community; the official launch date has yet to be determined. In the meantime, our Training and Education group would like to extend the offer of in-person training classes to all department/divisions. Classes are being held once a week thru the month of August.

Do not delay, space is limited and classes fill up quickly and we will no longer begin to accept submission through eDOCs sometime this fall. Please contact our Training and Education Analysts for more information and reservations:

        Nicole Walters   ntwalters@ucdavis.edu

        Miles McFann   mtmcfann@ucdavis.edu


Posted April 7, 2015

New IRB Electronic Database

We are happy to announce that we are launching IRBNet to the research community early this summer.

Since 2011, the UC Davis IRB Administration has been using a web-based system called IRBNet to administratively process the review all submissions sent to our office.  As part of our process, we have been creating a submission and uploading the documents you send through eDocs into the IRBNet system.

With this launch, you will have direct access to IRBNet and will upload your own submissions directly into this web based system.  You will also be able to manage, modify and track your submissions through this system.  In fact, this transition will allow you to:

  • Access to your submissions anytime and anywhere Internet access is available
  • Use an online questionnaire to automatically complete an Initial Review Application Form, which will streamline the submission process
  • Use electronic signatures instead of pen and paper signatures whenever Internet access is available
  • Receive real-time notifications of changes in submission status
  • Use the system for electronic storage for IRB correspondence and for all documents reviewed and approved by the IRB

One more advantage, is that you will no longer need to submit an HRP Form 503, Description of Study, when you use the new electronic Initial Review Application Form and submit a sponsor protocol.

These past months we’ve been testing IRBNet with principal investigators and coordinators to prepare for this launch. Now we’ll begin a pre-launch rollout of the system by offering departments (UCD or UCDMC) a chance to switch to IRBNet prior to the launch date. We are looking for departments that are willing to commit, as a group, to receive IRBNet training and transition to IRBNet two weeks after training.  If your department wants to participate in this pre-launch phase, you will need to schedule your department for training on the IRBNet system.  To schedule an appointment, please contact our Training, Education and Outreach team:

  • Nicole Walters at ntwalters@ucdavis.edu
  • Miles McFann at mtmcfann@ucdavis.edu

We are not accepting individual requests for pre-launch training and transition.  If you are not part of a department that chooses to obtain the training, we ask that you refrain from using IRBNet on your own until you are invited to do so.  We need to roll the system out slowly because there is a significant amount of work we have to do in the background each time an investigator access the system for the first time. If too many investigators initiate their first access at the same time, the additional background work will negatively impact on our ability to complete reviews and result in delays.

Until you receive log-in instructions for IRBNet from us, please continue to use our eDocuments system for all submissions (i.e. Initial Reviews, Continuing Review, Modifications and Reportable New Information).

 


Posted March 23, 2015

New Law Impacting Newborn Research

The Newborn Screening Saves Lives Reauthorization Act of 2014 (HR 1218) went into effect on March 16, 2015 and applies to blood samples obtained for federally mandated newborn screening tests.

The law requires the regulations for human research (45 CFR 46) to apply to research with newborn screening blood spots whenever the research is funded by the Public Health Service Act. As currently written, 45 CFR 46 excludes use of newborn screening bloodspots because the use is not considered human subjects research. This new law takes priority over the current regulation.  Second, the law eliminates the ability of the IRB to waive informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots.

The law was enacted December 18, 2014 and took effect March 16, 2015.  Submissions for IRB review on newborn screening research will follow the current review process. For more information about the review process refer to our Investigator Manual.

 


Posted February 2, 2015

Change to Administrative Due Date

We are pleased to announce that we are reducing the administrative due date for protocol renewals and closures from 60 days prior to study expiration to 45 days prior to study expiration.  This change will be effective on February 4, 2015, and will appear on approval letters  issued on and after February 4.

This change will have no impact on submissions already received by our office.  These submissions will be reviewed according to the previous schedule.  Our online forms have been updated to reflect this change.  We will accept the older versions of the form until March 5, 2015.  The IRB will not accept the older version of the forms after this date.

