Overview and General Directions
Institutional Review Board: Overview and General Directions
The Institutional Review Board (IRB) is an administrative faculty committee established to provide ethical review and protection of the rights and welfare of human research subjects. The IRB is tasked with reviewing all human studies conducted under the auspices of Belmont University.
This page contains information about the role of the IRB, who must submit applications to the IRB for ethical review, the different levels of IRB review, and the IRB process. Please read this page before preparing your IRB application.
Information on each of the following topics is provided below:
- IRB Purpose
- Indications for IRB Review
- Levels of IRB Review
- Process for Submitting an Application for IRB Review
- IRB Review of Applications
- IRB Decision Making
- IRB Requests for Modifications Prior to Approval
- Primary Investigator Responsibilities
- Requests for Protocol Modifications
- Requests for Protocol Extension
- Consequences of Performing Human Research without IRB Approval
The federal government requires every institution that receives federal research funding to maintain an Institutional Review Board (IRB) for the protection of human subjects. Failing to maintain federal standards governing this protection--whether from researchers pursuing research without proper approval or from the IRB granting improper approval--can result in the loss of all federal research funding at the school, whether or not the research in question had federal funding.
Why does the federal government take this research so seriously? Obviously, medical experiments on subjects whose consent is ill-informed or coerced can have disastrous consequences. Perhaps the federal government learned this from its own mistakes, such as the Tuskegee Syphilis Study1. In 1932, in order to study the long-term effects of syphilis on the human body, the U.S. Public Health Service enrolled 400 men in the study after diagnosing them with syphilis. The Health Service did not disclose the diagnosis to the patients, nor did it offer them treatment (penicillin, for example) which was an available and effective cure beginning in 1947. During the 40 years in which the study continued, many of the men unwittingly infected their wives, who then passed the infection on to their children. The IRB is a safeguard against this type of suffering, as IRB approval requires that subjects know the risks to them of participation and available treatments.
One need not inflict physical injury to harm someone. In the early 1960's, psychologist Stanley Milgram2 studied how much pain an average person would administer to a fellow citizen simply on the basis of someone else's authority. The actual subjects thought they were helping the researcher with another subject, a paid actor. The actor would pretend to receive pain from electric shock, which the actual subject administered as negative reinforcement. This progressed all the way to the actor faking death, leaving subjects with the impression that they had participated in the death of a fellow human. The subjects would beg and plead with the actor to give them the correct answer before administering larger voltage shocks, but would generally administer them anyway. Obviously, this kind of stress could have severe consequences for the subjects as well, though they had no idea they what they would be enduring.
Of course, few studies are quite so dramatic, but when dealing with human subjects, there is no study that is without risk to the subjects. The risk may be small and the consequences light, such as the risk of wasting an hour of your life, or the risk of adding an annoyance to an already trying day, but any intervention in someone's life carries risk. Submitting research applications to the IRB requires the researcher to identify, assess, and take steps to manage this risk. That's why we're here.
Section End Notes:
Alex Chadwick, "Remembering Tuskegee", National Public Radio, 2002, http://www.npr.org/programs/morning/features/2002/jul/tuskegee/
H. Russell Bernard, Social research methods: Qualitative and quantitative approaches, Sage Publications, 200, ISBN 0-7619-1403-X, pp. 70-73, found at http://books.google.com/
Indications for IRB Review
Any project or study involving human participants that meet the federal definition of research that is conducted by faculty, staff, or students at Belmont University, or on Belmont's premises, requires the submission of a application for review to the IRB. We say this not because we have a desire to increase our workload or yours--we all have enough work already as faculty, staff, and students--but because the federal government requires it. The IRB is responsible for protecting the rights and welfare of human subjects participating in research at Belmont University.
According to the Office of Human Research Protections (http://www.hhs.gov/ohrp/):
"Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." 45 CFR 46.102(d) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102
"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information." 45 CFR 46.102(f) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102
Levels of IRB Review
The good (and bad) news is that there are three levels of review, each more intensive than the next. The good news is that you will in all likelihood not have to fill out as much paperwork as the most intensive level of review requires. The bad news is that you have to figure out at which level of review to submit your application in order to know which set of paperwork to complete.
The three levels of review are Exempt Verification, Expedited Review, and Full Review. There are two additional types of review that are less commonly used, Undergraduate Departmental Review and Secondary Review.
Process for Submitting an Application for IRB Review
The steps involved in applying for IRB review of a research application are listed below:
Develop your application and determine the appropriate level of review.
