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)

 

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)