University of Pikeville

Institutional Review Board
147 Sycamore Street
Pikeville, Kentucky 41501
(606) 218-5421
Email: RitaThacker@upike.edu

 

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 (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’ Below *Required of all research study staff

2. Financial Conflict of Interests (FCOI) Certificate – see ‘Education’ Below *Required for NIH-funded research

3. Principal Investigator CV *Required for expedited full proposals

New studies and continuations of existing studies will not be processed by the UPIKE-IRB until all study staff have completed and submitted completion certificates for required training to the UPIKE-IRB administrator.

The university of Pikeville IRB (UPIKE-IRB) accepts web-based human subject’s protection training from the Collaborative Institutional Training Initiative (CITI) for certification in Human Subject Protection. Once initial training is completed, a refresher course must be taken every three years. A reminder will be sent to you via email.

The minimal training required is the applicable Human Subjects Research Basic Course module (Biomedical Research Investigators; Social & Behavioral Research Investigators; IRB Members; Students conducting no more than minimal risk research; or Research with data or laboratory specimens – ONLY) available at http://www.citiprogram.org.

Note: Your funding agency may impose other CITI modules.

All research investigators and study personnel must complete an online financial conflict of interest training module through the National Institute of Health. The link to the training module is http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.

We recommend that you print and save electronic copies of your certificates and keep easily accessible since the documents may be needed for future research applications. Also, we recommend that you keep a copy of the training website URL and your login information in a secure location.

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
Email: ritathacker@upike.edu
Phone: 606-218-5421


IRB Templates

1. Exempt IRB Application (IRB_Exempt Application Form)

2. Classroom Instructor’s Application (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)