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

      
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COOK COUNTY BUREAU OF HEALTH SERVICES

GRANTS NEWSLETTER



Volume 7, Number 5 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~May, 1999
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

FEDERAL REGULATORS SHUT DOWN MAJOR RESEARCH PROGRAMS

On May 12, the federal Office for Protection from Research Risks (OPRR) suspended all federally funded research at the Duke University Medical Center. With around $175 million in federal research funding, and about $225 million in overall research funding, Duke has the eighth largest medical research program in the country.

The OPRR cited a number of serious problems in the way Duke's Institutional Review Board (IRB) operated. According to a story in the Raleigh, North Carolina, News and Observer, the deficiencies cited include:

* The IRB violated rules that prevent IRB members from reviewing projects in which they have a potential interest. After regulators ordered that members of one Duke office not vote on certain projects, it twice found in the board's minutes that they had.

* During the site visit, regulators determined that the IRB "regularly failed to conduct substantive and meaningful continuing review of research." Later they found that the board's record-keeping was inadequate to figure out whether the problems had been fixed.

* Regulators could find "no evidence" the IRB made all the determinations that it should while reviewing research involving children.

* During the site visit, regulators found documents used to obtain consent from patients that significantly deviated from regulatory requirements. Duke administrators failed to correct the situation.

* The IRB had no full-time person in charge, despite Duke's assurances that it would find someone. IRB staffing was inadequate.

 
The Washington Post in its May 12 edition quoted Gary Ellis, Director of OPRR as saying,"When OPRR identified serious deficiencies in protecting human subjects in December 1998 at Duke University Medical Center, we believed that the university would move quickly to remedy them. It was disappointing to see a protracted and unsatisfactory response."

According to the Post story, "Others, however, said they suspected that the OPRR's action was also motivated in part by a need to prove its mettle to Congress in the wake of recent allegations by patient groups and others that the government is failing to protect research subjects."

This is the second time in 1999, and the third time in the past nine months, that OPRR has totally suspended a major research program for failing to adequately protect human subjects. In March the research program at the largest Veteran's Administration Hospital in the country, in West Los Angeles, was similarly suspended, as was that at Rush-Presbyterian-St.Luke's Medical Center last fall. Previous to those suspensions, the only time OPRR had ever suspended an entire institutional research program was in 1990.

Some of the allegations mentioned in the Post article cited above came from a report issued in 1998 by the Inspector General of the Department of Health and Human Services, which concluded that the current IRB system has a number of serious weaknesses, including the expectation that IRB's will review too much, too quickly and with too little expertise; minimal review of research after approval; conflicts of interest among IRB members; and lack of adequate training for investigators and IRB members. In a similar vein, the National Bioethics Advisory Commission has asserted that the current IRB system needs additional procedural safeguards to protect persons with limited decisional capacity such as those who are mentally ill.

In light of the intense scrutiny research and IRB's are currently receiving, the institutions of the Cook County Bureau of Health Services have undertaken a thorough review and revision of research policies and practices, with an eye toward establishing and maintaining Bureau-wide research standards. The goal is to ensure and document-- that research taking place anywhere in the system meets the highest possible ethical standards, and that both investigators and IRB members are equipped to meet those standards. As will be described in future Newsletters, a new program of Scientific Quality Assurance is being implemented by the Office of Research Development to help achieve this goal.
 


CYBERETHICS: ONLINE RESOURCES

Sites are being established all over the World Wide Web to foster discussion and dissemination of information about ethics, particularly in regard to science and research. A central source with links to many of these is offered by the Poynter Center at the University of Indiana at www.indiana.edu/~poynter/index.html

Those with an interest in the legal and ethical issues surrounding protection of human research subjects can visit the OPRR site at http://www.nih.gov:80/grants/oprr/oprr.htm and the one maintained by Public Responsibility in Medicine and Research (PRIM&R) at http://www.aamc.org/research/primr/

In addition, a "virtual symposium" on twentieth century values inquiry is being held until May 21 at http://cape.cmsu.edu/scripts/lyris.pl
 


Rush University Research Forum Schedule

May 18- 20, 1999
Room 500, Searle Conference Center

[NOTE TO POSTER EXHIBITORS: Poster number assignments and directions for participants may be found at www.rush.edu/rushforum. If you have additional questions, send email to fhughes@rush.edu]
 

