Disclosing non paternity in genetic counselling: in Italy the law overcomes the bioethical debate.
Abstract: Nowadays, the frequency of children identified as being biologically fathered by someone other than the man who believes he is the father is such that, in the field of genetic counselling, it is likely to encounter cases of false paternity. The false paternity information, neither requested nor expected by the families in many cases, seems to regard only the "father" of the family but has repercussions for the entire family. By now, it has been accepted that genetic information is, by its nature, both individual and familial.

The ethical-deontological debate centres on whether or not to inform the family about the necessity of a paternity test during the counselling and the counsellor's duty to reveal the results.

In this paper, we analyse the Italian legislation on medical professionals' position concerning the doctor's role in genetics counselling; recent Sentences by Italian Courts and The Italian Personal Data Protection Code have underlined that the councellor has to give complete information to the people involved, also regarding the possibility to disclose a false paternity, to enable both parents to choose whether they want to know the truth. Because of these statements, it seems that in genetic counselling the respect for the "client's autonomy" is today prevalent in Italy, not only from an ethicaldeontological point of view, but above all, from a legal one.

Keywords: legislation as a topic, medicine, paternity, genetic privacy, informed consent.
Article Type: Report
Subject: Bioethics (Analysis)
Genetic counseling (Ethical aspects)
Genetic counseling (Analysis)
Paternity (Ethical aspects)
Paternity (Analysis)
Authors: Caenazzo, Luciana
Tozzo, Pamela
Rodriguez, Daniele
Pub Date: 01/01/2010
Publication: Name: Archives: The International Journal of Medicine Publisher: Renaissance Medical Publishing Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2010 Renaissance Medical Publishing ISSN: 1791-4000
Issue: Date: Jan-March, 2010 Source Volume: 3 Source Issue: 1
Topic: Event Code: 290 Public affairs Advertising Code: 91 Ethics Canadian Subject Form: Genetic counselling; Genetic counselling
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 226568399
Full Text: INTRODUCTION

Misattributed paternity or false paternity is the condition in which it is assumed that a woman's partner is the biological father of a child but, in fact, he is not. Nowadays, the frequency of misattributed paternity has increased to the extent (1) that health-care professionals can sometimes discover cases of false paternity during their activity, in particular during genetic counselling.

In the field of consulting, information regarding the possibility to discover a misattributed paternity is not requested by families nor expected by them. This information, which seems to regard only the "father" of the family, actually has repercussions on the entire family. In recent times, it is frequent that a family asks to a forensic genetic laboratory to perform paternity testing, because of the possible doubts coming out from prior genetic counselling results. The request of a paternity test has become much easier since the appearance of websites which offer internet paternity testing without great limitations.

By now, it has been accepted that genetic information is by its nature both individual and familial. (2) In this article, we will consider the family as a whole, formed by partners (both parents) and the child involved in the consultation.

Based on our experience of the request of paternity testing by families involved in genetic counselling, and considering that we are involved in ethical-deontological debates about patient's information and consent, with this work we will point out how the Italian juridical context has recently overcome the bioethical debate about counselling behaviour in cases of discovering misattributed paternity, considering some recent Sentences and The Italian Personal Data Protection Code which affirm the duty to inform patients about familial implications during genetic counselling.

THREE ASPECTS OF THE BIOETHICAL DEBATE ON DISCLOSING MISATTRIBUTED PATERNITY

The counsellor's client(s)

According to what is reported in literature, both parents and the child are the counsellor's clients. (2-6) In contrast with other kind of medical information, which pertain primarily to individuals, information given by molecular genetic testing and/or pedigree analysis necessarily has implications for biologically related members of the family. The goal of counselling is "to promote client autonomy, [to help clients] understand their options and choose a course of action that is most appropriate to them in view of their risk and their family goals and act in accordance with that decision". (7)

According to the NSGC (National Society of Genetic Counsellors), counsellors should "enable their clients to make informed decisions, free of coercion, by providing or illuminating the necessary facts, and clarifying the alternatives and anticipated consequences" as well as "maintaining information received from clients as confidential, unless released by the client or disclosure is required by law".

According to what is reported in guidelines on ethical issues in medical genetics (8) it is "vital to recognize that hereditary information is a family possession rather than simply a personal one". Yet, if genetic information is treated as family property, the traditional boundaries, definitions, and obligations in the healthcare professional--patient relationship would be extended to all the family members, leaving the healthcare professional to deal with the potential conflict between the best interests of the traditionally defined patient and the best interests of the newly defined patients. (9-11)

If the result given by genetic counselling reveals a false paternity, and the counsellor doesn't consider all the family's members as his clients, non-disclosure to all members could result in the counsellor considering one of the members primary client related to the others.

