Transcript www.indianactsi.org

Sara Brand
Associate Director
Research Compliance Administration
OVERVIEW OF ACCREDITATION CHANGES
OBJECTIVES
Communicate recent changes in policies and procedures from recent
AAHRPP re-accreditation
NOTE: This is not a detailed explanation of how the changes will be
implement
•New policies and procedures and forms posted on website March 1, 2008
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WHY MORE CHANGES?
Detailed Self-Assessment
Accreditation Site Visit in December, 2007
Report from Self-Assessment and Site Visit Necessitated
Changes
Accreditation Council Meets in March, 2008 to Decide Outcome
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GENERAL CHANGES
Standard Operating Procedures
•All SOPs in one document
•Searchable
•One set of definitions
Meeting Deadlines
•5:00pm on Friday
New Forms
•Request Forms for Vulnerable Populations
•Continuing Review Forms
•Noncompliance Reporting Form
Human Subjects Research Engagement
•Examples of when an institution is or is not engaged in Human Subjects Research
•Requirements when an institution is engaged in Human Subjects Research (e.g. FWA,
letter of cooperation)
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SUMMARY SAFEGUARD STATEMENT
Section III.B: Entities Not Under PIs Direct Control
•List other facilities where research-related procedures will be performed (pharmacy,
pathology, etc.)
•Ensure these entities are adequately informed about the study and their research-related
duties
Section IV: Subject Population
•All questions removed, except those related to the involvement of students
•New request forms for children, cognitively impaired, prisoners
•“Targeted” changed to “reasonable expectation of enrollment”
Section VIII: Protection Procedures
•IUPUI is lead site of multi-center study – additional clarification on what IRB wants to
know
Section IX: Data Safety Monitoring Plan
•Checkbox for repository/database protocols where primary risk is loss of confidentiality
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SUMMARY SAFEGUARD STATEMENT
Section X: Confidentiality & Safeguards
•Study Manager added as Data Recording/Collection Method
•The use of Study Manager added as a measure for safeguarding information
Section XIV: Informed Consent Process
•Additional questions added regarding who and how informed consent will be obtained (adequate
training, language of consent interview, reminder to include language-appropriate consent documents)
•Checkboxes added to describe steps to minimize possible coercion or undue influence
•Clarification requested regarding waivers of informed consent process or modification of consent
document
Financial Conflict of Interest
•Section removed
Section XX: Investigational Drugs/Devices
•Clarification for when an IND or IDE may be required
•Questions removed regarding conditions that must be met to not require an IND
Section XXI: Investigators
•Revised how investigators are listed
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VULNERABLE POPULATIONS
Pregnant Women, Human
Fetuses and Neonates,
Prisoners, and Children SOPs
Vulnerable Populations SOP (also
includes Cognitively Impaired)
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PRISONERS
Request Form for the Inclusion of Prisoners in Research
• Replaces memo
• Includes additional Bureau of Prisons and Department of Corrections requirements
Additional Requirements
• Bureau of Prisons
• Department of Corrections
• No research involving medical testing, chemical, experimental drugs
• May request access to offender or juvenile records for research
VA Requirements
• VHA Handbook 1200.5, App. D.5: No research involving prisoners unless a waiver
granted by the Chief R&D Officer
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COGNITIVELY IMPAIRED
Request Form for the Inclusion of Cognitively Impaired
Individuals in Research
• Replaces questions in summary safeguard statement
• Includes questions regarding institutionalized individuals
IRB Responsibilities
• Appropriate provisions for determining subject’s ability to consent
• Plan for protecting individuals who may lose their capacity
• Appropriateness of obtaining assent from subjects who lack decision-making
capacity
VA Requirements
• Only incompetent persons are suitable as research subjects
• No significant risks
• Procedures for LAR to be well-informed re: roles and obligations to protect subjects
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CHILDREN
Request Form for the Inclusion of Children in Research
• Replaces questions in summary safeguard statement
• Additional questions added regarding waivers of assent and parental permission
Waiver of Child Assent
• For some or all children
• Limited capability
• Prospect of direct benefit important to the health and well-being/only available in
research
Waiver of Parental/Guardian Permission (Consent)
• Research is minimal risk
• Research is designed for conditions/subject population for which parental/guardian
permission is not reasonable to protect children (e.g. neglected or abused children)
