Transcript Slide 1

Human Research
Protection Program
Training
Lisa Voss, MPH, CIP
Assistant Director, HRPP
Quality Improvement Unit
[email protected]
415-514-2152
February 20, 2009
Preparing an Exempt or Expedited
Application
Introduction
HRPP Training: Upcoming Sessions
• The Study Coordinator's Role in Investigatororiginated Studies
Date and Time: Tuesday, March 10, 2009, 10 a.m.noon
Location: Parnassus campus, N-225
Speaker: Diane Davies RN, Manager, Clinical
Research Unit, Helen Diller Family Comprehensive
Cancer Center
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Protection
Program
• Preparing Consent and Assent Forms
Date and Time: Thursday, April 30, 2009, 10 a.m.noon
Location: Parnassus campus, N-225
Speaker: Richard Wagner, Associate Director
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Introduction
Outline for Today
• Demystifying the CHR review process
• The Exempt Application
• The Expedited Application
• Top Tips for Speeding Up CHR
Approval
• Getting Answers After this Class
• Open Questions and Answers
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Demystifying the CHR Review Process
HRPP Organization – January 2009
HRPP Director
John Heldens
HRPP Business Analyst
Judy Der - Analyst II
Manager
Assessment Unit
(Pre-CHR Review Activities)
Vacant
Analyst V Supervisor
Education & Assessment Unit
Anita Katona – Analyst IV
Joanne Mickalian– Analyst IV
Megan Sullivan – Analyst II - Supervisor
Fred Hendrickson – Analyst II
Committee Assistants
Administrative Assistant IIs
Meri Figueroa
Brian Hertzog
Denisha Otis
Mario Velez
-------------------------TEP for Data Entry
TEP for Filing
HRPP Assistant Director
Quality Improvement Unit
(Post CHR Approval Activities)
Lisa Voss
Analyst V Supervisor
HRPP Associate Director
CHR Review Unit
Richard Wagner
Analyst V Supervisor
Committee Coordinators
SFGH
Elizabeth Mendelsohn -- IV
Terry Colbert -- II
Committee Coordinators
Laurel Heights
Karen Chao - IV
Kate Nolan - Analyst II
QIU Group
Beth Shields -- Analyst IV
Susie Corl – Analyst IV
Jill Magee – Analyst II
Committee Coordinators
Mt. Zion
Michael Thomas -- IV
Nicole Ketroser -- II
Committee Coordinators
Parnassus
Annette Bugatto -- IV
Wendy Stephens -- II
Education Coordinator
Melanie Mace - Analyst IV
Cancer Ctr. Asst. Coordinator
Susanne Henderson -II
HRPP – Human Research Protection Program
CHR – Committee on Human Research
QIU – Quality Improvement Unit
Demystifying the CHR Review Process
First Step:
Determining
“Is the project human subject research?”
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Demystifying the CHR Review Process
Definition of Research
• A systematic investigation, including
– Research development, testing and evaluation
– Designed to develop or contribute to
generalizable knowledge
45 CFR 46.102
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Demystifying the CHR Review Process
Definition of Human Subject
• A living individual about whom an
investigator, whether professional or
student, conducting research obtains
– Data through intervention or interaction with
the individual, or
– Identifiable private information
DHHS 45 CFR 46.102
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Demystifying the CHR Review Process
When is it NOT a Human Subject
• If the Investigator obtains coded data or biological
samples under the following conditions:
– The coded private information or specimens cannot be
collected specifically for the current proposed research
project, and one or more of the following apply:
– The key to decipher the code is destroyed before the
researcher begins, or
Human
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– The PI and holder of the key enter into an agreement
prohibiting the release of the key under any circumstance
(The CHR recommends a written agreement be secured
between the recipient and the provider of the specimens or
data. The CHR will not require review of these agreements.),
or
– There are IRB-approved written policies for the repository or
data management that prohibit the release of the key.
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Demystifying the CHR Review Process
Determining Whether Human Subjects are Involved in Research When Obtaining§
Private Information (data) and/or Biological Specimens – October 2007
CAUTION: This diagram does not apply to 1) initial collection of tissue, 2) human stem cell research, 3) FDA
regulated research, and 4) research involving prisoners. All of these must be reviewed by Full Committee or
Expedited Review.
