GRANT PROFILE: 
MODEL SERVICES FOR CHILDREN WITH SICKLE CELL DISEASE

Infants born with Sickle Cell Disease need good health maintenance, monitoring and follow-up to maximize their chances for leading full lives. Newborn Screening for Sickle Cell Disease was first implemented in the State of Illinois in 1989. Initially, the families of infants identified with Sickle Cell Disease through this program were given counseling and referred for follow-up health monitoring. Subsequent evaluations, however, found that more than half of these infants did not receive optimal health care maintenance after leaving the hospital. 

Since October 1995, a Comprehensive Care Services Model, led by Dr. Sudha Rao of Cook County Children's Hospital, has been in place. This program, funded as a "Special Project of Regional and National Significance" by the Health Resources and Services Administration, aims to reduce morbidity and mortality in children with Sickle Cell Disease by providing adequate follow-up care. The goals of the project are to:
 

Ensure early confirmation of detected disease in infants within the first 2 months of life
Provide medical care every 4 weeks in the first year, every 8 weeks in the second and every 12 weeks thereafter 
Provide on-going parental education
Ensure parental compliance with oral penicillin prophylaxis
Arrange field out-reach services for families with poor compliance to follow-up 
Provide support groups for mothers and older children with Sickle Cell Disease
Work cooperatively with neighborhood health centers in the provision of health care
Educate primary care givers on Sickle Cell Disease
Test, educate and counsel families of infants with Sickle Cell Trait

Following newborn screening, if the disease is suspected, infants are referred to Cook County Hospital or Mount Sinai Hospital for confirmation and follow-up care. These two hospitals serve as Illinois Department of Public Health designated centers for Sickle Cell Services. Once the diagnosis is confirmed, the program offers a full range of services in a friendly and supportive environment. Ongoing services to these children are provided at 28 different neighborhood health centers. 

Besides primary care services at these centers, specialty services by Pediatric Hematologists are provided on an on-going basis. The service team consists of Pediatric Hematologists, Physician Coordinator, Nurse Coordinators, Social Worker, Field Out-reach Coordinator, and Support Group Coordinators. Testing, education and counseling for the families of affected children, on-going parental education about the disease, education of primary care physicians about management of Sickle Cell Disease, field out-reach for families with poor compliance, and support services are all an integral part of this project. In addition, health care personnel are readily accessible to the families and practicing physicians through a 24-hour Hot-Line Service. 

There are currently 98 infants and children who have been enrolled in the comprehensive program from birth. This number is expected to grow to 120 this year. Consumer satisfaction and fiscal impact of the model are being simultaneously measured to evaluate its effectiveness.

The program encourages referrals of new patients for consultation and for provision of field out-reach and peer-support/family support services. Referrals are also received from more than 10 community hospitals for free testing, education and counseling to families of infants detected to have Sickle Cell Trait on Newborn Screening. Couples at risk for a child with Sickle Cell Disease can be identified through these services. These services have been provided to more than 3000 families over the last 10 years through grant support from the Illinois Department of Public Health. 

On March 6, the National Institutes of Health issued the following policy on inclusion of children in NIH-sponsored research. The goal of this policy is to increase the participation of children in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may also affect children. 

Policy
It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all NIH conducted or supported research involving human subjects, including research that is otherwise "exempt" in accord with Sections 101(b) and 401(b) of 45 CFR 46 - Federal Policy for the Protection of Human Subjects. The inclusion of children as subjects in research must be in compliance with all applicable subparts of 45 CFR 46 as well as with other pertinent federal laws and regulations. Therefore, proposals for research involving human subjects must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion. 

In the research plan, the investigator should create a section titled "Participation of Children". This section should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research. When children are included, the plan must also include a description of the expertise of the investigative team for dealing with children at the ages included, of the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at the NIH will assess each application as being "acceptable" or "unacceptable" in regard to the age appropriate inclusion or exclusion of children in the research project, in addition to evaluating the plans for conducting the research in accord with these provisions. 

Justifications for Exclusions

It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified: 
 

1. The research topic to be studied is irrelevant to children. 

2. There are laws or regulations barring the inclusion of children in the research. For example, the regulations for protection of human subjects allow consenting adults to accept a higher level of risk than are permitted for children. 

3. The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant. Documentation of other studies justifying the exclusions should be provided. NIH program staff can be contacted for guidance on this issue if the information is not readily available.

4. A separate, age-specific study in children is warranted and preferable. Examples include:
 

a. The relative rarity of the condition in children, as compared to adults (in that extraordinary effort would be needed to include children, although in rare diseases or disorders where the applicant has made a particular effort to assemble an adult population, the same effort would be expected to assemble a similar child population with the rare condition);

b. The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network, so that requiring inclusion of children in the proposed adult study would be both difficult and unnecessary (in that the topic was already being addressed in children by the network) as well as potentially counterproductive (in that fewer children could be available for the network study if other studies were required to recruit and include them);

c. Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages or different age-related metabolic processes). While this situation may represent a justification for excluding children in some instances, consideration should be given to taking these differences into account in the study design and expanding the hypotheses tested or the interventions to allow children to be included rather than excluding them. 
 

5. Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis.

6. Study designs aimed at collecting additional data on pre-enrolled adult study participants (e.g., longitudinal follow-up studies that did not include data on children).

7. Other special cases justified by the investigator and found acceptable to the review group and the Institute Director.
 

This policy applies to all initial applications (Type 1)/proposals and intramural projects submitted for receipt dates after October 1, 1998.

If you would like a copy of the entire announcement, call Karen Smith at 312-633-4940.

Back to top

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] 

CALL FOR WORKSHOP PROPOSALS: The Association of American Medical Colleges' Group on Educational Affairs has issued a call for proposals for mini-workshops and small group discussion programs to be presented at its annual meeting October 30 - November 5 in New Orleans. Deadline for proposals is May 8; call 202-828-0665 for details.

How to Manage Clinical Trial Finances, a two-day short course given by Clinical Research Site Training, will take place June 11-12 at the Regal Knickerbocker Hotel in Chicago. For more information call 215-477-2515.

The Downtown Health Policy Series, given by the Chicago Health Policy Research Council, will continue on Friday, April 17, at the University of Chicago Downtown Gleacher Center. For more information, call 773-702-4335.

Post-Award Grant Administration Conference will be offered by the Office of Naval Research August 5-7 in Chicago. For more information, call 312-886-5423, ext 226.

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. 
 

Back to top

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 
 

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

SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS
(RFA AI-98-007) National Institute of Allergy and Infectious Diseases

CHEMOPREVENTION IN GENETICALLY-IDENTIFIED HIGH-RISK GROUPS: INTERACTIVE RESEARCH AND DEVELOPMENT PROJECTS (RFA CA-98-012)
National Cancer Institute

FAMILY AND CHILD WELL-BEING RESEARCH NETWORK (RFA HD-98-009)
National Institute of Child Health and Human Development

HIV/CNS TISSUE NETWORK (RFA MH-98-009) National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke

TREATMENT FOR ADOLESCENT ALCOHOL ABUSE AND ALCOHOLISM
(RFA AA-98-003) National Institute on Alcohol Abuse and Alcoholism, SAMHSA Center for Substance Abuse Treatment

IMAGING IN MEDICAL REHABILITATION (RFA HD-98-006) National Institute of Child Health and Human Development, National Institute of Arthritis and Musculoskeletal and Skin Diseases
 

CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS (RFA AG-98-006)
National Institute on Aging

MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABS (RFA AI-98-003) National Institute of Allergy and Infectious Diseases

GENETIC AND MOLECULAR BASIS OF LONGEVITY (RFA AG-98-005) National Institute on Aging

NINR/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY INVESTIGATORS (RFA NR-98-002) National Institute of Nursing Research,
Office of Research on Minority Health

NINR CAREER TRANSITION AWARD (RFA NR-98-001) National Institute of Nursing Research

BODY WEIGHT SUPPORTED AMBULATION TRAINING AFTER SPINAL CORD INJURY
(RFA HD-98-005) National Institute of Child Health and Human Development

HUMAN IMMUNOLOGY CENTERS OF EXCELLENCE (RFA AI-98-001) National Institute of Allergy and Infectious Diseases

TARGETED RESEARCH ON ORAL MICROBIAL BIOFILMS (RFA DE-98-006) National Institute of Dental Research, National Institute of Allergy and Infectious Diseases 

MOLECULAR GENETICS OF MENTAL DISORDERS (RFA MH-98-010) National Institute of Mental Health

BASIC AND CLINICAL RESEARCH ON FIBROMYALGIA (RFA AR-98-006) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Dental Research, National Institute of Neurological Disorders and Stroke, Office of Alternative Medicine, Office of Behavioral and Social Sciences Research, Office of Research on Women's Health

COGNITION AND BEHAVIOR IN DOWN SYNDROME (RFA HD-98-007) National Institute of Child Health and Human Development, National Institute of Neurological Disorders and Stroke

NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION (RFA DC-98-001) National Institute on Deafness and Other Communication Disorders, Office of Research on Minority Health
 

Back to top

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.

OPPORTUNITIES IN AIDS RESEARCH GRANT PROGRAM: HUMAN IMMUNOLOGY
(PAS-98-040) Office of AIDS Research National Institute of Allergy and Infectious Diseases, 
National Institute of Child Health and Human Development, National Cancer Institute, National Heart, Lung and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases,
National Institute on Aging

SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY (PAR-98-023)
National Cancer Institute

VASCULAR AND HEMATOPOIETIC DEVELOPMENT AND DISEASE (PA-98-035)
National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases

OPPORTUNITIES FOR RESEARCH AT REGIONAL PRIMATE RESEARCH CENTERS
(PA-98-036) National Center for Research Resources

HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS (PAS-98-037)
National Institute on Alcohol Abuse and Alcoholism

