NEW in June 2008: FEWER COPIES NEEDED

IRB-01 is now requiring fewer copies depending on the submission type.  Each form now instructs investigators how many copies are needed – so please pay close attention to the number indicated.  Failure to provide the correct number of copies will result in your submission being returned to you.

A comprehensive list of the number of copies required can be viewed at:  http://irb.ufl.edu/docs/Announcement.pdf.

Please contact Michael Mahoney at mmahoney@ufl.edu if you have any questions or comments.  Thank you!

IRB-01 Policies & Procedures Manual updated

At the Jun 4th, 2008 meeting the Board approved a change in our P&P pertaining to HURRC review of research and template language that may be needed in the Informed Consent forms of projects utilizing radiation. This new information is contained on pages 15-16 under the Other Committees section and now reads as follows:

Human Use of Radioisotopes and Radiation Committee (HURRC)

HURRC reviews all full Board projects to determine if the protocol involves the use of radiation or radioisotopes. (Note: HURRC does not review exempt and expedited projects because they should not contain any experimental use of radiation or radioisotopes).  HURRC review and approval includes suggested risk language for consent forms.  The IRB may use the suggested language or revise it as they deem appropriate.

Investigators may choose to submit to HURRC and the IRB simultaneously for therapeutic research projects with definite investigational use of radiation or radioisotopes.  Investigators are not required to submit research projects with no definite involvement of radiation or radioisotopes to HURRC for review.  However, a member of HURRC will review all new studies seeking full Board approval in order to determine the absence of experimental radiation/radioisotope usage in the project.  This will be accomplished by sending an electronic copy of all full Board meeting materials to the HURRC representative (identical to what is distributed to the full Board) prior to the meeting.  HURRC will notify the IRB, and the investigator, if HURRC approval needs to be obtained but has not been requested by the investigator.  In these instances IRB approval will be held until receipt of official written approval from HURRC.  Otherwise, without notification from HURRC, the IRB will proceed with review and/or approval as necessary.

For research involving non-therapeutic exposure to radiation the IRB will apply the exposure limits for radiation workers.  This limit is a maximum absorbed dose of not more then 5 rem per year or 1.25 rem per calendar quarter.  Children may not be involved in this type of research.  Consent forms for this type of research should contain a strong statement regarding the cumulative nature of radiation exposure.

ICF Template Language as follows:

The radiation exposure in this study is thought to be minor.  However, the effects of radiation add up over your lifetime.  Repeated exposures may increase your risk of injury or disease.  When deciding to enter this study you should consider previous and future potential exposures.  Examples would include x-rays taken for a broken bone or radiation therapy treatments for cancer.

The current P&P can be downloaded at: http://irb.ufl.edu/docs/irb01ppmanual.doc

Public Service Announcement #2!

Yesterday the University (not the IRB) released a new directive regarding "Payment to Research Subjects".

Please read the following e-mail from the University:

http://irb.ufl.edu/docs/paytosub.pdf

Public Service Announcement #1!

REMINDER: the UF Privacy Office is requiring all human subjects researchers to complete their new "Research & Information Privacy for 2008" training before March 1st, 2008 (even if you completed the training in early January 2008 or later). This is now a combined training and will need to be completed annually every January/February.

Click here to view a copy of the message that was sent out by the Privacy Office last month.

Click the link below to complete the training:

http://privacy.health.ufl.edu/training/Research08/online.shtml

The IRB would like to remind all investigators that the Principal Investigator is responsible for obtaining re-approval for their research before it expires.

