KU -Lawrence IRB FAQs

Preparing Documents
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?

A documents checklist can be found on our website.

The Human Research Protocol 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 Protections 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
 
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 kteel@ku.edu.
 
Projects are processed in the order of which they are received. For minimal risk studies, typically a researcher will hear from a reviewer in 5-10 business days. Approval varies based on the project, but an average approval for minimal risk projects can be expected within 5-14 business days.  Higher risk studies are reviewed by the IRB committee at a meeting on the first Thursday of every month, and may take 3-6 weeks to receive approval.
Our volume is high at the beginning of the semesters, so it's preferred that researchers give themselves 2-3 weeks to receive approval for minimal risk projects. Research activities (recruitment, consent, etc) should not take place until you have received IRB approval.
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 speed up the the IRB process, please make sure that you have done the following:
1) Filled out the Human Research Protocol completely
2) Uploaded all of your documents (See New study checklist)
3) Have completed the Human Subjects tutorial in the last 3 years
4) Respond quickly with any clarifications that the reviewers have sent

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 Human Research Protection tutorial must be completed every 3 years.
If the individual is not affiliated with KU, contact irb@ku.edu. 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 their own IRB, please have them talk to their institution's IRB to determine what is needed.
 

Conducting Research

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?

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.
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 (irb@ku.edu) and we will check to make sure you are added to the system.
Undergraduates 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 (785-864-7385).

Accessing Studies in 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

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
"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.
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 e-mail, 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 the HRPP Policy Updates (PDF) for more information.

Modifications

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

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:

1. Obtaining consent for research purposes

2. Interacting/intervening with participants for research purposes

3. 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

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
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

Continuing Reviews

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
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
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
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

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”.
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