The IRB must have at least five members The members must have experience in ethical research and determine if informed consent is sufficient The members of the IRB must not be from the same profession The IRB must include one scientist and one non-scientist The IRB must have one person who is not affiliated with the university- community member 6
Protect the rights and welfare of humans participating as subjects in a research study Protect subjects by reviewing research protocols and related materials Protect the ethics of the research and its methods Promote fully informed and voluntary participation by study subjects Seek to maximize the safety of subjects 7
Provide researchers with access to federal guidelines for protection of human subjects Track and follow up on each human research project to ensure continued compliance with 45 CFR 46 To ensure that all research involving human subjects meets or exceeds subject protection standards set forth in Title 45 Code of Federal Regulations Part 45 (45 CFR 46) 8
Signed Research Protocol Application Informed Consent Form Assent Form (if applicable) Survey Instrument Survey Consent Script Documentation of appropriate CITI Training Documentation of written permission from cooperating institutions 9
10 http://www.jsums.edu/research/compliance-unit/human-subjects/irb- protocol-submission/ Go to the Division of Research and Federal Relations website, click Compliance - Human-subjects; and click on “IRB Protocol Submission” for directions and a complete Application.
Please READ ENTIRE Application Please ANSWER ALL Questions List JSU email as the primary email Complete CITI Training Courses: Students: Students Conducting No More Than Minimal Risk Faculty/Staff: Social and Behavioral Research Students and Faculty must submit CITI Trainings found at www.citiprogram.org 12
Application is incomplete Application is predated Does not address protection of subjects confidentiality Where will the data be stored? (Provide building and office number) Application is not signed by applicant and faculty advisor 13
FULL IRB REVIEW ONLY: Must be submitted two weeks prior to the monthly IRB meeting to qualify for review If exempt from full review, then application is reviewed and modifications are noted Expedited reviews are routed to board members 14