Human Research Protections
News Brief
Internet-Based Research and Using Social Media Tools in Research
SUMMER 2015
Inside this issue:
InternetBased Research and
Using Social
Media Tools in
Research
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Although the federal regulations pre-date Internet-Based Research and Social Media
tools, the Common Rule and the Belmont Principles are still applicable.
A note about:
Comparative
Effectiveness
Research
(CER)
 Applying the Human Subjects Research definition:
2
and
Qualitative
Social Science
Research
Submitter’s
Corner
3
HRP Staff
Contact
Information
and
Reminders:
Research
HIPAA
Authorization
Researchers can use the internet to conduct research
in two ways, as:
 a research tool:
 recruit research subjects
 collect data via surveys, questionnaires
 gather information through online interviews
and focus groups
 access and collect existing information
 an environment to study human behavior:
 observe subjects’ online behavior
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 Living Individual: Distinguish whether you are interacting with a live
person, an avatar, or a Non-Player Character (NPCs, designed and
controlled by a computer through artificial intelligence)
 Interacting/Intervening with a living individual: Examples include actively
engaging
with subjects’ online to collect data, or collecting data by
observing the way subjects’ interact or behave online
 Access/Obtain Identifiable Private Information:
Distinguish what is
considered public or private online information, as well as subjects’
expectations of what are considered private online information/behavior
 Applying the Belmont Principle of Respect for Persons (Autonomy):
 When conducting Internet-Based Research, consider the informed consent
process; an acceptable consenting method is to include an online consent
with a “live button” that subjects can click to demonstrate their consent.
 Another important point of consideration are children as subjects:
determine how will parental permission and child assent be obtained, and
consider variations in state (and other countries) laws regarding the age of
legal majority.
 Also, consider whether your research involves incomplete disclosure/
deception (IRB Application Appendix G) and the alteration in the informed
consent process (IRB Application Appendix O). For example, an investigator
observing a private online chat room may explain to potential subjects that
the purpose of the research is focused on job applications; however, the
investigator may actually be studying gender discrimination; the consent
process would be altered because the true intent of the research was not
disclosed as it could change the subjects online behavior and create study
bias.
Mitigating Risks in Internet-Based Research and when using Social Media as a
research tool: the potential for harm includes violating an individual’s privacy and
breaching confidentiality that could damage subjects’ reputations, employability,
insurability, or potentially expose them to criminal or civil liability. The protocol
narrative and the informed consent process must clearly describe how the subjects’
privacy and confidentiality will be protected.
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A Note about CER, and Qualitative Social Science Research
SUMMER 2015
Comparative Effectiveness Research (CER)
CER is the generation and synthesis of evidence that compares the
benefits and harms of alternative methods to prevent, diagnose, treat,
and monitor a clinical condition or to improve the delivery of care. The
purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at
both the individual and population levels.
Points to consider
 Be sure that potential participants understand:
 that they are being asked to participate in research
 the nature of the research question being investigated (i.e.,
improve clinical practice; ensure appropriate use of resources;
etc.)
 how their care as research participants may differ from care
they would receive in the clinical context
 Assure that the protocol makes clear what question(s) are being
studied (i.e., comparison of the foreseeable potential harms and
benefits; comparison of costs; etc.)
 If randomization will occur, ensure participants understand the process of being randomized to a research group, and whether the
study design is single/double-blind
 Include the magnitude of potential risks and benefits associated
with the interventions being studied, so that potential participants
are provided with all the information necessary to make an informed decision
[CER image, JAMA 2010]
Qualitative research performed by anthropologists, ethnographers, sociologists, and others, include
observations that are typically conducted outside the laboratory. Someimes the purpose of qualitative research is to develop hypotheses rather than to test and validate them in controlled studies.
The criteria for IRB review remains the same for qualitative research, as with quantitative research:
 Research that meets the definition of human subjects research requires IRB review
 Research activities that meet the criteria for engagement in human subjects research requires
IRB review
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SUBMITTER’S CORNER
SUMMER 2015
Other Required Reviews
Before the IRB can review or approve research, there are other prerequisite
UCI reviews that may be required. Depending on the research procedures involved, you may require reviews from the following Committees: Protocol Review and Monitoring Committee (PRMC), Clinical Research Finance Assessment
(CRFA), Conflict of Interest Oversight Committee (COIOC), Institutional Biosafety Committee (IBC), Radiation Safety Committee Review, Scientific Merit
Review, Environmental Health and Safety, and Epidemiology and Infection
Prevention Committee (EIP).
Research Protections Roadmap
The Research Protections Roadmap is a web-based tool designed to help investigators
plan the regulatory and institutional pathway to research initiation. Depending on the
proposed activity, the number and type of regulatory committee approvals and/or processes varies. The timing of these approvals and processes is critical. The RP
Roadmap takes 5-10 minutes to complete. The user answers a series of yes/no questions about the proposed activity to help determine the applicable regulatory and institutional requirements. At the end, a PDF document listing the required approvals and
processes is provided. Traffic signal icons indicate the timing of these requirements
relative to three Office of Research committees: the Institutional Review Board (IRB),
the Institutional Animal Care and Use Committee (IACUC) and the Human Stem Cell
Research Oversight (hSCRO) committee for stem cell research.
