1. Helena Pereira de Melo Helena.melo@fd.unl.pt February 2012 1

2. Bioethics: “ethics of life”; term created by Van Rensselear Potter, in 1970. 2

3. VAN RENSSELAER POTTER (1911-2001): 3

4. Van Potter published: 1970 – the article “Bioethics, the Science of Survival” in Perspectives in Biology and Medicine; 1971 – the book Bioethics: Bridge to the Future. 4

5. Bioethics: a new philosophy that sought to integrate biology, ecology, medicine, and human values; “all the medical and natural issues that allow the survival of man in this planet, namely the preservation of an ecosystem that turns the planet inhabitable for human beings”. 5

6. Science: a way of knowledge that is sectorial and reduccionist; “when it studies deeply, and more and more disconnected from the complex and heterogeneous nature, it is potentially dangerous and constitutes a threat to life, in all its forms”. 6

7. This threat can be sustained by: reflecting on the knowledge with have; Bioethics as a new discipline that results from “the linkage of biology with anthropology and culture”. 7

8. Andre Hellgers creates: six months after the publication of Potter’s book; in Georgetown University (Washington d.C); Joseph and Rose Kennedy Institute for the Study of Human Reproduction and Bioethics. 8

9. Bioethics: “the researches, discourses, practices that are generally pluridisciplinar and aim at solving ethical dilemmas caused by the application of the new biomedical technologies” (Gilbert Hottois); the transdisciplinar knowledge that guides humanity when it interferes with birth, death, life quality and the interpendence among living beings (Luís Archer). 9

10. Bioethics’ History: a) the public acknowledgment of the research done, during World War II, by the Nazi physicians; b) the quick progress of biomedicine, posing new ethical dilemmas; c) the insufficiency of the traditional ethical concepts to solve the problems raised by biomedicine. 10

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12. Human experimentations in Buchenwald: a) inmates were used as test subjects for vaccines against epidemic typhus, with 280 of them dying as a result; b) hormones were given in order to cure homosexuality; c) prisoners were shot in order to study the injuries caused by the bullets; d) muscles were taken from women to see how tissue regeneration occurred. 12

13. Auschwitz – Joseph Mengel: a) sterilization experiments were conducted in Jewish women, to determine the effects of the injection of caustic chemicals into the uterus; b) blue ink was injected in children’s eyes to determine if their eyes would turn blue; c) female twins had sex with male twins to see if they had twins. 13

14. The Angel of Death 14

15. 1946 – Nuremberg trials: German physicians said that they had not practised war crimes, but only obeyed to orders; the Nuremberg Code was approved, providing the standards against which the practices of Nazis involved in human experimentation were jugged. 15

16. 16

17. Dr. Klaus Karl Schilling, a physician at the Dachau concentration camp, defends himself in at the Dachau trial. Schilling was charged with infecting over one thousand prisoners with malaria in his experiments at the camp, resulting in hundreds of deaths. He was condemned to death and hanged. 17

18. 1. December 1962: adoption of the Kidney Centre's Admission and Policy, defining the rules for the use of haemodialysis equipment. The decisions of who benefits from their use is taken not only by a physician, but also by citizens. 2. 1966: Beecher publishes in the New England Journal of Medicine an article in which he describes 22 clinical trials done without prior consent, that had been published in scientific magazines. 18

19. 3. December 1967: Christian Bernard performs the first heart transplantation at Groote Schur in Cape City. 4. July 1972: Tuskegee Study is publicised as a trial where natural history of syphilis was observed in 399 afro-American who died without treatment. 5. 1975: Karen Quilan’s parents ask the administration of the hospital where she was being taken care of, to turn off the machines that kept her alive. 19

20. 20

21. In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis. It was called the "Tuskegee Study of Untreated Syphilis in the Negro Male." 21

22. How can we distinguish Bioethics / / Ethics / Deontology? 22

23. 23

24. rules followed by each human being in his personal and social life; guides, according to chosen values (religious, secular, relativist), the human behaviour; refers only to the individual. 24

25. 25

26. Ethical responsibility: not conditioned by any entity external to the person; sanction – the degradation of the ethical being of the individual not external or coactive as the juridical sanction is. 26