Again, the 1998 ASHG Statement (American Society of Human Genetics) (6) indicates in the paragraph "Ethical Duty to Inform Patients about Familial Implications" that "at a minimum, health-care professionals should be obliged to inform patients about the implications of their genetic test results and about the potential risks to their family members".

The social /biological harm

Disclosing or not a false paternity implies different situations for the subjects involved both in biological and social matters. (3,12,13)

Even if the counsellor gives the correct information about health, the disclosure of a misattributed paternity to the family could lead to disruptive frustrations concerning the family's unity. In this case, the genetic counselling will have harmful social implications. In this case, the counsellor sets off the biological purposes of the counselling, because he could not know, before testing, the emotional consequences that could crop up after the disclosure. What happens, and the extent of the disruption, will depend on many factors, particular to the family, which the counsellor cannot predict.

With the decision to conceal misattributed paternity the counsellor aims to offset the social consequences even if they cannot be predicted. The risk to create a harm is related to incomplete information on the biological health condition of one of the family members: the presumptive father. For the counsellor, also, the incomplete disclosure means disrespecting of the duty to inform the client.

The WHO definition of health includes biological, psychological and social components, without the supremacy of one of them over the others. Disclosing or not a false paternity undoubtedly implies a conflict between the biological aspect and the social one.

The non-disclosure of a false paternity could imply, for the father, a diagnosis of no disease and so a positive message on the father's health condition, but it could be a destabilizing unity factor in the family and could give the counsellor a paternalistic role, leaving to the couple the risk for future decisions based on false information.

The client's autonomy

It is important to analyse the role of the client's autonomy in genetic counselling. In order to ensure that decisions are based on correct and complete information, the counsellor's role is to provide accurate genetic information to his clients as well as to answer to their questions and doubts. Counsellors minimize the risks of coercion or manipulation by communicating in value-neutral terms as much as possible and unconditionally supporting the clients' choices.

In other words, genetic counselling does not only include information and consent, but it is an effective and efficient mean to promote clients' consciousness and responsibility respecting their freedom to make their own decisions. (5,14,15) This behaviour is consistent with the emphasis on patient autonomy that currently dominates medical practice.

Furthermore, the directions expressed in the Oviedo Convention (16) and in the 1998 ASHG (American Society of Human Genetics) Statement (6) underline this aspect. The Oviedo Convention (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine) points out two aspects about information: the first one is reported in the article 5 of the second chapter (titled "Consent") and the second in the article 10 of the third chapter (titled "Private life and right to information"), which are reported below:

Article 5--General rule

1. An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

2. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.

3. The person concerned may freely withdraw consent at any time.

Article 10--Private life and right to information

1. Everyone has the right to respect for private life in relation to information about his or her health.

2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.

3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.

The information's concept regarding the client is reported in the article 10, paragraph 2, that underlines the right to know all information of client's health and implicitly to the heathcare professionals the duty to give this information.

Furthermore, the article 5, paragraph 2, affirms the client's right to be informed about his health and also in this case the duty belongs to the heath-care professionals.

Again, the 1998 ASHG Statement reports in the C paragraph entitled "Ethical Duty to Inform Patients about Familial Implications" that: "... at a minimum, health-care professionals should be obliged to inform patients about the implications of their genetic test results and about the potential risks to their family members. This duty to inform the patient about familial implications, both prior to genetic testing and again if the patient refuses to communicate results, is paramount".

In the Italian Deontological Medical Code, article 33, it is said that "The physician has to provide the patient with the most suitable information about diagnosis, prognosis, different prospects, the various diagnostic-therapeutic choices and the foreseeable consequences of the choices taken".

During genetic counselling, the revelation of misattributed paternity becomes unexpected information when it is not explained before the test that it is sometimes necessary to perform a paternity testing among the family members to discover the molecular basis of the disease.

The ethical-deontological debate centres on whether to inform or not the family about the possible necessity of a paternity test during the counselling and, afterwards, on the counsellor's duty to reveal the results.

THE ITALIAN LAW TAKES SIDES

Analysing legislation concerning medical professionals' behaviour during genetic counselling focusing the activity related to informed consent procedures, it is possible to find some references to the duty to inform the patient in recent Italian Sentences. These sentences have underlined that the information given has to be complete, concerning not only the technical aspects of the medical treatment, but also all its possible consequences in the patient's life.

