Identifying Data

2020/21

Subject (*)

Ethical and Legal Research in Health Sciences

Code

653862203

Study programme

Mestrado Universitario en Asistencia e Investigación Sanitaria (plan 2012)

Descriptors

Cycle

Period

Year

Type

Credits

Official Master's Degree

1st four-month period

First

Optional

Language

Spanish

Teaching method

Face-to-face

Prerequisites

Department

Dereito Privado
Dereito Público

Coordinador

Pereira Saez, Maria Carolina

E-mail

c.pereira.saez@udc.es

Lecturers

Pereira Saez, Maria Carolina

E-mail

c.pereira.saez@udc.es

Web

http://www.udc.es/fcs/ga/index.htm

General description

Coñecemento das principais pautas éticas e xurídicas da investigación en ciencias da saúde con seres humáns, animais e organismos modificados xenéticamente.

Contingency plan

1. Modificacións nos contidos: non hai. 2. Metodoloxías *Metodoloxías docentes que se manteñen: todas *Metodoloxías docentes que se modifican: a sesión maxistral impartirase a tavés de Teams en horario oficial. A proba de resposta múltiple farase a través de MOODLE en horario oficial. 3. Mecanismos de atención personalizada ao alumnado: correo electrónico, MOODLE e Teams (a demanda, previa solicitude por correo electrónico), en horario oficial de titorías. 4. Modificacións na avaliación: non hai. *Observacións de avaliación: o exame tipo test farase a través de MOODLE. 5. Modificacións da bibliografía ou webgrafía: non hai.

Study programme competencies

Code	Study programme competences
A3	Adquirir un sentido ético da investigación sanitaria.
B3	Compromiso pola calidade do desenvolvemento da actividade investigadora.
B4	Capacidade de análise e de síntese.
B6	Capacidade para traballar de forma colaborativa en equipos multi e interdisciplinar.
B7	Capacidade de establecer unha relación de empatía cos suxeitos implicados no desenvolvemento da actividade investigadora.
C1	Expresarse correctamente, tanto de forma oral coma escrita, nas linguas oficiais da comunidade autónoma.
C4	Desenvolverse para o exercicio dunha cidadanía aberta, culta, crítica, comprometida, democrática e solidaria, capaz de analizar a realidade, diagnosticar problemas, formular e implantar solucións baseadas no coñecemento e orientadas ao ben común.
C6	Valorar criticamente o coñecemento, a tecnoloxía e a información dispoñible para resolver os problemas cos que deben enfrontarse.
C8	Valorar a importancia que ten a investigación, a innovación e o desenvolvemento tecnolóxico no avance socioeconómico e cultural da sociedade.

Learning aims

Learning outcomes	Study programme competences
Understanding the meaning of ethical and legal dimension of research in health sciences	AR3	BC3 BC4 BC6 BC7	CC1 CC4 CC6 CC8
Grasping the basic ethical concepts and principles of research in health sciences	AR3	BC3 BC4 BC6 BC7	CC1 CC4 CC6 CC8
Grasping the basic legal concepts and norms of research in health sciences	AR3	BC3 BC4 BC6 BC7	CC1 CC4 CC6 CC8
Adding the ethical and legal dimension to research practice in health sciences	AR3	BC3 BC4 BC6 BC7	CC1 CC4 CC6 CC8
Familiarizarse co manexo dos conceptos, normas e principios éticos e xurídicos na investigación en ciencias da saúde	AR3	BC3 BC4 BC6 BC7	CC1 CC4 CC6 CC8
Achieving the abilities to identify and assess the ethical and legal problems of research in health sciencies	AR3	BC3 BC4	CC4 CC6

Contents

Topic	Sub-topic
Lesson 1. Ethics and Law	1. Why do we need norms? Types of norms and normative systems 2. Why do we need Law? 3. Why do we need virtues? Three models of normative ethics 4. Bioethics and the ethics of research
Lesson 2. Responsible research	1. Research as a practice 2. Facts and values. Is everything technically possible also ethically admissible? 3. The research imperative. Is there a (moral) duty to research? Is there an obligation to participate in research? 4. The freedom of research. Freedom of research as a basic right 5. Research misconduct
Lesson 3. Research on human beings and with human origin materials	1. What is biomedical research? Basic concepts and types of research with human beings and human origin materials 2. History of the ethics of biomedical research 3. Ethical requirements fo biomedical research 4. Legal regulation of biomedical research 5. Controversial issues. Research involving vulnerable subjects. Human embryo research. Genetic research. Posthuman research. Neuroscience
Lesson 4. Animal research	1. The case for animal research 2. Ethical positions concerning research with animals 3. Is licit the research involving animals? Ethical arguments. Scientific arguments 4. Legal regulation of animal research
Lesson 5. Research with biological agents and genetically modified organisms	1. Research, environment, and responsability 2. Biosecurity and laboratory good practices 3. Biotechnology and moral restraints. The precautionary principle 4. Legal regulation of research with biological agents (BA) and genetically modified organisms (GMO)