27. Deontology: ethical rules that are specific of a profession and are laid down in a code of ethics; rules of practice that guide the physician’s, the nurse’s professional behaviour. 27

28. Hippocrates (460 – 377 a.C.) 28

29. Medical ethics: ethical statements subscribed by the medical profession; standards of conduct which define the essentials of honourable behaviour for the physician and that must be upheld by all physicians. 29

30. The traditional medical ethics: based in the Hippocratic Oath as a summary of moral /medical wisdom; focuses on the relationship physician – individual patient; is not enough to solve Bioethical dilemmas that require concepts from Law, Economics, Philosophy… 30

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32. The complexity of bioethical dilemmas requires the intervention: of professionals that work in different disciplines; of all society and not only of the physicians. 32

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35. The infraction of a deontological rule: does not confer a legal claim to the offended patient, unless there is a legal rule with the same content; the patient can only complain to the medical association of the country where the rule was broken. 35

36. Deontology: lays down standards that are specific to a profession; not sufficient to assure the respect of the rights of the person who was offended by the action of a professional that did not respect medical ethics. 36

37. 37

38. in the intersection among different disciplines – Medicine, Biology, Philosophy, Law; transdisciplinar dialogue – the scientists have to become used to the criteria of social sciences and vice versa. 38

39. Form of dialogue that discusses “key- themes”: vg. – artificial procreation, euthanasia… constitutes a lasting set that is easy to determine; the questions that are raised are different if the person is a physician, a lawyer, a nurse, that look at reality from different points of view. 39

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41. it takes place in different institutions – universities, ethic committees; plural and open – it has the intervention of people that represent the different ways of thinking present in European societies; does not lead to one answer only, and there is no bioethical method to have it. 41

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43. No “bioethical method” exists since Bioethics: is a set of discourses and practices; is open to the plurality of methods as determined by the post- modern paradigm of knowledge. 43

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45. proposes a synthesis between natural and social sciences: appeals to the policompetence of the researcher; is transdisciplinar. 45

46. Bioethics is an example of a transdisciplinar field open to the open dialogue between specialists of different disciplines. 46

47. An open dialogue: there is not a unique moral that is shared by all citizens; there are different bioethical theories and their application leads to different solutions. 47

48. For instance, Beauchamp and Childress: introduced in the book Principles of Biomedical Ethics the approach of balancing conflicting principles in Bioethics; problems can be solved by reference to the principles – beneficence, non malficience, autonomy and justice. 48

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50. What is Justice? 50

51. Questions: Why these principles and not other ones? What do we exactly mean by each of them? How can we order them? How can we solve conflicts among competing principles? 51

52. In the analysis of the “ethical key-themes” of Bioethics: the option for one method is very important and leads to different solutions; we can use at the same time several methods since each of them represents one of the moral views present in our plural society. 52

53. 53

54. Where are the frontiers between Bioethics and Biolaw? 54

55. Jean Bernard (1907 – 2006) 55

56. “ The frontiers between countries are, sometimes, easy to devise: a river or a chain of mountains. Sometimes those frontiers have not yet been explored: a non-explored sea or a desert. The frontiers between Biolaw and Bioethics are of this kind. We do not know were to mark them”. 56

57. a) it is difficult to determine what is and what is not juridical when we study a Bioethics key- question; b) the determination of what is juridical is done according to a certain concept of Law. 57

58. There are several concepts of Law: Positivism is no longer dominant in European Countries; juridical reasoning is in a challenging situation, since there are new problems that must be solved. 58

59. Let us accept that Law: rules external behaviours; is coercive, since if broken there can be a sanction; aims at a virtue - Justice. 59

60. Ethics: philosophical study of morality; rules individual behaviour according to what is morally right; breaking a moral rule leads to no external sanction. 60

61. 61

62. Law is linked to Ethics since: human relations are ruled according to an ethical value – justice; law leads from ethics - a good law is an ethical law rooted in the most important values of each society. 62

63. Biolaw: ethical theories play an important part in this branch of law; legal production is almost always a posteriori, and dependent of progress in Biomedicine. 63

