The IRB is in place to protect the rights of patients participating in research trials, either clinical or social.  Whether you plan on conducting a survey in the outpatient clinic or a drug study on the inpatient wards, you will need to have your research study approved through the UAMS IRB.  

The UAMS IRB system is named CLARA.  Although the IRB process can be long and tedious at points, the UAMS CLARA system has gone a long way in streamlining the process and making submission as easy as possible for all researchers.  

To get started with a submission, you will need to log into CLARA using your UAMS username and password. The CLARA system is integrated with other UAMS systems, so there is no need to register for another account.  Upon entering the system, you will first need to create a new submission:

You can now choose to enter a:

• New study or

• Human Subject Research(HSR) Determination Request

See also: Primer for Submitting Health Professions Education Research to the IRB from Academic Medicine

If you choose to start a new study, it is best to gather the information you will need before beginning to fill in the IRB request as this will make the process faster and easier.  The CLARA system will walk you through a number of questions related to your study and also require the basic outline of your study and any funding sources.  A basic list of what you will need before you begin is below:

• Start (nature of study, what is included in study, responsible parties, basic summary) 
• Basic Details (title of study, party who initiated study, funding sources, location)
• Sites (location and contact information)
• Staff (staff members, roles, and responsibilities)
• Subjects (number of subjects, demographic information for subjects involved, advertising information, compensation details)
• HIPAA (consent needed?, how received?)
• Consent (consent process information)
• Risks (study procedures to minimize risk, security resources for data, research and testing details)
• Data and Safety Monitoring (information about data and safety monitoring plan, if required)
• Miscellaneous (guidance questions in case more information is needed, exp. - cancer studies, human tissue, etc.)
• Drugs and Devices (information about included drugs and devices used in study)
• Funding Sources (funding source details, contact information, if funded)
• Budget and Coverage (budget determination questions)
• Contract (contract information, if any)
• Documents (a place to upload documents to support your study)
  • Protocol - see example below
  • Any evaluation tools
  • Any advertising - flyers, electronic, etc.
  • CV's of other staff

Once all your information is entered, the study will go to review by the IRB staff.  If they find any details missing, you will be notified about what needs to be added.  Once all elements are in place, the submission can then be signed and submitted for a full review by the IRB board.

Some helpful pages:

• Templates and Training
• Research Resources
• How do I submit something ?
• Getting your study approved faster

Not sure if your study is or is not Human Research?  Access the CLARA system and fill out a Human Subject Research (HSR) Determination Request.  It's the quick and easy way to be sure you are doing the right thing.  This form will walk you through:

• Title of your project (including location).
• A Basic Summary of the project - including primary intent and if the project would continue without academic recognition.
• Ask if you are obtaining information from living individuals and if there will be any intervention or interaction.
• List of all project members
• Any documents already created for t.he project.

IRB staff will review the HSR Determination and let you know quickly if your project needs to be placed into CLARA for a full IRB review or not.