Human Research Protection Program
Accessing eIRB / eCompliance
How do I log in? ( - )
Go to: https://ecompliance.ku.edu. Log in using your regular KUMC user name and password.
Help! I'm having trouble logging in. ( - )
If you do not have an active KUMC account, you won't be able to log in.
• If you are having trouble with your KUMC username/password, contact KUSM-W IT Services at 316-293-2605, option 1, or firstname.lastname@example.org.
• If you do not have a KUMC account, request one by completing this form: http://wichita.kumc.edu/nts/account_request.html
I'm a new faculty or staff member. How soon will I have access to the system? ( - )
Human Resources Office is processing your account. As soon as they have completed their process, the HR database will automatically feed into the eIRB system and your access should be enabled. (It may take up to 4 weeks for new hires to be added to the eIRB / eCompliance database through the nightly data feed from KUMC HR).
Adding New Research Personnel to a Study
How do we add new study personnel to a study? ( - )
After logging in to the system and finding the study under the active tab in the IRB section, click Create Modification / CR button. Choose Modification if this is your only intent OR Modification and Continuing Review if you wish to submit a Continuing Review at the same time. Continuing to the next screen under Modification Scope, be sure you check the Study team member information box. On the Modification Information screen, answer questions 1 and 2 if applicable and briefly summarize the modification(s) you are making (e.g., adding John Doe to team). Continuing to the Study Team Members screen, you will click 'Add,' select the name from the drop down list, check his / her role in the study, and answer questions 3 and 4. If you are adding multiple names, click on OK and Add Another; if not, click OK. If only adding study team members, click Finish. On the next screen, click Notify PI so that the PI can sign off on the additional members.
I typically have members of the research team who are not KUMC faculty or unclassified staff. How do we request eIRB access for these affiliates? ( - )
Affiliates can request access to the eIRB system by completing this form.
Adverse or Serious Adverse Event
How do I report new information? ( - )
From the user's Home Page or inbox screen on eIRB, select "IRB" on the red bar at the top. Next, select the tab labeled "Active." From this list of active studies, choose the specific study for which you are reporting the RNI and click on the link. At that point, you may select the button to Report New Information under "My Current IRB Actions." See the Quick Start Guide on Reporting New Information for complete instructions.
Chair / Department Review / Approval
How will department chairs review and approve new studies in eIRB? ( - )
The department chairs will continue to document their review and approval by completing the Departmental and Scientific Review Form. This form contains fields for both department approval and scientific merit review. These sections do not need to be completed by the same person, but they do need to be completed by someone that is not affiliated with the research being reviewed. This signed form will be uploaded by the study team into the Supporting Documents section of the eIRB submission.
Changes / Modifications to a Study
How do I submit a protocol amendment? ( - )
In this system, amendments are called "modifications". Please access the main page of your study, and choose the button that says Create Modification / CR. Under Purpose, choose Modification and select the scope of "Other parts of the Study." After you answer the questions about Modification Information, you will be given access to all tabs of the study.
- On the Basic Information tab, choose "Update" on item #8. Upload the clean version of revised protocol. Then click the "Add" button to upload tracked changes versions of the protocol and/or a Summary of Changes.
- If the protocol amendment also involves a consent form change, use the "Jump To" menu on the grey bar at the top or bottom of the screen. Select the Consent Form Tab.
- Use the "Add" button to upload a Tracked Changes version of the consent form.
- Use the "Update" button to upload the revised clean copy of the consent form. The revised clean copy will be re-stamped with the new approval date after the amendment is approved. Please ensure consent forms are in Word with no footer.
Can I submit a protocol amendment (modification) and continuing review at the same time? ( - )
See FAQ on "Continuing Reviews" for guidance.
I've tried to submit two or three modifications, but the system will not accept them all. What's happening with those requests? ( - )
After you've submitted one modification, you can't submit a second modification until the first one has been approved by the IRB. It would be advisable to list all the known changes before submitting the initial modification.
Closing a Study
How do I close a study? ( - )
Please refer to the Screen Shot Guide on Closing a Study.
What are consent forms and does my study need them? ( - )
For most research, informed consent is documented in writing to provide key information about the research. The consent form should provide information for the subject's current and future reference, and document the interaction between the subject and the investigator. For more information about informed consent and consent form templates, visit our Informed Consent Overview page.
My study is up for a Continuing Review, but I want to make some changes. Can I submit a Modification AND a Continuing Review at the same time? ( - )
Yes, a Modification can be submitted with a Continuing Review. HOWEVER, if you have not yet uploaded your currently approved documents, we are requesting that you focus on getting those documents uploaded first and wait for processing by the IRB before you attempt to make any changes.
Select the Modification/Continuing review item and complete the continuing review portion to extend your project for an additional year. When prompted to summarize your modifications, describe this information in detail. Make applicable changes to your study and upload new materials and consent forms. Finally, click the submit button to send the project to IRB Pre-review.
