Develop and Submit
The instructions and forms necessary for IRB full review can be found on the following page. The attached forms may be reproduced as needed. All EAH investigators and key personnel involved in conducting human subjects research are required to complete the Collaborative Institutional Training Initiative Program web-based course on protection of human research subjects.
Proof of completion for the educational requirements is required at the same time an application is submitted to the IRB.
All documents on this page are available for download in PDF format. If you would like to receive the Word version of documents, please email research@eamc.org requesting the document.
Exempt Review Process and Application
The Procedure for Requesting an IRB Exemption
To apply for exemption from IRB review (45 CFR 46.104) the investigator must complete one copy of the exemption application and return it to the IRB office. A one-page synopsis of the project is to be attached to the application. There are no deadlines for submission of an exemption application, except it must be approved prior to beginning the project.
If a questionnaire is to be used, attach one copy to the application. If the investigator will be using pathological or diagnostic specimens, a release form is required from an EAMC medical staff physician or the chairperson of the department responsible for providing the specimens. If the investigator, the medical staff physician, and the chairperson of the department are one and the same, then a release form is required from the General Counsel of East Alabama Medical Center. The specimen release form should be attached to the IRB exemption application form.
If there are any questions regarding the exemption application, please call the IRB office at 334-528-1326. The completed application should be mailed or delivered to the Chairperson of the IRB.
Exempted Review for Research Involving Children
Exempted review categories 3a and 3b (survey or interview procedures) cannot be applied to research proposals involving children as subjects. In addition, category 4 is applicable to research involving children only where the investigator does not participate in the activities being observed. Children are defined for this purpose as persons less than 19 years of age.
Expedited Review Process and Application
Expedited Review: The IRB Procedures
Expedited review is allowed for research activities which involve no more than minimal risk to the human subjects and which can be placed in one or more of the ten categories listed on the application form (see page 11).(45 CFR 46.110(a))
"Minimal Risk" is defined as risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests.
In addition, clinical studies of FDA regulated products all present more than minimal risk to the study of subjects and, therefore, may not be presented for expedited review. Such studies must be presented for full IRB approval as outlined beginning on page 14 of this Guide.
To apply for expedited review:
The investigator must submit to the IRB office (1) the Expedited Review Application with a check by the category which they are claiming for Expedited review and (2) a copy of the Expedited Review: The Human Subjects Protocol.
If a questionnaire is to be used, please attach a copy to your application.
If the investigator will be using pathological or diagnostic specimens, a release form is required from an EAMC medical staff physician or chairman of the department responsible for providing the specimens. The specimen release should be attached to the application form.
If drugs are to be used, a drug release form from the EAMC Pharmacy is required. The Pharmacy Department can be reached at 334-528-2270 for further information. The drug release form should be attached to your application.
The original Expedited Application must be submitted. All materials should be mailed or delivered to the Chairperson of the IRB. There is no deadline for submission of an expedited review application, except it must be approved prior to beginning the project. If there are any questions, please call the IRB office at 334-528-1326.
Expedited Review for Research Involving Children
Expedited review is not allowed for research where children are the subjects. Children are defined as persons less than 19 years of age. In addition, for categories 3 and 4, expedited review is not allowed unless the subjects are 19 years of age or older.
Introduction to IRB Full Review
Deadline: The IRB meets quarterly or as specially called by the chairperson. All materials (including recommendation of Project Review Panel) should be delivered to the Chairperson of the IRB at least fourteen calendar days prior to the meeting. Should holidays appear to conflict with deadlines, please call the IRB office at 334-528-1326 for clarification.
The following list briefly describes the procedures to be undertaken by the investigator prior to the review of a study by the IRB.
- Form a panel of five or more persons to serve as a project review panel (see information below).
- Send a letter to the IRB office requesting approval of the panel. An example to follow for this letter can be found here.
- Call the IRB office at 334-528-1326 to confirm the panel approval if notification is not received within ten days.
- Complete the Human Subjects Protocol found here.
- Obtain any special approvals that may be required. Click here.
- Develop a consent form which is in compliance with IRB standards. Click here.
- Convene the project review panel to complete their report.
- Submit the following materials to the IRB office prior to the deadline and packaged in the following order.
- The original human subjects protocol signed by the investigator;
- The original report of the project review panel with the panel members' signatures;
- One copy of any special approvals;
- One copy of the consent form;
- One copy of the project protocol;
- One copy of any questionnaire to be used;
The Project Review Panel
The IRB requires that the scientific and clinical validity of the proposed research be examined by a Project Review Panel. It is the responsibility of the investigator to propose a panel of appropriate persons not involved with the research project to provide a critical review of the protocol before it is presented to the IRB. If the subject population has a significant medical condition which is to be studied or which could be affected by participation in this study, the panel should include at least one individual with specific professional competence pertinent to the area of study.
The panel must include at least two physicians in addition to the IRB Chairperson, EAMC Director of Pharmacy and an EAMC Vice President. Other members may be assigned at the request of the principal investigator.
After ascertaining their willingness to serve, the investigator should send a letter to the Chairperson of the IRB listing the names of the proposed panel members with a brief statement of their qualifications. An example to follow for this letter can be found HERE.
Upon approval of the panel by the IRB Chairperson, the investigator must meet face to face with this panel to review the protocol. “The Report of the Project Review Panel” will be completed by the panel during or after the meeting. If changes in the panel membership are necessary, please notify the IRB Chairperson by letter and request approval of the new panel.
The project cannot be approved unless all proposed members of the panel are present for the review.
If the review is required as a matter of continued review for an ongoing protocol and there has been no clinical events or changes in the protocol posing additional risk to the subjects; or, if the protocol is of simple clinical nature not to require additional clinical review, the Chairperson may direct that a panel pre-review is not required prior to FULL board review.