How do I get IRB approval?
First make sure you have documentation of completion of Human Subjects Training. You can obtain training from the Collaborative Institute of Training Initiative at their web site: www.citiprogram.org. See "On-line Human Subject Training" tab for more information.
Make sure you have a detailed plan for your research process. You should have already conducted a literature review, decided on your research methods, and your plan for analysing data. This information will be asked for in your IRB application.
Next, you should decide what kind of IRB review you will need. See the FAQ questions and links to aid you in this decision, or see the Decision Guide.
Fill out the appropriate IRB application form available at our IRB Forms page. Be thorough. If you are a student you will need an MTSU faculty member to sign-on as a Co-investigator and Research Advisor. Faculty advisors should thoroughly review their student's work before signing off and sending the application to the IRB.
You will likely need to submit a consent form. Use our Consent Template available on the forms page. You should submit the consent form to us in the form you will present it to your research subjects. We will stamp "approved" on the form and you should make copies and distribute the form bearing the "approved" stamp. If you want to waive the requirement for consent or would like to alter the Consent Form you will need to submit the "Request for Waiver or Alteration of Consent" document. Any alteration of consent must be justified and approved.
Email the completed application form and all supplemental documents to the Compliance Office @ firstname.lastname@example.org. Use the checklist at the end of the document to make sure that you have included everything you need.
Await our decision. We are generally quite prompt in making decisions about approval. If we need you to submit supplemental documents or need more information we will contact you via e-mail or telephone. The quicker you comply with our requests the sooner we will be able to approve your research.
Once you receive notice that we have approved your research you may begin. If your research is approved pending something (as occasionally happens when we are waiting on approval from an outside source), you should wait until we tell you everything has been received before you begin your research.
Is IRB approval required?
All human research authorized and conducted under the jurisdiction of Middle Tennessee State University is subject to review by the IRB for risk, benefit, and informed consent without regard to the source of financial, physical (facilities), or logistical support. This review must be conducted before a project is started.
Middle Tennessee State University is responsible for any research activity that involves physical, behavioral, or social welfare of human subjects that is:
The IRB shall have the authority to disapprove, discontinue, suspend, or limit research involving human subjects and, by its recommendations, can effect action that withholds or withdraws financial support from projects involving human subjects that are not in compliance with University policies or federal regulations.
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". Deciding not to obtain IRB review may be a risky choice. Also, you might consider the process of obtaining IRB approval an eduaction experience, so even if the results are not intended to contribute to generalizatble knowledge, exposing students to IRB review processes may be just as educational as exposing them to other parts of the research process.
How do I submit a new protocol application to the IRB?
Go to the forms page to download a protocol form. Read the directions of the form carefully. You will need to complete IRB training prior to sending your application. If you have questions about whether your protocol requires expedited review or full review, then you may find our decision-guide helpful or see below.
What kind of IRB review should I request?
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. 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.
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.
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.
Sending a complete protocol helps minimize time for review. An incomplete protocol is one that lacks documentation of training for the investigator and faculty supervisor, does not use the most current IRB form, or does not answer all questions. An incomplete protocol will cause delays. Please use the checklist on the application as a guide to sending a complete application.
Do I need to include Informed Consent or Assent form in my application?
Probably yes. If you will provide research participants with a consent or assent form you will need to have it approved by the IRB and should include it in the application packet. Use the consent and assent templates provided on the IRB Forms page and modify it to explain the purpose of your study, describe the procedures that will be followed, and indicate risks and benefits associated with participating in the research. There is a Interview Consent template that is inteneded for interview research. To request an alteration or waiver of a consent form submit the "Request Waiver or Alteration of Consent" document and indicate the reasons and your plan for obtaining consent. Assent is required when research involves children or other persons not capable of providing consent. In these case parental or guardian consent will be required in addition to the participant's assent.
What is a Waiver or Alteration of Informed Consent?
Waiving the requirement for obtaining informed consent or parental permission means that the IRB has determined that investigators need not obtain the subjects' informed consent to participate in research.
Examples where Waiver of Informed Consent may be requested:
Examples where Alteration of Consent may be requested:
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
How do I request a change in my protocol?
If you need to request a change in your protocol (for example, to change the number of participants) then you should contact the compliance officer at email@example.com. We can respond more quickly if you include the following information in your email:
Does IRB approval expire?
Yes. Applications approved under expedited or full review usually expire one year after the date they were approved;however, exempt studies have no expiration date. When you get approval, take note of the expiration date. If the date approaches and you have not completed your research you will need to apply for an Extension and submit a Progress Report.
What should I do when my expiration date is approaching?
If you have finished the data collection and analysis for the project you can submit a final report. If you need more time to complete data collection or analysis submit a progress report and request a continuation for up to 12 months. If it is passed your expiration date we can not approve a continuation, and any data that has been collected since the expiration date must be destroyed. DO NOT continue to collect or analyze data after your expiration date or after you have submitted a final report.
Should I submit a Progress report or a Final report?
Even if you are still in the process of completing a research project, thesis, or dissertation, you may be able to submit a final report. The IRB defines a completed project as all data has been collected and analyzed. If you will need to gather additional data or have not finished analyzing the data you should submit a Progress Report. If your data collection and analysis is finished you may submit a Final Report, even if you are still writing or conducting a literature review.
Please note that requests for continuation must be submitted prior to the expiration date with adequate time for review and approval. Continuations cannot and will not be provided retroactively.
How do I submit a progress/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.
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.
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 .