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…