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National Genetic Data Bank Law 23511 - Regulation - Full Text Of The Norm

Original Language Title: BANCO NACIONAL DE DATOS GENETICOS LEY 23511 - REGLAMENTACION - Texto completo de la norma

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image inicio sitio infoleg MInisterio de Justicia y Derechos Humanos
NATIONAL BANCO OF GENETIC DATA Decree No. 700/89.

Bs. As., 24/5/89

VISTO is proposed by the MINISTERIES OF HEALTH AND SOCIAL ACTION and INTERIOR, and

CONSIDERING:

That it is necessary to regulate Law No. 23.511, by which the NATIONAL BANCO of GENETIC DATA (BNDG) was established, by issuing the appropriate rules of procedure to comply fully with its provisions.

That, according to article 1 of the above-mentioned law, the Reference Bank must operate in the Immunology Service of the Hospital "Carlos G. DURAND", dependent on the MUNICIPALITY OF THE CIUDAD OF BUENOS AIRES, which is why it is necessary to delimit the expenses that will result in the commissioning and subsequent action of the Bank, making clear what the Municipality will face and which the National State

It is also necessary to set the guidelines to which the management of the resources of the NATIONAL DATA BANCO should be adjusted.

That the present act is determined under article 86, paragraph 2, of the National Constitution.

Therefore,

THE PRESIDENT OF THE ARGENTINA NATION

RIGHT:

Article 1 Artículo The NATIONAL BANK OF GENETIC DATA will have its seat in the Immunology Service of the General Hospital of "Carlos G. DURAND" dependent on the M.C.B.A. The structure and plant of personnel, physical environment, furniture and equipment are those detailed in Annexes I, II and III of the agreement referred to in Article 3 which, for all purposes, is part of the present.

The head of the Immunology Service at Carlos G Hospital. DURAND will receive the title of Director of the NATIONAL BANCO of GENETIC DATA (Law No. 23.511), and will have his office in units of it.

Art. 2o o The Director of the NATIONAL BANK OF GENETIC DATA will be responsible for the following functions:

(a) Organize, coordinate and monitor their own scientific and technical activities.

(b) Establish the scientific and technical guidelines and policies necessary for their development, as determined by law.

(c) Prepare the budget and calculation of resources of the NATIONAL GENETIC DATA BANCO and subject it to prioritization.

Art. 3o o The costs that demand the operation of the NATIONAL BANCO OF GENETIC DATA shall be covered by the national State and by the MUNICIPALITY of the CITY OF GOOD AIRES, in accordance with the guidelines set out in the agreement that is an integral part of the present decree. Art. 4o — The MUNICIPALITY OF THE CIUDAD OF BUENOS AIRES, to this end, must enable in the Hospital "Carlos G. DURAND" a "Special Account" whose funds will be allocated exclusively to the functioning of the National Genetic Data Bank. The funds of this account will be managed jointly between the director of the NATIONAL BANCO of GENETIC DATA and the Director of the establishment, who, for the purposes of the provision of the same, will have as a level of competition that governs the MUNICIPALITY of the CIUDAD of GOODS FOR THE GENERAL DIRECTION OF COMPAS AND CONTRACTIONS. Art. 5o o The Hospital "Carlos G. DURAND" and the Director of the NATIONAL BANCO OF GENETIC DATA shall jointly pay a documented account of the expenses they make, to the SECRETARIAT OF HEALTH of the MINISTERY OF HEALTH and SOCIAL ACTION. Art. 6o o The NATIONAL BANK OF GENETIC DATA will have an Advisory Council, which will have as a mission to advise the authority that directs it in all matters concerning the operation of it.

The Council shall be convened when it deems necessary by the Director and shall be composed of a representative of the Ministry of Health and Social Action, one by the SECRETARIAT for PUBLIC HEALTH AND ENVIRONMENT OF MUNICIPALITY OF THE CIUDAD OF GOOD AIRES; one by the SECRETARIAT OF JUSTICE OF THE MINISTERIAL

It will also include the Advisory Council, a representative of the Civil Association Grandmothers of Plaza de Mayo, when it comes to general operating topics of the NATIONAL BANK OF GENETIC DATA concerning the filiation of children who are missing or allegedly born in captivity.

