Saturday, December 13, 2008

MODEL FORM OF INFORMED CONSENT

MODEL FORM OF INFORMED CONSENT

I ..................................... son of ............................... aged ................ resident of ........................................... being under the treatment of ....................................... (state here name of doctor/hospital/nursing home) do hereby give consent to the performance of medical /surgical /anesthesia/ diagnostic procedure of ....................................................... (mention nature of procedure / treatment to be performed, etc.) upon myself/upon ................................................... aged ............. who is related to me as ................................... (mention here relationship, e.g. son, daughter, father, mother,wife, etc.).

I declare that I am more than 18 years of age.I have been informed that there are inherent risks involved in the treatment / procedure. I have signed this consent voluntarily out of my free will without any pressure and in my fell senses.

Place :

Date : SIGNATURE

Time : ( To be signed by parent /guardian in case of minor)

NOTES :

1. This Consent Form should be signed BEFORE the treatment is started. These formats may be modified as per individual requirements or experiences of Hospitals /Nursing Homes.

2. These formats should be in local language and in certain cases it would be prudent to record a proper witness to signature consent.

3. Informed consent forms for various situations can be made for Nursing Homes / Hospitals. Help of lamay have to be taken. Detailed forms on Medical history can also be maintained. Keep all records in order and safely.

4. It is important to note that written consent should refer to one specific procedure. Obtaining a ‘blanket’ consent on admission does not have legal validity.

Selected Provisions of The Consumer Protection Act 1986 Explained

Selected Provisions of The Consumer Protection Act 1986 Explained
( As Relevant to the Medical Profession )

The Consumer Protection Act, 1986 which came into force on 15th April,1987 is a welfare legislation mainly titling towards the consumer just as the Industrial Disputes Act is loaded in favour of workers. The aims and objects of the Act inter alia are,as given in its Preamble, better protection of the interests of the consumer and for settlement of consumer disputes. It provides for speedy and inexpensive settlement of disputes within a limited time frame, as against civil actions which are costly and take years in coming to a settlement. Provisions of the Act are in addition to and not in derogation of any other law for the time being in force and are compensatory in nature.

The Act envisages a three-tier quasi-judicial machinery, i.e.,District Consumer Disputes Redressal Forum at the district level State Consumer Disputes Redressal Commission of the state level and National Consumer Disputes Redressal Commission at the National level.

Recently, the Act has been amended by the Consumer Protection (Amendment) Act, 1993, w.e.f. 18.6.1993. We shall deal selectively with provisions of the Act which are relevant to the Medical Profession, as they exist as on today. The meaning of legal terms are being restricted to such terms only as concern the Medical Profession.

Definitions

Complainant means -

(i) a consumer ; or

(ii) any voluntary consumer association registered under the Companies Act, 1956 or under any other law for the time being in force; or

(iii) the Central Government or any State Government ;

(iv) one or more consumers, where there are numerous consumers having the same interests ; who or which makes a complaint.

Complaint means - Any allegation, in writing made by a complainant that the services hired or availed of or agreed to be hired or availed of by him suffer from deficiency in any respect.

Consumer means - Any "person" who hires or avails of any services for a consideration which has been paid or promised or partly paid and partly promised and includes any beneficiary of such services other than the person who hires or avails of the services for consideration paid or promised,or partly paid and partly promised, or under any system of deferred payment, when such services are availed of with the approval of the first mentioned person.

Comment

Consideration means fees /payment. Fees may have been fully paid in cash or cheque, or undertaking that it will be paid, which is accepted by the doctor hospital. The fees may have been given partly (as advance) with the understanding that the remaining bill will be paid subsequently. The payment may be done by the patient himself, or by someone else for the patient, e.g., father for his child, husband for wife, any person for someone.

A person who receives medical treatment in Government hospital or charitable hospital free of cost is not a consumer under the Act.

In case of death of patient who is a consumer, legal heirs (representatives) of the deceased will be considered as "consumer". If the payment has been made by any person who is not a legal heir of the deceased he too will be considered as "consumer."

The three words used above (deficiency, person, service) explained under this act are as follows :

Deficiency means - Any fault, imperfection, shortcoming or inadequacy in the quality, nature, and manner of the performance which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service.

Comment

Deficiency/negligence means fault, imperfection, shortcoming or inadequacy in quality, nature and manner of performance of the medical service rendered by a hospital and /or member of the medical profession.