What is study-wide information and how can I find it to enter into requested screens? ( - )
If your study is a multi-site trial, your study's sponsor should have that information and may be willing to share it as an aggregate number. If not, just enter "9999".
Correspondence from eIRB / eCompliance
I need to receive all system emails and letters sent to the PI. Is that possible? ( - )
Yes! If you are setting up the study from the beginning, you would assign yourself as the Primary Contact on the Pre-Submission screen. If the PI has already initiated the proposed study in eIRB, ask that she/he type your name in as the Primary Contact on the same screen ("my current actions" button on left panel). NOTE: If your PI, department, or center is using the Research Institute for a study, the project coordinator from that office should be listed as the primary contact for the study. You would collaborate with the RI project coordinator, as he/she and the PI will receive all the correspondence from the IRB.
The emails are generated by email@example.com. Is this a legitimate address or is it spam? ( - )
This email came from the electronic IRB, eCompliance. These emails have a "ku.edu" address because the software is used by all three campuses, hosted on a secured website. (We are aware of the cryptic tone of these emails, and we're working to get it changed.)
Where are my exempt studies? ( - )
All new exempt studies submitted ON or AFTER July 17, 2013 are found in the system under the Active Studies tab. Exempt studies submitted PRIOR to March 2013, remain in paper files in the HSC office.
What will happen with our HSC approval numbers? ( - )
Existing studies will keep the last 6 digits of their current HSC number (220 prefix is removed). New studies will be assigned a number by the system.
What are project descriptions and why do we still need them? ( - )
Each new proposal will be accompanied by an applicable Project Description. The Project Description provides the IRB with additional information, necessary for local review that is not captured in the electronic system. You can access the most current Project Descriptions at the Initial Study Submission screen under Step 3.
Provisos / Modifications Required for Approval
How do I find provisos in the system? ( - )
Provisos are called "Modifications Required to Secure Approval" in the eIRB system. The PI and the Primary Contact will receive an e-mail with the Proviso / Modifications Required letter attached. This letter can also be accessed on the study / modifications screen at a document link to "Correspondence..." near the top center of the screen.
How do I respond to provisos? ( - )
Please refer to this Quick Start Guide on Answering Provisos.
Submitting a Study
How do I create and submit a study? (PI or Study Coordinator) ( - )
Please refer to the Initial Study Submission screen, which outlines Steps 1-7 for new studies. Also see the Quick Start and Screen Shot Guides in Step 6 of that screen for more guidance in the electronic system.
Training (Human Subjects Compliance Requirement)
Why do we need to complete training in Human Subjects Reserch at KUSM-W? ( - )
As an institution holding an Office of Human Research Protection (OHRP) -approved Federalwide Assurance (FWA), KUSM-W is responsible for ensuring that our investigators understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects. KUSM-W investigators maintain continuing knowledge of and comply with relevant ethical principles, relevant federal regulations, written IRB procedures, OHRP guidance, other applicable guidance, state and local laws, and KUSM-W policies for the protection of human subjects. In some cases, other federal requirements regarding training for investigators must be met, such as the National Institute of Health's (NIH) requirement for the training of key personnel in NIH-sponsored or -conducted human subjects research. Refer to Research Related Certifications on the Conflict of Interest FAQs screen
How do I access the training in Human Subjects Research at KUMC? ( - )
KUMC Human Subjects Research Protection training is provided through the CITI training programs. CITI is the curriculum from the Collaborative Institutional Training Initiative, housed at University of Miami. For the latest information on KUMC requirements and access to Human Subjects Research, visit our Human Subjects Training page before you try ot log directly into CITI.
Viewing Active Studies
Where are my active, currently approved studies? ( - )
After logging into eIRB, the system will automatically take you to your inbox. To see studies that have already been approved, click "IRB" on the red bar in the upper left-hand corner. In the middle of the page, there is a tab labeled "Active," which lists all your current approved projects. By clicking on a study, you can review materials and request any modifications or continuing review.
If you have not yet uploaded your approved protocol and documents into the eIRB system, please refer to the Quick Start Guide "For Existing Approved Studies: Uploading your Study Documents into eCompliance for IRB" at our eCompliance/eIRB Overview web page. IMPORTANT: If you have already submitted a continuing review without uploading your current documents, please access the main page of your study again, and choose the button that says Create Modification/CR. Under Purpose, choose Modification and select the scope of "Other parts of the Study" and "Study Team Member Information". After you answer the questions about Modification Information, you will be given access to all the tabs of the study. Upload your protocol in the Basic Information tab. If the study involves drugs/devices, indicate this on the Study Scope page. Enter the drug or device, along with the investigator's brochure/device manual. Edit the study team member information as applicable. Upload the current consent forms, in Word with no footer, in the Consent section.