To that end the IRB tries to help investigators by sending out reminder notices to the PI roughly 90 and 45 days prior to the study's expiration date. Since we are not always notified when campus addresses change and/or mail can sometimes be lost or delayed, we strongly encourage PIs to utilize other methods for reminding themselves to submit their Continuing Review paperwork (http://irb.ufl.edu/docs/frm-cr.doc) before the project expires. We also try to help in this regard by providing a sorted list of your study expiration dates in our Web Tracking system (http://irb.ufl.edu/webtrack.html), which can be accessed by any investigator or study coordinator listed on the study. Another useful and accurate method is when you receive your approval letters to enter the expiration date in your electronic calendar (such as Outlook) and have it automatically generate a reminder at least 45 days prior to the expiration. We caution PIs who delegate the duty of obtaining continuing review to a study coordinator or other staff: be prepared to address the situation when staff leaves/changes since new coordinators may not be aware of when studies need to be reapproved or the importance of submitting paperwork well in advance of the expiration date. While the PI can delegate the duty they cannot delegate the responsibility.

Our reminder letters and website (http://irb.ufl.edu/irb01/crsubmit.html, http://irb.ufl.edu/irb01/help/cr.html) both advise investigators to submit their continuing reviews early enough to prevent expiration, including if the Board should request additional information.

"(1) Expedited Projects: IRB-01 strongly recommends submitting your Continuing Review report no later than 3 weeks prior to the expiration date. 4 weeks is ideal.
(2) Full Board Projects: IRB-01 strongly recommends submitting your Continuing Review report before the deadline for two meetings prior to the expiration date. This affords you time to still obtain timely approval if your project requires Explicit Changes, is tabled, or has other issues. Please visit http://irb.ufl.edu/irb01/deadlines.htm"

We have also added the above information as hidden text at the beginning of the Continuing Review Form itself. Please make sure you always turn the "Hidden Text" on to view the helpful information and directions in our forms (directions on how to turn "Hidden Text" on are provided at the beginning of each form).

If your study expires the IRB will have to evaluate if the expiration itself is serious and/or continuing non-compliance. Even if no subjects are at risk, repeated failure to obtain timely reapproval of any of your studies can result in the IRB finding continuing non-compliance. Should the IRB find for serious or continuing non-compliance they will at a minimum have to report this to all of the appropriate parties including federal regulatory agencies, the insititutional officials (e.g. Dr. Win Phillips), your Dean or Department Chair, etc. The IRB may also take additional action such as require a corrective action plan, require training, restrict or suspend researcher privileges, etc.

Lastly, we remind you that if your study expires you cannot:

1. collect, use, or report of any data;
   
2. perform any study interventions, unless the IRB finds that it is in the best interests of individual subjects to continue participating in research interventions or interactions;
   
3. enroll or screen any new subjects; and/or
   
4. receive any study funding.
   

If a study expires and enrolled subjects are undergoing study interventions, the PI must contact the IRB (and for VA Research, the VA Chief of Staff) who will determine if it is in the best interest of the subject to continue participation There is no grace period extending approval for the conduct of research beyond the expiration date. Once a project expires, IRB review and re-approval must occur before re-initiation of research occurs. According to federal regulations you may not conduct research without an effective IRB approval. Subsequent IRB approval does not authorize you to retroactively collect or use any data that occurred during a period without IRB approval.

Once your project expires, you have 30 days from the expiration date to submit the Continuing Review/Study Closure report. Failure to provide this information within 30 days will automatically move your project to Expired-Nonrenewable status. If this occurs you will need to re-submit your study as a new project if you wish to continue the research or to receive additional funding.

The above requirements are consistent with Federal regulations, AAHRPP accreditation standards, regulatory citations of other institutions, and have all been previously announced and discussed with our research community. This reminder is meant to help our researchers understand their obligations and conduct their research in compliance with the requirements.

Please let us know if you have any questions.

