COOK COUNTY BUREAU OF HEALTH
SERVICES
GRANTS NEWSLETTER
Volume 8, Number 4 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~April,
2000
Back Issues
Published by
OFFICE OF RESEARCH DEVELOPMENT
Hektoen Building
627 South Wood Street
Chicago, IL 60612
FAX: 312-738-3102
Karen M. Smith, PhD, Director
312-633-4940
email: kmsmith@wwa.com
Bennetta Anderson, Administrative Assistant
312-633-4941
Lillian Hampton, IRB Administrator
312-633-7792
email: lhampton@hektoen.org
Funeka Sihlali, RN, Scientific Quality Coordinator
312-572-3506
email: fsihlali@hektoen.org
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COOK COUNTY BOARD
OF
COMMISSIONERS
John H. Stroger, Jr.,
President
|
Jerry
Butler
Allan C. Carr
Earlean Collins
John P. Daley
Gregg Goslin
Carl R. Hansen
Ted Lechowicz
Roberto Maldonado |
William R. Moran
Joseph Mario Moreno
Mike Quigley
Herbert T. Schumann, Jr.
Peter N. Silvestri
Deborah Sims
Bobbie L. Steele
Calvin R. Sutker |
COOK COUNTY BUREAU OF HEALTH
SERVICES
Ruth M. Rothstein, Chief
Affiliates
Ambulatory & Community Health Network
of Cook County
Cermak Health Services of Cook County
Cook County Department of Public Health
Cook County Hospital
Oak Forest Hospital of Cook County
Provident Hospital of Cook County
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CONTINUING CONCERN ABOUT THE IRB SYSTEM
In June, 1998, the Office of the Inspector General of the Department
of Health and Human Services issued "Institutional Review Boards: A Time
for Reform," a scathing report about the system by which people participating
in research are protected. The system relies on local Institutional
Review Boards, or IRBs, to oversee research at each site where a significant
amount of research takes place. The 1998 report gave a number of reasons
to believe that human research subjects weren't adequately protected, including
the huge and increasing workload on IRBs, the lack of training for both
IRB members and researchers, and the typically minimal oversight provided
after a study has been approved by an IRB.
In April, the Inspector General issued a follow up report on the state
of the IRB system which finds many of the problems cited earlier still
remain. The report credits both the Office for Protection from Research
Rights (OPRR) and the Food and Drug Administration (FDA) for stepped up
inspection activities which have resulted in the suspension of research
at several large universities. These events have drawn significant
attention to the adequacy of IRB oversight and human subject protections.
The regulatory agencies are also praised for a number of ongoing initiatives
around education and reducing regulatory burden.
However, the report contends that few of the recommended reforms
from 1998 have been enacted. The report asserts that minimal progress
has been made in reforms to:
Increase the flexibility and accountability of IRBs;
Institute systems to oversee protections for subjects once the research
has begun;
Establish educational programs for research investigators and IRB
members;
Deal with potential IRB conflicts of interest;
Moderate IRB workload pressures;
Reengineer the Federal oversight process
The report acknowledges that the federal law itself is a barrier to accomplishing
these reforms quickly, since 17 federal agencies must agree on any changes
to the "common rule" (45
CFR Part 46) with which they all comply.
Other reforms, however, can be instituted by way of the regulatory process:
Methods to evaluate the effectiveness of individual IRBs, for instance,
can be incorporated into ongoing OPRR and FDA review and assurance procedures.
Both agencies can also put pressure on IRBs to improve ongoing monitoring
of studies and to institute training programs.
Bureau IRB Reforms: Expect Mandatory Training For Researchers
In the Bureau, we have already taken on the task of ongoing review of
research by initiating a research quality assurance program staffed by
a full time Research Quality Coordinator. This program addresses both the
compliance by researchers with requirements for human subject protection
and the effectiveness of the IRB's oversight. In the 8 months since it
began, this program has lead to several changes in IRB operations, and
has also brought to light a number of areas in which researchers need more
information (see "Are You a Ghost PI?", below).
