IRB, Office of Research Development COOK COUNTY BUREAU OF HEALTH SERVICES
Office of Research Development

      
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  Phone: 312-864-0716
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COOK COUNTY BUREAU OF HEALTH SERVICES

GRANTS NEWSLETTER



Volume 6, Number 6 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~June, 1998
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

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

RESEARCH ON HUMANS COMES UNDER FEDERAL SCRUTINY
 

The Department of Health and Human Services' Office of the Inspector General has issued a report on the system by which human research is overseen in this country. Nationwide, most of the review and oversight responsibilities for human research are given to local bodies called Institutional Review Boards (IRBs). Every institution which carries out federally-funded research, and every accredited hospital, must have an IRB to assure that people's rights are respected when they volunteer for research studies.

In the Cook County system there are three such boards: one at Cook County Hospital -- which also reviews projects at Cermak Health Services, in the ambulatory system and for the Department of Public Health as needed -- in addition to boards at Provident Hospital and Oak Forest Hospital.

In its report, the Inspector General's Office identified several areas in which the IRB review system might be vulnerable:
 

IRB's are asked to review too much, too quickly and with too little expertise;

Continuing review of approved research tends to be minimal;

IRB members face conflicts that may threaten their independence;

Too little training is provided to investigators and Board Members;

Evaluations of IRBs' effectiveness are rarely undertaken.


These problems, many of which stem directly from large and increasing workloads on IRBs, are will only become more urgent as federal funding for clinical research increases, and as mandates to include more representative samples are put in place. In the House of Representatives there is currently a proposal to raise the National Institutes of Health funding by more than 9% in the next fiscal year. Political and other pressures will steer a good deal of this increase into clinical research. In addition, the NIH has recently issued guidelines for including children in all clinical trials when feasible. These developments add up to even greater demands on IRBs in the near future.

As an example of these trends, the graph below shows the number of new human research studies brought to the Cook County Hospital IRB for review over the past four years, grouped in six month intervals. In all of 1994, there were 79 new studies reviewed; in 1997 there were 144. 
 

The Inspector General's Report made several recommendations to avert a crisis in overseeing human research. Among these are: 
 

Recast federal requirements to grant IRBs greater flexibility and hold them more accountable for results;

Strengthen the system for continuing protections of humans in ongoing research;

Enact federal requirements to ensure that investigators and IRB members are adequately educated about and sensitized to human subject protections;

Help insulate IRBs from conflicts that can compromise their mission in protecting human subjects

Recognize the seriousness of the workload pressures that many IRBs face and take actions to moderate them;

Reengineer the federal oversight process.

Some of these concerns have been addressed within the Bureau for several years. For instance, a one-day conference was given for all County-affiliated IRB members in 1996 to bring members up to date on regulations and responsibilities. A Bureau-wide IRB group meets two or more times a year to discuss issues pertinent to protecting human research volunteers. The Office of research Development offers a workshop on protecting human subjects Any department or affiliate can schedule a session of this workshop at its site. Finally, we are in process of hiring a Scientific Quality Coordinator whose full-time job it will be to help educate investigators and to monitor all activities surrounding human research within the Bureau.

If you would like a copy of the executive summary of the Inspectors General's report, contact Karen Smith at 312-633-4940. The complete report can be found on the Web at: http://www.hhs.gov/progorg/oei/whatsnew.html


DO YOU HAVE A GRANT TO PROFILE? If you would like to see the achievements of your grant-funded project profiled in this newsletter, please send a 1 to 2 page summary, preferably on disk, to Karen Smith, Hektoen 277, 627 S. Wood Street, Chicago, 60612


HRSA PREVIEW, SUMMER 1998

In the most recent edition of its Grants Preview, the health Resources and Services Administration (HRSA) gives this year's deadlines for a variety of grant opportunities. Some of these which may be of interest to Cook County programs are:

Geriatric Education Centers (12/21/1998) 
Nurse Anesthetist Program Grants (12/21/1998)

Nurse Anesthetist Traineeships, and Fellowships (11/02/1998)

Graduate Training in Family Medicine (09/14/1998)

Faculty Development in Family Medicine (09/28/1998)

Departments of Family Medicine (03/15/1999)

Residency Training in General Internal Medicine and General Pediatrics (09/30/1998) 
Faculty Development in General Internal Medicine and General Pediatrics (09/14/1998) 

Health Education and Training Centers (02/08/1999) 

