irb basics for administrators - john carroll...

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

email

TEAMWORK

Researcher

IRB ReviewerIRB

Administrator

Advisor