The IRB Review Process: A Comprehensive Overview by Dr. Kathryn Greene
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Navigating the IRB Review Process
Dr. Kathryn Greene
Professor, Communication
IRB Board Member
2
Introduction
•
Overview of presentation
–
Background, submission, resources, timing, procedure,
certification, forms, risk, consent, quality submissions, changes in
protocols
•
~60-75 Minutes plus question and answer
•
Regulations change and interpretations are updated, so this
area requires regular education
3
Why IRB? Tuskegee, Nazi, Zimbardo, Willowbrook
4
Why IRB?….Look at History
1948 Nuremberg Code (post WWII)
1964 Declaration of Helsinki (World Medical Assn.)
1974 Response to the Tuskegee Syphilis Study:
US National Commission
for the Protection of Human Subjects of
Biomedical and Behavioral Research
met from 1974-1978 (
in the
Belmont Conference Center of the Smithsonian Institute
)
1978 Belmont Report issued
2014 Questionable research continues . . .
One study manipulating facebook feeds to alter
people’s emotions (deception) and another study
trying to alter judicial elections in US states
5
What’s different about IRB?
•
Federally mandated process
(not like other committees)
•
Some issues NOT at discretion of members (regulations)
•
Regulations dictate much of the process
•
Investigators do
not
have authority to determine level of risk
•
Compliance issues can potentially affect entire Rutgers
community (i.e., it’s about all of us, not just about you)
6
W
h
a
t
i
s
t
h
e
I
R
B
?
•
Institutional Review Board for the Protection of Human Subjects in Research
•
Guidelines for IRBs in Federal regulations (45 CFR 46 & 21 CFR 50)
•
The Rutgers IRB reviews and approves
all
humans subjects research conducted at
the University. The IRB has the authority to:
–
Approve, require modifications in or disapprove all research activities
–
Monitor research activities records (Random Audits)
–
Suspend or terminate any research (non-compliance)
•
The IRB is now known as the Arts & Sciences IRB, within Office of Research
Regulatory Affairs (ORRA). Located in downtown New Brunswick.
•
RBHS has the Health Sciences IRBs which are located on both the Newark and New
Brunswick/Piscataway Campuses.
•
The IRB website includes specific details along with applications, instructions and
other FAQs. Please review the website first before completing any forms.
7
Do I have to submit?
Title 45 of the Code of Federal Regulations, Part 46
•
Involves research
–
Research is defined as a systematic investigation, including
research development, testing and evaluation, designed to produce
or contribute to
generalizable
knowledge
(45 CFR 46.102)
A
N
D
•
Involves human subjects
–
Human subject is defined as a living individual about whom an
investigator (whether professional or student) conducting research
obtains (either): data through intervention or interaction; or private,
identifiable information
(45 CFR 46.102(f)).
8
What makes something “Generalizable”?
•
Draw conclusions across some group/phenomena
•
Research may have “predictive value”
•
Difference between one interview & sampling for interviews
Examples could include public figures (politicians),
sports figures, survivors of a disaster, etc.
•
Oral histories, while scholarly, MAY not meet the criteria for
submission; this depends on the individual case (submit to IRB
and have them determine)
9
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Pass the Collaborative Institutional Training Initiative (CITI Program)
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View the online power-point presentation followed by a test
–
You must be certified
before
you can start your research
•
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–
Submit a new protocol for review and approval OR
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Request an amendment (modification) to an existing protocol
–
Undergraduates are not allowed to submit protocols on their own at
Rutgers; graduate students must have Co-PI full time faculty
10
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Respect for persons
(operationalized by Informed Consent)
–
Voluntary informed consent
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Respect for privacy
–
Added protections (children, prisoners, pregnant women/fetuses)
•
Beneficence (“do no harm”)
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Good research design and manage conflicts of interest
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Maximize benefits, minimize risks
•
Justice
–
Equitable selection of subjects, inclusion and exclusion criteria
–
Equal distribution of both benefits and burdens of research
11
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The charge of the IRB is to protect the rights and welfare of research
participants –the IRB must weigh risks vs. benefits
How a protocol is reviewed depends on the level of risk to subjects
Minimal
risk:
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Greater than minimal risk (GTMR)
:
“more than minimal risk” (literally the definition…)
12
Type of Collected Data
•
Anonymous
–
No link between name/identity and person
–
If identifiers are removed at data entry, CAN be anonymous
–
Note this involves specifics of details collected, not simply names
•
Confidential
–
Have a link, even for a short time (e.g., some longitudinal studies)
•
Cannot be both!!!
