KU -Lawrence IRB FAQs

HSCL Basics
Preparing Documents
I’m a KU student. Can I submit a study to the IRB?
How do I know what documents I should submit to the IRB?
What consent procedures should I follow for my project?
My project involves deception. What procedures should I follow?
I want to pay my participants. What policies should I follow?
How long does it take me to get approval for my project?
Is there anything I can do have the IRB expedite or fast-track my project?
Tutorial and Adding Personnel
How do I complete the Human Research Protection tutorial?
I cannot find an individual on my study in the Study Member tab. How do I add them to my study?
Conducting Research
Can I recruit for participants before I have IRB approval?
Can I start my research before I have IRB approval?
The KU-Lawrence IRB reviewed my project, and determined that it is “Not Human Subjects Research.” What does this mean?

eCompliance
Logging In
How do I log in to eCompliance?
I cannot log in to eCompliance. What do I do?
I can log into eCompliance, but I do not have the capability to add or modify a study. What do I do?
Accessing Studies
How do I access my approved studies on eCompliance?
New Study
Where do I upload documents in eCompliance when I’m creating a new study?
My study is in pre-submission. Why has it not been reviewed?
I received clarifications for a study. What do I do now?
I can’t open the initial submission form from the website, what should I do?
Continuing Review/Modifications
How do I close a study?
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?
I want to continue my project and make a modification at the same time. How do I do this?
What happens if my project lapses?
What happens if my project has been administratively closed?
Report New Information
What is an RNI and when do I submit one?

I’m a KU student. Can I submit a study to HSCL?
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: Ancillary review guide

How do I know what documents I should submit to the IRB?
A documents checklist can be found on our website: Documents needed checklist

The Initial Submission form 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

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

How long does it take me to get approval for my project?
Projects are processed in the order of which they are received. Typically a researcher will hear from a reviewer in 7-10 business days for minimal risk studies. Higher risk studies are reviewed by the IRB committee at a meeting on the first Thursday of every month.

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 speed up the the IRB process, please make sure that you have done the following:
1) Filled out the Initial Submission Form completed
2) Uploaded all of your documents
3) Have completed the Human Subjects tutorial in the last 3 years
4) Respond quickly with any clarifications that the reviewers have sent

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How do I complete the Human Research Protection Tutorial?
Instructions on how to complete the Human Reseach 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.

I cannot find an individual on my study in the Study Member tab. How do I add them to my study?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. Once the paperwork is complete, you will be able to add the individual to your study.

Can I recruit for 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 my research 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.

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 (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 his/her 7-digit KU student ID number to HRPP via encrypted email or via phone (785-864-7429).

Please note: Individuals who are not affiliated with KU will need to have a KU affiliate account made through HR. Please visit the HR website for more information: http://policy.ku.edu/human-resources/affiliates-and-volunteers.

I can log into eCompliance, but I do not have the capability to add or modify a study. What do I do?
Please email HRPP (irb@ku.edu) and we will check to make sure you were added with the appropriate system privileges.

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 upper left-hand corner. In the middle of the page, there should be a tab labeled “Active.” This is the list of all of your current approved IRB projects. By clicking on the study, you can review materials and request any modifications or continuing review.

Where do I upload documents in eCompliance when I’m creating a new study?
Once you’re logged into eCompliance by clicking the “create a new study” button the left-hand side of your screen you will be walked through a step by step detailed process outlining the information needed from you. It is crucial to mention that your consent form must be uploaded in the “Consent forms” section on the “Consent Forms and Recruitment Materials” page. Please refer to our quick-start guide for step by step instructions: eCompliance Guide

My study is in pre-submission. Why has it not been reviewed?
In order for the IRB to be able to review your submission, you must ensure you have clicked the “Submit” button on the left hand side for your study to be removed from “Pre-submission” status, and moved into the “Pre-Review” status. Please look at our guides on our website for creating and submitting a study: Creating a study

I received 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 e-mail, and the study appears in My Inbox for each member of the study team.

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.

Please refer to our quick-start guide for step by step instructions: Responding to clarifications

I can’t open the initial submission form from the website, what should I do?
If you are having trouble opening the initial submission form please follow the instructions on the Initial Submission Form Troubleshooting (pdf) guide.

How do I close a study?
In order to close a study, you will need to find the study in your “Active” tab, 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.

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 modification/continuing review guide on our website: MODS and CRs

I want to continue my project and make a modification at the same time. How do I do this?
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, briefly state this information in a few sentences. Complete and upload the Request Modifications MS Word document when it asks for the protocol. 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.

Note: In order to keep expiration dates for projects the same each year, HRPP will not process a Continuing Review until 1 month prior to the lapse date. If your modification for your project needs to be approved prior to this 1 month window, please submit ONLY a modification.

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?
HSCL staff administratively closes projects after 90 days from the project lapse date. If you want to continue work on this project, please submit a new application. 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 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”.

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