Transcript Slide 1
Richard Wagner
Associate Director, HRPP
415-476-1172 January 29, 2009
Human Research Protection Program Training
Preparing a Full Committee Application
Introduction
Human Research Protection Program
HRPP Training: Upcoming Sessions
• • •
Preparing an Expedited or Exempt Application
– – Friday, February 20, 1:30-3:30 p.m., N-225 Lisa Voss, Assistant Director
The Study Coordinator’s Role in Investigator originated Studies
– – March 2009 Diane Davies RN, Manager, Clinical Research Unit, Helen Diller Family Comprehensive Cancer Center
CHR Introductory Training
– – Spring 2009 Presenter TBD 2
Human Research Protection Program HRPP Website
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Change Is Coming
Human Research Protection Program
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New On-Line (iMedRIS) CHR Application
– Expected to be fully implemented before the end of 2009 – – A single application process with branching questions Based on current applications, but with simplified questions – – New database/document manager More information about progress of the application will be available on line
At present, you must use the current application form and supplements
(Downloaded from CHR website, filled out on your computer, submitted in hard copy) 4
Outline for Today
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Demystifying the CHR review process
Introduction •
The Full Committee Application
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Getting Answers After this Class Human Research Protection Program
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Open Questions and Answers
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Human Research Protection Program
HRPP Organization
Demystifying the CHR Review Process 6
Human Research Protection Program
Demystifying the CHR Review Process
Where does the application go?
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Assessment/Screening
Review by Full Board
Post-Review Correspondence
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Approval
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Human Research Protection Program
Demystifying the CHR Review Process
What do CHR members consider when reviewing a new study?
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Risks to subjects are minimized
– Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk.
– Study utilizes procedures already performed for diagnosis/treatment.
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
Selection of subjects is equitable
– – – Inclusion/Exclusion criteria are adequate Research purpose and setting is appropriate Recruitment process is fair 8
Human Research Protection Program
Demystifying the CHR Review Process
What do CHR members consider when reviewing a new study?
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Informed consent will be sought in accordance with 45 CFR 46.116
Informed consent will be documented in accordance with 45 CFR 46.117
Provisions for monitoring collected data are adequate to ensure the safety of subjects Provisions to protect privacy of subjects are adequate Provisions to maintain confidentiality of data are adequate Vulnerable populations are adequately protected by additional safeguards
– Children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons 9
Human Research Protection Program
Demystifying the CHR Review Process
Process FAQ
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How are studies assigned to CHR meeting agendas?
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How do I get more information about the review status of the study I submitted to CHR?
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Human Research Protection Program
Demystifying the CHR Review Process
Full Committee Application
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One application for clinical and behavioral research
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Research poses more than minimal risk, or
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Poses minimal risk but
– – Does not fit an expedited review category Requires a full committee determination 11
Human Research Protection Program
Demystifying the CHR Review Process
Minimal Risk
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Risk of daily life of a healthy individual
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Not relative risk
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 1: Administrative Requirements
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PI, Co-PI, Contact Person Key Personnel Financial Interests
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 1: Administrative Requirements
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Sites
– – – VAMC SFGH CCRC’s
Funding Scientific or Scholarly Review
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 1: Administrative Requirements
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Drugs, Devices & Biologics
– – – Include one copy of the Investigational Brochure Document IND/IDE numbers Is an IND/IDE needed?
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 2: Study Design
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Synopsis vs. Design vs. Procedures Hypotheses Specific Aims Background vs. Preliminary Studies
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 3: Procedures
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Differentiating between research and standard of care activities Identify any difference between local procedures and sponsor’s protocol Adding tables/charts Tissue Banking
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Human Research Protection Program Full Committee Application Part 4: Alternatives
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Be sure to identify standard or usual care at UCSF
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Also identify other available alternatives
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Consent form must say if study drug or treatment is available off study
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 5: Risks and Benefits
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A. Risks and Discomforts
• 1. Description of risks • 2. Steps to minimize risks – Reference to inclusion/exclusion criteria – Subject monitoring – Rules for withdrawing participants from study
B. Data and Safety Monitoring Plan (DSMP)
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 5. B. Data Safety Monitoring Plan
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Explain the plan to monitor study progress and safety Describe who will perform the monitoring reviews and at what frequency Describe the type of data and events (i.e., efficacy data, adverse events, unanticipated problems involving risk to participants or others) reviewed under the monitoring plan.
