Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board

1. Human Subjects Protection Committeeat Cal Poly PomonaThe Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator Office of Research and Graduate Studies September 21, 2007

2. - Agenda Basics of the IRB • Purpose of the IRB • Development of Research Ethics • Scope of Authority • Regulations re Human Subjects Review • Elements of Informed Consent • Forms and Procedures • Human Subjects Training and Education • Wrap-up

3. - Purpose Basics of the IRB • Protect the welfare of human research subjects (or participants). • Assure compliance with both federal law and ethical standards for the conduct of human subjects research. • Review protocols • Establish policy for the campus • a medical school IRB would be different than a program of behavioral sciences • Respond to non-compliance

4. - Purpose Basics of the IRB The Cal Poly Pomona IRB • The committee • faculty representing various disciplines • outside, unaffiliated members • administrator • Meets once per month generally • Chair is Dr. David Adams, a professor of philosophy and ethics

5. Respect for Persons Basics of the IRB - the IRB Principles • Voluntary participation • Informed consent • Privacy and confidentiality Beneficence • Risks must be justified by benefits to the research subject or to the community. • Risks must be minimized. • Data gathering must be monitored to ensure safety of subjects. Justice • Subjects must be selected equitably. • Avoid exploitation of vulnerable groups or populations of convenience. • Those likely to benefit are not systematically excluded.

6. - Development of Research Ethics Basics of the IRB Milestones: • 1940s - Nuremberg Code • 1950s-60s - Controversial studies • 1964 - Declaration of Helsinki • 1970s - “Common Rule” • 1970s - Belmont Report • 1990s - 2000s - IRBs and protections

7. - Research Ethics Basics of the IRB Nuremberg Code … At the end of World War II, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used as research subjects. That led to: • Informed consent is essential. • Risks must be justified by anticipated benefits. • Research must be conducted by qualified researchers. • Physical and mental suffering must be minimized.

8. - Research Ethics Basics of the IRB Controversial studies, examples, historical perspective… • Milgram study, ‘60s • The purpose of this study was to determine response to authority in normal humans. The researchers told recruited volunteers that the purpose was to study learning and memory. Each subject was told to teach a "student" and to punish the students' errors by administering increasing levels of electric shocks. The "student" was a confederate of the researcher who pretended to be a poor learner and mimicked pain and even unconsciousness as the subject increased the levels of electric shock. 63% of the subjects administered lethal shocks; some even after the "student" claimed to have heart disease. Some of the subjects, after being "debriefed" from the study experienced serious emotional crises.

9. - Research Ethics Basics of the IRB Controversial studies, examples • Tuskegee syphilis study, 1932-1971 • Initiated by the Public Health Service, this study was designed to document the natural history of syphilis in African-American men. • Willowbrook study, 1956 • In 1956, at an institution for mentally retarded children in Staten Island, New York, a study was initiated to determine the natural history of viral hepatitis and to test the effectiveness of gamma globulin as an agent for inoculating against hepatitis. Children were deliberately infected with a mild form of hepatitis.

10. - Research Ethics Basics of the IRB Declaration of Helsinki ... • The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. • Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research. • Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.

11. - Research Ethics Basics of the IRB Common Rule ... • The National Research Act was passed in 1974 which established: • a national commission for the Protection of Human Subjects of Biomedical and Behavioral Research. • the requirement for establishment of IRBs at institutions receiving federal monies. • the various regulatory standards known collectively as the “Common Rule.” • effective since 1991 • adopted by 19 federal agencies • based upon subpart A 45 CFR 46 • this, a set of basic regulatory standards

12. - Research Ethics Basics of the IRB Belmont Report ... • published in 1979 • included the Belmont Principles • respect for persons • beneficence and • justice

13. - Research Ethics Basics of the IRB Risks ... • Evaluated according to the probability and magnitude of any harm that might occur • Will the risk occur in almost all subjects or in only one of 10,000 subjects? • Quantify risk according to the magnitude of harm • minor itchiness • could some subjects die? • social, legal, economic, or psychological risks • risks may apply to the individual subject or may apply to a broader segment of the society.

14. - Scope of Authority Basics of the IRB Any research undertaken at Cal Poly Pomona, or involving Cal Poly faculty, staff, or students either as investigators or subjects.

