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Human Subjects - Institutional Review Board (IRB)

Human Subjects Submission Process:

Submission of all applications and supporting documents should be sent via email to humansubjects@ucmo.edu. Full review protocols must be received at least five working days prior to the meeting date to be placed on the agenda. Expedited proposals and requests for exemption can be submitted at any time and are reviewed on an ongoing basis. The responsible conduct of research (RCR) training is required prior to submission. Please see additional information provided below.

Special Instructions for Student Researchers: Fill out the appropriate forms and email them to your advisor and to humansubjects@ucmo.edu, along with required materials including surveys, informed consent documents, letters of permission and recruitment text. We will respond with a return email confirming that we have received it. Reviewers' decisions generally take about two weeks.

Before completing an application, please take a few minutes to review the Human Subjects Guidelines. The Guidelines walk the researcher step by step through the process.

Human Subjects Guideline

IRB Procedures

Not Human Subjects Research Determination - To determine whether or not an IRB review is required, the research activity and human subjects involvement must be evaluated. This form and the IRB staff can help you. When a formal "not human subjects determination" letter is needed, submit this application and an IRB compliance officer will help you.

Forms Each exempt, expedited or full review application will need a summary. Here are suggestions: Project Summary Outline.
Exempt Application 
Expedited Review Application
Full Review Application

When the study is done or needs renewal complete this: Project Status Form.

Kinesiology Majors - Please refer to your advisor for blood and body fluid policy, ACSM risk stratification/ParQ and emergency response policies as indicated.

Electronic data management/destruction - The UCM recommendation is that this data needs to be secured just like hard copies (locked and/or password protected), and regardless of how it is saved (electronic, microfiche, thumb drive, ect.) the data needs to be wiped clean from these source and not just deleted for others to possibly retrieve. The retention timeline for the actual data is at the discretion of the researcher, however adherence to professional guidelines are strongly encouraged.  

Informed Consent Templates Written informed consent forms for face to face interactions are typically required. Researchers may use the following forms as a cut and paste template to ensure that all of the requirements have been met. For online surveys, researchers often use this template in the survey and request the subject select an agree/disagree to participate checkbox.

Informed Consent Dr. Overa's information should be replaced with your advisor's information. If being used to consent a parent, modify the wording in language written to the parent, e.g. instead of "you" use "your child".

Informed Assent This form is for a child's consent and needs to be modified in language written to the child.

International Studies

FULL REVIEW Meeting date for the summer 2013 is pending. Exempt and expedited applications will be reviewed on an ongoing basis throughout the summer. Spring 2013 meeting dates will be: Jan. 18, Feb. 1,15, March 1,15, 29, April 12, 26

Official Charge

Members of the Human Subjects Committee

Name
College
Term
Sandy Hutchinson
At-Large
2013
Thomas Mitchell Chair
At-Large
2013
Amber Clifford
At-Large
2013
Steve Burns
At-Large
2013
Alice Ruleman Vice Chair
At-Large
2014
Eric Endsley
Community
2013
Suhansa Rodchua
At-Large
2014
Barbara Baker
At-Large
2014
Steve Shattuck
Alternate
2013
Annie Callicotte
SGA
2013
Jenny Robins
Alternate
2013
Bart Washer
Alternate
2013

Thesis and Responsible Conduct of Research Training

A responsible conduct of research training requirement applies to ALL new proposals submitted for review. This training requirement is free through the Collaborative Institutional Training Initiative Web-based Training Program (CITI Program). The following are instructions to logon to CITI for the first time:

User should be instructed to go to www.citiprogram.org to register for CITI online training.
Once there, they simply click on "New Users Register Here".
Under "Select your institution or organization" page they should select UCM in the "Participating Institutions" drop down box.
Next they should proceed to create their own username and password and select the Learner group.
After going through registration process they should be ready and setup as CITI Learners.
Please contact citisupport@med.miami.edu in case of any questions.

Select a social and behavioral, physical science, biomedical or the humanities program most appropriate for your research.These programs have about 8 modules which typically take between 2-4 hours to complete. You may log in and out at any time saving previous work. Make a copy of your completion report for your records. CITI automatically sends a copy to human subjects. If you are already certified, please forward your certification to human subjects with your application. Refresher courses are required every three years.

UCM Ethics Policy

Ethics Procedure

Whistleblower Procedures