Does your project involve direct interaction with participants or use identifiable data or specimens? Directly interactions with people
Use data or specimens about a person but will not directly interact with them
No direct interactions nor use of data and specimens. Use of data and specimens has to meet HIPAA criteria for de-identification.
Your Project is not a human subjects project. Please complete the Not Human Subjects Determination form .
Will your project generate information that is broadly applicable to settings outside of KUMC? * must provide value
Yes
No
Your project is not a research project needing IRB review, please complete a Quality Improvement determination form .
Since you are doing research but will not be directly interacting with participants, your study would be considered a secondary use. Please complete the Secondary Use Redcap application.
Do any of these federal funding characteristics apply to your project? (check all that apply) Funded by a direct federal grant
Funded through a sub-award or pilot grant associated with federal dollars
Includes personnel on a federally-funded training grant
Research conducted under a no-cost extension
Data will be used to support a pending application for FDA approval or a grant application (e.g., data collection in response to a scored grant submission with plans to re-submit)
Involves delivery of an FDA-regulated product or a dietary supplement
Involves data collection about FDA-regulated products
Conducted under a contract that requires the investigator to adhere to federal human subjects regulations (e.g., 45 CFR 46, 34 CFR 97 or other references to the HHS Common Rule)
Involves any services that could be billed to a federal program
There is no federal funding nor does the project study an FDA regulated product.
Does your project potentially involve physical, emotional, financial or social risks? Yes
No
If yes, what are the sources of the potential risks to participants? A drug
A medical device
Deception
Psychological risks
Financial risks
Social risks
Other
If other, please explain.
Do you plan to use KUMC as the IRB for this project? Yes
No
If no, please clarify which IRB will be reviewing this project?
Your response indicate that you would like to use an IRB that is not KUMC. Please see the KUMC IRB reliance pages for more information about submitting a reliance project.
Your project appears to be greater than minimal risks. Please complete the REDCap Full Board Project Description
Your project appears to be minimal risk and is not associated with federal funding. Please complete the REDCap Flexible IRB Project Description
Does your project fit into one of these categories? Education research
Surveys, interviews, educational tests, public observations (that do not involve children)
Benign behavioral interventions
Federal research/demonstration projects
Taste and food evaluation studies
None of these apply (Additional options will show)
Does your project fit into any of these other categories? Clinical study of drugs and medical devices being used as FDA approved or an IND is not required
Collection of blood by finder stick, heel stick, ear stick
Collection of biological specimens by non-invasive means
Collection of data by non-invasive means
Collection of recordings such a voice, video, or image recordings
Research behaviors that do not qualify for the survey/interview or benign interventions in the question above
None of these apply (Additional options will show)
You have indicated that none above categories apply to your project. Please complete the REDCap Full Board Project Description
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
You have indicated that your project is likely exempt, Please complete the Exempt Project Description .
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
Please confirm your project meets all the requirements for this category listed below. Yes
No
Your responses indicate that you should submit a expedited project description. Please complete the Expedited Project Description .
Your answers indicate that this definition doesn't match your project. Please return to the question where you selected a type of research project and select a different answer.
Working...