May 18: 
Symposium, Noon - 1:00 PM 
Poster Viewing, 1:00 - 5:00 PM

May 19: 
Symposium, Noon - 1:00 PM Poster Viewing & Student Poster Judging, 1:00 - 5:00 PM

May 20: 
Symposium, Noon - 1:00 PM College Award Talks, 1:00 -2:00 PM
Resident & Fellows Forum, 2:00-4:00 PM
Poster Tours, 4:00 - 6:00 PM
 

Symposia:

Tissue Replacement in the Next Millennium
Tuesday, May 18, 1999
12:00 noon - 1:00 p.m.
Room 540Chair: Tina Hieken, M.D., Department of General Surgery, Rush North Shore Medical Center

"Xenotransplantation: Replacement parts for the 21st century" Verdi J. DiSesa, M.D., Department of Cardiovascular - Thoracic Surgery, Surgical Director, Rush Heart Institute

"Bone marrow transplantation - the changing treatment" Hans Klingemann, M.D., Ph.D. Section of Bone Marrow Transplantation, The Rush Cancer Institute 
Degenerative Joint Disease: Wear and Tear in Our Aging Society

Wednesday, May 19, 1999
12:00 noon - 1:00 p.m.
Room 540Chair: Joel Block, M.D., Section of Rheumatology, Department of Medicine Rush-Presbyterian-St.Luke's Medical Center

"Osteoarthritis in human knee and ankle joints: biochemical not just biomechanical initiators" Ada Cole, Ph.D. Department of Biochemistry

"De and Regeneration of the intravertebal discs" Howard An, M.D., Department of Orthopedic of Surgery
Protecting Families in the Next Millennium
Thursday, May 20, 1999
12:00 noon-1:00 p.m.
Room 976Chair: M. Ramez Salem, M.D., Department of Anesthesiology, Illinois Masonic Medical Center

"Research using a psychoeducational program for parents raising the next generation" Deborah Gross, DNSc, RN, FAAN, Departments of Community & Mental Health Nursing

"The epidemiology of handgun violence"
Rob Smith, M.D., Department of Trauma
Cook County Hospital 

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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
 

Workshop on Teaching Academic Survival Skills and Ethics, offered by The University of Pittsburgh, will be held June 6-11. Call 412-624-7098 for details. 

Health Profession Analysis for Primary Care, a conference on health workforce issues, will be held June 3 and 4 in San Francisco, sponsored in part by the Health Resources and Services Administration. For more information call 301-443-3148.

Spirituality, Cross-Cultural Issues and End of Life Care, will be offered by AAMC and the National Institute for Healthcare Research September 24-25 in Denver. Call 301- 984-7162 for information.

Ethical Issues in International Health Research will take place June 14-18 at Harvard School of Public Health, Center for Continuing Professional Education. 
Also, Measurement, Design and Analysis Methods for Health Outcomes Research will be offered June 15-18. For more information call617-432-1171.

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 
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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

DEVELOPMENT OF MOUSE PHENOTYPIC SCREENS FOR HEART, LUNG, AND BLOOD
DISEASES (RFA-HL-99-010) National Heart, Lung, and Blood Institute

PROTEIN STRUCTURE AND FUNCTION IN AGING & LATE-LIFE DISEASE (RFA-AG-99-005) National Institute on Aging

NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS (RFA-CA-99-010) National Cancer Institute

ENVIRONMENTAL JUSTICE: PARTNERSHIPS FOR COMMUNICATION (RFA-ES-99-005) National Institute of Environmental Health Sciences

MENTAL RETARDATION RESEARCH CENTERS (RFA-HD-99-004) National Institute of Child Health and Human Development

MEDICAL REHABILITATION RESEARCH NETWORKS (RFA-HD-99-006) National Institute of Child Health and Human Development

THROMBOSIS OF THE ARTERIAL AND CEREBRAL VASCULATURE: NEW MOLECULAR GENETIC CONCEPTS FOR PREVENTION AND TREATMENT (RFA-HL-99-015) National Heart, Lung, and Blood Institute, National Institute of Neurological Disorders and Stroke

MECHANISTIC-BASED CANCER RISK ASSESSMENT METHODS (RFA-OH-99-003)
National Institute for Occupational Safety and Health, National Center for Environmental Research and Quality Assurance, National Cancer Institute

