Volume 4, Number 54 ..........................ORA News Online .....................June 4, 2004
DONT FORGET
 
CONFERENCES WORKSHOPS

DSR is requesting your participation in the eSNAP pilot. eSNAP is an electronic Streamlined Non-competing Award Process, which is a component of the NIH eRA Commons. eSNAP allows institutions to submit an electronic version of a Type 5 (non-competitive) progress report to NIH via a web interface.If you participate, you will be able to submit your progress report directly to NIH and eliminate the paper submission.

DSR, Proposal Processing has developed a eSNAP Overview Sheet to help in the completion your electronic Progess Report System. Login to the NIH Commons website https://commons.era.nih.gov/commons/index.jsp to began your Progress Report

If you have any questions or need to register you will ERA Commons, please email DSR ufproposals@rgp.ufl.edu with an active email address. (Posted 06/04/04)


IRB EDUCATIONAL EVENTS CALENDAR OF ONGOING TRAINING PROGRAMS

Working with Western IRB (WIRB)
June 10th, 2004 at 10:30 am
Room 2154

Frequent Form Muck-ups, Fixing Fouled-up Forms October 07, 2004

IRB Approval- It's what you want, it's what you need November 18, 2004

Informative Informed Consent Forms
December 09, 2004



Please call 846-1494 to register
(Posted 06/04/04)

WHAT'S NEW?
IN THE NEWS


2004 COLLEGE OF MEDICINE UFRF PROFESSORSHIP AWARD RECEIPIENTS

The Office of Research Affairs would like to congradulate the following recipients of the 2004 College of Medicine UFRF Professorship Award:

Nasser Chegini
Obstetrics & Gynecology

Marian Limacher
Medicine

Maurice Swanson
Molecular Genetics & Microbiology

William Hauswirth
Ophthalmology

Reuben Ramphal
Medicine

The UFRF professors were recommended by their college deans based on nominations from their department chairs, a personal statement, and an evaluation of their recent research accomplishments as evidenced by publications in scholarly journals, external funding, honors and awards, development of intellectual property, and other measures appropriate to their field of expertise.

The three-year award carries with it a $5,000 annual salary supplement and a one-time $3,000 grant. The professorships are funded from the university`s share of royalty and licensing income on UF-generated products.
(Posted 06/04/04)


2004 COLLEGE OF MEDICINE RESEARCH DAY

Once again the College of Medicine Research Day was a great success. A pat on the back to everyone who took part in making the day a true "Celebration of Research".

Congratulations to the following winners.

2004 Medical Guild
Graduate Research Competition
Medical Guild Graduate Research Competition
Medical Student Research Day Winners
Mary Ann Checkley 5th Place, Rahul Kanadia 2nd Place, Alaric Falcon 5th Place, Eric Sandberg 3rd Place, Edgar Rodriquez 4th Place and Karen Vieira 1st Place.
Siva S. Radhakrishnan and
Pui Y. Lee

2004 Resarch Day Awards

  Outstanding Basic Posters

Outstanding Clinical Posters

JeongHoon Joo

Linda Papa, M.D.

Basic Science Award Winner
Lyle L. Moldawer, Ph.D.
Department of Surgery


Clinical Science Award Winner

  Desmond A. Schatz, M.D.
Department of Pediatrics

Life Time Achievement Award Winner
Gerold L. Schiebler, M.D
Department of Pediatrics
In Recognition Of An Extraordinary Careerof Academic Achievement and Outstanding Service Your Dedication And Success Has Brought Great Honor And Recognition To The College Of Medicine And The University Of Florida.
(Posted 06/04/04)


COLLEGE OF MEDICINE POILCY FOR PEOPLESOFT PROPOSAL SYSTEM

Effective July 1, 2004, College of Medicine will require the use of the PeopleSoft Proposal Preparation and Processing system. For those who wish, you may begin to utilize the system after the PeopleSoft go live date (June 18, 2004).

Post July 1, 2004, COM will anticipate all proposals to be submitted via the Pre-award PeopleSoft system. The College will maintain the requirements of all documents that are currently needed to approve at the college level, i.e.

