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1.  Informed consent for cord blood donation. A theoretical and empirical study 
Blood Transfusion  2011;9(3):292-300.
Background and objectives
Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network.
Material and methods
The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the “NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration”.
Results
Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects.
Conclusion
Italian forms for CB collection, storage and use need standardisation to meet international criteria.
doi:10.2450/2010.0083-10
PMCID: PMC3136597  PMID: 21251456
cord blood; informed consent; biological specimens banks; transplantation
2.  Biobanking research on oncological residual material: a framework between the rights of the individual and the interest of society 
BMC Medical Ethics  2013;14:17.
Background
The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks.
Discussion
Biobank research cannot be conducted without considering arguments for obtaining the donors’ consent: in this paper we discuss to what extent consent in biobank research on oncological residual materials has to be required, and what type of consent would be appropriate in this context, considering the ethical principles of donation, solidarity, protection of the donors’ rights and the requirements of scientific progress. Regarding the relationship between informed consent and tissue collection, storage and research, we have focused on two possible choices related to the treatment of data and samples in the biobank: irreversible and reversible anonymization of the samples, distinguishing between biobank research on residual materials for which obtaining consent is necessary and justified, and biobank research for which it is not. The procedures involve different approaches and possible solutions that we will seek to define. The consent for clinical research reported in the Helsinki Declaration regards research involving human beings and for this reason it is subordinate to specific and detailed information on the research projects.
Summary
An important ethical aspect in regard to the role of Biobanks is encouraging sample donation. For donors, seeing human samples being kept rather than discarded, and seeing them become useful for research highlights the importance of the human body and improves the attitude towards donation. This process might also facilitate the giving of informed consent more willingly, and with greater trust.
doi:10.1186/1472-6939-14-17
PMCID: PMC3616854  PMID: 23547565
Biobanks; Consent; Oncological residual material; Cancer biobanks; Residual materials biobanks; Informed consent; Ethics; Research; Solidarity
3.  Cancer patient perceptions on the ethical and legal issues related to biobanking 
Background
Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.
Methods
We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.
Results
The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.
Conclusions
Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.
doi:10.1186/1755-8794-6-8
PMCID: PMC3599691  PMID: 23497701
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust
4.  Ethical and Legal Issues in Biobanking for Genomic Research in Nigeria 
The pursuit of genomic research and biobanking has raised concerns and discussions about the ethical and legal implications. Given the specific challenges that surround such enterprise in low and middle income countries, it is pertinent to examine them in the light of the advent of Biobanking and Genomic research in Nigeria. In this paper I discuss the issues and suggest model solutions derived from advanced jurisdictions. These ethical and legal issues are discussed within the context of the legal system of a typical African country whose jurisprudence derives from that of its erstwhile colonial master, the United Kingdom. This includes issues relating to law and human rights, informed consent, native and customary law.
PMCID: PMC3863711  PMID: 24353984
Biobanking; Genomic; Research; Nigeria; Law
5.  Beware of the commercialization of human cells and tissues: situation in the European Union 
Cell and Tissue Banking  2012;13(3):487-498.
With this analysis we would like to raise some issues that emerge as a result of recent evolutions in the burgeoning field of human cells, tissues, and cellular and tissue-based product (HCT/P) transplantation, and this in the light of the current EU regulatory framework. This paper is intended as an open letter addressed to the EU policy makers, who will be charged with the review and revision of the current legislation. We propose some urgent corrections or additions to cope with the rapid advances in biomedical science, an extensive commercialization of HCT/Ps, and the growing expectation of the general public regarding the ethical use of altruistically donated cells and tissues. Without a sound wake-up call, the diverging interests of this newly established ‘healthcare’ industry and the wellbeing of humanity will likely lead to totally unacceptable situations, like some of which we are reporting here.
doi:10.1007/s10561-012-9323-3
PMCID: PMC3432198  PMID: 22718427
Human cells and tissues; European Union; Directive; Quality and safety; Advanced therapy medicinal products; Globalization
6.  Attention deficit hyperactivity disorder: legal and ethical aspects 
Archives of Disease in Childhood  2006;91(2):192-194.