Maternal and Child Health Research (08/01/1998)

Long Term Training in Leadership Education in Neurodevelopmental and Related Disabilities (10/01/1998) 

Healthy Schools, Healthy Communities (07/15/1998)

Nursing Education Loan Repayment Program (08/31/1998)

To Obtain a Copy of the Preview
To have your name and address added to the Preview mailing list, call the toll free number 1-888-333-HRSA or e-mail: hrsa.gac@ix.netcom.com



CALLS FOR NOMINATIONS

The John P. Hubbard Award, given by the National Board of Medical Examiners, recognizes hose who have made a significant contribution to fostering excellence in evaluation at any level along the continuum of medical education and delivery of health care. Nominations are due September 4. Call 215-590-9535 for more information.
 

Robert Wood Johnson Health Policy Fellowships 1999, are conducted by the Institute of Medicine,National Academy of Sciences. The Robert Wood Johnson Health Policy Fellowships Program is designed to develop the capacity of outstanding mid-career health professionals in academic and community-based settings to assume leadership roles in health policy and management. This career development program provides opportunities for mid-career professionals to gain an understanding of the health policy process and to contribute to the formulation of new policies and programs. Nominations are due at the IOM by November 16, 1998. For more information, contact:
Marion Ein Lewin
Institute of Medicine, FO 3116
2101 Constitution Avenue, NW
Washington, DC 20418
Phone: 202/334-1506
FAX: 202/334-3862
E-mail: hppf@nas.edu

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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

THE IMPACT OF WELFARE AND IMMIGRATION REFORM ON IMMIGRANT HEALTH, part of the Downtown Health Policy Series, sponsored by the Chicago Health Policy Research Council, will be held July 17 at the University of Chicago Downtown Gleacher Center. For more information call 773-702-4335.

SUMMER PUBLIC HEALTH RESEARCH VIDEO CONFERENCE ON MINORITY HEALTH will be offered by the UIC School of Public Health, July 13-17 in the UIC Union, Room A. Sessions run from 12:30 to 3:30 each day.

ETHICAL & PRACTICAL ISSUES INVOLVING THE USE OF HUMAN SUBJECTS IN RESEARCH, will be offered by Tulane University, October 30-31, in New Orleans. Call 800-588-5300 for more information.

GENE REGULATION AND CANCER is a special conference to be given by the American Association for Cancer Research. It will be held October 14-18 in Hot Springs, VA. For more information, call 215-440-9300.

ANNUAL ARENA/PRIM&R INSTITUTIONAL REVIEW BOARD MEETING will take place November 8-10 in San Diego, sponsored by Public Responsibility in Medicine & Research. Call 617-423-4112 for information.
 

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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FUNDING OPPORTUNITIES

National Institutes of Health:
All NIH announcements from the past several years, including full text versions of RFA's and PA's, can be reached on the web at:  http://grants.nih.gov/grants/guide/index.html

To have the NIH Guide sent automatically to your e-mail address every week, click on the LISTSERV link on this page and follow the instructions.

To ask specific questions about NIH grant programs, send e-mail to: grantsinfo@nih.gov 
 



NIH RFA'S AND RFP'S: 

These are one time only opportunities. Call 312-633-4940 to check for due dates or to get copies of full announcements

HEPATITIS C: NATURAL HISTORY, PATHOGENESIS, THERAPY AND PREVENTION (RFA DK-98-017) National Institute of Diabetes and Digestive and Kidney Diseases, National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, Office of AIDS Research,
Office of Research on Minority Health, American Digestive Health Foundation

BASIC BEHAVIORAL AND COGNITIVE SCIENCE RESEARCH: APPROACHES TO THE STUDY OF HIV/AIDS AND DRUG ABUSE
(RFA DA-99-002) National Institute on Drug Abuse

ADVANCED RESEARCH COOPERATION IN ENVIRONMENTAL HEALTH (RFA ES-98-005)
National Institute of Environmental Health Sciences

POPULATION RESEARCH CENTERS (RFA HD-98-014) National Institute of Child Health and Human Development

GENESIS OF CARDIOMYOPATHY WITH HIV INFECTION AND ALCOHOL ABUSE (RFA HL-98-014) National Heart, Lung, and Blood Institute

BIOMIMETICS AND TISSUE ENGINEERING IN THE RESTORATION OF OROFACIAL TISSUES
(RFA DE-98-009) National Institute of Dental Research, National Institute of Arthritis and Musculoskeletal and Skin Diseases

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NIH PROGRAM ANNOUNCEMENTS 
(PA'S): These are ongoing funding priorities, with due dates usually October 1, February 1 and June 1 of each year. Note that HIV-related applications are due January 2, May 1 and September. Past PA's, many of which are still open, can be searched at the NIH Guide web site.