-Financial conflict of interest on all key personnel

-Cost share letter

- Certain sections of the clinical/research contract agreement

o 1st page of the contract that names the contract parties in agreement
o Section of the agreement referring to cost per patient or not to exceed an amount
o Attachments to the contract, i.e. cost information

- Letter of intent to establish a consortium or the agency face page signed by the consortium’s institutional official or company’s CEO

- Time commitment letter

- Completed sponsor forms (excluding the research plan)

o Agency face page or administrative information page
o Abstract or project description
o Agency budget and budget justification forms completed
o Facilities & administration (F & A) checklist page

§ Keywords – COM/ Office for Research and Development requires that keywords associated with the proposal be indicated. COM faculty are required to choose from a list of specific research themes (attached)

COM prefers the documents to be attached to the PeopleSoft proposal, but will accept faxed documents or by hard copy with the appropriate designation to the PI and sponsor indicated on the copies.

COM requires the PeopleSoft’s budget to be completed for effort and salary requested on all personnel. The PeopleSoft budget needs to match what has been completed on the agency forms. The supplies, expense, and equipment categories can be completed with a line item total, with the exception of tuition and patient care cost requested. The budget completed in PeopleSoft will replace the COM clinical trials and modular checklist page.

COM will no longer require a copy of the biographical sketches for review. It will be the responsibility of the PI to comply with all agencies requirements.

Memorandum of Understandings to set up sub-accounts will be replaced by setting up separate projects in the PeopleSoft system.

If the sponsor does not allow for Facilities and Administrative (F&A) cost, a copy or link to the sponsor guidelines should be attached to the PeopleSoft proposal (preferred) faxed, or sent via hard copy. F&A distribution should be completed on all projects set up in PeopleSoft sub-accounts.

If the PeopleSoft system is not functioning correctly or to the satisfaction of the COM, a hard copy of the proposal will be accepted. If any problems arise with the system, notifications will go out indicating the application to be completed using the DSR-1 on-line form and route a hard copy of the proposal as we do in our current policy.

If the system works in regards to completing the proposal submission information, but the workflow (electronic approvals) is not functioning, the COM will accept the DSR-1 on-line form as we are accepting in the current policy, with a notice to our office that the proposal resides in the PeopleSoft system for approval.

If you have any questions, please do not hesistate to contact us at (352) 273-5398.

OTHER HELPFUL LINKS:

UF BRIDGES OVERVIEW

UF BRIDGES FREQUENTLY ASKED QUESTIONS FOR PROPOSL PREPARATION


CREATING AND SUBMIITING GRANT PROPOSALS: GETTING STARTED

CREATING AND SUBMITTING GRANT PROPOSALS: ADVANCED FEATURES

UF START PROPOSAL PAGE TUTORIAL

UF START PROPOSAL PAGE INSTRUCTION GUIDE

DSR ANNOUNCEMENT ON TRANSITION TO PEOPLESOFT PROPOSAL PROCESSING/AWARD ADMINISTRATION
(Posted 06/04/04)

The Research and Research Training Grant Applications and Related Forms (PHS-398 PHS-2590 PHS-2271 PHS-3734), Revised Version 5/2004, have been submitted to OMB for review and approval. Once OMB approval is received, the new forms will become available for use and will be accessible on the NIH web site.

There will be a transition period when both the new or old forms will be accepted. Until that time grant proposals should continue to be submitted using the current versions.

For the full version of this annoucement, go to NOTICE: NOT-OD-04-044 of the NIH Guide. (Posted 06/04/04)


OER GRANTS WEB SITE GETS USABILITY
IMPROVEMENTS AND GOOLGE SEARCH ENGINE


In an effort to make its web site more user-friendly, the Office of Extramural Research (OER) has re- organized the "Grants - OER Home Page", as well as many of the top level site pages, and has made minor design changes, including a new left-side navigation bar. These changes are in response to a web survey and a follow-up usability study conducted earlier this year. In addition, all site searches now use a Google search engine and a search box has been added to the top right-hand corner of site pages.

It is hope that these changes will enhance your experience in using the OER web site. Please send any comments or suggestions to the OER Webmaster.