In addition, the courtesy renewal reminder notices will no longer be issued at 90 days prior to expiration.  Instead, the notices will be sent out 60 days prior to expiration.  Going forward, courtesy reminders will be sent according to the following schedule:

  • 60 days from protocol expiration
  • 30 days from protocol expiration*
  • On or after protocol expiration date**
*The IRB will require the principal investigator (PI) to submit a corrective and preventive action plan to address late submissions of Continuing Review Progress Reports (HRP-212) within the 45 day due date.  This plan should outline the actions that will be taken to ensure future reports are submitted on or before the due date. 
**The IRB will restrict PIs from submitting new protocols for review whenever approval of a protocol terminates because of the PIs failure to submit the HRP-212 progress report prior to the expiration date.  The PI will remain on the restricted list until the issue is resolved.

Please note that submissions received more than 90 days before the protocol expiration date will be rejected.

Principal investigators should not rely on the IRB’s courtesy reminders as the only means of meeting submission timelines. Instead, PIs and research staff should create their own personalized notification system to ensure that reports are submitted before the administrative due date.

 


Posted October 9, 2014

AAHRPP ACCREDITATION VISIT

JANUARY 5-7, 2015

The University of California, Davis is in the final stages of receiving institutional accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).  This organization accredits high-quality human research protection programs in order to promote excellent, ethically sound research.

As part of the accreditation process AAHRPP members will be visiting our campuses January 5 – 7 to assess UCD’s Human Research Protection Program. The site visit will include interviews with faculty and staff who are engaged in human subject research.  Individuals to be interviewed will be chosen by AAHRPP in early November.  As soon as we receive the list of individuals to be interviewed, UCD’s IRB Administration staff will contact those selected to schedule a one-hour training and interview preparation session.

If you have any questions about this accreditation process, please contact Kathryn Smith at 530-304-8051.

Starting a new chart review study? 

Try our new

Retrospective/Prospective Data Review Protocol Template

Using our template will save time, reduce the number of questions we ask you and reduce the number of questions you have for us.  You can find the template at:  Protocol Template – Retrospective/Prospective Data Review.

We have taken away the head scratching and guessing and have, instead, provided you with a way to include all of the information you need to include in your protocol through questions and answers.

Sample:

Indicate if this is a retrospective and/or prospective chart/data review:

☐ Retrospective Chart/Data Review (Retrospective means the data you will access are already in existence when the project is submitted to the IRB for initial review)

When were these data collected by the source?

From Month/Year  to Month/Year

☐ Prospective Chart/Data Review (Prospective means the data you will access are not in existence when the project is submitted to the IRB for initial review)

When will these data be collected by the source?

From Month/Year  to Month/Year

This simplified form is a win for both you and the IRB. It decreases the amount of time you spend filling out the form and decreases the amount of time the IRB spends on reviewing the form.

If you have any questions about the new template, please contact Miles McFann.

Tips: Documents the IRB Does Not Need

Often our office receives additional documentation that is not required for us to conduct our review. Please only submit documentation that is outlined on our HRP-211 – Application for Initial Review.

Below is a sample of forms we do not need to review:

  • HIPAA Authorization Form for Research (UCDMC Approved Form)
  • Self – Certification of Surrogate Makers for Potential Subject’s Participation in University of California Research (UC Approved Form)
  • IRB Worksheets
  • IRB Checklists

 


Posted September 10, 2014

Notice:  Using Electronic Signatures on IRB Forms

Please note: As a Principal Investigator, if you allow your staff to apply an electronic signature to a form submitted to the IRB, you are responsible for ensuring the form is accurate. You should have procedures in place to ensure you review these forms before they are submitted.

