Advisories

Subscribe to the IRB-Info listserve to stay informed of changes to the UC Davis IRB Administration Web site and/or policy and procedure changes of the UC Davis Institutional Review Board (IRB).

Posted:  April 17th 2009

Re: Three significant improvements to the human research protection program (HRPP) at UC Davis

The Institutional Review Board (IRB) Administration is pleased to announce three significant improvements to the human research protection program (HRPP) at UC Davis.
 
1) Electronic submissions to the IRB Administration via eDocs
Effective immediately, all submissions to the IRB Administration will be accepted electronically via the Office of Research’s eDocs portal at http://research.ucdavis.edu/edocs.
 
Hardcopy submissions to the IRB Administration office in person or via campus mail are no longer required. Please note: all signatures for a complete application should continue to be obtained prior to submitting the material to the IRB electronically.
 
We hope this pilot program will conserve valuable resources for researchers. Approval notices and IRB-stamped study documents will continue to be sent to researchers via campus mail (or held for pick-up upon request). Efforts are being made to develop a system to transmit approval notices and IRB-stamp-approved study documents electronically in the future.
 
Instructions are on how to submit to the IRB Administration electronically are available here and at the IRB Administration website.
 
2) Expanded online resources for researcher investigators
The IRB Administration is also piloting a blog to improve communication between the IRB, its staff, and investigators. We encourage you to regularly visit the blog at www.ucdirb.blogspot.com.
 
As new guidance, submission tips, and minor revisions to procedures and applications are generated, www.ucdirb.blogspot.com will be updated. We welcome your comments, frequent visits, and subscription to its RSS feed. The blog will not replace the IRB listserve which will continue to inform investigators of significant news and items of interest.
 
In addition, the IRB Administration website is being updated regularly. Please visit the homepage of the IRB at www.research.ucdavis.edu/IRBadmin and see the expanded “Guidance” section. You will always find the current applications and forms at the IRB website.
 
3) Correction to Adverse Event reporting procedures
After an internal review, it was discovered that the December 9, 2008 IRB Administration Advisory contained a significant error regarding appropriate reporting of adverse events to the UC Davis IRB for multisite research trials.
 
If a reportable adverse event occurs at a collaborative site or non-UC Davis site which is part of a multisite research trial following the same protocol as the UC Davis site, that adverse event must be reported to the UC Davis IRB within 10 days of the research investigator being notified.
 
As a reminder, an adverse event is reportable when the event:
 
a.  suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized, and
 
b.  is unanticipated (that is, the specificity or severity of the event is not consistent with the current Investigator’s Brochure, consent form, or other current risk information); and
 
c.  is related or possibly related to the research (Note:  an adverse event is “related to the research procedures” if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely than not that the event affects the rights and welfare of current participants).
 
If conditions a, b, and c are not met, the event should be reported at the renewal review to the UC Davis IRB as part of the continuing IRB review process or upon study closure. The IRB Administration standard operating procedure and adverse event forms have been revised to reflect this correction.
 

Posted:  December 9, 2008

**Please Note:  Update and Revision of this advisory appear at the April 17th 2009 Posting, Above**

Re: Reporting of Adverse Events and Unanticipated Problems

Based on guidance issued by the Office of Human Research Protection (OHRP), the IRB Administration office has updated its Standard Operating Procedure (SOP) regarding reports of “adverse events and other unanticipated problems”.  

Effective immediately, consistent with OHRP guidance, investigators are required to report “serious adverse events” as well as “other unanticipated problems” to the IRB Administration within five days of the investigator becoming aware of such an event, only if all of the following four criteria are met:  

The event or problem:

·         occurred at UC Davis; and

·         suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized, and

·         is unanticipated (that is, the specificity or severity of the event is not consistent with the current Investigator’s Brochure, consent form, or other current risk information); and

·         is related or possibly related to the research (Note:  an adverse event is “related to the research procedures” if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely than not that the event affects the rights and welfare of current participants).

In addition to the above reporting requirement, investigators are reminded to also report similar eventsoccurring at other sites, as well as ALL adverse events occurring at UC Davis (including the ones reported as stated above), in a table format (available on IRB website in the “Forms” section, http://www.research.ucdavis.edu/documentDisplay.cfm?id=409,doc) at the time of continuing review of their protocols.

Posted: November 19, 2008

Re: The number of copies required by the IRB Administration 

We have streamlined document processing at the IRB Administration which has resulted in the need for a substantially less number of copies to process each protocol.

Currently we require:

·         25 copies of each application package submitted for full committee review,

·         25 copies of each revised application package, required for further full committee review, should the full committee require substantive revisions to the initially submitted package. 

****  Effective immediately, the IRB Administration will require only two copies of any package submitted to IRB Administration for any type of review.  ****

To streamline the process further, and achieve higher efficiency, we are seeking your assistance and cooperation to ensure that:

·         The duplicate copies are complete and identical,

·         All packages include required supporting documents, and

·         The most current forms, available on the IRB Administration website, are used for    preparation of study documents. 

The forms are available in the "Forms" section of the website (at the following URL: http://research.ucdavis.edu/home.cfm?id=OVC,1,1069).  Please note that the use of outdated forms (that may not reflect the current regulation/policy/procedure) will certainly result in protocol review delays in order to collect the correct and current applicable information. 

As we continue to reduce the burden associated with these processes, we anticipate that the above enhancement is a welcome change by the Research Community that we serve.

