{"id":430,"date":"2020-03-27T10:01:07","date_gmt":"2020-03-27T14:01:07","guid":{"rendered":"https:\/\/blogs.bsu.edu\/research\/?p=430"},"modified":"2020-03-27T10:01:07","modified_gmt":"2020-03-27T14:01:07","slug":"important-irb-update-modification-in-response-to-covid19-effective-march-25-2020","status":"publish","type":"post","link":"https:\/\/blogs.bsu.edu\/research\/2020\/03\/27\/important-irb-update-modification-in-response-to-covid19-effective-march-25-2020\/","title":{"rendered":"Important IRB UPDATE: Modification in response to COVID19 ~ Effective March 25, 2020"},"content":{"rendered":"

A message from Ball State’s Office of Research Integrity:<\/span>
\nThe Officer of Research Integrity (ORI) and the Institutional Review Board (IRB) understand the implications and challenges that the pandemic has imposed on the research world. While at BSU all in-person human subjects research (HSR) has stopped and this restriction will last until further notice, we are offering some guidance and options for researchers who need to modify their current studies.<\/p>\n

Please note that this guidance may change at any time in response to new information, governmental requirements and so forth.<\/em><\/p>\n

What if I need to modify a current protocol that is not impacted by the pandemic?<\/strong><\/span>
\nIf you need to make modifications to your protocol that are not directly in response to the current pandemic situation or the cessation of all in-person human subjects research at BSU, you simply submit your modification request as normal. Plan for a little extra time for the review and approval to take place as a lot of researchers are submitting modifications at this time.<\/p>\n

Do I need to submit a modification to temporarily stop\/halt my study or to start it back up again?<\/strong><\/span>
\nIf the study is going to be stopped or halted for the duration of the pandemic, you do not need to submit a modification for stopping or halting or for starting the study back up again. If there are non-in-person portions of your currently approved research that you can continue with, you may do so. No modification is needed.<\/p>\n

Note, however, that you cannot restart the in-person portion of your study until the pandemic has passed and the IRB has given approval to researchers that they may resume their research.<\/p>\n

What if I need to modify my protocol to permanently change from in-person to virtual means?<\/strong><\/span>
\nIf you can change to a permanent method of interacting with the research participants, you should strongly consider it. Since no one knows how long these restrictions will last, if your research can be carried out virtually, you should adjust your procedures to do such as long as the data collection methods are able to fully support the research question within the study design. Permanent changes will need to be submitted as a normal modification and will become part of the permanent protocol. This includes changes made in your methodologies, recruitment and so forth.<\/p>\n

You also will need to update and submit any documentation that is impacted by the changes, such as the informed consent, advertisements, etc.<\/p>\n

If your modifications are in response to the pandemic, please note this in the modification form. This will help us track the overall impact the pandemic had on researchers and prioritize reviews.<\/p>\n

What if I only need to temporarily modify my study for the duration of the pandemic, can I and what do I do?<\/strong><\/span>
\nIf you need to modify your currently approved study to utilize virtual means in order to keep interacting and communicating with participants, you do not need to submit a modification request, subject to the following conditions:<\/p>\n