Human Research Protections
News Brief
SPRING 2011
The Informed Consent Process—Reminders and Updates
Inside this issue:
Key Features of Informed Consent
The requirement to obtain the legally effective informed consent of
individuals before involving them in research is one of the central
protections provided for under the HHS regulations at 45 CFR part 46.
The
Informed
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Consent Process–
The informed consent process involves three key features:
(1) disclosing to potential research subjects information needed to make an informed
decision;
Reminders and
(2) facilitating the understanding of what has been disclosed; and
Updates
(3) promoting the voluntariness of the decision about whether or not to participate in
the research. Informed consent must be legally effective and prospectively
obtained.
Good Practices with the Consent Process
When a Witness to
the Consent Process
2
is Required
 Informed consent involves an education and information exchange that takes place
between the researcher and the potential subject.
 The Investigator should not only field questions, but also ask questions to assess
comprehension (e.g. “Can you explain the purpose of this research study?”)
What is a “CIP”?
 Obtaining a signature on a consent form does not complete the consent process.
Maintaining informed consent requires that subjects be provided with any new
information that arises during the course of the study (such as changes to the
research plan, change in risk/benefit profile, the results of related research, etc.)
3
that may affect a subject’s decision whether or not to continue participation in the
study.
Updated Consent Templates Are Available
Updated consent templates are available on the Applications & Forms page under IRB
Consent Forms. Be sure to use the most recent version of the consent template.
Consenting Non-English Speaking Subjects
AAHRPP Site Visit
Scheduled!
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The medical and technical information discussed during the initial consent discussion,
as well as ongoing, study-related information, can be very complex and should be
communicated to non-English speaking-subjects through an interpreter with
training and understanding in medical terminology.
HRP Staff
Updated/New Foreign Language Translations
Contact
Information
AND
Education &
Reminders
As part of each consent discussion, investigators have an ethical and legal obligation to
assess the subject's understanding of the consent information to ensure that the
consent is truly "informed." When the investigator and subject do not share a
language, the investigator must depend on the accuracy of the translated consent
documents and the working relationship with the medical interpreter.
4
Updated/new foreign language translations have been obtained for the following IRB
forms: Experimental Subjects Bill of Rights, Short Forms, HIPAA Research
Authorization for Release of PHI, and Self Certification of Surrogate Decision Makers for
Research Studies. Additional languages have been added and IRB contact information
has been updated. Visit Applications and Forms under the IRB Forms - Translated into
Foreign Languages section.
Page 2
When a Witness Signature is Required
The Protection of Human Subjects in Medical Experimentation Act requires that a witness be included in
the informed consent process for medical experimentation studies. Per the California Health and Safety
Code, the witness must attest that the requirements for consent to the medical experiment have been
satisfied.
Effective May 1, 2011, the researcher obtaining consent may serve the purpose of confirming
that the requirements for consent to the medical experiment have been satisfied. An impartial
witness is no longer required for research that involves medical experimentation.
An Impartial Witness: An impartial witness signature is still required when consenting
subjects who are unable to read and write (this includes subjects that are cognitively capable
but cannot physically write due to disease or illness) and for studies where the IRB has
approved the use of short form consent.
The witness must be impartial, such as an adult who is not a member of the study team and who is not a
family member of the subject. The witness must also sign and date the consent form attesting that the
requirements for informed consent have been satisfied; that consent is voluntary and freely given by the
subject, guardian, or surrogate, without any element of force, fraud, deceit, duress, coercion, or undue
influence.
For additional guidance, refer to the below chart.
Witness to the Consent Process—Updated Practice Effective May 2011
Current Practice
Per the California Health and Safety Code, a witness
must attest that the requirements for consent to the
medical experiment have been satisfied. The witness
signature line is included in the consent form and is to
be signed for research involving medical
experimentation.
Per Federal regulations, when using the IRB-approved
foreign language Short Forms to consent non-English
speaking subjects, an impartial witness to the oral
presentation is required.
New Practice
UPDATED: We have updated our policy on this
practice. The researcher obtaining consent may
serve the purpose of confirming that the
requirements for consent to the
medical experiment have been satisfied.
An additional impartial witness is not required. In
order to take advantage of this new policy, the
revised Consent template that specifies the
conditions when an impartial witness is required.
Use of an existing IRB approved consent form still
requires an impartial witness signature.
No changes to current practice.
Consent template updated to specify under what
conditions an impartial witness is required.
An impartial witness is required when the subject or
the subject’s guardian or legally authorized rep. (LAR)
has decision making capacity, but cannot read, write
or speak. Remember, this includes those subjects
that are cognitively capable but cannot physically
write due to disease or illness (e.g. ALS, MS, etc.).
No changes to current practice.
An impartial witness is required when the subject or
the subject’s guardian or legally authorized rep (LAR)
has decision making capacity and is blind.
No changes to current practice.
When the IRB mandates that a witness
be used in the consent process
No changes to current practice.
Consent and Assent forms updated to specify under
what conditions an impartial witness is required.
Consent and Assent forms updated to specify under
what conditions an impartial witness is required.
Consent and Assent forms updated to specify under
what conditions an impartial witness is required.
SPRING 2011
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What is a Certified IRB Professional (CIP)?
The CIP® program was created in 1999 after many years of discussion and planning by organizational
members and leaders in the field of human research protections. The program was the result of a
broadly based, grassroots effort by IRB professionals and policy makers who are committed to improving
the quality of human research protection programs (HRPPs). Over 1,300 individuals have become
certified and are now entitled to use the designation of CIP.