64. 64

65. Bioethics is a “science’s moral” that: tries to halt science - not all that is technically possible is ethically desirable; is an ethics of responsibility towards actual and future generations; is rooted in the conception that everyone has inherent dignity and the right to have it respected. 65

66. Should they be complemented by legal rules? 66

67. Two positions in Europe: Bioethics’ rules are enough to rule this field and the legislator should not adopt legal rules to govern it; Legislator should adopt laws to fulfil spaces that are without law. 67

68. First position: a) human intelligence is part of Nature and science must not stop – law can not shut up a priori certain fields of research; b) the State is not competent to determine who is able to investigate or not. 68

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71. c) scientific progress is so quick that the legislator cannot adopt laws that will be in force for a long period and the law after being approved, may refer to an non- existent reality; d) the recent character and the broadness of this field turn it impossible to adopt a biolaw code and difficult to identify the values that law has to protect. 71

72. 72

73. e) the way problems are solved in Bioethics is different from country to country and the adopted laws are frequently altered; f) many practices in the Biolaw field are rare and belong to fiction, so law should not rule them before they really exist; g) the existent legal rules are sufficient to regulate the bioethical dilemmas. 73

74. 74

75. g) the resolution of ethical dilemmas is done not by applying predefined rules, but by balancing principles; h) the Bioethics’ field is opened to ethical discussion and so the ethical committees should determine the rules to which research obeys; i) while there is no social agreement about how to solve from a legal point of view the dilemmas, the adoption of a law is premature. 75

76. This position proposes a solution: of transferring the production of rules from the legislator to the society; of not legislating - law can be replaced by the consensus obtained in civil society. 76

77. The other position: a) the bioethical dilemmas are real – the legislator has to rule them because what is at stake is the human person; b) many of them are solved and now it is time that they are ruled by the law. 77

78. Louise Brown 78

79. a) it is convenient that the bioethical rules are assured by law since law is coercive; b) if the law is not adopted, unethical practices become “normal” and it will be very difficult to eradicate them in the future; c) what one law determines another law can alter - there is no reason not to legislate on relevant bioethical issues. 79

80. How and when should we adopt legislation on bioethical issues? 80

81. It its impossible to adopt a code: biomedical developments are recent and quick; the issues that are to be ruled are heterogeneous (from birth to death, animal rights…), and it is impossible to have a law that covers them all. 81

82. The legislator shall: a) adopt laws for each issue or group of bioethical issues; b) avoid the problem of adopting too many and unnecessary laws; c) not rule what is still unknown since Law does not aim at it; d) only formulate guidelines that consider the most important principles and the borders that can not be transposed. 82

83. Cesare Beccaria (1738 – 1794) 83

84. The law shall: be clear, precise and determined, since it may affect fundamental rights; contain only general clauses and not clauses that rule all technical questions, since the biomedical progress is fast. 84

85. The legislator shall: a) forbid behaviours that are prejudicial to society; b) seek solutions that are the result of a principles balancing, conditional and transitory, since the biomedical progress is accelerated. 85

86. 86

87. Bioethics: a) defines ethical norms according to the moral principles present in European societies; b) as it refers to society as a whole it differs from individual moral and from deontology; c) its norms can be disobeyed since their are not binding. 87

88. Law: a) is coercive; b) turns the bioethical norms compulsory when the legislator understands that they should be binding and determines which sanction shall be applied if they are not obeyed. 88

89. Biolaw: a) is rooted in the most important values of European societies; b) aims at ensuring the rights of the human being that may be endangered by the misuse of biology and medicine. 89

90. c) lays down principles protecting the dignity of the human being and human rights in regards to the application of Biomedicine; d) harmonizes freedom of research with the protection of fundamental rights; e) solves problems that belong to different branches of law (Constitutional, Civil, Criminal Law). 90

91. 91

92. Health Care Law: a) took the place of Medical Law in the second half of the 20th century, as a separate branch of law; b) corresponds to the fundamental reorientation in perspective caused by the shift in focus from the physician duties to the medical team duties. 92

93. Which are provisions that in European Law safeguard human dignity and the fundamental rights and freedoms of the individual with regards to Biomedical applications? 93

94. 94

95. Human dignity: a) everyone has the right to have their dignity respected; b) influenced by the ancient Judeo- Christianity influence in Europe; c) imposes the primacy of the human being over the interests of science or society. 95

