AUTHORITY: Implemented and authorized by the Alzheimer's Disease Research Act [410 ILCS 410] and Alzheimer's Disease Assistance Act [410 ILCS 405].
SOURCE: Emergency rules adopted at 10 Ill. Reg. 20029, effective November 21, 1986, for a maximum of 150 days; adopted at 11 Ill. Reg. 8743, effective April 15, 1987; amended at 13 Ill. Reg. 16488, effective November 1, 1989; amended at 25 Ill. Reg. 11159, effective September 1, 2001.
Section 710.10 Applicability
The Illinois Alzheimer's Disease
and Related Disorders Assistance Code (77 Ill. Adm. Code 710) applies to all
facilities and health care providers designated as part of the statewide
Alzheimer's disease and related disorders assistance network or facilities and
providers requesting research grants. This Code creates a statewide system of
regional and community-based services to provide for the identification,
evaluation, diagnosis, referral and treatment of persons with Alzheimer's
disease and related disorders. Further information concerning this Code can be
obtained from the Illinois Department of Public Health at the following
address:
Illinois Department of Public Health
Alzheimer's Disease Program
535 West Jefferson Street, Floor #2
Springfield, Illinois 62761-0001
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.20 Definitions
"ACT"
means the Alzheimer's Disease Assistance Act [410 ILCS 405].
"ADA
Advisory Committee" or "Advisory Committee" or
"Committee" means the Alzheimer's Disease Advisory Committee created
under Section 6 of the Act. (Section 3(e) of the Act)
"Alzheimer's
Disease and Related Disorders" or "AD" or "ADRD" means
a health condition resulting from significant destruction of brain tissue with
resultant loss of brain function, including, but not limited to, progressive,
degenerative and dementing illnesses including presenile and senile dementias,
including Alzheimer's Disease and other related disorders. (Section 3(a) of the
Act)
"Alzheimer's
Disease Assistance Network" or "ADA Network" means the various
health, mental health and social services agencies that provide referral,
treatment and support services under standards and plans adopted and
implemented in conjunction with a regional ADA center. (Section 3(d) of the
Act)
"Caregivers"
means those individuals that provide a continuum of care to persons with ADRD;
this definition includes family members, relatives, health care professionals,
legal guardians, and other individuals.
"Case
Management" means providing comprehensive needs assessment and services
coordination to assist persons with ADRD and their families in gaining access
to and receiving needed support services.
"Clearinghouse
Services" means the procedure for the correlation of data and matching
services to persons with ADRD and families.
"Clinical
Diagnosis" or "Diagnosis" means the process of identifying by
means of an examination "Probable AD", "Possible AD",
and/or "Definite AD".
"Consultation"
means information given by the multi-disciplinary team to persons who may be,
or who have been, diagnosed with Alzheimer's disease and related disorders and
to their family members and legal guardians.
"Dementia"
or "Primary Dementia" or "Dementing Illness" means a loss
of intellectual abilities of sufficient severity to interfere with social or
occupational functioning.
"Department"
means the Illinois Department of Public Health. (Section 3(f) of the Act)
"Detection"
means the process of determining through identification and diagnostic
evaluation the level of probable AD and geographic distribution of persons with
Alzheimer's disease and related disorders.
"Diagnostic
Evaluation" means evaluations of a person suspected of having Alzheimer's
disease through physical, neurological and psychiatric evaluations. After other
diseases have been ruled out, a determination of AD can usually be made on the
basis of medical history, mental status and the course of the illness; the
process of assessing cognitive abilities and deficits among persons who may be
or who have been diagnosed with Alzheimer's disease and related disorders; and
the process of assessing the social needs and capabilities of persons with
ADRD, caregivers and family members.
"Identification"
means the description of the specific form of dementing illness; it does not
imply that the condition will have a particular course, duration or end-point.
"Multi-Disciplinary
Team" or "Referral Team" means a team approach that assesses the
needs and capabilities of persons with ADRD and family members; team members
are drawn from the disciplines of medicine (general medicine, neurology,
psychiatry), nursing, social work, psychology and occupational therapy.
