irb basics for administrators - john carroll...
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IRB BASICS FOR ADMINISTRATORS
S A I N T M A RY S E M I N A RY
O C TO B E R 1 9 , 2 0 1 6
JOHN CARROLL UNIVERSITY
• Catherine Anson, MA, CRA, CIMDirector of Sponsored ResearchAssistant IRB Chair
• Carole Krus, MSResearch Compliance AdministratorIRB Administrator
• Jim Krukones, Ph.D.Associate Academic Vice PresidentIRB Member
PRESENTATION
• Part 1: What is an IRB?
• Part 2: Historical Perspective: why we have IRBs
• Part 3: Behind the Screen: How does the IRB work?
• Part 4: When should IRB review occur?
PA R T 1 :W H AT I S A N I R B ?
I R B : I N S T I T U T I O N A L R E V I E W B O A R D F O R T H E P R O T E C T I O N O F H U M A N S U B J E C T S
H S R B : H U M A N S U B J E C T S R E V I E W B O A R D
I E C : I N S T I T U T I O N A L / I N D E P E N D E N T
E T H I C S C O M M I T T E E
R E B : R E S E A R C H E T H I C S B O A R D
E R B : E T H I C A L R E V I E W B O A R D
DEFINITION AND PURPOSE
Federally-mandated ethics review committee that reviews and approves research projects that meet the following criteria:
• Risks to subjects are minimized and are reasonable in relation to anticipated benefits.
• The selection of subjects is equitable.
• Informed consent will be sought and appropriately documented.
• There is adequate provision for monitoring the data collected to ensure the safety of subjects, to protect the privacy of subjects, and to maintain the confidentially of the data.
45 CFR 46.111(a)
IRB COMPOSITION
A group of at least 5 people:
– One non-scientist
– One scientist
– One non-affiliated community member
– A mix of gender, race, etc., varying backgrounds
– A representative from the major subject pool
– Professional competence & experience
– “No IRB may consist entirely of members of one profession.”
45 CFR 46.107
LEGAL REQUIREMENTS
• Federally-funded research (biomedical, social and
behavioral science, education research projects)
• Research that falls under FDA regulations
(biomedical, medical devices, psychological
treatment research)
CODE OF FEDERAL REGULATIONS
• DHHS: 45 CFR 46 (Title 45, Part 46)
Subpart A (15 Common Rule agencies)
Subpart B (Pregnant Women, Fetuses, Neonates)
Subpart C (Prisoners)
Subpart D (Children)
• FDA: 21 CFR 50 (Title 21, Part 50)
DISCLAIMER
SBERSocial, Behavioral,
and Education
Research Projects
FDABiomedical Projects
45 CFR 46 21 CFR 50
THE IRB
Federal Best PracticeExpected Practice
PA R T 2 : H I S T O R I C A L P E R S P E C T I V E
REGULATIONS
Bad Events
Happen
Regulations
Written
History of Regulations Timeline
Tuskegee Syphilis Study 1932
Nazi Experiments on Prisoners 1940s
Radiation Experiments Begin 1944
Thalidomide Tragedy 1950s
Beecher Article 1966
Stanford Prison Experiment 1971
Tuskegee Syphilis Study Exposed 1972
1930s & 1940s Radiation Experiments Publicized 1993
1947 Nuremberg Code
1962 Amendments to Food, Drug & Cosmetic Act
1974 National Research Act passed by Congress
National Commission for the Protection of Human Subjects
of Biomedical & Behavioral Research established
45 CFR 46 Federal Regulations - IRBs Formed
1979 Belmont Report
1983 45 CFR 46 Subpart C established
1982 CIOMS Guidelines*
1991 Common Rule
1995 Final Report of the Advisory Committee on Human Radiation Experiments
1930
2000
1965
Events Regulatory Milestones
Milgram Obedience Study 1961
*International Ethical
Guidelines for Biomedical
Research Involving
Human Subjects
1964 Declaration of Helsinki“Tearoom Sex” Study Mid 1960s
SITES.JCU.EDU/RESEARCH
Wichita Jury Study 1953
1996 ICH Good Clinical Practice
History of Regulations Timeline
Tuskegee Syphilis Study 1932
Nazi Experiments on Prisoners 1940s
Radiation Experiments Begin 1944
Thalidomide Tragedy 1950s
Beecher Article 1966
Stanford Prison Experiment 1971
Tuskegee Syphilis Study Exposed 1972
1930s & 1940s Radiation Experiments Publicized 1993
1947 Nuremberg Code
1962 Amendments to Food, Drug & Cosmetic Act
