Loyola University Chicago - Health Sciences Division - Institutional Review Board Retrospective Chart and/or Material Review Studies Template

Sep 1, 2026

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This template supports Loyola University Chicago Health Sciences Division Institutional Review Board submissions for retrospective chart and/or material review studies involving human subjects. It outlines required submission steps, including a written protocol, IRB application through an information portal, IRB review and approval, consent and authorization waivers, and an approval letter for record custodians. It specifies approval conditions for confidentiality, data use limits, de-identification for journal publication, identifier protection, chart coding, and destruction timing, with waiver criteria grounded in 45CFR46.

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Retrospective Chart and/or Material Review Studies Submission Requirements

Approval conditions and confidentiality rules

Waiver of consent and waiver of authorization criteria

Retrospective Review Study Project Template

Purpose and objectives

Methods and materials

Data collection and identifier protection plan

Loyola University Chicago Health Sciences Division Institutional Review Board for the Protection of Human Subjects Retrospective Chart and/or Material Review Studies The following information and template are to be used when submitting a request to conduct retrospective chart and/or material review studies. Retrospective chart/existing materials reviews require: a written protocol (use the attached template), an IRB application through the information portal, IRB review and approval, waivers of consent and authorization, an approval letter provided to the keeper of the records. Conditions of approval will be: You are bound by the usual and customary medical, legal and ethical considerations governing the confidentiality of the medical record. The data you collect may not be sold or given to any third party outside the scope of this submission unless it is to a journal for publication. Data to a journal for publication must be de-identified. The chart reviewed is to be identified on the data collection form by a unique code number and the master list kept under lock and key. If you are not collecting data elements that can directly or indirectly identify the chart reviewed then this requirement is not relevant. The link of the patient to the project is to be destroyed when it is no longer necessary. To waive consent, the IRB must find: The study is of minimal risk and qualifies for expedited review 45CFR46.110, b-1, HHS Secretary Category). The requirement for consent is waived if: the research could not practicably be done without the waiver; the waiver does not adversely affect the rights of the individual; the research involves no more than minimal risk; there is no information that would need to be provided to the individual. (45CFR46.116, d1-4) To waive authorization, the IRB must find: The use or disclosure of protected health information involves no more than minimal risk to the individuals; The alteration or waiver will not adversely affect the privacy rights and the welfare of the individuals; The research could not practicably be conducted without the alteration or waiver; The research could not practicably be conducted without access to and use of the protected health information; The privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to 1) the anticipated benefits (if any) to the individuals, and 2) the importance of the knowledge that may reasonably be expected to result from the research. There is an adequate plan to protect the identifiers from improper use and disclosure; There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart. LOYOLA UNIVERSITY CHICAGO HEALTH SCIENCES DIVISION MAYWOOD, ILLINOIS Project Title: Principal Investigator: Co-Investigator: Clinical Research Nurse: 1. Purpose / Rationale (appropriately referenced): 2. Objectives: 3. Methods and Material: [Indicate: a) what will be reviewed, b) the criteria for pulling the charts for review, c) the dates for the chart review (for example: January 1, 2000 to January 1, 2020), and d) how you will know what charts to review. Examples: ICD-9 diagnostic codes, departmental database, etc.] 4. Data Collected: [Specify the data/samples that will be collected and where the data is originating; LUMC and/or an outside institution. Note samples or data from Epic Medical Records CANNOT be collected from Gottlieb and/or MacNeal.] 5. Plan to Protect Patient Identifi

FAQs

What are the key requirements to submit a retrospective chart and/or material review study request?

Submission requires a written protocol using the attached template, an IRB application through the information portal, IRB review and approval, waivers of consent and authorization, and an approval letter provided to the keeper of the records.

What conditions of IRB approval govern confidentiality and data use?

The study must follow customary medical, legal, and ethical confidentiality requirements. Collected data may not be sold or shared outside the submission scope unless de-identified for journal publication, and identifiers must be handled and protected as required.

What criteria must the IRB find to waive consent and to waive authorization?

For consent waiver, the IRB must determine minimal risk and that the research cannot practicably be done without the waiver without adversely affecting rights, and without information needing to be provided. For authorization waiver, the IRB must determine minimal risk to individuals, no adverse effect on privacy rights and welfare, practicable inability without protected health information access, and reasonable privacy risks relative to anticipated benefits and knowledge importance, plus adequate plans for protecting and destroying identifiers and assurances against reuse or disclosure.

Sep 1, 2026

Upload by Connor