"Primary
Alzheimer's Provider" or "Primary ADRD Provider"
or "Primary Provider" means a licensed hospital, a medical center
under the supervision of a physician licensed to practice medicine in all of
its branches, or a medical center that provides medical consultation,
evaluation, referral and treatment to persons who may be or who have been
diagnosed as persons with Alzheimer's disease or related
disorders pursuant to policies, standards, criteria and procedures adopted
under an affiliation agreement with a regional ADA center under the Act.
(Section 3(c) of the Act)
"Primary
Investigator" means the person with prime responsibility for conducting a
research project.
"Referral"
means the process of linking persons who may be or who have been diagnosed as
persons with Alzheimer's disease or related disorders with services in response
to those needs.
"Regional
Alzheimer's Disease Assistance Center" or "Regional ADA Center"
means any post-secondary higher educational institution having a
medical school in affiliation with a medical center having a National
Institutes of Health and National Institutes on Aging sponsored Alzheimer's
Disease Core Center. Any Regional ADA Center which was designated as having a
National Alzheimer's Disease Core Center but no longer carries such designation
shall continue to serve as a Regional ADA Center. (Section 3(b) of the Act)
"Research"
means a scientific investigation into possible causes, locations, progression,
treatment, care and cure of Alzheimer's disease and related disorders.
"Research
Act" means the Alzheimer's Disease Research Act [410 ILCS 410].
"Service
Area" means a specific geographic area of Illinois served by an ADA
network containing a Regional ADA Center.
"Social
Services Agencies" or "Social Agencies" or "Resource
Agencies" or "Other Public and Private Resources" means entities
that provide direct support and help to persons who may be or who have been
diagnosed with Alzheimer's disease and related disorders and to their
caregivers.
"Support
Services" means both formal and informal resources that are available to
the support system of caregivers, which include family members, in order to
meet the needs of persons with ADRD, including nursing, adult day care, long
term care, rehabilitation, mental health and social services.
"Training
and Continuing Education" means all in-service training, staff
development, refresher courses, workshops, conferences, institutes,
telelectures and other educational methods used to assist health care
professionals and caregivers in care and treatment of persons with ADRD.
"Treatment"
or "Patient Treatment" or "Care and Treatment" means
everything that can be done to treat and support persons who may be or who have
been diagnosed with Alzheimer's disease and related disorders in order to improve
the quality of life, including support for their family members.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.30 Incorporated
Materials
a) The following materials are incorporated in this Part:
1) Alzheimer's Disease Assistance Act [410 ILCS 405] (see Section
710.20).
2) Alzheimer's Disease Research Act [410 ILCS 410] (see Section
710.20).
b) The following materials are referenced in this Part:
1) Freedom of Information Code (2 Ill. Adm. Code 1126) (see
Section 710.40).
2) Rules of Practice and Procedure in Administrative Hearings (77
Ill. Adm. Code 100) (see Section 710.50).
3) Protection of Identity of Research Subjects (42 CFR
2.a4(a)-(j), 2a.6(a)-(b), and 2a.7(a)-(b)) (see Section 710.230).
c) All citations to federal regulation in this Part concern the
specified regulations in the 2000 Code of Federal Regulations, unless another
date is specified.
d) All incorporations by reference of federal regulations and the
standards of nationally recognized organizations refer to the regulations and
standards on the date specified and do not include any additions or deletions
subsequent to the date specified.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.40 Availability
of Information
a) All reports issued by the Department that are aggregated to
make it impossible to identify any patient or reporting facility, including the
ADA Plan, shall be made available to the public pursuant to the Department's
Freedom of Information Code (2 Ill. Adm. Code 1126) and the Freedom of
Information Act [405 ILCS 140].
b) All requests from researchers for access to data must be
submitted in writing to the Department. All these requests will be reviewed
according to the provisions in Sections 710.210 and 710.220 of this Part.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.50
Administrative Hearings
Departmental actions or
decisions concerning the designation of Regional ADRD Centers, primary
providers and the distribution of research grants under this Part and the Act
can be contested in an administrative hearing. All administrative hearings
shall be conducted in accordance with the Act and the Department's Rules of
Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100).