ANTIRETROVIRAL/IMMUNE PROPHYLAXIS AGAINST HIV-1 TRANSMISSION
(PA-98-038) National Institute of Allergy and Infectious Diseases

MODERN VACCINE FOR MYCOSES (PA-98-039) National Institute of Allergy and Infectious Diseases

SECONDARY ANALYSIS IN DEMOGRAPHY AND ECONOMICS OF AGING (PAS-98-041)
National Institute on Aging

EXPLORATORY GRANTS FOR CORRELATIVE LABORATORY STUDIES AND CLINICAL TRIALS (PA-98-042) National Cancer Institute

CENTERS FOR AIDS RESEARCH (CFARs) (PAR-98-043) National Institute of Allergy and Infectious Diseases, National Cancer Institute, National Heart, Lung and Blood Institute, 
National Institute of Child Health and Human Development, National Institute on Drug Abuse,
National Institute of Mental Health

ATHOGENESIS AND THERAPY OF THE MUSCULAR DYSTROPHIES (PA-98-044) National Institute of Neurological Disorders and Stroke, National Institute of Arthritis and Musculoskeletal and Skin Diseases
 

MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL STRATEGY (PA-98-045)
National Institute of Allergy and Infectious Diseases

DIET AND CARDIOVASCULAR DISEASE RISK IN CHILDREN AND ADOLESCENTS (PA-98-046) National Institute of Nursing Research, National Heart, Lung, and Blood Institute

INNOVATIVE APPROACHES TO DEVELOPING NEW TECHNOLOGIES (PAR-98-047)
National Center for Research Resources

MECHANISMS AND PATHOGENESIS OF PEDIATRIC HIV-1 INFECTION (PA-98-048)
National Institute of Allergy and Infectious Diseases

AHCPR HEALTH SERVICES RESEARCH - PROGRAM ANNOUNCEMENT (PA-98-049)
Agency for Health Care Policy and Research

NEUROSCIENCES TECHNOLOGY DEVELOPMENT (PA-98-050) National Center for Research Resources, National Institute on Aging, National Institute of Child Health and Human Development,
National Institute on Deafness and Other Communication Disorders, National Institute of Dental Research, National Institute on Drug Abuse, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke

May 15
CREATING HEALTHY WORK ORGANIZATIONS, Centers for Disease Control, NIOSH (513-533-8171, or 888-GRANTS4, announcement #98024)

Letter of Intent April 24, application June 11
OCCUPATIONAL RADIATION AND ENERGY-RELATED HEALTH RESEARCH, Centers for Disease Control, NIOSH (404-639-3343, or 888-GRANTS4, announcement #98030)

May 8, May 15
RUNAWAY AND HOMELESS YOUTH, Agency for Children and Families (http://www.acf.dhhs.gov/programs/fysb)

May 8
FOOD STAMPS: GRANTS FOR NUTRITION EDUCATION, US Department of Agriculture (703-305-2410)

May 1, November 1
MEDICAL RESEARCH, Robert Leet and Clara Guthrie Patterson Trust (860-986-4071)

May 1
HIV/AIDS SUPPORT AND ADVOCACY, Stewart B. McKinney Foundation (203-255-7965)

Open
BIOMEDICAL PILOT INITIATIVE, Culpeper Foundation (203-975-1240)

Letter of Intent May 1, Application June 23
NATIONAL OCCUPATIONAL RESEARCH AGENDA, Centers for Disease Control, National Institutes of Health (404-639-3343)

June 16 and December 16
INVESTIGATOR-INITIATED RESEARCH, National Institute of Justice (800-851-3420, refer to SL000240)

Open until February 7, 1999
STD DIAGNOSTICS CHALLENGE, Rockefeller Foundation (212-869-8500)

Open
FAMILY PLANNING, Scherman Foundation (212-832-3086)

May 27
WOMEN AND VIOLENCE, Substance Abuse and Mental Health Services Administration (301-443-8392)

May 27
COMMUNITY ACTION GRANTS FOR SERVICE CHANGE, Substance Abuse and Mental Health Services Administration (http://www.samhsa.gov)

May 27
COMMUNITY ACTION GRANTS FOR SERVICE CHANGE: HISPANIC INITIATIVE, Substance Abuse and Mental Health Services Administration (http://www.samhsa.gov)

June 25
EARLY HEAD START, Agency for Children and Families (800-351-2293)

Preproposal April 20
RISK-ASSESSMENT RESEARCH IN WATERBORNE PATHOGENS, Environmental Protection Agency (fax 513-569-7475, refer to NCEA-CIN-02)

April 20
INTERACTION OF MULTIPLE EXPOSURES TO PESTICIDES/AGE-RELATED RISKS, Environmental Protection Agency (fax 513-569-7475, refer to NCEA-CIN-01)

May 1
NURSING RESEARCH, American Nurses Foundation (202-651-7298)

October 15
HIV/AIDS AWARENESS: YOUTH PROGRAMS, Ryan White Foundation (800-444-RYAN)
 
 

LOST A LINK? 
Look in the alphabetical index to links on this site