Art. 7o o The services of the NATIONAL BANCO DE DATOS GENETICOS will be provided free of charge, with the stakeholder paying only the same, the cost of the reagents to be used for the conduct of the respective review.

They shall be exempt from paying the reagents referred to in the preceding paragraph, the relatives of children who are missing or allegedly born in captivity or those who credit the economic impossibility of facing the payment of the said reagents.

La SECRETARIAT OF PUBLIC HEALTH AND ENVIRONMENT OF MUNICIPALITY OF THE CIUDAD OF BUENOS AIRES, is entitled to set the amount to be paid by those interested in the provision of reagents, which may not exceed the cost of the same and to proceed to update it regularly according to the evolution of that cost.

The amount that is collected on the basis of the above, shall be entered into the special account provided for in Article 4.

Art. 8o o For the purpose of practising studies to persons residing abroad, referred to in article 3 of Act No. 23.511, the following institutions are recognized: Pr. Jean DAUSSET. (College de France) Paris, Pr. Laurent DEGOS (Hospital Saint Louis) Paris (RePUBLICA FRANCESA), Pr. Eckehart ALBERT, Munich, Pr. G.B. FERRAVA, Genoa (ITALIAN REPUBLIC) and Pr. R. DUQUESNAY, Pittsbourgh (UNITED STATES OF AMERICA).

The NATIONAL EXECUTIVE PODER, on the proposal of the NATIONAL BANK OF GENETIC DATA, may extend when the circumstances suggest it, the previous payroll, either to include institutions belonging to the same countries or others not contemplated in the preceding paragraph.

Art. 9o o The Ministry of Foreign Affairs And CULTO will be in charge of giving the instructions and issuing the necessary provisions for the Argentine consulates abroad to give adequate and timely compliance with the tasks set out in Article 3 of Law No. 23.511.

The cost of consular services, the fees for obtaining blood samples and for conducting studies and any tariffs on foreign territory shall be exclusively charged to those concerned.

They shall be excluded from paying the cost of consular services, relatives of children missing or allegedly born in captivity.

Art. 10. Genetic examinations to be performed by the NATIONAL BANCO OF GENETIC DATA should be in all cases ordered by the judge to intervene in the case, according to the prior determination of the type of study to be carried out.

The judicial resolution ordering the conduct of the studies should be submitted to the NATIONAL BANCO OF GENETIC DATA together with the request for services and the identity document of the party concerned.

Art. 11. The NATIONAL BANK OF GENETIC DATA will determine the day and time of the tests, proceeding to notify the interested parties, by means of a fruitful one.

All matters concerning the control of the evidence by the parties, such as the intervention of the technical consultants, shall be governed by the rules laid down in the Codes of Civil and Commercial Procedures and in Criminal Matters of the Nation and complementary laws.

The chronological order of the receipt of trade, which should not be altered except for the existence of force majeure or urgency derived from serious causes, should be strictly respected in the setting of the shifts for the conduct of the tests, which should be duly founded by the Director General of the NATIONAL BANCO OF GENETIC DATA

Art. 12. Consanguineous relatives referred to in article 5 of Law No. 23.511, to request and obtain the services of the NATIONAL BANK OF GENETIC DATA shall initiate before the competent judicial authority the relevant action in which it shall be accredited: (a) Sumarily the circumstances in which the child or those of which the presumption arises that the child is born in captivity; (b) The child ' s link with the child, in accordance with the applicable legal rules.

For the purpose of taking digital prints and photographs, a special sector will be provided in the NATIONAL BANCO OF GENETIC DATA by specialized staff.

Art. 13. The Directorate of the NATIONAL BANK OF GENETIC DATA shall issue the necessary rules to ensure the correctness and accuracy of the studies and shall enable officials responsible for the areas of identification of persons, extraction, immunogenetics, preservation of samples and registration to give evidence of the acts appropriate to them, under penalty of nullity. Art. 14. The NATIONAL BANK OF GENETIC DATA will not provide information to individuals on the recorded data, nor to public or private entities whatever the nature of the reasons alleged.

The information stored will only be supplied by judicial requirement, in a given case.