Data and/or specimens
are coded and
identifiers* are kept
separately
Data and/or
specimens have
identifiers
Data and/or
specimens are
de-identified*
Examples
1. Commercially available
specimens
Do the PI or Co-Investigators
on the study have access to the
“key” to link back to the
identifiers*?
Yes
2. Adult cells lines with no
identifiers, NOT stem cells
3. Cadaveric tissue with
no identifiers
No
Conditions:
Not human subjects
Human subjects
See the conditions
that must be met.
Definitions:
§
Obtaining - is defined as receiving or accessing data or biological specimens.
* Identifiers – Any of the 18 Protected Health Identifiers and other type of personal identifiers.
IMPORTANT NOTE: The data or biological specimens may include a limited set of data
including all elements of dates and geographical codes (zip codes) as long as the individuals
identity cannot be ascertained.
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The coded data and/or specimens
were not collected specifically for
the current proposed research
project, and one or more of the
following apply:
1. The key to decipher the code is
destroyed before researcher
begins, or
2. PI and holder of the key enter
into an agreement prohibiting the
release of the key under any
circumstances, or
3. There are IRB-approved written
policies for the repository or data
management that prohibit the
release of the key.
Important Note: If these are not
applicable then the coded data or
specimens are considered human
subjects.
Please see the PI Self-Certification
Form for Sponsors
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Demystifying the CHR Review Process
Human subjects
The data and/or specimens are pre-existing+,
and the information is recorded in a manner that
subjects cannot be identified directly or through
identifiers* linked to the subject.
No
Expedited Review or
Full Committee
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s
Exempt Certification
Definitions:
§
Obtaining - is defined as receiving or accessing data or biological specimens.
* Identifiers – Any of the 18 Protected Health Identifiers and other type of personal identifiers.
IMPORTANT NOTE: The data or biological specimens may include a limited set of data including all elements of dates and
geographical codes (zip codes) as long as the individuals identity cannot be ascertained.
+ Pre-existing - means collected (i.e., on the shelf) prior to the research for a purpose other than the proposed research. It includes
data or specimens collected during research and/or non-research activities.
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Demystifying the CHR Review Process
Second step:
Determining the Level of Review/Type
of Application to Submit
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Demystifying the CHR Review Process
Review Level Based on Risk to the
Subject
• The level of risk to the subject determines the
level of review required and therefore the type
of application
• The risk level is compared to “minimal risk” as
defined by federal regulations
• “Minimal risk” means the probability and
magnitude of harm or discomfort anticipated in
the research are not greater in and of
themselves than those ordinarily encountered in
daily life or during the performance of routine
physical or psychological examinations or tests
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45 CFR 46.102
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Demystifying the CHR Review Process
CHR Levels of Review/Applications
• Greater than minimal risk:
– Full Committee
• Less than minimal risk:
– Expedited Review (Category 1-4, 6, 7)
– Expedited Review: No Subject Contact (Category 5)
– Exempt (Category 1, 2, 3)
– Exempt (Category 4)
• Not Human Subjects
– Self-Certification Form
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Demystifying the CHR Approval Process
Expedited Review Categories
1. Research with approved drugs or
devices
2. Blood sampling (small amounts)
3. Noninvasive specimen collection
4. Noninvasive clinical procedure
5. Use of data or specimens collected
for nonresearch purposes
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Demystifying the CHR Review Process
Expedited Review Categories
6. Research recordings: voice, video,
digital, or image recordings
7. Low risk behavioral research
8. Renewal of inactive research
protocols or protocols that are
essentially complete
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9. Renewal of other minimal risk
research protocols
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Demystifying the CHR Review Process
Exempt Review Categories
1. Research conducted in established or
commonly accepted educational settings
2. Research involving the use of educational
tests, survey procedures, interview
procedures, or observations of public
behavior if they are anonymous or
disclosure of individuals identity does not
put them at risk
– DOES NOT APPLY to research with UCSF patients,
children (minors), and prisoners
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3. Interviews or surveys with public officials
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Demystifying the CHR Review Process
Exempt Review Categories
4. Research involving the collection or
study of existing data, documents,
records, pathological specimens or
diagnostic specimens, if these sources
are publicly available or if the
information is recorded by the
investigator in such a manner that
subjects cannot be identified, directly or
through identifiers linked to the
subjects.
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Important note: Exempt Categories
involve human subjects.
