Law firm of the year

Informed consent and confidentiality agreement

Audrey Shum Partner Stephenson Harwood 2012

Informed consent

Informed consent

Informed”

The risks The benefit

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vs

Information you need to tell the patient – (1)

ICH GCP (Cl 4.8.10) – the trial involves research – the purpose of the trial – the trial treatment(s) and the probability for random

assignment to each treatment Giving of placebo

– medical treatment/procedure during and after termination of the study

– subject’s obligations in the study – those aspects of the trial that are experimental – foreseeable risks or inconvenience – the reasonably expected benefits or the absence of any – alternative treatments (if any) available to the patient and

their potential benefits and risks – compensation (if any)/treatment available if the study goes

wrong – payment to the subjects (if any)

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Information you need to tell the patient – (2)

– any expense to be borne by the subject – patient’s right to leave the study, to withdraw consent – IRB/IEC and the regulatory authorities will be granted direct

access to the subject’s medical records – a subject’s personal identifying records will be kept

confidential – a subject will be informed of information relating to the study

which may affect its willingness to continue with the trial – a contact person for the subject – foreseeable circumstances/reasons under which a trial may

be terminated – duration of the study – number of subjects involved

Information you need to tell the patient – (3)

Other requirements

rights to access his own medical record and update or correct his personal data – Personal Data (Privacy) Ordinance

must use language as non-technical as practical and should be understandable to the subject (and the impartial witness) – Cl 4.8.6 ICH GCP

give time and opportunity to the subject to inquire about details of the trial and to make decision. All questions must be answered to the satisfaction of the subject – Cl 4.8.7 ICH GCP

Importance of informed consent – (1)

Requirements specifically for clinical trials

– Sponsor’s requirement

Contractual

Legal requirement in sponsor’s country

– ICH GCP’s requirement

“freely given informed consent should be obtained from every subject prior to clinical trial participation” – Cl 2.9 (see also Cl 4.8)

Importance of informed consent – (2)

Other general legal and professional requirements

– Common law – “every person’s body is inviolate”

battery

negligence

– Criminal law

– Code of professional conduct of the Medical Council of Hong Kong

Consent to medical treatment (Section 2.1)

“Consent has to be given voluntarily by the patient after having been informed of the relevant aspects of the medical procedure including the general nature, effect and risks involved”

Importance of informed consent – (3)

To limit or exclude liabilities?

– Control of exemption clauses ordinance (Cap 71)

No exclusion or limitation of liability for death or personal injury resulting from negligence (Section 7(1))

– ICH GCP

Cannot ask a subject to waive his legal rights or to release the investigator, the institution, the sponsor, or their agents from liability for negligence (Cl 4.8.4)

Who can give consent?

The subject, but what about: – Minors – Mentally disordered persons Mental Health Ordinance See “Incapacity” below

– Drunken or unconscious persons

Consequences of invalid consent – Breach of clinical trial agreement – Breach of tort law (or even criminal law) – Breach of professional conduct (if applicable)

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Minors – (1)

<16

– Gillick v. West Norfolk and Wisbech Area Health Authority (1985)

Parental right is not absolute

“if and when the child achieves a sufficient understanding and intelligence to enable him or her to understand fully what is proposed”

“a question of fact”

> 16 but < 18

– Hong Kong Mental Health Ordinance

A minor over 16 could become a voluntary patient of a mental hospital by his own accord

– However, no absolute right to give or refuse consent

– Parent also has the right to give or refuse consent

Contracts for necessaries

– For examples: food, drink, clothing, lodging, medicine and medical services

Other contracts => voidable at the minor’s option

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Minors – (2)

ICH GCP

– “The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject’s legally acceptable representative…” – Cl 4.8.5

– Even if consent from the subject legally acceptable representative has been obtained, minors should still “be informed about the trial to the extent compatible with the subject’s understanding and, if capable, the subject should sign and personally date the written informed consent” – Cl 4.8.12

– Special note on non-therapeutic trials on minors – Cl 4.18 13 and 14

Cf. Re D (UK case law)

Code of professional conduct of the Medical Council of Hong Kong (Section 2.2)

– “Consent is normally given by the patient himself”

– Otherwise, “the view of the family members should be considered provided that such views are compatible with (i) the patient’s best interests; and (ii) the patient’s right of self –determination”

Mentally disordered persons – (1)

Mentally disordered persons (MDP)

– General rule under contract law => binding

– Unless:

the person can prove he did not understand what was doing; and

the other party was aware of this incapacity.

