Transcript Research - UC Davis Health System

UC DAVIS OFFICE OF RESEARCH
IRB Submission
Miles McFann
IRB Administration
Outreach, Training, and Education
Smallpox Vaccination
Objectives
Explain the history of
Institutional Review Boards
(IRBs)
Define “Research” and
“Minimal Risk”
Describe the IRB review
categories and regulatory
criteria for approval
Discuss the IRB application
process
Discuss tips for success
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History of Human Research Protection
Nuremberg Code (1947)
 Created the first principles of:
• Informed Consent
• Proper formulated scientific
experimentation
• Beneficence towards
participants
History of Human Research Protection (cont.)
Declaration of Helsinki (1964)
 Created by the World
Medical Association
 Further focus on clinical
research
 Considered the cornerstone
document of human
research ethics
History of Human Research Protection (cont.)
Belmont Report (1978)
Established three
fundamental ethical
principles:
• Respect for Persons
• Beneficence
• Justice
Institutional Review Board (IRB)
UC Davis IRB Administration
 Federalwide Assurance #00004557
 Approve/modify/disapprove
research protocols involving human
subjects
 Protect rights and welfare of human
subjects
 Multi-campus collaborative review
and agreements
 Education and training
 Administration and record-keeping
The Common Rule
45 CFR 46 (Public Welfare)
Research
FDA Definition:
Clinical Investigation: An experiment involving a
test article and control when the results must
meet requirements for prior submission to the
FDA or are intended to be later submitted to or
held for inspection by the FDA
OHRP Definition:
Research: A systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge.
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What is a Human Subject?
A living individual about whom an
investigator (professional or
student) conducting research
obtains:
data through intervention or
interaction with the individual,
or
identifiable private information.
45 CFR 46.102(f)
UCD is “engaged” in
human subject research
when:
1.If UC Davis is the grant recipient;
2. If for purposes of human subject research:
(a) Data about subjects through intervention or
interaction;
(b) Identifiable private information
(c) Informed consent from a research subject
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Definition of Minimal Risk (45 CFR 46.102(i))
Risk
encountered
in your daily
life……
Types of IRB Review
Determinations not
requiring IRB review
Exempt
Expedited Review
Full Board Review
Exempt Review
 Must be minimal risk research
 Fits one of six categories
 Review is typically conducted
by a designated IRB member
Exempt Review Categories
1. Research conducted in established or commonly accepted educational settings, involving normal
educational practices.
1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior.
1. Research involving the use of educational tests, survey procedures, interview procedures, or
observation of public behavior that is not exempt under paragraph (b)(2) of this section. (Public
Official)
1. Research involving the collection or study of existing data that subjects cannot be identified,
directly or through identifiers linked to the subjects.
2. Research and demonstration projects which are conducted by or subject to the approval of Dept.
or Agency heads.
3. Taste and food quality evaluation and consumer acceptance studies.
Expedited Review
Must be minimal risk
Rigor same as full
committee review, but only
one IRB member reviews
the project
Fits one or more of the nine
categories
Expedited Review Categories
1. Clinical studies where an IND or IDE is not required
2. Blood Collection
3. Prospective collection of biological specimens for research purposes by
noninvasive means
4. Collection of data through noninvasive procedures routinely employed in
clinical practice
5. Research involving materials that have been collected for any purpose
6. Collection of data via audio/visual recordings made for research purposes
7. Research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies
8. Continuing review of a study previously reviewed by a convened IRB and
meets three categories.
9. Continuing review of research, where categories (2) through (8) do not apply
but the IRB has determined and documented at a convened meeting that the
research involves no greater than Minimal Risk.
Full Committee Review
 Any study which does not meet
the Exemption or Expedited
Criteria
 A full quorum is assembled
 Decision is rendered by a majority
of the assembled quorum
 No member with a conflict of
interest can participate in the
decision
 All members participate in the
discussion and comments
How does the IRB figure this all out?
