Perspectives of consent in

clinical studies in some referral

hospitals in Vietnam
Accepted consent processes for
research should be culturally
appropriate and tailored to the
context.
Researchers con7nue to grapple with
what valid consent means within
specific stakeholder groups.
Consent practices and attitudes regarding
essential information required for the
consent process within hospital-based
trial communities.
- Surveys
- Interviews about various elements of the
consent process.
•Words and regulation
•Reimbursement, suspicions,
and joining
•Responsibilities
Stakeholders had highly varied
perspectives of nghiên cứu (Eng.:
research)
Researchers used varying levels of detail
regarding all aspects of the study in the
consent process to build trust with
promote potential research participants’
choices about taking part in research.
•Participants focused on reimbursement
or alternative reasons for joining the
study (health related benefits, altruism.

•Participants often relied on their

physician to help them decide about
joining a study or not.
•Researchers and par,cipants make sense of
prac,ce consent
•Par,cipants’ decision-making about research
par,cipa,on.
•To promote valid consent, engage with
hospital-based trial communi,es as a whole.
• Council for Interna/onal Organiza/ons of Medical
Sciences (CIOMS) defines a valid consent process as
providing “poten/al research par/cipants with the
informa/on and the opportunity to give their free and
informed consent to par/cipate in research”.
• In prac/ce, the amount of informa/on that is considered
sufficient is not easily defined.
Developing a consent process with the right
amount of information for sufficient
understanding continues to be a challenge for
researchers, especially with complex study
designs.
Several methods have been designed to adapt
the consent process.
-An enhanced consent process that reduces the
amount of information presented.
-Maintaining international regulations or rapid
ethical assessments prior to development of
specific consent processes.
•Structural factors that shape individuals’ lives
•Participants decide to join a study prior to the
consent process, based on informal information
circulating in the community about the
personal and health benefits of joining the
study.
•Research is the one of few routes to access
(be?er) healthcare, the “anBcipated
therapeuBc benefit” may overshadow study
risks or enhance per- ceived study benefits, yet
not offering enough benefits can result in
exploitaBon.
•Complex gender
Formal and informal information about
studies both shape perceptions of
research and decision making processes
for joining a study.
Highlight the importance of
acknowledging the context beyond the
consent session itself when trying to
understand what consent means to
potential participants, research staff and
ethics committee members.
- Vietnamese Ministry of Health Na4onal
Ethics Guidelines for Biomedical
Research, released in 2013
- Requirements for clinical trial consent
forms and basic principles for obtaining
consent.
•Interviewees’ experiences related to
their role in the research process
•ALtudes regarding inclusion of the
elements of consent as described in the
Interna4onal Conference of
Harmoniza4on Good Clinical Prac4ce
(ICH-GCP) guidelines
•Indicating essential information
•Indicating a neutral view
•Indicating non-essential
information.
• The interviews took place in settings within the
hospital that would protect the stakeholders’ privacy
as much as possible, or a place where the
stakeholder felt most comfortable.
• All interviews were audio-recorded, with
stakeholders’ consent. Prior to the interview with
participants, provided the information sheet for the
studies and it was available to them during the
interview for reference.
Same survey and asked the same main interview
questions to all stakeholders, and probed specific
topics when necessary.
ABer reviewing the interview summaries
and reading the transcripts, created an
iniCal codebook based on a set of core
themes from the research quesCons, coded
the interview transcripts with these codes.
•All potential stakeholders were provided with
explanations of the purpose of the study, procedures,
risks, benefits, and alternatives to study participation.
•Written consent was obtained from all stakeholders
prior to the survey and interview, as required by the
local research ethics committees.
•Interview
•Occupation of participants
•Data collection
The consent process iden6fied during
analysis including

