Multiple Project Assurance of Compliance with DHHS Regulations
for Protection of Human Research Subjects

The Cook County Bureau of Health Services, its components and the Hektoen Institute for Medical Research, LLC, hereinafter known as the "institution" (see Appendix A), hereby gives Assurance, as specified below, that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects, 45 CFR Part 46, as amended to include provisions of the Federal Policy for the Protection of Human Subjects (56FR28003) as Subpart A, and as may be further amended during the approval period for this Assurance. 

Three Institutional Review Boards, known as Scientific Committees, will be bound by this Assurance: 
 

1) The IRB of the Cook County Hospital/Bureau of Health Services 
2) The IRB of Provident Hospital of Cook County 
3) The IRB of Oak Forest Hospital of Cook County. 

These IRBs are responsible for review and oversight of human research in all the components of the Cook County Bureau of Health Services, including Cook County Hospital, Provident Hospital of Cook County, Oak Forest Hospital of Cook County, Cermak Health Services of Cook County , the Cook County Ambulatory & Community Health Network, and the Cook County Department of Public Health. These IRBs also oversee human research conducted jointly with the Hektoen Institute for Medical Research, LLC. 

The following describes the relationship(s) of each IRB covered by this Assurance to components of the institution: 

(1) (a) The Cook County Hospital/Bureau IRB will oversee projects that fit the criteria for applicability under Part III.A of this Assurance for the following components: 

Cook County Hospital 
The Ambulatory & Community Health Network of Cook County 
Cermak Health Services of Cook County 
Cook County Department of Public Health 
The Hektoen Institute for Medical Research, LLC

(b) Research projects which will take place in more than one of the component facilities operated by the Cook County Bureau of Health Services will be overseen by the Cook County Hospital/Bureau Scientific Committee. When applicable, the other hospital(s) involved (Provident Hospital or Oak Forest Hospital) will be represented on this Board by voting member(s) appointed by the IRB(s) to act in this capacity for these projects.

(2) The Provident Hospital IRB will oversee projects that fit the criteria for applicability under Part 1.III.A of this Assurance for Provident Hospital, except for multi-component projects described in (1)(a) above.

(3) The Oak Forest Hospital IRB will oversee projects that fit the criteria for applicability under Part 1.III.A of this Assurance for Oak Forest Hospital except for multi-component projects described in (1)(a) above.

 
Back to Top

Affiliate

an institution or independent investigator which is legally separate from the signatory (s) to an Assurance but has a formal affiliation with the signatory institution(s) through an OPRR-approved Inter-Institutional Amendment or Assurance

Agreement

a document (e.g., AII or NIA) which assures individual compliance with 45 CFR 46 by an independent non-institutional investigator

Agreement for an Independent Investigator (AII)

an OPRR-approved document entered into between a signatory institution and non-institutional affiliate investigator (e.g., private practitioner) which assures compliance with 45 CFR 46 specified activities that are not CPRP in nature

any formal addition to an Assurance (e.g., CA or IIA to an MPA)

an OPRR-approved document which assures institutional compliance with 45 CFR 46(e.g., SPA, CPA, or MPA)

Collaboration

engagement by two or more entities in human subject research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support (e.g., money, drugs, identifiable specimens), coauthorship, intellectual property, or credits

Component

any entity that is legally inseparable from the signatory institution(s)

Cooperative Amendment (CA)

a document requiring OPRR approval (formerly referred to as a Agreement) which is jointly agreed to by two or more MPA institutions (or otherwise with prior OPRR consultation) for the purpose of specifying arrangements for relying on one another's IRBs to avoid duplication of effort

Cooperative Project Assurance (CPA)

an Assurance designed to accommodate CPRP multi-protocol, multi-site research specifically recognized by OPRR

Cooperative Protocol

DHHS multi-site, multi-protocol Research Programs (CPRP) trials which are explicitly recognized by OPRR as suited for CPAs (e.g. cooperative oncology trials of the National Cancer Institute)

Federal

departments and agencies of the Federal government that are a party to the Federal Policy.