Planning

Methodologies / tests	Competencies	Ordinary class hours	Student’s personal work hours	Total hours
Case study	A3 B3 B4 B6 B7 C1 C4 C6 C8	5	5	10
Guest lecture / keynote speech	A3 B3 B4 C6 C8	11	33	44
Multiple-choice questions	B4	1	4	5
Document analysis	A3 B3 B4 B6 C6 C8	4	10	14

Personalized attention		2	0	2

(*)The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies

Methodologies	Description
Case study	The knowledge of historical evolution and of the ethical and legal requirements of research in health sciences is supplemented by means of the analysis of classical and contemporary cases. The main learning aim of case study is to achieve argumentation, deliberation and decision-making abilities. Case study includes other methodologies: analysis of bibliographical and normative sources, as well as research papers.
Guest lecture / keynote speech	Lectures ease the understanding of the special features, language, and concepts of ethics and law in research, specifying the meaning of bibliographical and normative sources and stressing the main topics fo the subject
Multiple-choice questions	Examen tipo test para a avaliación dos conocimientos.
Document analysis	Ethical and legal answers to research in health sciencies are usually stated in normative documents and legal norms. These documents provide both a historical and a systematic explanation of the ethical and legal perspectives of research in health sciences.

Personalized attention

Methodologies

Document analysis

Case study

Description

Guidance for searching, managing, understanding, and assessing of teaching materials.
Guidance for deliberating in concrete cases, implementing the basic ethical and legal concepts and norms.

Assessment

Methodologies	Competencies	Description	Qualification
Case study	A3 B3 B4 B6 B7 C1 C4 C6 C8	Assessment of participation and argumentation abilites. Assessment of understanding and implementation of ethical and legal language and concepts. Analysis of bibliographical and normative (ethical and legal) sources is included.	50
Multiple-choice questions	B4	Examen tipo test para a avaliación dos coñecemento.	50

Assessment comments
The multiple-choice questions is in person.

