Human Research
Protection Program
John Heldens, CIP, CCRP
Director
Richard Wagner, MA, CIP, CCRP
Associate Director
Michael Thomas, CIP, CCRP
Manager
Melanie Mace, MA, CIP, CCRP
Education Coordinator
415-476-1814
www.research.ucsf.edu/chr
HRPP Town Hall
Meeting
May 31, 2012
Outline for Today
• Reviews by Western IRB for Some Clinical Research
• Extended Approvals for Minimal Risk Research
Projects That Have No Federal Oversight
• Exempting More Research and Exempt Consent
Templates
• Simplifying Signature Requirements When Consenting
Non-English Speakers
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HRPP Mission Statement
The Mission of the HRPP is
• to promote the welfare and rights of human
research participants
• to facilitate excellence in human research and
• to provide timely and high quality education,
review and monitoring for human research
projects.
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Western IRB
• Why did we decide to rely on WIRB?
• What studies are eligible for review by WIRB?
• What the process for IRB review?
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Why Rely on WIRB?
• HRPP has been pursuing IRB reliances with
other IRBs for many years for multicenter
research
• Many industry-funded clinical trials have already
been approved by private IRBs before being
submitted to UCSF
• Relying on an AAHRPP-accredited private IRB is
a logical next step, especially for research that
must be approved by a UCSF scientific review
committee.
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Eligibility
• Phase III and Phase IV clinical trials
• Industry-funded
• Industry-authored
• Approval from UCSF scientific review committee
– Cancer Center Protocol Review Committee
– CTSI Advisory Committees
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Exceptions
Research involving the following must be
reviewed by CHR:
• Surgical techniques or procedures
• Transplant research
• Neonates
• Stem cell therapies
• Gene transfer, gene therapy
• Investigational radiologic procedures
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• Research involving SFVAMC
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HRPP reserves the right to make
additional exceptions and has
final say on whether research
must be reviewed by CHR
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Financial Issues
• Sponsor must pay all WIRB fees.
• HRPP will charge a fee for these studies, but it
will be less than current fee. Fee has not yet
been approved.
• Contracts may not be signed until WIRB
approval has been received.
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HRPP Process overview
1. PI submits an abbreviated CHR application
through iMedRIS
2. HRPP staff review to confirm eligibility,
including scientific review
3. HRPP notifies PI and WIRB of eligibility
4. PI submits application to WIRB
5. WIRB reviews
6. WIRB notifies PI and HRPP of approval
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Additional information
1. Only one submission to HRPP is necessary.
Once eligibility has been confirmed, all future
submissions and reporting are between PI and
WIRB
2. HRPP will communicate with PRC or AC
regarding scientific review.
3. Studies involving the CTSI Clinical Research
Services will automatically be routed for AC
review with CHR submission
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4. PI can submit to HRPP, WIRB and scientific
review in parallel
5. WIRB will not review until HRPP confirms
eligibility
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Details:
Sections of CHR Application
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1.0
General Information
•
2.0
Setup Department Access
•
3.0
Grant Key Personnel Access
•
4.0
Qualifications of Key Study Personnel
•
5.0
Initial Screening Questions
•
6.0
Funding
•
7.0
Statement of Financial Interest
•
8.0
Sites
•
9.0
Relying on Another IRB
•
10.0
Drugs and Devices*
•
11.0
Other Approvals and Registrations
•
12.0
Subjects
•
13.0
CTSI Screening Questions*
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Initial Screening Questions
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Relying on Another IRB
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Attachments
• Sponsor’s protocol is the only attachment HRPP
needs to receive
• The consent form submitted to WIRB must
follow UCSF template
• WIRB is responsible for ensuring consistency
with that template
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Other Reviews
• Conflicts of Interest
– HRPP will forward COIAC findings and management
plans, if any, to WIRB. WIRB has final say on
management plan for research they oversee.
Management plan may require a modification to the
study.
• Radiation Safety Committee
– Radiation Safety may require specific consent form
wording. This may require a modification to the
study.
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Training
• HRPP will publish a web page shortly
• WIRB is responsible for training users on their
system
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Questions about WIRB?