(Source: Amended at 13 Ill. Reg. 16488, effective November 1, 1989)
SUBPART B: REGIONAL ALZHEIMER'S DISEASE AND RELATED DISORDERS ASSISTANCE NETWORK
Section 710.100 Description
of the Network and Regions
The purpose of the Act is to
create a network of services for patients suffering from Alzheimer's disease
and related disorders and to establish diagnostic and treatment centers for
Alzheimer's disease and related disorders. At least 2 Regional ADA Centers will
serve the Chicago metropolitan and surrounding area (Department of Public
Health Regions 6 and 7), and at least one Regional ADA Center will serve the
rest of the State (Department of Public Health Regions 1, 2, 3, 4, and 5).
(See Section 710.Appendix A.) These centers will be required to establish a
network for the provision of services in their region. This network will
consist of health services, mental health services, social services and primary
providers accessible to patients and family members and will take advantage of
community-based services that are already available and can be developed. The
establishment of the Alzheimer's disease and related disorders assistance
network will facilitate development of a system for delivery and coordination
of services to these patients and their families.
a) An Alzheimer's disease assistance network is composed of 3
elements:
1) A Regional Alzheimer's Disease Assistance Center that enters
into affiliation agreements with primary and other providers for the provision
of services. The principal duties of the Centers will be diagnostic
evaluation, treatment, referral and research.
2) Primary ADRD providers provide direct medical consultation,
evaluation, referral and treatment.
3) Other public and private resources providing health, mental
health, and social services, such as local physicians, nursing homes, home-care
providers, self-help and support groups.
b) The ADRD regions consist of the following Illinois Department
of Public Health regions:
1) The ADRD Chicago Region consists of Illinois Department of
Public Health regions 6 and 7 that are the same as Illinois Department on
Aging's Regions 2, 12, and 13.
2) The ADRD Downstate Region consists of Illinois Department of
Public Health regions 1, 2, 3, 4, and 5 that are the same as Illinois
Department on Aging's Regions 1, 3, 4, 5, 6, 7, 8, 9, 10, and 11.
c) An illustration of the Department of Public Health regions by
county is located at Appendix A.
1) Region 1: Rockford Region
Rockford
Regional Office
4302 North
Main Street
P.O. Box 2903
Rockford,
Illinois 61105
2) Region 2: Peoria Region
Peoria
Regional Office
5415 North
University Avenue
Peoria,
Illinois 61614
3) Region 3: Edwardsville Region
Edwardsville
Regional Office
22 Kettle
River Drive
Edwardsville,
Illinois 62034
4) Region 4: Marion Region
Marion
Regional Office
2309 West Main
Street
Marion,
Illinois 62959
5) Region 5: Champaign Region
Champaign
Regional Office
2125 South
First Street
Champaign, Illinois
61820
6) Region 6: West Chicago Region
West Chicago
Regional Office
245 West
Roosevelt Road, Building 5
West Chicago,
Illinois 60185
7) Region 7 (2 offices): Chicago Region
Chicago
Regional Offices
A) Bellwood Office
4212 West St.
Charles Road
Bellwood,
Illinois 60104
B) Chicago Office
100 West
Randolph, Room 6-600
Chicago,
Illinois 60601
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.110 Designation
Criteria for Regional ADA Centers
To be designated by the
Department as a Regional ADA Center, an applicant must meet all of the
following criteria:
a) Be a post-secondary higher educational institution having a
medical school in affiliation with a medical center and have a National Institutes
on Health and National Institutes on Aging sponsored Alzheimer's Disease Core
Center or any Regional ADA Center that was designated as having a National
Alzheimer's Disease Core Center, but no longer carries this designation.
b) Identify a Regional Coordinator with responsibilities for
monitoring all aspects of the Center's duties.
c) Have a plan describing how the region will be served
(complying with Section 710.100), which shall include at a minimum:
1) Specific geographic areas to be covered with specific
services.
2) Target populations to be served, including age groups by sex,
race and population size.
d) Have on-site comprehensive diagnosis, treatment and services
available that shall include at a minimum:
1) Specific services that comply with the criteria set forth in
Sections 710.150 to 710.180.
2) Professional medical staff specially-trained for detection,
diagnosis and treatment available to persons with ADRD and
families in the following areas:
A) Geriatric medicine (including Internal Medicine
and Family Practice).
B) Neurology.
C) Psychiatry.
D) Pharmacology.
3) Support staff trained as caregivers to persons with
ADRD and families.
4) Equipment necessary for diagnosis and treatment available
to persons with ADRD and families.