Sources of information

Basic	Javier Sánchez-Caro, Fernando Abellán (cords.) (2006). Ensayos clínicos en España. Aspectos científicos, bioéticos y jurídicos. Granada: Comares Ezequiel J. Emanuel et al. (ed.) (2003). Ethical and regulatory aspects of clinical research. Baltimore and London: Johns Hopkins University Press Robert J. Levine (1986). Ethics and regulation of clinical research (second edition). New Haven: Yale University Press Javier Sánchez-Caro, Fernando Abellán (cords.) (2007). Investigación biomédica en España: aspectos bioéticos, jurídicos y científicos. Granada: Comares Adil E. Shamoo, David B. Resnik (2009). Responsible conduct of research (second edition). New York: Oxford University Press Baruch A. Brody (1998). The ethics of biomedical research. An international perspective. New York: Oxford University Press Ezequiel J. Emanuel et al. (ed.) (2011). The Oxford Textbook of clinical research ethics. New York: Oxford University Press Ezequiel J. Emanuel, David Wendler, Christine Grady (2000). What makes clinical research ethical?. JAMA 283/20 (2000), 2701-2711 Daniel Callahan (2003). What price better health. Hazards of research imperative. Berkeley: University of California Press, New York: The Milbank Memorial Fund
	Ethical documents The Nuremberg Code (1947). Declaration of Helsinki (World Health Association, Ethical Principles forMedical Research Involving Human Subjects 1964; 7th revisión, Seoul 2008). The Belmont Report (TheNational Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principlesand Guidelines for the Protection of Human Subjects of Research (1979) Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization(WHO), International Ethical Guidelines for Biomedical Research Involving Humanubjects (2002). UNESCO, Universal Declaration on bioethics and human rights (2005). Legal norms General legal norms Spanish Constitution (1978) (BOE nº 311, 29.12.1978). Basic Law 41/2002, of 14 November, regulating patient’s autonomy and rights and obligations regarding clinical information and documentation (BOE nº 274,15.11.2002). Organic Law 5/2018, of 5 December, on personal data protection. Convention for the protection of human rights and dignity of the human being with regard to the application of Biology and Medicine (Convention on human rights and b iomedicine). (BOE nº 251, 20.10.1999.Rectification BOE n.º 270, 11.11.1999). Council of Europe, Additional Protocol to the Convention on human rights and biomedicine concerning biomedical research (Strasbourg, 25.1.2005). Research with human beings Law 14/2007, of 3 July, on biomedical research (BOE nº 159, 4.7.2007) Law 14/2006, of 26 May, on assisted human reproduction techniques (BOE nº 126, 27.5.2006) Royal Decree 223/2004, of 6 February, regulating clinical trials with drugs (BOE nº 33, 7.2.2004) Law 29/2006, of 26 July, of guarantees and rational use of drugs and health products (BOE nº 178, 27.7.2006) Royal Decree 1716/2011, of 18 November, establishing the basic requirements on biobanks with biomedical research purposes... (BOE nº 290, 2.12.2011) Animal research Law 8/2003, of 24 April, of animal health Royal Decree 1201/2005, of 10 October, on protection of animals used for experimentation and other scientific purposes (BOE nº 252, 21.10.2005) Law 32/2007, of 7 November, for the care of animals regarding their exploitation, transportation, experimentation, and sacrifice (BOE nº 268, 8.11.2007). Directive 2010/63/EU of the European Parliament and of the Council, of 2 September 2010, on the protection of animals used for scientific purposes (OJEU L276, 20.10.2010) Research with biological agents and genetically modified organisms Law 9/2003, of 25 April, establishing the legal conditions for confined use, intentional release, and commercialization of genetically modified organisms (BOE nº 100, 26.4.2003) Royal Decree 178/2004, of 30 January, passing the general Regulation developing and executing the Law 9/2003, of 25 April, establishing the legal conditions for confined use, intentional release, and commercialization of genetically modified organisms (BOE nº 37, 31.1.2004. Correction: BOE nº 42, 18.2.2004) Royal Decree 1369/2000, of 19 July, modifying the Royal Decree 822/1993, of 28 May, establishing the principles of laboratory good practices and their implementation in non-clinical studies on chemical substances and products (BOE nº 173, 20.6.2000) Royal Decree 1697/2003, of 12 December, creating the National Commission on Biovigilance (BOE n.º 310, 27.12.2003)
Complementary	Carlos M. Romeo Casabona (2011). Enciclopedia de Bioderecho y Bioética. Granada: Comares; Deusto: Cátedra Interuniversitaria Fundación BBVA-Diputación Foral de Bizkaia de D Stephen G. Post (ed.) (2004). Encyclopedia of bioethics (3rd edition. New York: Macmillan Reference

Recommendations

Subjects that it is recommended to have taken before

Subjects that are recommended to be taken simultaneously

Subjects that continue the syllabus

Other comments

Programa Green Campus FCS

Para axudar a conseguir un entorno inmediato sustentable e cumprir cos obxectivos estratéxicos 1 e 2 do "III Plan de Acción do Programa Green Campus FCS (2018-2020)", os traballos documentais que se realicen nesta materia:

a. Solicitaranse maioritariamente en formato virtual e soporte informático. 

b. De realizarse en papel: 

- Non se empregarán plásticos. 

- Realizaranse impresións a dobre cara. 

- Empregarase papel reciclado. 

- Evitarase a realización de borradores.

PLAxio

A detección de fraude, copia ou plaxio na redacción do traballo da materia implicará un suspenso na oportunidade de avaliación afectada (0,0) e a remisión directa á oportunidade seguinte.

Dita circunstancia comunicarase á Comisión Académica e ao resto de profesores do título. En caso de que se reitere a irregularidade nunha 2ª avaliación, a Comisión poderá solicitar ao Reitor a expulsión temporal ou definitiva do/a estudante do título cursado.

(*)The teaching guide is the document in which the URV publishes the information about all its courses. It is a public document and cannot be modified. Only in exceptional cases can it be revised by the competent agent or duly revised so that it is in line with current legislation.