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CHILDREN
When a Child Reaches Legal Age of Consent
• Obtain informed consent from now adult subject for ongoing interactions
• Waiver of informed consent
VA Requirements
• VHA Handbook 1200.5, App. D.7: No research involving children unless a waiver
granted by the Chief R&D Officer
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IND/IDE GUIDANCE
In general, institution did not provide adequate guidance to
investigators and IRB members regarding:
• When an investigational new drug (IND) application or investigational device
exemption (IDE) was required
• Responsibilities when an investigator is the holder of the IND or IDE
IND and IDE Checklists
• Help determine when an IND or IDE is required for a research study
Responsibilities when investigator is Holder of an IND or IDE
• Face-to-Face Discussion
• On-line Information
Validation of IND or IDE Number
• Sponsor Protocol
• Communication from FDA
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UNANTICIPATED PROBLEMS
Regulations: Unanticipated Problems
•45 CFR 46.103(b)(5) & 21 CFR 56.108(b): IRB establishing procedures for reporting
unanticipated problems
•21 CFR 312.53(c): Investigators promptly reporting unanticipated problems to the IRB
Regulations: Adverse Events
•21 CFR 312.32: IND Safety Report Definitions
•Adverse Drug Experience
•21 CFR 812.3: IDE Definitions
•Unanticipated Adverse Device Effect
OHRP Guidance (Jan 15 2007)
•Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or
Others and Adverse Events
FDA Draft Guidance (Apr 2007)
•Guidance for Clinical Investigators, Sponsors, and IRB: Adverse Event Reporting – Improving
Human Subject Protection
For more info . . .
OHRP Guidance: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.pdf
FDA Guidance: http://www.fda.gov/cber/gdlns/advreport.pdf
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UNANTICIPATED PROBLEMS
IUPUI/Clarian Policy
• Unexpected
• Related or possibly related (more likely than not) to research participation
• Suggests research places subjects or others at greater risk of harm
• Requires revision to protocol or IC process/document or other action to protect
subjects
How Do I Report?
• Prompt Reporting Form
When Do I Report?
• Within (5) five business days for event or notification of event (internal or external)
Additional Reporting Requirements
• Anytime the IRB determines that an event is an unanticipated problem, it must be
reported out to federal agencies (OHRP, FDA) and other entities, as applicable
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UNANTICIPATED PROBLEMS
What if my sponsor wants me to report an adverse event that
is not reportable under the new policy?
•No regulatory requirement
•Sponsor letter on website
•Tracking log going away
Are there other unanticipated problems besides adverse events?
•Yes, they are listed in the SOP and on the Prompt Reporting Form
•Major internal protocol deviations
•Investigator- or sponsor-initiated suspensions or holds
When Do I Report?
•Within (5) five business days for event or notification of event (internal or external)
Additional Reporting Requirements
•Anytime the IRB determines that an event is an unanticipated problem, it must be
reported out to federal agencies (OHRP, FDA) and other entities, as applicable
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NONCOMPLIANCE
IUPUI/Clarian Policy
• Report all noncompliance
How Do I Report?
• Noncompliance Reporting Form
When Do I Report?
• Within (5) five business days or noncompliance
Additional Reporting Requirements
• Anytime the IRB determines that noncompliance is serious or continuing, it must be
reported out to federal agencies (OHRP, FDA) and other entities, as applicable
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VA-SPECIFIC REQUIREMENTS
Continuing Review
•VA studies the do not receive a continuing review by the expiration date are automatically
suspended.
•Investigator must submit a list of subjects for whom suspension would cause harm
•IRB Chair and Chief of Staff at VA will determine if continued intervention/interaction is
best for subjects
Determine Level of Risk – Flagging Medical Records
•Generally, all full board studies
•Minutes will reflect this requirement
Enrollment of Non-Veterans
•Only when insufficient number of veterans available
•Regulations pertaining to veterans in research also pertain to non-veterans enrolled in VA
studies
Waiver of Consent for Planned Emergency Research
•Prohibited at the VA
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VA-SPECIFIC REQUIREMENTS
Waiver of Authorization/Informed Consent for Recruitment
• Office of Research Oversight (ORO) Guidance (10/09/2007)
• Accessing patient records for recruitment into research requires the IRB to approve
a waiver of authorization and waiver of informed consent for recruitment purposes
(even when accessing own patients’ records)
How will this practically be done?
• Standard responses provided to investigators for each waiver criteria
• Requires approval by the IRB Executive Committee
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