human subjects protection committee at cal poly pomona the institutional review board bruce w....

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Committee Committee at at Cal Poly Pomona Cal Poly Pomona The Institutional Review The Institutional Review Board Board Bruce W. Kennedy, MS RLATG CMAR Bruce W. Kennedy, MS RLATG CMAR Compliance Associate Compliance Associate IRB Administrator IRB Administrator Office of Research and Graduate Office of Research and Graduate Studies Studies September 21, 2007

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Page 1: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

Human Subjects Protection CommitteeHuman Subjects Protection Committee

atat Cal Poly Pomona Cal Poly Pomona

The Institutional Review BoardThe Institutional Review Board

Bruce W. Kennedy, MS RLATG CMARBruce W. Kennedy, MS RLATG CMARCompliance AssociateCompliance Associate

IRB AdministratorIRB AdministratorOffice of Research and Graduate StudiesOffice of Research and Graduate Studies

September 21, 2007

Page 2: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Agenda- Agenda Purpose of the IRBPurpose of the IRB Development of Research EthicsDevelopment of Research Ethics Scope of AuthorityScope of Authority Regulations Regulations rere Human Subjects Review Human Subjects Review Elements of Informed ConsentElements of Informed Consent Forms and ProceduresForms and Procedures Human Subjects Training and EducationHuman Subjects Training and Education Wrap-upWrap-up

Basics of the IRBBasics of the IRB

Page 3: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Purpose- Purpose Basics of the IRBBasics of the IRB

Protect the welfare of human research subjects Protect the welfare of human research subjects (or participants).(or participants).

Assure compliance with both federal law and Assure compliance with both federal law and ethical standards for the conduct of human ethical standards for the conduct of human subjects research.subjects research.

Review protocolsReview protocols Establish policy for the campusEstablish policy for the campus

a medical school IRB would be different than a a medical school IRB would be different than a program of behavioral sciencesprogram of behavioral sciences

Respond to non-complianceRespond to non-compliance

Page 4: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Purpose- Purpose Basics of the IRBBasics of the IRB

The Cal Poly Pomona IRBThe Cal Poly Pomona IRB The committeeThe committee

faculty representing various disciplinesfaculty representing various disciplines outside, unaffiliated membersoutside, unaffiliated members administratoradministrator

Meets once per month generallyMeets once per month generally Chair is Dr. David Adams, a professor of Chair is Dr. David Adams, a professor of

philosophy and ethicsphilosophy and ethics

Page 5: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

Respect for PersonsRespect for Persons Voluntary participationVoluntary participation Informed consentInformed consent Privacy and confidentialityPrivacy and confidentiality

- the IRB Principles- the IRB Principles

BeneficenceBeneficence

JusticeJustice

Risks must be justified by benefits to the research subject or to Risks must be justified by benefits to the research subject or to the community.the community.

Risks must be minimized.Risks must be minimized. Data gathering must be monitored to ensure safety of subjects.Data gathering must be monitored to ensure safety of subjects.

Subjects must be selected equitably.Subjects must be selected equitably. Avoid exploitation of vulnerable groups or populations of Avoid exploitation of vulnerable groups or populations of

convenience.convenience. Those likely to benefit are not systematically excluded.Those likely to benefit are not systematically excluded.

Basics of the IRBBasics of the IRB

Page 6: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Development of Research Ethics- Development of Research Ethics

Milestones:Milestones: 1940s - Nuremberg Code 1940s - Nuremberg Code 1950s-60s - Controversial studies1950s-60s - Controversial studies 1964 - Declaration of Helsinki1964 - Declaration of Helsinki 1970s - “Common Rule”1970s - “Common Rule” 1970s - Belmont Report1970s - Belmont Report 1990s - 2000s - IRBs and protections1990s - 2000s - IRBs and protections

Basics of the IRBBasics of the IRB

Page 7: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research Ethics

Nuremberg Code …Nuremberg Code …

At the end of World War II, 23 Nazi doctors and At the end of World War II, 23 Nazi doctors and scientists were put on trial for the murder of scientists were put on trial for the murder of concentration camp inmates who were used as concentration camp inmates who were used as research subjects. That led to: research subjects. That led to:

Informed consent is essential.Informed consent is essential. Risks must be justified by anticipated benefits.Risks must be justified by anticipated benefits. Research must be conducted by qualified researchers.Research must be conducted by qualified researchers. Physical and mental suffering must be minimized.Physical and mental suffering must be minimized.