WORKSHEET: Human Research Determination
NUMBER
HRP-310
Answer: Worksheets
HRP-310 Human Research
Determination
HRP-311 Engagement
Determination
HRP-312 Exemption
Determination
DATE
0/0/0000
PAGE
1 of 1
The purpose of this worksheet is to provide support for individuals in determining whether an activity is Human Research or how it is regulated. This
worksheet is to be used. It does not need to be completed or retained.
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Is activity “Human Research”
as defined by DHHS?
Yes
Yes
Is activity “Human Research”
as defined by FDA?
“Human Research”
under DHHS and FDA
No
Is activity “Human Research”
as defined by FDA?
No
Yes
“Human Research”
under DHHS only
“Human Research”
under FDA only
No
NOT
“Human Research”
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Research as Defined by DHHS Regulationsi (Check if “Yes”.)
Is the activity an investigation? (Investigation: A searching inquiry for facts; detailed or careful examination.)
Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.)
Is the systematic investigation designed to develop or contribute to knowledge? (Designed: observable behaviors used to develop or
contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.)
Is the knowledge the systematic investigation is designed to develop or contribute generalizable? (Generalizable: Universally or widely
applicable.)
2
Human Subject Under DHHS Regulations (Check if “Yes”.)
Is the investigator conducting the Research gathering data about living individuals?
3
Human Subject Under DHHS Regulations (Check if “Yes”.)
Will the investigator gather that data through either of the following mechanisms (specify which mechanism(s) apply):
Physical procedures or manipulations of those individuals or their environment for research purposes (“intervention”).
Communication or interpersonal contact with the individuals. ("interaction”).
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Human Subject Under DHHS Regulations (Check if “Yes”)
Will the investigator gather data that is either? Specify which category(s) apply if yes:
The data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is
taking place (i.e. “Private information”).
Individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will NOT be made public,
such as a medical record (i.e. “Private information”).
Can the individuals’ identities be readily ascertained or associated with the information by the investigator (i.e. “Identifiable information”)?
If all items are checked under 1, 2, and 3 or 1, 2, and 4, the activity is Human Research under DHHS regulations.
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Human Research Under FDA Regulations (Check if “Yes”)
Does the activity involve any of the following? (Check all that apply)
In the United States: The use of a drugii in one or more persons other than use of an approved drug in the course of medical practice iii.
In the United States: The use of a deviceiv in one or more persons that evaluates the safety or effectiveness of that device.
Data regarding subjects or control subjects submitted to or held for inspection by FDA v.
Data regarding the use of a device on human specimens (identified or unidentified) submitted to or held for inspection by FDAvi.
If “Yes”, the activity is Human Research under FDA regulations.
If the activity is Human Research under DHHS regulations or under FDA regulations, it is Human Research under organizational policy.
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HRP-313 Eligibility for Review
Using the Expedited Procedure
Engagement Determination (Complete if the activity is Human Research. (Check if “Yes”)
The organization is engaged in Human Research. Use WORKSHEET: Engagement Determination (HRP-311))
Criteria for Approval of Research
1. Risks to subjects are minimized by using procedures, which are
consistent with sound research design and which do not unnecessarily
expose subjects to risk.
2. Risks to subjects are minimized by using procedures already being
performed on the subjects for other purposes.
3. 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.
4. Selection of subjects is equitable.
5. The research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects.
Criteria for Approval of Research (cont.)
6. There are adequate provisions to protect the privacy of subjects.
7. There are adequate provisions to maintain the confidentiality of
data.
8. Additional safeguards have been included in the study to protect
the rights and welfare of subjects vulnerable to coercion or undue
influence. (“N/A” if no vulnerable subjects)
9. The informed consent process is adequate.
10. The documentation of informed consent is adequate.
How Do
Researchers
Meet These
Regulations?