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The Expedited Review Application
Third Step: Expedited Review
Filling out the Expedited Review
Application and Supplements
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The Expedited Review Application
The Expedited Review Application
Part 1: Administrative Requirements
• PI, Co-PI, Contact Person
• Study sites
• Funding
• Scientific Merit
• Key Personnel
• Financial Interests
• PI Signature
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The Expedited Review Application
The Expedited Review Application
Part 2: Study Design
• Synopsis vs. Design vs. Procedures
• Hypotheses
• Specific Aims
• Background vs. Preliminary Studies
• Design
• Statistical Analysis
• Sample Size
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The Expedited Review Application
Expedited Review Application
Part 3: Procedures
• Clear description of research procedures
• What is the subject being asked to do for the purpose of
the research study
• How does this compare or what is the subject being
asked to do in addition to their normal standard of care
• Written in a way that can be replicated and understood
by someone not in your field
• Tables, charts, or flow-diagrams may help
explain the process and timeline
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The Expedited Review Application
Expedited Review Application
Part 4: Alternatives
• Provide a discussion of the alternatives to
participation
• Many times includes not participating!
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The Expedited Review Application
Expedited Review Application
Part 5: Risks and Discomforts
• Description of risks
• Physical risk of blood draw to emotional risk of asking
questions
• Steps to minimize risks
• Providing an opportunity for questions, follow
recommended recruitment guidelines
• Maintaining confidentiality – data
• Maintaining privacy – individuals
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The Expedited Review Application
Expedited Review Application
Part 5: Risks and Discomforts
• HIPAA section
• Identify source and personal health information that will
be collected
• How will it be maintained and protected
• Disclosures
• Benefits – Overall risk/benefit analysis
• Explanation of why the benefit outweighs the risk of loss
of confidentiality
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The Expedited Review Application
Expedited Review Application
Part 6: Subject Information
• CHR Supplements?
• Inclusion & Exclusion Criteria
• Be specific
• Determining eligibility
• Non-regulated vulnerable populations
• HIV
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The Expedited Review Application
Expedited Review Application
Part 7: Recruitment
• How, when, where, and by whom are potential
subjects approached
• Respect for privacy
• Lack of pressure
• Unbiased presentation
• Who conducts initial contact?
• Written so that it can be understood by a
reviewer that is not in your scientific field or
works in your department
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The Expedited Review Application
Expedited Review Application
Part 8: Informed Consent
• How, where, when and by whom informed
consent will be obtained
• Ensuring understanding
• Consent
• Signed consent
• Waiver of signed consent
• Waiver of consent
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The Expedited Review Application
Expedited Review Application
Part 9: Financial Considerations
• Will there be reimbursement for subjects?
• How will they be paid? Check? Cash? Gift Card?
• Is the amount coercive?
• Will subjects have to pay for any costs
associated with the study?
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The Expedited Review Application
Expedited Review Application
Part 10: Bibliography
Part 11: Attachments
• Bibliography
• Provide a comprehensive list of references as it
pertains to your application
• Attachments
• Sponsor’s protocol
• Survey instruments
• Recruitments and advertisement materials
• Consent forms
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The Expedited Review Application
CHR Application Supplements
• Inclusion of Children and Minors
• Human Biologic Specimen Collecting and/or
Banking for Future Research
• Waiver of Informed Consent/Authorization for
Minimal Risk Research or Screening
• Disclosure of Investigator’s Financial Conflict of
Interest
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• IRB Approval Certification for UCSF
Researchers Involving Non-UCSF Affiliated
Sites
• More on HRPP website
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The Expedited Review Application
Expedited Review Application:
No Subject Contact
Differences from other applications
• Procedure section (Part 3)
• Biological specimen or data analysis involving
identifiers
• Identify source and how collected
• Consent section (Part 6)
• Waiver of consent/authorization
• Does not include
• Alternatives, recruitment, payment and cost sections
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The Exempt Application
Fourth step: Exempt Certification
Filling out the Exempt Certification
Application
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The Exempt Application
Exempt Certification Application
Part 1: Administrative Requirements
• PI, Co-PI, Contact Person
• Study sites
• Funding
• Key Personnel
• Financial Interests
• PI Signature
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The Exempt Application
Exempt Certification Application
Part 2: Study Specific Information for
Category 1, 2, 3
• Study purpose and design
• Describe human research subject population
• How human research subjects will be contacted
• Study instruments (surveys, questionnaires)
• How to inform subjects of research study –
consent regulations do not apply to Exempt
research but UCSF requires some form of
information sheet. See Exempt Guidance on
HRPP website
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• How information obtained will be recorded and
maintained
• PI Signature
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The Exempt Application
Exempt Certification Application
Part 2: Study Specific Information for
Category 4
• Briefly describe study activities
• Identify source of biological specimens and/or
data
• Must be pre-existing at time of proposed research
• Can have access to identifiers if information is
publicly available or information is recorded in a
way that the biological specimen or data cannot
be identified, directly or through identifiers linked
to the subjects.