Federal Policy (56FR28003)

minimum Federal standards for the protection of human research subjects, effective August 19, 1991 (see FR Volume 56, No. 117, Tuesday, June 18, 1991) and contained in 45 CFR 46 as Subpart A- also known as the Common Rule

45 CFR 46 (DHHS Regulations)

Title 45 of the Code of Federal Regulations, Part 46, which consists of Subpart A (the Federal Policy for the Protection of Human Subjects) and Subparts B, C, and D which apply to fetuses, pregnant women and in-vitro fertilization of human ova; prisoners and children as vulnerable subject populations

Inter-Institutional Amendment (IIA)

an amendment to an MPA for compliance with 45 CFR 46 by affiliate institutions that do not have their own MPA, regularly serve as a Performance Site for research conducted by an Multiple Project Assurance signatory institution(s), and usually do not possess their own Institutional Review Boards.

Back to Top

Multiple Project Assurance (MPA)

a DHHS Assurance which applies during fixed and renewable periods to a broad spectrum of unrelated research activities

Noninstitutional Investigator Agreement (NIA)

an OPRR-authorized document entered between a signatory institution and non-institutional affiliate (e.g., private practitioner) which assures compliance with 45 CFR 46 OPRR-recognized CPRP activities (e.g.,  cooperative oncology group trials)

Office of Research Administration for Human Subject Research (ORA)

the resources maintained by each signatory institution or the primary signatory institution (if applicable) which provides a central focus for researchers, IRB(s), and administrators in processing protocols, arranging IRB review, keeping records, reporting, and communicating pertinent information about human subject research

Performance Site

any entity (institution or independent investigator) where human subjects involved in research for which an MPA IIA, SPA, CPA, AII, or NIA is required

Primary Signatory Institution

where applicable, signatory institution of two or more which may be chosen to assume the function of the ORA for all signatory institutions

Signatory Institution

an institution which OPRR finds eligible to enter into an Assurance and which has signed the Assurance

Single Project Assurance (SPA)

an Assurance document which is submitted to OPRR by an institution, upon request, for a specific DHHS research activity at a Performance Site where an MPA, IIA, or CPA, does not apply.

Back to Top

PART 1 - PRINCIPLES, POLICIES, AND APPLICABILITY

I.     Ethical Principles 

A.     This institution is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the "Belmont Report"]), regardless of whether the research is subject to Federal regulation or with whom conducted or source of support (i.e., sponsorship). 

B.    All institutional and non-institutional Performance Sites for this institution, domestic or foreign, will be obligated by this institution to conform to ethical principles which are at least equivalent to those of this institution, as cited in the previous paragraph or as may be determined by the DHHS Secretary

II.     Institutional Policy 
 

A.     All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all federally- supported research, and all other human subject research regardless of sponsorship, except as otherwise noted in this Assurance. Federal funds for which this Assurance applies may not be expended for research involving human subjects unless the requirements of this Assurance have been satisfied.

B.     Except for those categories specifically exempted or waived under 45 CFR 46 Section 101(b)(1-6) or 101(i), all research covered by this Assurance will be reviewed and approved by a Scientific Committee, hereinafter called an Institutional Review Board (IRB), which has been established under a Multiple Project Assurance (MPA) with OPRR or as may be otherwise agreed to by OPRR (see Part 1, II, G of this Assurance). The involvement of human subjects in research covered by this Assurance will not be permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject's legal representative (see 45 CFR 46 Sections 111, 116, and 117), unless properly waived by the IRB under Section 116(c),(d) or by any applicable waiver under Section 101(i).

C.     This institution assures that before human subjects are involved in nonexempt research covered by this Assurance, the IRBs will give proper consideration to: 

1. the risks to the subjects, 
2. the anticipated benefits to the subjects and others, 
3. the importance of the knowledge that may reasonably be expected to result, and 
4. the informed consent process to be employed

D.     Certification of IRB review and approval for all Federally-sponsored research involving human subjects will be submitted to the Office of Research Development, hereinafter called the Office of Research Administration for Human Subject Research (ORA), for forwarding to the appropriate Federal department or agency. Compliance will occur within the time and in the manner prescribed for forwarding certifications of IRB review to DHHS or other Federal departments or agencies for which this Assurance applies.

As provided for under section 118, applications and proposals lacking definite plans for involvement of human subjects will not require IRB review and approval prior to award. However, except for research exempted or waived under 45 CFR 46 Section 101 (b) or (i), no human subjects may be involved in any project supported by such awards until IRB review and approval has been certified to the appropriate Federal department or agency.

As required under 45 CFR 46 Section 119, the IRB will review proposed involvement of human subjects in Federal research activities undertaken without prior intent for such involvement, but will not permit such involvement until certification of the IRB's review and approval is received by the appropriate Federal department or agency.