ALCOHOL RESEARCH CENTER GRANTS
(RFA-AA-99-005) National Institute on Alcohol Abuse and Alcoholism

MECHANISMS OF CHONDROPROTECTION
(RFA-AR-99-004) National Institute of Arthritis and Musculoskeletal and Skin Diseases

INTERNET CONNECTION FOR HEALTH INSTITUTIONS (RFA-LM-99-001) National Library of Medicine

NIMH COLLABORATIVE HIV/STD PREVENTION TRIAL (RFA-MH-99-011) National Institute of Mental Health

EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN-VITRO TECHNIQUES (RFP
N01-CN-85093-63) National Cancer Institute

MEDICATION DISCOVERY USING RAT MODELS OF RELAPSE TO COCAINE
SELF-ADMINISTRATION (RFP N01DA-9-8096) National Institute on Drug Abuse

PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS (RFP
N01DA-9-7074) National Institute on Drug Abuse

SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS (RFA-DK-99-017) National Institute of Diabetes and Digestive and Kidney Diseases

COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK
(RFA-HD-99-005) National Institute of Child Health and Human Development

EXPLORATORY PROJECTS FOR LONGITUDINAL GENETIC EPIDEMIOLOGIC STUDIES ON AGING (RFA-AG-99-007)
National Institute on Aging, National Institute of Environmental Health Sciences

COOPERATIVE PROSTATE CANCER TISSUE RESOURCE (RFA-CA-99-012) National Cancer Institute

STUDIES OF THE ETHICAL, LEGAL AND SOCIAL IMPLICATIONS OF RESEARCH INTO HUMAN GENETIC VARIATION (RFA-HG-99-002) National Human Genome Research Institute, National Institute on Deafness and Other Communication Disorders, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences
 
 

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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.

NCI TRANSITION CAREER DEVELOPMENT AWARD (K22) (PAR-99-094) National Cancer Institute

CANCER EDUCATION AND CAREER DEVELOPMENT PROGRAM (PAR-99-095)
National Cancer Institute

MECHANISMS UNDERLYING SECONDARY CONDITIONS IN MOBILITY DISORDERS
(PA-99-096) National Institute of Child Health, and Human Development, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of General Medical Sciences, National Institute of Nursing Research

DIVERSITY IN MEDICATION USE AND OUTCOMES IN AGING POPULATIONS
(PA-99-097) National Institute on Aging, National Center for Complementary and Alternative Medicine, Office of Research on Minority Health, Office of Research on Women's Health

NIAAA SMALL GRANT PROGRAM (PAR-99-098) National Institute on Alcohol Abuse and Alcoholism

NIAMS SMALL GRANT PROGRAM FOR NEW INVESTIGATORS (PAR-99-099) National Institute of Arthritis and Musculoskeletal and Skin Diseases

NIA PILOT RESEARCH GRANT PROGRAM
(PA-99-049) National Institute on Aging

CLINICAL INTERVENTIONS FOR MANAGING THE SYMPTOMS OF STROKE (PA-99-088) National Institute of Nursing Research, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Deafness and Other Communication Disorders, National Institute of Child Health and Human Development

INDIVIDUAL PREDOCTORAL NATIONAL RESEARCH SERVICE AWARDS FOR M.D./PH.D. FELLOWSHIPS (PA-99-089) National Institute of Mental Health, National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, National Institute of Environmental Health Sciences

PREVENTION AND EARLY INTERVENTION IN PSYCHOTIC DISORDERS (PA-99-090)
National Institute of Mental Health

MINORITY ACCESS TO RESEARCH CAREERS (MARC) ANCILLARY TRAINING
ACTIVITIES GRANTS (PAR-99-091)
National Institute of General Medical Sciences

INNOVATION GRANT PROGRAM: APPROACHES IN HIV VACCINE RESEARCH - UPDATE (PA-98-075) National Institute of Allergy and Infectious Diseases

DEVELOPMENT OF DIGITAL MAMMOGRAPHY DISPLAYS AND WORKSTATIONS (PA-99-082) National Cancer Institute

DEVELOPMENT OF DIGITAL MAMMOGRAPHY DISPLAYS AND WORKSTATIONS (SBIR/STTR) (PA-99-083) National Cancer Institute