After developing your research question(s) and methodology, determine the appropriate level of review. Read the descriptions of the different types of review (Exempt Verification, Expedited Review, and Full Review) and determine which best describes your project. If you are still uncertain about the appropriate level of review, please contact the IRB for assistance.
Download and complete the appropriate application form and instructions for your study. Be sure to complete all parts of the form. For many studies you will also need to develop an Informed Consent Form and submit it with your application. Be sure to include all other relevant supporting documents (e.g., Letters of Agreement, interview questions, survey questions, and recruitment posters and materials where applicable). Please click on the appropriate link above for more specific directions for each level of review.
Submit the application to the Institutional Review Board. First, email all documents to email@example.com, with a copy to your faculty advisor(s). The attachments must be complete and consistent; the receiver must be able to open, print and edit every document in an electronic submission.1 Then, deliver one completed paper application, with all required signatures on the certification page and any appendices (such as Consent Forms), to the IRB office.The application must be signed by the PI, faculty advisor (if student PI), and the department chair. Any needed Letters of Agreement should also be signed at this point.
Deadlines for submission depend on the level of review. Exempt and Expedited applications are accepted whenever you complete them, and are reviewed on a rolling basis. Full applications are due 10 working days before the next IRB meeting, as shown on the calendar.
- Wait for written IRB approval before beginning data collection. For information about the IRB review process and investigator responsibilities, refer to the section below about the IRB process.
Section End Notes:1
Supporting documents such as brochures or cited papers, which are not available to the PI in electronic form, may be sent as an appendix with the paper submission and omitted from the electronic submission. In that case, the application must clearly refer to the paper appendices.
IRB Review of Applications
After IRB review applications are received, they are dispersed to various IRB members to review. During this process, you may be asked for further documentation or to clarify the material you have already submitted.
If you have submitted an Application for Full Review, you may be asked to attend the IRB meeting for a short period of time to answer any questions the IRB may have. The IRB meets one time per month August through May, as shown on the calendar. IRB members discuss each Application for Full Review that has been submitted by the published deadline, as well as any Exempt or Expedited applications about which they have questions.
IRB Decision Making
The IRB can act upon your application in one of four ways:
- Your application may be approved. If this is the case you will receive an IRB approval letter and you may begin data collection upon receipt of this letter. The IRB will place an IRB-approved stamp in the bottom right corner of the approved informed consent forms and return it to you along with a letter of IRB approval. Please use copies of your IRB-approved stamped consent forms for obtaining informed consent from your subjects.
- Your application may receive an IRB Hold. This is can occur if:
- an Application for Full Review is not received 10 working days prior to the IRB meeting. The IRB must have ample time to review your application.
- the application is missing required signatures. Applications must be signed by the Principal Investigator(s), the department chair, and the faculty advisor (if the PI is a student). The faculty advisor may also require student Associate Investigators to sign the application.
- the application is missing necessary documentation. Be sure that your informed consent form, letters of agreement, copies of interviews, data sheets, etc., are all included with your submission. If your submission contains many separate documents, a good practice is to list them on a cover sheet.
- the copies differ from the original documents. This problem is especially common when the copies are electronic. Make sure that you save files in the same form that they are printed, and that you throw away (or mark obsolete) old versions of your application documents.
- the application is illegible, unedited, or incomplete. Given the limited time and resources of IRB members, it is very important that you proofread your application and all supporting documents carefully and do your best to produce a clean, complete, typewritten submission.
- Your application may be approved with comment. This means that although your application is approved in concept, you will be asked to make changes to your application and resubmit the changes and receive full IRB approval in writing before beginning data collection. You will be given specific feedback in your letter from the IRB about what you need to change in order for your application to receive full approval. Please remember that you may NOT begin any type of data collection until you have received full IRB approval in writing.
- Your application may be disapproved. Disapproval of an application can occur for several reasons:
- Your study poses significant risks to your subjects without a reasonable benefit to either your subjects or your area of study.
- The purpose and procedures of your study are not clearly described; therefore, the IRB is unable to determine what you are asking of your subjects and if the level of risk is reasonable for the type of study.
- Belmont University does not have the resources for you to safely complete your study. For example if an investigator proposed performing surgery on Belmont Campus, the application would likely be disapproved because Belmont University does not have the appropriate facilities for this activity.
Please remember that you may NOT begin any type of data collection until you have received full IRB approval in writing.
