BUREAU-WIDE RESEARCH
 

As the Cook County Bureau of Health Services becomes more closely integrated into a single health care system, the opportunities for studying significant medical problems an a large scale also increase. A case in point is the urgent issue of discovering how to prevent infectious agents from becoming resistant to commonly-used antimicrobial medicines. In the 1990's, patterns of hospitalization have changed, with more and more patients being treated on an outpatient basis. This means that the populations that are still treated in the hospital are increasingly older, sicker, and more likely to have compromised immune systems. At the same time, the widespread use of antimicrobial drugs has contributed to the development of bacteria and other infectious agents which are resistant to these drugs. Many health experts fear that this combination of factors more vulnerable patients in the hospital along with more resistant bacteria will greatly increase the risks of patients acquiring untreatable infections while in the hospital. Before this happens, we need to find out the most effective ways to keep these resistant organisms under control.

A health system such as the Cook County Bureau of Health Services is in an excellent position to serve as the laboratory to find out how best to do this. Because of the large number of patients treated in Bureau facilities, as well as the ability to follow key aspects of their care and medical experiences, we have an opportunity to not only study how the antimicrobial resistance problem is affecting urban hospitals, but also to study the impact of measures intended to control the problem. In recognition of this fact, the Centers for Disease Control and Prevention has awarded a group of Cook County researchers, headed by Dr. Robert Weinstein, a 5-year, $3 million grant to carry out a comprehensive study of antimicrobial resistance across 
all the Bureau facilities, as well as at Rush-Presbyterian-St.Luke's Medical Center. (Those who would like to know more about this topic can go to http://www.cdc.gov/ncidod/EID/vol4no3/weinstein.htm for an article by Dr. Weinstein published on line by the CDC).

This is only one example of the important insights that may be gained by looking at a health problem across the whole Bureau system. Carrying out such research, however, means that we need to look at research from a system-wide perspective. Especially in light of intense concern about the rights of patients participating in research, the Bureau must be prepared to maintain the highest possible standards in doing this kind of research.

For this reason, the top administrators in the Bureau the Bureau Chief, the Chief Operating Officers, the Medical Directors, and others have agreed to adopt a single set of policies and procedures for research Bureau-wide, and to seek a Multiple Project Assurance that includes all Bureau facilities. A Multiple Project Assurance, or MPA, is akin to a federal "license" to oversee federally-funded research without reporting back to the federal Office for Protection from Research Risks for every single project. It was the temporary suspension of the MPA at Duke University Medical Center, as reported in last month's Newsletter, which brought the entire research program at Duke to a halt for a time.

Currently an MPA is in effect that covers research that takes place under the auspices of Cook County Hospital, Cermak Health Services, and the Hektoen Institute. A revised version of this MPA, which is now under consideration by the federal government, will cover all projects in all Bureau facilities. All three of the Institutional Review Boards (IRBs) in the Bureau (at Cook County Hospital, Provident Hospital, and Oak Forest Hospital) will be bound by this assurance, and a single set of investigators' guidelines will be issued for all Bureau researchers. Along with this change, the Bureau will adopt a system in which an investigator wishing to do research in more than one Bureau facility will only need to apply to one IRB for approval. Further details on the new system will be published in this Newsletter as soon as the new MPA is approved.

In addition to the adopting a common MPA, the Bureau affiliates have also pledged to adopt common policies in two other research-related areas investigating alleged misconduct in science and monitoring financial conflict of interest in research. Both policies are required to carry out federally-funded or federally-regulated research. Their adoption, along with the new MPA, will make it possible for federally funded research to take place at any Bureau site and be fully compliant with federal regulations. As with the MPA, the details of these new policies, now under review, will be published as soon as they are finalized. 

These procedural changes are intended to pave the way for Cook County investigators to look at health research from a system-wide perspective. As with antimicrobial resistance, many pressing problems in medicine and public health can be examined in a powerful way using this approach. In the years to come, Cook County researchers will undoubtedly lead the way in this arena.
 

NIH STREAMLINES ADVERSE EVENT REPORTING
 

One of the most difficult responsibilities in carrying out research on experimental drugs is the assessment and reporting of adverse events that might be related to the study drug. The clinical investigator has the duty to carefully evaluate each adverse event for severity and for the likelihood of its being caused by the drug. If the investigator cannot rule out the possibility of the event having been caused by the drug, he/she has an obligation to report any serious adverse event to the IRB and to the study sponsor. Such reports are distributed to all the investigators at all study sites, who in turn are expected to send copies to their local IRBs.

