Current Announcements

General Postings:
Check out our FAQ section for exciting news regarding student research! 
 
ANNOUNCEMENTS
 
Updated 06/15/09
New Form!
The HSPP Office proudly announces a new Deviation/Violation/Non-Compliance Form. This form meets updated OHRP and FDA guidances released over the last year and a half, and should be used when reporting any protocol deviations, protocol violations, or study non-compliance.  For more information on the form, please contact Judy Skroback, Co-Director, Education and Compliance at skroback@email.arizona.edu or 626-7575.
 
New addition!
(Updated 06/01/09)
The HSPP staff proudly introduces the addition of a helpful, new tool for investigators. The“Attachments for IRB Submission” checklist includes a detailed listing of documents required for New Projects, Continuing Review, or Amendment applications. Completed checklists are intended only for guidance and organization of materials, and do not need be included with application packets submitted to the HSPP Office. Thank you for your continued support towards improved customer service.  For inquires and/or feedback please contact:
 
Wendy Tate, PSM, CIP
Co-Director,
Operations
(520) 626-2979
 
 
Making Grant, Graduation, and Travel Deadlines 
(Posted 05/18/09)
IRB Committee members and HSPP staff make every effort to review and complete your submitted applications as quickly and efficiently as possible.  Coordinating grant, graduation, and travel deadlines with the IRB application process can be challenging and time-consuming. To reduce committee approval time and provide a seamless process for meeting auxiliary deadlines, the HSPP staff offers the following tips: 
  • Submit your application as early as possible;
  • Identify your deadline dates in large, bold type on the first page of the IRB application;
  • If you chose to attach a post-it or other note listing deadline dates, please be sure to fasten the item securely to the first page of the IRB application;
  • Avoid “burying” the deadline dates within the content of the application;
  • If you are hand delivering your application to our office, please notify the front desk receptionist of any pending deadlines associated with your application.
Updated WIRB Application Process (Posted 5/18/09)
In keeping with our dedication to increased quality of customer service, HSPP proudly offers the following documents to simplify and standardize the WIRB application process:
The HSPP staff appreciates and thanks you for your assistance with our continued process improvement initiatives.
For additional information or questions, please contact Wendy R. Tate, Co-Director, HSPP Operations at (520) 626-2979 or wrtate@email.arizona.edu
 
Worksheet for Determining if Research Involving Human Subjects Requires IRB Review
(Posted 05/08/09)
 
Investigator Guidance & Determination Tools
Guidance and Determination Forms are intended only for departmental use by Principal Investigators.  We recommend that PIs complete Guidance and Determination forms and file copies with other internal project records; however, Investigators need not include these documents in applications submitted to HSPP.  Where indicated, Investigators will need to provide copies of completed Guidance and Documentation Forms to Department Chairs, Department Heads, and/or Departmental regulatory coordinators. Departments may require additional documentation to verify that the project does not need IRB review.
UA-NAU-ASU Project Applications
This form is to be used for studies in which the PI of the overall project represents either ASU or NAU, but a co-investigator represents The University of Arizona. PIs must submit this completed form accompanied by the ASU or NAU IRB approval letter to the UA HSPP office. In the event that the UofA IRB does not act as the lead institution for the project, oversight will be deferred to either the ASU-IRB or NAU-IRB. This determination will be given in writing.

Posted 5/5/2009

Unanticipated problems involving risk to participants or others may include, but are not limited to: serious adverse events, adverse events, breach of confidentiality, or noncompliance with Federal, state, local and institutional regulations and policies. Reportable events must meet all three of the following criteria: 
 
1. Unanticipated or unexpected in nature, frequency or severity, AND; 
2. Related or possibly related to participation in the research (there is a reasonable possibility that it is related), AND;
 3. The event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (not already referenced inexisting study documents, such as the protocol, consent form or Investigator’s Brochure)
 
Note: For industry-sponsored studies, it is the responsibility of the sponsor or data safety monitoring board to assess events and to provide sufficient information to investigators to determine which events meet criteria as unanticipated problems involving risk to participants or others.
 