Art. 15. In cases where there is manifest physical impossibility of consanguineous relatives to personally attend the NATIONAL BANK OF GENETIC DATA, the judge may have the necessary measures to proceed with the removal of appropriate blood samples at his home, complying with the other precautions established in articles 10 and 13. Art. 16. It will be up to the NATIONAL BANCO OF GENETIC DATA to determine what type of studies should be carried out in each case where the intervention is required in accordance with the criteria arising from the state of scientific knowledge. Art. 17. The incorporation of existing data to date, in accordance with article 7 of the Act, shall be done in each case, with the intervention of the authorized official of the NATIONAL BANCO OF GENETIC DATA, as indicated in article 13.

Such data, as well as blood samples, will be stored in the NATIONAL BANK OF GENETIC DATA in order to ensure their comparison with the data that are incorporated in the future.

Art. 18. Contact, post, give to the National Directorate of the Official Register and archvese. . ALFONSIN. . Enrique C. Nosiglia. . Ricardo Barrios Arrechea. Dante Caputo.

Among the Municipality of the City of Buenos Aires, represented in this act by the Municipal Intendent, Doctor FACUNDO SUAREZ LASTRA, with domicile in Avenida de Mayo 525, Capital Federal, henceforth "LA MUNICIPALITY", on the one hand, and on the other, the Ministry of Health and Social Action, represented in this act by its head doctor RICARDO A. BARRIOS ARRECHEA, with a domicile in Defense 120, Capital Federal, henceforth "EL MINISTERIO", in view of the significant importance with which the entire human rights problem has been addressed by the authorities of the Nation, resolve to conclude the agreement that implements the following clauses:

FIRST: The purpose of this agreement is to achieve through a programme of cooperation and appropriate coordination between national, municipal and judicial agencies, the effective operation of the National Bank for Genetic Data in order to give timely and efficient response to the requirements that both in terms of filiation and of children who are disappeared or who are allegedly born in captivity are formulated by the judicial authorities in accordance with Law No. 23.511.

SECOND: The National Genetic Data Bank will operate in the Immunology Section of the "Carlos G. Durand" Hospital under the "MUNICIPALITY" and the Technical Directorate of the same, will be headed by the head of that Section.

THIRD: "Municipality" takes over: 1) The integration of the staffing of the National Genetic Data Bank according to the detail that as Annex I is incorporated into the present. " MUNICIPALITY" is committed to appointing in a first stage .Año 1989. a fourteen (14) agents according to the priorities established by the director of the National Genetic Data Bank, assuming payment of the respective remunerations. (2) Provide the necessary equipment for the operational functioning of the Bank and as described in Annex II, which is also incorporated into the present. The adequacy of the physical ambition and equipment will be gradually made in accordance with the feasibility of the municipal budget.

FOURTH: For the exclusive management of the funds allocated to the National Genetic Data Bank, a "Special Account" will be granted. The management of the same will be combined between the Director of the Hospital "Carlos G. Durand" and the Bank, officials to whom, to the sole effect of the present, they are assigned the level of competition that governs in "THE MUNICIPALITY".

FIFTH: "MINISTERY" takes charge of: 1) Assigning a budget line to meet the requirements of the NATIONAL BANCO of GENETIC DATA for reagents and other materials described in annex III to the present; 2) To provide through the HEALTH SECRETARIAT that will be responsible for the item referred to in the previous point, in a fluid, sufficient and timely manner the funds to meet the requirements of the Bank, which will be forwarded from the Special Account referred to in the previous clause.

SEXTA: For the purpose of specifying the allocation of the above-mentioned item, " MUNICIPALITY" will provide the "MINISTERY" on an annual basis and within the dates that it informs you of the estimated requirements for reagents and other elements described in Annex III, as well as their cost.

SEPTIMA: Both parties agree to the integration of a joint commission consisting of two (2) representatives of each of them, which will be coordinated by the director of the NATIONAL BANCO OF GENETIC DATA and will aim to propose the complementary and/or widening norms of this agreement, with a view to achieving a smooth and efficient functioning.

Four (4) copies of the same tenor and one effect are signed in Buenos Aires on December 28th, a thousand nine hundred and eighty-eight.

