IRB Instructions and Forms
IRB Submission Process

When submitting your application to the IRB, the following items will or may need to be included:

Study Documents
1. IRB Application Form *One of the following three is Required
- Exempt IRB Application (IRB_Exempt Application Form)
- Expedited/Full IRB Application (IRB-Full_Application)
- Classroom Instructor’s Application (IRB_Instructor_Form)
2. Research Protocol (http://www.who.int/rpc/research_ethics/format_rp/en/ or equivalent funding agency template) *Required for expedited and full proposals
3. Informed Consent Form including HIPAA authorization
*Required for expedited and full proposals (IRB_Informed_Consent_Template)
4. Data Collection Tool(s) *Required
5. Recruitment Materials (Ads, Flyers, Posters, Phone Scripts, Press Releases, etc.) *Required if used

Required Investigator / Research Study Staff Documents
1. Human subjects protection training certificate – see ‘Education’ Tab *Required of all research study staff
2. Financial Conflict of Interests (FCOI) Certificate – see ‘Education’ Tab *Required for NIH-funded research
3. Principal Investigator CV *Required for expedited full proposals

Upon completion of required documents, save as a PDF and email or hand-deliver to the IRB Administrative Assistant

Rita Thacker, KYCOM IRB Administrator
Office Location: Coal Building 717
Phone: 606-218-5421

IRB Templates
1. Exempt IRB Application (IRB_Exempt Application Form)
2. Classroom Instructor’s Application (IRB_Instructor_Form)
3. Expedited/Full IRB Application (IRB-Full_Application)
4. Informed Consent Template (IRB_Informed_Consent_Template)
5. Protocol Template (http://www.who.int/rpc/research_ethics/format_rp/en/)

IRB Review Categories

o Exempt
Certain human research activities may be considered exempt. Only the UPIKE IRB may classify a study as exempt. If you believe your study may be exempt, please submit the Exempt Categories Checklist (IRB_Exempt Categories-Checklist) and Exempt IRB (IRB_Exempt Application Form) to the UPIKE IRB for review. You may not conduct any type of research at the University of Pikeville without UPIKE IRB review and written approval.

More information about Exempt Research > (IRB_ExemptResearchDescriptor)

o Expedited
Research activities involving no more than minimal risk may receive Expedited Review by the IRB. Minimal risk means that the probability and magnitude of harm anticipated in the research is not greater than what is normally encountered in daily life or during the performance of routine physical or psychological examinations or tests. If you believe your study may be expedited, please submit the Expedited Categories Checklist (IRB_Expedited Categories Checklist) and Full IRB Application (IRB-Full_Application) to the UPIKE IRB for review. You may not conduct any type of research at the University of Pikeville without UPIKE IRB review and written approval.

More information about Expedited Review > (IRB_ExpeditedResearchDescriptor)

o Full Board
Research activities involving greater than minimal risk to participants must be reviewed at a convened meeting of the IRB as part of the approval process. The IRB meets once a month and the schedule is posted on the website. If your study requires full IRB approval, submit the Full IRB Application (IRB-Full_Application) to the UPIKE IRB for review. You may not conduct any type of research at the University of Pikeville without UPIKE IRB review and written approval.

More information about Full Board Review > (IRB_FullBoardResearchDescriptor)
 
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