Joint announcement from DSR, RAC, and the IRB (e-mailed 10/09/2009)

New IRB Submission Requirement!

The terms of the fiscal language in the ICF and the Clinical Trial contract must be consistent.  There has been an unacceptably high percentage of IRB approved informed consent forms (both IRB-01 and WIRB) that seriously conflicted with the terms of the UF-Sponsor contract or conflicted within the ICF.    The offices of Research Administration and Compliance (RAC), Division of Sponsored Research (DSR) , and the IRB have worked together to rectify this issue – including benchmarking how other institutions address the issue,  as well as polling some of UF’s more experienced research groups as to how they deal with the local system. The  IRB,  DSR, and  RAC have agreed to implement a serial submission process to (1) help ensure subjects are properly informed and billed, (2) decrease changes to the ICF after patients have already enrolled (3) minimize the possibility of billing non-compliance, and (4) reduce workload and cost to the PI, RAC, and IRB if ICF and/or the Clinical Trial Agreement (CTA) are in error and must be corrected.  As a result, follow these steps:

1. As soon as you intend to conduct research that involves any drugs, substances, devices or clinical services (i.e. blood draws, tissue samples, lab tests, clinical examinations), you should submit the completed RAC packet (includes the Study Initiation Checklist for Research with Human Subjects - http://ctc.health.ufl.edu/freqUsed/freq_used_forms.shtml) to the RAC. 
   NOTE: This process applies to all studies regardless of funding,  including unfunded research or UF internally  funded research.  The only exemption is research conducted by VA personnel that only involves VA facilities, resources, and/or subjects. 
   
   
2. After RAC receives a completed packet, RAC will assess the information and give the researcher a “Financial Language Assessment” (FLA) form.  You must have this RAC-signed form to submit your project to IRB-01 or WIRB.
   
   
3. IRB-01 is revising the Introductory Questionnaire (IQ) to request the FLA form any time the research involves any drugs, substances, devices or clinical services (excluding solely VA).  This request will be placed at the beginning of the IQ to alert the PI of this new requirement.   Without the completed FLA form, IRB-01 will return your clinical services research submission.

• You should ensure the language in the ICF you submit to IRB-01 is consistent with what is recommended in FLA form.  Otherwise the IRB may not be able to approve the study.
• WIRB will be instructed not to accept research from UF-Gainesville faculty or staff without the FLA form.

RAC, DSR, and the IRB are extremely concerned that this process may cause delays in approval of clinical research.  Several of UF’s larger research groups already follow this process voluntarily with little to no impact to the time it takes to begin the research.  Researchers, however, must be proactive and provide a completed RAC packet to RAC as soon as possible to initiate the compliance review process.  RAC, DSR, and the IRB will monitor the time to get research approved and may take additional steps if the current process causes excessive delays.

As of this moment IRB-01 is unable to approve research without the RAC’s assessment.  If you are working on a new study that involves any drugs, substances, devices or clinical services, you should submit your completed  RAC packet to the  RAC office ASAP  to obtain the required FLA.

The new IQ will be available on Monday 10/12/09 and should be downloaded and used for all new studies.  You may continue to submit the most recent version of the IQs through Friday October 30th, 2009 (particularly if you have already started working on a new study).  However, please note the IRB cannot approve the research unless you obtain and provide the RAC’s FLA form.

On and after Monday November 2nd, 2009 IRB-01 will return any submissions that do not provide the RAC FLA or fail to use the newest version of the IQ.

A  “Brown Bag” seminar, scheduled for

Tuesday October 13th from 12 PM to 1:30 PM
McKnight Brain Institute room LG110A

This meeting will be devoted to this and any other topics of interest.

For answers to questions please contact:

DSR:
	Tom Walsh twalsh@ufl.edu (352) 392-1582

IRB:
	Michael Mahoney mmahoney@ufl.edu (352) 846-1706

RAC:
	Yvonne Brinson ybrinson@ufl.edu 273-5946

Privacy Office requirements for the use of Social Security Numbers in research.