Please read the three important updates below:

1. AAHRPP ACCREDITATION + NEW FORMS

I am honored to announce that on December 14th, 2007 the North Florida/South Georgia Veterans Health System (NF/SGVHS) received FULL Accreditation status from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This is a difficult and significant accomplishment and I want to congratulate the VA on receiving Full Accreditation on the initial application. I would also like to personally thank everyone who helped successfully complete the IRB's considerable portion of the Accreditation application/process: the IRB staff, Board Members, our General Counsel Dianne Farb, Assistant Director of Compliance Michael Scian, and most particularly our former Quality Assurance Coordinator Kristine Wynne. http://www.aahrpp.org/www.aspx?PageID=230

As you should already know, many of our forms and policies were changed in order to meet the accreditation standards. Please remember that starting January 2nd, 2008 the IRB-01 office will only accept submissions on our newest forms in order to be compliant with our accreditation submission/standards. If you are presently in the middle of preparing a submission please make sure to either (a) submit it prior to January or (b) insure that you are using the newest forms from the website: http://irb.ufl.edu/irb01/forms.htm .

One major change in our policies is the need to report all deviations. If you did not attend one of the IRB Forums last month please be sure to read our "Deviation Reporting Guide & Definitions" available at: http://irb.ufl.edu/docs/guide-dev.doc . Major Deviations (potentially affecting subject welfare or rights and other issues as described in the Guide) must be reported within 5 days on our "Protocol Deviation or Regulatory Noncompliance Reporting Form" available at: http://irb.ufl.edu/docs/frm-dev.doc . Minor Deviations (that do *not* affect subject welfare or rights and other issues as described in the Guide) must be reported on the Minor Deviation Tracking Log due with every Continuing Review after January 1st, 2008. The Table is available at: http://irb.ufl.edu/docs/DevTable.doc You must start tracking your Minor Deviations on Jan 1st, 2008 onward (you are not required to enter minor deviations that occurred prior to that date). Please feel free to contact Michael Mahoney at mmahoney@ufl.edu if you have any questions about the deviation policy. NOTE: this policy not only meets AAHRPP accreditation standards but was benchmarked across a variety of other institutions including WIRB, Partners in Boston, and others.

2. HOLIDAY OFFICE HOURS

The IRB-01 Office will be CLOSED on the following dates in accordance with University policy:

Monday December 24th, 2007
Tuesday December 25th, 2007
Tuesday January 01st, 2008

The IRB-01 Office will be OPEN from 7 AM to 4 PM from Wednesday December 26th to Friday December 28th, and Monday December 31st. However due to the TEAMS holiday benefit the office will only be minimally staffed.

3. JANUARY IRB-01 FULL BOARD MEETINGS CHANGED

IRB-01 will meet on the 2nd and 4th Wednesdays of January in the McKnight Brain Institute Room 110 from 8:30 AM to 2 PM. In February we will resume meeting in Shands 10-214 on the first and third Wednesdays. Please check our Deadlines page at: http://irb.ufl.edu/irb01/deadlines.htm

URGENT: The IRB has been asked to help distribute the following information which applies to research conducted at UF or Shands (but not VA) facilities:

A moratorium has been placed on infusion of drugs in all outpatient clinics. A quality assurance review of clinic procedures and personnel training is under way.

Any UF outpatient clinics that are permitted to infuse drugs must use a double-signoff system involving two qualified professionals to ensure the right patient, the right drug and the right dose.

Before any medication is dispensed from a Shands Outpatient Pharmacy for intravenous infusion in a University of Florida Physicians Clinic, a pharmacy manager will confirm that the clinic has been reviewed and is allowed to infuse intravenous medications; that the instructions from the physician and the labeling placed on the product clearly indicates both the dose and volume of medication to be administered; and that the dose is appropriate for the condition being treated/diagnosed.

Additional information about this event may be found at: http://news.health.ufl.edu/story.aspx?ID=4961

We will share additional information as it becomes available.

Previously announced to the IRB-01 Mailing List:

Attention researchers:

As you know earlier in the year many of our forms were changed in preparation for an accreditation inspection of the human research protection program (HRPP) at the North Florida/South Georgia Veteran's Health System. This process has included the following:

1. In May 2007 we mailed our initial application to the accreditting body. The application was over 1300 pages long and took over 15 months to prepare.
   
