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Application Procedures and Forms

Do I need to submit an application to the IRB in the first place?

Feel free to take a look at the flow chart below and/or fill out this handy determination form to help answer this question. If your project doesn't meet the criteria of "human subjects' research" according to the federal definitions included, you are not obligated to submit your project to the IRB. If you have any doubt whatsoever, please contact the IRB at irb@roanoke.edu.

IRB determination form flow chart

If your research project does meet the criteria of human subjects' research, you must complete a New IRB Application. You're encouraged to draft your responses with the help of this fillable preview form, but please note that this document will not be accepted as the application. You must submit your application using the online form above in order for it to be reviewed.

While response times may vary, you can expect to hear back within 10 business days of receiving a complete application. Some research projects involving more risk may take as long as 20 business days. You must receive official approval in the form of a Certificate of Action from the IRB before you can begin any research activities (e.g., recruitment, data collection, data analysis).

What if I've already received approval but my project has changed in some substantial way?

You must submit an Amendment to a Previously-Approved IRB Protocol. You must receive official approval in the form of a Certificate of Action from the IRB before you can implement any of the changes you'd like to make.

What kinds of things count as "substantial changes"? Things like:

    • the addition of a new co-investigator
    • a big change to your recruitment procedures (e.g., you're calling people on the phone now instead of using SONA)
    • a big change to your recruitment materials (e.g., you're posting flyers on social media when you weren't before)
    • the number of participants you're recruiting has increased drastically
    • you're using a completely different survey/questionnaire/set of stimuli
    • you're increasing the amount of time participation is expected to take
    • you'd like to compensate people for their participation when this hadn't been included previously

You may need to use your best judgment, because sometimes these changes can be relatively subjective. When in doubt, you should seek advice from your faculty advisor and/or from the IRB.

What if the end date of my project has passed, but I'd like to continue research activities for this project?

In that case, you must submit a Renewal of a Previously-Approved IRB Protocol. You must receive official approval in the form of a Certificate of Action from the IRB before you can continue any of the research activities you'd like to conduct.

What kinds of things count as "research activities"? Things like:

    • subject recruitment
    • data collection
    • data analysis

If you're unsure, please contact the IRB.

What if my project involves working with Zebrafish, but not humans?

You are also responsible for submitting a New IRB Application, but you should be sure to use the one designed for working with Zebrafish (available here). Amendments and renewals, whether you're working with humans or Zebrafish, should all use the same forms described above.