This seemingly simple concept has led to a welter of both confusion and paperwork currently besieging both investigators and IRBs. Many trials of new drugs take place at 100 or more centers nationwide. Many trials involve new treatments for serious diseases such as advanced cancer or AIDS. In this context, the number of serious events reported is often staggering a recent week brought 39 separate reports about adverse events from a single trial of an AIDS drug. Added to the volume of reports is the inconsistency between the requirements imposed by the National Institutes of Health for reporting adverse events, and those imposed by the FDA.

The notification requirements described in the Common Rule followed by the NIH define adverse events as "unanticipated problems" involving risks to study participants or others. Generally, the funding Institutes and Centers establish operational definitions of adverse events that apply to the particular trial. The National Cancer Institute (NCI), for example, defines adverse drug reactions in its clinical trials involving antineoplastic agents, as: (1) previously unknown toxicities; and (2) life-threatening or fatal toxicities regardless of whether or not previously unknown. Toxicity criteria are generally included in the protocols.

The FDA, in Federal regulations 21 CFR Part 312, defines adverse events as any untoward medical occurrence that may present itself during treatment or administration with a pharmaceutical product, and which may or may not have a causal relationship with the treatment. In the guideline entitled "Clinical Safety Data Management: Definitions and Standards for Expedited Reporting", the Agency further defines serious adverse events stemming from a drug study as any untoward medical occurrence that at any dose results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; creates persistent or significant disability/incapacity, or a congenital anomaly/birth defects
(http://www.fda.gov/cder/guidance/iche3.pdf).

The criterion used by NIH is both broader and more variable than that used by FDA. In many cases, as when NIH funds a multi-center trial of a new drug, both rules apply. This means that in many cases, any and all reactions to the drug, whether serious or not, and whether unexpected or not, are reported individually to all investigators and all IRB's involved in the trial.

In a notice published June 11, the National Institutes of Health seeks to reduce the burden on investigators and local IRBs for reviewing, interpreting and documenting the plethora of adverse event reports they receive from other sites. To do this, they will rely on summary reports of the trial's Data Safety Monitoring Board (DSMB). Most multi-center clinical trials have a DSMB that periodically reviews the developing outcome and safety data. DSMBs monitor toxicity and discuss any concern in this regard. They also review data on such aspects as participant enrollment, site visits, study procedures, forms completion, data quality, losses to follow-up, and other measures of adherence to protocol. The DSMB makes recommendations based on those data regarding appropriate protocol and operational changes. 

Under the new procedure, individual investigators will not be required to forward separate adverse event reports originating at other sites to their local IRBs. Instead, investigators are expected to forward periodic summary reports issued by the study's DSMB, which will incorporate adverse event information from all sites. The report will document that a review of data and outcomes across all centers took place on a given date, and will summarize the DSMB's review of the cumulative toxicities reported from all participating sites. It will also inform
investigators about the DSMB's conclusion with respect to need for modification of the protocol. The investigator is required to transmit the report to the local IRB.

This streamlined process does not relieve the investigator of the duty to promptly report all adverse events which take place at his/her own site to the local IRB as well as to the study sponsor. It will, however, give both investigator and the IRB a context in which to judge off-site adverse events and will relieve both of a growing paperwork burden.

Anyone who wishes to see the entire NIH notice on adverse event reporting in multi-center trials can go to http://www.nih.gov/grants/guide/notice-files/not99-107.html , or call Karen Smith at 312-633-4940 to request a copy. 
 

The Agency for Health Care Policy and Research is seeking research topics for evidence-based practice centers. In this round of funding the arena will include not only medical technologies, procedures and alternative therapies, but also organizing and healthcare financing. Nominations for topics should be sent before July 6 to Douglas Kamerow, MD, MPH, Director, Center for Practice and Technology Assessment, AHCPR, 6010 Executive Blvd, Suite 300, Rockville MD. For more information, go to http://www.ahcpr.gov/news/.
 

Spirituality, Culture and End-of-Life Conference, sponsored by the Association of American Medical Colleges and the National Institute for Healthcare Research, to be held September 24-25 in Denver, is seeking proposals for workshops and posters. Deadline for submissions is July 1. For more information, call 301-984-7162. 

CALL FOR SESSIONS:
Governor's Conference on Aging and Human Services, which will be held December 1-3, seeks proposals for sessions before June 22. Call 217-785-3377.
 

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[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] 
 

Improving Child Health Through Health Services Research, a meeting sponsored by the American Academy of Pediatrics, will take place in Chicago June 26. Call 847-228-5005 for more information.