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• DOES NOT APPLY to research with medical
records
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The Expedited and Exempt Application
Fifth step: Consent
Preparing a consent form, assent form,
information sheet, or requesting
waiver of consent
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The Expedited and Exempt Application
Three types of consent
• Signed consent
– Consent forms, parental consent forms, assent forms
• Waiver of signed consent
– Information sheet or verbal script
• Waiver of consent
– Waiver of Informed Consent/Authorization for
Minimal Risk Research or Screening Supplement
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The Expedited and Exempt Application
Sixth step: Review Process
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The Expedited and Exempt Application
Review Process
• Expedited and Exempt Applications
– Assessment/screening 

– Review by IRB member(s) or Chair 

– Post-review correspondence 

Approval 
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The Expedited and Exempt Applications
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
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– Inclusion/exclusion criteria are adequate
– Research purpose and setting is appropriate
– Recruitment process is fair
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Make sure science is sound. Study
should be reviewed by scientific merit,
preferably by a group of peers, before
submitting to the CHR
• Determine appropriate level of review, or
if review is required.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Download and follow the most current
CHR Application Forms and Consent
Templates from the HRPP Website. Click
on the links in the application for help.
• Check the HRPP Website to see which
Application Supplements are needed for
your particular study.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Consider the audience when writing application
and consent documents
• Avoid acronyms if possible; if needed, spell out before
first use.
• Write application with understanding that not all
members are scientists, and few if any are experts in
your field
• Consent documents should be written in lay language
at a grammatical level appropriate for the prospective
subjects. Avoid jargon, legalese, long complex
sentences, and use of passive voice.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Strive for consistency within and among the
various parts of the submission:
• Assure that all sections within the CHR Application are
consistent with each other, i.e., the purpose, benefits
and alternatives.
• Assure that all sections within the consent form are
consistent (see above).
• Assure that the protocol and consent form are
consistent.
• Use the same name for the subject groups throughout
the application and consent documents.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Provide a detailed discussion of the
recruitment and consent process.
Include the who, what, when, where, and
how of each. Submit copies of all
recruitment materials and consent
documents, including scripts.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Write a cover letter to:
• Explain and highlight any particularly difficult or
sensitive issues to show that you have thought them
though ahead of time, or ask for CHR input, or
• Inform the CHR is you have special time constraints
i.e., if study is being sent in “just in time” for NIH funding
or you have a patient waiting.
• Explain how many consent forms are being used if
there are several. This is particularly important for
research involving minors.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• Do a final review of CHR Application and
study documents. If you are preparing
the application and are not the study PI,
make sure the study PI has read the
application. This is critical if the PI is
your mentor.
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Top Tips for Speeding Up CHR Approval
Top Tips for Speeding Up Your
CHR Approval
• If you have any questions about the
process, call the CHR office at 476-1814
and ask to speak to the Analyst of the
Day or e-mail [email protected] Calls and emails will be returned within 24 hours.
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• Bonus Tip: Get a separate CHR approval
for each discrete study. Do not group
related studies into a complicated
application.
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Top Tips for Speeding Up CHR Approval
Ask Questions
• Ask your PI or Mentor
• Call or email the CHR and ask for the
Analyst of the Day
• Main CHR Line: 415-476-1814
• Main CHR Email: [email protected]
• www.research.ucsf.edu/chr/
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Getting Answers After this Class
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Getting Answers After This Class
Topics from Survey Request
• Pre existing data and how to get it
published
• What to look for when preparing an
application for International work
• Research with other sites
• Collaborative studies that only involve
laboratory analysis
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• How long does it take to get an
approval?
• Documentation for Exempt applications
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Getting Answers After This Class
More Resources
• 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
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