The UF Privacy Office has updated its policies concerning the use of social security numbers in research. As a result, please note the following:

IF you are paying subjects, then the collection of the social security number is appropriate and the
subject must be informed in the consent document. Current template language in the consent document
for payment purposes follows:

• Item 15 – If you are paid for taking part in this study, your name and social security number will
  be reported to the appropriate University employees for purposes of making and recording
  payment. You are responsible for paying income taxes on any payments provided by the study. If
  the payments total $600 or more, the University must report the amount you received to the
  Internal Revenue Service (IRS).
  
• Item 17 – your social security number for payment purposes.
  IF you are collecting the social security number for the purpose of checking the social security death
  index or for any other purpose, then you MUST submit an approved “Request to Collect, Use, or Store
  Social Security Numbers” form. This form is found on page 29 of the “University of Florida Information
  Privacy Policies & Procedures” manual (http://privacy.ufl.edu/pdf/PrivacyPolicyProcedures.pdf) and must
  be submitted to the Privacy Office for review and approval before you can collect social security
  numbers for use in your study.

IF you are collecting the social security number for the purpose of checking the social security death
index or for any other purpose, then you MUST submit an approved “Request to Collect, Use, or Store
Social Security Numbers” form. This form is found on page 29 of the “University of Florida Information
Privacy Policies & Procedures” manual (http://privacy.ufl.edu/pdf/PrivacyPolicyProcedures.pdf) and must
be submitted to the Privacy Office for review and approval before you can collect social security
numbers for use in your study.

If you have an approved consent document indicating that you are collecting social security numbers to
track mortality or for any purpose other than payment, you must immediately submit the exception to
the University of Florida Privacy Office. Once it has been approved, a copy must be provided to the IRB
office for your file.

This form is required for each study that requests the use of the social security number for any
purpose other than payment.

View the letter from Linda Fallon, HIPAA Coordinator, that was sent out on 09/01/09.

http://irb.ufl.edu/hipaa/ssn.pdf

IRB Registration for new FDA and OHRP requirements

In order to comply with the FDA's new rule concerning IRB Registration (http://edocket.access.gpo.gov/2009/pdf/E9‐682.pdf) we have appropriately updated the registration for all
three UF IRB's with the Federal Office of Human Research Protections(OHRP).

The IRB registration number for IRB‐01 = 00000335

Registration information may be reviewed on OHRP's web site at: http://ohrp.cit.nih.gov/search/

Important Deadline Updated

Several Tabled deadlines for 2009 have been updated. Please be sure to review and use the corrected dates.

In addition, the Meeting dates and deadlines have been updated in the Tabled Response Form.

Reminder to all researchers:

Starting January 1st, 2009 the IRB will no longer send hard copy Continuing Review expirations notices (90 and 45 day) out to researchers. Instead, these reminders will *only* be sent out via e-mail to the PI plus any coordinators indicated in our database.

As a result it is critical that you review the e-mail account listed for you at http://my.ufl.edu.  Follow the directions below (see the 10/20/08 news item) on how to review and update your official UF business e-mail account.   (Remember to update your address with my.ufl.edu anytime your address changes)

This information was e-mailed to our IRB listserv and posted here on our News page on 10/20/2008 and 12/10/2008.

Please let me know if you have any questions.  Thank you!

Michael Mahoney
352-846-1706

Please be advised that the IRB-01 office will be closed for the UF TEAMS holiday period from 12/25/08 thru 01/04/09.  We will reopen Monday 01/05/09.

We will not be accepting any paperwork during this time.

If you have an emergency situation – as defined as (a) a life threatening or severely debilitating to a subject AND (b) no alternative treatments are possible/available – you may page our Chairman, Peter Iafrate, at (352) 491-5513.

Otherwise all other questions or issues should be directed via a message to our main line at (352) 846-1494 or e-mail to irb1@grove.ufl.edu.  Someone from the office will contact you after the office re-opens on Monday 01/05/09.