As far as training requirements go, even before the Inspector General's
Report was issued, it was generally expected that OPRR and FDA would soon
require that institutions doing federal research provide training for their
investigators. In the Bureau a number of educational programs have been
offered over the years for both researchers and IRB members. Attendance
at researcher educational programs has been very disappointing, however.
Because our voluntary training program has reached so few researchers
within the Bureau, the IRBs of the Bureau recently agreed, at their quarterly
Bureau-wide meeting, to design and implement a program of mandatory investigator
training. If you have comments or suggestions about what such a program
should entail, please contact Karen Smith, Funeka Sihlali, or Lillian Hampton.
If you would like to see a copy of the Inspector General's report, it
can be found on line at: http://www.hhs.gov/progorg/oei/reports/a447.pdf
WOULD YOU LIKE HELP WRITING YOUR CONSENT FORMS?
CONSENT FORM CLINIC NOW AVAILABLE
Probably the most common reason for delay in obtaining IRB approval
for a new protocol is the need to make changes in the consent form. Writing
good consent forms is an art, and investigators who are new to the process
sometimes need help to make their consent documents acceptable. To
assist with this problem, for the next six months we will pilot a new service,
called the Consent Form Clinic. This clinic is a supportive one-on-one
session designed to help researchers refine their consent forms before
they are submitted to the IRB. (Those who would like help rewriting a consent
form that has been reviewed by the IRB are also welcome).
The Clinic will be offered by Funeka Sihlali, RN, CRC, the Research
Quality Coordinator for the Bureau. Among other things, Ms. Sihlali
can help you to:
Insure that all the required elements of informed consent
are included;
Check that the document is written at an appropriate literacy level;
Identify lay terms that can be substituted for medical terminology;
Review the ways the risks and benefits of the study are described
to make sure they are clearly communicated;
Make sure the local situation is reflected in consent forms that
have been supplied by a study sponsor
Although using the Consent Form Clinic can't guarantee a speedy approval
by the IRB, it can eliminate all the common problems that frequently delay
IRB approval. The Consent Form Clinic will also provide some hands-on instruction
that will, we hope, make writing consent forms easier for all your future
research.
The Consent Form Clinic will be offered the second Thursday and third
Monday of every month, from 8:00 AM to noon.
Reservations will be required to insure that you will get individual
attention. The schedule of Consent Form Clinics for the six month trial
period is given below, with the workshop schedule.
To make an appointment, please call 312-572-3506.
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BOOMING ECONOMY MEANS LOTS OF FOUNDATION MONEY
The Foundation Center issued a report recently which shows how much
the philanthropic world has benefitted from the current economic boom.
Both foundations' investments and the gifts from individuals have grown
precipitously, making much more money available to distribute. At the end
of 1998, foundation endowments were $385 billion. The Internal Revenue
Service requires most foundations to give away at least 5 percent of their
assets each year to maintain their tax exempt status. This requirement,
combined with the growth in endowments, gifts and income, means more and
bigger foundation grants. Among the numbers cited in the report are:
A record $22.8 billion in grants was given by foundations
in 1999;
This compares with compares with $19.5 billion in 1998,
and $8.7 billion in 1989;
The number of grants of $5 million or more was 147 in 1998,
compared to 50 or fewer recorded for most of the 90's
The number of foundations has more than doubled
since 1980 to nearly 47,000;
Corporate grants were up to $3 billion in 1999, an increase of
22 percent.
If you would like to get a copy of the Foundation Center's report, it can
be obtained at:
http://fdncenter.org/about/news/pr_0003b.html
If you would like to find out more about seeking foundation funding,
go to http://cookcountyresearch.net/funding.html
Also, you can search among several hundred private and corporate foundation
web sites at http://cookcountyresearch.net/search.html
ARE YOU A GHOST PI?
Do you sign consent documents even when someone else actually carried
out the informed consent process? As a result of the Bureau's research
quality assurance program the Scientific Committee has become aware that
some principal investigators sign consent forms after someone else usually
a resident or junior member of the research team has carried out the
informed consent process, when the PI was not actually present to
witness the interaction.
The signed consent document attests that the consent process -- the
verbal exchange between investigator and potential subject -- was carried
out appropriately and completely. You cannot attest to that fact if you
were not there for the entire informed consent process.