2. In August 2007 accreditation representatives visited for 3 days in order to inspect our files and to interview a variety of people associated with the research program including not only IRB Board members but researchers as well. During the exit interview the representatives expressed high praise for our program.
   
3. In September 2007 we received written findings from the onsite visit and review of our application. A variety of issues were identified, some of which necessitated changes to our forms and P&P manual.
   
4. The response to the findings had to be mailed in within 30 days of receiving the findings. The response included 260 pages of altered IRB documents.

The accreditting body, AAHRPP, will now review the response along with the results from the onsite inspection and application. AAHRPP is scheduled announce a decision on the VA's accreditation status in December 2007.

In the meantime we must educate everyone about the additional changes and then implement them in a timely fashion.

I have made arrangements for two IRB Forums to present the numerous changes made in response to the AAHRPP inspection. The topics include:

- Expired Continuing Reviews
- New policy for reporting deviations or noncompliance
- Adverse Events
- Unanticipated Problems
- Privacy vs Confidentiality
- IND/IDE Exemptions
- Waivers of Informed Consent
- Definitions
- Conflict of Interest

Topics specific to VA only research

- Children & Prisoners
- Drug & Device Studies
- Flagging Medical Records
- VA consents

The sessions will be held as follows:

Thursday November 15th
12:30 PM to 2:30 PM
C1-7 in the Communicore Building

Or

Monday November 19th
9 AM to 11 AM
VA Auditorium

Please rsvp mmahoney@ufl.edu to attend one of the sessions.

Our on-going preparations for an upcoming accreditation required multiple changes to our forms. Always download and use the newest forms! All of our new forms are required after 12 PM on 25 May 2007. Click here to read one of our recent announcements about the new forms.

URGENT: IRB-01 has a new Continuing Review/Study Closure report (see our Forms page). Investigators need to start using this form as soon as possible. We will not accept any older versions of the form after 05/01/2007. If you are already working on a Continuing Review/Study Closure and are using the old form, you may still use it for your submission provided it is turned in prior to 05/01/2007. Submissions including old versions of the form submitted on 05/01/2007 or thereafter will be returned to the PI.

The biggest changes, all identified as a result of preparation for our AAHRPP accreditation:

(1) Question 1: Attach a clean copy of the protocol.
Rationale: federal guidance stipulates that the protocol must be reviewed along with any changes. The IRB has provided our reviewers with a copy of the original protocol plus information from our database that is meant to detail the changes. While preparing for our upcoming AAHRPP accreditation it was determined that our prior method may not pass inspection. Therefore this change is being implemented to insure complete compliance with the continuing review guidelines.

(2) Question 31: Involvement of the VA
Rationale: a careful review of VA regulations (1200.5) revealed that the IRB must review certain information for research conducted at the VA. Items 31 a. through d. insure we comply with the requirements detailed in 1200.5. Only investigators who are conducting their research at the VA must answer this question.

(3) Question 37: Subject complaints
Rationale: Question 37 existed previously and requests a description of how subjects responded to the research. This change was simply to add information that investigators need to describe any subject complaints about the research.

(4) Question 42: Safety monitoring
Rationale: the Introductory Questionnaire has long as how investigators will monitor the safety of subjects (e.g. is there a DSMB, will there be a report, etc). This question is to help us insure that the safety monitoring plan is occurring as described and again is required to insure we better comply with requirements.

Reminder: IRB Forums this month

Michael Mahoney will host IRB Forums this month to discuss a variety of new items including:

New forms
New Web Based Tracking System
Data Security
Research that involves children
Research at the VA

Please RSVP mmahoney@ufl.edu with the meeting date that you would like to attend (please disregard if you responded to a previous announcement).

April 12, 2007
C1-7 (Communicore Building, near the Med Library)
11 AM to 1 PM

or

April 27, 2007
VA Auditorium
11 AM to 1 PM

Information Security - Encryption of Restricted Data - PART II

SPICE has posted a "The Myths and Facts about SPICE for Researchers". Please click here for more information.