5) Written plans for transportation services for outreach that
assure access to services for persons with ADRD and families.
6) Any additional services, equipment or medical and
support staff available to persons with ADRD and families.
7) Medical and financial eligibility for services available to
persons with ADRD and families. (Section 4 of the Act)
e) Have consultation and referral services available to persons
with ADRD and their families, and for each service:
1) Have written procedures to assure informed consent for
referral and disclosure of information.
2) Have copies of consent forms available to persons with ADRD
and family members.
3) Have written procedures used to assist persons with ADRD and
their families in obtaining support services through primary and other
providers.
f) Have research facilities and programs conducted by faculty and
students to discover the cause of, diagnosis, cure or treatment for Alzheimer's
disease and related disorders that shall include at a minimum:
1) Research under the Research Act that complies with the
criteria set forth in Sections 710.210 and 710.220.
2) Research group members and affiliations.
3) Copies of progress reports for ongoing research, including
research objectives.
4) Current source and amount of funding for research programs.
5) Procedures and forms used to obtain patient consent to
participate in research.
6) Any preliminary or final reports on results and conclusions.
g) Have a list of scientific and medical research programs
concerning Alzheimer's disease and related disorders other than those
identified in subsection (f) that are designed to qualify for Federal funds
that shall include for each program:
1) Principal investigator, research group members and
affiliations.
2) Copies of progress reports for ongoing research, including
research objectives.
3) Current source and amount of funding for research programs.
4) Potential sources of Federal financial participation.
5) Any preliminary or final reports on results and conclusions.
h) Have a centralized data collection, processing and storage
system that will serve as a clearinghouse of information within the service
area and that system shall include at a minimum:
1) Automated equipment available for recording, updating and
tracking information to assist person's with Alzheimer's disease and related
disorders, families, professionals and other providers.
2) Forms and procedures used to report and process information in
the patients' medical records in relation to consultations, referrals and
treatments by service providers within the Alzheimer's Disease Assistance
Network.
3) Telecommunications services available to persons with ADRD,
families, professionals and other providers.
4) Information summaries describing the purpose, nature and scope
of clearinghouse services available to persons with Alzheimer's disease and
related disorders, families, professionals and other providers.
5) Current fact sheets and information packets developed in areas
of interest to family members, professionals and other providers.
i) Maintain a description of training and continuing education
programs provided or planned for personnel and caregivers (including family
members) within the service area. For each program, the description shall
include:
1) Goals, objectives, activities and outcomes.
2) Number of programs, participants and instructors.
3) Curriculum materials, non-print media and audiovisual and
electronic equipment.
4) Evaluation forms and results.
j) Have a plan for the identification of Primary Providers that
will provide services throughout the region within the ADA Network.
k) Have a plan for the identification of other providers of
service within the ADA Network, and for each other provider of service that is
identified:
1) Copies of written plans for complying with minimum standards
for referral, treatment and support services (as set forth in Sections 710.150
to 710.170) adopted in conjunction with the Regional ADA Center.
2) Financial eligibility criteria for receiving services.
3) Utilization reports on facilities and services available from
other providers of service to persons with ADRD and families within the area.
4) Copies of reports on research and treatment.
l) Have written affiliation agreements with all identified and
designated primary providers.
m) Have written procedures for recording and reporting research
and treatment results from primary providers and other providers to the service
providers within the Network and to the Department.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.120 Designation
Procedures for Regional ADA Centers
a) The Department shall designate 2 Regional ADA Centers in the
Chicago metropolitan region (Department of Public Health Regions 6 and 7) and
at least one in the downstate region (Department of Public Health Regions 1, 2,
3, 4, and 5) based upon meeting the definition of a Regional ADA Center as
defined in Section 710.20.
b) Specific information concerning the designations can be
obtained by contacting the Alzheimer's Disease Program, Illinois Department of
Public Health, 535 West Jefferson Street, Floor #2, Springfield, Illinois
62761-0001.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.130 Designation
Criteria for Primary Providers
To be considered for designation
as a primary provider, an applicant must provide the following documentation
and information:
a) Documentation that the applicant meets the definition of
primary provider. (See Section 710.20, Definitions.)
b) Documentation of the applicant's actual or proposed
affiliation with a Regional Alzheimer's Disease Assistance Center.
c) A description of the proposed service area shall include at a
minimum all of the following items:
1) Specific geographic areas to be covered with specific
services.