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Extended Approvals: Background and Policy
• UCSF’s Federalwide Assurance (FWA) allows
some flexibility in applying human subjects
federal regulations to non-federally supported
research.
• HRPP has implemented a procedure for granting
approval for up to 3 years for research projects
that:
a) involve no more than minimal risk to
participants (as defined by 45 CFR 46.102)
and
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b) are not subject to federal oversight.
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Studies Not Eligible for Extended Approval
Research Subject to Federal Oversight: Projects that
receive federal support, that are implemented at the
direction of federal agencies, or otherwise subject to
federal oversight are excluded.
Examples include:
• Federal sponsorship (directly or indirectly) including
federal training and program project grants
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• Research directed or overseen by a federal agency
that has signed on to the Common Rule, including
every agency within Department of Health and
Human Services
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Studies Not Eligible for Extended Approval (cont.)
• Student projects when the faculty sponsor uses
federal funding for the student’s project
• Federal no-cost extensions
• Studies subject to FDA oversight
• Studies seeking or obtaining Certificates of
Confidentiality (which are granted by NIH)
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Studies Not Eligible for Extended Approval (cont.)
Studies where the CHR is serving as the IRB of record
for an institution that applies the federal standards to all
research regardless of funding source.
– San Francisco VAMC
– (NCIRE) Northern California Institute for Research and Education
– Lawrence Berkeley National Laboratory
– San Francisco Department of Public Health
– Ernest Gallo Clinical and Research Center
– J. David Gladstone Institutes
– The Jewish Home
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– Institute on Aging
– Blood Centers of the Pacific
– Blood Systems Research Institute
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Studies Not Eligible for Extended Approval (cont.)
Other Exceptions and Exclusions:
• Studies that involve greater than minimal risk.
• Studies that involve the following:
– Contractual obligations or restrictions that preclude
eligibility in this policy, e.g., nonfederal sponsor or
funder requires an annual review.
– UCSF is serving as IRB of record for an institution
not mentioned above that requires annual review
– Involves prisoners or parolees as subjects
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– Funded by the CIRM (California Institute for
Regenerative Medicine)
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The HRPP reserves the right to make exceptions
to this policy, and inclusion/exclusion of any
research project under this procedure will be at the
HRPP’s discretion.
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Post-approval Submission Requirements
Studies with extended approval periods will continue to
have the same post-approval submission requirements.
PIs continue to be responsible for submitting:
• modifications;
• reports of adverse events, protocol violation/
incidents, and other safety information meeting
HRPP reporting criteria;
• continuing review submissions; and
• a closeout report when the study is complete.
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IMPORTANT NOTE
If the study becomes ineligible for an extended
approval period because of new federal
funding or other changes, the PI is responsible
for promptly submitting a modification to notify
CHR. The CHR will issue a new approval letter
with a shortened approval period, as
appropriate.
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Questions about the extended approval
policy?