Requirements for Institutional Biosafety Committee (IBC) Review

As a reminder, the UC Davis Institutional Biosafety Committee (IBC) provides oversight of campus and UCDHS research, teaching, and related activities that involve recombinant DNA technology, infectious agents, and other biohazardous materials (e.g. materials that fall under the Bloodborne Pathogens Standard). The IBC assesses each project, determines the appropriate containment (biosafety) level, and approves these activities through the Biological Use Authorization (BUA) process. The IBC membership and business activities conform to the requirements of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.  The Vice Chancellor for Campus Planning, Facilities, and Safety appoints IBC members and provides staff support to the IBC.  If you would like more information on BUAs, please visit this website (http://safetyservices.ucdavis.edu/ps/bis/f_p/bua/bioUseAuthorization_BUA) or contact the Biosafety Office (biosafety@ucdavis.edu).

Faculty Still Needed:  Chancellor Requests Feedback on Research Compliance Infrastructure

Chancellor Linda Katehi has commissioned an external assessment of research compliance and integrity at UC Davis. To this end, on October 13-15, 2014 we will host a team of five nationally recognized research administrators on campus conducting a peer review of our research compliance structures as part of the National Council of University Research Administrators (NCURA) peer review program. This review, similar in nature to an academic program review, is being done to ensure that we are appropriately organized to advance excellence in research and ensure the ethical conduct of research while also encouraging creative accomplishments with the UC Davis community.

The site visit in October provides an opportunity for the NCURA peer reviewers to interact with representatives of important constituent groups in the UC Davis research community. The NCURA peer review team would like to meet established faculty and junior faculty (faculty with 3-5 years of independent research) whose research requires oversight by one or more research compliance committees (IRB, IBC, COI, SCROC, HASTOC, etc).

The NCURA group has requested two sessions of up to 20 faculty researchers (one for established faculty and one for junior faculty).  As such, the following times have been established for this purpose.

Wednesday, October 15, 2014 – location Alumni Center, Founder’s Board Room

Established Faculty Session:  1-1:30 pm

Junior Faculty Session:  2:30-3:15 pm

Please confirm your availability to participate as soon as possible by email to Compliance Analyst Larisa King (loking@ucdavis.edu; 530-752-6550).

 


Posted September 2, 2014

IMPORTANT NOTICE

We recently updated the Human Research Protection Program Plan,  

the Investigator Manual, and many of our SOPs.

We also updated most of our forms.

Please read the revised Plan and Manual.

 Please download the forms from our website for new submissions.

Updated Submission Forms

This past week we released a multitude of revised documents (e.g. Forms, Templates, Checklists, etc.) on our website in response to AAHRPP’s requested changes as part of our Step 1 and Step 2 applications for accreditation.  Most of the changes are minor.  However, the Human Research Protection Program Plan, the Investigator Manual, and three forms have important revisions (HRP-212, HRP-213 and HRP-507).

The Continuing Review Progress Report (HRP-212) form now includes two new fields:

  • A new field has been added to capture information about modifications, revisions, or changes made to the research without first obtaining approval. The IRB is required to have procedures in place to ensure that changes to research are not implemented without IRB approval, unless the change is required to protect a participant from an immediate hazard.  If you did not make any unapproved changes to your research, you need only check the “No” box.  However, if you made unapproved changes to the research, you will need to complete additional forms to provide information about the change(s).
  • A new field has been added to address the IRB’s requirement for you to submit your plan to comply with the IRB’s reporting requirements whenever you submit the continuing review progress report after the due date. Before this revision, you were required to submit an additional form (HRP-214) to describe your reasons for submitting the report late and to describe your plan to ensure you submit future reports before the due date.  This revised form captures the same information as the HRP-214 form, so you no longer need to complete that additional form.  If you submit your report to the IRB on time, you need only mark “No” in the first box of this new field.  If you submit the report after the due date, you need to complete the remaining fields in the section.

The Modification (HRP-213) form now includes:

  • A new field to quickly identify when a modification involves new foreseeable risk information. The new field also captures information that will help the IRB determine whether the plan for notifying participants about the new risk information is sufficient.   Previously we requested investigators to submit a Reportable New Information (HRP 214) form whenever a modification included new foreseeable risk information.  This revision replaces the need for the additional form HRP 214.

The updated Informed Consent Short Form (HRP-507) now includes fields for investigator contact information. You must include this information before using the form.