Words and regula,on

Reimbursement, suspicions, and joining
Responsibili,es
•Researchers must be honest with potential
participants both as a moral obligation and to
obtain more honest responses from
participants.
•Tell them about our research because it
requires cooperation to get better results.
•Obviously, tell the patients our work is nghiên
cứu.
•The amount of information provided during consent
did not matter at all.
•when there was trust, participants would join the
studies.
It is better when you say nghiên cứu
because people will understand right
away that this is a topic that needs
research to find out something [that we
don’t know], because just saying
“programme...” they won’t know what
programme they’re participating in, and
then they’ll say: “Oh! What programme
are you inviting me into?”
Reimbursement, suspicions, and
joining
Participants are reimbursed for their
time and transport costs, and if enrolled
in a clinical trial, Vietnamese guidelines
require that the study sponsors pays all
hospital bills accrued during the
research.
•The researchers and participants had
differing views about the implications of
reimbursement.
•Researchers expressed concerns around
using financial terminology in study
information sheets and consent forms
because in Vietnamese culture, these words
sounded commercial or equivalent with
being cheated.
The reason is: when people have something
for free they feel they are being cheated. It
means they will wonder why it’s free? Why is
it so weird? Is it dangerous or not?
Researchers also described their views about
reimbursement and its effect on mo@va@ons
for par@cipants to join research.
In the researchers’ opinion, wealthier study
par@cipants were viewed as caring less about
reimbursement than those with fewer
resources, but the narra@ve was that
par@cipants cared about the money on some
level, al- though it was not always an
immediate concern.
•People usually do not care much [about
reimbursement] in the period of their sickness,
but after they get cured, they asked a lot.
•It’s not important, I don’t care, but after that,
people would ask in detail. Such as, how much
money for?
Most parCcipants stated that they did
not join the study solely for the
reimbursement.
The line between medical care and
research is easily blurred when the
research takes place within a hospital
and the physicians that treat the
patients are also the physicians that
recruit them as research participants.
In practice, it may be difficult for a
patient to turn down a research
opportunity from their physician, even
if the physician assures them that
they can choose whether or not to join
the study and that their future care will
not be impacted.
Further, in the context of a hospital,
participants may think that they are
obtaining individualized care in a
clinical trial (i.e. therapeutic
misconception) when this is not the
case.
•Researchers need to help study
participants distinguish between
individualized care and research to
promote free decision-making about
participation, which could begin with
sufficient information or perhaps
including an expanded discussion of
nghiên cứu instead of changing the term
to reduce fear.
SUBMISSION OF APPLICATION
The researcher should submit an appropriate
applica@on in a prescribed format along with the
study protocol at least three weeks in advance.
•Clear research objec,ves and ra,onale for
undertaking the inves,ga,on in human
subjects in the light of exis,ng knowledge.
•Recent curriculum vitae of the Inves,gators
indica,ng qualifica,on and experience.
•Subject recruitment procedures
•Inclusion and exclusion criteria for entry of
subjects in the study
•Precise description of methodology of the
proposed research, including intended dosages
of drugs, planned duration of treatment and
details of invasive procedures if any.
•A descrip@on of plans to withdraw or withhold
standard therapies in the course of research
•The plans for sta@s@cal analysis of the study
•Procedure for seeking and obtaining informed
consent in English and / or vernacular language.
•Safety of proposed interven@on and any drug or
vaccine to be tested including results of relevant
laboratory and animal research.
•An account of plans to provide medical therapy
for research carrying more than minimal injury,
toxicity due to over dosages
•Proposed compensa@on and reimbursement of
incidental expenses
•Details of storage and maintenance of data
collected during the trial
•Plan for publica@on of results – posi@ve or
nega@ve – while maintaining the privacy and
confiden@ality of the study par@cipants.
•A statement on probable
ethical issues and steps
taken to tackle the same
•All other relevant
documents related to the
study protocol including
regulatory clearances.
•Agreement to comply with institutional
ethical guidelines for clinical trials.
•Details of Funding agency / Sponsors and
fund allocation for the proposed work.
•New proposals will be received every
quarter as per following schedule.
Emergency meeting can be called by the
Chairman anytime.
CHECK-LIST FOR PROTOCOL
•Title of study
•Summary of proposed research
•Statement of jus@fica@on of study
•Summary of previous studies including the nature,
extent and relevance of animal studies and other
pre-clinical studies
•An account of the previous submissions of the
protocol for ethical review, if any, and its outcome.
•Brief descrip@on of the site where the research is to
be conducted
•Relevant demographic and epidemiological
informa@on
•Name and address of the sponsor
•Name, address and qualifica@on of the Principal
Inves@gator
• The objec@ves of the trial
•The design of the trial
•The number of the research subjects with
justification
•Inclusion and exclusion criteria
•Description and explanation of all interventions
including the method of treatment, route of
administration, dose, dose interval treatment
period, and other details of the investigational
product in case of drug trials
THE DECLARATION OF HELSINKI – 1964

Unlike the Nuremberg Code the declara@on of

Helsinki focused on the integrity and the
experience of scien@fic inves@gators, in the
protec@on of human subjects.
THE DECLARATION OF HELSINKI – 1964
Declaration of Helsinki focused on the integrity
and the experience of scientific investigators,
in the protection of human subjects. According
to the declaration of Helsinki issued by World
Medical Assembly each potential subject
involved in a clinical investigation must be
adequately informed of the aims, methods,
anticipated benefits and the potential hazards
of the study and the discomfort it may entail.
The declaration of Helsinki forms the basis of
ICH GCP 6.0. Therefore, it is a more universally
used document than the Nuremberg code. It
has the following principals.
The World Medical Associa1on has developed
the declara1on of Helsinki as a statement of
ethical principle to provide guidance to
physicians and other par1cipants in medical
research involving human subjects. Medical
Research involving human subjects includes
research on iden1fiable human material or
iden1fiable data.
•It is the duty of physician to promote and
safeguard the health of the people. The
physicians knowledge and conscience are
dedicated to the fulfillment of this duty.
•The Declara1on of Geneva of World Medical
Associa1on binds the physician with the
words
•“The health of my pa1ent will be my first
considera1on”, and the Interna1onal code of
medical ethics declares that, “A physician
shall at only in the pa1ents interest when
providing medical care which might have the
effect of weakening the physical and mental
condi1on of the pa1ent”.
•Medical progress is based on research, which
ultimately must rest in part on
experimentation involving human subjects.
•In medical research on human subjects,
considerations related to the well-being of the
human subject should take precedence over
the interest of science and society.
•The Primary purpose of medical research
involving human subject is to improve
prophylac1c, diagnos1c and therapeu1c
procedures and the understanding of the
ae1ology and pathogenesis of disease. Even
the best proven prophylac1c, diagnos1c, and
therapeu1c must con1nuously be challenged
through research for their effec1veness,
efficiency, accessibility and quality.
•In current medical prac1ce and in medical
research, most prophylac1c, diagnos1c and
therapeu1c procedures involved risks and
burdens.
• Medical research is subject to ethical standards that
promote respect for all human beings and protect their
health and rights. Some research populations are
vulnerable and need special protection. The particular
needs of the economically and medically disadvantaged
must be recognized. Special attention is also required for
those who cannot give a refuse consent for themselves,
for those who may be subject to giving consent under
duress, for those who will not benefit personally from
the research and for those whom the research is
combined with care.
•Research investigators should be aware of
ethical, legal, and regulatory requirements for
research on human subject in their own
countries as well as applicable international
requirements. No national ethical, legal or
regulatory requirement should be allowed to
reduce or eliminate any of the protections for
human subjects set-forth in this Declaration.
THANK YOU