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 5. B. Data Safety Monitoring Plan
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How will results of monitoring reviews be communicated to the study sponsor and the CHR?
As appropriate:
• Plan for conducting and reporting interim analyses • Study stopping rules 21
Human Research Protection Program
When is a DSMB needed?
The Full Committee Application •
Phase III Clinical Trials
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Phase II Clinical Trials when
• Randomized and blinded, or • High Risk 22
Human Research Protection Program
The Full Committee Application
More on Risks and Benefits
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Adequacy of Resources Confidentiality and Privacy Information Security Benefits Risk/Benefit Analysis
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 6: Subject Information
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CHR Supplements
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Inclusion and Exclusion Criteria
• Be specific • Explain differences from sponsor’s protocol •
Determining Eligibility
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Non-regulated vulnerable populations
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The Full Committee Application
The Full Committee Application
Part 7: Recruitment
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Respect for privacy
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Lack of pressure
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Unbiased presentation
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The “Therapeutic Misconception” Human Research Protection Program Be sure to include all pertinent details in Part 7.B.
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 8: Informed Consent
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How, Where, When and By Whom?
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Ensuring Understanding
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Waiver of Consent Supplement
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Human Research Protection Program
The Full Committee Application
The Full Committee Application
Part 9: Financial Considerations
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Payment of Subjects
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Costs to Subjects
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The Full Committee Application
Treatment and Compensation for Injury
Human Research Protection Program
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Three options:
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Standard UC wording naming both UC and the sponsor
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Standard UC wording naming only UC
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Standard UC wording naming only UC, followed by a very limited statement about the sponsor’s policy
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Human Research Protection Program
The Full Committee Application
Attachments
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Consent and Assent forms
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Sponsor’s protocol
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Investigator’s brochure
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Survey instruments
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Recruitment and contact materials
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The Full Committee Application
CHR Supplements
Human Research Protection Program
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Inclusion of Children and Minors Human Biologic Specimen Collecting and/or Banking for Future Research
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IRB Approval Certification for UCSF Researchers Involving Non-UCSF Affiliated Sites Disclosure of Investigator’s Financial Interests Supplement
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Waiver of Informed Consent/Authorization for Minimal Risk Research or Screening
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The Full Committee Application
CHR Supplements (continued)
Human Research Protection Program
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Non-Significant Risk Determination for an Investigational Device Surrogate Consent Inclusion of Prisoners Human Gene Transfer / Recombinant DNA Research Supplement Human Stem Cell Research Emergency Medical Research Waiver of Informed Consent
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Human Research Protection Program
Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your CHR Approval
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Please see brochure available at this presentation.
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Brochure is also available at CHR website, Applying and Reporting to the CHR, Overview of Application Process, Top Tips for Speeding Up Your CHR Approval
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Where to Go for Help
Human Research Protection Program
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Call the HRPP Office at 476-1814
– Explain your concern to the person who answers the phone – Specialists handle various areas such as renewals, modifications, and adverse event reporting – For complex problems, ask to speak to the Analyst of the Day.
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Visit the HRPP Website at www.research.ucsf.edu/chr/
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Open Questions and Answers
More Resources
Human Research Protection Program
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CITI Training (Required Education for Key Personnel)
• https://www.citiprogram.org
CTSI: Clinical and Translational Science Institute
• http://ctsi.ucsf.edu/
RKS: Regulatory Knowledge and Support
• http://ctsi.ucsf.edu/rks/request/ • Marlene Berro – [email protected]
; 476-3426
BREAD: Biostatistics, Research Ethics and Design Program
, 502-7893 34