The most common form of IRB application consists of four core documents:
The IRB Application Form
The Informed Consent Document
A Research Protocol
The Signed Research Agreement
*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.
The IRB Initial Review Submission Form
The application for research involving human subjects is the official document requesting IRB review of a research proposal. Each section is to be completed by the Principal Investigator as it applies to his/her research. The information provided must include sufficient detail to facilitate an effective review by all
members of the IRB.
The Informed Consent Form
All consent forms are required to reflect the IRB format and style. Only
IRB reviewed and approved consent forms can be used to obtain subjects' consent.
The Research Protocol
A detailed research protocol is required for complete IRB review.
All submissions should include a detailed scientific protocol that incorporates
a complete explanation of the following information:
Background
Objectives
Significance
Thorough description of how human subjects will participate
Clinical information (when applicable) (for medically invasive research)
Analysis of the
collected data
References
The Signed Research Agreement
By signing the research agreement, the investigator assures that he/she will abide by all regulations.
Recruitment
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 name of the investigator and contact information
A simple and concise description of the purpose of the research
General eligibility criteria for participation
A truthful description of the possible benefits, which may result from participation in the research; if there are no benefits, indication of whether subjects are paid for their participation or receive free treatment
Internet Postings
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.
Hospital Recruitment
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:
Main lobby
Cafeteria
Elevators
Hallways
Parking garages
Preliminary Review
The Human Subject Protection Office 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 Human Subject Protection Office,
it is reviewed to:
Make sure all materials the IRB needs have been received
with the application
Identify potential questions and issues that may arise
during IRB review
Assist researchers in preparing for the IRB meeting
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.
Submitting a Completed Application for Review by the IRB
Send your complete IRB application (with all attachments) to the Human Subject Protection Office. Submissions may be in hard copy or electronic form. Electronic submissions should be sent to irb@mchs.com. If your application is submitted electronically, you must send/fax a hard copy of the signature page to the Human Subject Protection Office.
Mail your IRB application to:
Mount Carmel Human Subject Protection Office
6150 East Broad Street
Columbus, Ohio 43213
IRB Review
Once the Human Subject Protection Office 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 from 7 to 9 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 IRB office.
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.
Checklist of documents to be submitted with initial application:
Mount Carmel IRB Initial Review Submission Form
Protocol (unbound, unstapled)
Consent form (unstapled)
Medical license(s)
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
Device-related documentation
Response to Appendix M of the NIH guidelines
Waiver of Authorization request
Consent process SOP
Payment schedule
Signed Principal Investigator Acknowledgement of Responsibility (last page
of initial application)