LIVER AND BILIARY DISEASES AMONG WOMEN AND MINORITIES (PA-98-086)
National Institute of Diabetes and Digestive and Kidney Diseases, National institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, Office of Research on Minority Health,
Office of Research on Women's Health

QUANTITATIVE APPROACHES TO THE ANALYSIS OF COMPLEX BIOLOGICAL SYSTEMS (PA-98-077) National Institute of General Medical Sciences, National Institute of Mental Health

GENETIC ARCHITECTURE OF COMPLEX PHENOTYPES (PA-98-078) All Institutes

HIV/AIDS AND THE SEVERELY MENTALLY ILL (PA-98-080)National Institute of Mental Health

NIDCD-NSBRI PROGRAM FOR THE SUPPORT OF VESTIBULAR RESEARCH (PAS-98-081)
National Institute on Deafness and Other Communication Disorders, National Space Biomedical Research Institute

FELLOWSHIPS IN QUANTITATIVE BIOLOGY
(PA-98-082) National Institute of General Medical Sciences

SHORT COURSES ON MATHEMATICAL AND STATISTICAL TOOLS FOR THE STUDY OF COMPLEX PHENOTYPES AND COMPLEX SYSTEMS (PA-98-083) National Institute of General Medical Sciences, National Institute of Mental Health, National Institute on Drug Abuse,
National Institute of Diabetes and Digestive and Kidney Diseases, National Human Genome Research Institute

MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD IN ANESTHESIOLOGY, CLINICAL PHARMACOLOGY, AND TRAUMA AND BURN INJURY (PAR-98-084) National Institute of General Medical Sciences

INSTITUTIONAL RESEARCH AND ACADEMIC CAREER DEVELOPMENT AWARD (PAR-98-085) National Institute of General Medical Sciences



OTHER OPPORTUNITIES

August 7
RADIATION STUDIES AND RESEARCH, Centers for Disease Control (770-488-7040, refer to announcement 98068)

September 30
DOMESTIC VIOLENCE, Nicole Brown Charitable Fund 9714-443-4200, or http://www.nbcf.org)

August 13
VIOLENCE PREVENTION EVALUATIONS, Centers for Disease Control (770-488-4646, refer to announcement 98070)

August 10
UNINTENTIONAL INJURY PREVENTION AMONG OLDER AMERICANS, Centers for Disease Control (770-488-4652, refer to announcement 98088)

September 17
GENOME RESEARCH ETHICS, Energy Department (301-903-6488, refer to notice 98-19)

August 12
REHABILITATION RESEARCH AND TRAINING CENTERS: AGING, ARTHRITIS, STROKE, Department of Education (202-205-5880)

September 30
REHABILITATION RESEARCH AWARDS, Department of Education (202-205-8207)

July 31
INCIDENCE OF OCCUPATIONAL ASTHMA, Centers for Disease Control (304-285-6161, announcement number 98058)

August 3
YOUNG WORKER COMMUNITY-BASED HEALTH EDUCATION, Centers for Disease Control (513-533-8172, announcement number 98050)

August 11
SCHOOL-BASED VIOLENCE PREVENTION, Centers for Disease Control (770-488-4646, announcement number 98071)

August 4
EVALUATION OF INTERVENTIONS TO PREVENT SUICIDE, Centers for Disease Control (770-488-4646, announcement number 98072)

August 10
HEALTHY HOME/HEALTHY COMMUNITY Centers for Disease Control (770-488-7277, announcement number 98065)

October 5 (letter of intent)
PUBLIC HEALTH CONFERENCE SUPPORT, Centers for Disease Control -- Agency for Toxic Substances and Disease Registry (770-488-2508 announcement number 99006)

August 1 and February 1 (letter of inquiry)
MEDICAL, PHARMACY AND RESEARCH INSTITUTIONS, Pfeiffer Foundation (973-983-0480)

September 1
CLINICAL RESEARCH, Burroughs Wellcome Fund (919-991-5100, or http://www.bwfund.org/trans99.html)

July 24
SPECIAL EDUCATION SERVICES, Department of Education (202-260-9182)
 
 


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