E.     Institutions that are not direct signatories to this Assurance are not authorized to cite this Assurance. This institution will ensure that such other institutions and investigators not bound by the provisions of this Assurance for DHHS-sponsored research will satisfactorily assure compliance with 45 CFR 46, as required (see Part 2, I, D and II, K of this Assurance), as a prior condition for involvement in DHHS-sponsored human subject research which is under the auspices of this institution (see Part 1, III, A of this Assurance). Institutions that have entered into an Inter-Institutional Amendment (IIA) to this Assurance must submit a Single Project Assurance (SPA) to the Office for Protection from Research Risks (OPRR) of DHHS for DHHS-sponsored research, on request of OPRR or the sponsor, when that research is not conducted under the auspices of a signatory institution to this Assurance. 

Back to Top

F.     This institution will make an affirmative effort to ensure that any of its Affiliates materially engaged in the conduct of non-federally sponsored research involving human subjects will possess mechanisms to protect human research subjects that are at least equivalent to those procedures provided for in the ethical principles to which this institution is committed (see Part 1, I of this Assurance).  This institution will ensure that its investigators are informed that collaborating entities which:

a) are not formally affiliated with it through an OPRR-approved Inter-Institutional Amendment or Assurance and 
b) are materially engaged in the conduct of non-federally sponsored research involving human subjects, 

must possess mechanisms to protect human research subjects that are at least equivalent to those procedures provided for in the ethical principles to which this institution is committed (see Part 1, I of this Assurance).

G.     This institution will comply with the requirements set forth in 45 CFR 46 Section 114 of the regulations regarding cooperative research projects. When research covered by this Assurance is conducted at or in cooperation with another entity, all provisions of this Assurance remain in effect for that research. This institution may accept, for the purpose of meeting the IRB review requirements, the review of an IRB established under another DHHS MPA. Such acceptance must be (a) in writing, (b) approved and signed by an official of this institution's Office of Research Development (ORA), and (c) approved and signed by correlative officials of each of the other cooperating institutions (i.e. a Cooperative Amendment to this MPA). The original of the signed understanding will serve as an addendum to this Assurance and will be forwarded to the OPRR of DHHS by the Office of Research Development (ORA) for OPRR approval.

H.     This institution will exercise appropriate administrative overview to insure that the institution's policies and procedures designed for protecting the rights and welfare of human subjects are being effectively applied in compliance with this Assurance.

I.       Description of this institution's policy for the protection of human subjects is contained in its internal written procedures which are available to OPRR and other Federal departments or agencies, upon request. Appendix D to this Assurance abstracts pertinent organizational, personnel, and reporting procedures sufficient to describe the substance and relative prominence conferred upon the protection of subjects.

Back to Top

 
 A.   Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46 Section 101(b)(1-6) or 101(i), this Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply: 
 

1.  the research is sponsored by this institution, or 
2.   the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or 
3.   the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or 
4.    the research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects.

 B.   All human subject research which is exempt under 45 CFR 46 Section 101(b)(1- 6) or 101(i) will be conducted in accordance with: (1) the Belmont Report, (2) this institution's administrative procedures to ensure valid claims of exemption, and (3) orderly accounting for such activities. 

 C.   Components of this institution are bound by the provisions of this Assurance.  Those components which can be expected to participate in human subject research sponsored by DHHS or other Federal departments or agencies for which this Assurance will apply are identified in Appendix A. The relationships of each IRB to these components is described in Appendix A.  Appendix A will be revised as changes occur and revisions forwarded to OPRR. 

 D.   This Assurance must be accepted by other Federal departments or agencies that are bound by the Federal Policy for the Protection of Human Subjects when appropriate for the research in question and therefore applies to all human subject research so sponsored. Research that is neither conducted nor supported by a Federal department or agency but is subject to regulation as defined in 45 CFR 46 Section 102(e) must be reviewed and approved, in compliance with 45 CFR 46 Sections 101, 102, and 107 through 117. 

Back to Top

PART 2 - RESPONSIBILITIES

I. Institution

A. This institution acknowledges that it bears full responsibility for the performance of all research involving human subjects, covered by this Assurance, including complying with Federal, state, or local laws as they may relate to such research.