The Civil Cassation Court Sentence n. 10014/94 establishes that "The patient has to be informed about the nature of the intervention, about the consequences and the meaning of its results and about the possibilities and probabilities related to the same results". The sentence n. 364/97 of the same Court declares that "The duty to inform the patient is extended ... also to the particular foreseeable risks connected with the intervention" and "The duty to inform has to be extended ... to the attainable effects". The Court of Genova (Sentence 10-012006) has pointed out that "Assuming that the omitted information from the physician (...) damages the respect of patients' autonomy also referring to medical information which is not strictly related to the patient's health".

The duty to inform the patient has the purpose to respect and/or promote patient autonomy, which is essential for the expression of a valid consent. This aspect has been underlined in the Sentence of the Civil Cassation Court n. 5444/2006 which states: "In terms of medical-surgical responsibility, the positive outcome of the medical treatment has no importance to determine the presence of the offence for informed consent breach, which exists for the simple reason that the patient has not been able to accept the treatment, because of the lack of information". If we see "the patient" as "the client" involved in the genetic counselling, from a civilian point of view we have these sentences which establish that the counsellor must inform the subjects in detail about the possibility to discover a false paternity during the genetic counselling.

The Italian Personal Data Protection Code (17), which came into effect on 1st April 2007 (with the obligation of adjustment by 1 September 2007) establishes that the health-care professionals who make the genetic data processing must inform the clients concerned about:

--the specific pursued (analytically identified) aims and the procedures of the data processing;

--the subjects the data can be communicated to (the data diffusion is not admitted);

--the possibility for the clients concerned to limit the data communication or the biological specimen transfer;

--the possibility to use the biological specimens for further aims;

--the period of data and specimens conservation;

--the attainable results, with reference to possible, unexpected news too.

The same law recognises the counsellor's duty to help his clients to take the most appropriate decision in autonomy, considering the genetic risk, the family aspiration and clients' ethical and religious principles. The counsellor informs the clients on the individual genetic variability and on family Law and he points out the possible psychological and social consequences of the test.

Concerning the clients' consent, the treatment of the genetic data is allowed only with their consent regarding the following: that it be obtained without any coercion and/or any conditioning, that it may be withdrawn at any time and, in case of genetic test, extended also to the wish to know the results of the tests, including possible unexpected results (the right not to know).

DISCUSSION AND CONCLUSIONS

Within the limits of the bioethical debate, considering what has been suggested by the Oviedo Convention and by the Italian Deontological Medical Code, it seems that the genetic counsellor has the duty to inform both parents about the possibility of disclosing misattributed paternity during the counselling.

This debate in Italy seems to be heading towards a resolution on the basis of some Italian civil sentences and the Italian Personal Data Protection Code which state that once the "clients" have been correctly informed, the counsellor has the duty to reveal to them only what they have previously declared of wanting to know, because the respect of the "clients' autonomy" is fundamental. In this way, both parents have to decide after receiving complete and correct information concerning all the aspects of the counseling they're going to face with, whether or not to have the paternity disclosed to them, so the problem is no longer the counsellor's choice.

From a practical point of view, the first important step to confront in this kind of situation is that the counsellor has to inform in a complete and exhaustive way all the persons involved, that is in this case both the woman and the man, explaining to them that it is possible to discover a false paternity performing genetic counselling. This advice has its sources in what is recommended not only in ethical and deontological documents, but today in Italy it's above all based on the current juridical guidances.

APPENDIX

Luciana Caenazzo, Ph.D., is a researcher and teacher in the Department of Environmental Medicine and Public Health of University of Padua. Her main interest is on Forensic Genetics.

Pamela Tozzo, M.D. is a post graduate trainee in Legal Medicine in the Department of Environmental Medicine and Public Health of University of Padua.

Daniele Rodriguez, M.D. is Professor of Legal Medicine in the Department of Environmental Medicine and Public Health of University of Padua. He has special long standing interest on ethical and deontological issues in informed consent.

Conflict of interest: None declared.

Luciana Caenazzo, Pamela Tozzo and Daniele Rodriguez

Department of Environmental Medicine and Public Health, Legal Medicine Unit, University of Padua, Padova, Italy

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Corresponding author: Luciana Caenazzo, Department of Environmental Medicine and Public Health, Legal Medicine Unit, University of Padua Via Falloppio, 50 35121 Padova, Italy Phone: +390498272234, fax +390498272214, e-mail: luciana.caenazzo@unipd.it
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