Annex I

STRUCTURE AND STAFF DOTATION

Staff to designate for the NATIONAL BANCO OF GENETIC DATA

1 Medical Professional

2 Biochemical Professionals

1 Professional Biologist

6 Laboratory technicians

4 of clinical analysis

2 hemotherapy

1 Extraction of blood

1 Mathematic/statistical

1 Computer Operator

1 Computer programmer

1 Legal adviser

1 Administrative Clerk

1 Mucama

2 Material preparations

2 Monitoring personnel

2 Dactiloscopists

Annex II

FISTIC AND EQUIPMENT

(1) The existing one in the unit, as to its surface

(2) Conditioning of the existing physical environment:

(a) Modification of surfaces in current areas:

Displaced dividing panels

Adding fixed and mobile work tables and lighting, water and gas systems.

(b) Cold chamber construction.

c) Camera for authorradiography (DNA polymorphism).

(3) Permanent cooling of the physical plant with temperature between 20/22oC to ensure cell vitality during manipulations.

(4) Provide a mobile unit (vehicle type Renault Traffic) to move the sample extraction equipment, administrative notary, fingerprint and photographic equipment.

5) Cover the entire exterior stained surface with protective anti-term material.

6) Alarm system for the physical plant.

7) Change of panels from the ceiling of the unit.

8) Change of coverage of the unit floor.

To complete and improve the existing equipment:

1) Dual fluorescence system for CARL ZEISS microscopes.

(2) Accessories (tubes, holders and rotor) for SORVALL cooled centrifuges.

(3) Nitrogen Liquid Thermal Tanks.

(4) Electrophoretic Cubas and Power Sources (for DNA polymorphism) and other interconnected elements to the existing Multiphor LKB system in the service.

To add to the existing one:

1) Table centrifugals with fixed head x 36 tubes (2).

2) Bathrooms Mary table with stirr and adjustable temperature (2).

(3) MILLIPHORE MILLIRU type water distillation system.

4) Horizontal programmable Freezer to -90/-120oC with Inventory System.

5) Liquid Nitrogen container with Inventory System and capacity for 250 liters approx.

6) Liquid programmable. Nitrogen Freezer (Cryomed MH, Clemens MI).

7) CRYOSON -Bu- 6 (Hellonda).

8) Registrar LINSETS L -600 (Hellonda).

9) Automatic micropipetes (6 units).

10) Polaroid photographic machine.

11) System for fingerprinting.

12) Electrical machine to write, with memory, corrector.

13) IBM or similar (2 units).

13) Director telephone with DDI.

14) Telephone to operate with the computer collected on a database basis.

15) Télex and Telefax.

MOBILIARIO

1) Archives.

2) Files

3) Writers.

4) Chairs.

5) Computer tables.

6) Library.

7) Intercoms from the Directorate to the different areas of work and reception.

8) Photocopier (last generation).

MATERIAL IMPRESS

(1) Reporting protocols.

(2) Admission and study protocols.

(3) Foliated books.

4) BNDG paper and envelopes.

5) Counseling brochures.

Annex III

MATERIALS AND REACTIVES (Consumption Goods).

1) Disposable plastics.

(a) Jerings and needles.

(b) Tubes (Eppendorf, hemolysis, Mahn, Beckman).

(c) Pipetas (Pasteur, graduates, traditional).

(d) Plastic plates for typing HLA (Teresaki x 60 or 72).

(e) Nylon Fiber.

(f) Plastic vials for cryopreservation.

(g) Nitrocellulose filters for DNA polymorphism.

2) Glass material.

(a) Hamilton Jerings and Dispensers.

(b) Teresaki Multiple Dispenser for sowing and placement.

(c) Glass wool.

3) Reactive.

(a) Means of cell culture and conservation.

(b) Antisueros for blood groups.

(c) Antisueros for HLA antigens.

(d) Drugs and reagents to determine plasma proteins.

(e) Drugs and reagents to determine erythrocyte isoenzymes.

(f) Drugs and reactants for DNA polymorphisms.

(g) Means for the preparation of cell separative gradients.

(h) Cell freezing means.

4) Liquid Nitrogen.

5) Daily supply of chopped ice.