ContentsWhat is the Institutional Review Board? What are the responsibilities of the PI? Is IRB approval required? Types of Reviews Applying to the IRB About Informed Consent and Assent What will happen after IRB approval? Other Questions
The IRB is charged with reviewing and monitoring research involving human subjects conducted at MTSU and by MTSU students, faculty, and staff regardless of the source of funding. The IRB has the authority to approve, require modifications (to secure approval), or disapprove research. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research. This review must be conducted before a project is started unless the research involves "on the shelf" data - the IRB will not give "after the fact" approval.
MTSU's IRB is guided by ethical principles outlined in The Belmont Report, and federal regulations from the Department of Health and Human Service (45 CFR 46) and the Food and Drug Administration (21 CFR 50 and 56).
Am I engaged in "research" under MTSU Policy and Federal Regulations?
You are engaged in research if you are involved in a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Examples of research are:
Does my research involve human subjects?
If you engage in some intervention or interaction with a person as part of your research then human subjects are involved. Interaction or intervention involves direct human contact with individuals or manipulation of an individual's environment. Examples of intervention and interaction include the performance of physical exams, obtaining blood samples, performing x-rays, altering light, temperature using student course materials, or archival data obtained from humans.
Does my class project require IRB review?
Class Projects have the same requirements as any other projects. If your class is conducting a systematic investigation intended to contribute to generalizable knowledge (aka research), and is contacting human subjects or using archival data that could be connected to humans, then this would require IRB review. Also, all students, faculty, and research advisors or colleagues who are involved in data collection or analysis will need to complete the appropriate training before they can begin working on data collection or analysis.
In some cases, when the project is not intended to contribute to generalizable knowledge, and is just intended to be an education experience for the students, IRB approval would not be required. However, you or your students would not be able to publish or present any of the findings, the project could not be used as a McNair Project, Thesis or Dissertation, and you could in no way represent the project as "research." Also, projects on sensitive topics or with vulnerable populations will need IRB approval. Also, you might consider the process of obtaining IRB approval an education experience, so even if the results are not intended to contribute to generalizable knowledge, exposing students to IRB review processes may be just as educational as exposing them to other parts of the research process.
You can view the requirements for each of the types of review by clicking the links below. The examples given on this page are listed only as a starting point to help you decide what kind of review to request. You should thoroughly read and understand the requirements which are detailed in the PDFs linked below.
Research qualifying for Exempt Review must present no more than minimal risk to participants. Most research qualifying as Exempt at MTSU will fall into one of the following categories below. Surveys or interviews on sensitive topics will not qualify for Exempt review. Additionally, research involving videotaping subjects will not qualify for exempt review (in some cases audiotaping may qualify). Download the PDF linked above for complete details about qualifying for Exempt Review and for other categories that are rarely used. You will need to indicate what category you believe your research meets on your Exempt Review Application.Exempt reviews are conducted by staff in the Research Compliance Office.
Research qualifying for Expedited Review must present no more than minimal risk. Most research qualifying for Expedited review at MTSU will meet one of the following categories. See the PDF linked above for complete details about qualifying for Expedited Review. Expedited reviews are conducted by 1 member of the IRB committee. The reviewer will communicate directly with you about any necessary revisions or additional information needed before granting approval.
If your research presents more than minimal risk or does not meet the qualifications for Exempt or Expedited review you will need to apply for Full Review. Read the PDF above carefully and follow all directions including strict adherence to time requirements. Examples of research that would require full review are listed below.The Full IRB committee will review your protocol at a convened meeting. After the meeting the IRB Chair will contact you with the IRB's decision along with any additional questions and revisions needed.
How long does it take to get approval?
The length of the review process is dependent upon the type of review, the time of year submitted (peak times are at the beginning of the semester), and the thoroughness of the application. Be sure to submit all application materials (e.g., surveys, letters of permission) with your application to accelerate the review process. We review applications in the order they are received. Average times from submission to approval are as follows:
Exempt = 1 week
Expedited = 3 weeks
Full = 2 months
What type of training do I need?
