Axiom Research Compliance

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Periodic Self-Checks to Remain IRB Compliant

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I assisted a student researcher with submitting his first IRB protocol through Axiom Mentor. After he hit “save,” he leaned back in his chair and said, “Well, glad that’s all over. Now, I never have to worry about IRB.”

I politely chuckled and reminded him that maintaining a high standard of ethics is a daily commitment. I explained that throughout the lifecycle of his work, he should run period checks to make sure that he’s adhering to the research standards he set in his IRB protocol.

I told him that I routinely use Five-Self-Checks and I always end each self-check by reflecting if it’s necessary for me to submit a modification to my existing protocol. For example:

SELF-CHECK #1:  Risks/Benefits
  1. Have the risks or benefits changed since my original IRB protocol submission?
  2.  Have I made any new discoveries that could impact the future risks or benefits of this study that are important to address immediately? 

SELF-CHECK #2: Recruitment:

  1.  Has recruitment become ineffective? In what ways can I improve my recruitment methods?
  2. Has recruitment become overly effective or overwhelming? Am I recruiting more participants than I originally anticipated?

SELF-CHECK #3: Informed Consent/Debriefing

  1. Are participants expressing any confusion or misunderstanding with the informed consent process?
  2. Is the debriefing process going as planned? Are participants raising questions or concerns? 

SELF-CHECK #4: Privacy and Confidentiality:

  1. Has storage of the digital or physical data raised any issues? For example, does my locked filing cabinet have limited space or does my digital data storage require a backup?
  2.  Is the coding system I used to maintain participant confidentiality sufficient, effective, and efficient? 

SELF-CHECK #5: Monitoring communication/research assistants

  1. Are there any issues or concerns with disseminating the information associated with this study?
  2. Are research assistants expressing any concerns about interacting with participants? 

Part of being a steadfast researcher is to take notes and observe the lifecycle of your research. Sometimes initial research decisions pan out and other times they need adjusting. Making notes on what works and what doesn’t and using these self-checks will only improve your research in the future.

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