The program is overseen by the Council for Certification of IRB Professionals (CCIP). Since its inception,
the CCIP’s mission has been to develop a certification program that will be useful to all IRB/HRPP
professionals.
The CIP is supported by Public Responsibility in Medicine and Research (PRIM&R), whose mission is to
advance the highest ethical standards in the conduct of biomedical, social science, behavioral, and
educational research.
This certification program is for individuals whose primary job responsibilities include substantial
participation in overseeing, administering or performing the daily activities of an IRB. Individuals
involved in IRB activities who meet the eligibility requirements (a combination of education and related
IRB experience) are eligible to take the examination.
The CIP Credential…
 Promotes the ethical conduct of research by strengthening the professional administration of IRBs.
 Validates an individual’s professional experience and demonstrated mastery of the body of
knowledge determined by national experts to be essential to competent IRB/HRPP administrative
practices.
 Strengthens the quality of HRPPs by certifying a cadre of committed and educated individuals.
All of the current UCI IRB Chairs, as well as many of the HRP Staff have completed the CIP credential as
part of their ongoing commitment to the protection of human research subjects.
A special note of congratulations to Theresa Sanchez, CIP, IRB Analyst—the most recent UCI
HRP Staff to successfully complete the CIP certification!
AAHRPP Reaccreditation Site Visit Scheduled!
The Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
has confirmed that they will conduct a site visit of UC Irvine’s HRPP
June 13 – June 15, 2011. Interviewees have been chosen and we are working with
them to prepare for the site visit.
More specific information about the site visit will be shared with the research community
as it becomes available. Also, the Office of Research will conduct education and outreach
efforts to assure investigators, research coordinators, IRB members and staff understand their roles and
responsibilities in UC Irvine’s HRPP.
Stay tuned for more details!
SPRING 2011
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HRP Staff Contact Information
Institutional Review Board “A”
Biomedical
Matt Kinder, CIP
Administrator
949-824-9819
mkinder@uci.edu
Mihaela Nistor
Senior Analyst
949-824-3711
Education & Reminders:
IRB Team “D”
Biomedical
ICTS CLINICAL RESEARCH
Expedited and Exempt Submissions
ETHICS CONSULT SERVICE
Jessica Sheldon, CIP
Administrator
949-824-3831
jessica.sheldon@uci.edu
OPEN POSITION
Senior Analyst
949-824-5057
The ICTS clinical research ethics consult
service (CRECS) was created to assist
clinical investigators in working out
experimental design problems when the
nature of the subject population or the
research situation pose ethical issues.
Services provided by CRECS include:
Project planning consultation
Advice and information about critical
ethical issues
Joy Chu
Analyst
949-824-6068
—————————————————
Institutional Review Board “B”
Biomedical
Valerie Sanchez, MA, CCRP
Administrator
949-824-7109
valerie.ms@uci.edu
Kin Hang
Analyst
949-824-0665
—————————————————
Karen Allen, MA, CIP
Director
Human Research Protections
949-824-1558
karen.allen@uci.edu
Beverley Esparza, CIP
Assistant Director
Human Research Protections
Senior Analyst
949-824-5746
949-824-5622
besparza@uci.edu
cheree.dubose@rgs.uci.edu
Debbie Melamud, MPH
Analyst
949-824-2125
tmsanche@uci.edu
——————————————————
Institutional Review Board “C”
Social - Behavioral
Administrator
Human Research Protections
Human Research
Protections
U.S. Mail:
Christine Hegel Cantarella, PhD
University of California, Irvine
Administrator
5171 California Ave., Suite 150
Alicia Asgari
Senior Analyst
Irvine, CA 92697-7600
The Office is Open:
Monday—Friday
8am—5pm
949-824-7114
alicia.asgari@uci.edu
Kaycie Craib
An investigator seeking a consultation
will engage in an informal discussion
with a colleague who has experience in
medical ethics issues in research. The
consultant will provide a short written
report to the investigator. These
consultations are NOT mandatory - they
are optional and purely advisory. Some
examples of possible
issues where a
consultation may be useful include:
When is it appropriate to include a
placebo arm in a clinical trial?
How does one structure a pilot clinical
trial to avoid excessive risk?
How do I structure an interventional
clinical study that is designed to
gather biological data, not to cure a
disease?
This service is not an alternative to
the IRB. Similarly, the CRECS will
not provide reviews of non-research
situations that are better handled by
the institutional Clinical Ethics
Consult Service. CRECS consults
may be self-referred or referred
from the IRB, the ICTS Scientific
Review Committee, or other UCI
bodies.
The CRECS is coordinated by Professor
Emeritus
Sidney
Golub,
significant experience with
who
has
biomedical
ethics. He is a member of the UCI IRB,
General Email:
IRB@research.uci.edu
We’re on the Web!:
Analyst
http://www.research.uci.edu/ora/hrpp/
949-824-6662
index.htm
kcraib@uci.edu
Education on research ethics issues
debbie.melamud@uci.edu
Office of Research
949-824-4779
regarding ethical
problems raised in external or internal
reviews
kin.hang@uci.edu
Cheree DuBose, CIP
Theresa Sanchez, CIP
S u g g e s t i o n s
chairs the UCI Human Stem Cell Research
Oversight
on
issues
Committee, and has taught
relating
to
ethics
in
biomedical research.
Investigators interested in obtaining
a consultation should email Dr.
Golub at sgolub@uci.edu.
SPRING 2011