2) Target populations to be served, including age groups by sex,
race and population size.
d) A description of the specific services to be provided that
comply with the criteria in Sections 710.160 to 710.180.
e) A description of the professional medical staff, support staff
and equipment to be provided.
f) Written plans for transportation services for outreach that
assure access to services for persons with ADRD and families.
g) Copies of written plans for complying with minimum standards
for referral, treatment and support services under Sections 710.160 to 710.180.
h) Financial eligibility criteria for receiving services.
i) Utilization reports on facilities and services available from
primary providers to ADRD patients and families within the service area.
j) Copies of reports on research and treatment.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.140 Designation
Procedures for Primary Providers
An applicant may pursue
designation as a primary provider through either of 2 methods:
a) In cooperation with an applicant seeking designation as a
Regional ADA Center. The applicant for Center designation would submit
information and documentation related to the potential primary provider in
accordance with the criteria set forth in Sections 710.100(j) and 710.130.
1) All applicants that meet the definition of "Primary
Providers" and provide the information required in Section 710.130 shall
be designated by the Department.
2) Each Regional Center will certify an applicant's documentation
and information for designation as a primary provider.
b) By application to the Alzheimer's Disease Program, 535 West
Jefferson, Floor #2, Springfield, Illinois 62761-0001, and according to the
criteria set forth in Section 710.130.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.150 Services
provided by Regional ADA Centers and Primary Providers
a) Regional ADA Centers shall make available, at least, the
following services:
1) Identification;
2) Diagnostic Evaluation;
3) Referral;
4) Treatment;
5) Support Services;
6) Case Management;
7) Research Programs;
8) Training and Continuing Education;
9) Reporting to Primary and other Providers;
10) Centralized Data Collection; and
11) Communication among Regional Centers.
b) Primary providers shall make available, at least, treatment
and support services. In addition, the primary providers shall report all
service-related information requested by the Regional ADA Center and be willing
to participate in research programs.
Section 710.160 Diagnostic
Evaluation of ADRD Patients
a) Clinical criteria used to make the diagnosis of probable
Alzheimer's disease shall include at a minimum:
1) A history of gradually declining cognitive function over at
least six months;
2) A general physical and neurological examination;
3) A mental status examination reflecting deficits in more than
one area of cognition;
4) A laboratory evaluation to rule out other causes of dementia;
5) No evidence of other physical or psychiatric illnesses which
could explain the dementia picture.
b) Psychiatric and psychosocial tests to provide the information
to meet the criteria for clinically probable Alzheimer's disease, shall include
at a minimum:
1) Brief assessment of cognitive state, with emphasis on memory;
2) Brief assessment of social function, activities of daily
living, and instrumental activity of daily living;
3) Global assessment of dementia stage;
4) An assessment of depression and agitation.
c) Consultation among the patient, family caregivers and
evaluation team (attending physician, nurse and/or social worker) shall include
at a minimum consideration of the following:
1) Diagnosis;
2) Patient's prognosis (when determined appropriate by the
multi-disciplinary team);
3) Explanation of findings in subsections (a) and (b);
4) Recommendations to patient and family caregivers, including:
A) Medications;
B) Community support services/systems;
5) Plan of care.
Section 710.165
Multi-disciplinary Team Responsibilities
a) A multi-disciplinary team shall be responsible for preparing
and evaluating a care plan to meet the needs of the patient. This care plan
shall include at a minimum all of the following items:
1) Examinations on inpatient or outpatient basis.
2) Review of prescriptions, medications, and ancillary
treatments.
3) Backup for support services provided by other health care
professionals.
4) Nursing needs assessment.
5) Education and training of family and caregivers on care and
treatment.
6) Psychosocial services to ADRD patient and caregivers.
7) Evaluation of home environment of ADRD patient and caregivers.
8) Counseling caregivers and family members.