Information Security - Encryption of Restricted Data

Effective February 5th, 2007, the UF Health Science Center has new requirements for using restricted information **(see below) on portable computing devices (laptops, PDAs, "smart phones" such as Blackberry, etc) and electronic media (external hard drives, cds, dvds, USB jump/flash drives, etc). This information should have been communicated to you via your departmental IT staff. I am forwarding this information to help you stay in compliance with the new requirements.

Click here to view the policy.

Click here to view the standards.

A couple of significant highlights concerning the use of Restricted Information on portable computing devices and media:

1. Any "users who have a need to store Restricted information on a portable computing device or media must have expressed written authorization by the Unit Dean, Director or Department Chair or his/her delegate to remove such information from the University premises."
2. As detailed in 4.c. of Standard TS0010, laptops and tablet PCs must have full disk encryption. Encrypting individual files is not adequate. The HSC is implementing the use of PGP Encryption software. Visit https://security.health.ufl.edu/faculty_researcher/secure_your_pc.shtml#encryption for more information about encryption alternatives.
3. Restricted data must be protected by encryption during data transmission over any wireless network and any non-University wired network (e.g. e-mailing outside of the University).

There are a number of other very important issues described in the policy and the standard. Everyone needs to read these documents to insure they are complying with the new requirements. If you have any questions please contact your department Information Security Administrator or Information Security Manager (visit this web site to find out who your ISA/ISM is: https://security.health.ufl.edu/staff/find.shtml)

**Restricted information includes but is not necessarily limited to any identifiable records - research, clinical, teaching, billing, etc. Each department is responsible for identifying the restricted information that it handles. The SPICE policy concerning Information Classification is located at: https://security.health.ufl.edu/policies/Standard%20GP0001-Information%20Classification.pdf

While I (Michael Mahoney) can assist IRB staff or Board members with questions concerning the policy, others should direct any questions to your ISA or ISM.

March 07, 2007 meeting RELOCATED

We have been required to move the 07 March 2007 full Board meeting to the PHHP Building, room 1102. A map is available at:

http://irb.ufl.edu/graphics/maps/hpnpmap5.doc

We're sorry for the inconvenience and expect to return to our usual room (Shands 10-214) for the 21 March 2007 meeting. Thank you!

Dr. Iafrate's "State of the Union" Presentation

Dr. Iafrate recently gave an overview of IRB-01. Click here to see his Power Point presentation. A few important highlights:

New Tools for Involving Children in Research :

Our "Researcher Tools" page now offers five new tools to assist you with involving children in researcher. First is a Worksheet for involving children which walks you through the different requirements for including children, whether one or both parents would need to sign the Informed Consent to enroll the child, whether the child needs to assent, as well as what is necessary to enroll "wards of the state". Second is a flowchart that captures the signature requirements for parents and children that can posted for easy reference. The next three items all concern what you need to do if you enroll a child who with the consent of a parent and during the course of the research the child achieves the ability to legally consent on their own behalf (either by turning 18 years of age or being emancipated through marriage, court order, etc). These subjects need to be reconsented in order to continue participating in the research. We have a flow chart, an FAQ, and a special short consent form for studies where the subject has completed all study interventions but the researcher continues to collect long term follow up data about the subject's health. Please be advised that researchers must comply with the information provided in these forms.

Protocol or Revision Copies to Shands Investigational Drug Service :

Effectively immediately the IRB-01 office will no longer provide copies of IRB approved paperwork to the Shands Investigational Pharmacy. As a result, any investigators conducting research that involves drugs or the Shands Investigational Drug Service (IDS) must provide a copy of their new or revised protocols directly to IDS.

