Every application submitted for review and approval shall have attached to it a page organized in numerical brief paragraph form as outlined below.

 

 

1.      Identify the sources of the potential subjects, derived materials or data. Describe the characteristics of the subject population, such as their anticipated number, age, sex, ethnic background, and state of health. Identify the criteria for inclusion or exclusion. Explain the rationale for the use of special classes of subjects, such as fetuses, pregnant women, children, institutionalized mentally disabled, prisoners, or others, especially those whose ability to give voluntary informed consent may be in question.

 

2.      Describe the procedures for recruitment of subjects and the consent procedures to be followed. Include the circumstances under which consent will be solicited and obtained, who will seek it, the nature of information to be provided to prospective subjects, and the methods of documenting consent. (Include applicable consent form(s) for review.) If written consent is not to be obtained, this should be clearly stated and justified.

 

3.      Describe the project’s methodology in detail. If applicable, detail the data collection procedures, the testing instruments, the intervention(s), etc.   If using a survey, questionnaire, or interview, please provide a copy of the items or questions.

 

4.      Describe any potential risks — physical, psychological, social, legal or other — and state their likelihood and seriousness. Describe alternative methods, if any, that were considered and why they will not be used.

 

5.      Describe the procedures for protecting against or minimizing any potential risks and include an assessment of the likely effectiveness of those procedures. Include a discussion of confidentiality safeguards, where relevant, and arrangements for providing mental health or medical treatment, if needed.

 

6.      Describe and assess the potential benefits to be gained by the subjects, as well as the benefits that may accrue to society in general as a result of the proposed study.

 

7.      Clearly describe any compensation to be offered/provided to the participants. If extra credit is provided as an incentive, include the percentage of extra credit in relation to the total points offered in the class.  Also, if extra credit is provided, describe alternatives to participation in your research for earning extra credit.

 

8.      Discuss the risks in relation to the anticipated benefits to the subjects and society.

 

9.      Identify the specific sites/agencies to be used as well as approval status. Include copies of approval letters from agencies to be used (note: these are required for final approval). If they are not available at the time of IRB review, approval of the proposal will be contingent upon their receipt.

 

10. If you are a student, indicate the relationship of the proposal to your program of work and identify your supervising/sponsor faculty member.

 

11. In the case of student projects, pilot studies, theses, or dissertations, evidence of approval of Supervising Professor or Faculty Sponsor should be included. Thesis and dissertation proposals must be approved by the student’s committee before proceeding to the IRB for review.

 

12. If the proposed study has been approved by another IRB, attach a copy of the letter verifying approval/disapproval and any related correspondence. If the proposed study has not been reviewed/approved by another IRB, please state this explicitly.

 

13. Identify all individuals who will have access, during or after completion, to the results of this study, whether they be published or unpublished.