Human Research Protections
News Brief
SPRING 2013
Inside this issue:
The Short
Form
Consent
Process
REVISED
1
THE SHORT FORM CONSENT PROCESS—REVISED
The Short Form consent process should be used for the
occasional and unexpected enrollment of non-English
speaking subjects.
The IRB will use its best judgment to ensure the protection of
human research subjects when considering whether the use of the short form
method for non-English speaking subjects is appropriate based on the researcher’s
justification and the specifics of the research.
For example, given the patient census of UCI Medical Center the short form method
should not be used for Spanish speaking subjects. Should a clinical researcher
believe that enrollment of Spanish speaking subjects is not expected based on the
disease or condition being studied and/or the anticipated study enrollment, study
specific justification must be provided in Appendix Q.
The
Informed
Consent
Process
2
Also the short form method should not be used for Phase 1 clinical trials, clinical
research that targets vulnerable subject populations such as children and pregnant
women, and for ‘true’ placebo-controlled studies.
When the short form method is approved by the IRB, the investigator is required to
provide the subject the short form consent translated into the subject’s
language. In addition, the English version of the IRB-approved consent form must
be orally interpreted by a qualified interpreter. Further, once the subject has
consented and eligibility is confirmed, the English version of the IRB-approved
consent form must be translated into the subject’s language by a professional or
certified translator and provided to the subject within one month from the subject’s
initial consent.
What is a professional translator?
ClinicalTrials.gov
3
A professional translator is an individual who is fluent in the language
specified. Fluency in another language means being able to comprehend, speak,
read, and write in that language at the level of an educated native speaker. This
includes the ability to speak, read, and write in that language using medical or
other technical terminology.
What is a certified translator?
When a translation is certified, both it and the original are accompanied by a signed
statement from the translator attesting to the completeness and accuracy of the
translation. This is then notarized by a notary public. Due to the costs related to a
certified translation, researchers should plan for these costs as part of their study
budget.
HRP Staff
Contact
Information
AND
Education &
Reminders:
Record
Keeping
4
For more information about the short form process visit the HRP page: ’Informed
Consent Process.’
For access to translated short forms (along with other translated forms) visit the
HRP page: ‘Application and Forms’ and look under the subheading of ‘IRB Forms
Foreign Language Translations.’
Page 1
The Informed Consent Process
Page 2
Congratulations! Your new study has been approved by the IRB! If your study involves a prospective
informed consent process, are you prepared to obtain the subjects’ consent ?
This article describes some key considerations to incorporate
as part of your consent process.
The Consent Process: Print out a copy of the IRBapproved consent document from the IRB Document
Depot (Doc Depot). Use this version to obtain informed
consent.
Key Point #1:
UCI policy requires that you
use the most current version of the
UCI IRB-approved consent form to
obtain the subject’s consent. This
document contains the UCI seal and
IRB approval period in the footer and
is available on the Doc Depot.
Remember that both written consent and verbal consent for
participation in research must involve an informed consent
process. Informed consent involves an education and information exchange that takes place between the researcher and
the potential subject. This process is ongoing. The responsibility
of ensuring that a potential subject understands the research and the risks and benefits involved in the
research falls upon the Investigator and not upon the potential subject.
Unless a waiver of signed consent has been granted by the IRB, once an individual has had all his/her
questions answered and has agreed to participate in the study, the subject must sign and date the UCI
IRB-approved consent form; next the Investigator who answered the questions and obtained the subject’s consent must sign and date the consent form.
Is a Witness Needed? A witness to the consent process is
required when:
 Consent is obtained from the subject via the Short Form
process, as approved by the IRB.
 The subject has decision-making capacity, but cannot read,
write, talk or is blind.
 The subject’s guardian/legally authorized representative
(LAR) cannot read, write, talk or is blind.
 The IRB specifically mandated a witness signature for this
study (e.g., high risk and/or invasive research procedures).
 The witness must be impartial (i.e. not a member of the
subject’s family, not a member of the study team).
Is HIPAA Research Authorization Required? If the IRB
requires HIPAA Research Authorization this form must also be
signed and dated. HIPAA Research Authorization requirements are listed on the IRB approval letter. The form should
also be available for download from the Doc Depot.
Does the Subject Need a Copy of the Consent? The subject should always receive a copy of the consent form and a
copy of the HIPAA Research Authorization form to use as
continual reference for items such as scheduling of procedures
and for emergency contact information.
Questions? Visit the HRP page, ’Informed Consent Process.’
Key Point #2:
The subject is not technically
enrolled until both the subject and
the Investigator have signed the consent form.
Key Point #3:
IRB approval requirements,
including informed consent and
HIPAA Research Authorization requirements are noted on the IRB
approval letter. Download your
IRB approval letter from the Doc
Depot.
Key Point #4:
The UC HIPAA Research
Authorization form is NOT the same
as the Notice of Privacy Practices.
Download your HIPAA Research Authorization from the Doc Depot or
the HRP ‘Applications & Forms’ page.
SPRING 2013
ClinicalTrials.gov
Page 3
What is ClinicalTrials.gov?: ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov captures significant summary protocol information before and during the trial as well as summary
results and adverse event information of a completed trial.
The purpose of ClinicalTrials.gov is to disclose to the public key information about clinical trials that are currently available or that
have been conducted.
Do I Need to Register My Clinical Trial?: Yes, if your research meets the
definition of clinical trial and you meet the requirements of the responsible
person for registering the trial.
What Is the Definition of a Clinical Trial for Registration Purposes?:
If your study meets any one of these definitions, the trial must be registered.
1. The Food and Drug Administration (FDA) requires registration for
“applicable clinical trials” defined as follows: For any trials of drugs
and biologics: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation. For trials of biomedical
devices: controlled trials with health outcomes of devices subject to FDA
regulation, other than small feasibility studies, and pediatric post-market
surveillance.
2. International Committee of Medical Journal Editors defines a
clinical trial as any research study that prospectively assigns human subjects or groups of humans to one or more health-related interventions to
evaluate the effects on health outcomes.
CLINICALTRIALS.GOV
What are the Consequences
of Not Registering a Trial? Federal laws and regulations
as well as editors of
prominent medical journals
require registration of a
clinical trial.
In addition, there are
penalties (including monetary
penalties) for responsible
parties who fail to register
clinical trials, keep the
information up to date, or
who submit false or
misleading information.
3. The National Institute of Health defines a clinical trial as a prospective biomedical or behavioral
research study of human subjects that is designed to answer specific questions about biomedical or behavioral
interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
Who is Responsible for Registering the Trial? By law, the “responsible party” must register a clinical trial.
The responsible party is:

