Whether you are a masters or doctoral student, you may find that you want to do research during your time at AOMA.  Here's what you need to know!

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#1 All research must be approved by the Scientific Review Committee (SRC) and then submitted to the Institutional Review Board (IRB)

Both the SRC and IRB are required by the Department of Health and Human Services (DHHS).  The SRC is tasked with ensuring that your research is feasible and has merit.  Doctoral students will complete this step as part of the research (INQ) courses.  To submit a protocol to the SRC, please email DStanley@aoma.edu. 

 

The IRB is tasked with ensuring that human research participants are protected during research endeavors.  While no project can proceed without IRB approval, it should be noted that the obligation of the IRB is to ensure safety.  It's not to approve any individual project.  To that end...

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#2 The IRB may request that you make certain changes.
This is called "conditional approval."  The IRB may not see any insurmountable flaws, but they may require that certain actions are taken to ensure the utmost safety of those involved in and/or affected by the research conducted.

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#3 How to submit an IRB application as exempt, expedited, or full review

Your IRB application information will be the same regardless of whether it is a project that can be designated as "exempt," "expedited," or "full review."  All projects will go before three first-line reviewers who will decide what level of review your project merits and what issues need to be addressed.  The director of research coordination and IRB oversight, Dr. Stanley, will be in contact with the applicants on the outcomes of this first level of review.  First line reviewers will designate the level of review that your project requires and issues that should be discussed by the committee.

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#4 What is meant by exempt, expedited, or full review

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It is a question of "minimal risk."  
Minimal Risk – The probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 
 

45 CFR 46.102(i) (pre-2018 Common Rule), 45 CFR 46.102(j) (2018 Common Rule) and 21 CFR 50.3(k) (FDA regulations). (This definition is cited in Policies 3014-204, 3014-303, 3014-402 and 3014-403)

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• Exempt projects:
  Exempt projects are projects that present less than minimal risk, such as anonymous surveys or analysis of previously collected data.  Exempt projects do not require a convened meeting with IRB committee members.  First line reviewers submit their initial designations through an online form.  If all agree that your project is exempt and approved, it will be approved on the spot.

• Expedited projects:
  These projects present no more than minimal risk.  An example of an expedited project would be an investigation noninvasive diagnostic methods or collecting identified qualitative data, such as case vignettes with identified interviews.

• Full Review Projects:
  These projects have the potential to present more than minimal risk.  An example would be a randomized controlled trial.  In a full review, more participants will join the committee to ensure that all angles are evaluated.  For example, you may be wanting to collaborate with a facility outside of Austin or work with a specific population.  It would be important to have a representative who could speak to any cultural implications of your protocol.

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#5 How do I complete my PHRP Training

NIH no longer offers Protecting Human Research Participants training, but this educational requirement can be met by completing the training from the Office for Human Research Protections.

Please visit: Human Research Protection Training | HHS.gov