Section 1580.10  Purpose and Applicability

 

a)         The Illinois Criminal Justice Information Authority (Authority) establishes this Part to institute procedures applicable to the creation and operation of an Institutional Review Board (IRB). The IRB shall review research involving human subjects that is conducted, sponsored, or supported by the Authority, to ensure the protection of human subjects. All research subject to this Part must have IRB review and approval before data collection for the research begins.

 

b)         This Part was derived from and corresponds to 28 CFR 46, which requires institutions that receive federal funding for purposes of research involving human subjects to adhere to, and to establish and operate an IRB in accordance with, federal regulations. This Part is applicable to all research that is conducted, sponsored, or supported by the Authority that involves human subjects, whether or not it is federally funded.

 

c)         Research involving human subjects that is conducted, sponsored, or supported by the Authority, for purposes of this Part, includes the following:

 

1)         Research involving human subjects that is conducted by an Authority employee, within the scope of the employee's employment, that has not otherwise been reviewed and approved by an IRB that adheres to all applicable laws and regulations. The executive director of the Authority reserves the right to require research conducted by an Authority employee, within the scope of the employee's employment, that has been reviewed and approved by an IRB that adheres to all applicable laws and regulations to be subject to additional IRB review and approval, in accordance with this Part.

 

2)         Research involving human subjects that is funded by the Authority, but conducted by an independent contractor, that has not otherwise been reviewed and approved by an IRB that adheres to all applicable laws and regulations. The executive director of the Authority reserves the right to require research involving human subjects that is funded by the Authority, but conducted by an independent contractor, that has been reviewed and approved by an IRB that adheres to all applicable laws and regulations, to be subject to additional IRB review and approval, in accordance with this Part.

 

Section 1580.20  Definitions

 

"Certifications" means the official notification by the Authority to the appropriate funding agency that a research project or activity involving human subjects has been reviewed and approved by an IRB; and the official notification by the Authority to the funding agency that applicable laws and regulations regarding confidentiality and privacy of identifiable research information have been adhered to.

 

"Exempt research" means research that involves human subjects, but according to applicable laws and regulations, including but not limited to 28 CFR 46.101(b), does not require IRB review and approval.

 

"Human subject" means a living individual about whom a researcher obtains data through intervention or interaction with the individual or identifiable private information.

 

"IRB" means an institutional review board established in accordance with and for the purposes expressed in this Part.

 

"IRB approval" means the determination of the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other applicable laws and regulations.

 

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge.

 

Section 1580.30  Institutional Review Board Composition  

 

a)         An IRB shall be qualified through the experience, expertise, and diversity of its members, considering race, gender, cultural backgrounds and sensitivity to issues such as community attitudes. The IRB shall review proposed research in light of existing Authority commitments; applicable laws, regulations and guidelines; and standards of professional conduct and practice. The IRB shall include persons with expertise in these areas.

 

b)         IRB members shall be appointed by the executive director of the Authority. An IRB must consist of at least five members with varying backgrounds. The Authority must adhere to the following IRB membership rules:

 

1)         Every nondiscriminatory effort must be made to ensure that an IRB does not consist entirely of men or entirely of women.

 

2)         An IRB must not consist entirely of members of one profession.

 

3)         An IRB must include at least one member whose primary concerns are in scientific areas.

 

4)         An IRB must include at least one member whose primary concerns are in nonscientific areas.

 

5)         An IRB must include at least one member who is not otherwise affiliated with, or part of the immediate family of a person who is affiliated with, the Authority.

 

6)         An IRB member must not participate in the initial or continuing review of any project in which the member has a conflict of interest, except to provide information requested by the IRB.

 

7)         An IRB may, in its discretion, invite individuals with special expertise to assist in the review of issues requiring that expertise. These individuals may not vote with the IRB.

 

8)         An IRB must reflect all applicable laws and regulations regarding IRB membership.

