Download - IRB Submission
UC DAVIS OFFICE OF RESEARCH
IRB Submission
Miles McFannIRB AdministrationOutreach, Training, and Education
Smallpox Vaccination
ObjectivesExplain 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 success3
History of Human Research Protection
Created the first principles of: • Informed Consent• Proper formulated
scientific experimentation• Beneficence towards
participants
Nuremberg Code (1947)
History of Human Research Protection (cont.)
Created by the World Medical Association
Further focus on clinical research
Considered the cornerstone document of human research ethics
Declaration of Helsinki (1964)
History of Human Research Protection (cont.)
Established three fundamental ethical principles:• Respect for Persons• Beneficence• Justice
Belmont Report (1978)
Institutional Review Board (IRB)UC Davis IRB AdministrationFederalwide Assurance
#00004557Approve/modify/disapprove
research protocols involving human subjects
Protect rights and welfare of human subjects
Multi-campus collaborative review and agreements
Education and trainingAdministration and record-keeping
The Common Rule45 CFR 46 (Public Welfare)
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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.
Research
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,
oridentifiable private
information.45 CFR 46.102(f)
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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
UCD is “engaged” in human subject research when:
Definition of Minimal Risk (45 CFR 46.102(i))
Risk encountered in your daily life……
Types of IRB ReviewDeterminations 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 Categories1. Research conducted in established or commonly accepted educational settings, involving
normal educational practices.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.
3. 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)
4. Research involving the collection or study of existing data that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of Dept. or Agency heads.
6. 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 Categories1. Clinical studies where an IND or IDE is not required2. Blood Collection3. Prospective collection of biological specimens for research purposes by
noninvasive means4. Collection of data through noninvasive procedures routinely employed in
clinical practice5. Research involving materials that have been collected for any purpose6. Collection of data via audio/visual recordings made for research
purposes7. 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? Answer: Worksheets
HRP-310 Human Research Determination
HRP-311 Engagement Determination
HRP-312 Exemption Determination
HRP-313 Eligibility for Review Using the Expedited Procedure
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.
Is activity “Human Research” as defined by DHHS?
Is activity “Human Research” as defined by FDA?
“Human Research” under DHHS and FDA
Is activity “Human Research” as defined by FDA?
“Human Research” under DHHS only
NOT “Human Research”
“Human Research” under FDA only
No
NoNo
Yes
Yes Yes
START
1 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”).
4 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.
5 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 FDAv. 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.
6 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?
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IRB Documents (Available on the IRB Website) Human Research Protection Program Plan (HRP-101)
Investigator Manual(HRP-103)
Application FormsInitial (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)
Basic Elements of Informed Consent (45 CFR 46.116(a))
1. Research Description2. Risks3. Benefits4. Alternatives5. Confidentiality6. Compensation7. Contacts8. Voluntary participation and
withdrawal
The 8 Necessities
California Health and Safety Code Section 24170
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
Impact on Informed Consent
Alteration or Waiver of Informed Consent (45 CFR 46.116 (d))
What criteria need to be met?
Consent Form Common MistakesInformation 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
Application for Initial Review (HRP-211)Administrative Approvals (HRP-226)
The following forms, if applicable:Sponsor Fee FormQualifying Clinical Trials Form
IRB Submission Forms
REQUEST FOR INFO
INITIAL SUBMISSION
REVIEW
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 IRBForms
research.ucdavis.edu/gt/f
Guidanceresearch.ucdavis.edu/f/gt
Standard Operating Proceduresresearch.ucdavis.edu/gt/irb-sop
eDocsresearch.ucdavis.edu/gt/edocs
IRB Certification (CITI)research.ucdavis.edu/c/cs/hrp/res/roe
Additional Resources
Contact the IRB Staffresearch.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!
