1. IRB 101: Introduction to Human Subject Research
UC DAVIS OFFICE OF RESEARCH
IRB 101: Introduction to Human Subject Research
Prepared By:
Miles McFann, CIP
IRB Administration

2. Objectives Knowledge of the Ethical Principles
Describe what the IRB does
Know the definitions of human subject research
Know the forms
Describe the IRB process
Helpful Tips

3. Ethical principles of Human Subject Research:
Respect for persons – autonomy Beneficence – do no harm Justice – distribution of risks and burdens
Jeopardy Question:
What are these? In the form of a question
Why the important to know?
They are the ethical principles in which all our federal regulations, overseeing human subject research, are based upon

4. Institutional Review Board (IRB)
UC Davis IRB Administration
Protect rights and welfare of human subjects
Approve/modify/disapprove research protocols involving human subjects
Multi-campus collaborative review and agreements
Education and training
Administration and record- keeping
UC COLLABORATIVE RESEARCH—A Streamlined Approach
Multi-UC Campus Research at University of California Campuses and UC-Managed Laboratories
Research to be reviewed by a single UC IRB instead of multiple UC IRBs
For UCLA, UCSF, UCSD, UCB, UCI, UCSB, UCSC, UCD, LLNL, LBNL--research eligible for expedited or exempt review only
For UCB, UC Davis, UCSF and LBNL- research eligible for full committee review as well as expedited and exempt review
For UC Davis and LLNL—research for full committee, expedited or exempt review.
Committee A – Clinical (12 interdisciplinary members)
Committee B – Clinical (20 interdisciplinary members)
Committee C – Social/Behavioral (6 interdisciplinary members)
Committee D – Fast Track/Emergency (5 interdisciplinary members)

5. Research as defined by Department of Health and Human Services:
What is Research?
Research as defined by Department of Health and Human Services:
“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”
Examples of systematic investigations include:
surveys and questionnaires
interviews and focus groups
analyses of existing data or biological specimens
epidemiological studies
evaluations of social or educational programs
cognitive and perceptual experiments
medical chart review studies
Examples of activities that typically are not generalizable include:
biographies
oral histories that are designed solely to create a record of specific historical events
service or course evaluations, unless they can be generalized to other individuals
services, courses, or concepts where it is not the intention to share the results beyond the UCD community
classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the UCD community.
45 CFR (d)

6. data through intervention or interaction with the individual, or
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 (f)

7. When is UCD “engaged” in human subject research?
1.If UC Davis is the federal 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
– even if all research activities are done at other organizations;
UC Davis employees/agents obtain

8. Not Human Subject Research (NHSR)
Review Types
Not Human Subject Research (NHSR)
Exempt
Expedited
Convened Meeting
Let’s go over the difference between these review types:
Not “Human Research”: Activities must meet the organizational definition of “Human
Research” to fall under IRB oversight. Activities that do not meet this definition of are
not subject to IRB oversight or review. Review the IRB Office’s “WORKSHEET:
Human Research (HRP-310)” for reference. Contact the IRB Office in cases where it is
unclear whether an activity is Human Research.
• Exempt: Certain categories of Human Research may be exempt from regulation but
require IRB review. It is the responsibility of the organization, not the investigator, to
determine whether Human Research is exempt from IRB review. Review the IRB
Administration’s “WORKSHEET: Exemption Determination (HRP-312)” for reference
on the categories of research that may be exempt.
• Review Using the Expedited Procedure: Certain categories of non-exempt Human
Research may qualify for review using the expedited procedure, meaning that the project
may be approved by a single designated IRB reviewer, rather than the convened board.
Review the IRB Administration’s “WORKSHEET: Eligibility for Review Using the
Expedited Procedure (HRP-313)” for reference on the categories of research that may be
reviewed using the expedited procedure.
• Review by the Convened IRB: Non-Exempt Human Research that does not qualify for
review using the expedited procedure must be reviewed by the convened IRB.

9. Submitting to the IRB

10. 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)
Designed w/input from investigators
Clearly indicates what is needed
Focuses on what the IRB must review to make a determination

11. Record/Data Research Submissions :
Retrospective Chart Review:
(data existing at time of initial IRB submission)
HRP-211 Initial Application Form
HRP-226 Administrative Approvals
Protocol (Research Involving Record/Data Review)
Prospective Chart Review
(data not existing at time of IRB submission)
HRP-211 Initial Application Form
HRP-226 Administrative Approvals
Protocol (Research Involving Record/Data Review)
Consent Form (HRP-502)
Advertisements (if applicable)

12. Common Research Submissions :
Specimen Collection
HRP-211 Initial Application Form
HRP-226 Administrative Approvals
Protocol (HRP-503)
Consent Form (HRP-502)
Surveys and/or Questionnaires (if applicable)
Advertisements (if applicable)
Survey/Interview
HRP-211 Initial Application Form
HRP-226 Administrative Approvals
Protocol (HRP-503)
Consent Form (HRP-502)
Surveys and/or Questionnaires
Advertisements (if applicable)

13. Forms online: www.research.ucdavis/irbadmin
eDocument System:
cs/index.cfm
For assistance contact:
Miles McFann –
Nicole Walters –

14. Principal Investigator
Create Protocol
Submit via eDocs
Principal Investigator
Review
Request Revisions/ Information
IRB
Reply to Request
Respond to Reviewer
Review Response
Approve
Review Process

15. How Long Does Review Take?
Initial Review
Minimal Risk Research: 2 to 3 weeks
Greater than Minimal Risk Research: 35 days
Modifications
2 to 4 weeks
Continuing Review

16. Yeah, it’s approved! Anything else?

17. Investigator Responsibilities after Approval
Protected Human Subjects
Comply with protocol requirements and determinations of IRB
Avoid undue influence/coercion in enrolling subjects
Ensure that informed consent is adequate and understandable to subjects
Report new information
Submit changes in research to IRB

19. Don’t enroll prisoners
Don’t enroll prisoners. State of California does not allow biomedical research to be conducted on prisoners.
De-identified doesn’t mean anything regulatory. Your data is one of the following three descriptions:
Identifiable: the data will be directly labeled/recorded with the personal identifying information when acquired.
Coded: the research personnel can link the research to personal identifying information when acquired.
Anonymous: not be labeled with any personal identifying information, nor with a code that this research team can link to personal identifying information.
Be consistent with the information amongst the documents (e.g. enrollment numbers, procedures being done, inclusion/exclusion criteria)

20. Address all the IRB analysts concerns and revisions request in a timely manner.
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.
Follow all UCDHS regulations.

21. Resources www.research.ucdavis.edu/irbadmin Investigator Manual
Human Research Protection Program Plan
Standard Operating Procedures
Policies and Procedures
Additional Training

22. Questions?
Remind them of the Resources and Reference Handouts

23. Miles McFann, CIP mtmcfann@ucdavis.edu