Susan Beltz, PharmD
Debbie Kahler, PharmD
Investigational Drug Service Department of Pharmacy Shands Hospital at the University of Florida
Box 100316
Gainesville, FL 32610-0316
Phone: 352-265-0111 ext 4-4716 or 4-4237

New website/office: College of Medicine Clinical Trials Compliance: Check out the extensive information designed to help investigators navigate the Clinical Trial process, including pre- and post-award responsibilities.

http://ctc.health.ufl.edu/index.shtml

Closed for Homecoming! The University is giving employees the day off for Homecoming, Friday 10/06/2006 (see UF's announcement). As a result the IRB-01 office will be closed. We apologize for any inconvenience. Due to the day off the deadline for TABLED items has moved from 9 AM Monday 10/09/2006 to 9 AM Tuesday 10/10/2006. The deadline for REGULAR items for the November 1st meeting remains unchanged (12 PM Monday 10/09/2006)

Administrative Withdraw System implemented! If you submit something to the IRB and we request additional information (as is the case when your submission is Tabled, requires Explicit Changes, or has other kinds of "Needs Reply" letters generated), researchers now have 30 days from the date of our letter to submit some form of a response (even if only to request another 30 days). If the IRB-01 office does not receive an official written response in 30 days our database will automatically execute one of two options: click here for additional information.

Have you ever had a potential research subject that did not fit all of your protocol’s inclusion or exclusion criteria?  In all likelihood everyone has experienced having a potential subject who for one reason or another did not perfectly meet eligibility criteria.  For example – maybe a lab value is just barely outside the value listed in the exclusion criteria, the potential subject’s age is a couple weeks, or even days off of the allowable range in the inclusion criteria, etc.

Can you enroll a potential subject if they do not meet all of the criteria perfectly?

Most researchers will tell you that this subject can be enrolled IF you contact the sponsor and get their approval to enroll the subject.  The protocol itself is not actually revised – this is handled as a single patient exception/variation. 

While obtaining the sponsor’s permission is definitely required, it is NOT the only thing you must do.

***Once you receive the sponsor’s permission, you must then also receive IRB approval PRIOR to enrolling the subject.***

Why? Click here for additional information.

Thank you to everyone who attended on of the IRB Forums last week. You may download a copy of the hand-outs here: :

If you were unable to attend you may either watch a video of the presentation on your computer or attend another live session to be scheduled for the middle of November (date and location pending). If you are interested in the video simply visit our office and check out the Forum CD. It can be viewed on any computer and also contains copies of the handouts.

We've expanded our information on conducting research at the GCRC. This includes giving the GCRC it's own link in our Navigation Bar, it's own page on our web site, and expanded information about submitting to both committees including information about the new "Harmonization Process" for pursuing faster approval between both committees. Check it out at: http://irb.ufl.edu/gcrc/

In order to avoid the confusion that we've witnessed when the principal investigator on a project is changed, IRB-01 announces a new form:

Principal Investigator Change - Revision Addendum
located at: http://irb.ufl.edu/docs/frm-revpi.doc

When revising your project to change your PI (with or without any other changes), use our

1. Revision Memo - to document what is changing, to justify the changes, etc.
   
2. Revision Addendum - Changing the Principal Investigator form - to detail that the former/departing PI agrees to surrender the study, to detail the new PI's qualifications, and to certify that the new PI is accepting responsibility for the new project.
   
3. Strike-out/underline copies of the affected project paperwork reflecting the PI change. Be sure to change your Introductory Questionnaire, Protocol, Informed Consent form(s), and any other project paperwork that might list the PI.
   
4. Appropriate clean copies as required and described on the Revision Memo.

New Position Paper: Who can consent when the subject cannot?

SPECIAL ANNOUNCEMENT FROM THE COORDINATOR

On February 16, 2005 the North Florida/South Georgia Veterans Health System officially presented the University of Florida a copy of the National Committee for Quality Assurance (NCQA) Accreditation Certificate. NCQA Accreditation is a new program that all Veteran Health Systems are required to pass in order to conduct human subjects research. NCQA specifically reviews several facets of the human research protection program at the VA, with about 77% of the review focusing on IRB-01. For the past year and a half the NF/SG VHS and IRB-01 have collaborated closely to prepare for this accreditation inspection. Together we achieved a near perfect score of 99.7% and were awarded a full 3 year accreditation.

