集美麻豆

Before you can submit an Institutional Review Board Application,  you will need to determine your level of review (risk).

• Level I: Exempt (no foreseeable risk)
• Level II: Expedited Review (minimal risk)
• Level III: Full Board Review (more than minimal risk and protected subjects)

This information is required for your IRB Application. Please take a moment to carefully consider the checklist worksheet and follow the corresponding instructions.

• A copy of the certifications of completion from the following online training program must be submitted to the IRB.
• You will need to complete and submit your certificates for each lesson.  

Informed consent is the cornerstone of ethical human subjects research.  There are specific requirements for consent material to meet the criteria of "Informed Consent."  The video below presents the Informed Consent process from the perspective of the participant.  Keep these points in mind when you create your informed consent material.

Templates for Informed Consent

What MUST be included in Informed Consent Material?

1. What is the name of the project? Who is the Principal Investigator/Student Investigators.?  
2. Describe the purpose of the research in under 100 words.  If the project is a class project include the class name and number.
3. Describe what the participant will do in under 100 words.
4. How will you record the information? How will you store and secure the information?  How long will you store the information?
5. What are the risks to the participant?
6. What are the benefits to the participant?
7. Is there any compensation for participating?  If there is compensation/benefit, what are the alternatives?
8. Will the data you collect be used for other research?
9. Are the data collected anonymously? How will you maintain confidentiality?
10. Information about withdrawal from the study.
11. Who does the participant contact if they have concerns or questions (Faculty PI/Sponsor and IRB email addresses)?

Once you have gathered all of the materials required above, you may fill in your application.

Approval of a human subject research proposal is good for one year, unless the project has acceptable but potential risk in which case approval is given for a six-month period. If the project will continue beyond the approval period, principal investigators are required to resubmit documents for review prior to the expiration date of the initial approval.