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IRB Research Review Request Form


Date:_____ Department(s):___________________________________________

Principal Investigator (PI) & Co-investigators (CO):________________________________
__________________________________________________________________________

Phone Number of PI: (W)_________________ (H)___________________

Project Title:_______________________________________________________________

Funding Source: ___External ___ Internal ___ No Funding Requested

Participant Compensation: __No __Yes (specify amount)_________

Type of participants: (check all that apply)
   __ Millikin students __ Millikin employees __Minors (under age 18) __Other adults
   __Other (please specify):___________________________________________________

 

Source of participants: (check all that apply)
__Posted notices
__Public Schools
__Classrooms
__Community
__Letter
__Telephone
__Newspaper Ad
__Prisons
__Hospitals / Nursing Homes

Invasive or sensitive procedures:
__None
__Urine Samples
__Stress exercise
__Physical Measurements
__Blood Samples
__Alcohol, drugs, sex
__Depression Inventory
__Depression / Suicide
__Learning Disability
__Other (specify)__________________________________________________________

Informed Consent
: ___Oral   ___Written
   Indicate location and person storing consent forms:___________________________

Confidential materials usage (check all that apply):
__Anonymous data
__Coded data (#=name)
__Audiotaped data
__Videotaped data
__Name linked data
__Other (specify)____________________

Data Storage
:
  Retained:___No ___Yes     If yes, destruction date:_______________________________

Types of review
:
     Submit 2 copies   
__Exempt (optional)
__Annual renewal     
   (required, unchanged 
    procedure only)      
      Submit 3 copies
__Expedited (required)
     
      Submit 6 copies
__Standard (required)
     


INSTRUCTIONS: For Annual Renewal, submit 2 copies of the 1st page of this  form.  For Exempt, Expedited, & Standard Research review requests, staple the 1st page of this form to your typed responses to Questions 1-8 below. Please limit your responses to the questions to  5 pages.

1. Describe, in layman's terms, the rationale or reason for conducting the research. 
If technical language is necessary, please define the terms either in the text or in an 
appendix.
2. Describe the characteristics of the proposed participant population and provide a rationale for using these participants. In addition, explain how participants will be recruited (e.g., participants pool, newspaper) and/or selected (e.g., selection based on pretest data) and what, if any, compensation participants will receive for their role in the study.
3. Describe how informed consent will be obtained. Include a copy of the informed consent form or a summary of the oral statement that will be used with the participants. If feel you can not obtain written consent, then a full justification for using oral consent must be provided. If you are using "special populations" such as children, prisoners, persons with mental or physical disabilities, or other individuals whose ability to give informed consent may be questionable, then provide a detailed explanation of how you will comply with the informed consent guidelines.
4. Describe the research apparatus (e.g., EEG) or materials (e.g., survey instrument) that will be used in the study, and its purpose and effect(s) on the participant.
5. Summarize the procedures of the study and the type(s) of data to be collected (e.g., test scores, interview data, observations). Attach any survey instruments or tests to be used in the study. Also include a transcript or summary of the instructions participants will receive. Indicate how you will inform participants of their right to withdraw from the study. Finally, summarize the debriefing that participants will receive (if appropriate).
6. If participants will be deceived or there are features of the study that can not be revealed to the participants prior to their participation, then provide an explanation and justification. Explain why alternative methods can not be used. Indicate how you will safeguard the participant's right to withdraw under these conditions. Also, describe how your debriefing will deal with the deception or incomplete information, and inform the participant that they have the right to request their data be discarded and destroyed if they disagree with the need for deception.
7. Please indicate the potential risks and benefits to participants and the public. Provide specific detail about any procedure that is likely to place the participant at "more than minimal risk" or is potentially harmful (e.g., unusual stress, invasion of privacy, invasive procedures). If there are any alternative procedures that would present less risk to participants, a description of these procedures and an explanation for why they can not be used must be provided. Finally, indicate how you plan to detect any harm to participants as a result of their participation, and how these effects will be removed or alleviated.
8. Describe how confidentiality will be protected. This information is usually contained in the required informed consent form.

 

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