Institutional Review Board (IRB) Forms

Mission

The Chicago Department of Public Health (CDPH), through the Institutional Review Board (IRB), monitors research involving the Chicago Department of Public Health patients/clients and staff. Special attention is given to the protection of patients/clients rights, safety and privacy.

This IRB, appointed by the Commissioner, will assure compliance with the Code of Federal Regulations for the Protection of Human subjects (45 CFR 46)

Source: U.S. Dept. of Health & Human Services – http://www.hhs.gov/ohrp/.

Overview of Responsibility and Activities

What is the IRB responsible for?

The IRB is responsible for assuring that all research projects conducted at CDPH sites or under CDPH auspices (i.e., funded through CDPH, conducted by CDPH staff, or using CDPH staff or clients as subjects) protect the rights, welfare, and privacy of all participants. Further, the IRB assures that all research aims at securing benefit, direct or indirect, to the participants and the people of Chicago, and that the merits and costs of the research are in the best interests of the people of Chicago. IRBs are required for all projects funded by the Federal government. In practice, they become a requirement for all human research at many institutions, including CDPH.

Who is on the IRB?

The CDPH IRB is constituted in a manner that follows Federal CDPH employees and non-employees, some with medical or scientific backgrounds and some with a variety of other backgrounds participate on the IRB. Dr. Carol Ciesielski serves as chair of the committee.

How does IRB work?

IRB meets monthly to review proposals for new research projects and to oversee ongoing projects. As a central part of this process, the IRB that researchers obtain valid informed consent of participants before their participation.

What requires IRB review?

Any research project that involves human subjects requires IRB review. A guide to determining what constitutes research is included on the opposite of this page. Some research involving "minimal risk" may be eligible for expedited review, and some forms of research such as evaluation of certain programs or projects may be exempt from IRB oversight. Additionally, there are some circumstances where written consent can be waived by the IRB. IRB determines whether these criteria are met for any given project, but more information on these categories can be found on the U.S. Dept. of Health & Human Services' web site. 

Source: U.S. Dept. of Health & Human Services – http://www.hhs.gov/ohrp/policy/index.html#decision. 

Who may conduct research under CDPH auspices?

A qualified investigator who has received training in protection of human subjects must be responsible for each research project. While the principal investigators for many projects conducted at CDPH are affiliated with other institutions, every research project must have a CDPH sponsor who serves as liaison and takes responsibility for the conduct of the research within the CDPH environment. In addition, awareness and approval of all research in a given CDPH program or site should be signed off at the Division level.

How do I submit a project for IRB review?

Submission forms and standard operating procedures for the IRB can be obtained from Joslyn James by e-mail: joslyn.james@cityofchicago.org

IRB Procedures (pdf)  /  word document

IRB HIPAA Waiver Form (pdf) / word document

Submission Forms (pdf)  /  word document

Application for Exempt (pdf) word document

Periodic Review for Research Involving Human Subjects Forms (pdf)  /  word document

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