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Exemptions: Regulatory Status the Same
• 4 Exempt Categories
– #1: Research conducted in established or commonly
accepted educational settings, involving normal
educational practices
– #2: Educational tests, survey procedures, interview
procedures, or observations of public behavior, except
when collecting identifiers and information that could
place subjects at risk
– #3: Educational tests, survey procedures, interview
procedures, or observations of public behavior when
subjects are elected or appointed public officials or
candidates for office
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– #4: Collection or study of existing data, documents,
records, specimens, if sources are publicly available or
if the information is recorded so that subjects cannot
be identified, directly or indirectly
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Regulatory Status the Same
• CHR does not approve exempt research,
but reviews and certifies that the study
qualifies for exemption
• Investigators cannot self-certify study as
exempt
• CHR certifies exemptions for 3 years
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Expanded UCSF Definitions of What CHR
Will Consider Exempt
Contact with outpatients at UCSF or
affiliated health care facility
Some educational, survey, or interview
research involving outpatients may now be
exempted
– Exclude inpatients
– May not collect or record Protected Health
Information (PHI) even for recruitment
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Expanded UCSF Definitions of What CHR
Will Consider Exempt
Review of Medical Records or other use of
Protected Health Information (PHI)
– If collected prior to research for purpose
other than the proposed research, and
– Investigator does not record any identifiers
Access to PHI is not exempt from HIPAA, so
CHR must provide privacy board review and
documentation
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Minor Changes to Exempt Research Are
Allowed Without Notifying CHR
– Editorial or administrative changes to
consent forms or other documents
– Adding non-sensitive questions to survey or
interview guide, or revising current questions
– Adding new recruitment material following
CHR guidelines
– Increasing or decreasing number of subjects
(but not adding a new subject population)
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Significant Changes Still Must Be
Submitted for Review
– Adding a new subject population
– Adding new procedures
– Adding a new funding source
– Adding questions about sensitive aspects of
the subjects’ behavior – such as illegal conduct,
drug use, sexual behavior, or use of alcohol – to a
survey or interview
– Disclosing a new financial interest
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– Any change that makes the study no longer
eligible for exemption
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Exempt Research Consent Guidance and
Templates Available
– If study involves interaction with subjects,
you usually should have a process to ask
subjects to participate and confirm their
agreement
– Signed consent is not required
– Process and documents can be simpler than
for non-exempt studies
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– CHR website has several short consent
templates as well as a verbal consent
script
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Questions about the changes to exempt
research?
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Consenting Non-English Speaking Subjects
#1 Preferred Method – Use this
method if many potential subjects are
non-English speakers.
– Obtain written translations of the consent form(s)
after the study is approved and submit to CHR
for approval.
– Qualified interpreter facilitates the consent
discussion.
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Preferred Method Documentation
Translated Informed Consent
Experimental Subject’s Bill of Rights
CHR Approved
Download in the subject's language – contact CHR for add’l
translations
Signatures required:
1. Subject
2. Person obtaining consent
Signatures required:
None
Give a copy to the subject.
Document in the research file
that an interpreter was used.
Give a signed copy to the
subject.
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Consenting Non-English Speaking Subjects
#2 Short-form Method – Only use for
the occasional and unexpected
enrollment of a non-English-speaking
subject.
– A qualified interpreter verbally presents the
English-language consent form to the subject
and facilitates the consent discussion.
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Short Form Method Documentation
English-Language Consent
Experimental Subject’s Bill of Rights
CHR Approved
Download in the subject's language
Signatures required:
1. Person obtaining consent
2. Witness
Signatures required:
1. Subject
2. Witness
Document in the research file
that an interpreter was used.
Write a statement on the Bill of Rights that the
elements of consent were presented orally.
Give a signed copy to the
subject.
Give a signed copy to the subject.
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Updates to the Short Form Method
• Witness Can Sign Instead of Interpreter With
Short Form Consent Method
– The witness can be the interpreter or another person
who witnesses the involvement of an interpreter.
– Should be someone other than the person obtaining
consent.
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Updates to the Short Form Method
• What if your consent includes a “Translator”
signature line?
– Suggest you replace the “Translator” signature line
with a “Witness” signature line. Submit to CHR as a
minor modification.
– In the meantime, add a “Witness” signature line and
date line by hand, when necessary.
Date
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Witness – Only required if the participant is
a non-English speaker
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Using Interpreters
• Who is a qualified interpreter?
– Medical interpreters
OR
– Fluent investigators or knowledgeable Key Personnel
– Strongly discourage using bilingual family members as
medical interpreters.
• Interpreting via phone is OK
– If used for short form method, a witness should sign
the consent and Bill of Rights.
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HIPAA and Non-English Speakers
• UCSF HIPAA Authorization form is now available
in 19 languages
• If a translated HIPAA authorization form is
available:
– Subject signs the translated version.
– A translator should be available to speak with the subject
about the form, but does not need to sign the form.
– Document that a translator was available in research file.
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HIPAA and Non-English Speakers
• If a translated authorization form is not available:
– An interpreter verbally presents the English-language
form.
– The subject, interpreter, and a separate witness sign
the form.
Check your CHR approval
letter for HIPAA
determinations.
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Quick Guides (available in the Recruitment and Consent section):
– Consenting Non-English Speaking Subjects
– Consent Process and Documentation
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