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What do I Have to Report to the IRB

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					What do I Have to Report to the IRB?
(and Other Mysterious Things!)

“If we knew what it was we were doing, it would not be called research, would it?” ~Albert Einstein
Marie Curie with Albert Einstein

Objectives
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Participants will be able to identify the major reporting requirements of IRB’s Participants will be able to identify how to report events to the IRB Participants will be able to identify noncompliance issues in reporting

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What Does the Seton Office of Research Administration Do?
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It is the responsibility of the Seton Office of Research Administration:
To protect and provide guidance to our patients involved in research, our physicians, and the organization as a whole.  To manage and educate our Institutional Regulatory Boards, Researchers, Research Team Members.
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What is an IRB?
Institutional Review Boards (IRB) –
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The primary responsibility of IRB is to protect human subjects. The board evaluates the safety and ethical issues surrounding potential research. The board is concerned with adequate research subject informed consent, potential risks and benefits to research subjects, protection of human subject rights, and potential ethical and financial impact of research studies. The IRB is also charged with the responsibility of evaluating the science, methodology, design, and statistical validity and reliability of potential research studies. These boards are monitored directly by the DHHS.

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Primary Responsibilities of IRB’s
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Institutional Review Boards Review Requirements as required by law include but are not limited to:
1) Risk must be minimized

2) Risk/Benefit ratio must be reasonable 3) Selection must be equitable 4) Informed consent must be documented 5) Data must be monitored to ensure subject safety 6) Confidentiality must be maintained 7) Vulnerable populations must be protected

What Else Is the IRB Concerned With?
Patient/Human Subject Protection and Safety  Confidentiality  Investigator Protection  Institutional Protection  Research Integrity  Public and Institutional Trust
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Ethics
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Nuremberg Code 1947
Informed Consent, i Risk, Results Valuable

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Declaration of Helsinki 1964
Independent Review, Preserve Confidentiality

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Belmont Report 1979
Respect for Persons, Beneficence, Justice

Ethics
Research Timeline 6th Century B.C. to Present  Things still go wrong despite our best efforts Nicole Wan - 1996 Jessie Gelsinger – 1999 Ellen Roche – 2001  Transparency and Effective Communication and crucial between researchers and IRB’s
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Regulation of Clinical Research HHS
45 CFR 46 – Protection of Human Subjects in Research (aka: “Common Rule”)  This rule applies to all research funded in whole or in part by the Health and Human Services.  This rule is generally considered the authority for all research and applies in addition to all FDA regulated research.
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Regulation of Clinical Research FDA
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Protection of Human Subjects Title 21 Part 50 – Informed Consent Title 21 Part 56 – Institutional Review Boards New Drug Development and Use Title 21 Part 312 IND Applications and Responsibilities of Sponsors, Monitors, and Investigators Title 21 Part 314 Approval of New Drugs This rule applies to all research involving products regulated by the Food and Drug Administration.

What does an IRB expect of an applicant?
Consideration and demonstration of understanding of ethical guidelines and obligations  Clarity in statement of problem, research questions & proposed communication with participants  Consistency in content of documents  Completeness of all materials
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Reporting
Unanticipated Problems  Protocol Violations  Protocol Deviations  Administrative & Substantive Amendments  Continuing Reviews  Annual Reports  Other Categories
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OHRP defines unanticipated problem, as any incident, experience, or outcome that:

(i) is unexpected; (ii) is related or possibly related to participation in the research; and (iii) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unexpected?
An unexpected adverse event is an adverse event not consistent with known or foreseeable risks associated with research procedures involved or with subject’s underlying disease or condition.

Unexpected?

Most adverse events cannot be considered unexpected due to the known toxicities and side effects of the research procedures, the expected natural progression of subjects’ underlying conditions and subjects’ predisposing risk factor profiles for the adverse events.

Related?
If participation in research can be considered to have even partially caused or contributed to the adverse event, then it is related. An adverse event is possibly related to participation in the research if there is a reasonable possibility that it may have been caused by the procedures involved in the research.

Additional Risk?
An adverse event must generally be considered serious to place subjects at a greater risk of harm. OHRP defines a serious adverse event as one that results in death, is life-threatening, results in inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or may jeopardize the subject’s health and may require medical or surgical intervention to prevent any of the above listed outcomes.

Not Serious?
However, other adverse events that are unexpected and related or possibly related to participation in the research, but not serious, would also be unanticipated problems if they suggest that the research places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized.

Adverse Event = Unanticipated Problem?
The following Venn diagram summarizes the general relationship between adverse events and unanticipated problems (Office for Human Research Protections, Department of Health and Human Services, January 15, 2007):

Adverse Event = Unanticipated Problem?
The diagram illustrates three key points:  The vast majority of adverse events occurring in human subjects are not unanticipated problems (area A).  A small proportion of adverse events are unanticipated problems (area B).  Unanticipated problems include other incidents, experiences, and outcomes that are not adverse events (area C).

Protocol Violations and Deviations
No definition for terms protocol violation or protocol deviation exists in regulations governing clinical research involving human subjects.

Protocol Violations and Deviations
Protocol Violation – a significant unapproved change or departure from the study design or procedures of a research project that is: (i) under the investigator’s control; (ii) has not been approved by the Seton IRB; and (iii) has significant potential to increase risk to subjects and/or undermine the scientific integrity of the study.

Protocol Violations and Deviations
Protocol Deviation – a departure from the defined procedures and treatment plans as outlined in the protocol version approved by the Seton IRB and have less than significant potential to increase risk to subjects and/or undermine the scientific integrity of the study.

Administrative & Substantive Amendments
Administrative Amendments (i.e. change of address, typographical errors, addition of sites, etc)

Substantive Changes (i.e. protocol changes, changes in data collection forms, changes in methodology, increase or decrease in risk level, new finding, etc)

Continuing Reviews
All protocols are required to under Continuing Review at least every 365 days.  An IRB can require more frequent review of a protocol based on risk level and other factors.  Data Reporting Elements (i.e.# enrolled, # unanticipated problems, # violations & deviation, etc)
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Annual Reports
Any completed Annual Reports should be submitted to the IRB as “Information.”  These are generally created by Pharmaceutical and Device Manufactures.
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Other Categories
Information  Publications  Monitoring Visits  For Cause Audits (all agencies)  Debarrments  Study Closure
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You've carefully thought out all the angles.
You've done it a thousand times. It comes naturally to you. You know what you're doing, its what you've been trained to do your whole life. Nothing could possibly go wrong, right ?

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Think Again.

Contact Information
Heather J. Gipson, JD, MA, CIM Director, Human Subject Protections & Research Services Office of Research Administration (512) 324-7991 hjgipson@seton.org


				
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