S A I N T M A RY S E M I N A RY O C T O B E R 1 9,

IRB BASICS FOR ADMINISTRATORS S A I N T M A RY S E M I N A RY O C T O B E R 1 9, 2 0 1 6

JOHN CARROLL UNIVERSITY Catherine Anson, MA, CRA, CIM Director of Sponsored Research Assistant IRB Chair Carole Krus, MS Research Compliance Administrator IRB Administrator Jim Krukones, Ph.D. Associate Academic Vice President IRB 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 SBER FDA Social, Behavioral, and Education Research Projects Biomedical Projects 45 CFR 46 21 CFR 50

THE IRB Federal Best Practice Expected 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 Events 1930 Regulatory Milestones Tuskegee Syphilis Study 1932 Nazi Experiments on Prisoners 1940s Radiation Experiments Begin 1944 Thalidomide Tragedy 1950s Wichita Jury Study 1953 Milgram Obedience Study 1961 Tearoom Sex Study Mid 1960s Beecher Article 1966 Stanford Prison Experiment 1971 Tuskegee Syphilis Study Exposed 1972 1947 Nuremberg Code 1965 *International Ethical Guidelines for Biomedical Research Involving Human Subjects 1962 Amendments to Food, Drug & Cosmetic Act 1964 Declaration of Helsinki 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 1982 CIOMS Guidelines* 1983 45 CFR 46 Subpart C established 1930s & 1940s Radiation Experiments Publicized 1993 1991 Common Rule 1995 Final Report of the Advisory Committee on Human Radiation Experiments SITES.JCU.EDU/RESEARCH 2000 1996 ICH Good Clinical Practice

History of Regulations Timeline Events 1930 Regulatory Milestones Tuskegee Syphilis Study 1932 Nazi Experiments on Prisoners 1940s Radiation Experiments Begin 1944 Thalidomide Tragedy 1950s Wichita Jury Study 1953 Milgram Obedience Study 1961 Tearoom Sex Study Mid 1960s Beecher Article 1966 Stanford Prison Experiment 1971 Tuskegee Syphilis Study Exposed 1972 1947 Nuremberg Code 1965 *International Ethical Guidelines for Biomedical Research Involving Human Subjects 1962 Amendments to Food, Drug & Cosmetic Act 1964 Declaration of Helsinki 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 1982 CIOMS Guidelines* 1983 45 CFR 46 Subpart C established 1930s & 1940s Radiation Experiments Publicized 1993 1991 Common Rule 1995 Final Report of the Advisory Committee on Human Radiation Experiments SITES.JCU.EDU/RESEARCH 2000 1996 ICH Good Clinical Practice

History of Regulations Timeline Events 1930 Regulatory Milestones Tuskegee Syphilis Study 1932 Nazi Experiments on Prisoners 1940s Radiation Experiments Begin 1944 Thalidomide Tragedy 1950s Wichita Jury Study 1953 Milgram Obedience Study 1961 Tearoom Sex Study Mid 1960s Beecher Article 1966 Stanford Prison Experiment 1971 Tuskegee Syphilis Study Exposed 1972 1947 Nuremberg Code 1965 *International Ethical Guidelines for Biomedical Research Involving Human Subjects 1962 Amendments to Food, Drug & Cosmetic Act 1964 Declaration of Helsinki 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 1982 CIOMS Guidelines* 1983 45 CFR 46 Subpart C established 1930s & 1940s Radiation Experiments Publicized 1993 1991 Common Rule 1995 Final Report of the Advisory Committee on Human Radiation Experiments SITES.JCU.EDU/RESEARCH 2000 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 Events 1930 Regulatory Milestones Tuskegee Syphilis Study 1932 Nazi Experiments on Prisoners 1940s Radiation Experiments Begin 1944 Thalidomide Tragedy 1950s Wichita Jury Study 1953 Milgram Obedience Study 1961 Tearoom Sex Study Mid 1960s Beecher Article 1966 Stanford Prison Experiment 1971 Tuskegee Syphilis Study Exposed 1972 1947 Nuremberg Code 1965 *International Ethical Guidelines for Biomedical Research Involving Human Subjects 1962 Amendments to Food, Drug & Cosmetic Act 1964 Declaration of Helsinki 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 1982 CIOMS Guidelines* 1983 45 CFR 46 Subpart C established 1930s & 1940s Radiation Experiments Publicized 1993 1991 Common Rule 1995 Final Report of the Advisory Committee on Human Radiation Experiments SITES.JCU.EDU/RESEARCH 2000 1996 ICH Good Clinical Practice

BELMONT REPORT 1979

BELMONT REPORT 1979 1. 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

MAXIMIZED BELMONT REPORT 2. Beneficence Benefits Risks Minimized

BELMONT REPORT 3. Justice

BELMONT REPORT 3. Justice

BELMONT REPORT

PA R T 3 B 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 Jurisdiction Exempt Expedited Full Board

4 RESEARCH CATEGORIES Not Under IRB Jurisdiction Exempt Expedited Full Board RISK is not a factor in determining IRB jurisdiction. 3 CONDITIONS 1. Research 2. Human Subjects 3. Generalizable

WHAT FALLS UNDER IRB JURISDICTION?* 1. Research 2. Human Subjects 3. develop/contribute to generalizable knowledge *According to 45 CFR 46

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 Research Human Subjects Generalizable Knowledge 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.

CASE 2: PROGRAM EVALUATION Research Human Subjects Generalizable Knowledge 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.

CASE 3: PROGRAM EVALUATION Research Human Subjects Generalizable Knowledge 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.

4 RESEARCH CATEGORIES Not Under IRB Jurisdiction Exempt Expedited Full Board RISK is not a factor in determining IRB jurisdiction. 3 CONDITIONS 1. Research 2. Human Subjects 3. Generalizable

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

LEVEL OF RISK 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 IRB RESOURCES USED

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 Advisor Researcher IRB Administrator IRB Reviewer