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. See the FAQ on "Adding New Research Personnel to a Study" for guidance. You can also email HRPP firstname.lastname@example.org or call us at 588-1240 and we will check to make sure you are listed in the system. If you do have an active KUMC account, the KUMC help desk can check the account and password. 8-7995. Please let the Help Desk know if you are paid university faculty / unclassified university staff OR an affiliate (non-university) so you can communicate clearly with the help desk.
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)
How do we add new study personnel to a study ?
After logging in to the system and finding the study under the active tab, 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.
My department conducts research and PIs frequently identify members of the research team who are not KUMC faculty or unclassified staff. How do we request eIRB access for these affiliates?
The account request form you've used for Chalk has been updated to include a box to check for COI and IRB / Human Research. Access instruction for COI / eIRB Request Process here. Chalk access will be arranged within 24 to 48 business hours; COI / IRB will take longer.
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 2nd tab on labeled "Active." From this list of active studies, choose the specific study for which you are reporting the RNI nd 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.
How will department chairs review and approve new studies in eIRB?
Refer to the Quick Start Guide for Administrative / Department Approval for details.
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.
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.
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 KUMC 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, during these first few months while you are uploading 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?
Your study's sponsor should have that information and may be willing to share it as an aggregate number. If not, just enter "9999".
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).
The emails are generated by email@example.com Is this a legitimate address or is it spam?
This email came from the new electronic IRB we've been advertising. These emails have a "ku.edu" address because the software is used by all three campuses, with the servers stored on the Lawrence campus. (We are aware of the cryptic tone of these emails, and we're working to get it changed.) New information is posted on our website at: http://www.kumc.edu/compliance/human-research-protection-program/institutional-review-board/forms.html
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 July 17, 2013, will remain in paper files in the HSC office.
What will happen with our HSC approval numbers?
Existing studies will keep their current HSC number. 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.
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.
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.
Why do we need to complete training in Human Subjects Research at KUMC?
As an institution holding an Office of Human Research Protection (OHRP) -approved Federalwide Assurance (FWA), KUMC 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. KUMC 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 KUMC 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 our Conflict of Interest FAQs screen
How do I access the training in Human Subjects Research at KUMC?
Currently, the KUMC tutorial on Human Subjects Research can be accessed through our CHALK testing site. This fall 2014, we will begin to use 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.
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, which launched July 17, 2013, please refer to the Quick Start Guide "For Existing Approved Studies: Uploading your Study Documents into eCompliance for IRB" at our Electronic IRB Submission 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." 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. Upload the current consent forms, in Word with no footer, in the Consent section.