Information for the Investigators - FAQ
FREQUENTLY ASKED QUESTIONS
- I have a question. How do I contact you?
- What is the role of Institutional Review Board?
- What are the responsibilities of a PI?
- Is IRB approval required?
- Do I need an IRB approval for my CLASS PROJECT?
- I plan to present a poster in the scholars' week. Do I need IRB approval?
- Does my URECA project require IRB oversight?
- I am completing a thesis/dissertation. Do I petition for IRB approval?
- What are the types of IRB Reviews?
- What are the essential details I will need to apply for IRB approval?
- What are the reviewers looking for in my IRB application?
- How do I submit my IRB application? (TO BE COMPLETED)
- What do I need to know about Informed Consent and Assent? (TO BE COMPLETED)
- Can I get a waiver to informed consent?
- I want to advertise my study. How to I recruite participants?
- What will happen after IRB approval? (TO BE COMPLETED)
- What are the typical review steps?
- How long does it take to get IRB approval?
- What type of training should I complete?
- How do I respond to the reviewers' comments?
- The reviewer is too unfair/unreasonable - Whom do I complain to?
- Does my IRB protocol expire?
- How long is my IRB approval valid for?
- I wish to make some changes to my IRB protocol. How do I do it?
- I am done with my research. How do I close-out?
- Can I conduct my study outside of MTSU?
- What are permission letters and why do I need to collect them?
- HOW DO I REPORT AN ADVERSE EVENT?
- HOW DO I REPORT A COMPLIANCE BREACH?
- I am collaborating with a non-MTSU researcher. What do I do?
- My survey will be conducted outside of MTSU. Will the MTSU IRB approve this process?
About the Application Process
- 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.
- 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.
- 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.
- 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.).
- 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 email@example.com.
- 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).
- 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.
- 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.
- 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.
- 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.
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.