Transcript IRB Education for Certification

IRB Education for Certification
Justine Schober
Ethical Principles
•
Respect for Persons
Individuals should be treated as autonomous agents.
Persons with diminished autonomy are entitled to
protection.
• Beneficience
Do no harm.
Maximize possible benefits/minimize possible harms.
• Justice
Who bears the burdens of the research?
Who receives the benefits?
Application of Principles
1. Informed Consent – the right to choose (Respect for Persons)
•
•
•
Information – Convey what a reasonable volunteer would want to know.
Comprehension – Present information in a manner and context which the
subject can understand.
Voluntariness – Agree to participate in conditions free of coercion and/or
undue influence.
2. Assessment of Risks and Benefits (Beneficience)
•
•
•
. Ensure a scientifically and medically valid study design.
. Determine whether risks are justified in relation to benefits.
3. Selection of Subjects (Justice)
•
. Employ fair procedures and outcomes when selecting subjects.
Study Scheme
The following processes must occur before a study protocol
can be implemented:
•
..
•
..
•
Protocol reviewed and approved by investigators
•
..
•
•
..
•
..
•
Study site evaluated by the sponsor
Budget reviewed by investigator/coordinator
Regulatory documents completed
Peer Review and approval, Administrative Review and approval
(including budget), Service Line Leader Review (device studies)
Study presented to the IRB by the principal investigator
IRB approval granted
Before Study Initiated
• Study contract reviewed by legal counsel (through the Research
Center), edited (as appropriate), and signed by the principal
investigator
• Study processes developed
• Study site initiated by the sponsor
• Staff inserviced
• Study implemented
..
• Continuing (annual) and Final IRB Review
Study Team
When implementing a study key study
personnel includes:
• Principal Investigator responsibilities (All
phases of study)
• Co-investigator
• Coordinator
Principal Investigator
responsibilities
•
•
•
•
•
•
•
•
•
1. Performance of study team,
2. Storage and administration of drug or device,
3. Implementation of study protocol,
4. Discussing and obtaining informed consent,
5. Adherence to regulations and policies (FDA, HHS,
Sponsor, IRB, Research Center),
6. Ensuring integrity of data,
7. Obtaining IRB approval (initial approval and for
changes in study including personnel changes,
advertisements, etc.),
8. Reporting adverse events and protocol deviations to
IRB, and
9. Continuing (annual) and Final IRB Review.
Co-investigator responsibilities
• 3. Implementation of study protocol,
• 4. Discussing and obtaining informed
consent,
• 5. Adherence to regulations and policies
(FDA, HHS, Sponsor, IRB, Research
Center),
• 6. Ensuring integrity of data
Coordinator responsibilities
• Management of clinical trial
• Liasion to study team, sponsor, IRB, hospital
departments
• Study process development and implementation
• Staff education
• Study accounting
• Research data collection and documentation.
Protocol Implementation
•
•
•
•
•
•
•
•
•
•
•
•
To conduct research, the Study Team must have a thorough
understanding of the:
Study protocol
Inclusion/exclusion criteria
Study procedures
Patient withdrawal procedure
Experimental drug/device (mode of action, side effects, etc.)
Study procedures
Initial patient evaluation
Drug administration/device implantation
Study monitoring
Testing (lab, radiology, EKG, EP, etc.)
Protocol Implementation
Study documentation
• Medical/office charts
• Patient notebooks (These are usually designed by the
coordinator to record study-specific data not normally
recorded in the patient’s chart)
• Case report forms (These are usually designed by the
sponsor to record FDA-required study data)
• Normal hospital/office processes - similarities and
differences with study procedures must be identified and
addressed.
Protocol Implementation
• Education required of all involved
departments.
• Closely monitor study implementation for
the first two to three patients to identify
potential problems, assess current
processes
• modify as needed
• educate staff accordingly.
Good Clinical Practices
for the Study Team
• Good Clinical Practices are guidelines
from the Food and Drug Administration
and Health and Human Services
Department that assist the investigator
and Study Team in performing high quality
clinical trials
Good Clinical Practices
for the Study Team
• Review and approve investigator
brochure, protocol, case report forms.