96. 96

97. Charter of the United Nations: adopted on 26 June 1945; the peoples of the United Nations are determined “to reaffirm their faith in fundamental human rights, in the dignity and worth of the human person (…)”. 97

98. Universal Declaration of Human Rights: adopted by the General Assembly of the UN on December 10; “(…) recognition of the inherent dignity of all members of the human family” (preamble); “all human beings are born free and equal in dignity and rights” (art. 1). 98

99. Índia: 99

100. International Covenant on Civil and Political Rights: General Assembly of the UN (16 December 1966); “the recognition of the inherent dignity and of the equal and inalienable rights of the human being” (preamble). 100

101. International Covenant on Economic, Social and Cultural Rights: adopted by the General Assembly of the UN on 16 December 1966; “the recognition of the inherent dignity and of the equal and inalienable rights of the human being” (preamble). 101

102. 102

103. Universal Declaration on the Human Genome and Human Rights: adopted by UNESCO on November 1997; “Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics” (art. 2). 103

104. Down Syndrome 104

105. International Declaration on Human Genetic Data: adopted by the General Conference of UNESCO on October 2003; “the aims of this Declaration are: to ensure the respect of human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data (…)” (art. 1). 105

106. Universal Declaration on Bioethics and Human Rights: adopted by UNESCO on October 2005; “the aims of this Declaration are: to promote respect for human dignity and protect human rights (…)” (art. 2). 106

107. 107

108. Convention on Human Rights and Biomedicine: adopted by the General Assembly on November 1996; “Parties to this Convention shall protect the dignity and identity of all human beings” (art. 1). 108

109. 109

110. Charter of Fundamental Rights of the European Union: proclaimed by the European Parliament, the Council and the Commission on December 2000; “Human dignity is inviolable. It must be protected and respected” (art. 1). 110

111. The right to respect for one’s dignity: the right to be respected as one who belongs to the class of human beings; the right against unwilled interventions by others that are damaging to the circumstances that are essential if one is to flourish as a human. 111

112. 112

113. The recognition of the: absolute value of human dignity; rights based in human dignity. Turns legally unacceptable all acts that can violate it. 113

114. International Law appeals to human dignity as a constraint to some practices: 114

115. Prohibition of financial gain raised by the human body or its parts, as such: art. 21 of the Additional Protocol to the CHRB concerning Transplantation of Organs and Tissues of Human Origin (January 2002); art. 7 of Recommendation Rec.(2006)4 on Research on Biological Materials of Human Origin (March 2006); n.º 23 of the Appendix to Recommendation 1100 (1989) on the use of human embryos and foetuses in scientific research. 115

116. 116

117. The implantation of a human embryo in the uterus of another animal or the reverse: N.º 14 of Recommendation 1046(1986) o the Use of Human Embryos and Foetuses for Diagnostic, Therapeutic, Scientific, Industrial and Commercial Purposes, adopted by the Parliamentary Assembly of Council of Europe on September 1986. 117

118. The fusion of embryos or other operation which might produce chimeras: a) n.º 14 of Recommendation 1046 (1946) of Council of Europe; b) n.º 42 of European Parliament’s Resolution on the Ethical and Legal Problems of Genetic Engineering, adopted on April 1989. 118

119. Interventions seeking to create a human being genetically identical to another human being: a) Additional Protocol to CHRB, on the Prohibition of Cloning Human Beings, adopted on January 1998; b) n.º 14 of Recommendation 1046 (1946) of Council of Europe; c) n.º 41 of European Parliament’s Resolution on the Ethical and Legal Problems of Genetic Engineering; d) art. 3 of ECHR. 119

120. The use of techniques of medically assisted procreation for the purpose of choosing a future child’s sex: except where serious hereditary sex-related disease is to be avoided; it instrumentalises the offspring; art. 14 of CHRB; n.º 14 of Recommendation 1046 (1946) of Council of Europe. 120

121. 121

122. Surrogate motherhood: a) n.º 11 of European Parliament’s Resolution on Artificial Insemination in vivo and in vitro, adopted on April 1989; b) principle 15.º of Council of Europe’s Report on Human Artificial Procreation adopted on 1999. 122