IRB New Submitters Training online video
If you are submitting an IRB application for the first time, we highly encourage you to review the IRB New Submitters Training online video. The informative 30-minutes video discuss the following topics: application process, pre-submission work, levels of review, resources and forms, nontechnical summary, roles and responsibilities, methods and procedures,
participants, recruitment, informed consent, risks, data security, the IRB
Application, uploading files, submitting, and post-submission process.
Viewers may watch the entire video, or skip to specific topics.
Signing the IRB Application
Please remember to provide a signed IRB Application. The IRB Application
requires signatures from the Lead Researcher, Faculty Sponsor (if applicable), and the Department Chair /Organized Research Unit (ORU) Director.
The signed IRB Application can be faxed, emailed, mailed, or hand carried
to the Office of Research.
If the Department Chair or ORU Director is on leave, obtain a signature
from the delegated authority and provide the delegation of signature
authority letter.
If the Department Chair or ORU Director is a part of the research team, the
signature must be obtained from the next highest level of authority (i.e.,
the Dean or Vice Chancellor).
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HRP STAFF CONTACT INFORMATION
Institutional Review Board ’A’
IRB Team ‘D’
Biomedical
Biomedical Expedited and Exempt
IRB Chair: Tahseen Mozaffar, MD
Matt Kinder, CIP
Mihaela Nistor, CIP
949-824-9819
949-824-3711
mkinder@uci.edu
mnistor@uci.edu
Le’Quan Jackson
Senior Analyst
Senior Analyst
949-824-5047
949-824-3367
ldjackso@uci.edu
joy.chu@uci.edu
Michael Baird, CIP
Kirsten McDaniel
Analyst
Analyst
949-824-0665
949-824-6068
bairdm@uci.edu
k.mcdaniel@uci.edu
—————————————————
—————————————————
Institutional Review Board ‘B’
Karen Allen, MA, CIP
Biomedical
IRB Chair: Kenneth Linden, MD, PhD
Rachna Singh, MS, CCRP
Director
Research Protections
949-824-1558
karen.allen@uci.edu
Administrator
949-824-2576
rachnas@uci.edu
EDUCATION & REMINDERS:
RESEARCH HIPAA
AUTHORIZATION
Administrator
Administrator
Joy Chu
SUMMER 2015
Beverley Alberola, CIP
Associate Director
Research Protections
Melissa Eng, CIP
949-824-5746
Senior Analyst
beverley.alberola@uci.edu
949-824-5622
melissle@uci.edu
Laverne Estañol, MS, CHRC, CIP, CCRP
Theresa Sanchez
Human Research Protections
Assistant Director
Analyst
949-824-4704
949-824-2125
lestanol@uci.edu
tmsanche@uci.edu
What to do if you forget to obtain research
HIPAA Authorization:
The Institutional Review Board (IRB) requires
investigators to obtain signed HIPAA Research
Authorization from all participants if Protected
Health Information (PHI) will be used or disclosed for research purposes, unless a waiver is
granted. The HIPAA Research Authorization
form is not the Notice of Privacy Practice form
used with clinical patients. The template HIPAA
Authorization form is available on the Applications and Forms page.
 Be sure to review your IRB approval letter
(or the IRB continuing approval letter): Verify whether HIPAA Research Authorization is
required
If you enroll patients in a research study that
involves PHI, but did not obtain signed HIPAA
Research Authorization, you need to immediately do the following:
 Take Corrective Actions:
 Obtain signed authorization at the next
study visit
 If authorization cannot be obtained submit
an Adverse Events and Unanticipated
Problems report within 10 working days
HUMAN RESEARCH PROTECTIONS
——————————————————
Jessica Sheldon, CIP
U.S. Mail:
Institutional Review Board ‘C’
EQUIP Administrator
Social - Behavioral
Human Research Protections
Office of Research
IRB Chair: Elizabeth Cauffman, PhD
949-824-3831
jessica.sheldon@uci.edu
University of California, Irvine
5171 California Ave., Suite 150
Irvine, CA 92697-7600
Valerie Sanchez, MA, CCRP
Administrator
949-824-4779
valerie.ms@uci.edu
Melissa Camarena
Senior Analyst
949-824-7114
mccamare@uci.edu
Roy Taggueg
Debbie Melamud, MPH
Administrator
The Office is Open:
Human Research Protections
Monday—Friday
debbie.melamud@uci.edu
8am—5pm
Cathryn Lucas, CIP
Administrator
Human Research Protections
General Email:
IRB@research.uci.edu
949-824-7735
cathryn.lucas@uci.edu
Human Research Protections Webpage
Analyst
949-824-6662
IRB Fast Facts
rtaggueg@uci.edu
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