Please feel free to contact the IRB Administration staff (http://research.ucdavis.edu/home.cfm?id=OVC,1,1062,1074) if we can be of further assistance.

Posted: August 24, 2008

Re: IRB Review Fees

Please note that these fees apply to all research involving human subjects, fully, or in part funded by extramural funds, and conducted by UC Davis employees, students, or agents, except for those projects that are fully funded by the following sources:
 
1. Federal government
2. State of California and its local governments
3. Non-profit foundations
4. UC Davis Departmental discretionary funds 
 
Additionally, the following projects will not be assessed IRB review fee:

• Unfunded projects, such as projects conducted by undergraduates, as a part of their educational activities are also exempt from the application of IRB review fees,
• Projects that qualify as “Exempt Review”, as defined by the Federal regulations (please see details at the URL provided below),
• Reporting of noncompliance, potential unanticipated problems, or adverse events,
• Applications involving a non-research use of a Humanitarian Use Device,
• Application for emergency or one-time use of an investigational drug or device, or
• Medical records research that is not industry-sponsored,
• Modification of an approved protocol, when the only noted change in a proposed modification is the study personnel change. 
   
  To expedite the review, with each project subject to IRB Review Fess submitted to IRB, please provide the completed one-page “Sponsor Information Form for IRB Fees” currently available at: 
  http://research.ucdavis.edu/home.cfm?id=OVC,1,1069  
   
  Details of the updated IRB Review Fees are available at the following URL: 
  http://research.ucdavis.edu/home.cfm?id=OVC,1,1988

Posted:  October, 12, 2007

Re:  Version dates on forms

OHRP has recommended that IRBs require Investigators to include version dates on all informed consent documents, descriptions of study, and all other documents requiring IRB approval.  This requirement is an attempt to avoid confusion by IRB members, IRB staff, and Investigators regarding which version of a document was approved by the IRB.

All documents submitted on or after November 1, 2007, must identify the date these documents were developed (using the footer feature of the document).  Each time a document is revised, the date must be updated to reflect the date when those changes occurred. 

In addition, Investigators are advised of a change in the VA/UCD Joint Model Consent Form, Section “Radiation (X-Ray) Risks”.  Effective immediately, Investigators are referred to the UC Davis Radiation Safety Manual, Human Research Use Research Application (Form 5, Attachment 3) to determine the appropriate radiation risk statement(s) to be included in the consent document.  For questions, contact the Radiation Use Committee at 734-3355.

Posted:  July 2, 2007
Re: UC Davis CTSC Clinical Research Center (CCRC)

In an arrangement with the VA Northern California Health Care System IRB, the UC Davis IRB has agreed to serve as the IRB of Record for all clinical trials carried out at the UC Davis CTSC Clinical Research Center (CCRC) and the UC Alzheimer’s Disease Center (ADC).  Review of these studies by the VA IRB will no longer be required. 

Under this arrangement:

·        All CCRC studies must be clearly identified by including the acronym “CCRC” at the beginning of the study title.  All ADC studies must be clearly identified by including the acronym “ADC” at the beginning of the study title.

·        Protocol applications that have not previously been reviewed by the Cancer Center Scientific Review committee must be submitted for review by IRB Clinical Committee A

·        Protocol applications that have previously been reviewed by the Cancer Center Scientific Review committee may be submitted for review by either UC Davis IRB Clinical Committee A or B

·        Upon approval of the protocol by the UCD IRB, the approved protocol must be submitted to the VA R&D committee

A joint VA-UCD model consent form has been developed which includes standard language requirements for both the VA and UCD.  In addition, a joint VA-UCD HIPAA research authorization form has been developed which satisfies the requirements for both the VA and UCD.  All new and continuing CCRC or ADC applications received after September 1, 2007 must include the consent form in the new format and must use the new HIPAA research authorization.  For applications submitted prior to September 1, 2007, PIs are strongly encouraged to use the new forms if feasible.

The joint model consent form and joint HIPAA research authorization form may be found on this website under Forms 

Posted: March 30, 2006
Re: New and Revised UC Davis IRB Policies and Forms

The IRB Administration recently completed a rigorous review of Federal, State and Institutional policies and regulations regarding the protection of human subjects in research. As a result, the IRB Administration is issuing a significant number of new and revised IRB policies, which primarily reflect current IRB practices. Various forms have also been revised or newly developed. The new policies are located under the heading Policies, Regulations & Guidance on this website. Revised and new forms are located under the heading Forms. Please ensure that future submissions adhere to the use of these new/revised policies and forms.

UC Davis is currently in the process of seeking accreditation of its Human Research Protection Program from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). As part of this process, the policies are being submitted to AAHRPP for review. During this review process, the policies will be marked as INTERIM, although unless otherwise noted they will be effective immediately.

The IRB also welcomes comments and/or suggestions regarding the policies from the UC Davis research community. To submit your comments please use the Suggestion Box for Comments also located on the IRB Administration website.

To stay current with IRB policies and procedures, we strongly urge you to subscribe to the IRB List serve. This moderated list will notify you of all significant changes to the UC Davis Human Research Protection Program.

Posted: March 20, 2006
Re: Revised IRB Standard Model Consent form

Effective immediately, the Standard Model Consent Form has been revised. The revised form includes language on Certificates of Confidentiality and various edits to better clarify information in the document. In addition, the Future Use of Specimens for Research Purposes Consent Form has now been incorporated into the Standard Model Consent Form.