Preparing Your IRB Application

ooOOO Please note that some of the links are still under construction OOOoo

  • Allow a minimum of 4 business days BEFORE you call us regarding the status of your petition
  • Please allow at least 2 weeks for protocols to be reviewed AFTER your application is complete
  • During the months of September-October and February-March, expect a minimum processing time of 3 weeks

 

There are many reasons why you would send a petition to the Office of Compliance.  Some of the frequent reasons are:

  • You are requesting a new protocol for conducting human subject research
  • You want to request an amendment to a previously approved protocol
  • You wish to close-out your protocol
  • You will be continuing your protocol for an additional year
  • Or you may request other specific IRB action(s)

Regarless of your reason for petition, the submission of documents and the pre-review processes are almost identical.  The general requirements for all three IRB review mechanisms are also very similar.  Please read and review the instructions for each of the forms posted in the IRB FORMS link.  The Office of Compliance is currently revising the forms and publications posted in the IRB website and it is important the investigators download the most recent form(s) for their IRB application process.  

Before you fill your application

First determine if your research qualifies for exemption.  This would lead you to a different set of forms. Follow this simple decision chart to decide if you qualify for an exemption:

Screening Questions to Determine Exemption Status Response
1. Are the subjects from a vulnerable group (prisoners, seriously ill or cognitively imparied)? Yes No
2. Do you plan to collect behavior information that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the individual's financial standing, employability or reputation? Yes No
 3. Will you collect sensitive information or personal aspects of the subject's behavior (drug/alcohol use, illegal conduct, sexual behavior, mental health, etc)? Yes  No
 4. Except for researching normal education practices, will this study involve minors (under 18)? Refer below for a clarification for "EDUCATION PRACTICES"  Yes No
 5. Will this research expose the subjects to dicomfor or stress beyond the levels encountered in daily life? Yes No
6. Do you plan to videotape the participants (in some cases audiotaping may qualify for exemption)? Yes No

 

If you +answered Yes to any of the above questions, then you WILL NOT qualify for an exemption.  You  have to file a petition through either the EXPEDITED or the FULL REVIEW process.  Refer below for additional clarification to determine if your study qualifies for an exemption.

Additional questions on projects that involve minors and other protected individuals for determining exemption:

  • Will the study involve the participation of protected individuals?
    • Minors (less than 18 years of age)
    • Pregnant women
    • Prisoners
    • Protected minority races
    • Subjects who are incapable of providing consent

If you answered "YES" to "minor children" go to the next question, and if you answer "YES" to any of the remaining questions, then you will have to fill out an expedited or a full review form.

  1. Other than non-identifiable demographics, will the data collection involve name(s), addresses and other types of personal information, including health data of the minors or their relatives?
    1. YES – the study is NOT exempt
    2. NO – go to question 2
  2. Will the study involve the delivery of education?
    1. NO – the study is NOT exempt
    2. YES – go to question 3
  3. Does the education delivery entail typical curriculum and activities involving testing?
    1. NO – the study is NOT exempt
    2. YES go to 4
  4. Will the data collection involve videotaping or recording the voices of the minors?
    1. YES – the study is NOT exempt
    2. NO – go to 5
  5. Will an evaluation assessment be conducted to address a “research” question? (Refer to the FAQ page on OHRP’s definition of “research”)
    1. YES – the study is NOT exempt
    2. NO – the testing is done to evaluate an education method or technique – go to question 6
  6. Will the students in class do the same activity/activities?
    1. NO – the study MAY NOT BE exempt AND go to question 7
    2. YES – go to question 7
  7. Regardless of your response to question 6, Will you be recruiting participants randomly or through purposeful selection
    1. YES – the participants will be selected randomly through a clear acceptable inclusion criteria
    2. NO – the participants will be selected purposefully – you will need parental consent and child assent

 

Regardless of your application track, the investigator(s) must complete the following steps before submiting their proposal for review.  Incomplete petitions will be administratively returned to the researchers without a review

 

Steps to be completed before submission:

  1. All of the investigators MUST HAVE completed their CITI training
  2. For studies to be conducted outside of MTSU, appropriate written permission notifications MUST be included to the application form(s)
  3. Recruitment materials, such as flyers, online advertisements, correspondence emails and trascript of personal communications must be submitted with your application
    1. The flyer notices or online advertisemtns should not be misleading but instead they should clearly state that the participants are invited for a study
    2. The researchers are allowed to provide small compensations to the participants (like food or small amounts of cash) but they should not be the main focus of the advertisement
    3. For online advertisements, the investigators should provide all of the disclorsures up front before the participants take the study
    4. Click here for examples of a few flyers notices our office has reviewed and approved in the past 
  4. Student investigators must convene with their faculty sponsors and ensure faculty endorsements are obtained

What are the Revewers looking for in your petitions?

  1. A clear purpose to the study - hypothesis, procedures and how this study would be useful
  2. Recruitment is proper
  3. Inducement is reasonable
  4. The investagors' experience in this type of research is adequate
  5. The subjects are adequately informed
  6. The informed consent documents are proper
  7. Are there any risks? if so, are they necessary? Did the researcher did everything to minimize the risk?
    1. Risky participants are exclused by prescree
    2. The researcher has a proper debriefing process
    3. Appropriate minotiring procedures are in place to assess the safety of the participants
  8. There are benefits to the study
  9. The investigators make every effort to protect the confidentiality of the participants
  10. The researchers explain the data usage properly - data analysis

Whether you make new requests or petition to continue or propose ammendments to existing protocols, it is essential the researchers have answers to the above frame work for reviewers' concerns