Please contact me if you have any questions at this time.  Thank you!

Michael Mahoney
352-846-1706

As part of our efforts to enhance service to investigators we have modified our current database to automatically e-mail certain information to researchers.

We have tested this system and are now ready to take the next step to actually send notices to researchers.

As a result our database will soon start sending our continuing review expiration notices via e-mail to not only the PI, but also any research coordinators indicated in our database.   These notices include: 90 days to expiration, 45 days to expiration, expired, and expired-nonrenewable.

IMPORTANT:  these e-mails will be sent to the business e-mail address that is designated in PeopleSoft.  Please take the time now to update your e-mail address there. 

1. Visit http://my.ufl.edu/
2. Click the “My Account” link
3. Click the “Modify My UF Business Email”.  You will see the address they currently have listed for you.  Change the address if appropriate.

We will continue to generate hard copies of the Expired and Expired Non-renewable notices because they officially notify you of a change in your study status.

However, we will only generate hard copies of the 90 day and 45 Expiration notices unitl January 1st, 2009, after which time those notices will ONLY be sent via e-mail.  As a result it is critical that you insure that the e-mail address listed at MyUFL is accurate now and should it change in the future.

Please let me know if you have any questions or issues.

Lastly, we expect to utilize this functionality in additional ways in the near future.  We’re also open to suggestions!

Thank you.

Michael Mahoney
352-846-1706

Revising Documents
During today’s full Board meeting the Board reiterated that the office should not accept revised documents that fail to include a strike-out/underline copy highlighting the changes.  This requirement also replies to Tabled Responses, Explicit Change Responses, and Full Board Corrections.

Rationale:  it is very difficult, time consuming, and sometimes impossible to identify and thoroughly examine changes without the strike-out/underline version.

Changes can be tracked automatically in Microsoft Word.  Instructions are available at: http://irb.ufl.edu/irb01/formsinstruct.htm

As a result, the IRB Office will automatically return any submissions that fail to provide strike-out/underline versions when needed.  We will not consider submissions that fail in this regard to have met our deadlines.

Please help us to serve you as efficiently as possible and include a strike-out/underline version whenever you are submitting revised pages (not just for Revisions, but also for Tabled Responses, Explicit Change Responses, and Full Board Corrections). 

Please contact me if you have any questions.

Thank you.

Michael Mahoney
IRB-01 Coordinator
352-846-1706
mmahoney@ufl.edu

Revised Continuing Review/Study Closure Form!

We're listening to our researchers!

First, in order to hopefully improve the Continuing Review/Study Closure form we carefully examined the Continuing Review requirements and compared our form to the forms used by other IRBs. We've made a variety of modifications - some as minor as reordering questions to improve flow due to applicability, expanded help text, dropping a few questions that we could not find a justification for keeping, and most significantly changed how enrollment numbers are reported. In regards to the enrollment numbers, the new form no longer asks researchers to tease out how many subjects have been enrolled in the past year AND since the study started in a wide variety of categories. Instead the new forms only asks for the total number of subjects since the study started in a greatly simplified number of categories.

Second, in addition to hopefully improving the form, we've posted a strike-out/underline version showing exactly how this new beta version of the form differs from the old form. You'll find the link to this document below the beta version.

You may choose to use either the new beta version or the old version between now and January 1st, 2009 - at which time we do not plan to accept the old version of the form. Please note that the new form may undergo some minor tweaking as it is used by researchers and reviewed by the Board - so please be sure to always download and use the newest version off of the website.

The new forms are currently available on our Alphabetical Listing of Forms at: http://irb.ufl.edu/irb01/forms1.htm

Please let me know if you have any questions or feedback.  Thank you!

Michael Mahoney
mmahoney@ufl.edu
(352) 846-1706

New form for Retrospective Record/Data Review Studies!

Based on feedback from our researchers we’ve created a new Introductory Questionnaire just for Retrospective Record/Data Review studies.

Previously researchers conducting these types of studies had to decide whether or not to submit their project on our Exempt paperwork or Expedited paperwork.   Unfortunately sometimes submissions couldn’t be approved in the category that the project was submitted under… and the researcher would have to resubmit their project using the other category of paperwork.

In order to simply the process and avoid the pitfall of completing and submitting two sets of paperwork, we’ve created a single Introductory Questionnaire just for Retrospective Record/Data Review studies.  This form gathers all the information we need to determine if the research can be approved under a Nonhuman, Exempt, or Expedited category.

This submission type also includes a newly created Addendum R: Review of Shands Medical Records.  You’ll only have to complete this addendum if you are using Shands medical records.   Shands has indicated they will only release medical records after you provide them a IRB approved and stamped copy of this Addendum R.

IMPORTANT NOTE:  this paperwork is only for RETROSPECTIVE record/data reviews.  The federal government’s definition of retrospective is that the records/data exist on or before your submission to the IRB.  As a result this paperwork is not appropriate for any research that intends to include any records/data that will be created after the date of submission to the IRB.

The new forms are currently available on our Alphabetical Listing of Forms at: http://irb.ufl.edu/irb01/forms1.htm

Please let me know if you have any questions or feedback.  Thank you!

Michael Mahoney
mmahoney@ufl.edu
(352) 846-1706

Posting Recruitment Flyers

Please be reminded that the University has specific regulations about where recruitment flyers/advertisements may be posted (6C1-2.003 – available at http://regulations.ufl.edu/chapter2/2003.pdf ).  As you can see below, the Director of Operations at the Reitz Union recently complained about researchers failing to abide with University’s regulations by posting materials inappropriately in the Reitz Union.

Although it is not the IRB’s direct mission to enforce these regulations, as a member of University we will assist appropriate parties as needed.

Please take a moment to review the regulations at http://regulations.ufl.edu/chapter2/2003.pdf and be sure to comply with the University’s requirements.

Feel free to contact me if you have any questions.  Thanks.

-Michael Mahoney
IRB-01 Coordinator

From: Mike Mironack [mailto:mikem@UNION.UFL.EDU]
Sent: Tuesday, September 16, 2008 12:41 PM
Subject: Posting of flyers

Please be advised that per UF Regulation 6C1-2.003 regarding the Distribution of Printed Material, “No printed material may be posted or placed on trees, any interior or exterior walls or doors of campus buildings, or on any campus property other than permanent official bulleting boards of the University designated for that purpose.”

We recently found flyers for two research studies [redacted] taped to walls throughout the J. Wayne Reitz Union.  [redacted]  These are currently being removed.

This seems to reoccur most fall semesters and is most often done by [redacted] researchers.

We would appreciate the assistance of the IRB offices and the College of [redacted] in informing faculty and staff who are involved in research on campus of the policies pertaining to posting of flyers and other advertisements for their studies.

Thank you for your cooperation and understanding.

Mike Mironack, Ph.D.
Director of Operations
J. Wayne Reitz Union
PO Box 118505
Gainesville, FL 32611-8505
(352) 392-4781
(352) 392-5100 - fax
www.union.ufl.edu

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:

1. Sample notes for documenting the informed consent process in the medical record or research chart.
2. A log to track your IRB submissions.
3. A log to track your adverse events.
4. How to set up a regulatory binder.
5. A log to track duties that are delegated by the PI.

Please visit the Researcher Tools page. This link has also been added to the IRB-01 Navigation Bar on the left of all of our pages.

The VA now offers two new resources to assist researchers conducting research at the NF/SG VAMC:

1. Study Resource Utilization Form
2. Documenting reseach informed consents in the subject's electronic medical record (CPRS

URGENT ISSUE: PeopleSoft, Expiring Protocols, and Grant Supported Salaries:

Please be aware that on June 18th, 2004 the entire university payroll system is converting to a new software system (PeopleSoft). It has come to our attention that there may be issues paying salaries on those grants that experience an expiration of their IRB approval. In other words: in the coming weeks if your IRB approval expires for a project that pays some or all of someone's salary, it is possible that the person will not receive part or all of their salary.

As a result the IRB reminds investigators to submit their continuing reviews in a timely manner: at least two meetings prior to the expiration date for studies requiring full Board review, or four to six weeks prior to the expiration date for studies requiring Expedited review. The IRB already strives to assist investigators with obtaining timely review - we send out expiration notices 90 and 45 days prior to the expiration, as well as provide the IRB Web Functions which allows investigators to view their expiration dates at any time.

In addition to proactively alerting investigators to this potential problem, we are also taking internal steps to help minimize the issue. For example: We are in the process of informing our reviewers to make extra efforts to resolve any issues with PIs before our meetings in order to increase the chances of approval / decrease the likelihood of tabling the continuing review. We are also asking our chairs to prioritize all expedited continuing reviews in order to avoid expiration.

Should some of your staff salaries be affected because your protocol expires, please contact the IRB-01 Coordinator, Michael Mahoney, directly at 846-1706 or mmahoney@ufl.edu. We will work with you and the fiscal offices in order to resolve the situation in as timely a manner as is possible within regulations and university policies. Hopefully this will at most be a minor, short term issue that will impact few if any employees. However it is impossible to predict how the software conversion will unfold and what difficulties the fiscal staffs will face.

Please remember: it is the Principal Investigator's responsibility to obtain timely continuing review for their projects. As demonstrated above we will collaborate with investigators and other university offices to resolve any issues as quickly as possible.

HIPAA Training required for ALL research staff
Effective 6/10/2004 everyone participating in research (including but not limited to the principal investigator, sub-investigators, study coordinator, and staff/students preparing research paperwork or collecting data) must complete the "HIPAA for Researchers" training. This training can either be completed on-line at:

http://privacy.health.ufl.edu/training/research/online.asp#

or by attending one of our live "HIPAA & Research" training sessions offered once every month. Click here for more information.

Consenting subjects who do not speak or read English:
What is the researcher supposed to do when a potential subject cannot speak or read English? So long as your study is not specifically directed at enrolling non-English speakers you are unlikely to have a translated version of the consent form. Since the federal guidance permits the use of a short form Informed Consent to be used in conjunction with your usual approved Informed Consent form, the IRB has added a position paper to explain this practice to researchers as well as provided an English version of the short form to be used with a translator. In the not to distant future we will also provide translated versions of the short form based on statistical determination of the other languages most likely to be encountered when enrolling subjects here in Gainesville.

New Checklist for Informed Consent Forms:
Federal regulations dictate that certain information MUST be in all Informed Consent forms. 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. Note this checklist is intended to help reduce any problems that the Board may have with your

New IRB E-Mail List:
In order to further facilitate communicating important information to researchers we have created an IRB ListServ mailing list:
IRBMAIL-L@lists.ufl.edu

If you wish to be added to this IRB e-mail announcement system, send an e-mail to listserv@lists.ufl.edu with only the following in the body of your message (be sure to delete all other text, including your electronic signature): subscribe IRBMAIL-L

Click here to subscribe to IRBMAIL-L.

If at any point you wish to discontinue your participation in this list, send another e-mail to listserv@lists.ufl.edu with the following text in the body of your message: signoff IRBMAIL-L

Click here to signoff.

IRB POLICY ANNOUNCEMENT:
Some survey research conducted by Health Science Center faculty, staff, and students may now be submitted to IRB 02 instead of IRB 01. For more information please view the official policy announcement at http://irb.ufl.edu/irb01policy.htm

All researchers and/or staff associated with human subjects research need to familiarize themselves with our new page, Researcher Responsibilities. These responsibilities were previously outlined in our old Multiple Project Assurance (MPA) to the government. The responsibilities are now listed on our web site rather than the Assurance because (1) the MPA has expired and was recently replaced with a Federal Wide Assurance (FWA), and (2) the FWA does not specifically list researcher responsibilities.

Closed studies doing data analysis on IDENTIFIED data:
From August 2002 until February 2004 the IRB allowed investigators to close research that had completed enrollment and all study interventions but was continuing to perform data analysis. This policy has now changed due to recent government findings at another institution. As a result, researchers may only close studies that have completed enrollment and study interventions and are doing data analysis on de-identified/anonymous data. If data analysis continues on identified data then you must continue to obtain IRB approval for your research.

What if I previously closed my study and am doing or will need to do data analysis on identified data?
Since you must have IRB approval to perform data analysis on identified data, you will need to submit a new expedited protocol to the IRB consisting of a our regular Introductory Questionnaire and a protocol. Please be sure to tell us the IRB project number that you used to originally collect the data that you now need to analyze.

Enrolling Prisoners in Research: This is a reminder to all investigators that you may NOT enroll any prisoners in your research projects unless the IRB has previously approved the inclusion of this vulnerable population. The federal regulations have additional safeguards for enrolling prisoners in research that must be met.

How do you know if the IRB has approved you to enroll prisoners? Look at your most recently approved Introductory Questionnaire and see if you indicated that you were going to enroll prisoners.

What should you do if you've enrolled a prisoner but your Introductory Questionnaire does not indicate that were approved to do so? This is a protocol deviation and must be reported to the Board as soon as possible.

What if a subject is not prisoner when enrolled in my study, but sometime later during the course of the study the subject becomes incarcerated/jailed? You must report this to the IRB if your protocol is not previously approved for prisoners.

Does this apply to full Board studies only? No, this applies to ALL research.

HIPAA Covered Studies

Subjects enrolled in studies after April 13, 2003 are required to sign an appropriate HIPAA authorization. If the IRB-01 office discovers that subjects were enrolled without signing a HIPAA authorization we will refer the issue to the UF Privacy Office. Until the UF Privacy Office has resolved the situation the IRB will be unable to process any accompanying submissions. This may affect protocol revisions or the timeliness of a continuing renewal.

Current UF Privacy Office policy allows PIs 30 days to obtain a signed authorization from previously enrolled study subjects. If the authorization is not or cannot be obtained within the time limit then the PI may be required to destroy any data collected without authorization. PIs should be aware that the UF Privacy Office may take more severe actions in egregious cases. Please contact the UF Privacy Office directly for more information.

Principal Investigators are reminded that they are ultimately responsible for the proper conduct of their study. This responsibility cannot be delegated to staff.

New Tissue Bank / Data Bank forms:
Do you want to create a "bank" in order to provide data and/or tissue to other research studies? Do you have a clinical database of your patients that you would like to use for research purposes? We have created two new forms in hopes of making it easier to obtain approval for tissue/data banks: (1) Introductory Questionnaire - Tissue/Data Banks ONLY, and (2) UF/Shands Informed Consent form for Tissue/Data Banks ONLY (we hope to add a VA ICF shortly). These forms are available at our Forms page.

NOTE: if your research project includes other study interventions (e.g. therapeutic measures), you may NOT use the Tissue/Data paperwork described above. The Tissue/Data Bank paperwork does not adequately address the issues pertinent for other study interventions. In these other cases you should use the regular Introductory Question and regular Informed Conset form.

Continuing Review and HIPAA:
Do you have an IRB approved HIPAA Authorization separate from your Informed Consent form? UF Administration has determined that separate Authorizations for research must be phased out at Continuing Review. As a result, all PIs must use the Informed Consent with HIPAA Language if your research includes the collection, creation, use, or disclosure of PHI. When submitting Continuing Reviews, be sure to update your Informed Consent form to include HIPAA language. Failure to do so will result in automatic return of your submission after August 1st, 2003.

VA Privacy Board:
Research projects that are conducted at any of the NF/SG VAMCs will need to receive separate VA Privacy Board approval for the following HIPAA related documents: (1) Waivers of Authorization, (2) Certificates for Preparatory Research, and (3) Certificates for Research with Decedents Information.

For more information please visit our HIPAA Information page.

WIRB experiencing delays:
Please be aware that WIRB is experiencing delays in reviewing and approving research, as well as with sending us copies of your approval paperwork (which we need in order to tell DSR they can activate your funding). On Monday May 5th WIRB stated the following:

"There have been delays in the processing of submissions since the onslaught of HIPAA and WIRB's implementation of the new database. Please be assured that is temporary and WIRB is diligently working towards rectifying the inconveniences that the delays are causing."

Please also remember when submitting paperwork to WIRB that you must inform them that you are a UF investigator by including a copy of our cover letter. Once WIRB knows you are affiliated with UF they will send a copy of your approval paperwork to our office. Once we receive the approval paperwork we can inform DSR that your study is approved and DSR can activate your funding. Failure to inform WIRB that you are affiliated with UF will delay the activation of your funding. Please visit our WIRB web pages for more information.

Many investigators are also experiencing difficulty getting through on the telephone to WIRB. Again, due to the issues cited above WIRB is being flooded with phone calls. We recommend e-mailing inquiries to WIRB at wirb@wirb.com. We have routinely received a response the same day and no later than the next business day.

Lastly, do not hestitate to contact UF's liaison, Michael Mahoney, to WIRB if you have any unresolved issues or problems with WIRB. Michael will work with you to resolve the issue. You may reach Michael at 846-1706 or mmahoney@ufl.edu.

IMPORTANT! New Submission Acceptability Standards:
As Announced in our April 25th and 28th IRB Forums: Effective May 1st, 2003, all submissions to IRB-01 must meet our Submission Acceptability Standards. If your submission fails to meet these standards, we will automatically return your submission to your campus mailbox via campus mail. For more information please see our Submit Paperwork page.

IMPORTANT! Minor deadline change:
As Announced in our April 25th and 28th IRB Forums: Effective May 1st, 2003, our Monday Full Board Deadlines have been moved from 5 PM to 12 PM. Please visit our Deadlines page for more information.

All new April 2003 IRB FORUM!
Click here for more information.

HIPAA IS NOW IN EFFECT!
All subjects consenting to participate in research must now also authorize the collection/use/disclosure of their protected health information. Subjects need to sign either (1) an IRB approved Informed Consent form with HIPAA language included or (2) an IRB approved Informed Consent form AND an IRB approved HIPAA Authorization. Please contact our office if you have any questions.

Fix older versions of Microsoft Word!
Do the page numbers on your Informed Consent Form appear correctly on the computer screen but print out incorrectly? Click here for instructions on how to fix this problem so your page numbers print correctly.

New tool: Recruiting Research Subjects!
HIPAA has created many questions on how investigators may properly identify and approach potential research subjects. Click here to view a table which addresses some of the more common recruiting methods.

New form: Non-reportable Adverse Events!
Frequently sponsors ask investigators to submit events which IRB-01 does not require for review. We have updated our Adverse Event Definitions and Adverse Event Evaluation Guide, as well as provided a new Adverse Event Report - Non-reportable Event form.

New Office Information on the web!
In order to assist investigators we have added (1) a staff directory with direct contact information, and (2) a listing of who to contact if you have questions about specific issues (such has who to contact in order to receive an approval letter for a newly approved protocol). In addition, we have created a new IRB-01 Home page which separates the web site pages by content.

Deadline for HIPAA paperwork - 9 AM Tuesday April 1st, 2003:
Error-free (1) HIPAA authorizations and (2) Informed Consents revised only to include HIPAA elements, that are submitted by April 1st, 2003 will be processed by April 14th, 2003. Incorrect paperwork submitted on this deadline or any paperwork submitted after this deadline will be processed as quickly as possible, but will not be guaranteed for April 14th. Remember: you may not consent any subjects after April 13th without an approved HIPAA authorization or approved Informed Consent with HIPAA elements.

Submitting HIPAA paperwork: We will not start accepting HIPAA paperwork until Monday March3rd. In order to assist investigators and insure that HIPAA submissions are processed quickly and correctly at that time, we will have exclusive HIPAA IN-BOXES. One box will be at a table in Shands Atrium during specific times, and the other will be in available during all of our office hours in our office at CB-169. Click here to see our announcement and for dates and times that submissions may be submitted in the Atrium.

Updated Continuing Review/Study Closure (CR/SC): This form has been updated (1) to reflect the new requirements for when you must submit new, clean copies of your project's Informed Consent form in our newest format, and (2) to clarify certain questions which researchers were not completing correctly. Please be sure to download and use the current form! HIPAA NOTE: you may use the new Informed Consent with HIPAA Authorization language at time of Continuing Review.

HIPAA Forms are NOW AVAILABLE! Click here to download and complete the Authorization form (for EXISITING studies which will continue enrollment after 04/13/03) and the Certification forms for preparatory research and research with decendents information. Please note the following: (1) do NOT submit any HIPAA paperwork to us until March 1st, 2003. Our HIPAA officer should be on board at that point and ready to administratively process HIPAA paperwork. (2) The following forms for new research are not available at this time: Introductory Questionnaires or Informed Consent Form with HIPAA language/questions. We will make these forms available as soon as they are ready.

Web Functions Activated! We've added some additional functionality to our web site in order to assist researchers. These functions are PI specific and require the PI to submit a password to us. The functions are: (1) Advertise your clinical trial on the Shands.org web site in order to recruit new subjects. (2) View the expiration dates for all your IRB approved studies. (3) View the status of submissions to our office. Click here to get started!

Patients view of advertised trials: Once an ad has been submitted to, reviewed and approved by IRB-01 AND your project has an active approval, the ad will be visible to patients on the Shands.org web site at: http://shands.org/find/irb/

2004 is a critical year for the IRB. We are undergoing an accreditation process as part of our affiliation with the VA. Some of our processes and forms will change in order to meet accreditation standards. For example we recently added a question to the Continuing Review/Study Closure report requesting the numbers of males and females enrolled to date in your project. Again, please be sure to always download the current forms in order to be sure that all of our submissions meet accreditation standards. Thank you!

HIPAA Training begins January 6th, 2003! Training is MANDATORY for all principal investigators and faculty, and strongly recommended for other key research staff. Click here to visit our HIPAA page for the training schedule and to view a copy of memo from Dr. Phillips and Dr. Iafrate.

New IRB Forum - January 17 and 23, 2003! Learn about the new IRB web site functions: view study expiration dates, status of current submissions, and advertise your studies on Shands.org. Hear about our changes in some of our policies concerning new consent forms at time of Continuing Review as well as how we will act on expired studies or when PIs fail to respond in a timely fashion to IRB requests. There will also be a brief update on HIPAA, how to get 6 CME through on-line research training, introduction to two new forms, and, if available, preliminary results from our October 2002 Customer Service Satisfaction Survey. Click here to learn more and to reserve a seat. Seating is limited, so don't delay!

Special Presentation - January 30, 2003: "Coping Successfully with the IRB: Common Problems and Their Solutions" hosted by IRB-01 Board member Sheila Eyberg, PhD. Learn about some of the more frequent problems the Board reviews in submissions, solutions to these problems, as well as the differing perspectives on these problems. Open discussion will follow. Click here to learn more and to reserve a seat. Seating is limited, so don't delay!

October 2002: 5 copies (signed "original" plus 4 photocopies) needed for all submissions!
In order to facilitate faster processing of submissions, we now require 5 copies of all submissions (new, revisions, adverse event reports, continuing review/study closures, etc.). The 5 copies should consist of (1) the signed "original" plus (2) four photocopies.

October 2002: New Forms Required!
October will be a month of sweeping changes, including the required use of all our new forms. We will not accept submissions on older forms. Please be sure to download and submit the new forms.