9) Identification of health care, support services, and other
community based services to assist caregivers.
b) Persons who may be or who have been clinically diagnosed as
probably having Alzheimer's disease and related disorders shall be referred by
the multi-disciplinary team to social service agencies and other sources of
care in response to identified needs.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.170 Treatment
Treatment plans must be
multi-disciplinary in nature and directed toward the elimination, modification
or control of the disease and its complications including therapy, drugs,
medical tests, support services and education for the patient and caregivers. These
plans shall be developed in consultation with patient and caregivers utilizing
the services listed in Section 710.180 of this Part.
Section 710.180 Support
Services
The following partial list of
services must be utilized at a minimum to identify the appropriate services for
patient, family and caregivers.
a) Home Health services;
b) Adult Day Care services;
c) Respite Care services;
d) Psychological services;
e) Nutritional services;
f) Transportation services;
g) Homemaker or Chore services;
h) Legal services;
i) Financial services;
j) Housing services;
k) Medical services;
l) Recreational services;
m) Institutional Care services (eg. Skilled or Intermediate
Long-Term Care Facilities, State Rehabilitation Facilities);
n) Case Management services.
Section 710.200 Grants to
Regional F7ADAF2 F7F2 Centers
All designated Regional ADA
Centers shall receive grants, subject to appropriation, from the Department
based upon the funding formula provided in the Alzheimer's Disease Assistance
Act.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.210 Grants from
the Alzheimer's Disease Research Fund
a) The Department shall make grants from the Alzheimer's Disease
Research Fund. These grants will take 2 forms: General Research Grants not to
exceed $30,000 and Early Researcher's Grants not to exceed $35,000. General
Research Grants must meet all of the criteria in Section 710.220, except
subsection (c). Early Researcher's Grants must meet all of the criteria in
Section 710.220. The Department will fund General Research Grants on an annual
basis. The maximum number of years of funding any one research project shall
be 2. An annual renewal application must be submitted for grants funded for 2
years.
b) Applications shall be approved based upon the following
criteria: degree of compliance with the Act and this Part, and recommendations
from the Alzheimer's Disease Advisory Committee.
c) The exact amount and number of grants will depend upon amount
of funds appropriated to the Department and the number of applications received
and approved.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.220 Funding
Criteria for Grants from the Alzheimer's Disease Research Fund
To be considered for grant
funding from the Alzheimer's Disease Research Fund, an applicant must provide
the Department with the following documentation and information:
a) For a Research Grant, certification that the applicant is one
of the following:
1) A physician licensed in Illinois to practice medicine in all
of its branches.
2) A licensed hospital in Illinois.
3) A licensed laboratory in Illinois.
4) A post-secondary higher educational institution in Illinois.
5) Any other medical professionals (e.g., nurses, therapists,
etc.).
b) For a Research Grant, an applicant shall submit the following
documentation and information on research methodology:
1) A brief description of the specific problem to be studied and
a brief overview of the proposed methodology.
2) Any hypotheses to be tested.
3) The experimental design and procedures to be used.
4) The research timetable.
5) The methods for collecting, analyzing and interpreting data.
6) The facilities, equipment and other resources to be used,
along with methods of use.
7) A description of how the Research Grant would enable the
applicant to pursue research that differs from any ongoing research by the
applicant.
8) The general background, experience and qualifications of the
applying institution or individuals.
9) A list of proposed personnel, both full-time and part-time,
including curricula vitae of the principal researcher and other staff.
10) The identification of the project's primary contact person.
11) The total budget for the research project for which the
application is being made.
12) All proposed funding sources and amounts, including this
grant, other grants, institutional support, and other sources.
13) A line item budget for the funding period using a Budget
Format provided by the Department.
14) The identification of potential funding sources if the
applicant is pursuing or intends to pursue on-going research.
c) Additional Criteria for Early Researcher's Grant
1) Definition
A) An early researcher is one who at the time of funding:
i) has not been a primary investigator on any federally funded
grant.
ii) is no more than 3 years past completion of specialty
training.
B) A researcher who applies for a multi-year project must meet
criterion in subsection(c)(1)(A)(ii) only for the first year of the project.
2) Responsibility
The design, organization, management and overall execution of
the research must be carried out by the early researcher. Secretaries,
technicians, statisticians, and the like may be used in an adjunction role, but
specialized skills of the early researcher (e.g., clinical interviews,
pyschological tests, physical examination, complex laboratory studies) must be
carried out by the early researcher.
