A message from Ball State’s Office of Research Integrity:
The 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.
Please note that this guidance may change at any time in response to new information, governmental requirements and so forth.
What if I need to modify a current protocol that is not impacted by the pandemic?
If 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.
Do I need to submit a modification to temporarily stop/halt my study or to start it back up again?
If 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.
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.
What if I need to modify my protocol to permanently change from in-person to virtual means?
If 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.
You also will need to update and submit any documentation that is impacted by the changes, such as the informed consent, advertisements, etc.
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.
What if I only need to temporarily modify my study for the duration of the pandemic, can I and what do I do?
If 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:
- PIs are expected to use all caution and due diligence in the methods they use;
- Appropriate confidentiality and privacy protections must be maintained;
- Informed consent still needs to occur;
- If your temporary modifications change the risk level of the study, this must be submitted as a modification request and be approved by the IRB. For assistance determining possible risk changes, please click here to submit online request.
- Temporary changes cannot be used to gather data/information from participants that were not already approved (except for information pertaining to preferred contact method); and
- Complete the online form.
Please note that even though you may be able to temporarily modify your study to use virtual means to interact and communicate with participants, it does not grant you the right to waive or alter other legal/regulatory requirements. For example, if you need to get a signed authorization from participants to use FERPA protected data, you still need to get that authorization. If you are working with minors, you still need parental consent.
What if I already modified my study to online or other virtual means, but I did this only because of earlier guidance.
We understand that there has been a lot of changing guidance over the last few weeks in response to the pandemic. If your study modification can remain permanent and it does not impact your research, there is nothing more you need to do.
If your modification was only meant to be temporary, but you submitted it in response to earlier guidance, please click here to complete the online form.
We will make a note of this in the protocol and allow you to switch back to in-person methods once the pandemic emergency has lifted and the IRB allows researchers to resume in-person research. You will not need to submit another modification to switch back.
With all of the modification coming in, will the process be faster for pandemic impacted protocols?
Yes, we are working on reviewing pandemic impacted protocols on a more rolling basis in order to reduce the time delay in research. This includes all review level, though modifications to Full Board protocols may still take a little more time to review than an Exempt modification.
For more information about our guidance regarding research activities in response to COVID-19, please visit our website and see our updated guidance.
If you have any concerns or questions, please contact Sena Lim at firstname.lastname@example.org or Chris Mangelli at email@example.com. The ORI and the IRB will continue to work with all of our researchers during this challenging time.