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. See the FAQ on "Adding New Research Personnel to a Study" for guidance. You can also email HRPP email@example.com 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, 913-945-9999 option 2. 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 university 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, 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.
Adverse or Serious Adverse Event
How do I report new information?
Please refer to the HRPP webpage on Reporting New Information for the most current guidance on your reporting requirements. Then follow these instructions on using the electronic system: 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.
Chair / Department Review / Approval
How will department chairs review and approve new studies in eIRB?
Refer to the Quick Start Guide for Administrative / Department Approval for details.
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. You may also use 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 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.
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.
(HOWEVER, if you have a modification already in process, you will need to wait until that modification has been approved before creating another one of a like category. i.e if a Study personnel modification is already created, you would need to wait until that one is processed to create another personnel modification within the continuing 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".
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 or the Cancer Center for a study, the project coordinator from that respective office should be listed as the primary contact for the study. You would collaborate with the RI or the Cancer Center project coordinator, as he/she and the PI will receive all the correspondence from the IRB.
The emails are generated by firstname.lastname@example.org 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.) 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.
Does the KUMC IRB review studies that are conducted on our campus by outside persons or organizations?
The IRB evaluates any proposed human subjects research that uses the physical or patient resources of the institution, to determine whether the activity engages KUMC in research and thus requires IRB oversight.
Navigating the System
How do I use the eIRB system?
Please enroll in an eIRB assistance session through our HRPP events/training calendar.
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.
I need access to O2 for my human subjects research study. How can I acquire access to it?
O2 access is managed by the University of Kansas Health System. Persons who need O2 access for research purposes must be approved by the IRB as research personnel on the project.
Additional information about obtaining O2 access the Health System and the request form are posted at: http://intranet.kumed.com/workplace-support/computer-access-request-forms#O2Rev
If you are not able to log on to O2 using your KUMC user ID and password, please contact Information Resources Customer Support at 913-945-9999 option 2 .
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 see the IRB webpage on Recruitment Resources
Scientific Merit Review
What is the new requirement for scientific review?
The Human Research Protection Program requires documentation of scientific review on new proposals for expedited and full-committee review. Departments are responsible for ensuring that scientific review has occurred prior to submission to the institutional review board (IRB).
What is the purpose of the scientific review?
The purpose of the scientific review is to ensure that proposals reflect an acceptable level of scientific rigor and merit prior to ethical review. Ensuring scientific merit is a key component in protecting the rights and welfare of our human research participants. Through the scientific review process we ensure that the study is well-designed and has adequate resources so that we do not expose research subjects to unnecessary harms. Specifically, accreditation standards require the scientific review to confirm the following:
a) the research uses procedures consistent with sound research design, which do not unnecessarily expose subjects to risk;
b) the research is likely to answer the proposed question; and
c) the knowledge reasonably expected to result from the research has scientific importance.
Which studies need scientific review?
Any study requiring "expedited" or full-committee review must demonstrate prior scientific review. There is no requirement for scientific review of exempt research.
What are the options for accomplishing scientific review?
If an external peer review process (such as NIH) has been accomplished, or if there are plans for review by the Cancer Center's Protocol Review and Monitoring Committee (PRMC) or the CTSA Scientific Advisory Research Council (SARC), then the scientific review requirement is met. Otherwise, the scientific review must be accomplished at the departmental level.
Who can perform the departmental scientific review?
Each department may decide whether the review occurs by the department chair, by a designee or by a departmental research committee. Departments are given the discretion to arrange the review in a manner that best suits the needs of the department. Any colleague with relevant expertise can perform the review, provided he/she is not on the study team. For studies that represent high-risk to subjects or a novel area of investigation, departments should consider review by more than one individual.
How is scientific merit evaluated for pilot studies?
Pilot studies must meet standards for sound rationale, minimized risks, clear objectives, and measurable outcomes. While not statistically powered to definitively answer the research question, the pilot study should be designed to contribute important knowledge about whether further studies are justified.
How should non-interventional studies (such as those using questionnaires, interviews and focus groups) be evaluated?
Non-interventional studies should be evaluated for sound rationale, minimized risks, clear objectives and measurable outcomes. While these studies may not pose a risk of physical harm, reviewers should consider any psychological, social, legal and economic risks that might be involved in study participation. Steps should be taken to minimize those risks, and any remaining risks should be reasonable in relation to the potential benefits of the study.
Is a scientific review still required for industry-sponsored multi-center clinical trials?
Yes. While it is recognized that multi-center clinical trials have already undergone one or more levels of scientific review, the departmental review still should confirm the overall soundness of the study. For example, reviewers would use their knowledge of best practices to confirm that appropriate comparators are being used in a randomized trial of a new drug's efficacy. In most cases, the departmental review of multi-center trials will focus on whether or not the study is appropriate for KUMC. Reviewers should consider the expertise of the local PI, the availability of appropriate and sufficient research subjects, facilities, and expertise of ancillary services in order to ensure the safe conduct of the research.
When should the scientific review occur?
The scientific review should occur before the department chair or center director signs the IRB application (unless the project is being referred to PRMC or SARC). For studies using the services of the RI Clinical Trials Division, investigators should only submit the study to the RI when they have the final version of the protocol. All protocols should be labeled with a version date.
What paperwork does IRB need?
Through the Administrative Certification Checklist, the department chair or center director will indicate how the scientific review process is being accomplished. If the review is not being done by NIH, PRMC, SARC or another entity, then a departmental/center review will be required. The IRB submission should include a copy of the departmental checklist as well as any correspondence between the PI and the scientific reviewer. The correspondence about scientific issues may facilitate IRB deliberations.
What form should be used for the departmental review?
For studies that do not have NIH, PRMC, SARC or other review, departments should use a scientific review checklist they have created for their own purposes. The Human Research Protection Program provides a sample template for departments to adapt, or departments can develop their own forms. Specific questions can be directed to the HRPP Director at 588-0942.
If I have an internal grant from the KUMC Research Institute, do I still need departmental review?
If you have a clinical research pilot funded by the Research Institute, those projects have undergone a peer review by external experts prior to approval for funding. The IRB would not require a departmental review. The IRB application form should indicate that the scientific review has already been accomplished by an external review process.
How will scientific review benefit departments?
The scientific review process offers departments an opportunity to improve the quality of research in several important ways. The process facilitates mentoring of young researchers, identification of synergies among related lines of investigation, and knowledge of current research that can support plans for departmental growth.
Status of Submission / Study
How do I know where my study stands in the IRB process?
The eIRB system contains a workflow at the top of each submission (initial, modification or continuing review) that depicts exactly where your study stands in the IRB process. The current stage is indicated by the darker blue bubble. Whe you first create your study and prior to pushing the "submit" button, you will see that your study is in Pre-Submission. After you submit, the darker blue bubble moves to the Pre-Review stage. When the study status indicates Pre-Reivew, IRB Review, or Post-Review, you will not be able to edit it as the study is in the IRB workflow. In any other status, the study will be in YOUR workflow.
If your study is in the state of Clarifications Requested or Modifications Required (see below), please note that adding a comment does not push the study back to the IRB office for review. The PI still needs to Submit Changes by hitting that action link in the left panel under My Current Actions in order to move forward with the IRB review. Once you have submitted the changes, the dark blue bubble will move to the top row (Pre-Review, IRB Review, or Post-Review) which indicates IRB staff action is needed.
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 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?
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 to 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.