The HSPP office will be returning submittals to the investigators when the above criteria have not been met. An informational memorandum will be attached to document why the submitted event(s) did not qualify as an unanticipated problem(s).
For detailed information concerning examples of classifications, follow these links:
 
For questions regarding this information, please contact Judy Skroback Co-Director, HSPP jskroback@email.arizona.edu; (520) 626-7575
  
HSPP Office Re-Organization
Posted 4/7/2009
Thank you for your patience during our office closure from April 1st through 3rd. Over the past several weeks we have been revising job descriptions and workflow processes in order to make our office more efficient. We hope that this reorganization will better serve investigators, the IRB Committees, and our research community as a whole.

As part of the reorganization, our current staff has been reorganized. The positions of the new structure are below. We apologize for the change in phone numbers. 
Wendy Tate – Co-Director, Operations – 626-2979
Judy Skroback – Interim Co-Director of Education and Compliance – 626-7575
Simona Janisch – IRB1 Coordinator – 626-0026
Mariette Marsh – IRB2 Coordinator – 626-8630
Rick Reed – IRB3 Coordinator – 626-6282
Daniel Jeffrey – IRB4 Coordinator – 626-1744
Leslie Lee – IRB2 Associate – 626-7889
Ruth Daniels – IRB2 Associate – 626-0256
Danielle Griffin – Data and Support Associate – 626-0433
 
For more information regarding what types of projects are reviewed by a specific IRB and which IRB Coordinator is your primary contact, please see our website athttp://www.irb.arizona.edu/contactus.
 
"Submitting Electronic Documents for IRB Review"
Posted 4/7/2009 
The HSPP IRBs have recently begun using Confluence to review study protocols.  This involves the posting of electronic files, which both reduces the amount of paper consumed and speeds the review process because comments and changes can be recorded in real time. Please link to the memo below for more detailed information. 
Link to ⇒MEMO "Submitting Electronic Documents for IRB Review" 
 
"Process for Review of Protocols involving Human Subjects and Radiation"
Posted 4/7/2009   
In a joint meeting with Dan Silvain, Radiation Control, Joanne Osuna, Ruth Canamar, Dr. Stea and Dr. Kuo of the Arizona Cancer Center, we determined a process for submitting protocols for review by both the HSPP and the Radiation Control Office.  The process is detailed in the memo below.
Link to ⇒MEMO "Process for Review of Protocols involving Human Subjects & Radiation"
 
Consent Form Guidelines:
Posted 4/2/2009
The Guidelines associated with Human Subjects Consent forms are temporarily unavailable on our website.  We are updating the materials as part of or ongoing effort to improve the quality of services we provide.  We apologize for the inconvenience and plan to have the updated materials posted as soon as possible.  If you have questions regarding Guidelines, please do not hesitate to call Wendy Tate, HSPP Co-Director at (520) 626-2979. 
We are working to improve our services!
Posted 3/24/2009
In order to improve our research support services, we are reorganizing
the Human Subjects Protection Program. Our office will be closed Wednesday, April 1, 2009 through Friday, April 3, 2009 for Training and Reorganization. During this time, thelobby of our building will be open for submission drop-off only.  HSPP staff will not be available via phone, email, or in person during this time. In the event of an emergency (matters of subject safety, emergency use of a test article, etc.) please contact Wendy Tate or Judy Skroback immediately at 626-6721.  Please note that paperwork will not be processed during this closure For additional information regarding this 3-day closure, please contact Wendy Tate at (520) 626-2979 or wrtate@email.arizona.edu  We apologize for the inconvenience and thank you for your patience during this transition. We will re-open for business on Monday, April 6, 2009 at 8:00 a.m.

HSPP Fee Updates:  IRB Review and Indirect Costs - Posted 2/17/2009
In order to meet the growing costs associated with the review of research involving human subjects, the University of Arizona will no longer be able to waive indirect costs on IRB review fees.  Beginning April 1, 2009, all IRB fees on new industry sponsored projects involving human subjects shall be charged full F&A costs. Please visit the new fee schedulefor more details.

