Understanding Institutional Review Boards (IRBs) and Their Importance in Research

 
Institutional Review Board
 
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Nuts and Bolts of CGU IRB Procedures
 
One man's life or death were but a small price to pay for the
acquirement of the knowledge which I sought, for the dominion I
should acquire and transmit over the elemental foes of our race.
 
Why do we need an IRB?
 
- Mary Shelley, 1818, Frankenstein (Letter 4.21)
Why do we need an IRB?
 
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Physics – atomic science
Medical experiments in Nazi prison camps
Triggered Nuremberg trials 
 Nuremberg Code
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1949 – Human radiation exposure experiment
1956-70 – Willowbrook hepatitis study
1960s – Army/CIA LSD experiments
1931-1972 Tuskegee syphilis experiment
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Why do we need an IRB?
 
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None but those who have experienced them can conceive of the
enticements of science. In other studies you go as far as others
have gone before you, and there is nothing more to know; but
in a scientific pursuit there is continual food for discovery and
wonder.
 
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“Guards” behavior led to
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Many “prisoners” emotionally
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IRB—Not just for medical science
 
 
 
Essential IRB: The Belmont Principles
 
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Equitable distribution of
burden and benefits
 
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Do no harm
Maximize benefits &
minimize harm
 
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Individual autonomy is
respected
Extra protection for persons
with diminished autonomy
 
IRB Mission
 
Facilitate 
ethical
 conduct of research with
human subjects
Promote a culture of research that aspires
to highest ethical standards
 
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The Purpose of IRB Review
 
Assure that all investigators meet specific
ethical standards
 in all research that
involves 
human subjects.
Assure compliance with federal regulations
and university policies
 
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9
 
IRB Process in a Nutshell
 
PI completes human subjects protections training
Faculty, or students 
with faculty endorsement,
 submit
“protocols” (specific descriptions of study designs)
An IRB staff member reviews protocol for
completeness
At least one IRB analyst or member reads each entire
application package
Research is designated by the risk level into exempt,
expedited, or full board review
Often necessary for IRB to correspond with
investigator(s) to seek written clarification or revision
of one or more protocol elements
 
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IRB Classifications
 
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Completing & Submitting the Protocol
 
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IRB protocol completely filled out
Signature of PI, Faculty Advisor, and Co-PI (if
applicable)
Informed Consent form / Assent form (minors)
Recruitment scripts, email, or flyers
Copies of all Questionnaires or other Research
Materials (if applicable)
Protecting Human Subjects training certificate
 
citiprogram.org/
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Minimum 2-3 wks (Exempt & Expedited)--
seasonally longer
Full Board Review may require additional time;
note the IRB calendar deadline for assuring
review by the next monthly full board meeting
 
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Pay Attention to….
 
Consent Vs. Assent (samples on website)
Deception (Temporary only!  Is it really
necessary? Causes extra scrutiny)
Confidentiality (keeping it secret) Vs. Anonymity
(no names are taken or learned)
Special populations
Clarity and Organization
Grammar and Spelling
 
 
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Consent Components
 
Study leadership (who is the PI? Who is the faculty advisor?)
Sponsorship (if applicable)
Purpose of the study
Eligibility (inclusion and exclusion criteria)
Participation (what will participants be asked to do, for how long?)
Risks of participation
Benefits of participation (remember: helping you out with a study is NOT a
benefit to participants)
Compensation
Voluntary participation**
Confidentiality
Further information
Consent statement (either signed or click-box)
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Informed Consent
 
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Consent = subjects over 18 years of age
Assent = minors (under 18 years of age)
 
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(1) When the only record linking the subject and the research
would be the consent document and the principal risk would be
potential harm resulting from a breach of confidentiality.
(2) When the research presents no more than minimal risk of
harm to subjects and involves no procedures for which written
consent is normally required outside of the research context.
 
 
 
15
 
How to Respond to IRB
Questions/Comments
 
IRB Responses are sent via Mentor (& email notification) to
the PI and Faculty Advisor—PI can respond directly or login to
Mentor
 
Respond directly to each IRB point using different font, italics,
or bold text to highlight your response
 
Submit revised materials two ways: with bold or other markers
to show changes, and in a final (clean) version
 
16
 
After Submission and Approval
 
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For changes to approved protocols, use the Amendments tab
at the bottom of the protocol.
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To request continuation of approved research, use the
Renewals tab at the bottom.
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Something goes wrong or you deviate from protocol, use tab
at bottom
 
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More Information:
 
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http://www.cgu.edu/irb
 (See Links menu)
http://www.hhs.gov/ohrp/policy/faq/index.html
 
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     Email:   
irb@cgu.edu
    Phone:  909-607-9406
Hours: 8:30AM – 5:00PM
Website: http://www.cgu.edu/irb
Location: 152 Harper Hall
 
18
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Explore the significance of IRBs in research, tracing back to historical events like WWII and ethical violations that led to the establishment of principles such as the Belmont Principles. Learn about the diverse scope of IRB oversight, from medical to social science studies, and the core mission of promoting ethical research practices and protecting human subjects.