Before applying to the IRB, the PI should ensure CITI training has been completed by all research investigators, including co-PIs, co-investigators, research assistants, and faculty advisors (www.citiprogram.org). All faculty should complete the "Social and Behavioral Research" module. Students conducting thesis and dissertation projects should complete the "Social and Behavioral Research" module, too. Students assisting with research projects should complete the "Students conducting no more than minimal risk research" module.
About the Application Process
What is my IRB number?
Your IRB number will be written on the top your letter of approval. It will look something like 14-000. Additionally, we try to write your IRB protocol number on all correspondence, and we hope you will do the same.
Obtaining Consent for Exempt Research
The consent process and documents can be simpler than those required for research categorized as expedited or full reviews. A one page consent template is located at the last page of the Exempt Application; however, verbal or implied consent can be utilized for some studies (e.g., a consent statement at the top of an anonymous, non-sensitive survey).
Exempt consent documents/statements should include the following:
Informed Consent for Non-Exempt Research (Expedited/Full Reviews)
No investigator should involve human subjects in research unless the investigator has obtained legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate, and in a manner that minimizes the possibility of coercion or undue influence. The consent process is not just about getting the signature; consent is an ongoing process throughout participation. A consent template is available on the forms page which covers all of the required elements (see below).
Required elements of consent:
When appropriate, additional elements of informed consent can be provided to the subjects including the following:
In instances where the participant is not legally capable of giving informed consent (e.g., minors) or where the participant is cognitively impaired, the IRB must find that adequate provisions are made for obtaining the assent of the participant when the participant is capable of doing so. Permission must also be obtained from the legally authorized representative (e.g., parent). An assent template is available on the IRB forms page.
Waiver of Obtaining Consent/Altering the Elements of Consent
In certain cases, the Federal Regulations allow for approval of procedures which alters the elements of informed consent or waives the requirement to obtain any informed consent. A waiver must be completed and submitted with the application form. The following criteria must apply:
Waiver of Obtaining Signed Consent Forms
Federal regulations allow for approval of a waiver of obtaining signed consent forms if:
A waiver must be completed and submitted with the application form.
Other Questions about Informed Consent?
See The US Department of Health Office for Human Research Protections FAQ section on Informed Consent http://answers.hhs.gov/ohrp/categories/1566
You may begin research after you have received an approval letter from the Research Compliance Office or IRB member designated as your reviewer.
Expiration of Approval and Submitting Reports
Expedited and Full reviews are granted approval for up to one year. If at the end of your approval period you wish to continue the project, you must submit a Progress Report requesting continuing review prior to the expiration of your project. The PI and/or co-investigators are responsible for the timely submission of continuing review materials. If the approval of a protocol expires, all Human Subjects Research procedures related to the protocol must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. The Progress Report will be reviewed by either Expedited Review or Full Committee and a letter of continuation will be sent to the investigators once the continuation has been approved. Final Reports should be submitted once the project is completed.
Exempt projects have no expiration. The Research Compliance Office will contact PI's of Exempt projects to inquire if the project is ongoing or can be closed out of our system.
If during data collection you realize a change should be made to your project, contact the Research Compliance Office--in writing (e.g., email)--requesting a modification or addendum be added to your protocol. The Office and/or Committee will contact you with their decision. Any changes to a protocol should not be implemented until after the requested changes have been reviewed and approved.
How do I submit a Progress or Final report?
Download the IRB Progress/Final Report. You can submit it by attaching it in an email to firstname.lastname@example.org or by sending it to our office at the address below. Please make sure your email includes your name and the names of any other investigators, your faculty advisor if applicable, the IRB number and the title of your research.
See the US Department of Health & Human Services Office for Human Research Protections FAQ questions: http://www.hhs.gov/ohrp/faq/index.html
If you have any questions and/or seek further clarification, please do not hesitate to call (615) 494-8918 or e-mail email@example.com .