Departure of Human Subjects Protection Program Director, Dr. Rebecca Dahl.
Posted 1/28/09
Dr. Rebecca Dahl has left the University of Arizona effective December 24, 2008.  For questions regarding education/training sessions, unanticipated problems involving risks tosubjects or others, or compliance, please contact Judy Skroback, Co-Director, Education and Compliance, at 626-7575 or skroback@email.arizona.edu. For questions regarding WIRB/CIRB; HSPP requirements for Radiation Control, Institutional Biosafety, Committee, or Clinical Biomedical Engineering; Federalwide Assurances; or Memorandums of Understanding (MOUs), please contact Wendy Tate, Co-Director, Operations at 626-2979 or wrtate@email.arizona.edu. For questions regarding exempt projects or HSPP requirements for the Conflicts of Interest Committee, please contact Mariette Marsh, Research Specialist, at 626-9034 ormarshm@email.arizona.edu.  For general questions, please call Anne Torio at 626-6721.  

Updated application forms -
Posted 1/28/09 
As announced in November 2008, updated application forms have been posted on our website adding information requested by our accreditation entity.  The new application forms will be required for all new project submissions, effective February 2, 2009. 

VA Verification of Human Subjects Training Form (VOTF) - 
Posted 1/28/09 
In accordance with VA guidelines requiring the PI to attest to the ability of study personnel to obtain informed consent, there is a new VA Verification of Human Subjects Training Form (VOTF) on our website.  This form is located under "Supplemental Forms" in our "Forms Online" section(http://www.irb.arizona.edu/forms/Supplemental). All projects being conducted through a VA hospital (new and continuing) is required to use this new form in order to comply with the VA guidance.  

Signature requirements - 
Posted 1/28/09
Effective immediately, all submissions received in the HSPP office without the required signatures will be returned to the PI. Note that this applies for new projects, amendments, study related problems, continuing reviews, and concluding/not begun paperwork. Continuing reviews that are returned for lack of signatures must be submitted to the HSPP office with appropriate signatures prior to the project's expiration date or the project will be administratively closed in accordance with HSPP Policy.  Note the signature requirements below: 

New project:
1 - Principal Investigator
2 - Supervising Official (Department Head, Section Chief, Dean, Director, or comparable authority)
3 - Departmental Review Chair
* The Supervising Official and Departmental Review Chair signatures must be different people and cannot be included as research personnel on the study.

Continuing Review (Category A or B):
1 - Principal Investigator or Co-Principal Investigator
2 - Supervising Official

Amendments/Study Related Problems Forms/Concluding/Not Begun:
1 - Principal Investigator or Co-Principal Investigator

HSPP and Radiation Control Process - 
Posted 1/28/09 
In order to streamline processes, the Human Subjects Protection Program and Radiation Control Offices are announcing a revision to the approval process for projects that involve both human subjects and radiation, MRI, or lasers.  These projects must be first approved by the Medical Radiation Safety Committee (regardless of whether the use of radiation, MRI, or lasers is clinically indicated).  Once approval is granted by the Radiation Control Office, the project may be submitted to the HSPP office for review.  Projects submitted to the HSPP office will not be processed until Radiation Control approval is granted. This revision aligns the Radiation Control/HSPP process with the HSPP processes currently in place with Institutional Biosafety Committee and Clinical Biomedical Engineering. Please visit The Radiation Control Office website at: http://radcon.arizona.edu/. 

Contacts Page -
Posted 1/28/09 
We have updated our Contacts page. Please visit http://www.irb.arizona.edu/contactus for updated information for whom to call regarding your project or other HSPP questions.
 
HSPP Office Will Be Closed on Friday, March 20, 2009 for File Organization -
Posted 3/3/2009 
The lobby of our building will be open only for submission drop-off.  HSPP staff will not be available via phone, email, or in person during this time; however, in the event of an emergency (matters of subject safety, emergency use of a test article, etc.) please contact us immediately at 626-6721.  ♦♦Please note that paperwork will not be processed on this day (March 20, 2009).♦♦For additional information regarding this 1-day closure, please contact Wendy Tate at 520) 626-2979 or wrtate@email.arizona.edu. We apologize for the inconvenience and thank you for your patience during this process. We will re-open for business on Monday, March 23rd.