B. This institution will require appropriate additional safeguards in research that involves: (1) fetuses, pregnant women, or human ova in vitro fertilization (see 45 CFR 46 Subpart B), (2) prisoners (see 45 CFR 46 Subpart C), (3) children (see 45 CFR 46 Subpart D), (4) the cognitively impaired, or (5) other potentially vulnerable groups. 

C. This institution, including all its named components (see Appendix A), acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this Assurance.

D. This institution is responsible for acquiring appropriate Assurances or Amendments, when requested, and certifications of IRB review and approval for federally sponsored research from all its standing Affiliates (see Appendix B) and Assurances or Agreements for all others, domestic or foreign, which may otherwise become Affiliated on a limited basis in such research. 

E. This institution is responsible for ensuring that no Performance Site for this institution cooperating in the conduct of federally sponsored research for which this Assurance applies do so without Federal department or agency approval of an appropriate Assurance of compliance, in whatever form, and satisfaction of IRB certification requirements. 

F. In accordance with the compositional requirements of 45 CFR 46 Section 107, this institution has established three IRBs listed in the attached rosters (see Appendix C). Certain research supported by the U.S. Department of Education will be reviewed in accordance with the requirements of Title 34 CFR Parts 350 and 356 which require that the IRB reviewing the project include one person who is primarily concerned with the welfare of handicapped children or mentally disabled persons.

G. This institution will provide both meeting space and sufficient staff to support the IRB's review and record keeping duties.

H. This institution recognizes that involvement in research activities of any OPRR-recognized Cooperative Protocol Research Programs (CPRPs) will involve additional reporting and record keeping requirements related to human subject protections. 

I. This institution is responsible for ensuring that it and all its Affiliates comply fully with all applicable Federal policies and guidelines, to the extent permitted by State law and regulations, including those concerning notification of seropositivity, counseling, and safeguarding confidentiality where research activities directly or indirectly involve the study of human immunodeficiency virus (HIV).

Back to Top

II. Office of Research Administration for Human Subject Research (ORA)

The Bureau Office of Research Development will function as the ORA for all projects to be overseen by the Institution. Components at which there is an IRB will assign staff to carry out administrative support for their respective IRBs. For these activities these staff will be overseen by the Director of the ORA. These relationships are summarized in Appendix D.
 

A.     The ORA will receive from investigators, through their supervisors, all research protocols which involve human subjects, keep investigators informed of decisions and administrative processing, and return all disapproved protocols to them.

B.     Determinations of exemption: See Part 2 of this Assurance, Institutional Review Board.

C.     Determinations of eligibility for expedited review: See Part 2 of this Assurance, Institutional Review Board.

D.     An institutional officer will review all research (whether exempt or not) and decide whether the institution will permit the research. If approved by the IRB, but not permitted by the institution, the ORA will promptly convey notice to the investigator and the IRB Chair. Neither the ORA nor any other office of the institution may approve a research activity that has been disapproved by the appropriate IRB.

E.     The ORA will forward certification of IRB approval of proposed research to the appropriate Federal department or agency only after all IRB-required modifications have been incorporated to the satisfaction of the IRB.

F.     The ORA will designate procedures for the retention of signed consent documents for at least three years past completion of the research activity.

G.     The ORA will maintain and arrange access for inspection of IRB records as provided for in 45 CFR 46 Section 115.

H.     The ORA is responsible for ensuring constructive communication with the research administrators, department heads, research investigators, clinical care staff, human subjects, and institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.

I.     The ORA will arrange for and document in its records that each individual who conducts or reviews human subject research has first been provided with a copy of this Assurance, as well as with ready access to copies of 45 CFR 46, regulations of other Federal departments or agencies as may apply, the Belmont Report, and all other pertinent Federal policies and guidelines related to the involvement of human subjects in research.

J.     The ORA will report promptly to the IRB(s), appropriate institutional officials, the Office for Protection from Research Risks (OPRR), and any other sponsoring Federal department or agency head:

1.     any unanticipated injuries or problems involving risks to subjects or others,
2.     any serious or continuing noncompliance with the regulations or requirements of the IRB, and
3.     any suspension or termination of IRB approval for research.

Back to Top

K.     The ORA will ensure (a) solicitation (or confirmation where applicable Assurances to comply already exist), receipt, and management of all Assurances of compliance (whatever the appropriate format), and (b) certifications of IRB review (where appropriate) for all Performance Sites to this institution (including those listed in Appendix B) and subsequent submission of new documents to the proper Federal department or agency authorities (e.g., OPRR for DHHS) as a condition for involvement of each site in human subject research activities sponsored by DHHS or any other Federal department or agency and conducted under the auspices of this institution.

