Investigator Information

Contents

What 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

What is the Institutional Review Board?

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).

What are the responsibilities of the PI?

  1. Protecting the rights and welfare of human research subjects and for complying with all applicable policies, procedures, and federal regulations;
  2. Ensuring research staff are qualified (e.g., training, education, expertise) to perform procedures and duties assigned to them during the study;
  3. Updating the IRB office with any changes to the list of study personnel;
  4. Personally conducting or supervising the project in accordance with the current protocol as approved by the IRB;
  5. Prepare and submit reports of adverse events in a timely manner and modifications to the protocol prior to implementing these changes;
  6. Follow appropriate guidelines for all recruitment materials/advertising and submit these materials to the Committee for review.  It is the PI's responsibility to ensure there is no undue coercion or influence when obtaining consent from participants.
  7. Maintenance of records, including signed consent documents, for at least three years after completion of the research;
  8. The timely submission of Progress Reports and Final Reports to the Committee.

Is IRB approval required?

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:

  • Surveys
  • Interviews
  • Observational Research
  • Analysis of Archival Data
  • Internet Research
  • Social and Behavioral Research
  • Ethnographic Research
  • Educational Research
  • Innovative Instructional Methods, Procedures, or Treatments
  • Clinical Investigations

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.

Types of Reviews

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.

 Exempt Review

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.

  • Evaluation or Comparison of Commonly Accepted Instructional Strategies/Curricula
  • Educational Tests, Surveys, Interviews, or Observations
  • Collection or Study of Existing Data

Expedited Review

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.

  • Research involving exercise studies or studies using physical devices. 
  • Collection of data from voice, video, digital or image recordings made for research purposes
  • Research on group or individual characteristics of behavior (when not meeting Exempt Requirements)
  • Collection of blood samples
  • Collection of biological specimens for research purposes collected by noninvasive means.
  • Collection of data through noninvasive procedures.
  • Clinical studies of drugs and medical devices.
  • Research involving materials that have been collected for non-research purposes (when not meeting Exempt Requirements)

Full 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.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.

  • Research that might put subjects at risk
  • Research involving deception that might have adverse effects on the subjects
  • Research involving vulnerable populations (e.g. individuals with cognitive impairments)

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

Applying to the IRB

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

  1. Make sure you have a detailed plan for your research process.  You should have already conducted a literature review and decided on your research methods.  This information will be asked for in your IRB application.
  2. Depending on the type of review required, fill out the appropriate application located on the forms page.  Please note forms are updated on an ongoing basis, so always download the most recent copy from the webpage.  Answer all questions in detail--do not skip questions or attach thesis documents for our office to have to sort through to find the answers.
  3. Thoroughly describe your informed consent process in your application.  If applicable, describe how you will obtain parental consent and assent.  Informed conent and assent templates are located on the IRB webpage and include all of the required elements.  Any informed consent documents should be forwarded with your application and other materials.
  4. Other application materials should be attached to the application, too.  This includes, but is not limited to: suvery or questionnaire materials, interview questions/protocol, email invitations, flyers or other recruitment materials, permission letters (required if utilizing an external organization, school--both school and district permission will be needed--business, etc.).  
  5. Students should have their faculty advisors submit the completed application with all application materials with an indication of their approval to the Research Compliance Office at compliance@mtsu.edu.
  6. Once we have processed and reviewed your materials, the IRB/IRB reviewer/Research Compliance Office (depending on the type of review) will provide you will a decision.  The protocol could be approved or modifications/clarifications could be requested.  Only the full IRB committee can disapprove the protocol.  Decisions are typically communicated via the PI's email address (faculty advisors will be copied on emails).
  7. If the IRB has approved your protocol, research may commence once all other organizational approvals have been met.  IRB approval for Expedited and Full reviews will have an expiration date--check the approval letter for this date.
  8. If the IRB requires modifications or clarifications, make the requested modifications and provide the clarifications and submit them to the reviewer.  If all requested modifications are made, an approval letter will be sent.  Research cannot begin until the final approval letter is received. 
  9. If the IRB tables or defers your protocol, they will provide a statement of the reasons for deferral and suggestions to make the study approvable; you will have an opportunity to respond in writing.
  10. If the IRB disapproves your protocol, they will provide a statement of the reasons for disapproval and give you an opportunity to respond.  You have the right to address your concerns to the IRB directly at an IRB meeting.

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.

About Informed Consent and Assent

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:

  • That the activity involves research and participation is voluntary.
  • A brief description of what the study will involve.
  • A statement informing subjects they can stop participating at any time.
  • Name and contact information for the investigator.

 

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:

  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • A description of any benefits to the subject or to others that may reasonably be expected from the research;
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • A statement describing the extent to which confidentiality of the records identifying the subject will be maintained;
  • For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained;
  • An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits which the subject is otherwise entitled and the subject m
  • A statement that the study involves research, an explanation of the purposes of that research, and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures experimental in nature;
  • A statement that subjects may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

When appropriate, additional elements of informed consent can be provided to the subjects including the following:

  • A statement that treatment or procedure(s) may involve risk(s) to the subject and are currently unforeseeable;
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  • Any additional costs to the subject that may result from participation in the research;
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that significant new findings developed during the course of the research which may relate to the subject's willingness ot continue participation will be provided to the subject; and
  • The approximate number of subjects involved in the study.

Assent

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:

  • The research involves no more than minimal risk to subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waiver or alteration;and
  • Whenever appropriate, the subject will be provided with additional pertinent information after participation.

Waiver of Obtaining Signed Consent Forms

Federal regulations allow for approval of a waiver of obtaining signed consent forms if:

  • The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, or
  • The research presents no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context.

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

What will happen after IRB approval?

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 compliance@mtsu.edu 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.

Other Questions?

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 compliance@mtsu.edu .