Please see below for information on using OneAegis for any human subject research protocols, request for amendments, continuing reviews, and/or development activities.
MSOE uses OneAegis to streamline the protocol submission and review process. Sign into OneAegis to complete human subject research protocols, request for amendments, continuing reviews, and/or development activities.
All students, staff, and faculty at MSOE planning to conduct research involving human subjects must submit an IRB protocol application packet for review by the IRB. Investigators must obtain approval from the MSOE IRB before human subject recruitment and research begins.
Start the approval process by reading the document Investigator Responsibilities.
Prior to completing and submitting a protocol application to MSOE IRB, investigators should fulfill human subject research certification through CITI Program. Instructions for registering for a CITI account and details about course descriptions are available in OneAegis.
MSOE IRB highly encourages researchers to use Qualtrics for their online surveys. MSOE has a Qualtrics campus-wide license as a resource for all faculty, staff and students. To proceed with Qualtrics, send an email request to IRB@msoe.edu to have an account created for you.
Complete a Continuing Review if your MSOE IRB-approved protocol will continue beyond the IRB protocol expiration date listed on the protocol approval letter you received from MSOE IRB or if your project approval requires annual continuing review, as indicated in the protocol approval letter. If there have been ANY CHANGES to the project please fill out a Request for Amendment xForm via OneAegis.
Research work may not continue after the IRB protocol expiration date.
Complete a Continuing Review xForm for an approved human research protocol via OneAegis.
Federal Regulations require IRB review and approval of amendments to open protocols to identify any change in the level of risk to research participants and ensure appropriate measures are in place, as needed.
No action may be made to change an approved protocol until the principal investigator (PI) receives written notification from the MSOE IRB Administrator.
Complete a Request for Amendment xForm and submit all new or revised materials to request an amendment to an approved human research protocol via OneAegis.
Unanticipated events are any deviation from approved protocol procedures including, but not limited to, an injury/illness or unanticipated death of human subject(s), the loss of confidentiality of data, etc. Unanticipated events must be reported to MSOE IRB within 24 hours in the event of a death or serious illness/injury or within 5 days for any other situation.
YOU MAY NOT CONTINUE to work on your research project until the principal investigator (PI) has received written notification from the MSOE IRB Administrator with approval to resume the project.
Complete a Unanticipated Problem/Adverse Event xForm and submit informed consent documents and any other relevant materials to MSOE IRB for review via OneAegis.
Upon conclusion of your approved research study when human participants are no longer recruited, enrolled, studied, or contacted submit a Completed Study xForm via OneAegis.
If you are continuing to write reports or analyze data, the protocol may not be closed until all elements are finished. If your project is nearing its expiration date and you need more time, submit a Continuing Review xForm via OneAegis to receive a new expiration date.