L.     The ORA will make an affirmative effort to ensure that all Affiliated Performance Sites that are not otherwise required to submit Assurances of compliance with Federal regulations for the protection of research subjects at least document mechanisms to implement the equivalent of ethical principles to which this institution is committed (see Part 1, I of this Assurance).

M.     When an IRB of this institution accepts responsibility for review of research which is subject to this Assurance and conducted by any independent investigator who is not otherwise subject to the provisions of this Assurance, the ORA will either: (a) obtain and retain an Noninstitutional Investigator Agreement (NIA) for CPRP activities (with copy to the investigator and the authorizing CPRP) or (b) obtain an Agreement for an Independent Investigator (AII) for review and approval by the appropriate Federal department or agency for non-CPRP activities to document the investigator's commitment to abide: (1) by the same requirements for the protection of human research subjects as does this institution(s) and (2) the determinations of the IRB(s).

N.     The ORA assumes responsibility for ensuring conformance with special reporting requirements for any OPRR-recognized CPRPs in which the signatory institution(s) participate(s).

O.     The ORA will be responsible for procedural and record-keeping audits not less than once every year for the purpose of detecting, correcting, and reporting (as required) administrative and/or material breaches in uniformly protecting the rights and welfare of human subjects as required at least by the regulations and as may otherwise be additionally required by this institution(s).

P.     The ORA will ensure compliance with the requirements set forth in this Assurance and 45 CFR 46 Section 114 regarding cooperative research projects. In particular, where the IRB of another institution with a DHHS MPA is relied upon, the ORA will ensure that documentation of this reliance will be (a) in writing, (b) approved and signed by the ORA, (c) approved and signed by the correlative officials of each of the other cooperating institutions, and (d) retained by the ORA for at least three years past completion of the research project, if limited in scope to a specific research project or retained as a permanent addendum to the MPA if not restricted to a specific project. For all Cooperative Amendments (CAs), the ORA will forward the original of the required signed understanding to OPRR for approval and inclusion in this Assurance as an addendum.

Back to Top

III. Institutional Review Board (IRB)
 

A.     An IRB will review, and have the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research, according to the assignment of responsibilities described in this Assurance. For approved research, the IRB will determine which activities require continuing review more frequently than every year or need verification that no changes have occurred if there was a previous IRB review and approval.

The appropriate IRB Chair or Co-Chair is responsible for reviewing the preliminary determinations of exemption by investigators and supervisors and for making the final determination based on 45 CFR 46 Section 101 of the regulations. Notice of concurrence for all exempt research will be promptly conveyed in writing to the investigator. All nonexempt research will be forwarded to the appropriate IRB. 

The appropriate IRB Chair or Co-Chair will make the preliminary determination of eligibility for expedited review procedures (see 45 CFR 46 Section 110). Expedited review of research activities will not be permitted where full board review is required.

B.     IRB decisions and requirements for modifications will be promptly conveyed to investigators and the ORA in writing. Written notification of decisions to disapprove will be accompanied by reasons for the decision with provision of an opportunity for reply by the investigator, in person or in writing. 

C.     Initial and continuing convened IRB reviews and approvals will occur in compliance with 45 CFR 46 and provisions of this Assurance for each project unless properly found to be exempt (45 CFR 46 Section 101[b] or [i]) by an IRB Chair or Co-Chair. Continuing reviews will be preceded by IRB receipt of appropriate progress reports from the investigator, including available study-wide findings.

D.     Each IRB will observe the quorum requirements of 45 CFR 46 Section 108(b). This institution's IRBs have effective knowledge of subject populations, institutional constraints, differing legal requirements, and other factors which can foreseeably contribute to a determination of risks and benefits to subjects and subjects' informed consent and can properly judge the adequacy of information to be presented to subjects in accordance with requirements of 45 CFR 46 Sections 103(d), 107(a), 111, and 116.

E.     The appropriate IRB will determine, in accordance with the criteria found at 45 CFR 46.111 and Federal policies and guidelines for involvement of human subjects in HIV research, that protections for human research subjects are adequate. 

F.     The appropriate IRB will ensure that legally effective informed consent will be obtained and documented in a manner that meets the requirements of 45 CFR 46 Sections 116 and 117. The IRB will have the authority to observe or have a third party observe the consent process.