These revisions were designed to reduce the number of forms that need to be submitted while increasing everyone’s ability to remain compliant with standard operating procedures, UCD policies, state law and federal regulations.  To reduce your workload, please start using the new version of the forms today.  The IRB will no longer accept outdated versions of these forms after November 3, 2014; only the newer version will be accepted.

Tip: Using the Updated Informed Consent Short Form

Since we work in a fast-paced environment, it is not always convenient to complete the form after a potential non-English speaking participant is identified.  We recommend completing these forms in advance so you will have a “ready to use” copy of each translation of this form.

 


Posted August 19, 2014

Informed Consent Short Form

In our continuous efforts to increase efficiency and consistency, the IRB Administration updated our short form (Informed Consent (HRP-507) so that it is similar in design, formatting and wording with our Informed Consent (HRP-502). The new short form will include the experimental bill of rights, updated boilerplate language, and new signature blocks (i.e. assenting children and cognitively impaired). The form will be available in the following languages; Vietnamese, Chinese, Hmong, Russian and Spanish.

The forms will be posted to our website on August 15, 2014.

An IRB gentle reminder, whenever you need to use the short form Informed Consent (HRP-507), you must follow the regulations and UC Davis policies.  It important that you review our Standard Operating Procedure Informed Consent Process for Research (HRP-090) and Standard Operating Procedure Written Documentation of Consent (HRP-091) to ensure that you conduct the consent process and document consent in compliant manner.

Chancellor Requests Feedback on Research Compliance Infrastructure

Chancellor Linda Katehi has commissioned an external assessment of research compliance and integrity at UC Davis. To this end, on October 13-15, 2014 we will host a team of five nationally recognized research administrators on campus conducting a peer review of our research compliance structures as part of the National Council of University Research Administrators (NCURA) peer review program. This review, similar in nature to an academic program review, is being done to ensure that we are appropriately organized to advance excellence in research, ensure the ethical conduct of research while also encouraging creative accomplishments with the UC Davis community.

The site visit in October provides an opportunity for the peer reviewers to interact with representatives of all the important constituent groups in the UC Davis research community. The NCURA peer review team would like to meet established faculty whose research requires oversight by research compliance.

The NCURA group has requested 1-3 sessions of up to 20 faculty researchers apiece. Therefore, the following times have been established for this purpose.

Wednesday, October 15, 2014 – location Alumni Center, Founder’s Board Room

Faculty Session 1: 1-1:30 p.m.

Faculty Session 2: 1:30-2 p.m.

Faculty Session 3: 2-2:30 p.m.

Please confirm your availability to participate by August 22, by email to Compliance Analyst Larisa King (loking@ucdavis.edu; 530-752-6550). While we understand that many of you may not be available at the specified time, we are hoping to garner as much participation as possible. NCURA is looking for your unique viewpoints and perspectives and this would be an opportune time to express the challenges and opportunities of our research compliance program.

Additionally, NCURA has requested to meet with junior faculty (faculty who have been conducting between 3-5 years of independent research) at a meeting which has been scheduled to take place on the same day, October 15th, from 2:30-3:15 p.m. If you consider yourself to be a junior faculty member, NCURA is interested in hearing your perspectives as well. Again, please contact Larisa King at loking@ucdavis.edu with your availability by August 22.

 


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 Listforms. New versions of these forms have been available since November 26, 2013.  You should start using the new forms immediately.

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:

  • HRP-503
    Protocol
  • HRP-502
    Consent Form, if applicable

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:

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:

    • HRP-211
      Application for Initial Review
    • HRP-213
      Modification
    • HRP-503
      Protocol
    • HRP-090
      Standard Operating Procedures: Informed Consent Process for Research
    • HRP-091
      Standard Operating Procedures: Written Documentation of Consent
    • Research Personnel List Template (NEW)
 

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://research.ucdavis.edu/policiescompliance/irb-admin/researchers/meetings/.

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://research.ucdavis.edu/policiescompliance/irb-admin/researchers/citi/.

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:

  • 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.
  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • 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.
  • 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:

  • 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
http://research.ucdavis.edu/policiescompliance/irb-admin/irb-forms/  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