Attention deficit–hyperactivity disorder (ADHD) remains a controversial disorder, despite it now being a well validated clinical diagnosis. Ethical and legal issues are important in determining how doctors should behave in offering a diagnosis or treatment that may generate strong and unpredictable reactions from children, their families, or other agencies. A model for routine ethical practice was proposed, based on three sets of assumptions. Firstly, that ethical practice is consistent with the four principles of beneficence, non‐maleficence, justice, and respect for autonomy. Secondly, ethical concerns lead to legal processes, whose task is to ensure ethical practice. Thirdly, that we are working in the interests of our patients. Current relevant literature was organised in terms of this model, and recommendations for practice derived from it. Though there is no general ethical problem regarding either the routine diagnosis or treatment of ADHD, ethical difficulties surround some special cases, especially when doctors are working in conjunction with other agencies or coping with non‐medical frameworks. Particular care needs to be taken with confidentiality and consent, the limits of which are currently confused. The model worked well with everyday ethical problems, though more difficult cases required careful individual scrutiny.
doi:10.1136/adc.2004.064576
PMCID: PMC2082674  PMID: 16428370
ADHD; ethics; hyperactivity; hyperkinesis; law
7.  Advance directives in the UK: legal, ethical, and practical considerations for doctors. 
The British Journal of General Practice  1998;48(430):1263-1266.
In the United Kingdom (UK), advance directives have recently received considerable attention from professional and voluntary organizations as well as medical journals and the media. However, despite such exposure, many doctors remain uncertain of the importance or relevance of advance directives with regard to their own clinical practice. This paper addresses these uncertainties by first explaining what advance directives are and then describing the current legal status of such directives in the UK. Examination of the cases underpinning this status reveals several key elements: competence, information, anticipation, applicability, and freedom from duress. Each is discussed. Although this paper focuses on legal issues, it is important that medical law does not dominate medical ethics. Accordingly, the paper also discusses some important philosophical and sociological considerations that have remained largely unexplored in the medical press. Finally, the paper deals with practical matters, including how the general practitioner might be involved.
PMCID: PMC1410166  PMID: 9692290
8.  Review of the Italian Current Legislation on Research Biobanking Activities on the Eve of the Participation of National Biobanks' Network in the Legal Consortium BBMRI-ERIC 
Biopreservation and Biobanking  2013;11(2):124-128.
The ethical-legal framework of research biobanking activities is still scarcely defined in Italy, and this constitutes a major obstacle to exploit the potential benefits of existing bioresource patrimony at the national and international levels.
Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), which aims to become a major interface between biological samples and data and top-level biological and medical research, is undertaking the crucial transformation to the ERIC (European Research Infrastructure Consortium) legal entity. In this scenario, there is a need to address the national legal and ethical concerns that are strictly correlated with the use of human biosources in research across European countries participating (and not) in BBMRI. In this perspective, this article aims to review the legal framework applying to research biobanking in Italy, including both “soft” nonbinding instruments and binding regulations. Since ethical and societal aspects impact biobanking research activities, the article discusses both the critical ethical and legal open issues that need to be implemented at the national level.
doi:10.1089/bio.2012.0058
PMCID: PMC3696949  PMID: 23840925
9.  Notifying patients exposed to blood products associated with Creutzfeldt-Jakob disease: integrating science, legal duties and ethical mandates 
The issue of notifying people who have been exposed to blood products that have been associated with Creutzfeldt-Jakob disease (CJD) has arisen at a time when the Canadian blood system is under intense scrutiny. As a result, the Canadian Red Cross Society issued a recommendation to health care institutions that recipients of CJD-associated blood products be identified, notified and counselled. Although Canadian jurisprudence in the realm of informed consent may support a policy of individual notification, a review of the scientific evidence and the applicable ethical principles arguably favours a policy of a more general public notification. Indeed, situations such as this require a unique approach to the formation of legal and ethical duties, one that effectively integrates all relevant factors. As such, the authors argue that individual notification is currently not justified. Nevertheless, if a system of general notification is implemented (e.g., through a series of public health announcements), it should provide, for people who wish to know, the opportunity to find out whether they were given CJD-associated products.
