Arja Halkoaho, PhD. Development manager University Hospital of Kuopio, Research Ethics Committee,
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1 Arja Halkoaho, PhD Development manager University Hospital of Kuopio, Research Ethics Committee,
2 Constitution of Finland Medical Research Act (488/1999, 294/2004, 794/2010) Act of Medical Use of Human Organs and Tissues (101/2001, 547/2007, 778/2009, 653/2010,277/2013) Personal Data Act (523/1999)
3 Health research is firmly regulated by national legislation and internationals agreements Nuremberg Code Declaration of Helsinki, version Universal Declaration on Bioethics and Human Rights Good Clinical Practice (GCP), mainly in drug trials International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS (Council for International Organization of Medical Sciences)
4 Term for various ways of understanding and examining the moral life. Consist of values, ideals and principles Task is to help people to make choices and evaluate peoples operation as well as study the grounds of actions
5 Regulations and legislations emphasis autonomy of the research participants and free informed consent prior to the initiation of research. Main ethical question is the participant s awareness of possible risks and harm compared impending benefit.
6 Dignity Autonomy Beneficence (benefit) Non-maleficence (harm) Justice Privacy
7 The value of dignity was recognized already in the year 1948 in the United Nations Universal Declaration of Human Rights. Article 1 states: All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood. Constitution of Finland: Everyone has the right to life, personal liberty, integrity and security. The right to privacy, which also includes one s right to freely control oneself and one s body. Medical Research Act: Medical research shall respect the inviolability of human dignity
8 Author/Organisation The Belmont report 1979 Beauchamp & Childress 1989 Rendtorff & Kemp 2000 Nuffield Council on Bioethics 2011 Lev 2011 Vähäkangas 2011 Ethical principles 1.Respect for persons: a) autonomy and b) protection those with diminished autonomy 2.Beneficence 3. Justice 1.The respect of autonomy, 2.Beneficence 3.Nonmalefince 4.Justice 1.Respect of autonomy 2.Dignity 3.Integrity 4.Vulnerability 1.Altruism 2.Autonomy 3.Dignity 4.Justice 5.Maximizing health and welfare 6.Reciprocity 7.Solidarity 1.Solidarity 2.Personal responsibility 3.Equality 4.Autonomy Individual level 1.Beneficence and non-maleficence 2.Justice 3.Autonomy 4.Confidentiality Population/global level 1.Equality 2.Solidarity 3.Benefit sharing 4.Global justice 5.Cultural pluralism 6.Societal Responsibility
9 Patient has the right to benefit not to be harmed autonomy privacy and confidentiality Research and research ethics differ from patient care Research participant is not a patient as a moral status Must understand difference between care and research: Therapeutic misunderstanding
10 To get benefit in own care is also reason for participate in health research (eg. cancer drug trials) Written information do NOT assure true understanding: pay attention to communication Linguistic misunderstanding: education Purpose of the communication Therapeutic misunderstanding: participants, recruiter, researchers (Appelbaum et al 2004, Schron et al. 1997, Daugherty et al. 1995, Sankar 2004, Chou et al. 2012)
11 Main questions are: 1. What are the chosen words? 2. How do you introduce your goals? 3. Are expected study results real results? 4. Do all stakeholders understand difference between patient care and research?
12 Care Research Purpose Individual good Common good: aim is to find new treatments Method of the intervention Care is individual choise Usually by randomizing Realization of the intervention Care, dose of medication, follow-up are individual Treatment is known to be effective Risks and harm are known (mostly) Dose, follow-up, examinations based on study protocol Placebo possibility Benefits and risks are not well known Lemaire 2004; Miller ja Rosenstein
13 Clinical research Conventional care Therapeutic procedures Non-Therapeutic procedures Is conventional care to be realization normal way Are all interventions well-matched Are participants risk balance with possible benefits? Vulnerable groups Are participants risk balance with possible benefits? Effect and harm of the conventional care Weijer ja Miller 2004, rewrite by KeränenTapani Only minor risk is acceptable Research is ethically acceptable
14 Participant s capacity to make personal choices The process of free and informed consent in writing, withdraw possibility Accurate and understandable information Voluntariness, no coerced or unduly influence (eg. Financial)
15 Collaboration of different stakeholders eg. hospital personel INFORMATION TO ALL STAKEHOLDERS Potential participant in clinical settings: 1. Place and time to consider 2. Competence to understand information 3. Realisation of voluntariness 4. Decission, consent or refusal
16 1. Treshold elements: Competence to understand and decide, Voluntariness in deciding 2. Information elemets: Disclosure of material information, recommendation of a plan, understanding of disclosure and recommendation 3. Consent elements: Decision and authorization Beauchamp & Childress: Principles of Biomedical Ethics
17 Halkoaho A Ethical Aspects of Human Tissue research views of the stakeholders
18 Research involving persons not able to consent: people who, owing to a mental health disorder, retardation or other similar reason (Medical Research Act 7 ) Research involving minors (8 ) Research involving pregnant women and nursing mothers (9 ) Research involving prisoners or forensic patients (10 )
19 Moral obligation to maximise potential benefit and minimize potential harm Understanding difference between care and research The balance between risks and benefts
20 Minors and other special groups Chance findings; genetic counselling, patient education, medical care Remember: Interest and well-being of the research subjects shall always be put before any benefits to science or society. But there must be reason to start research justification. Genetic information, right to know or not to know
21 Ethics commitees are tasked to do a riskbenefit assessment of proposed research To verify the scientific validity of the research since unscientific research is unethical research To ensure that the risks that the participants are exposed to, are necessary, justified and minimized How to do risk assessment? Who should do assessment? When it should be done?
22 (Rid & Wendler 2011) 1. Ensure and enhance the study s social value study should have minimum level of social value. Studies without any social value cannot justify exposing participants to risk, now matter how low. how these benefits will be distributed presence of social value does not depend on positive study results (e.g. drug lacking a clinical effect is a good result. Prevents future patients from being exposed to unnesessary risk)
23 2. Identify the research interventions All research interventions should be evaluated individually 3. Evaluate and reduce the risks to participants 4. Evaluate and enhance the potential benefits for participants must be evaluated from the perspective of the average prospective participants, which implies that clinical benefits may not apply to some individuals.
24 Dimensions of the concept are: Physical eg. personal space, clinical settings Psychological eg. right to determinate with whom and under what circumstances people will share thoughts or reveal intimate information Informational, handling and confidentiality of personal information Social eg. ability and effort to control social contacts (see more: Leino-Kilpi et al. 2001, Privacy: a review of the literature, International Journal of Nursing Studies 38, )
25 Importance of informational privacy is increasing Genetic data, effect to others, duty to tell? Personal Data Act Biobank Act Do we know enough how to protect study participants privacy? What are the main concerns and how to explore it?
26 Fairness and equity. This principle has been generally defined in relation to biomedicine but also has particular relevance for research. Who ought to receive the benefits of the research and who should bear its risk and burden Social justice
27 Participant s true understanding Community consent versus individual consent Consent on complex issues e.g. Genetic research Evidence gap, little is known about the validity of the process and the relationship of various informed consent procedures to actual outcomes and participant s experiences of research
28 Ask questions Important issues first, highlight the main issues Use innovative materials e.g. videos, written information with capital letter. Make sure your material is understandable Family members Evaluate room, noise etc. Non-verbal communication
29 The Oxford Textbook of Clinical Research Ethics by Emanuel, Grady, Crouch, Lie, Miller, Wendler
30 Ethical issues in Clinical Research: A Practical Guide by Bernard Lo
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