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If you want to disclose a name (e.g., an interview), you must address
this in consent form!
13
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Definition is “exempt from further (yearly) review” (does not mean exempt from
applying)
–
“Anonymous”
–
No children outside of category 1
–
Note NHR
•
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–
Yearly Continuing Review
•
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–
Yearly Continuing Review
14
Timing
•
See CURRENT Deadlines Online:
https://orra.rutgers.edu/irb-
deadlines-meetings
–
Exempt Review: Due each Wednesday (5 pm). Plan for 2-3 weeks
for review/approval
–
Expedited Review: Due 12th of each month (except in August-no
meeting). Plan for 6-8 weeks for review/approval
•
Expect any questions 1-3 weeks after submission via email and
respond ASAP (the board only meets monthly, so delay can
send an application to the next meeting)
•
When responding, do so item by item (like a review)
•
Notices of Approval/CR Reminders sent via email to PI/Faculty
Advisor.
15
Procedure
•
Each submission sent to IRB members (usually 2)
•
The reviewers confer and may request clarification
–
Note timing, try to respond quickly
–
You will be working with Administrator through email
•
When all inquiries are addressed, goes on official roster
–
Meets once a month
–
No meeting in August
–
Will need all letters of authorization, revisions for final approval
–
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16
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•
The consent form is a permanent record of conveyed information and
the subject’s willingness to participate
•
A subject can withdraw consent and drop out of the study at any time
for any reason without penalty
(Computerized surveys must be allowed to skip
questions/prorate payments)
•
Default: signed w/ copy to participant (can request alteration)
17
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8 basic consent elements
Description of the research (purpose, duration, procedures)
Foreseeable risks/discomforts
Potential benefits
Alternatives to participating (if any)
Confidentiality (protection of personal information, data
storage/protection)
Compensation
Contact Information (Investigator and IRB)
Voluntary Participation
S
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!
!
!
18
Consent: Waivers & Alterations
Waiver of
Informed
Consent –PI must request & address all points:
1.
No more than minimal risk
2.
Not adversely affect subjects
3.
Could not
practicably
be carried out (definition: capable of being put into practice or of
being done or accomplished; feasible, note this is not ease)
4.
Additional information will be provided (debriefing)
Example: Secondary data analysis involving a large private dataset
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Waiver of
Written
Consent –PI must request & address the following:
1.
Consent is only record linking subject and research; the link poses risks; or
2.
Research presents no more than minimal risk of harm to participants; and
3.
Involves no procedures for which written IC is normally required outside of the
research context
Example: Telephone-based research or research where you do not want to store names
(e.g., not legally in the country)
19
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•
Plan ahead
–
Students should plan to submit 2-3 months prior to when they plan
to begin the research.
–
Review all current deadlines for IRB submissions
•
Use Current Application Forms
–
See website for current versions: https://orra.rutgers.edu/irb-
applicationsforms
–
Examples of consent forms available on the website and within the
instructions attached to each application
–
Your Faculty Advisor/Mentor is your very best resource!!!!
•
Ensure the submission is complete
–
Don’t ignore check-lists, attachments, questions you think are irrelevant
–
Incomplete submissions will be returned without review
20
“
C
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e
”
p
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p
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s
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s
•
Use Current Application Forms: (2014.a right now)
•
All CITI dates for ALL personnel
•
No missing attachments---
–
Attachment 1: Research Protocol: On average, provide a 2-5 page
summary NOT a 50 page dissertation proposal (some grants require
attachment of grant proposal; in addition write a 1 page summary of
rationale and methods).
–
Attachment 4: Consent (see sample on website, all IRB contact info)
–
Attachment 6: Authorization letters or Letters of Cooperation
–
Attachment 7: Outcome Measures-surveys, focus group guides or
interview items
–
Attachment 9: Debriefing (required if any deception)
–
For International Sites-Must include Appendix C or D
•
Attach a cover letter if anything is missing or unusual
21
Quality proposals--conceptual
•
Overall protocol quality
–
NOTE that the IRB does NOT comment on the science (theory,
design, etc.) [unless it affects human subjects!]
•
Must address level of risk, demonstrate understanding of the balance
and issues
–
Could be the topic, the population, etc.
•
Consent form is in layperson language (readability programs)
22
Emerging Issues
•
Regulations and guidance change over time; there is a current
proposal under consideration to change regulations. At BEST, this
would be several years away from implementation
•
Important to update education
•
RU moving to online for submission/review (eIRB)
•
The merger is affecting many things (HIPPA issues)
•
Examples of current “issues”
–
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F
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)
–
Genetic testing and medical samples
–
Storage of blood/tissue samples (with no expiration date)
–
Consent of cognitively impaired individuals
23
When Does IRB Review “end” for a Study?