For industry-authored clinical trials, the industry sponsor is responsible.

For cooperative group trials, the cooperative group is usually responsible.

For UCI investigator-authored clinical trials, where the investigator initiates and conducts the trial, the
investigator is responsible.

To ensure that extramurally-authored and funded trials are properly registered, check whether the trial is
listed in ClinicalTrials.gov, or contact the study sponsor for clarification.

Also see NIH’s definition of a responsible party and a clinical trial @ http://prsinfo.clinicaltrials.gov/
ElaborationsOnDefinitions.pdf.
When should a investigator register a trial? UCI recommends registering a trial before any subjects are
enrolled to satisfy both the ICMJE requirements and the law (Section 801 of the Food and Drug Administration
(FDA) Amendments Act).
What are the Steps for Registering? Clinical trials are registered at ClinicalTrials.gov via a web-based data
entry system called the Protocol Registration System (PRS). UCI School of Medicine Research Support
Services (SOMRSS) serves as a PRS Administrator. Visit the HRP page, ‘ClinicalTrials.gov Registry’
for contact information for SOMRSS and for the step-by-step registration details.
SPRING 2013
HRP Staff Contact Information
Education and
Institutional Review Board ’A’
IRB Team ‘D’
Record
Biomedical
Biomedical
Keeping
Matt Kinder, CIP
Expedited and Exempt Submissions
Administrator
Jessica Sheldon, CIP
949-824-9819
Administrator
mkinder@uci.edu
949-824-3831
jessica.sheldon@uci.edu
Mihaela Nistor
Senior Analyst
Kaycie Craib
949-824-3711
Senior Analyst
mnistor@uci.edu
949-824-5057
kcraib@uci.edu
Joy Chu
Analyst
949-824-6068
joy.chu@uci.edu
—————————————————
Institutional Review Board ‘B’
Michael Baird
Analyst
949-824-0665
bairdm@uci.edu
—————————————————
Biomedical
Karen Allen, MA, CIP
Cheree DuBose, CIP
Research Protections
Director
Administrator
949-824-1558
949-824-2576
karen.allen@uci.edu
cheree.dubose@rgs.uci.edu
Beverley Williams, CIP
Anya Coultas
Human Research Protections
Assistant Director
Senior Analyst
949-824-5746
949-824-5622
beverley.williams@uci.edu
acoultas@uci.edu
Debbie Melamud, MPH
Theresa Sanchez, CIP
Human Research Protections
Analyst
debbie.melamud@uci.edu
Administrator
949-824-2125
tmsanche@uci.edu
——————————————————
Human Research
Protections
Institutional Review Board ‘C’
Social - Behavioral
U.S. Mail:
Valerie Sanchez, MA, CCRP
University of California, Irvine
Office of Research
Administrator
949-824-4779
valerie.ms@uci.edu
Melissa Camarena
Senior Analyst
949-824-7114
mccamare@uci.edu
Le’Quan Jackson
Analyst
949-824-6662
ldjackso@uci.edu
5171 California Ave., Suite 150
Irvine, CA 92697-7600
The Office is Open:
Monday—Friday
8am—5pm
General Email:
IRB@research.uci.edu
Web:
http://www.research.uci.edu/
ora/hrpp/index.htm
Page 4
Reminders:
The first thing
you should do when you receive
IRB approval is download the
UCI IRB Approval Letter, Protocol
Narrative, Consent Form or
Study Information Sheet, Recruitment Material and Data Abstraction Sheet (and anything
else approved by the IRB) from
the Document Depot.
Keep a copy of each IRBapproved document for your
research records.
Also keep a copy of any applications that are formally submitted
to the IRB (preferably signed
versions), including the signed
copy of the IRB Application,
which includes affirmation of the
Investigator’s Assurance Statement.
Remember, the Document Depot
only maintains the LATEST
versions of your IRB-approved
documents. Once a modification
request or continuing application
is approved, the previously
approved documents are removed from the Document
Depot.
Regarding record retention, the
official retention period begins
upon submission of a closing report to the IRB or study
expiration. IRB records should
be maintained a minimum of 3
years.
For more information on recordkeeping and specific record
retention requirements (it can
vary based on the research) visit
the HRP page on record keeping.
SPRING 2013