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Compliance

I Cannot Be Reached While Traveling; Can My Assistant Update My Clinical Trial Protocol from My Account While I'm Away?

Reader Question: I will be out of the country for two weeks, traveling in a sparsely populated mountainous region where Internet connectivity will be impossible. I am obligated to take this trip. In order to keep the administrative part of my clinical trial protocol up to date, I have re-assigned the task to one of my research assistants. She will be entering routine information via my user name, password, and pass code. I will reset them when I return. Her integrity is beyond reproach, but am I leaving too much to chance? What alternative do I have?

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Expert Comments:

If your assistant is not listed on the protocol, there should be no problem if she'll simply be entering routine information such as subject applications for submission to the Institutional Review Board (IRB).

But to cover yourself fully, you should put her on the protocol. Things could get problematic if she is not on it but has to access and work closely with Private Health Information (PHI.) That's a compliance violation and would trigger an investigation. Any resulting actions taken would depend on the sensitivity of the information.

Compliance officers would ask you for a written explanation of the situation and a corrective action plan. They would conduct a preliminary review, with a member of the Institutional Review Board (IRB) present, and then send the matter to the full IRB for review.

The IRB could approve your corrective action plan and take no further action if it deems the issue not serious. But it could decide the compliance issue was serious enough to be reported to federal officials. If PHI rules are violated, the HIPAA privacy officer would be notified. Having the assistant on the protocol avoids these issues.

As far as your passwords and pass codes are concerned, some institutions have online application systems requiring a user name and a pass code to access forms to be submitted. Your assistant might need all of your information to make modifications depending on your online application system. That in and of itself wouldn't present a problem, but if she will be dealing with adverse events or specific information about the subjects, she needs to be on the protocol.

You can easily get her listed by submitting a Request For Change, which usually goes through very quickly. She would then be required to take CITI training, human ethical research training that's done online. Then you can travel without concerns.

Expert Comments by Sue Logsdon, Institutional Review Board (IRB) compliance coordinator, University of Nebraska.

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