• Review and approve consent forms.
• Review all existing data regarding the
experimental drug/device – indications,
use, precautions, warnings, and
contraindications.
Good Clinical Practices
for the Study Team
• Obtain IRB approval for study in writing.
• Account for drug/device trials.
Good Clinical Practices
for the Study Team
• Adhere to protocol.
• Fill out all case report forms completely and
legibly.
• Review data as compiled.
• Provide continuing review data to the IRB and
progress reports to the sponsor, as requested.
• Report any unexpected or serious adverse
event to the IRB and sponsor (verbally within 24
hours and in writing within five working days).
• Submit any study and/or consent modifications
to the IRB within ten days of receipt.
Good Clinical Practices
for the Study Team
• On continuing review, explain in detail any
patient withdrawals or deaths.
• Provide final reports to the sponsor and
IRB.
• Return any unused, experimental drug or
device.
Adverse Event Definitions
•
•
•
•
•
•
•
•
•
•
Adverse Event (AE): Any unintended, unfavorable clinical sign or symptom,
any new illness/disease or deterioration of existing illness/disease
regardless
of whether it is considered related to study treatment.
Serious Adverse Event (SAE): Any occurrence during participation in a
protocol that is fatal, life-threatening, or permanently disabling. An
occurrence that requires or prolongs inpatient hospitalization, or results in a
congenital anomaly, cancer, or overdose.
Unexpected Adverse Event (UAE): Any adverse experience that is not
identified in nature, severity, or frequency in the current investigator
brochure
or general investigational plan.
Reporting Requirements
Record all AEs, SAEs, and UAEs in study documents. Report
whether the event is possibly, probably, or unrelated to
investigational drug or device.
Report to sponsor:
• AE-next monitoring visit
• SAE - by telephone within 24 hours and a written report per sponsor
instructions
• UAE - by telephone within 24 hours and a written report per
sponsor instructions
Report to IRB:
• AE-next continuing review
• SAE - by telephone within 24 hours and a written report within five
days
• UAE - by telephone within 24 hours and a written report within five
days
IRB/Investigator Interactions
When amending a protocol/consent, or advertising for patients,
the following procedures should be implemented:
Amendments (Changes in the Protocol, Consent, and/or Study Personnel) Submit all amendments in
writing to IRB Secretary within ten calendar days. If changes are minor, expedited review may be
provided.
Implement changes after written approval is obtained. (Exception: if patient safety is involved,
implement immediately)
Advertisements Any information reviewed by prospective study patients for recruitment purposes
must receive IRB review and approval in writing. This includes newspaper advertisements,
posters, radio spots, TV advertisements, billboards, brochures, etc.
Elements required by FDA:
•
. Name and address of investigator
•
. Purpose of the research
•
. Eligibility criteria
•
. Benefits
•
. Time commitment
•
. Contact person
Informed Consent
Except in emergencies, a physician owes a duty to
a patient to obtain the informed consent of the
patient, or the patient’s authorized
representative prior to administering an
• experimental medication,
• using an experimental device, or
• using an approved drug/device in an
experimental manner
• Act 135, 40 P.S. 1301.811-A.
Consent Process
•
Use the IRB-approved consent form.
•
•
Allow patient time to READ the entire form in a quiet room.
Discuss the nature, purpose, procedures, risks, and benefits of study
participation with the patient.
Answer questions.
Have patient initial each page and date and sign final page.
Have witness date and sign final page. Witness should not be a member of
study team.
Make at least two copies of the original consent document:
Place original consent on patient chart.
Place one copy in the patient notebook.
Give the other copy to the patient.
All patients or guardians of patients who agree to study participation by the
patient must sign the consent, even if the subjects are randomized into a
control group.
•
•
•
•
•
•
•
•
Communicate with the IRB
• Submit and obtain written approval for changes
to the protocol, consent and/or study team.
• Promptly report protocol deviations.
• Immediately report (verbally within 24 hours and
written within five working days) serious and/or
unexpected adverse events.
• Provide accurate continuing review information.
• Provide a final report.