IRB Documents (Available on the IRB Website)
 Human Research Protection Program Plan (HRP-101)
 Investigator Manual(HRP-103)
 Application Forms
Initial (HRP-211)
Continuing Review Progress Report (HRP-212)
Modification (HRP-213)
Reportable New Information Form (HRP-214)
 Template Protocol (HRP-503)
 Template Consent Document (HRP-502)
 SOPs on consent process and documentation (HRP-90, HRP-91)
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Basic Elements of Informed Consent (45 CFR 46.116(a))
The 8 Necessities
1. Research Description
2. Risks
3. Benefits
4. Alternatives
5. Confidentiality
6. Compensation
7. Contacts
8. Voluntary participation and
withdrawal
California Health and Safety Code Section 24170
Impact on Informed Consent
 States that subjects in a “medical experiment” must sign a consent form
 California’s definition of “medical experiment”;
(a) The severance or penetration or damaging of tissues of a human
subject or the use of a drug or device, as defined in Section 109920
or 109925, electromagnetic radiation, heat or cold, or a biological
substance or organism, in or upon a human subject in the practice
or research of medicine in a manner not reasonably related to
maintaining or improving the health of the subject or otherwise
directly benefiting the subject.
(b) The investigational use of a drug or device as provided in Sections
111590 and 111595.
(c) Withholding medical treatment from a human subject for any
purpose other than maintenance or improvement of the health of the
subject
Alteration or Waiver of Informed Consent (45 CFR 46.116 (d))
What criteria
need to be met?
Consent Form Common Mistakes
 Information in the Consent
Form is not consistent with
the Protocol
 Utilization of medical jargon
 Not fully identifying risks
 Consent Form is not a
HIPAA Authorization form
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My protocol is
ready, what do I
do now?
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Submit the Protocol
IRB Submission Forms
 Application for Initial Review (HRP-211)
Administrative Approvals (HRP-226)
The following forms, if applicable:
Sponsor Fee Form
Qualifying Clinical Trials Form
INITIAL SUBMISSION
REVIEW
REQUEST FOR INFO
PI RESPONSE
REVIEW
APPROVAL
ACCEPT w/CHANGES
MEETS REQUEST
Yeah, it’s
approved!
Anything else?
Investigator Responsibilities after Approval
Protect human subjects.
Ensure all personnel comply with protocol requirements
and determinations of IRB.
Avoid undue influence in enrolling subjects.
Ensure that informed consent is adequate and
understandable to subjects.
Report new information as stated within HRP-214,
Reportable New Information Form.
Submit changes in research to IRB for approval prior to
implementation.
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Submitting to the IRB
Forms
research.ucdavis.edu/gt/f
Guidance
research.ucdavis.edu/f/gt
Standard Operating
Procedures
research.ucdavis.edu/gt/irb-sop
eDocs
research.ucdavis.edu/gt/edocs
IRB Certification (CITI)
research.ucdavis.edu/c/cs/hrp/r
es/roe
Additional Resources
Contact the IRB Staff
research.ucdavis.edu/a/cu/contact-irba
Subscribe to our Listserv
research.ucdavis.edu/r/ls
Advisories
research.ucdavis.edu/c/cs/hrp/a
References
Regulatory Agencies
www.hhs.gov/ohrp
www.fda.gov
UC Davis IRB
www.research.ucdavis.edu/c/cs/hrp
Belmont Report
www. hhs.gov/ohrp/humansubjects/guidance/belmont.html
Download applications and forms from our website to
ensure you have the latest version.
Gather all signatures prior to submission.
Place version dates on your documents at initial
submission and only change them when updating the
document.
Utilize and follow the Protocol and Consent Form
Template instructions when creating your application
and forms.
Attach all relevant documentation. If it is listed on
HRP-211 and applicable to your research, submit it.
Have your research staff complete their human
subject research certification (CITI and GCP training)
prior to submission.
Respond to the IRB in a timely manner.
Follow all UCDHS regulations.
When in doubt, contact us!
Input?
Suggestions?
Feedback?
Miles McFann
[email protected]
916-703-9156
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