Regardless of the disposition of the IRB, you will receive a letter explaining the actions taken by the IRB. In this letter you will also receive specific feedback if your application did not receive full approval. If you have any questions about the content of the letter you receive, please contact the IRB.
IRB Requests for Modifications Prior to Approval
If your application is approved with comment or subject to an IRB Hold, respond to the letter from the IRB by making requested revisions and providing additional information and/or documents. If you feel you need to revise your application in a way not requested by the IRB and the change you propose is minor, make the change along with the requested revisions and be sure to make a special note in your e-mail to the irb that you are doing so. Send electronic copies of all revised documents to firstname.lastname@example.org, with revisions highlighted in some way. If the revisions are minor, you do not have to resubmit a paper copy with new signatures of advisors, etc. However, if the changes are significant (such as a change in location of research), the revised documents must be re-signed to indicate acceptance of the revisions by all the original parties and a copy sent to the IRB.
Please remember that you may NOT begin any type of data collection until you have received full IRB approval in writing.
Primary Investigator Responsibilities
After you have received full IRB approval in writing you may begin data collection. Be sure to obtain informed consent for each subject using either the informed consent form or letter of invitation approved for your study by the IRB. Along with your IRB approval letter you will receive a copy of your informed consent form that has an IRB-approved stamp in the bottom right corner of each page. Please use copies of this informed consent form when obtaining informed consent from your subjects.
The primary investigator also assumes the following responsibilities:
- Immediately report serious or unexpected adverse effects that occur to human subjects to the Office of the Provost. You must contact the Provost by telephone (615-460-6441) and send information by facsimile (615-460-6492) or email (email@example.com) using an Unusual or Adverse Event Report form.
- Promptly report unanticipated problems in the research activity to the IRB.
- Submit any changes to the protocol for IRB approval. Guidelines and a description of the modification process are described in a separate document.
- File an Investigator Progress Report (project renewal application) with the IRB every year that the study continues. The PI cannot continue the study without IRB approval of this report.
- Submit a Final Report to the IRB upon completion of the study.
- Maintain all documents associated with the project (data, informed consent forms, etc.) for the period stated in your application. All signed and witnessed informed consents must be available if requested for review, and all data protection procedures must be in evidence.
Requests for Protocol Modifications
The IRB strongly recommends that investigators carefully consider study design and procedures prior to submitting an application for IRB review; however, there are times when changes in protocol may be necessary for the study to continue.
If the investigator is contemplating any major changes in study design or protocol that will significantly alter the level or risk to the subject, then the investigator will need to submit a new application for IRB review at the appropriate level and wait for IRB approval before collecting any data using the modified protocol.
For minor changes to study design that do not involve any change in risk to the subjects, investigators should submit a Protocol Modification Request form and a copy of the revised Consent Form(s) and/or recruitement flyers, if applicable. If you would like to make this change at the annual application renewal, you do not have to submit an Investigator's Progress Report as well. E-mail forms to firstname.lastname@example.org. You will need to wait for IRB approval before collecting any data using the modified protocol.
If your have any questions as to whether the changes you are contemplating are major or minor changes, please contact the Chair of the IRB. The IRB will review your request upon receipt of all required materials. If the request is granted the IRB will send you an approval letter for your proposed modifications and a copy of your updated consent form with an IRB-approval stamp on it. Please use copies of your revised consent form with the IRB-approval stamp when obtaining informed consent.
Requests for Protocol Extension
Complete an Investigator Progress Report. You will also need to submit a clean copy of your Informed Consent Form. Submit both documents and any other required supporting documentation to the chair of the IRB. The IRB will review your request and respond to you in writing. You will also receive a copy of your informed consent form with an updated IRB-approved stamp in the bottom right corner. Please use copies of the new IRB-approved stamped consent form when obtaining informed consent from your subjects. You should submit these documents no less than one month prior to the expiration date of approval for your study.
Consequences of Performing Human Research without IRB Approval
IRB approval must be obtained before commencing any research involving human subjects. Please review the IRB Purpose if you are not clear on this point. Belmont University risks losing federal funding if investigators perform research on human subjects without appropriate IRB approval. Even more important, we want to ensure that the rights and welfare of all subjects involved in research by Belmont University faculty, staff, and students are protected.
Belmont University has specific policies and procedures for dealing with students, faculty, and staff who do not obtain appropriate IRB approval before beginning research with human subjects.