•
Includes data analysis (not just recruitment and testing/data
collection)
•
Be sure to notify of personnel changes (even new GA/RA)
•
When the study is completed – terminate the approval (notify IRB
staff)
•
Expiration dates/renewals are PI responsibility!
–
Continuing review
–
IRB is not required to send a letter
–
Expiration date is on the approval letter
–
No work on a project can proceed if a proposal is closed
–
There is no “grace period” (prohibited by the regulations)
24
What if my Study Changes? (a form…)
•
Alterations, even minor, must be sent to IRB, called “Amendment” (a
modification to an approved project)
•
Some can be approved by staff, others are sent to reviewers
•
Sometimes shows up with Continuing Reviews; take care of this
beforehand so your study is not interrupted
•
Remember that the application is a signed document specifying very
specific procedures and details
•
Examples
:
–
Number of subjects
–
Criteria for participant recruitment (even labels)
–
Adding new data collection sites
–
Altering an instrument (e.g., add items to a survey)
–
Staff person leaves project or new person is hired
25
Summary
•
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t
=
I
R
B
R
e
v
i
e
w
•
CITI, no longer HSCP
•
Adherence to Approved Protocol (specific details)
•
Continuing Review
•
Ongoing Communication with IRB
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.
26
Questions?
•
Speak 1
st
with your Faculty Advisor
•
Visit IRB Human Research Website for FAQs & to Obtain Templates
•
If Contacting IRB staff for specific questions, you must copy Faculty Advisor
M
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https://orra.rutgers.edu/irb-contact-us
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Delve into the essential aspects of the IRB review process with Dr. Kathryn Greene, a professor and IRB board member. Explore the historical context, regulations, significance, and procedures involved in navigating the IRB review process. Gain insights into the importance of IRB in protecting human subjects in research and ensuring ethical practices. Discover the key responsibilities of researchers and the pivotal role of the Institutional Review Board in upholding research standards.
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Presentation Transcript
Navigating the IRB Review Process Dr. Kathryn Greene Professor, Communication IRB Board Member
IRB Presentation Introduction Overview of presentation Background, submission, resources, timing, procedure, certification, forms, risk, consent, quality submissions, changes in protocols ~60-75 Minutes plus question and answer Regulations change and interpretations are updated, so this area requires regular education Dept. of Communication 2
IRB Presentation Why IRB? Tuskegee, Nazi, Zimbardo, Willowbrook Dept. of Communication 3
IRB Presentation Why IRB? .Look at History 1948 Nuremberg Code (post WWII) 1964 Declaration of Helsinki (World Medical Assn.) 1974 Response to the Tuskegee Syphilis Study: US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research met from 1974-1978 (in the Belmont Conference Center of the Smithsonian Institute) 1978 Belmont Report issued 2014 Questionable research continues . . . One study manipulating facebook feeds to alter people s emotions (deception) and another study trying to alter judicial elections in US states Dept. of Communication 4
IRB Presentation What s different about IRB? Federally mandated process (not like other committees) Some issues NOT at discretion of members (regulations) Regulations dictate much of the process Investigators do not have authority to determine level of risk Compliance issues can potentially affect entire Rutgers community (i.e., it s about all of us, not just about you) Dept. of Communication 5
IRB Presentation What is the IRB? Institutional Review Board for the Protection of Human Subjects in Research Guidelines for IRBs in Federal regulations (45 CFR 46 & 21 CFR 50) The Rutgers IRB reviews and approves all humans subjects research conducted at the University. The IRB has the authority to: Approve, require modifications in or disapprove all research activities Monitor research activities records (Random Audits) Suspend or terminate any research (non-compliance) The IRB is now known as the Arts & Sciences IRB, within Office of Research Regulatory Affairs (ORRA). Located in downtown New Brunswick. RBHS has the Health Sciences IRBs which are located on both the Newark and New Brunswick/Piscataway Campuses. The IRB website includes specific details along with applications, instructions and other FAQs. Please review the website first before completing any forms. Dept. of Communication 6
IRB Presentation Do I have to submit? Title 45 of the Code of Federal Regulations, Part 46 Involves research Research is defined as a systematic investigation, including research development, testing and evaluation, designed to produce or contribute to generalizable knowledge (45 CFR 46.102) AND Involves human subjects Human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (either): data through intervention or interaction; or private, identifiable information (45 CFR 46.102(f)). Dept. of Communication 7