SBIR/STTR STUDY AND CONTROL OF MICROBIAL BIOFILMS (PA-99-084) National Institute of Dental and Craniofacial Research, National Heart, Lung, and Blood Institute, National Institute of Allergy and Infectious Diseases, National Institute on Deafness and Other Communication Disorders, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of General Medical Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development, National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research, Office of Research on Women's Health

BONE AND THE HEMATOPOIETIC AND IMMUNE SYSTEMS (PA-99-085) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Aging, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Heart, Lung, and Blood Institute

NOVEL APPROACHES TO ENHANCE STEM CELL RESEARCH (PA-99-086) National Center for Research Resources, National Heart, Lung and Blood Institute, National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Mental Health

MENTORED QUANTITATIVE RESEARCH CAREER DEVELOPMENT AWARD
(PA-99-087) National Heart, Lung, and Blood Institute, National Human Genome Research Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute of Environmental Health, Sciences, National Institute of General Medical Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke

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OTHER OPPORTUNITIES

June 24
CHILDREN AT RISK OF EMOTIONAL DISTURBANCE: TECHNICAL CENTER, Substance Abuse and Mental Health Services Administration (301-443-1333)

June 18
RESEARCH IN POST-TRANSPLANT COMPLICATIONS, The Marrow Foundation (612-632-3425)

June 24
COMMUNITY FOOD PROJECTS, US Department of Agriculture (202-401-1898 or http://www.reeusda.gov)

July 1
RESEARCH ON FAMILY MEDICINE, American Academy of Family Physicians Foundation (800-274-2237, x4470 or http://www.aafp.org)

July 12
MODEL ORGAN DONOR PROGRAMS, Health Resources and Services Administration 9301-443-7577 or http://www.hrsa.gov)

June 2
EVALUATION STUDIES ON VIOLENCE AGAINST WOMEN, National Institute of Justice (800-851-3420 or http://www.ncjrs.org/fedgrant.htm#nij)

June 1
SAFE SCHOOLS, Health and Human Services, Department of Education, Department of Justice (http://www.mentalhealth.org)

June 14
SAFE START (VIOLENCE PREVENTION & EARLY CHILDHOOD DEVELOPMENT), Department of Justice (202-514-5084)

October 31
ALTERNATIVE REFUGEE ASSISTANCE, Administration for Children and Families (202-401-4558)

June 1
HIV/AIDS SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE, Health Resources and Services Administration (301-443-5650 or http://www.hrsa.dhhs.gov)

June 1
EMERGENCY MEDICAL SERVICES FOR CHILDREN, Health Resources and Services Administration (301-443-6192 or http://www.hrsa.dhhs.gov)

June 30
HEALTH COMMUNICATION, Centers for Disease Control and Prevention(404-639-7275, or http://www.cdc.gov)

July 1
EDUCATIONAL PROGRAMS IN OCCUPATIONAL HEALTH, Centers for Disease Control and Prevention(513-533-8241, or http://www.cdc.gov)

June 30
YOUNG WORKER SAFETY, Centers for Disease Control and Prevention(304-285-6012, or http://www.cdc.gov)

July 1, November 1
CAREER AND SMALL GRANTS IN OCCUPATIONAL HEALTH RESEARCH, NIOSH/ Centers for Disease Control and Prevention (404-639-3343 or http://www.nih.gov/grants/guide/index.html, refer to PAS 99-053)

May 21(letter of intent)
ACADEMIC DIGITAL INFORMATION & PUBLISHING PROJECTS, Scholarly Publishing and Academic Resources Coalition (202-296-2296 or http://www.arl.org/sparc)

July 31
AWARDS FOR EXCEPTIONAL WORK, Rolex Awards for Enterprise (http://www.rolexawards.com)

June 30
HEALTH INTERVENTIONS IN THE CONSTRUCTION INDUSTRY, Centers for Disease Control and Prevention(513-841-4493, or http://www.cdc.gov)

June 1 and December 1
SPINAL CORD INJURY/DYSFUNCTION, Paralyzed Veterans of America (800-424-8200, x655 or http://frontpage.pva.inter.net/prof/etfgd/index.htm)

June 2 (letter of intent) July 6 (application)
CENTERS FOR EXCELLENCE IN HEALTH STATISTICS, Centers for Disease Control and Prevention(301-436-7016, or http://www.cdc.gov/nchswww)
 
 

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