The Institutional Review Board:
A Community College Toolkit
Dr. Geri J Anderson
Overview
•
•
•
•
•
Why an IRB at Community Colleges
Overview of the IRB Design
Type of Research & Reviews
Where to Begin: Implementation of the IRB
The Research Proposal Process
History of the IRB
• The Belmont Report: Three Basic Ethical Principles
• Respect for Persons
• Beneficence
• Justice
• Federal Regulations & Policy
– 45 CFR 46-Basic DHHE Policy for Protection of Human Research
Subjects
• Federal Policy for the Protection of Human Subjects
– “The Common Rule” June 18, 1991
• Food & Drug Administration
– 45 CFR 46-Basic DHHE Policy for Protection of Human Research
Subjects
What is an IRB
• An Administrative Body Established to Protect the
Rights of Welfare of Human Research Subjects
Recruited To Participate in Research Activities
• Independent of Other Committees & Independent of
the Needs of the Institution
• All Research Involving Human Subjects (or their
records) Must Be Reviewed by an IRB
Duties of an IRB
• Review all research activities involving human
participants and document the findings
–
–
–
–
Risks to subjects are minimized
Selection of subjects is equitable
Informed Consent is obtained
Privacy and confidentially is protected
• Responsible for ensuring compliance with FWA,
federal regulations & institution policies
Additional IRB Duties
• Review research protocols with authority to:
–
–
–
–
Approve
Require Modifications
Deny
Terminate
• Conduct continuing reviews of approved research;
review proposed amendments
• Ensure Progress Reports & Findings are provided
IRB Oversight
• Human Subjects Research
–Review of records
–Clinical investigations
–New interventions
•Data Repositories
•Case Studies
•Internet Research
•Pilot Studies
•Non-human Subject/Non-research check
Composition of an IRB
Membership = 5 Members
–
–
–
–
–
–
–
Scientific Area
Nonscientific Area
External to the Institution
Institutional Researcher
Institution General Counsel
Diversity of Representation
Diversity of Gender
Other IRB Components
• IRB Members May Not Participate in Review of Their Own or
Students’ Projects
• IRB May Seek Advice From Non-Member Experts
• By Federal Definition, the IRB is a BOARD not an Institution
COMMITTEE
• The Mission of an IRB is to Ensure the Protection,
Safety and Welfare of Human Subjects
The Bottom Line
 No One Can Be Objective About Their Own Work
 People Underestimate The Risks Involved In
Things in Which They Are Familar
People Overestimate The Benefit Of Things That
Are Important To Them
 Protects Subjects & The Institution
 Ensures Research Is Shared
Establishing Your Institution’s IRB
 Create Charter. Written Procedures & Operating
Principles
 Establish Approval Process (& Forms) For Types
of Review
IRB Decision Matrix
Full Review
Expedited
Exempt
Training
BENEFICENCE
Risk/Benefit Analysis
Experimental Design
Qualifications of PI
JUSTICE
Subject Selection
Inclusion/Exclusion
Recruitment
Respect For Persons
Informed Consent
Privacy & Confidentiality
Surrogate Consent
Protection of Subjects
The Review Process
Proposal
Submitted
Changes?
Review by
IRB
Notification
of Decision
Need
Additional
Review
Annual
Review
Required
Share
Results of
Study
What Review Required
FULL STANDARD REVIEW
– More Than Minimal Risk
• Generally Invasive Studies
– Requires Review & Approval (by Vote) of Full IRB
– Should Be Reviewed Regularly
• Informed Consent (10th Grade Reading Level)
• Research Design
EXPEDITED REVIEW
– Very Minimal Risk
– Non-Invasive
– Study of Materials Collected For Non-Research Purposes
EXEMPT
– Surveys, Educational Tests
– No Follow-up Needed
– Important: Study done with minors, inmates or other special populations
cannot be exempt
Important Definitions
– Research: a systematic investigation designed to
develop or contribute to generalizable knowledge
– Human Subject: a living individual about whom
an investigator conducting research obtains
• Data through intervention or interaction with the
individual
• Identifiable private information
– Informed Consent: Not a single event or just a
form—but, an educational process between
investigator and the perspective subject
Informed Consent Elements
o Full Disclosure of the Nature of the Research & The
Subjects’ Participation
o Adequate Comprehension on the Part of the Potential
Subjects
o The Subjects’ Voluntary Choice to Participate
o Document Informed Consent and Assent In Accord
With Federal Regulations and as Approved by the IRB
IRB Decision Matrix
Approval Without Any Changes
Approval Pending Minor Changes
Tabled
major questions raised about the study design
but study is believed to be worthwhile
Disapproved (rare)
Proposal Components
•
•
•
•
•
An Application
A Consent Form
A Protocol
Training Completion Certificate for PI
Additional Supporting Documents (questionnaires, interview
questions, surveys)
IRB Training
It is a federal requirement that all institutions
conducting federally-funded human subjects
research provide proof of training in human subjects
research protections
Investigators who conduct human subjects research
that is exempt from IRB review MUST comply with
the education requirement
Institution Designed Training
• Basic Ethical Principles Underlying Research with
Human Participants (The Belmont Report Guidelines)
• Federal Regulations for Protection of Research
Participants
• History & Ethics of Research with Human Participants
Note: Completion of training must be documented and
maintained for 3 years
Training Options
The Collaborative Institutional Training Initiative (CITI)
Human Subjects Research Education Program through
the University of Miami provides a comprehensive
selection of educational modules that can be used to
satisfy institutional instructional mandates
Modules include:
17 basic modules focused on biomedical research
11 basic modules focused on Social and Behavioral
research
Continuing Education (CE) modules
Completion Certificate Available
www.citiprogram.org
Suggested IRB Chair Responsibilities
• Maintain Federalwide Assurance (FWA) and ensure
compliance
• Develop & Implement human subject protection
policies and procedures
• Conduct Required Trainings
• Preside over IRB meetings & ensure the IRB carries
out duties appropriately
• Review & Approve Protocol Submissions For Review
• Notify Investigators/PI of IRB Decisions
• Maintain IRB Documentation; Track Needed Updates
Action Plan
 Review the OHRP Institutional Review Board Guidebook
(http://www.hhs.gov/ohrp/)
 Establish Charter, Written Procedures & Operating Principles
 Recruit and train IRB members using federal guidelines
(http://ohsr.od.nih.gov/IRBCBT/intro.html)
 Design and Implement Training Program
 Establish Record Keeping Procedures
Thank You & Questions
For Sample IRB Charter, Forms, or
Questions, please feel free to contact:
Geri J. Anderson
[email protected]
Download

The Institutional Review Board