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  1. Institutional Review Board Nuts and Bolts of CGU IRB Procedures James Griffith Institutional Review Board Manager

  2. Why do we need an IRB? One man's life or death were but a small price to pay for the acquirement of the knowledge which I sought, for the dominion I should acquire and transmit over the elemental foes of our race. - Mary Shelley, 1818, Frankenstein (Letter 4.21)

  3. 3 Why do we need an IRB? WWII represents a turning point in the ethics of science Physics atomic science Medical experiments in Nazi prison camps Triggered Nuremberg trials Nuremberg Code Nuremberg code violated even in U.S. 1949 Human radiation exposure experiment 1956-70 Willowbrook hepatitis study 1960s Army/CIA LSD experiments 1931-1972 Tuskegee syphilis experiment Recognition of ethical issues led to push for acceptance of Belmont Principles and finally the Common Rule

  4. IRBNot just for medical science Abuses not limited to biomedical studies Milgram s obedience studies Stanford Prison Experiment Guards behavior led to dangerous and psychologically damaging situations Many prisoners emotionally traumatized Breech of confidence can be a major risk

  5. 6 Essential IRB: The Belmont Principles Justice Equitable distribution of burden and benefits Beneficence Do no harm Maximize benefits & minimize harm Respect for persons Individual autonomy is respected Extra protection for persons with diminished autonomy

  6. 7 IRB Mission Facilitate ethical conduct of research with human subjects Promote a culture of research that aspires to highest ethical standards

  7. 8 The Purpose of IRB Review Assure that all investigators meet specific ethical standards in all research that involves human subjects. Assure compliance with federal regulations and university policies

  8. 9 Do You Need IRB Review? Determining the Applicability of 45 CFR Part 46 Consider the following questions: Does the activity involve Research? Does the activity involve Human Participants?

  9. 10 IRB Process in a Nutshell PI completes human subjects protections training Faculty, or students with faculty endorsement, submit protocols (specific descriptions of study designs) An IRB staff member reviews protocol for completeness At least one IRB analyst or member reads each entire application package Research is designated by the risk level into exempt, expedited, or full board review Often necessary for IRB to correspond with investigator(s) to seek written clarification or revision of one or more protocol elements

  10. 11 IRB Classifications Exempt. Studies to improve or evaluate standard practices in educational institutions; fully anonymous non-sensitive surveys; analysis of pre-existing anonymous data; other specific exemptions Expedited. No more than minimal risk, no special populations such as pregnant women, prisoners, minors, mentally disabled Standard(Full Board Review). Higher than minimal risks or studies of special populations

  11. 12 Completing & Submitting the Protocol Checklist for Initial Review IRB protocol completely filled out Signature of PI, Faculty Advisor, and Co-PI (if applicable) Informed Consent form / Assent form (minors) Recruitment scripts, email, or flyers Copies of all Questionnaires or other Research Materials (if applicable) Protecting Human Subjects training certificate citiprogram.org/ Timeline Minimum 2-3 wks (Exempt & Expedited)-- seasonally longer Full Board Review may require additional time; note the IRB calendar deadline for assuring review by the next monthly full board meeting

  12. 13 Pay Attention to . Consent Vs. Assent (samples on website) Deception (Temporary only! Is it really necessary? Causes extra scrutiny) Confidentiality (keeping it secret) Vs. Anonymity (no names are taken or learned) Special populations Clarity and Organization Grammar and Spelling

  13. 14 Consent Components Study leadership (who is the PI? Who is the faculty advisor?) Sponsorship (if applicable) Purpose of the study Eligibility (inclusion and exclusion criteria) Participation (what will participants be asked to do, for how long?) Risks of participation Benefits of participation (remember: helping you out with a study is NOT a benefit to participants) Compensation Voluntary participation** Confidentiality Further information Consent statement (either signed or click-box) See Informed Consent Form with Embedded Instructions for in-depth instructions

  14. 15 Informed Consent Consent form vs. Assent form Consent = subjects over 18 years of age Assent = minors (under 18 years of age) Waiver of Signed Consent Documentation (1) When the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. (2) When the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

  15. 16 How to Respond to IRB Questions/Comments IRB Responses are sent via Mentor (& email notification) to the PI and Faculty Advisor PI can respond directly or login to Mentor Respond directly to each IRB point using different font, italics, or bold text to highlight your response Submit revised materials two ways: with bold or other markers to show changes, and in a final (clean) version

  16. 17 After Submission and Approval Amendments For changes to approved protocols, use the Amendments tab at the bottom of the protocol. Renewals To request continuation of approved research, use the Renewals tab at the bottom. Closure Use Terminate Protocol button at top of protocol. Adverse Events Something goes wrong or you deviate from protocol, use tab at bottom

  17. 18 More Information: Frequently Asked Questions http://www.cgu.edu/irb (See Links menu) http://www.hhs.gov/ohrp/policy/faq/index.html Contact the IRB for clarifications Email: irb@cgu.edu Phone: 909-607-9406 Hours: 8:30AM 5:00PM Website: http://www.cgu.edu/irb Location: 152 Harper Hall

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