IRB Presentation What makes something Generalizable ? Draw conclusions across some group/phenomena Research may have predictive value Difference between one interview & sampling for interviews Examples could include public figures (politicians), sports figures, survivors of a disaster, etc. Oral histories, while scholarly, MAY not meet the criteria for submission; this depends on the individual case (submit to IRB and have them determine) Dept. of Communication 8
IRB Presentation What do I do before I start? Become certified to conduct human subjects research Pass the Collaborative Institutional Training Initiative (CITI Program) View the online power-point presentation followed by a test You must be certified before you can start your research Work with Faculty Advisor to obtain IRB approval for research Submit a new protocol for review and approval OR Request an amendment (modification) to an existing protocol Undergraduates are not allowed to submit protocols on their own at Rutgers; graduate students must have Co-PI full time faculty Dept. of Communication 9
IRB Presentation Belmont Report: Three Basic Ethical Principles Respect for persons (operationalized by Informed Consent) Voluntary informed consent Respect for privacy Added protections (children, prisoners, pregnant women/fetuses) Beneficence ( do no harm ) Good research design and manage conflicts of interest Maximize benefits, minimize risks Justice Equitable selection of subjects, inclusion and exclusion criteria Equal distribution of both benefits and burdens of research Dept. of Communication 10
IRB Presentation Two Levels of Risk The charge of the IRB is to protect the rights and welfare of research participants the IRB must weigh risks vs. benefits How a protocol is reviewed depends on the level of risk to subjects Minimal risk: Federal guidelines state that, "minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Greater than minimal risk (GTMR): more than minimal risk (literally the definition ) Dept. of Communication 11
IRB Presentation Type of Collected Data Anonymous No link between name/identity and person If identifiers are removed at data entry, CAN be anonymous Note this involves specifics of details collected, not simply names Confidential Have a link, even for a short time (e.g., some longitudinal studies) Cannot be both!!! Example: Application says that the PI will use a linked code and consent might read: Your participation in this study is anonymous. If you want to disclose a name (e.g., an interview), you must address this in consent form! Dept. of Communication 12
IRB Presentation Three Categories of Review Exempt (minimal risk) cannot self-exempt, must submit Definition is exempt from further (yearly) review (does not mean exempt from applying) Anonymous No children outside of category 1 Note NHR Expedited (also minimal risk) Specific types of research qualify (7 approved categories) Yearly Continuing Review Full Board Review (less common) greater than minimal risk and/or vulnerable populations (e.g., prisoners, pregnant women) Yearly Continuing Review Dept. of Communication 13
IRB Presentation Timing See CURRENT Deadlines Online: https://orra.rutgers.edu/irb- deadlines-meetings Exempt Review: Due each Wednesday (5 pm). Plan for 2-3 weeks for review/approval Expedited Review: Due 12th of each month (except in August-no meeting). Plan for 6-8 weeks for review/approval Expect any questions 1-3 weeks after submission via email and respond ASAP (the board only meets monthly, so delay can send an application to the next meeting) When responding, do so item by item (like a review) Notices of Approval/CR Reminders sent via email to PI/Faculty Advisor. Dept. of Communication 14
IRB Presentation Procedure Each submission sent to IRB members (usually 2) The reviewers confer and may request clarification Note timing, try to respond quickly You will be working with Administrator through email When all inquiries are addressed, goes on official roster Meets once a month No meeting in August Will need all letters of authorization, revisions for final approval All notices now sent via pdf/email (no more campus mail), new Note that the notice contains expiration date! Dept. of Communication 15
IRB Presentation Informed Consent Consent is a PROCESS in which the investigator shares all relevant information about the study and the potential subject has the opportunity to ask questions and decide if he/she wants to participate The consent form is a permanent record of conveyed information and the subject s willingness to participate A subject can withdraw consent and drop out of the study at any time for any reason without penalty (Computerized surveys must be allowed to skip questions/prorate payments) Default: signed w/ copy to participant (can request alteration) Dept. of Communication 16
IRB Presentation Basic Requirements of Informed Consent 8 basic consent elements Description of the research (purpose, duration, procedures) Foreseeable risks/discomforts Potential benefits Alternatives to participating (if any) Confidentiality (protection of personal information, data storage/protection) Compensation Contact Information (Investigator and IRB) Voluntary Participation So, use the templates on the website and make it easier!!! Dept. of Communication 17