Person includes -

* a firm whether registered or not;
* a Hindu undivided family;
* a co-operative society
* every other association of persons whether registered under the Societies Registration Act, 1860 or not.

Service means - Service of any description which is made available to potential users and includes the provision of facilities in connection with banking, financing, insurance, transport, processing, supply of electrical or other energy, board of lodging or both, housing construction, entertainment, amusement or the purveying of news or other information but does not include the rendering of any service free of charge or under a contract of personal service.

Although medical profession has not been included under the term "service" but in many of the decided cases medical services have been deemed to be included in the definition of service in view of the expression ; ‘service means service of any description.’

Charge means - Fee / payments with element of profit making motive involved. As Government hospitals/certain charitable hospitals do not charge fees, hence such services rendered are exempted from this Act. In certain situations where hospitals are charging nominal stamp fees, contributions are made by Govt.employees to the CGHS , payments are made for cottage wards, diagnostic tests are done under auto-finance scheme, such services do not have any element of profit motive. Hence the persons availing of these services are not consumers and the services rendered do not fall under the Act, as there is no consideration paid for hiring of such services.

The second category of "service" exempt under this Act are those services which are rendered under a contract of personal service.

It has been held by the National Consumer Disputes Redressal Commission ( National Commission) on April 21,1992 in the case of Cosmopolitan Hospitals and Anr. v. Vasantha P. Nair [ 1 (1992) CPJ 302 (NC) ] that the medical treatment rendered to a patient by a private doctor or clinic for consideration is clearly a service falling within the ambit of section 2 (1) (o) of the Consumer Protection Act. It is not a contract of personal service but a contract to render professional service. It is now well settled that hospital authorities rendering service for consideration are liable to the patient for caused by him by the negligence or other fault of the doctors, surgeons, nurses, anesthetists and other members of the hospital in the course of their work. The liability of the hospital authorities extends to the faults of doctors and other employees whether their employment is permanent or temporary or casual, paid or honorary, whole or part-time as happens in the case of visiting physicians/surgeons.

Consumer Protection Act and Medical Profession

The Background

The best way to come directly to the issue would be to know about the rights of the consumer. The eight rights as defined by the International Organization of Consumers’ Union ( IOCU) are as follows :

THE CONSUMER RIGHTS

1. The Right to Safety

Which means the right to be protected against products, production processes and services which are hazardous to health or life. The right to safety has been broadened to include the concern for consumers’ long-term interests, not only their immediate desires.

2. The Right to be Informed

Which means the right to be given the facts needed to make an informed choice or decision. The right to be informed now goes beyond avoiding deception and the protection against misleading advertising, labelling or other practices. Consumers should be provided with adequate information, enabling them to act wisely and responsibly.

3. The Right to Choose

Which means the right to have access to a variety of products and services at competitive prices and in the case of monopolies, to have an assurance of satisfactory quality and service at a fair price. The right to choose has been reformulated to read : the right to basic goods and services. This is because the unrestrained right of a minority to choose can mean for the majority a denial of its fair share.

4. The Right to be Heard

Which means the right to be represented so that consumers’interest receive full and sympathetic consideration in the formulation and execution of economic policy. This right is being broadened to include the right to be heard and represented in the development of products and services before they are produced or set up; it also implies a representation, not only in government policies, but also in those of other economic powers.

5. The Right to Redress

Which means the right to a fair settlement of just claims. This right has been generally accepted since the early 1970s. It involves the right to receive compensation for misrepresentation or shoddy goods or services, and where needed, free legal aid or an accepted form of redress for small claims should be available.

6. The Right to Consumer Education

Which means the right to acquire the knowledge and skills to be an informed consumer throughout life. The right to consumer education incorporates the right to the knowledge and skills needed for taking action to influence factors which affect consumer decisions.

7. The Right to a Healthy Environment

Which means the right to a physical environment that will enhance the quality of life. This right involves protection against environmental problems over which the individual consumer has control. It acknowledges the need to protect and improve the environment for present and future generations.

8. The Right to Basic Needs

The right to basic needs means that availability of articles which are the basic need of every consumer must be ensured.15th March is celebrated as World Consumer Rights Day. On this day in 1962, President J.F. Kennedy declared four consumer rights ( No.1 to 4 ) in the special message to the American Congress. Consumer rights number 5 to 8 were subsequently added by IOCU.

Govt. of India also included the above rights in its Twenty-Point Programme. The Consumer Rights No. 1 to 6 are also enshrined in our Consumer Protection Act, 1986.