The Substance Abuse and Mental Health Services' Second National Conference on Women will be offered June 27-30 in Los Angeles. Call 202-973-8657 for information.

NIH Regional Seminar in Program Funding and Grants Administration, hosted by the University of Wisconsin-Madison, will be held
July 15-16, in Madison, Wisconsin. For information call (608) 263-1672
 
 
 

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

VACCINE IMMUNOLOGY BASIC RESEARCH CENTERS (RFA-AI-99-008) National Institute of Allergy and Infectious Diseases

STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON COCAINE (AND OTHER
PSYCHOMOTOR STIMULANTS) ADDICTION PHARMACOTHERAPY (SPIRCAP) (RFA-DA-00-001) National Institute on Drug Abuse

SUMMER RESEARCH EXPERIENCES FOR UNDERGRADUATES (RFA-GM-99-006)
National Institute of General Medical Sciences

PATHOLOGY SUPPORT FOR THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (RFP NIH-ES-99-33) National Institute of Environmental Health Sciences

PATHOLOGY SUPPORT FOR THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (RFP NIH-ES-99-34) National Institute of Environmental Health Sciences

DEVELOPMENT OF RAPID ASSAY FOR CREUTZFELDT-JAKOB DISEASE
(NINDS-99-RFI-01) National Institute of Neurological Disorders and Stroke 

NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION (RFA-DC-99-001)
National Institute on Deafness and Other Communication Disorders, Office of Research on Minority Health

PRODUCTION, ANALYSIS AND DISTRIBUTION OF CANNABIS AND MARIJUANA CIGARETTES (RFP N01DA-9-7078) National Institute on Drug Abuse

GENETIC SUSCEPTIBILITY & VARIABILITY OF HUMAN MALFORMATIONS (RFA-HD-99-002)
National Institute of Child Health and Human Development, National Institute of Dental and Craniofacial Research, National Institute of Environmental Health Sciences, Environmental Protection Agency

NHLBI SHORT-TERM TRAINING FOR MINORITY STUDENTS PROGRAM (T35M)
(RFA-HL-99-018) National Heart, Lung, and Blood Institute

NHLBI MINORITY INSTITUTION RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) (RFA-HL-99-019) National Heart, Lung, and Blood Institute

NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD (K01) (RFA-HL-99-020) National Heart, Lung, and Blood Institute

HEPATITIS C COOPERATIVE RESEARCH CENTERS (RFA-AI-99-007) National Institute of Allergy and Infectious Diseases, National Institute of Diabetes, Digestive and Kidney Diseases, National Institute of Alcoholism and Alcohol Abuse, National Institute of Drug Abuse

NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32M) (RFA-HL-99-017) National Heart, Lung, and Blood Institute

LARGE-SCALE COLLABORATIVE PROJECT AWARDS (RFA-GM-99-007) National Institute of General Medical Sciences

PREVALENCE AND DIAGNOSIS OF CELIAC DISEASE (RFA-DK-99-015) National Institute of Diabetes and Digestive and Kidney 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.

BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM (PA-99-107) National Institute on Drug Abuse

CANCER PREVENTION, CONTROL AND POPULATION SCIENCES CAREER DEVELOPMENT AWARD (PAR-99-108) National Cancer Institute

INTEGRATIVE AND COLLABORATIVE APPROACHES TO RESEARCH (PA-99-109) National Institute of General Medical Sciences

INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER: PHASED INNOVATION AWARD (R21/R33)
(PAR-99-100) National Cancer Institute

INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER:
SBIR/STTR INITIATIVE (PAR-99-101) National Cancer Institute

APPLICATIONS OF INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER: PHASED TECHNOLOGY APPLICATION AWARD (R21/33) (PAR-99-102) National Cancer Institute

APPLICATIONS OF INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER: (SBIR/STTR) INITIATIVE (PAR-99-103) National Cancer Institute

RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITIES
(PA-99-104) National Institutes of Health

RESEARCH SUPPLEMENTS FOR INDIVIDUALS WITH DISABILITIES (PA-99-105) National Institutes of Health

SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS (PA-99-106) National Institutes of Health

EXPLORATORY GRANTS IN PEDIATRIC BRAIN DISORDERS: INTEGRATING THE
SCIENCE (PAS-99-080) National Institute of Neurological Disorders and Stroke, National Institute of Child Health and Human Development, National Institute of Mental Health
 
 

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June 30
RACIAL AND ETHNIC HEALTH DISPARITIES, Centers for Disease Control (770-488-5426 or http://www.cdc.gov)

