Institutional Review Board Guidance.  Independent Ethics Committee  Ethical Review Board  Research Ethics Committee 2.

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Presentation transcript:

Institutional Review Board Guidance

 Independent Ethics Committee  Ethical Review Board  Research Ethics Committee 2

 Governed by Title 45 Code of Federal Regulations Part 46  National Research Act of 1974  Department of Health and Human Services (HHS)  Office of Human Research Protections with HHS 3

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 Exempt Review  Expedited Review  Full Board Review 5

 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 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.

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 Please READ ENTIRE Application  Please ANSWER ALL Questions  List JSU as the primary  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 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

  6 th Floor of Administration Tower 15

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