– Result => voidable at the MDP’s option

Mentally incapacitated person (MIP) – a guardian or the Court can give consent to medical

treatment (other than special treatment) on behalf of a mentally incapacitated person provided:-

the MIP is incapable of understanding the general nature and effect of any such treatment

the court or the guardian must ensure the MIP is not deprived of the treatment due to his lack of capacity to give consent

the Court or the guardian must ensure the treatment is carried out in the best interest of the MIP

Mentally disordered persons – (2)

– Consent is not required if

– (i) MIP detained mandatory under the Mental Health Ordinance

– (ii) if medical treatment is

needed as a matter of urgency

necessary

in the best interest of the MIP

Unconscious persons

Exception to the common law principle that every person’s body is inviolate:-

– Re F [1990] 2 AC 1

Principle of necessity

Best interests of the patient

– “only if, it is carried out in order either to save the patient’s life or to ensure improvement or prevent deterioration in the patient's physical or mental health”

Must an informed consent be in writing?

Not a legal requirement

– Evidentially desirable

– But, it is a ICH GCP requirement

“prior to a subject’s participation in the trial, the written informed form should be signed and personally dated by the subject or by his legally acceptable representative and by the person who conducted the informed consent discussion” – Cl 4.8.8

“the subject or the legally acceptable representative should receive a copy of the signed and dated written informed consent form…” – Cl 4.8.11

– Code of professional conduct of the Medical Council of Hong Kong (Section 2.3)

Writing is preferred

Witnessing the signing of the informed consent

Not a legal requirement

But, it is a ICH GCP requirement if the subject (or the legally acceptable representative) is unable to read – Cl 4.8.9

– A witness needs to be present at the informed consent discussion

– Obtain oral (and written, if possible) consent from the subject or the legally acceptable representative

– A witness signs and personally dates the consent form confirming that the informed consent discussion has taken place and that informed consent was freely given by the subject or the legally acceptable representative

If a patient is a minor or a mentally disordered person, the present of a witness could not perfect the consent

Difficult cases

– Not clear whether a patient is actually a mentally disordered person

– Will a witness help in such case? 17

Undue Influence

No person should be allowed to retain the benefit of his own fraud or wrongful act Actual undue influence Presumed undue influence

– A relationship of trust and confidence Solicitor and client Medical advisor and patient

– Manifest disadvantage – Independent advice ICH GCP

– “Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial” – Cl 4.8.3

Consequence => restitution, accounts of profit, etc.

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Confidentiality agreements

Duty of confidentiality

Common law

Under a contract

ICH GCP

– “The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)” – Cl 2.11

Personal data (Privacy) Ordinance

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Duty of confidentiality – common law

Nature of the common law duty

– The duty exists without contract

– Confidential information => not a property

– It is a duty to prevent the recipient of the confidential information from misuse

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Duty of confidentiality – common law (‘cont)

What would be required to bring a claim for the breach of this common law duty?

– Was the information, by its nature, confidential?

– Was the information communicated in circumstances to indicate that it was confidential information?

– Did the party to whom the information was communicated misuse the information?

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Types of confidential information

Commercial records, like customer lists, sales information, strategy and commercial plans, etc. Unpublished copyrights works Mathematical formulae and manufacturing techniques Source code and algorithms Marketing techniques and procedures Personal information Price lists Plans, sketches and diagrams, etc…

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When does the above information becomes secrets or confidential information?

Based on the circumstances

Recipient of the information should have known that the information was given to him in confidence

The existence of certain relationships:

– Employer and employee

– Doctors/nurses and patients

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Consequences of breach

Damages

– The loss caused to the disclosing party

– The illegal gains made by the infringer from the unauthorised use

Injunction

Difficulties in relying on the common law duty of confidentiality

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Confidentiality agreements

Common terms – Definition of confidential information – Disclosing party – Receiving party – Scope of the confidentiality obligation – Restriction of use of confidential information – Steps to be taken by the recipient to protect the confidential

information – Consequences of breach (limitation of liability) – Inadvertent or innocent disclosure – Circumstances which permit disclosure – Time period – Exceptions

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Confidentiality agreements (‘cont)

Before entering into a confidentiality agreement, you should consider – Who are the contracting parties? Are you entering into the agreement on your own behalf? If not, do you have the necessary approval to enter into the

agreements on behalf of others?

– Whether the scope is reasonable? – Whether the duration of the obligation is reasonable? – Can you comply with all the obligations practically? If foreign law is referred to, do you understand your legal

obligations under such foreign law?

– Would you in practice have to share the disclosed information with others in the hospital? If yes, does the confidentiality agreement allow you to do so?

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Data protection principles

Six principles

– Purpose and manner of collection personal data

purpose must be specific

– Accuracy and duration of retention of personal data

– Use of personal data

– Security of personal data

– Information to be generally available

– Access to personal data

Consequences of breach

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Any questions?

Audrey Shum

E: Audrey.Shum@shlegal.com D: +852 2533 2763

F: +852 3150 3877 www.shlegal.com

© copyright 2012 Stephenson Harwood