July 25
GENITAL HERPES PREVENTION RESEARCH, Centers for Disease Control (770-488-5426 or http://www.cdc.gov)

July 6
HIV PREVENTION/TRAINING INTEGRATION WITH REPRODUCTIVE HEALTH, Centers for Disease Control (770-488-2753 or http://www.cdc.gov)

July 15
MINORITY HEALTH STATISTICS DISSERTATION RESEARCH, Centers for Disease Control (301-436-7062 or http://www.cdc.gov)

July 16
HIV/AIDS PREVENTION AND CARE IN CORRECTIONS, Centers for Disease Control (404-639-8025 or http://www.cdc.gov)

July 16
INTERVENTION EPIDEMIOLOGIC RESEARCH OF HIV/AIDS, Centers for Disease Control (404-639-6130 or http://www.cdc.gov)

July 15
CHILDREN RIDING IN MOTOR VEHICLES, Centers for Disease Control (770-488-4545 or http://www.cdc.gov)

July 15
APPLIED RESEARCH ON NEW VACCINES, Centers for Disease Control (404-639-8204 or http://www.cdc.gov)

July 12
VARICELLA SURVEILLANCE AND EPIDEMIOLOGIC STUDIES Centers for Disease Control (404-639-8230 or http://www.cdc.gov)

July 7
POISON PREVENTION AND CONTROL, Centers for Disease Control (770-488-4031 or http://www.cdc.gov)

August 1
OPHTHALMIC LENS RESEARCH, American Optometric Foundation (301-984-4734 or http://www.ezell.org/awards/solagrant.html)

September 30
RESEARCH ON RETINAL DEGENERATION, Foundation Fighting Blindness (http://www.blindness.org/html/science/bawardtype.html)

August 1
SOCIAL AND ENVIRONMENTAL INTERVENTIONS TO REDUCE HIV, Centers for Disease Control (770-488-2756 or http://www.cdc.gov)

July 22
DETECTION AND MONITORING OF DIABETIC HYPOGLYCEMIA, Centers for Disease Control (770-488-4452 or http://www.cdc.gov)

July 16
RESEARCH, PREVENTION EDUCATION
AND SERVICES IN OCCUPATIONAL HEALTH, Centers for Disease Control (304-285-5749 or http://www.cdc.gov)

September 15
NEUROFIBROMATOSIS RESEARCH, US Army Medical Research and Materiel Command (301-682-5517, ext. 101, or http://cdmrp.army.mil)

July 19
YOUTH VIOLENCE, Centers for Disease Control (770-488-1567 or http://www.cdc.gov)

July 28
INTIMATE PARTNER VIOLENCE COMMUNITY-BASED PREVENTION, Centers for Disease Control (770-488-1390 or http://www.cdc.gov)

July 26
AFRICAN AMERICAN COMMUNITY COALITIONS TO ADDRESS HIV/STD/TB, Centers for Disease Control (770-488-1281 or http://www.cdc.gov)

July 19
HIV/AIDS IN PREGNANT WOMEN, CHILDREN AND ADOLESCENTS, Centers for Disease Control (404-639-6130 or http://www.cdc.gov)

July 23
HIV APPLIED RESEARCH AND PROFESSIONAL EDUCATION, Centers for Disease Control (404-639-0927 or http://www.cdc.gov)

August 1
CLINICAL RELEVANCE OF HIV SUPERINFECTION, Centers for Disease Control (404-639-6131 or http://www.cdc.gov)

July 15
ENVIRONMENTAL JUSTICE IN MINORITY/UNDERSERVED COMMUNITIES, Agency for Toxic Substances and Disease Registry, Centers for Disease Control (404-639-5060 or http://www.cdc.gov)

July 12
OCCUPATIONAL RESEARCH, Centers for Disease Control (404-639-2376 or http://www.cdc.gov)

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

Nominations August 31
NORMAN COUSINS AWARD FOR RELATIONSHIP-CENTERED CARE, Fetzer Institute (616-375-2000, or http://www.fetzer.org)

July 20
TECHNOLOGY TRANSLATION AND TRANSFER OF EFFECTIVE HIV BEHAVIORAL INTERVENTIONS, Centers for Disease Control (770- 488-2720 or http://www.cdc.gov)

July 12
IMPROVING EFFECTIVENESS OF TUBERCULOSIS PREVENTION AND CONTROL PROGRAMS IN DEVELOPING COUNTRIES, Centers for Disease Control (770- 488-2734 or http://www.cdc.gov)

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