IRB QA Coordinator Kris Wynne deserves special recognition for spearheading the project for the IRB. In addition, Linda Fallon, Tiffany Robinson, and Jessica Johnson deserve special recognition for authoring the IRB minutes which received praise for their unmatched quality. I also want to thank and recognize the rest of the staff: Cheryl Dykeman, Debby Barnes, Emily Lovesky, Mimi Barter, Ken Kepler, and Michael Scian for their on-going contributions without which we would have never been able to pass the accreditation. And obviously the Board itself needs to be acknowledged for appropriately reviewing research. As IRB-01 Chairman Dr. Iafrate is quoted in this month's "The Post":

"This reaffirms the IRB does what we thought we should be doing. It lets others know that we are running a good IRB."

Last but not least I want to acknowledge our partners at the VA who we had the privelege of collaborating closely with over the past couple of years: Katie Yeckring, Marjorie Wilson, Cheri Chebret, Ilena Koerner, Karen Helms (who received special recognition for the exceptional practices at the VA pharmacy), Faye Coorpender, Dr. Hoffman, and Dr. Wingo. Preparing for accreditation not only helped improve our human research protection program, but it also fostered a closer relationship between our two institutions.

MANY, MANY THANKS TO EVERYONE WHO CONTRIBUTED TO THE SUCCESSFUL ACCREDITATION!

Michael Mahoney
Coordinator, IRB-01

<Click here to see the article about NCQA Accreditation in "The Post".>

Investigators conducting research with WIRB:

Effective June 1, 2005 WIRB will require investigators to attest to successful completion of training in human research subject protection. WIRB offers links to a variety of on-line training courses at:

http://www.wirb.com/html/OnlineTraining.html

Or you can attend one of their live sessions to fulfill this requirement:

http://www.wirb.com/html/WIRBTraining.html

As part of the University's continuing HIPAA training all Principal Investigators, sub-Investigators, coordinators, and study related staff must re-take the required HIPAA training for researchers every 2 years. The training can be done on-line or at one of the live training sessions. If you initially took the training before 4/14/2003 you must take it again by 4/14/2005. If you initially took the training on or after 4/14/2003 you must take it again by your two year anniversary date.

Click here for the link to UF's Privacy Office web page in order to complete the training on-line (http://privacy.health.ufl.edu/training/research/)

or

Click here to see when you can attend one of the live training sessions.

PLEASE NOTE: this training is research specific, and is in addition to any training that Shands, UF, or the VA requires you to complete for your clinical duties.

UF Faculty and Staff: UPGRADE YOUR MICROSOFT WORD/OFFICE FOR FREE!!

UF has signed a contract with Microsoft to extend a site license for all Microsoft Office software including: Word, Access, Outlook, PowerPoint, Publisher and Excel. For those with Mac computers: Word, Excel, PowerPoint and Entourage are included. This means that all paid personnel (faculty and staff) can have the most recent versions of the software listed above loaded on their UF owned computers for free.

Prior to trying to update your Microsoft products you should first determine what version you are using. In terms of dealing with the IRB you should be most concerned with Word, so open/run that program, click on the "Help" menu, and then select "About Microsoft Word" (see below).

A new window will open and indicate if you are using Word 97, Word 2000, or Word XP (2002).

You must upgrade your software if you are using Word 97 since several of our forms do not work properly in Word 97 (the Continuing Review/Study Closure Report, for example).

Word 2000 or Word XP(2002) users do not need to update to the newest version of Word. Word 2000 users may want to update in order to protect/unprotect our forms and not lose any of your answers (if you unprotect a form in order to track changes and then re-protect the document you will lose all of your answers!). The newest version of Word allows you to unprotect/protect a document as often as you like and not lose any data.