G.     Where appropriate, the IRB will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and children, as required by Subparts B, C, and D of 45 CFR 46. The ORA will notify OPRR promptly when any IRB's membership is modified to satisfy requirements of 45 CFR 46.304 and when each IRB fulfills its duties under 45 CFR 46.305(c).

H.     Scheduled meetings of each IRB for review of each research activity will occur not less than every 12 months and may be more frequent, if required by the appropriate IRB on the basis of degree of risk to subjects. An IRB may be called into an interim review session by its Chairperson at the request of any of its members or institutional official to consider any matter concerned with the rights and welfare of any subject. 

I.     Each IRB will prepare and maintain adequate documentation of its activities in accordance with 45 CFR 46 Section 46.115 and in conformance with ORA requirements. 

J.     Each IRB, will report promptly to appropriate institutional officials, the Office for Protection from Research Risks (OPRR), and any other sponsoring Federal department or agency head:

1.     any unanticipated injuries to human subjects or problems involving risks to subjects or others, 
2.     any serious or continuing noncompliance with the regulations or requirements of the IRB, and
3.     any suspension or termination of IRB approval.

Back to Top

K.     In accordance with 45 CFR 46 Section 113, the appropriate IRB will have the authority to suspend or terminate previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

L.     Each IRB for this institution will ensure effective input (consultants or voting or nonvoting members) for all initial and continuing reviews conducted on behalf of Performance Sites where there will be human research subjects. IRB minutes will document attendance of those other than regular voting members. Each IRB listed in Appendix C includes those who are identified as knowledgeable about any Affiliate institution having entered into an Inter-Institutional Amendment or other institutional Performance Site for which an Assurance is required when relying on one or more of the IRB's of this institution.

M.     The appropriate IRB will act with reasonable dispatch, upon request, to provide full board review of protocols of OPRR- recognized Cooperative Protocol Research Programs (CPRP). No IRB will employ expedited review procedures for CPRP protocols when they are to be entered into for the purpose of research. Although emergency medical care based on such protocols is permitted without prior IRB approval, patients receiving emergency care under these conditions will not be counted as research subjects and resultant data will not be used for research purposes.

N.     Certifications of IRB review and approval will be forwarded through the ORA to the appropriate Federal department or agency for research sponsored by such departments or agencies.
 

Back to Top

IV.     Research Investigator
 

A.     Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance.

B.     Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulations or provisions of this Assurance.

C.     Research investigators are responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement. All signed consent documents are to be retained in a manner approved by the ORA.

D.     Research investigators will promptly report proposed changes in previously approved human subject research activities to the appropriate IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.

E.     Research investigators are responsible for reporting progress of approved research to the appropriate IRB, as often as and in the manner prescribed by the approving IRB on the basis of risks to subjects, but not less than once per year.

F.     Research investigators will promptly report to the appropriate IRB any injuries or other unanticipated problems involving risks to subjects or others.

G.     No research investigator who is obligated by the provisions of this Assurance, any associated Inter-Institutional Amendment, or Noninstitutional Investigator Agreement will seek to obtain research credit for, or use data from, patient interventions that constitute the provision of emergency medical care without prior IRB approval. A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by law (see 45 CFR 46 Section 116[f]). However, such activities will not be counted as research nor the data used in support of research. 

H.     Research investigators will advise the appropriate IRB, ORA and the appropriate officials of other institutions of the intent to admit human subjects into another hospital who are involved in research protocols for which this Assurance or any related Inter-Institutional Amendment or Noninstitutional Investigator Agreement applies. When such admissions are a planned part of DHHS-supported research, those institutions must possess an applicable OPRR-approved Assurance prior to involvement of such persons as human subjects in those research protocols at those institutions.

Back to Top

V.     Affiliated Institutions and Investigators (i.e., all Performance Sites, with or without IIAs)
 

A.     This institution will require that each Performance Site for this institution that is involved in federally sponsored research activities provide to the ORA an appropriate written Assurance of compliance with the Belmont Report and the Federal Policy, include Subparts B, C, and D or 45 CFR 46 where appropriate (or equivalent protections if a foreign site), for review and approval, as specified by the sponsoring Federal department or agency (e.g., by OPRR for DHHS), prior to involvement of human subjects or expenditure of funds or other support to do so.

B.     This institution will require that each institutional Performance Site for this institution respond to a request by the ORA of this institution for Inter-Institutional Amendment, SPA, or CPA (as appropriate), whichever is most suited to the circumstances, prior to involvement of human subjects or expenditure of funds or other support to do so.