PMCID: PMC1228467  PMID: 9371070
10.  Bioethics in popular science: evaluating the media impact of The Immortal Llife of Henrietta Lacks on the biobank debate 
BMC Medical Ethics  2013;14:10.
Background
The global expansion of biobanks has led to a range of bioethical concerns related to consent, privacy, control, ownership, and disclosure. As an opportunity to engage broader audiences on these concerns, bioethicists have welcomed the commercial success of Rebecca Skloot’s 2010 bestselling book The Immortal Life of Henrietta Lacks. To assess the impact of the book on discussion within the media and popular culture more generally, we systematically analyzed the ethics-related themes emphasized in reviews and articles about the book, and in interviews and profiles of Skloot.
Methods
We conducted a content analysis of a population of relevant English-language articles and transcripts (n = 125) produced by news organizations and publications in the U.S., Canada, Great Britain/Ireland, and Australia/New Zealand. We scored each article for the emphasis and appearance of 9 ethics-related themes. These were informed consent, welfare of the vulnerable, compensation, scientific progress, control/access, accountability/oversight, privacy, public education, and advocacy.
Results
The informed consent theme dominated media discussion, with almost 39.2 percent of articles/transcripts featuring the theme as a major focus and 44.8 percent emphasizing the theme as a minor focus. Other prominent themes and frames of reference focused on the welfare of the vulnerable (18.4 percent major emphasis; 36.0 percent minor emphasis), and donor compensation (19.2 percent major; 52.8 percent minor). Ethical themes that comprised a second tier of prominence included those of scientific progress, control/access, and accountability/oversight. The least prominent themes were privacy, public education, and advocacy.
Conclusions
The book has been praised as an opportunity to elevate media discussion of bioethics, but such claims should be re-considered. The relatively narrow focus on informed consent in the media discussion generated by Skloot’s book may limit the ability of ethicists and advocates to elevate attention to donor control, compensation, patenting, privacy, and other ethical issues. Still, ethicists should view the book and a pending major TV film translation as opportunities to highlight through media outreach, consultation exercises and public forums a broader range of bioethical concerns that would otherwise be under-emphasized in news coverage. Such efforts, however, need to be carefully planned and evaluated.
doi:10.1186/1472-6939-14-10
PMCID: PMC3598530  PMID: 23446115
11.  Biobanking in a Constantly Developing Medical World 
The Scientific World Journal  2013;2013:343275.
Biobank is a very sophisticated system that consists of a programmed storage of biological material and corresponding data. Biobanks are created to be used in medical research, in clinical and translational medicine, and in healthcare. In the past 20 years, a large number of biobanks have been set up around the world, to support the modern research directions in medicine such as omix and personalized medicine. More recently, embryonic and adult stem cell banks have been developed. Stem cell banking was reported to be required for medical research as well as clinical transplant applications. The quality of the samples stored in a biobank is very important. The standardization is also important; the biological material stored in a biobank must be processed in a manner that allows compatibility with other biobanks that preserve samples in the same field. In this paper, we review some issues related to biobanks purposes, quality, harmonization, and their financial and ethical aspects.