If you determine you want/need to update your Microsoft Word (or other Office software), please contact your local IT administrator. If your IT personnel have any questions they can review UF's new policy on the Office of Information Technology web site at

http://www.it.ufl.edu/projects/microsoft.html

or contact Dr. Mike Conlon of the UF Office of Information technology at 392-3261.

Do you work on IRB forms at home as well? It appears that you may also be able to have the Microsoft programs loaded onto a single home computer for either free or a very low rate (less than $10). We will post additional details when this program is confirmed.

Lastly, this program does not apply to UF students, Shands employees, or VA faculty or staff.

The IRB office will be open Monday 12/27 through Thursday 12/30, from 8 AM to 4 PM. Please note: due to the TEAMS holiday not all employees will be available until Monday January 3rd, 2005. Please contact the main line at our office (846-1494) if you have any issues. Thank you.

Please remember that you must always download and use the newest Informed Consent Forms with all submissions to the IRB when a new consent must be created (for example: new studies, continuing review, revisions to the consent form, etc). The current template was posted in August and contains significant changes to the language in many places. Do NOT transfer questions on the new form to any old forms you have. Instead, you may transfer answers from the old form to the new form. The rationale for this is that there are several changes to the standardized language throughout the document that will be lost if you do not use the new form as your template.

In addition, remember you must always download and use the newest forms when making submissions to the IRB.

Shands Conference Room 10-214 renovations continue. As a result the IRB Full Board meetings scheduled for September 1st and 15th, 2004 has been relocated.

The September 1st meeting will be in room G301 in the HPNP complex on the north side of the Health Science Center. Due to the late notice and the start of classes the meeting is scheduled for 7:30 AM to 12:30 PM.

Room G301 is on the ground floor in the west wing of the HPNP Complex. Click here for a map of the HPNP Complex and the location of the room.

We apologize for any inconvenience. We were informed that we would be back into the normal conference room prior to this and were notified recently of the continued unavailability of the room. Please contact Michael Mahoney if you have any problems or questions. Thank you!

We've changed our Forms page! Rather than list the numerous different Informed Consent templates alphabetically among the many other forms, we've created a single Informed Consent Forms link that will take you to a special page devoted to Informed Consents. In addition to listing the consent templates in hopefully a more helpful fashion, we've also consolidated all of the other resources dedicated to Informed Consents. We welcome your feedback!

We've added a new position paper about Federal Certificates of Confidentiality.

Shands Conference Room 10-214 renovations continue. As a result the IRB Full Board meeting scheduled for August 18th, 2004 has been relocated to room 1102 in the HPNP complex on the north side of the Health Science Center. The September 1st meeting also needs to be relocated, and an announcement will be made when the arrangements are finalized.

Room 1102 is on the first floor in the Nursing Building of the HPNP Complex. Please note that the first floor is one floor up from the ground floor. Click here for a map of the HPNP Complex and the location of the room.

We apologize for any inconvenience. We just learned of the renovations and announced the change as soon as we located a suitable room for the meeting. Please contact Michael Mahoney if you have any problems or questions. Thank you!

Shands Conference Room 10-214 is about to undergo renovations. As a result the IRB Full Board meetings scheduled for July 21st, 2004 and August 4th, 2004 have been relocated to room 1102 in the HPNP complex on the north side of the Health Science Center. If renovations are not complete, the August 18th meeting will also be relocated to this room.

Room 1102 is on the first floor in the Nursing Building of the HPNP Complex. Please note that the first floor is one floor up from the ground floor. Click here for a map of the HPNP Complex and the location of the room.

We apologize for any inconvenience. We just learned of the renovations and announced the change as soon as we located a suitable room for the meeting. Please contact Michael Mahoney if you have any problems or questions. Thank you!

The IRB now offers several new resources to assist researchers, including: