|
IRB Calendar of Events |
| 01-Board |
01B-Board |
| February 1, 1999 |
February 16, 1999 |
|
DID YOU KNOW THAT?
IRB FORMS ARE ON THE WEB |
| The IRB has requested that all investigators use the most
recent forms that are available on the World Wide Web. To access these templates simply go
to the Research Office home page which is located at http://www.research.usf.edu/
and then click Division of Compliance Services and then click Download Compliance Forms,
Templates and Procedures. From this page it is possible to download the
most current Microsoft Word form or to print a copy using Adobe Acrobat. |
|
IRB Feature
Article:
Continuing Reviews after IRB Approval |
| The Food and Drug Administration (FDA) requires that all
Institutional Review Boards (IRBs) be responsible for continuing review of approved
ongoing research studies to ensure that the rights and welfare of human subjects are
protected. All USF IRB studies whether they were approved by full board or expedited, are
subject to at least an annual review. The FDA regulations regarding continuing review
are as follows:
· IRBs conduct continuing review of research at intervals
appropriate to the degree of risk, but not less than once per year as per 21 CFR 56.108(a)
(1) and 56.109 (e);
· IRBs must determine which studies need verification from
sources other than the investigator that no material changes in the research have occurred
since the previous IRB review as per21 CFR 56.108 (a) (2);
· IRBs ensure that changes in approved research are promptly
reported to, and approved by, the IRB as per 21 CFR 56.108 (a) (3-4); and that
· IRBs are responsible for review of the entire study and not
just any changes.
· IRBs are responsible for suspending or terminating approval
of research that is not conducted in accordance with the IRB’s requirements as per 21
CFR 56.108 (b)(2) and 56.113.
All ongoing USF IRB approved studies are subject to an annual continuing review. The
Principal Investigator is responsible for submitting to the IRB a Progress Report using
the most current forms that are available on the USF Division of Compliance Services web
site (see Did You Know That? Page 1). If you do not have access to our web site, the IRB
office has the forms on floppy disc, so just call 631-4498 and request that a floppy disc
be sent to you. |
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ABBREVIATIONS |
ACH: |
All Children’s Hospital |
| BPVA: |
Bay Pines Veterans Hospital |
| CFR: |
Code of Federal Regulations |
| DHHS: |
Department of Health and Human Services |
| DSR: |
Division of Sponsored Research |
| FDA: |
Food and Drug Administration |
| IDE: |
Investigational Device Exemption |
| IND: |
Investigational New Drug |
| IOL: |
Investigational Intraocular Lens |
| IRB: |
Institutional Review Board |
| JAHVA: |
James A. Haley Veterans Hospital |
| MCC: |
H. Lee Moffitt Cancer Center and Research
Institute |
| OPRR: |
Office for Protection from Research Risks |
| TGH: |
Tampa General Hospital |
| USF: |
University of South Florida |
|
ANNOUNCEMENT
IRB-02 SOCIAL AND BEHAVIORAL
STUDIES TRAINING SEMINAR
TITLE:
The Protection of Human
Subjects in Social & Behavioral
USF Research Studies
WHEN:
JANUARY 29, 1999
9-11 AM
WHERE:
USF EDUCATION BLDG.
ROOM EDU 411 (4TH FLR)
For more details email: rlarson@research.usf.edu |
|
|
| Final Rule on Research with Children as Subjects
On December 2, 1998, the Food and Drug Administration (FDA) issued a final rule which
will require more research involving children as subjects. Affecting 21 CFR Parts
201,312,314, and 601, the final rule will become effective on April 1, 1999. The rule
requires:
"… the manufacturers of new marketed drugs and biological products to
evaluate the safety and effectiveness of the products in pediatric patients, if the
product is likely to be used in a substantial number of pediatric patients or would
provide a meaningful therapeutic benefit to pediatric patients over existing
treatments" (63 Federal Register 66631-66672 at p. 66633).
In the past, the FDA has been relying on voluntary efforts to conduct such studies.
However, citing "disappointing" results, the agency has now instituted this new
requirement. While waivers will be possible, the impact upon industry and affected
Institutional Review Boards (IRBs) could be substantial.
Each year more than half of newly approved drugs and biologics that are likely to be
used in children lack information to permit safe and effective use, because there is not
enough research involving children to provide such information. This will now change.
"We are committed to ensuring that health care providers get the best information
they need to treat children," said Michael A. Friedman, M.D., Acting FDA
Commissioner.
Impact on IRBs Could Be Substantial
IRBs reviewing drug studies could see a discernible increase in the number of studies
now involving children. Research with children adds more steps to IRB deliberations.
Further, FDA noted in this new rule that it plans to convene a special panel of experts to
consider whether even more regulations are needed to protect children in such research.
One IRB, which submitted comments about the earlier version of the rule, recommended
that consideration of new dosage levels or new indications of existing drugs only be
included on a case-by-case basis. Presumably, this request was made to limit the number of
IRB reviews. But FDA explicitly rejected this notion and will require pediatric studies
for those types of projects as well.
Other rule comments stated that additional liability insurance should be provided for
IRBs, for investigators, and for others who become involved in such research. However, FDA
said no proof was provided linking participation of children as subjects with more
lawsuits.
While the estimates of commenters and FDA clearly differed regarding the various costs
of this proposal, the agency estimated the total number of children that would become
involved now as research subjects at an additional 10,860 subjects a year nationally. How
this will actually turn out remains to be seen.
(Note: This article appeared in Human Research Report, January 1999 Vol. 14 #1, p. 3.) |
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USF/FIO Diving Safety Program:
USF’s Best Kept Secret
By William Dent, USF Diving Safety Officer
A little known
program is carrying a large load in the underwater research community. The USF Diving
Safety program was started in the late 1960’s by a group of underwater researchers at
USF who saw the need to set standards to provide a safe environment for collecting
underwater data while on SCUBA (self-contained underwater breathing apparatus). This
program was initiated independently from any other university or "umbrella"
organization. As other underwater research programs across the United States continued to
expand, it became evident that a national organization was needed. This concept was the
start of the "American Academy of Underwater Sciences" (AAUS). AAUS was
developed with several objectives in mind. "Community standards" for diving
needed to be developed.  Once the standards were developed, it
allowed for the smooth data exchange of underwater researchers between member
organizations. AAUS also acts as a liaison representing the interests of the research
diving community in the political arena. The University of South Florida (USF), as well as
the Florida Institute of Oceanography (FIO) are active members of AAUS.
AAUS collects SCUBA diving data from all of its member organizations. The current AAUS
membership includes many internationally recognized oceanographic members such as Woods
Hole Oceanographic Institute, Scripps Institute of Oceanography and Harbor Branch
Oceanographic Institute. The State of Florida universities are well represented, with the
University of Florida, Florida State University, Florida International University and The
University of Miami all being active members within AAUS.
Over the past 5 years, the University of South Florida, along with the Florida
Institute of Oceanography, has remained within the top 5 universities conducting
underwater research. This claim is documented in the current AAUS Statistics Report. In
1997, USF/FIO was listed first among universities in the number of research certified
divers currently in the program and third in the number of dives completed and total time
underwater. We are extremely pleased to announce that this has been achieved without any
accidents! This clearly demonstrates the effectiveness of the diving safety program.
THE USF/FIO Diving Safety Program is overseen by a "Diving Control Board"
(DCB) with a representative from each of the departments that might have a need for
underwater research. Dr. Pamela Muller chairs the DCB. William Dent is the USF Diving
Safety Officer (DSO). The DSO has the responsibility of making sure the overall diving
program adheres to all the necessary standards that ensure a safe productive program.
If you would like more information about the USF/FIO Diving Safety Program, please
contact William Dent at 974-5018 or via e-mail at wdent@research.usf.edu. |
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| USF
RADIATION SAFETY NEWS
P-32 Wipe Test/Survey Changes |
| In the past, it was a requirement for all
P-32 users to document both a wipe test and a lab survey for their weekly laboratory
contamination check. Effective immediately, recording a weekly wipe test for P-32 use is
no longer required. You are now only required to survey with your lab survey meter and
record those readings onto the appropriately dated laboratory schematic. NOTE:
If you find P-32 surface contamination with the survey meter (any reading that is >2X
background), you are required to clean the contaminated area, resurvey with your meter and
to ensure that there is no further removable contamination, do a wipe test! New Whole Body Film Dosimeters |
| Effective January 1999, you will be
receiving a new type of whole body film badge dosimeter. This will replace the film
dosimeter you are currently using and it is also to be worn clipped to the top pocket of
your lab coat. The new dosimeter will be a solid piece of plastic and will have a
hexagonal (6-sided) shape and it snaps into its holder. The new holder will be included
with your January 1999 badges along with instructions on how to snap the dosimeter to its
holder (see picture below). The ring finger dosimeter will remain the same. |
 |
| The other important change regarding your
dosimeters is that you will wear them for a two- (2) month period instead of exchanging
them monthly. So please be careful not to lose your dosimeters, as our office does not
have temporary badges! Also, please return the old style film badge holders along with
your December film badges. USF Rated #
1! |
| The Florida Department of Health Radiation
Control Office recently inspected the USF Radiation Safety Office. This was our biannual
inspection and for the third time in a row, the USF Radiation Safety Program was rated #1
amongst all the State university radiation safety programs! Thanks to all the Principal
Investigators and their laboratory staff for helping us remain the top-rated radiation
safety program in Florida.The results of this inspection
indicated that we should re-submit our license renewal application and clearly define the
manner in which we administer the program. The Radiation Safety Committee and the
Radiation Safety Officer (RSO) have begun to review this application and they will be
working on this project until mid-April. Should any of the Principal investigators have
suggestions or recommendations regarding areas in which we could amend our procedures to
make your work easier please either FAX (631-4550) or mail (MDC Box 35) them to the RSO.
There are minimum requirements that must be met but we do have some flexibility and any
suggestions would be welcome. |
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USF INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
(IACUC) NEWS
NEXT IACUC MEETING DATE |
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| Questions? Or Comments
The Division of Compliance Services welcomes your comments, questions or suggestions
for topics for future issues. Please send your ideas either by fax (631-4550, Attn: Ron
Larson) or e-mail: rlarson@research.usf.edu
USF COMPLIANCE NEWS:
ON THE WEB |
| Beginning with this issue, the USF Compliance News will be posted on
the USF Research Office web site. The address is http://www.research.usf.edu and then
click on Division of Compliance Services
link. |
|
USF Compliance News is published monthly
by the USF Division of Compliance Services.
Editor: Ron Larson |
|
|
USF Division of
Compliance Services 
Institutional Review Board (IRB)