When a PI signs a document for a consent process he/she did not witness,
the document itself can be called into question. If a signature suggesting
that the PI witnessed the interaction is misleading, then what else may
not be true?
It is completely appropriate, of course, for a PI to review the signed
documents to insure that all the blanks have been filled correctly. A signature
attesting that all the blanks have been filled is more than a little redundant,
however, and a signature that suggests that the PI has overseen more than
the paper work can undermine the whole rationale for documenting informed
consent.
NEW RESOURCES FROM THE NATIONAL CANCER INSTITUTE
The NCI recently announced the availability of a site dedicated to finding
grants for research training, career development and education in areas
related to cancer. It can be found at http://cancer.gov/cancertraining
In addition, several new publications are available:
"The Researcher's Toolbox", a periodical for researchers working with
minority and medically underserved populations, which will provide information
about new grant opportunities. To subscribe, call 301-435-1505, or email
cholletv@mail.nih.gov
"Breast and Cervical Cancer Programs in your Community: A Guide to Outreach,
Screening and Follow-up Care (T408)" reviews programs and strategies for
screening programs; and "Spread the Word about Mammograms and the Pap Test"
a set of flip charts, available in both Spanish (G445) and English(G445),
to help women understand the importance of early cancer detection. Both
are free, and can be ordered by faxing a request to 301-330-7968, or on
line at http://publications.nci.nih.gov
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SEMINARS, CONFERENCES, WORKSHOPS, ETC
[A long-term calendar showing most of the major academic medical society
meetings can be found on the web at: http://www.aamc.org/meetings/mjmtgcal.htm]
Information Technologies for Quality Improvement in Health Care, the
spring Congress of the American Medical Informatics Association, will be
held in Boston May 23-25. Call 301-657-1291 for more information.
Futures for Kids, a conference on community involvement, will be offered
by the Illinois Department of Human Services August 9-11 in Chicago. For
more information, call 888-648-2033.
2nd Annual Women's Health Conference, presented by the Illinois Department
of Public Health, will take place November 1-2 in Rosemont. Call 217-524-6088
for information.
Justice for Children, sponsored by the U.S. ffice of Juvenile Justice
and Delinquency Prevention, will be held December 12-14, in Washington,
DC. Call 800-638-8736 or go to http://www.ojjdp.ncjrs.org/nconf2000.htm
Contracting & Negotiating Clinical Trials is a workshop offered
by the Strategic Research Institute. It will take place May 24-25 in Philadelphia.
For more information, call 800-599-4950.
New Century, New Challenges Intensive Bioethics Course, will be given
by the Kennedy Institute of Ethics at Georgetown University, June 6-11.
Call 202-687-8099 for more information.
Sharpening Our Focus Genetics, Tissue Banks & Cognitive Impairment,
sponsored by OPRR and Rush-Presbyterian-St. Luke's Medical Center, will
be held in Chicago on June 8-9. Call 312-942-5498 for information.
OPRR/FDA Town Hall Meeting will take place in Chapel Hill, NC, sponsored
by the University of North Carolina, June 16. For more information call
919-966-1344.
Office of Research Development Workshops
These workshops are open to any County-affiliated investigator or grant-seeker.
Enrollment for some sessions is limited, so please register only for those
you will be able to attend.
Grant Writing Seminar:
Gives an overview of the entire process of developing a project
and applying for funding. Includes information on approaching both governmental
and private funders, describes an approach to developing grant budgets,
discusses stylistic and content issues that are frequent stumbling blocks
in writing grant applications.
Constructing a Grant Budget:
Covers many of the technical aspects of developing an accurate
time line and budget for a grant proposal.
What Are All These Forms? Interacting With the Scientific Committee:
Gives an orientation to procedures -- and the associated forms
-- used by the Scientific Committee to
ensure that patients are protected from undue risks in research. The
Bureau forms will be discussed, and new policies and changes in federal
regulations will be covered.
To register for any of these, call Bennetta Anderson at 312-633-4941.
If you would like to schedule one or more of these workshops in your Department
or at another site, please call Karen Smith at 633-4940.
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