KU-Lawrence IRB FAQs
I’m a KU student. Can I submit a study to the IRB?
The KU-Lawrence IRB does allow KU students to submit their projects for review. However, all KU students must have a faculty supervisor listed on their study team. The faculty supervisor must complete an ancillary review before a study can be approved. Refer to our guidance on our website for more information on how to complete a faculty ancillary review.
How do I know what documents I should submit to the IRB?
The Human Research Protocol (PDF) is required for all applications. Other documents depend on your research project. Examples of documents to submit include consent documents, recruitment materials, surveys, questionnaires and interview questions.
What consent procedures should I follow for my project?
Whether you are acquiring oral consent, written consent, or using an internet information statement, please refer to our guidance on our website to make sure that you include the necessary items: http://research.ku.edu/hscl_forms_documents
The Office for Human Research Protection provides FAQs on Informed Consent: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html
Quorum IRB has an article that describes ways to improve consent comprehension: https://www.quorumreview.com/6-approaches-increasing-participant-comprehension-informed-consent/
My project involves deception. What procedures should I follow?
Debriefing is required for studies that include deception. A debriefing template can be found on our website: http://research.ku.edu/hscl_forms_documents
I want to pay my participants. What policies should I follow?
Information on paying participants can be found on our website: http://research.ku.edu/human_subjects_committee_lawrence_policies_guidance
HRPP encourages investigators to use ClinCards as an alternative to cash for payments. Information on ClinCards can be found on our website: http://research.ku.edu/human_research_participant_payment_method
If you have questions about participant payments, please contact Kevin Teel at email@example.com.
How long does it take me to get approval for my project?
Projects are processed in the order in which they are received. Research activities, including conducting pilot tests, receiving identifiable data, recruitment, consent, and paying for printing, participant incentives, or other costs associated with the participants, must not take place until you have received HRPP approval.
For minimal risk studies, a researcher will typically receive an initial response from a reviewer in 5-10 business days. Timeline to approval varies based on the number of clarifications that must be resolved before approval. Approval for most minimal risk projects takes between 5 and 15 business days. During periods of high volume (generally October-November and mid-February-mid-April) time to approval may be at the higher end of the range, 10-15 business days.
Higher risk studies are reviewed the first Thursday of every month by the IRB committee. Plan on 3-6 weeks to receive approval.
Is there anything I can do have the IRB expedite or fast-track my project?
The IRB must make a determination about your project. It is not up to the researcher to decide if the project can fit into an "exempt" or "expedited" category of review.
To expedite the IRB process, please ensure that you have done the following:
Tutorial and Adding Personnel
How do I complete the Human Research Protection tutorial?
Instructions on how to complete the Human Research Protection tutorial can be found on our website: http://research.ku.edu/human_subjects_compliance_training
The tutorial must be completed every 3 years.
I cannot find an individual on my study in the Study Member tab. How do I add that person to my study?
If the individual is not affiliated with KU, contact firstname.lastname@example.org. We will provide you with the correct forms to fill out and help you make a determination about the type of account the individual will need and any additional paperwork. If the person is affiliated with another institution/university that has its own IRB, please have them talk to their institution's IRB to determine what is needed.
Can I start recruiting participants before I have IRB approval?
No, your study must be approved by the KU-Lawrence IRB before you can begin recruiting participants.
Can I start any research procedures (including consent) before I have IRB approval?
No, your study must be approved by the KU-Lawrence IRB before your project can begin.
The KU-Lawrence IRB reviewed my project and determined that it is “Not Human Subjects Research.” What does this mean?
The federal government has very strict guidelines for human subjects research. Sometimes this definition does not line up with the academic definition of research. If it is determined your project is not considered human subjects research, then you can proceed with your research without IRB oversight.
What are my responsibilities as a human subject researcher?
Check out OHRP's FAQs on investigator responsibilities: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/investigator-responsibilities/index.html
Logging in to eCompliance
How do I log in to eCompliance?
Go to: ecompliance.ku.edu. You should log in using your designated KU ID and password. This information is the same as your log in for KU email, Kyou, and Enroll and Pay.
I cannot log in to eCompliance. What do I do?
All faculty, staff and graduate students should be able to log in to the system using their KU ID and password. If the log in is not working and you are affiliated with KU, email HRPP (email@example.com) and we will check to make sure you are added to the system.
