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Human Research Protection Program Training
Preparing an Exempt or Expedited Application
Lisa Voss, MPH, CIPAssistant Director, HRPPQuality Improvement UnitLisa.Voss@ucsf.edu415-514-2152
February 20, 2009
2
Human Research Protection Program
HRPP Training: Upcoming Sessions
• The Study Coordinator's Role in Investigator-originated StudiesDate 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
• Preparing Consent and Assent FormsDate and Time: Thursday, April 30, 2009, 10 a.m.-noon Location: Parnassus campus, N-225 Speaker: Richard Wagner, Associate Director
Introduction
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Human Research Protection Program
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
Introduction
Demystifying the CHR Review Process
Committee AssistantsAdministrative Assistant IIs
Meri Figueroa Brian HertzogDenisha OtisMario Velez
--------------------------TEP for Data Entry
TEP for Filing
HRPP Director John Heldens
Manager Assessment Unit
(Pre-CHR Review Activities) Vacant
Analyst V Supervisor
HRPP Associate DirectorCHR Review UnitRichard Wagner
Analyst V Supervisor
HRPP Assistant Director Quality Improvement Unit
(Post CHR Approval Activities)Lisa Voss
Analyst V Supervisor
Committee CoordinatorsMt. Zion
Michael Thomas -- IVNicole Ketroser -- II
Committee CoordinatorsParnassus
Annette Bugatto -- IVWendy Stephens -- II
Committee CoordinatorsSFGH
Elizabeth Mendelsohn -- IVTerry Colbert -- II
QIU GroupBeth Shields -- Analyst IV
Susie Corl – Analyst IVJill Magee – Analyst II
Education & Assessment UnitAnita Katona – Analyst IV
Joanne Mickalian– Analyst IVMegan Sullivan – Analyst II - Supervisor
Fred Hendrickson – Analyst II
HRPP Business Analyst Judy Der - Analyst II
Cancer Ctr. Asst. CoordinatorSusanne Henderson -II
Committee CoordinatorsLaurel Heights
Karen Chao - IVKate Nolan - Analyst II
HRPP Organization – January 2009
Education CoordinatorMelanie Mace - Analyst IV
HRPP – Human Research Protection Program CHR – Committee on Human Research QIU – Quality Improvement Unit
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Human Research Protection Program
First Step:
Determining
“Is the project human subject research?”
Demystifying the CHR Review Process
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Human Research Protection Program
Definition of Research
• A systematic investigation, including
– Research development, testing and evaluation
– Designed to develop or contribute to generalizable knowledge
45 CFR 46.102
Demystifying the CHR Review Process
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Human Research Protection Program
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
Demystifying the CHR Review Process
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Human Research Protection Program
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
– 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.
Demystifying the CHR Review Process
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Human Research Protection Program
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 have
identifiers
Data and/or specimens are coded and
identifiers* are kept separately
Data and/or specimens are de-identified*
Human subjects
Not human subjects
See the conditions that must be met.
Conditions:
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
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.
Do the PI or Co-Investigators on the study have access to the
“key” to link back to the identifiers*?
Examples1. Commercially available specimens
2. Adult cells lines with no identifiers, NOT stem cells
3. Cadaveric tissue with no identifiers
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Human Research Protection Program
Demystifying the CHR Review Process
Human subjects
Expedited Review or Full Committee 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.
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.
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Human Research Protection Program
Second step:
Determining the Level of Review/Type of Application to Submit
Demystifying the CHR Review Process
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Human Research Protection Program
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
45 CFR 46.102
Demystifying the CHR Review Process
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Human Research Protection Program
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
Demystifying the CHR Review Process
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Human Research Protection Program
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
Demystifying the CHR Approval Process
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Human Research Protection Program
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
9. Renewal of other minimal risk research protocols
Demystifying the CHR Review Process
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Human Research Protection Program
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
3. Interviews or surveys with public officials
Demystifying the CHR Review Process
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Human Research Protection Program
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.
