Human Research Protection Program Training Preparing a Full Committee Application Richard Wagner...

Human Research Protection Program Training

Preparing a Full Committee ApplicationRichard WagnerAssociate Director, [email protected]

January 29, 2009

mailto:[email protected]

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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

Introduction

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HRPP Website

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Change Is Coming

• 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)

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Outline for Today

• Demystifying the CHR review process

• The Full Committee Application

• Getting Answers After this Class

• Open Questions and Answers

Introduction

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HRPP Organization

Demystifying the CHR Review Process

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Where does the application go?

• Assessment/Screening

• Review by Full Board

• Post-Review Correspondence

• Approval


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What do CHR members consider when reviewing a new study?

• 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


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What do CHR members consider when reviewing a new study?

• 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


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Process FAQ

• How are studies assigned to CHR meeting agendas?

• How do I get more information about the review status of the study I submitted to CHR?


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Full Committee Application

• One application for clinical and behavioral research

• Research poses more than minimal risk, or

• Poses minimal risk but– Does not fit an expedited review category

– Requires a full committee determination


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Minimal Risk

• Risk of daily life of a healthy individual

• Not relative risk


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The Full Committee Application

• PI, Co-PI, Contact Person

• Key Personnel

• Financial Interests

Part 1: Administrative Requirements


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• Sites

– VAMC

– SFGH

– CCRC’s

• Funding

• Scientific or Scholarly Review



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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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• Synopsis vs. Design vs. Procedures

• Hypotheses

• Specific Aims

• Background vs. Preliminary Studies

Part 2: Study Design


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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

Part 3: Procedures


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Full Committee Application Part 4: Alternatives

• Be sure to identify standard or usual care at UCSF

• Also identify other available alternatives

• Consent form must say if study drug or treatment is available off study

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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)

Part 5: Risks and Benefits


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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.

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

Part 5. B. Data Safety Monitoring Plan


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When is a DSMB needed?

• Phase III Clinical Trials

• Phase II Clinical Trials when• Randomized and blinded, or

• High Risk


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More on Risks and Benefits

• Adequacy of Resources

• Confidentiality and Privacy

• Information Security

• Benefits

• Risk/Benefit Analysis


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• CHR Supplements

• Inclusion and Exclusion Criteria• Be specific

• Explain differences from sponsor’s protocol

• Determining Eligibility

• Non-regulated vulnerable populations

Part 6: Subject Information


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• Respect for privacy

• Lack of pressure

• Unbiased presentation

• The “Therapeutic Misconception”

Be sure to include all pertinent details in Part 7.B.

Part 7: Recruitment


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• How, Where, When and By Whom?

• Ensuring Understanding

• Waiver of Consent Supplement

Part 8: Informed Consent


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• Payment of Subjects

• Costs to Subjects

Part 9: Financial Considerations


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Treatment and Compensation for Injury

• Three options:

1. Standard UC wording naming both UC and the sponsor

2. Standard UC wording naming only UC

3. Standard UC wording naming only UC, followed by a very limited statement about the sponsor’s policy


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Attachments

• Consent and Assent forms

• Sponsor’s protocol

• Investigator’s brochure

• Survey instruments

• Recruitment and contact materials


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CHR Supplements

• Inclusion of Children and Minors

• Human Biologic Specimen Collecting and/or Banking for Future Research

• IRB Approval Certification for UCSF Researchers Involving Non-UCSF Affiliated Sites

• Disclosure of Investigator’s Financial Interests Supplement

• Waiver of Informed Consent/Authorization for Minimal Risk Research or Screening


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CHR Supplements (continued)

• 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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Top Tips for Speeding Up Your CHR Approval

• Please see brochure available at this presentation.

• 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

Top Tips for Speeding Up CHR Approval

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Where to Go for Help

• 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.

• Visit the HRPP Website at

www.research.ucsf.edu/chr/

http://www.research.ucsf.edu/chr/

http://www.research.ucsf.edu/chr/

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More Resources

• 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

• [email protected], 502-7893

Open Questions and Answers

https://www.citiprogram.org/



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