Undergraduate students are not automatically added to the system. An undergraduate student can request to be added by providing their 7-digit KU student ID number to HRPP via encrypted email or via phone at 785-864-7385.
Accessing Studies in eCompliance
How do I access my approved studies on eCompliance?
After logging into eCompliance, the system will automatically take you to your inbox. To see studies that have already been approved, click “IRB” in the red banner. Detailed directions can be found on our website: http://research.ku.edu/ecompliance
Creating/Submitting New Studies in eCompliance
How do I create a study to submit to the IRB?
After logging on to eCompliance, click the "Create New Study" button on the left side of the screen. Step-by-step instructions for creating a new study can be found on the IRB website:http://research.ku.edu/ecompliance
My study flowchart shows my study is in pre-submission. What does that mean?
"Pre-Submission" means that your study is in a draft submission stage and has not yet been submitted to the IRB for review. Follow the directions in the red banner at the top of your study to submit to the IRB.
I received a request for clarifications for a study. What do I do now?
At any stage during the review process, the IRB may request clarifications to the study content. Similarly, the official IRB determination may be that the study requires changes before research can begin. Both situations require the study staff to take similar actions. In either case, the PI and the study's primary contact receive an email, and the study appears in My Inbox for each member of the study team. Directions for responding to clarifications can be found on our website: http://research.ku.edu/ecompliance
Please note that the IRB has a new policy concerning clarifications. Due to non-responsiveness to clarification requests, initial submissions that have not received a response to clarification requests within 180 days will administratively closed. Please see HRPP Policy Updates (PDF) for more information.
Do I need to let the IRB know if I make any changes to my study procedures/documents?
Yes, the IRB needs to approve any changes to your study procedures or documents before any changes are implemented. You can update your study with the new information by submitting a modification to your study. Directions for submitting a modification can be found on our website: http://research.ku.edu/ecompliance
There are new researchers that will be helping with my study team. Do I need to let the IRB know?
If the researchers are engaged in any of the following procedures, they need to be added to your study team before they conduct any research activities:
- Obtaining consent for research purposes.
- Interacting/intervening with participants for research purposes.
- Will have access to identifiable participant data for research purposes.
Directions for submitting a study team modification can be found on our website:http://research.ku.edu/ecompliance
How do I change the Principal Investigator for an approved study?
Directions for changing the Principal Investigator on an approved study can be found on our website (labeled Changing the PI): http://research.ku.edu/ecompliance
I received federal funding after my study was approved by the IRB. There is currently no funding listed in my study. Do I need to submit a modification to add the funding information?
Yes, the IRB needs to be aware of any human research projects that receive federal funding. Submit a modification to add your funding source. Directions for adding your funding source can be found on our website: http://research.ku.edu/ecompliance
How do I close a study?
In order to close a study, find your study in the IRB tab in red, then look under "All Submissions," click on the study, and click the “Modification/CR” tab in the left-hand corner. You will need to complete a “Continuing Review” in order to request closure of your study. This allows for us to gain some final information on the results of your project. Directions for submitting a Continuing Review can be found on our website: http://research.ku.edu/ecompliance
I received a notification email regarding an approaching deadline for continuing review on my project. I want to continue my project without any changes. What should I do?
Continuing review reminders are sent out 90, 60, 30 and 15 days before your project’s expiration date. Click the study number link that displays in the email and log in to the system. Open your study and select “Create Modification/CR” under “My Current Actions.” Please reference our continuing review guide on our website: http://research.ku.edu/ecompliance
What happens if my project lapses?
You have 90 days to complete a Continuing Review or study will be administratively closed by HRPP staff. Please note that continuation of research activities without prior IRB review and approval is a violation of federal regulations. Please see the HRPP Policy Updates (PDF) for more information.
What happens if my project has been administratively closed?
HRPP staff administratively close projects after 90 days from the project lapse date. If your project has been administratively closed and you want to continue with research activities, you will need to create and submit a new study for review. Please note that continuation of research activities without prior IRB review and approval is a violation of federal regulations. Please see the HRPP Policy Updates (PDF) for more information.
Report New Information
What is an RNI and when do I submit one?
An RNI (Reportable New Information) is a report encompassing any information that affects the confidentiality of the participants or any news regarding a situation with a participant that was beyond the risks of the consent form. This form should only be filled out when there is new information regarding possible risks for the participants that are not already outlined in the consent form. An RNI is new terminology for an “adverse event”.