1974 National Research Act passed by Congress
National Commission for the Protection of Human Subjects
of Biomedical & Behavioral Research established
45 CFR 46 Federal Regulations - IRBs Formed
1979 Belmont Report
1983 45 CFR 46 Subpart C established
1982 CIOMS Guidelines*
1991 Common Rule
1995 Final Report of the Advisory Committee on Human Radiation Experiments
1930
2000
1965
Events Regulatory Milestones
Milgram Obedience Study 1961
*International Ethical
Guidelines for Biomedical
Research Involving
Human Subjects
1964 Declaration of Helsinki“Tearoom Sex” Study Mid 1960s
SITES.JCU.EDU/RESEARCH
Wichita Jury Study 1953
1996 ICH Good Clinical Practice
History of Regulations Timeline
Tuskegee Syphilis Study 1932
Nazi Experiments on Prisoners 1940s
Radiation Experiments Begin 1944
Thalidomide Tragedy 1950s
Beecher Article 1966
Stanford Prison Experiment 1971
Tuskegee Syphilis Study Exposed 1972
1930s & 1940s Radiation Experiments Publicized 1993
1947 Nuremberg Code
1962 Amendments to Food, Drug & Cosmetic Act
1974 National Research Act passed by Congress
National Commission for the Protection of Human Subjects
of Biomedical & Behavioral Research established
45 CFR 46 Federal Regulations - IRBs Formed
1979 Belmont Report
1983 45 CFR 46 Subpart C established
1982 CIOMS Guidelines*
1991 Common Rule
1995 Final Report of the Advisory Committee on Human Radiation Experiments
1930
2000
1965
Events Regulatory Milestones
Milgram Obedience Study 1961
*International Ethical
Guidelines for Biomedical
Research Involving
Human Subjects
1964 Declaration of Helsinki“Tearoom Sex” Study Mid 1960s
SITES.JCU.EDU/RESEARCH
Wichita Jury Study 1953
1996 ICH Good Clinical Practice
IRB COMPOSITION
A group of at least 5 people:
– One non-scientist
– One scientist
– One community member
– A mix of gender, race, etc., varying backgrounds
– A representative from the major subject pool
– Professional competence & experience
– “No IRB may consist entirely of members of one profession.”
45 CFR 46.107
History of Regulations Timeline
Tuskegee Syphilis Study 1932
Nazi Experiments on Prisoners 1940s
Radiation Experiments Begin 1944
Thalidomide Tragedy 1950s
Beecher Article 1966
Stanford Prison Experiment 1971
Tuskegee Syphilis Study Exposed 1972
1930s & 1940s Radiation Experiments Publicized 1993
1947 Nuremberg Code
1962 Amendments to Food, Drug & Cosmetic Act
1974 National Research Act passed by Congress
National Commission for the Protection of Human Subjects
of Biomedical & Behavioral Research established
45 CFR 46 Federal Regulations - IRBs Formed
1979 Belmont Report
1983 45 CFR 46 Subpart C established
1982 CIOMS Guidelines*
1991 Common Rule
1995 Final Report of the Advisory Committee on Human Radiation Experiments
1930
2000
1965
Events Regulatory Milestones
Milgram Obedience Study 1961
*International Ethical
Guidelines for Biomedical
Research Involving
Human Subjects
1964 Declaration of Helsinki“Tearoom Sex” Study Mid 1960s
SITES.JCU.EDU/RESEARCH
Wichita Jury Study 1953
1996 ICH Good Clinical Practice
BELMONT REPORT 1979
BELMONT REPORT 19791. RESPECT for persons: "Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection" (informed consent)
2. BENEFICENCE, "Maximize possible benefits" of the research while "minimizing possible harms" (risk/benefit ratio)
3. JUSTICE, distribution of the burden of research (Participants should represent the target population)
BELMONT REPORT
1. Respect for Persons
• Informed Consent
• Ability to Withdraw
• Protections for
Vulnerable
Populations
BELMONT REPORT
2. Beneficence
Benefits RisksM
AX
IMIZ
ED
Min
imize
d
BELMONT REPORT
3. Justice
BELMONT REPORT
3. Justice
BELMONT REPORT
PA R T 3B E H I N D T H E S C R E E N : H O W D O E S T H E I R B W O R K ?
4 RESEARCH CATEGORIES
Not Under
IRB
JurisdictionExempt Expedited Full Board
4 RESEARCH CATEGORIES
Not Under
IRB
JurisdictionExempt Expedited Full Board
3 CONDITIONS
1.
Research
2. Human
Subjects
3.
Generalizable
RISK is not a factor in determining IRB jurisdiction.
