Preparing for U of L SOM Scholarly Activity that Includes Human Subjects           

If your scholarly activity includes human subjects (e.g. data provided by or pertaining to living persons at the individual level), your study will most likely need to be reviewed by the Institutional Review Board (IRB), administered by the Human Subjects Protection Program.  

If you are unsure if your study needs IRB review, contact the IRB analyst for your department for that determination. And save that email! Even if your study is not deemed human subjects research by our IRB, almost all peer-reviewed publications and conference selection committees now ask for an IRB designation when you make a submission.

Here is a very quick guide on how to prepare and submit an application ...

Preparing the Study Protocol:

The IRB has provided a useful guide to preparing a protocol. Think of your protocol as the first draft of a journal article. Make your review of literature, research problem, research questions, and hypotheses as professional as possible. You will use a great deal of this text in your final article, abstract, or presentation.

• Your study question must fill a gap in current knowledge, and we identify gaps by reviewing the literature. The experts at the Kornhauser Medical Sciences Library can provide a great deal of assistance with your literature search, and with the use of EndNote™ to manage the citation process.
• Your protocol is your “work plan” and includes appendixes such as your timeline and copies of all planned communication with your human subjects. Your IRB analyst can explain to you the type of consent documents you will need.
  • Your study may require signed content, unsigned consent, or a waived consent depending on the type of intervention, observation, and/or data collection you have planned. For young participants, an assent form rather than a consent form is appropriate.
  • Your protocol also includes all data collection instruments including observation forms and surveys. Even if you will collect these data online, have a Word™ version included in your protocol.
• Your methodology will determine your success. Collecting data without a plan to analyze it is like treating a patient without a diagnosis!
• Have your department’s research director, your research mentor, and other experts available to you review your protocol beforeyou submit. This expert review will save a great deal of time in the long term.
  • Keep notes on who assisted you so you can acknowledge them in your final product.
• Work with your Principle Investigator (PI) to identify all members of your research project team before you submit your protocol. Adding team members is possible but requites an addendum. Anyone who has direct contact with your human subjects or their individualized data (raw data before it is analyzed) should be included on your team and listed on the protocol.     

Submitting the Study thru iRIS:

• Students may not be the PI on a study, but they are often co-investigators, or key personnel. (You do not have to be the PI to be first author on a resulting article or presentation.)
• Students can prepare the study protocol (detailed description) and enter it into iRIS, U of L’s IRB study management system. Use your U of L user ID and password to log onto iRIS.
• If you are a new researcher, iRIS will prompt you to complete an Attestation and Disclosure Form (ADF) to report and manage any conflicts of interest, to upload your current CV, and to complete your online CITI training.
  • CITI training focuses on research ethics and responsibilities and includes brief modules ending with a quiz. CITI training is now the same for clinical and educational/behavioral studies.
  • All members of a study must complete the Attestation and Disclosure Form, upload their CV, and completed required CITI and HIPAA training.
  • Handy HIPAA/PHI Guide on the HSPPO Website: http://louisville.edu/research/humansubjects/policies/016HIPAAPHI.pdf
  • Set aside 3 to 4 hours to complete the CITI modules and post-tests.
  • Completing your CITI training is a professional asset and should be added to your CV.
  • It is valid for 4 years and accepted by all US institutions of higher learning.      
  • Your online study application in iRIS will ask for two types of “input”:
    • Word™ documents (e.g. Informed consent Forms, HIPAA documents, data collection forms, subject recruitment materials, and the investigators brochure).
      • Have these in Word™ rather than as pdfs for uploading.
  • Online “check boxes” and text boxes for brief responses. The text boxes will allow you to cut-and-paste sections from your protocol.
  • Check in again with your IRB analyst (you can do this by phone) to make sure everything is complete before you submit. This can save several days in the review process.
  • It is good practice to send an email to your faculty mentor, the department Chair and also the assigned Scientific Merit Reviewer so he or she knows your study is coming for review.
  • Make sure your language is consistent throughout the documents. This can be an issue when there are several writers on the team. Just as with article preparation, it’s a good idea to have a colleague read it through to catch errors and gaps.  
  • Watch for any automated or staff emails from the IRB asking for clarifications or additions to your submission, and be prompt with your reply.
  • Your designation will include your study number (e.g. 17.0700) and “Approved” or “Exempt”.
    • The term “exempt” indicates the study is very low risk and does not need on-going review by the IRB. But you are still obligated to adhere to the protocol as submitted. 
    • Studies are approved for 12 months at a time. It is good practice NOT to close a study until your final report, journal article, or presentation is complete since there may be a need for you to revisit your original data, or to add someone to the study to help with that analysis.   

HSPPO is hosting a monthly IRB submission workshop to help new investigators/students/staff with their submissions. These will be held the 2nd Thursday of the month from 9am-12pm.

• 2017 IRB/HSPPO Calendar up on the website: http://louisville.edu/research/humansubjects

• Includes Lunch & Learn and Submission Workshop dates

Please contact hsppofc@louisville.edu to RSVP and schedule a meeting a time.