123. Post-mortem artificial procreation: principle 7.º of Council of Europe’s Report on Human Artificial Procreation. 123

124. The transfer of an embryo from the uterus of one woman to the uterus of another: principle 12 of Council of Europe’s Report on Human Artificial Procreation. 124

125. 125

126. The creation of human embryos for research: a) art. 18 of CHRB; b) principle 16 of Council of Europe’s Report on Human Artificial Procreation; c) n.º 21 of the Appendix to Recommendation 1100 (1989) of Council of Europe; d) n.º 14 of Recommendation 1046 (1946) of Council of Europe. 126

127. The creation and use of embryos or foetuses for commercial or industrial purposes: point B) of the Appendix to Rec. 1046 (1946) of Council of Europe; n.º 20 of the Appendix to Recommendation 1100 (1989) of Council of Europe; n.º 41 of European Parliament’s Resolution on the Ethical and Legal Problems of Genetic Engineering; n.º 11 of European Parliament’s Resolution on Artificial Insemination in vivo and in vitro. 127

128. The importance of ensuring the dignity of the human being determines: the principle of the primacy of the human being; “The interests and welfare of the human being shall prevail over the sole interest of society or science” (art. 2 CHRB). 128

129. Right to life, to the integrity of the person integrity, to liberty, to personal identity and to privacy. 129

130. 130

131. Right to life: the most important rights one has – the damage caused by death is the most serious one a person may suffer; natural, universal, invariable, not transmissible, almost absolute right – no one shall be deprived of his life intentionally. 131

132. Recognised by: art. 3 of UDHR; art. 6 of ICCPR; art. 6 of UN’s Convention on the Rights of the Child, of November 1989; art. 2 of European Convention on Human Rights, of November 1950, art. 2 of CFREU. 132

133. What protection is conferred to in vitro human life, to the embryo that results from artificial procreation? 133

134. 134

135. For instance, the European Parliament: Resolution on Artificial Insemination in vivo and in vitro; “aware of the need to protect the human embryo from the moment of fertilisation”; “expresses concern at the ‘waste’ of embryos involved in artificial insemination and calls for the use of techniques that do not produce spare embryos”. 135

136. Council of Europe: Recommendation 1046(1986) on the Use of Human Embryos and Foetuses for Diagnostic, Therapeutic, Scientific, Industrial and Commercial Purposes; “human embryos and foetuses must be treated in all circumstances with the respect due to human dignity”. 136

137. “ 1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2. The creation of human embryos for research purposes is prohibited”. 137

138. The adequate protection of the in vitro embryo determines: 138

139. 1. Artificial insemination should avoid the “waste” of embryos: n.º 5 of European Parliament’s Resolution on Artificial Insemination in vivo and in vitro. 139

140. 2. Embryos should only be frozen when absolutely necessary and if they are to be implanted to produce a pregnancy in the “biological” mother: n.º 8 of European Parliament’s Resolution on Artificial Insemination in vivo and in vitro. 140

141. 3. Embryo donation, when permitted, shall be for free: n.º 10 of European Parliament’s Resolution on Artificial Insemination in vivo and in vitro. 141

142. 4. The embryo must not be subject to arbitrary experimentation: principle 17 of Council of Europe’s Report on Human Artificial Procreation; points A) and B) of the Appendix to Recommendation 1046 (1946) of Council of Europe; n.º 9 of the Appendix to Recommendation 1100 (1989) of Council of Europe; N.º 32 of Resolution on Artificial Insemination in vivo and in vitro. 142

143. These solutions aim at balancing: a) the parents’ whish to have a child by artificial procreation; b) freedom of research; c) the respect due to the dignity of every human being since fertilisation. 143

144. 144

145. Right to the integrity of the person: fundamental right; assures the respect of physical and mental integrity. 145

146. Recognised by: art. 5 of UDHR; art. 7 of ICCPR; art. 19 of Convention on the Rights of the Child; art. 3 of European Convention on Human Rights, of November 1950, art. 3 of CFREU. 146

147. The respect for the person’s integrity determines that, in the fields of medicine and biology, an intervention has to be preceded by the free and informed consent of the person concerned. 147

