institutional review board guidance. independent ethics committee ethical review board research...
TRANSCRIPT
Jackson State University
Division of Research and Federal Relations
Institutional Review Board Guidance
2
Independent Ethics Committee Ethical Review Board Research Ethics Committee
Institutional Review Board Defined
3
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
Institutional Review Board- U.S. Mandate
4
Brief History of the IRB System
5
Exempt Review Expedited Review Full Board Review
Institutional Review Board Exemptions
6
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
Institutional Review Board Composition
7
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
Institutional Review Board Responsibilities
8
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)
Institutional Review Board Responsibilities
9
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
Required Documents for IRB Protocol Submission
10
IRB Protocol Submissionhttp://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.
11
IRB Application
12
Specific Instructions for Completion of 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
13
Common Concerns Regarding IRB Applications
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
14
Review Process 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
16
QUESTIONS?