For the full version of this annoucement, go to OER Grants: Current News Flashes & Archives, May 13, 2004.(Posted 06/04/04)


ENROLLING PATIENTS IN RESEARCH

According to the Office of Human Research Protection (OHRP), the primary issues surrounding the participation of prisoners in research has always been whether prisoners have a real choice regarding their participation in research, or whether their situation prohibits the exercise of free choice. A secondary issue is whether confidentiality of participation and of data can be adequately maintained in the prison. DHHS regulations have special requirements regarding the membership of an IRB that reviews research involving prisoners. At least one member of the IRB must be a prisoner or a prisoner representative with the appropriate background and experience to serve in that capacity.

In order to enroll prisoners into a study here at the University of Florida, the investigator must indicate on the Introductory Questionnaire he or she intends to do so. This allows the IRB to arrange for the inclusion of a prisoner advocate during the review process in accordance with the Federal guidelines. This means investigators may NOT enroll any prisoners in a research projects unless the IRB has approved the inclusion of this vulnerable population. If a prisoner is enrolled in a study not approved for prisoners it must be reported immediately as a protocol deviation.

If a subject who is enrolled in your study becomes incarcerated, the investigator should notify the IRB and withdraw the subject. If the investigator wishes to keep the “incarcerated” subject enrolled in the study, a study revision must be submitted for IRB approval. (Posted 06/04/04)


New Checklist for Informed Consent Forms

Federal regulations dictate that certain information MUST be in all Informed Consent forms. These elements have been determined to meet the requirements for “Respect for Persons” as detailed in the Belmont Report. While most of this information is built into our blank template form, the IRB sometimes is unable to approve Informed Consent forms because required information is absent. In order to facilitate faster reviews for researchers we have developed the Informed Consent Checklist to help you verify that your consent forms possess the mandatory elements of Informed Consent. Please use this form to check any new consent forms (including those submitted with Revisions and/or Continuing Review). Note this checklist is intended to help reduce any problems that the Board may have with your consent, and thereby speed up the approval process for your study. (Posted 06/04/04)


Alert!! IRB-02 has Expanded Review Responsibilities

Principal Investigators at the Gainesville Health Science Center may now choose to use either IRB 01 or IRB 02 for previously un-submitted / un-reviewed survey Research provided it meets specific criteria.

If any component of the research involves the following, it cannot be submitted to IRB-02:

· Drug and device clinical trials

· Treatment related projects (surgical, physical therapy, etc)

· Tissue/Data Banks

· Projects that involve the utilization of VA employees, resources or patients

· Projects that use or disclose Protected Health Information (PHI) from a covered entity, which requires compliance with HIPAA privacy regulations.

· Projects previously approved by and conducted under another UF IRB
· Projects disapproved by another IRB

If IRB 02 determines that it does not have the requisite expertise to review a Particular protocol, then the submission will be forwarded directly to IRB 01. Should this occur, the investigator would be notified and required to revise the submission based on IRB 01’s forms and policies. Projects that have already been approved at or submitted to IRB 01 must continue to be reviewed there.
(Posted 06/04/04)


CHANGE IN WIRB FEES

For those of you who utilize the Western Institutional Review Board (WIRB)
for industry-sponsored clinical trials, they have announced a new fee schedule that went into effect on June 1, 2004. This information has been posted on the Jacksonville IRB website since the first announcement was made but I am sending this notice to all researchers on the Jacksonville campus to be sure everyone is aware.

Click here for WIRB Fee Schedule Revision

If you have questions about the new fee schedule, please feel free to contact me in the IRB office or you may contact WIRB directly at 1-800-562-7489.
(Posted 06/04/04)

NEW FUNDING
OPPORTUNITIES

For funding opportunities annouced by Research and Graduate Programs FYI http://rgp.ufl.edu/fyi/

New NIH notices, requests for applications and program announcements can be found at NIH Notice.

CLOSING INFORMATION

ORA News Online is a bi-weekly publication of the College of Medicine Office for Research Affairs in the Health Science Center at the University of Florida, JHMHSC M134, PO Box 100215, Gainesville, FL 32611-0215. Please send any comments or suggestions about this newsletter to Aundrea Corbit with "SUGGESTIONS" in the subject line. If you do not wish to receive any more issues, please reply to Aundrea Corbit with "UNSUBSCRIBE".