IRB Presentation Consent: Waivers & Alterations Waiver of Informed Consent PI must request & address all points: 1. No more than minimal risk 2. Not adversely affect subjects 3. Could not practicably be carried out (definition: capable of being put into practice or of being done or accomplished; feasible, note this is not ease) 4. Additional information will be provided (debriefing) Example: Secondary data analysis involving a large private dataset In sum, it is very rare to waive informed consent! Waiver of Written Consent PI must request & address the following: 1. Consent is only record linking subject and research; the link poses risks; or 2. Research presents no more than minimal risk of harm to participants; and 3. Involves no procedures for which written IC is normally required outside of the research context Example: Telephone-based research or research where you do not want to store names (e.g., not legally in the country) Dept. of Communication 18
IRB Presentation To Make the Process go Smoothly Plan ahead Students should plan to submit 2-3 months prior to when they plan to begin the research. Review all current deadlines for IRB submissions Use Current Application Forms See website for current versions: https://orra.rutgers.edu/irb- applicationsforms Examples of consent forms available on the website and within the instructions attached to each application Your Faculty Advisor/Mentor is your very best resource!!!! Ensure the submission is complete Don t ignore check-lists, attachments, questions you think are irrelevant Incomplete submissions will be returned without review Dept. of Communication 19
IRB Presentation Complete proposals Use Current Application Forms: (2014.a right now) All CITI dates for ALL personnel No missing attachments--- Attachment 1: Research Protocol: On average, provide a 2-5 page summary NOT a 50 page dissertation proposal (some grants require attachment of grant proposal; in addition write a 1 page summary of rationale and methods). Attachment 4: Consent (see sample on website, all IRB contact info) Attachment 6: Authorization letters or Letters of Cooperation Attachment 7: Outcome Measures-surveys, focus group guides or interview items Attachment 9: Debriefing (required if any deception) For International Sites-Must include Appendix C or D Attach a cover letter if anything is missing or unusual Dept. of Communication 20
IRB Presentation Quality proposals--conceptual Overall protocol quality NOTE that the IRB does NOT comment on the science (theory, design, etc.) [unless it affects human subjects!] Must address level of risk, demonstrate understanding of the balance and issues Could be the topic, the population, etc. Consent form is in layperson language (readability programs) Dept. of Communication 21
IRB Presentation Emerging Issues Regulations and guidance change over time; there is a current proposal under consideration to change regulations. At BEST, this would be several years away from implementation Important to update education RU moving to online for submission/review (eIRB) The merger is affecting many things (HIPPA issues) Examples of current issues Anonymity and web-based data collection (new FAQs posted on website) Expectations of privacy for online discussion groups (see new FAQs) Genetic testing and medical samples Storage of blood/tissue samples (with no expiration date) Consent of cognitively impaired individuals Dept. of Communication 22
IRB Presentation When Does IRB Review end for a Study? Includes data analysis (not just recruitment and testing/data collection) Be sure to notify of personnel changes (even new GA/RA) When the study is completed terminate the approval (notify IRB staff) Expiration dates/renewals are PI responsibility! Continuing review IRB is not required to send a letter Expiration date is on the approval letter No work on a project can proceed if a proposal is closed There is no grace period (prohibited by the regulations) Dept. of Communication 23
IRB Presentation What if my Study Changes? (a form ) Alterations, even minor, must be sent to IRB, called Amendment (a modification to an approved project) Some can be approved by staff, others are sent to reviewers Sometimes shows up with Continuing Reviews; take care of this beforehand so your study is not interrupted Remember that the application is a signed document specifying very specific procedures and details Examples: Number of subjects Criteria for participant recruitment (even labels) Adding new data collection sites Altering an instrument (e.g., add items to a survey) Staff person leaves project or new person is hired Dept. of Communication 24
IRB Presentation Summary Research AND Human Subject = IRB Review CITI, no longer HSCP Adherence to Approved Protocol (specific details) Continuing Review Ongoing Communication with IRB The purpose and role of the IRB is to ensure the protection and safety, rights and welfare of human subjects in research. Dept. of Communication 25
IRB Presentation Questions? Speak 1stwith your Faculty Advisor Visit IRB Human Research Website for FAQs & to Obtain Templates If Contacting IRB staff for specific questions, you must copy Faculty Advisor Main ORRA Website: https://orra.rutgers.edu/irb Main Arts & Sciences IRB Human Subjects Research Website: https://orra.rutgers.edu/rutgers-irb Inquiries should be directed to: Any IRB Administrator listed under Contact Us page: https://orra.rutgers.edu/irb-contact-us Submission must be emailed directly to: irb-admin@grants.edu Dept. of Communication 26
IRB Presentation Dept. of Communication 27