 

Section 1580.40  Institutional Review Board Procedures

 

a)         The general counsel of the Authority shall review all research applications involving human subjects to determine whether the application involves exempt research. If the general counsel determines that the research is exempt, the general counsel shall provide notice of, and justification for, this determination to the IRB members and the executive director of the Authority. If the general counsel does not receive any notice of disagreement with a determination of exempt status from IRB members within 10 working days after the mailing date of the notice, then the determination that the research is exempt will be considered approved by the IRB. If the general counsel receives notice of disagreement with a determination of exempt status from any IRB member, the research will be considered non-exempt and subject to IRB review and approval under this Part. Research projects determined to be exempt are not subject to further IRB review and approval. A determination by the IRB that a research project is exempt is subject to override by the executive director of the Authority.

 

b)         All research applications involving human subjects that do not involve exempt research shall be reviewed by the IRB, in accordance with this Part. The IRB review of research applications must occur at meetings subject to the Open Meetings Act [5 ILCS 120]. IRB meetings must include a majority of IRB members who are present at the meeting in person or by electronic means, including at least one member whose expertise is in nonscientific areas. Minutes covering all activities will be taken and made available to the Authority.

 

c)         The IRB shall operate in accordance with all applicable laws and regulations. The IRB has the authority to approve or disapprove, require modification to, or observe research. The IRB must provide written notification to the executive director of the Authority and researchers of approval or disapproval of, or required modifications to, proposed research.

 

d)         The IRB may approve research applications involving human subjects if the IRB has determined that all of the following requirements are satisfied:

 

1)         Risks to subjects must be minimized; researchers must use procedures that are consistent with sound research design and do not unnecessarily expose subjects to risk;

 

2)         Risks to subjects must be reasonable in relation to the expected benefits to subjects and the knowledge that may reasonably be expected to result from the research;

 

3)         The selection of subjects must be equitable;

 

4)         Unless otherwise authorized by law or regulation, informed consent must be obtained and appropriately documented for each participating subject or the subject's legally authorized representative. When the IRB determines that the research project must include procedures for obtaining informed consent, the IRB shall ensure that informed consent is obtained under circumstances and through procedures that adhere to all applicable laws and regulations, and minimize any coercion or undue influence upon the subject or representative. Unless otherwise authorized by law or regulation, the following elements of informed consent must be provided to each human subject:

 

A)        An explanation of the purposes of, and procedures involved in, the research and the expected duration of the subject's participation;

 

B)        A description of any reasonably foreseeable risks or discomforts to the subject;

 

C)        A description of any benefits to the subject or to others that may reasonably be expected from the research;

 

D)        A statement describing how the confidentiality of records identifying the subject will be maintained;

 

E)        Information regarding who should be contacted for answers to questions about the research and research subjects' rights and in the event of a research-related injury to the subject;

 

F)         A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of those benefits; and

 

G)        Any additional information that the IRB determines would further protect the rights and welfare of the subject;

 

5)         The research must make any necessary provisions for data monitoring to ensure the safety of subjects;

 

6)         There are adequate provisions for assuring the privacy of subjects and confidentiality of data;

 

7)         When the research involves subjects likely to be vulnerable to coercion or undue influence, additional safeguards must be included to protect the rights and welfare of these subjects; and

 

8)         The research must comply with applicable laws and regulations.

 

e)         The IRB may deny requests to conduct the research for reasons including, but not limited to, that the risks posed to human subjects are too great and for noncompliance with applicable laws and regulations. A notice of disapproval must include the reasons for denial in sufficient detail that allows the researcher to respond. The researcher must be given the opportunity to respond to the denial in person or in writing to the IRB.

 

f)         Research subject to this Part must have the approval of a majority of IRB members present at the meeting before data collection may begin.