Basics of the IRBBasics of the IRB

Page 8: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research Ethics

Controversial studies, examples, Controversial studies, examples, historical perspective…historical perspective… Milgram study, ‘60sMilgram study, ‘60s

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

Basics of the IRBBasics of the IRB

Page 9: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research EthicsControversial studies, examplesControversial studies, examples Tuskegee syphilis study, 1932-1971Tuskegee syphilis study, 1932-1971

Initiated by the Public Health Service, this Initiated by the Public Health Service, this study was designed to document the natural study was designed to document the natural history of syphilis in African-American men.history of syphilis in African-American men.

Basics of the IRBBasics of the IRB

Willowbrook study, 1956Willowbrook study, 1956 In 1956, at an institution for mentally retarded children in Staten In 1956, at an institution for mentally retarded children in Staten

Island, New York, a study was initiated to determine the natural Island, New York, a study was initiated to determine the natural history of viral hepatitis and to test the effectiveness of gamma history of viral hepatitis and to test the effectiveness of gamma globulin as an agent for inoculating against hepatitis. Children globulin as an agent for inoculating against hepatitis. Children were deliberately infected with a mild form of hepatitis.were deliberately infected with a mild form of hepatitis.

Page 10: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research Ethics

Declaration of Helsinki ...Declaration of Helsinki ... The World Medical Association has developed the Declaration of The World Medical Association has developed the Declaration of

Helsinki as a statement of ethical principles to provide guidance Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research to physicians and other participants in medical research involving human subjects. Medical research involving human involving human subjects. Medical research involving human subjects includes research on identifiable human material or subjects includes research on identifiable human material or identifiable data.identifiable data.

Medical progress is based on research which ultimately must Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. In the rest in part on experimentation involving human subjects. In the field of biomedical research a fundamental distinction must be field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and research the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the without implying direct diagnostic or therapeutic value to the person subjected to the research. person subjected to the research.

Biomedical research involving human subjects must conform to Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature. and on a thorough knowledge of the scientific literature.

Basics of the IRBBasics of the IRB

Page 11: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research Ethics

Common Rule ...Common Rule ... The National Research Act was passed in 1974 which The National Research Act was passed in 1974 which

established:established: a national commission for the Protection of Human Subjects a national commission for the Protection of Human Subjects

of Biomedical and Behavioral Research.of Biomedical and Behavioral Research. the requirement for establishment of IRBs at institutions the requirement for establishment of IRBs at institutions

receiving federal monies.receiving federal monies. the various regulatory standards known collectively as the the various regulatory standards known collectively as the

“Common Rule.”“Common Rule.” effective since 1991effective since 1991 adopted by 19 federal agenciesadopted by 19 federal agencies based upon subpart A 45 CFR 46based upon subpart A 45 CFR 46 this, a set of basic regulatory standardsthis, a set of basic regulatory standards

Basics of the IRBBasics of the IRB

Page 12: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research Ethics

Belmont Report ...Belmont Report ... published in 1979published in 1979 included the Belmont Principlesincluded the Belmont Principles

respect for personsrespect for persons beneficence andbeneficence and justicejustice

Basics of the IRBBasics of the IRB

Page 13: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Research Ethics- Research Ethics

Risks ...Risks ... Evaluated according to the probability and Evaluated according to the probability and

magnitude of any harm that might occur magnitude of any harm that might occur Will the risk occur in almost all subjects or in only one Will the risk occur in almost all subjects or in only one

of 10,000 subjects? of 10,000 subjects? Quantify risk according to the magnitude of harmQuantify risk according to the magnitude of harm

minor itchinessminor itchiness could some subjects die? could some subjects die? social, legal, economic, or psychological riskssocial, legal, economic, or psychological risks risks may apply to the individual subject or may apply risks may apply to the individual subject or may apply

to a broader segment of the society.to a broader segment of the society.

Basics of the IRBBasics of the IRB

Page 14: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Scope of Authority- Scope of Authority

Any research undertaken at Cal Poly Any research undertaken at Cal Poly Pomona, or involving Cal Poly faculty, Pomona, or involving Cal Poly faculty, staff, or students either as investigators or staff, or students either as investigators or subjects.subjects.