WHAT FALLS UNDER IRB JURISDICTION?*
*According to 45 CFR 46
1. Research2. Human
Subjects
3. develop/contribute
to generalizableknowledge
FEDERAL DEFINITIONS
Research
• “Research means a systematic investigation, including research development, testing and evaluation”
Human Subject
• “a living individual about whom an investigator… obtains: (1) Data through intervention or interaction...or (2) Identifiable private information…”
Generalizable
• ????
*According to 45 CFR 46
EXPANDED DEFINITIONS
Belmont on Research
• “An activity designed to test an hypothesis, permit conclusions to be drawn [and] is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.”
Human Subject
Generalizable
• Research findings can be applied to populations or situations beyond that studied.
• BELMONT: “expressed, for example, in theories, principles, and statements of relationships.”
• Result adds to or extends a field of knowledge.
NOT UNDER IRB JURISDICTION• Journalism projects (newspaper articles, investigative journalism, filmed
documentaries)
• Biographies
• Program Reviews (done for the purposes of improving the program)
• Case Studies (1 to 3 participants)
3 CASE STUDIES
CASE 1: PROGRAM STUDY
A student will conduct a focus group with at
least 5 parishioners regarding their opinions
and experiences with a program to determine
the effectiveness of the program. The results
will be used to support thesis research.
ResearchHuman
Subjects
GeneralizableKnowledge
CASE 2: PROGRAM EVALUATION
A student wants to survey priests to
determine the most popular times to hold
mass. Data on the number of people attending
and the type of mass will be collected.
The study is being conducted for a doctoral
dissertation project.
ResearchHuman
Subjects
GeneralizableKnowledge
CASE 3: PROGRAM EVALUATION
A faculty member is working with a parish to
determine if drug counseling program is
effective. Surveys will be given to participants
in the program. The results will be used to
support the efficacy of the program to
funders and other parishes.
ResearchHuman
Subjects
GeneralizableKnowledge
4 RESEARCH CATEGORIES
Not Under
IRB
JurisdictionExempt Expedited Full Board
3 CONDITIONS
1.
Research
2. Human
Subjects
3.
Generalizable
RISK is not a factor in determining IRB jurisdiction.
MINIMAL RISK
“Minimal risk means that the probability and magnitude of
harm or discomfort …are not greater … than … ordinarily
encountered in [the] daily life [of a healthy person].”
45 CFR 46.102.(i)
SBER RISK FACTORS
• Psychological damage
• Emotional distress (traumatic events)
• Breach of privacy
SBER RISK FACTORS:BREACH OF PRIVACY
• Stigmatization
• Legal concerns
• Humiliation
• Employability
• Reputation
• Open to gossip
HIERARCHY OF CATEGORIES
Full Board
Expedited
Exempt
Copies made & circulated;
all reviewers; revisions;
minutes generated;
more recordkeeping
1-2 reviewers; revisions
often requested;
continuing
review
1 person
review;
few to no
changes
LE
VE
LO
FR
ISK
IRB
RE
SO
UR
CE
SU
SE
D
PA R T 4 :W H E N S H O U L D I R B R E V I E W O C C U R ?
RETROSPECTIVE APPROVAL
DISSERTATION TIMELINE
• Project plan is approved by the dissertation committee.
• IRB review and approval is sought and received.
• The human subjects research portion of the project commences.
STUDENT CONSULTATION (BEFORE IRB APPLICATION SUBMISSION)
• Class presentation at Saint Mary’s
• Email questions
• Phone discussion
• In-person meeting at John Carroll
STUDENT RESEARCH RESPONSIBILITIES• Take CITI training
• Compete the IRB application and all appropriate material
• Submit with application to Carole with signature from the faculty
advisor
FACULTY ADVISOR
• Take CITI training
• Approve the project and research plan
• Supervise the project
I have examined this completed form and I am
satisfied with the adequacy of the proposed
research design and the measures proposed for
the protection of human participants. For
student projects, I will take responsibility for
informing the student of the need for the
safekeeping of all raw data (e.g., test protocols,
tapes, questionnaires, interview notes, etc.) in a
University or computer file.
POST APPROVAL
• Notify the IRB office of any problems involving human subjects.
• File an addendum request for any changes.
• File a continuation request if required for projects longer than one
year.
REVIEW, REVISE, RESUBMIT
• Initial check for completeness; Acknowledgement
• Reviewer; Researcher; Reviewer communication
• Approval email and letter
• Faculty sponsor copied on all emails
• Department chair copied on acknowledgement and final decision
TEAMWORK
Researcher
IRB ReviewerIRB
Administrator
Advisor
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