3) Commitment
The early researcher must demonstrate by past achievements as
well as future plans apart from the grant project that the person intends to
commit a major part of the future to research in Alzheimer's disease related
areas.
4) Other Qualifications/Requirements
A) Certification that the applicant has completed within the past
3 years or will be in his/her final year of higher education training during
the grant period.
B) The criteria outlined in subsections(b)(1) through (7).
C) The applicant's qualifications and experience and a brief
overview of the applicant's career goals as they relate to Alzheimer's disease
and related disorders research.
D) A proposed line item budget for the funding period using a
Budget Format provided by the Department.
E) Three letters of recommendation, including one from the
applicant's supervisor or academic advisor.
d) Funded applicants must comply with the following reporting
procedures:
1) Submission to the Department of semiannual and yearly progress
reports.
2) Submission of a project year narrative to the Department.
e) Solicitation of Research Proposals
Research proposals will be solicited in response to a Request
for Proposals prepared and distributed by the Department.
f) Proposal Evaluation
Research proposals will be evaluated by a review panel
selected from the Alzheimer's Disease Advisory Committee. The applications
shall be evaluated and ranked according to degree of compliance with the
Alzheimer's Disease Research Act and this Part.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.230 Criteria for
Approval of Alzheimer's Disease Research Act Proposals
a) All requests by researchers for confidential data must be
submitted in writing to the Department. The request must include a study
protocol that contains: objectives of the research; rationale for the
research, including scientific literature justifying current proposal; overall
study methods, including copies of forms, questionnaires, and consent forms
used to contact facilities, physicians or study subjects; methods for the
processing of data; storage and security measures taken to ensure confidentiality
of patient identifying information; timeframe of the study; a description of
the funding source of the study (e.g., federal contract); the curriculum vitae
of the principal investigator and a list of collaborators. (See 42 CFR
2.a4(a)-(j), 2a.6(a)-(b), and 2a.7-(b).)
b) All requests to conduct research and modifications to approved
research involving the use of data that includes patient identifying
information shall be subject to a standardized review. The Department will
enter into contracts for research that require the release of patient
identifying information when requests meet the following conditions:
1) The request for patient identifying information contains
stated goals or objectives.
2) The request documents the feasibility of the study design in
achieving the stated goals and objectives.
3) The request documents the need for the requested data to
achieve the stated goals and objectives.
4) The requested data can be provided within the timeframe set
forth in the request.
5) The request documents that the researcher has qualifications
relevant to the type of research being conducted.
6) The research will not duplicate other research already
underway using the same data.
7) Other conditions relevant to the need for the patient identifying
information and the patient's confidentiality rights.
c) The researcher shall include an assurance that use of data is
restricted to the specifications of the protocol. Any departures from the
approved protocol must be submitted in writing and approved by the Director
prior to initiation. No patient identifying information may be released by a
researcher to a third party.
d) The Department, by signed and reciprocating agreement, may
disclose individual patient information concerning residents of another state
to the individual's state of residence only if the recipient of this
information is legally required to hold the information in confidence and
provides protection from disclosure of patient identifying information
equivalent to the protection afforded by Illinois law.
e) The patient identifying information submitted to the
Department by those entities required to submit information under the Act,
Alzheimer's Disease Research Act, and this Part shall be privileged and
confidential and shall not be available for disclosure, inspection or copying
under the Freedom of Information Act [5 ILCS 140] or the State Records Act [5
ILCS 160]. The prohibitions stated in this Section shall not apply, however, to
that information that is made available under Section 710.40(a) and (b).
f) The patient identifying information submitted to the
Department by those entities required to submit information under the Act,
Alzheimer's Disease Research Act, and this Part will be used in the course of
medical study under Article VIII, Part 21 of the Code of Civil Procedure [735
ILCS 5/Art. VIII, Part 21]. Therefore, this information is privileged from
disclosure by the Medical Studies Part of Article VIII of the Code of Civil
Procedure.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)
Section 710.APPENDIX A Regions
of Illinois Department of Public Health and Regional ADA Centers' Service Areas
Regional ADA Centers' Service
Areas:
A. Chicago ADA Region:
Department's Chicago/West Chicago Regions.
B. Downstate ADA Region: All
other Department Regions.
(Source: Amended at 25 Ill. Reg. 11159, effective September 1, 2001)