The most common form of IRB application consists of four core documents:
*Depending on the type of research, other documents may be required as part of the submission.
Investigators are urged to review the requirements for submission of applications to the IRB. Submission of incomplete proposals will delay the review and approval process. The review process will not be initiated if the protocol is incomplete and/or does not fulfill all of the IRB guidelines.
Using Advertisements, Posters, Fliers, Press Releases, Etc.
The IRB is required to review any advertisements, fliers, Internet postings (with the Internet address), etc., for subject recruitment, and correspondence to subjects or other cooperating individuals such as referring physicians or facilities. In addition, the Committee reviews all press releases intended to facilitate recruitment of subjects. Only IRB approved documents may be used in the conduct of research.
If possible, recruitment materials should be included with the initial application. If the material is not ready at the time of initial application, investigators may submit the material as an addendum to an already approved project. Requests for approval of recruitment materials following initial IRB review of the protocol should allow sufficient time for any necessary revisions before publication.
For medical studies, contact documents should not make any claims, either explicitly or implicitly that the research is superior to any current practice. Information in advertisements should be limited to:
The content of all Internet postings must be reviewed and approved by the IRB prior to implementation.
Surveys, Questionnaires, Etc.
The IRB is required to review all research instruments, such as surveys, questionnaires, etc. These should be included with the initial application. Investigators may submit draft versions of study instruments for IRB review. The IRB is required to review any modifications to research instruments. An addendum should be submitted to the IRB when requesting changes to previously approved instruments. If the IRB approved the project before the review of the final instruments, the investigator will receive an approval notice indicating that the instruments cannot be used until they are reviewed and approved by the Committee.
The IRB is required to examine the Investigator's Drug Brochure and/or device manual in order to adequately assess the risk/benefit ratio for subjects participating in the research.
Fliers may be posted only in designated areas such as clinics and the Women's Health Center. Requests must first be submitted to the IRB along with a description of the arrangements to be made by the investigator for distribution and removal of the fliers.
Recruitment materials should not be placed in such public areas as:
The Office of Research Affairs conducts a preliminary review of all new applications. The purpose of the review is to facilitate the final review and expedite the approval process.
When a new application is received in the Office of Research Affairs, it is reviewed to:
Based on the preliminary review, researchers can update and revise their IRB application to incorporate clarifications or additional information. The updated or revised IRB application is then submitted to the full IRB for review.
Send your complete IRB application (with all attachments) to the Office of Research Affairs. Submissions may be in hard copy or electronic form. Electronic submissions should be sent to firstname.lastname@example.org. If your application is submitted electronically, you must send/fax a hard copy of the signature page to the Office of Research Affairs.
Mail your IRB application to:
Mount Carmel Office of Research Affairs
6150 East Broad Street
Columbus, Ohio 43213
Once the Office of Research Affairs has received a complete application, a staff member will contact the principal investigator to schedule his/her attendance at an IRB meeting. The IRB application is generally scheduled for review at the next IRB meeting, if the principal investigator's schedule allows.
The IRB meets the first Tuesday of every month at 7 a.m. The principal investigator is scheduled to attend the meeting for approximately 15 minutes to present the study to the IRB. The specific time is arranged with the principal investigator prior to the meeting. If the investigator's schedule requires a specific date or time, a cover note should be attached to the application when it is submitted to the Office of Research Affairs.
Other members of the research team may attend the meeting as desired.
The IRB Chairperson will ask the investigator to give a brief overview of the study. The Board members will then ask questions of the investigator. In evaluating the risks and benefits of the research, the IRB considers both human subjects' protections and scientific design.
For studies that qualify for expedited or exempt review, the chairperson or a designated IRB member will review these applications.
For all studies, within one week of IRB review, a letter is sent to the principal investigator documenting the IRB's action and any recommendations. After addressing the IRB's conditions for approval and submitting material that respond to these concerns, the researcher will receive a letter of the final IRB approval. The research may begin only after the study has received final approval.
Mount Carmel IRB Initial Review Submission Form
Protocol (unbound, unstapled)
Consent form (unstapled)
U.S. FDA form 1572
Mount Carmel Financial Interest Disclosure Form (with initial application)
Documentation of training in protection of human subjects
List of any additional sites
Names and roles of additional study team members
Documents submitted for Board approval (recruitment materials, diaries, questionnaires, etc.)
Grant (if applicable)
Federal contract (if applicable)
Explanation of why an IND number was not obtained (if applicable)
Investigator's Drug Brochure, applicable package insert(s), or background information on food supplements
Response to Appendix M of the NIH guidelines
Waiver of Authorization request
Consent process SOP
Signed Principal Investigator Acknowledgement of Responsibility (last page of initial application)