Informed Consent in Clinical Research · 2015-08-28 · Informed Consent in Individuals with Mental...
Transcript of Informed Consent in Clinical Research · 2015-08-28 · Informed Consent in Individuals with Mental...
Informed Consent in Clinical Research
Prof Dato’ Dr Ishak Abdul Razak BDS, DDPHRCS, MSc, PhD, FICD
AIM of Presentation
Making investigators and Ethic Review
Committee aware of issues of informed
consent in clinical research.
Scope :
i) General issues of informed consent
ii) Its applicability in clinical research
Consent
The respect for individual autonomy
Permission of the patient to receive treatment
Process is voluntary and continuing
The fact that a subject has consented to a procedure
on one occasion, does not create an open-ended
consent which can be extended to subsequent
occasions.
Applies even when undertaking a procedure
Consent
3 types of consent
1. Implied consent for examination
2. Verbal consent Presence of 3rd party as witness
3. Written consent esp when a procedure involve a special risk
Treatment without consent is regarded as
“trespass upon the patient” and constitute a
“technical assault”
CONSENT
For consent to be valid, the law requires :
person must be competent
adequate information must be provided
voluntary, without duress, deceit or constraint
Consent
Person must be competent
Age of majority 18 yrs
< this age – must have consent from parents
others eg mental disorder.
Adequate information must be provided
informed vs true/ real
– Nature
– risk (inherent/potential hazard, risk of having no treatment)
– Alternatives
– Consequences of no treatment
– Cost
Voluntary
given freely, without duress, deceit or constraint
Consent
Avoid giving guarantees
“ I guarantee you will have no problem”
“I have not encountered any complication in all my years of practise”
May lead to a breach of contract even when no negligence is present
Consent
(Precedence?)
‘Gillick competence’ is where a child’s maturity and understanding is sufficient to enable an appreciation of what is involved.
If a child under 16 (UK) is not ‘Gillick competent’, then the practitioners should fully inform the parent or legal guardian about any consultation.
NB : This case has not been applied in Malaysia
Only Doctors Know Best?
The Myth Punctured by the
Nation’s Highest Court of Law
Bolam Principle (1957)
the doctor is not negligent if he acts within a practice
accepted at the time as proper by a body of responsible medical opinion or his own peers who possess similar skills and competence.
it is enough that he has acted in accordance with one of the bodies opinion and the courts can never declare his action to be in any way negligent.
Rogers vs. Whitaker (1992)
The court affirmed that:
a doctor has a duty to warn a patient of any material risk involved in a proposed treatment.
a risk is considered material if a reasonable person in similar circumstances will attach significance to the risk, or if the particular patient will express concern about the risk.
In Practice Some Doctors:
are uncertain how much they should tell their patients, or
do not wish to tell their patients of the risks involved, or down play the risks and side effects.
They fear that telling everything patients may not want to undergo the necessary treatment.
30/12/06
Confidentiality
Information SHOULD NOT be conveyed to a third party in any normal circumstances.
The duty of confidentiality extends also to the staffs, not only to the dentist himself alone.
Definition: The statutorily protected right and duty of health professionals not to disclose information acquired during consultation with a patient.
Informed Consent in Clinical Research
REFERENCES
WMA Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Subject 2008
Council for International Organizations of Medical
Sciences (CIOMS) International Ethical Guidelines
for Biomedical Research Involving Human
Subjects.2002
Individual Informed Consent
For all biomedical research involving humans the
investigator must obtain :
voluntary informed consent of the prospective
subject or,
permission of a legally authorized representative
in accordance with applicable law.
Obligations in Obtaining Informed Consent
Investigators have a duty to:
refrain from deception, undue influence, or intimidation;
ensure subject has adequate understanding, sufficient
opportunity to consider whether to participate;
as a general rule, obtain written consent.
renew the informed consent if there are significant
changes in the procedures of the research or if new
information becomes available .
Obtaining Informed Consent: (What information to give?)
Ensure that the individual can understand :
• individual is invited to participate, hence participation
is voluntary;
• free to withdraw from the research at any time
without penalty or loss of benefits
Obtaining Informed Consent: (What information to give?)
Ensure that the individual can understand :
• purpose of the research, the procedures to be
carried, explanation of features of the research
design (e.g., randomization, double-blinding), how
does the research differs from routine medical care
• and that the subject will not be told of the assigned
treatment until the study has been completed and
the blind has been broken
Obtaining Informed Consent: (What information to give?)
Ensure that the individual can understand :
• duration of participation
• any foreseeable risks, pain or discomfort, or
inconvenience
• direct benefits of the research
• available alternative interventions
• confidentiality of records
Obtaining informed consent: (What information to give?)
Ensure that the individual can understand :
• Subjects will be informed of the findings of the
research in general and that which relates to
their particular health status;
• whether money or other forms of material
goods will be provided in return for
participation .
Obtaining Informed Consent: (What information to give?)
Ensure that the individual can understand :
• Biological specimens be taken and for what benefit
• What happens to the biological specimens
collected in the research.
Research Involving Children
Ensure that:
the research cannot be done adults;
the purpose of the research is to obtain knowledge
relevant to the health needs of children;
permission is obtained from a parent or legal
representative of each child
the agreement of each child has been obtained to
the extent of the child`s capabilities; and,
a child`s refusal to participate or continue in the
research will be respected.
Informed Consent in Individuals with Mental Disorders
Ensure that: the research cannot be done on such persons whose mental
capacity is not impaired;
the purpose of the research is to obtain knowledge relevant to the particular health needs of persons with mental disorders;
the consent of each subject has been obtained to the extent of that person's capabilities, and a prospective subject's refusal to participate in research is always respected
permission is obtained from a responsible family member or a legally authorized representative in accordance with applicable law.
Pregnant Women as Research Participants
Ensure that :
they are adequately informed about the risks
and benefits to
themselves,
their pregnancies,
the fetus and their subsequent offspring
their fertility.
Conclusion
Medical progress has to rely in part on research
involving human subjects.
Research should be beneficial and not life
threatening and must adhere to the highest ethical
standards.
The respect for personal autonomy to make
decisions for him/herself and especially when
dealing with vulnerable communities and individuals.
Thank you for your kind attention…
Thank you
for your kind attention…