Important note: Exempt Categories involve human subjects.
Demystifying the CHR Review Process
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Human Research Protection Program
Third Step: Expedited Review
Filling out the Expedited Review Application and Supplements
The Expedited Review Application
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Human Research Protection Program
The Expedited Review Application
• PI, Co-PI, Contact Person
• Study sites
• Funding
• Scientific Merit
• Key Personnel
• Financial Interests
• PI Signature
Part 1: Administrative Requirements
The Expedited Review Application
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Human Research Protection Program
The Expedited Review Application
• Synopsis vs. Design vs. Procedures
• Hypotheses
• Specific Aims
• Background vs. Preliminary Studies
• Design
• Statistical Analysis
• Sample Size
Part 2: Study Design
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• 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
Part 3: Procedures
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• Provide a discussion of the alternatives to participation
• Many times includes not participating!
Part 4: Alternatives
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• 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
Part 5: Risks and Discomforts
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• 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
Part 5: Risks and Discomforts
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• CHR Supplements?
• Inclusion & Exclusion Criteria
• Be specific
• Determining eligibility
• Non-regulated vulnerable populations
• HIV
Part 6: Subject Information
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• 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
Part 7: Recruitment
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• How, where, when and by whom informed consent will be obtained
• Ensuring understanding
• Consent
• Signed consent
• Waiver of signed consent
• Waiver of consent
Part 8: Informed Consent
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• 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?
Part 9: Financial Considerations
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application
• 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
Part 10: BibliographyPart 11: Attachments
The Expedited Review Application
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Human Research Protection Program
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
• IRB Approval Certification for UCSF Researchers Involving Non-UCSF Affiliated Sites
• More on HRPP website
The Expedited Review Application
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Human Research Protection Program
Expedited Review Application: No Subject Contact
• 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
Differences from other applications
The Expedited Review Application
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Human Research Protection Program
Fourth step: Exempt Certification
Filling out the Exempt Certification Application
The Exempt Application
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Human Research Protection Program
Exempt Certification Application
• PI, Co-PI, Contact Person
• Study sites
• Funding
• Key Personnel
• Financial Interests
• PI Signature
Part 1: Administrative Requirements
The Exempt Application
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Human Research Protection Program
Exempt Certification Application
• 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
• How information obtained will be recorded and maintained
• PI Signature
Part 2: Study Specific Information for Category 1, 2, 3
The Exempt Application
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Human Research Protection Program
Exempt Certification Application
• 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.
• DOES NOT APPLY to research with medical records
Part 2: Study Specific Information for Category 4
The Exempt Application
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Human Research Protection Program
Fifth step: Consent
Preparing a consent form, assent form, information sheet, or requesting
waiver of consent
The Expedited and Exempt Application
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Human Research Protection Program
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
The Expedited and Exempt Application
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Human Research Protection Program
Sixth step: Review Process
The Expedited and Exempt Application
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Human Research Protection Program
Review Process
• Expedited and Exempt Applications
– Assessment/screening
– Review by IRB member(s) or Chair
– Post-review correspondence
Approval
The Expedited and Exempt Application
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Human Research Protection Program
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
The Expedited and Exempt Applications
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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 chr@ucsf.edu Calls and e-mails will be returned within 24 hours.
• Bonus Tip: Get a separate CHR approval for each discrete study. Do not group related studies into a complicated application.
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
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: chr@ucsf.edu
• www.research.ucsf.edu/chr/
Top Tips for Speeding Up CHR Approval
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Human Research Protection Program
Getting Answers After this Class
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Human Research Protection Program
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Human Research Protection Program
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
• How long does it take to get an approval?
• Documentation for Exempt applications
Getting Answers After This Class
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Human Research Protection Program
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
– Marlene.Berro@ucsf.edu; 476-3426
• BREAD: Biostatistics, Research Ethics and Design Program
• CtsiBread@ucsfmedctr.org, 502-7893
Getting Answers After This Class
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