C.     This institution will require that each non-institutional Performance Site (e.g., a private physician not otherwise an employee of this institution or who otherwise would not ordinarily be bound by the provisions of Assurance or any other applicable institutional Assurance) who is involved in human subject research of this institution respond to a request by the ORA of this institution for either an Agreement for an Independent Investigator or a Noninstitutional Investigator Agreement, as appropriate, depending on the nature of the research activity, prior to involvement of human subjects or expenditure of funds or other support to do so.

D.     Performance Sites that are legally separable from this institution (whether an institutional or non-institutional Performance Site) are not authorized to cite this Assurance.

Back to Top

I. Institutional Endorsements

The officials signing below assure that any research activity conducted, supported, or otherwise subject to DHHS or other Federal departments or agencies that are authorized to rely on this Assurance (Parts 1, 2, 3 and Appendices) or any other sources provided for in this Assurance, will be reviewed and approved by the appropriate IRB in accordance with the requirements of all applicable Subparts of Part 46, Title 45 of the Code of Federal Regulations, with this Assurance, and the stipulations of the appropriate IRB.

A. Primary Signatory Institutions:

1. Cook County Bureau of Health Services
 

Components: 
1.A. Cook County Hospital
1.B. Ambulatory & Community Health Network
1.C. Cermak Health Services of Cook County 
1.D. Cook County Department of Public Health
1.E. Provident Hospital of Cook County
1.F. Oak Forest Hospital of Cook County

2. Hektoen Institute for Medical Research, LLC

Back to Top

APPENDIX A

COMPONENTS WHICH ARE LEGALLY INSEPARABLE FROM EACH DESIGNATED SIGNATORY INSTITUTION AND ARE AUTHORIZED TO CITE THIS MPA OR PARTICIPATE IN RESEARCH OF THE SIGNATORY

Names, Cities, and States

Signatory Institution #1: Cook County Bureau of Health Services
 

Components Authorized to Cite MPA

A. Cook County Hospital, Chicago, Illinois
B. Ambulatory & Community Health Network, Chicago, Illinois
C. Cermak Health Services of Cook County, Chicago, Illinois
D. Cook County Department of Public Health, Oak Park , Illinois
E. Provident Hospital of Cook County, Chicago, Illinois
F. Oak Forest Hospital of Cook County, Oak Forest, Illinois

Components Authorized to Cite MPA

Hektoen Institute for Medical Research, LLC, Chicago, Illinois

APPENDIX B

STANDING AFFILIATES WHICH ARE LEGALLY SEPARATE FROM EACH DESIGNATED SIGNATORY INSTITUTION WHERE OPRR-APPROVED INTER-INSTITUTIONAL AMENDMENTS ARE REQUIRED

None

Back to Top

APPENDIX C

Assurance NO: M-1150

INSTITUTIONAL REVIEW BOARD (IRB) MEMBERSHIPS

ABSTRACT OF INSTITUTIONAL PROGRAM FOR HUMAN SUBJECT PROTECTIONS 

Information for Investigators: Investigators are informed of requirements for IRB review and procedures for protection of human subjects by way of the "Guidebook for Grants & Research" which contains written guidelines, the institutional MPA, the Belmont Report, forms for applying for IRB review and institutional policies on scientific misconduct and financial conflict of interest in research. The IRB application form includes a signature block in which each named investigator certifies that he/she has read the guidelines and will comply with them. In addition to the Guidebook, a "Grants Newsletter" is sent to more than 500 persons in the Bureau on a monthly basis. As needed, this newsletter informs Bureau investigators of new requirements in human subjects protections and also includes articles clarifying existing expectations. For IRB 1, a computer program automatically adds the names and addresses of new principal investigators to the mailing list for this newsletter. 

Investigator training: In addition to the Guidebook and newsletter, at least twice per year a workshop is offered on Human Subject Protection, with voluntary participation by investigators. Mandatory departmental meetings on human subject protections are held every 2-3 years.

IRB and IRB staff training: New IRB members are given an individual orientation by the Chair, and are provided with personal copies of the Bureau Guidebook, the OPRR Guidebook and the FDA Information Sheets. A quarterly Bureau-wide discussion group focusing on issues in human subjects protection is organized by the Office of Research Development; all IRB members within the bureau are invited to attend. By request, the Director offers educational sessions to any of the IRBs. The institution also provides funds for IRB members and IRB staff to attend conferences offered by PRIM&R and OPRR.