15. - Regulations Basics of the IRB Code of Federal Regulations … • Title 21, CFR Part 50 and CFR Part 56 • Food and Drug Administration (FDA) • Focused on clinical, medical, therapeutic studies • Title 45, Public welfare, CFR Part 46 (45 CFR 46) • Department of Health and Human Services (DHHS) • Protection of human subjects in general • Miscellaneous others at the federal, state, and institutional levels

16. - Regulations Basics of the IRB Definition of subject … • A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains: (a) data through intervention or interaction with the individual or (b) identifiable private information.” • Vulnerable subjects • prisoners, children, pregnant women, fetus, medically-afflicted, plus others

17. - Regulations Basics of the IRB Definition of research ... • Covered research is any “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

18. - Regulations Basics of the IRB Is it research? ... • Collecting data for the purpose of publication, professional presentation at a conference or seminar, dissemination to colleagues on the Internet, or inclusion in a dissertation does count as research. • For teachers, gathering data from students to: (a) improve your teaching, (b) assess your course or program, or (c) collect student input for employment actions does not constitute research.

19. - Regulations Basics of the IRB Are you doing research? Assess your role ... • Conducting “typical” research as a principal investigator, abbreviated as PI. • student, graduate student, clinician, investigator • Acting in the capacity of a teacher with the intention of assisting your students to learn. • Acting in the capacity of a researcher with the intention of studying the process of teaching and learning. Publication of results is not a necessary condition.

20. - Regulations Basics of the IRB What are data? • Examples • Survey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper and electronic records, and more • Existing (archived) data or samples • Observation of public behavior • Collection of new data though human intervention • Privacy and de-identification • Storage and retention • Protected • Medical records and HIPAA • Confidential vs. anonymous collection • Definitions • Can the collected data be traced back? • Can the data identify one or more persons?

21. - Regulations Basics of the IRB Means of protocol review ... • Exempt • Research using existing data or samples. • Observation of public behavior. • Research involving surveys or questionnaires where no personally identifying information is gathered or retained. • Eligibility for exemption must be determined by the IRB, not the investigator. • Expedited • Poses no more than “minimal risk” to the subject, i.e., “no more than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." • Approvable by review of two members of the Board. • Doesn’t necessarily mean quick or fast review. • Full board • Research that is neither exempt nor expeditable must receive review by the full committee. • Means a convened meeting of the IRB for face-to-face discussion.

22. - Informed consent Basics of the IRB Elements of informed consent include … • Explanation of the purpose(s) of the research. • Description of the procedure(s) to be followed. • Summary of the data to be collected. • Description of any foreseeable risks or discomforts to the subject. • Description of the benefits to the subject or to others, including compensation. • Explanation of how the investigator (PI) will maintain confidentiality of records. • Contact information of all PIs. • A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that the subject may discontinue at any time. • Anything else that will help the subject to understand.

23. - Forms and Procedures Basics of the IRB • Protocol • purpose, methodology, recruitment and description of subjects, risk evaluation, anonymity and confidentiality, benefits, compensation, etc. • Informed consent form • consent for adults • assent for minors • Surveys and questionnaires • paper • electronic (Zoomerang)

24. - Forms and Procedures Basics of the IRB • Submit protocol electronically as a MS Word file • send attachments like consent form or surveys • send front page by regular mail with signatures • Provide evidence of training • Allow IRB time to review • comments are summarized by chair and sent to PI • response by PI is evaluated by the chair • could be 1 week or 1 month • Approval memo is sent • approval is granted for up to one year • renewals and amendments are permitted

25. - Training and education Basics of the IRB • IRB adopted www.citiprogram.org in early 2006 • 30+ modules, various groups, completion reports • required of all researchers with human subjects • To demonstrate experience and appreciation for human subjects protection.

26. IRB approval - aspects • A memo is issued • Protection for many • the investigator(s) • the subjects • the institution • Compliance • we live in a regulated world • with federal regulations and institutional policies • Perspectives from peers • IRB members can contribute to the study • suggestions to the methodology

27. - Wrap-up Basics of the IRB • These are the basics • every protocol is unique • Federalwide Assurance • a document submitted to the federal government • Cal Poly Pomona will comply with the regulations • More info? • www.csupomona.edu/~research/irb/ • www.hhs.gov/ohrp/ • members of the IRB Thank you for your interest in the IRB and its practices!