148. This general rule can be found: art. 5 of CHRB; Recommendation 779 (1976) on the rights of the sick and dying, adopted by the Parliamentary Assembly of Council of Europe on January 1976; Recommendation 934 (1982) on genetic engineering, adopted by the Parliamentary Assembly of the Council of Europe on January 1982; art. 3 of CFREU. 148

149. 149

150. Right to liberty: respected by rules that prescribe free and informed consent prior to interventions in the health field; right to self-determination in the health field – to decide to undergo or not undergo medical treatment. 150

151. It is recognised by: art. 3 of UDHR; art. 9 of ICCPR; art. 5 of European Convention on Human Rights. art. 6 of CFREU. 151

152. It is related with the: right to be informed about her /his health status, and about the diagnosis, prognosis and progress of treatment; right not to be informed about the medical facts about her /his condition; right to choose who should be informed on her / his behalf; 152

153. right of obtaining a second opinion; the right to self-determination; the right to refuse or halt a medical intervention; the right to decide to participate or not in scientific research. 153

154. 154

155. Protects what identifies each individual as a unique person. 155

156. It is related with the: a) right to have a name; b) right to personal history; c) right to be informed or not to be informed about his/her genes. 156

157. 157

158. It relates also to the principle of equality before the law recognised in: art. 7 of UDHR; art. 26 of ICCPR; art. 14 of ECHR. 158

159. The respect of this principle determines: 1. Any form of discrimination against a person on the grounds of her or his genetic characteristics is prohibited (art. 11 of CHRB); 2. Everyone has a right to respect for their dignity and their rights regardless their genetic heritage (art. 2 of UDHGUR). 159

160. 3.Predictive genetic tests: which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease; can only be preformed for health purposes and not, as a general rule, insurance or labour purposes (art. 12 of CHRB). 160

161. 4. Everyone has the right to inherit a genetic heritance which has not been artificially interfered with (n.º 4 of Recommendation 934 (1982) of Council of Europe); 5. Interventions on the human genome that aim at introducing modifications in the genome of any descendents are forbidden (art. 13 of CHRB). 161

162. A man’s castle is his home 162

163. Right to the protection of the law against arbitrary interference with his private and family life. 163

164. It is recognised: a) art. 12 of UDHR; b) art. 17 of ICCPR; c) art. 8 of ECHR; d) art. 7 of CFREU; e) art. 16 of Convention on the Rights of the Child. 164

165. This right includes: respect for family life, home, correspondence, honour and reputation; protection of information about health and genetic data (art. 10 of CHRB and art. 13 of International Declaration on Human Genetic Data adopted by UNESCO in 2003). 165

166. The information about a person’s health: is confidential; can not be disclosed or made accessible to third parties except for an important public interest reason or where the prior consent of the person concerned has been obtained (art. 14 of IDHGD). 166

167. The patient has the right to: a) access to her / his medical files; b) to obtain, rectificate or erasure health personal data that have undergone automatic processing if they are inaccurate or not kept up to date (Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data adopted by Council of Europe in 1981). 167

168. Health professionals have the duty to: a) respect the patient’s privacy when providing him health care; b) safeguard personal health data that are stored in medical files against unauthorised access (n.º 7 of Recommendation 934 (1982) of Council of Europe). 168

169. International Biolaw: a) normative decisions of international organisations (EU’s directives); b) International covenants (ICCPR); c) soft law rules (UDUGHR). 169

170. The fundamental Biolaw principles derive from: Bioethics; the values most shared in European societies – slowly the Bioethics’ rules tend to turn into legal rules. 170

171. Underlying all laws there is: a compromise with a certain ethical theory (deontological, utilitarianism…); an ethical option – law is never ethically neutral. 171

172. In Bioethics and in Biolaw there are rules: a) ethical (like the ones adopted by the International Bioethics Committee of UNESCO); b) deontological (v.g. the ones adopted by the World Medical Association); c) legal (that are binding for the citizens are for the States). 172

173. “ The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law.” 173

174. “ The ethical objections against cloning also rule out any attempt to make genetically identical embryos for clinical use in assisted reproduction (…)”. 174

175. “ The subjects must be volunteers and informed participants in the research project.” 175