Basics of the IRBBasics of the IRB

Page 15: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- Regulations

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

Basics of the IRBBasics of the IRB

DHHShas these components

FDA NIH OHRPand the research is overseen by the

IRB

Page 16: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- Regulations

Definition of subject …Definition of subject … A human subject is a “living individual about A human subject is a “living individual about

whom an investigator (whether professional or whom an investigator (whether professional or student) conducting research obtains:student) conducting research obtains:

(a) data through intervention or interaction with the (a) data through intervention or interaction with the individual orindividual or

(b) identifiable private information.”(b) identifiable private information.” Vulnerable subjectsVulnerable subjects

prisoners, children, pregnant women, fetus, prisoners, children, pregnant women, fetus, medically-afflicted, plus othersmedically-afflicted, plus others

Basics of the IRBBasics of the IRB

Page 17: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- Regulations

Definition of research ...Definition of research ... Covered research is any “systematic Covered research is any “systematic

investigation including research development, investigation including research development, testing and evaluation, designed to develop or testing and evaluation, designed to develop or contribute to generalizable knowledge.”contribute to generalizable knowledge.”

Basics of the IRBBasics of the IRB

Page 18: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- Regulations

Is it research? ...Is it research? ... Collecting data for the purpose of publication, Collecting data for the purpose of publication,

professional presentation at a conference or professional presentation at a conference or seminar, dissemination to colleagues on the seminar, dissemination to colleagues on the Internet, or inclusion in a dissertation Internet, or inclusion in a dissertation doesdoes count as research.count as research.

For teachers, gathering data from students to: For teachers, gathering data from students to: (a) improve your teaching, (b) assess your (a) improve your teaching, (b) assess your course or program, or (c) collect student input course or program, or (c) collect student input for employment actions does for employment actions does notnot constitute constitute research.research.

Basics of the IRBBasics of the IRB

Page 19: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- Regulations

Are you doing research? Are you doing research? Assess your role ...Assess your role ... Conducting “typical” research as a principal Conducting “typical” research as a principal

investigator, abbreviated as PI.investigator, abbreviated as PI. student, graduate student, clinician, investigatorstudent, graduate student, clinician, investigator

Acting in the capacity of a teacher with the Acting in the capacity of a teacher with the intention of assisting your students to learn.intention of assisting your students to learn.

Acting in the capacity of a researcher with the Acting in the capacity of a researcher with the intention of studying the process of teaching and intention of studying the process of teaching and learning. Publication of results is not a learning. Publication of results is not a necessary condition.necessary condition.

Basics of the IRBBasics of the IRB

Page 20: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- RegulationsWhat are data?What are data? Examples

Survey sheets and questionnaires, biological samples, audio and Survey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper video tapes, transcripts of verbal communication, photographs, paper and electronic records, and moreand electronic records, and more

Existing (archived) data or samplesExisting (archived) data or samples Observation of public behaviorObservation of public behavior Collection of new data though human interventionCollection of new data though human intervention

Privacy and de-identificationPrivacy and de-identification Storage and retentionStorage and retention ProtectedProtected Medical records and HIPAAMedical records and HIPAA

Confidential vs. anonymous collectionConfidential vs. anonymous collection DefinitionsDefinitions Can the collected data be traced back?Can the collected data be traced back? Can the data identify one or more persons?Can the data identify one or more persons?

Basics of the IRBBasics of the IRB

Page 21: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Regulations- RegulationsMeans of protocol review ...Means of protocol review ... ExemptExempt

Research using existing data or samples.Research using existing data or samples. Observation of public behavior.Observation of public behavior. Research involving surveys or questionnaires where no personally Research involving surveys or questionnaires where no personally

identifying information is gathered or retained.identifying information is gathered or retained. Eligibility for exemption must be determined by the IRB, not the Eligibility for exemption must be determined by the IRB, not the

investigator.investigator. ExpeditedExpedited

Poses no more than “minimal risk” to the subject, i.e., “no more than 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 those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."routine physical or psychological examinations or tests."

Approvable by review of two members of the Board.Approvable by review of two members of the Board. Doesn’t necessarily mean quick or fast review.Doesn’t necessarily mean quick or fast review.