Submission and handling of proposals: At each site, an administrator is designated as the point of submission for protocols for review. Submissions are checked for completeness and transmitted to the IRB Chair for assignment to a primary reviewer from among the membership of the IRB. The primary reviewer completes a review using a standard checklist and makes a presentation and recommendation to the next convened meeting of the IRB. Members who are not primary reviewers receive copies of the protocol abstract and consent form(s). Decisions of the IRB are communicated to the investigator in writing. Approval letters include reminders of the requirement to provide progress reports for renewal, and to transmit requests for revisions and adverse event reports to the IRB. Primary reviewers are encouraged to consult with principal investigators to help them correct deficiencies that prevent IRB approval. 

Requests for expedited review or exemption from review are considered by the IRB Chair. In both cases, investigators must cite the criteria by which they believe the research qualifies for expedition or exemption. When the Chair deems a protocol eligible for expedited review, he/she assigns it to an IRB member for review. The Chair makes final determinations on exemptions.

Continuing review: For IRB1, a computer program identifies on a weekly basis which protocols are within 60 days of needing renewal of IRB approval. For IRBs 2 and 3, the administrative assistants maintain reminder schedules for these notices. Notices are generated and sent by IRB administrators to PI's approximately 60 days, 30 days and 10 days before expiration of the current approval. The notice sent at 10 days is a suspension notice, informing the PI that research activity must cease on the expiration date if approval has not been renewed by that date. When a progress report is received, any request for renewal is reviewed by the original primary reviewer for the protocol, who makes a recommendation at the next convened IRB meeting.

Institutional self-audit: A full-time Scientific Quality Coordinator carries out on-site audits, makes regular reports to the IRBs and to the Office of Research Development, and provides consultation and educational support for investigators and prospective research subjects. The Director carries out regular reviews of information reflected in the data base and central files, and acts to correct any evident deficiencies. The data base used by IRB 1 includes a quality assurance menu for administrators to use to identify gaps in recorded information.

Required record-keeping: Each IRB administrator maintains a central file in which all IRB documents relating to a protocol are grouped under its identification number (protocols, approved consent forms, requests for revisions, revised protocols and revised consent forms, progress reports, adverse event reports, copies of all correspondence from the IRB to the PI regarding the protocol, and any other relevant documents). The central file also contains all IRB minutes, a membership roster, and resumes of all IRB members. For IRB1, essential aspects of the central file are reflected in a computerized data base which is used to track approvals, revisions, renewals, and adverse events, as well as to generate agendas and meeting minutes. IRB records are maintained indefinitely. Records of protocols which have been closed for five or more years are boxed and put in storage.

Administrative responsibilities: An IRB administrator or administrative assistant is assigned to each IRB to manage ongoing routine documentation, internal correspondence, agendas and minutes for meetings and distribution of protocols, abstracts and consent forms to IRB members for review. For these purposes, these staff are overseen by the Director of Research Development and their respective IRB Chairs. 

Communication with OPRR, other federal agencies and collaborating entities for which an Assurance is needed are the responsibility of the Director of Research Development, as is ongoing liaison among the components of the institution and with its top administrators. Required reports to OPRR, such as changes in membership or reports of non-compliance, or to other agencies, are prepared by the Director, or by the Chair in consultation with the Director. The Director also publishes the Guidebook and Newsletter and organizes and implements educational activities. 

Problems, noncompliance, and suspensions or terminations of IRB approval: Each IRB takes responsibility for responding to information indicating problems or noncompliance for the protocols it oversees. Protocols which have not received necessary re-approval are automatically suspended until IRB continuing review is complete. Identified problems are investigated by a site visit by the Scientific Quality Coordinator and/or IRB member(s) assigned by the Chair to investigate. These investigations result in both oral and written reports to the IRB at a convened meeting. The full IRB makes a determination as to how the problem will be handled, which is reflected in the minutes and communicated to the principal investigator and institutional officials, OPRR or federal funding agencies as appropriate. Written reports of investigations are maintained as confidential documents in the central IRB file.

Back to Top

SUMMARY OF OPERATIONS FOR ALL IRBS

Back to Top

COOK COUNTY BUREAU OF HEALTH SERVICES/HEKTOEN INSTITUTE

* Represented on IRB 1