 

Section 1580.50  Expedited Review

 

a)         Research that involves no more than minimal risk to human subjects and their privacy and confidentiality may be eligible for an expedited review procedure. If so requested by the researcher, the IRB chairperson shall examine the research application and applicable laws and regulations to determine whether the research project involves no more than minimal risk and is eligible for the expedited review procedure.  Research projects that are eligible for expedited review include those projects found in the list of research categories published as eligible for expedited review in the Federal Register by the Department of Health and Human Services (see 28 CFR 46.110(a)), and previously approved projects for which minor changes are proposed during the period for which the IRB has already given approval, when those projects or changes involve minimal risk.

 

b)         If a research project is eligible for an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Under an expedited review procedure, the reviewers must consider provisions of Section 1580.40(d) and may approve the research application if those provisions are adhered to.

 

c)         In reviewing the research application under an expedited review procedure, the reviewers may not disapprove the research application; a research application may be disapproved only after review in accordance with the non-expedited review procedure. Research applications that have been reviewed under, but not approved through, the expedited review procedure shall be subject to further review under the non-expedited review procedure described in Section 1580.40.

 

d)         The IRB chairperson shall keep all IRB members and the executive director of the Authority informed of research proposals that have been approved under the expedited review procedure.

 

Section 1580.60  Additional Review Requirements

 

a)         Research projects are subject to IRB review and approval whenever changes are proposed to the research project. Changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subjects.

 

b)         For research projects that already have IRB approval, the IRB must perform continuing, periodic reviews at intervals commensurate to the degree of risk the research poses, but at least once a year.

 

c)         Research that is subject to this Part may be subject to further review and approval or disapproval by the executive director of the Authority. Research reviewed by the executive director of the Authority shall be conducted in a manner consistent with the provisions of Section 1580.40. However, the executive director of the Authority may not approve the research if it has not been approved by an IRB.

 

Section 1580.70  Reporting Requirements

 

a)         Researchers must report proposed research changes to the IRB and the executive director of the Authority. The executive director of the Authority shall inform the appropriate funding agency.

 

b)         Any unanticipated problems involving risk or harm to subjects or others, noncompliance with applicable laws or regulations, or IRB requirements or determinations, must be immediately reported by the researcher to the IRB and the executive director of the Authority. The Authority and the IRB shall have the authorization and duty to suspend or terminate approval of research that is not being conducted in accordance with applicable laws or regulations, or IRB requirements or determinations, or that has been associated with unexpected risks or harm to subjects or others. Any suspension or termination of approval by the Authority or the IRB shall include a statement of the reasons for that action.

 

c)         The executive director of the Authority shall notify the appropriate funding agency of any unanticipated problems involving risk or harm to subjects or others, any instance of serious or continuing noncompliance with applicable laws or regulations, or IRB requirements or determinations, and all suspensions and terminations of research approval.

 

d)         The executive director of the Authority will forward all required certifications and documentation regarding the IRB review to the appropriate funding agency.

 

e)         The researchers may be required to submit progress reports to the IRB, the nature and frequency of which will be specified by the IRB.

 

f)         The IRB shall submit a report to the Authority's Planning and Research Committee on the actions of the IRB, prior to the committee's regular meetings.

 

Section 1580.80  Requirements for Submitting Research Proposals

 

a)         The person or entity requesting the research involving human subjects must submit to the general counsel of the Authority a research application that includes the following written documentation:

 

1)         A formal research proposal including the names and vitae of the researchers; an abstract of the project; a full description of the project purpose, methodology, protocol, and duration; the number of subjects, the amount of time required for each subject, and a detailed description of the interaction with the subjects; the procedures for obtaining informed consent; the testing or measurement instruments; and Authority resources to be utilized;

 

2)         Identification of funding sources for the research proposal;

 

3)         Any certifications and assurances regarding the protection of human research subjects, privacy and confidentiality, that are required by applicable law or regulations; and

 

4)         Any other information necessary to the IRB review procedure.

 

b)         The general counsel of the Authority will review the application, in accordance with Section 1580.40(a).