Full boardFull board Research that is neither exempt nor expeditable must receive review Research that is neither exempt nor expeditable must receive review

by the full committee.by the full committee. Means a convened meeting of the IRB for face-to-face discussion.Means a convened meeting of the IRB for face-to-face discussion.

Basics of the IRBBasics of the IRB

Page 22: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Informed consent- Informed consentElements of informed consent include …Elements of informed consent include … Explanation of the purpose(s) of the research.Explanation of the purpose(s) of the research. Description of the procedure(s) to be followed.Description of the procedure(s) to be followed. Summary of the data to be collected.Summary of the data to be collected. Description of any foreseeable risks or discomforts to the Description of any foreseeable risks or discomforts to the

subject.subject. Description of the benefits to the subject or to others, Description of the benefits to the subject or to others,

including compensation. including compensation. Explanation of how the investigator (PI) will maintain Explanation of how the investigator (PI) will maintain

confidentiality of records. confidentiality of records. Contact information of Contact information of allall PIs. PIs. A statement that participation is voluntary, that refusal to A statement that participation is voluntary, that refusal to

participate involves no penalty or loss of benefits, and participate involves no penalty or loss of benefits, and that the subject may discontinue at any time.that the subject may discontinue at any time.

Anything else that will help the subject to understand.Anything else that will help the subject to understand.

Basics of the IRBBasics of the IRB

Page 23: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Forms and Procedures- Forms and Procedures ProtocolProtocol

purpose, methodology, recruitment and description purpose, methodology, recruitment and description of subjects, risk evaluation, anonymity and of subjects, risk evaluation, anonymity and confidentiality, benefits, compensation, etc.confidentiality, benefits, compensation, etc.

Informed consent formInformed consent form consent for adultsconsent for adults assent for minorsassent for minors

Surveys and questionnairesSurveys and questionnaires paperpaper electronic (Zoomerang)electronic (Zoomerang)

Basics of the IRBBasics of the IRB

Page 24: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Forms and Procedures- Forms and Procedures Submit protocol electronically as a MS Word fileSubmit protocol electronically as a MS Word file

send attachments like consent form or surveyssend attachments like consent form or surveys send front page by regular mail with signaturessend front page by regular mail with signatures

Provide evidence of trainingProvide evidence of training Allow IRB time to reviewAllow IRB time to review

comments are summarized by chair and sent to PIcomments are summarized by chair and sent to PI response by PI is evaluated by the chairresponse by PI is evaluated by the chair could be 1 week or 1 monthcould be 1 week or 1 month

Approval memo is sent Approval memo is sent approval is granted for up to one yearapproval is granted for up to one year renewals and amendments are permittedrenewals and amendments are permitted

Basics of the IRBBasics of the IRB

Page 25: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Training and education- Training and education IRB adopted IRB adopted www.citiprogram.orgwww.citiprogram.org in early 2006 in early 2006

30+ modules, various groups, completion reports30+ modules, various groups, completion reports required of all researchers with human subjectsrequired of all researchers with human subjects

To demonstrate experience and appreciation for To demonstrate experience and appreciation for human subjects protection.human subjects protection.

Basics of the IRBBasics of the IRB

Page 26: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

A memo is issuedA memo is issued Protection for manyProtection for many

the investigator(s)the investigator(s) the subjectsthe subjects the institutionthe institution

ComplianceCompliance we live in a regulated worldwe live in a regulated world with federal regulations and institutional policieswith federal regulations and institutional policies

Perspectives from peersPerspectives from peers IRB members can contribute to the studyIRB members can contribute to the study suggestions to the methodologysuggestions to the methodology

IRB approvalIRB approval- aspects- aspects

Page 27: Human Subjects Protection Committee at Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator

- Wrap-up- Wrap-up These are the basicsThese are the basics

every protocol is uniqueevery protocol is unique Federalwide AssuranceFederalwide Assurance

a document submitted to the federal governmenta document submitted to the federal government Cal Poly Pomona will comply with the regulationsCal Poly Pomona will comply with the regulations

More info?More info? www.csupomona.edu/~research/irb/www.csupomona.edu/~research/irb/ www.hhs.gov/ohrp/www.hhs.gov/ohrp/ members of the IRBmembers of the IRB

Basics of the IRBBasics of the IRB

Thank you for your interest in the IRB and its practices!