doi:10.1155/2013/343275
PMCID: PMC3794514  PMID: 24174912
12.  Ethical and legal points of view in parenteral nutrition – Guidelines on Parenteral Nutrition, Chapter 12 
Adequate nutrition is a part of medical treatment and is influenced by ethical and legal considerations. Patients, who cannot be sufficiently fed via the gastrointestinal tract, have the fundamental right to receive PN (parenteral nutrition) even so patients who are unable to give their consent. General objectives in nutrition support are to supply adequate nutrition with regards to the prevention of malnutrition and its consequences (increased morbidity and mortality), and thereby promoting improved outcome and/or quality of life for the patient considering always the patient’s needs and wishes. The requests of the patient to renounce PN should be respected where a signed living will is helpful. During the course of a terminal illness the nutrition has to be adapted individually according to the needs and wishes of a patient in the corresponding phase. Capability of consent should be checked in each individual case and for each measure on an individual basis. Consent should only be accepted if the patient is capable of recognizing the nature, meaning and importance of the intervention as well as the consequences of relinquishment of such an intervention, and is capable to make a self-determined decision. If the patient is not capable of consenting, the patient’s living will is the most important document when determining their assumed will and legally binding. Otherwise a guardian appointed by the patient, or the representative appointed by the court (if the patient has made no provisions) can make the decision.
doi:10.3205/000075
PMCID: PMC2795379  PMID: 20049079
13.  Legal and ethical issues in the international transaction of donor sperm and eggs 
Pertinent ethical and legal issues in the international transaction of donor sperm and eggs are discussed. Firstly, there may be legislative and ethical “contradiction” by the local health authority in permitting import of donor gametes, due to varying policies on donor reimbursement in different countries. This is particularly significant in countries where the underlying principle of gamete donation is altruistic motivation, and where reimbursement is given only for direct “out-of-pocket” expenses i.e. traveling costs. Secondly, there is a lack of clear and coherent internationally-binding legislation and regulatory guidelines overseeing the exchange of donor gametes across international borders. In particular, provisions should be made for donor traceability if gametes are sourced from abroad. Thirdly, in the case of “frozen-egg donation” from abroad, patients must rightfully be informed that current cryopreservation technology is still sub-optimal, and all studies have consistently shown that the chances of conception are always lower with “frozen-eggs” compared to freshly-retrieved eggs. Finally, regulatory safeguards should be put in place to prevent fertility clinics and medical professionals from “re-selling” imported donor gametes at a profit to the patient, since it would be thoroughly unprofessional for them to earn a profit simply through the ‘brokerage’ of donated human material.
doi:10.1007/s10815-007-9107-z
PMCID: PMC3455062  PMID: 17450429
Eggs; Ethics; Export; Gametes; Import; Legal; Sperm
14.  Organ Transplantation: Legal, Ethical and Islamic Perspective in Nigeria 
Organ transplantation dates back to the ancient times and since then it has become one of the important developments in modern medicine; saving the lives, as well as improving the quality of life of many patients. As the demand for organ transplantation far exceeds the organ availability, the transplant program is often saddled with complex legal and ethical issues. This review article highlights the legal and ethical issues that might arise regarding organ transplantation and appraises the existing legal frame work governing organ transplantation in Nigeria. Information on legal, cultural, religious and medical ethical issues regarding organ transplantation in Nigeria was obtained by searching the PubMed and Google Scholar, conference proceedings, seminar paper presentations, law library and other related publications were collated and analyzed. In decision making for organ transplantation, the bioethical principles like autonomy, beneficence and justice must be employed. It was believed by Catholic theologians that to mutilate one living person to benefit another violates the principle of Totality. Among Muslim scholars and researchers, there are those who throw legal support as to its permissibility while the other group sees it as illegal. Organ/tissues transplantation is considered a medical intervention that touches on the fundamental rights of the donor or the recipient. Where there is an unlawful infringement of the right of such persons in any way may be regarded as against Section 34 of the 1999 Nigerian Constitution dealing with right to dignity of the human person. Worldwide, the researchers and government bodies have agreed on informed consent for organ/tissue donation and for recipient should be obtained without coercion before embarking on such medical treatment Worldwide organ transplantation has become the best medical treatment for patients with end stage organ failure. However, there is no law/legislation backing organ/tissues transplantation in Nigeria. The government should take measures to combat transplantation tourism and the problem of national and international trafficking in human tissues and organs, ethics commission and National Transplant registry should be established in order to monitor and regulate the programme in the country.
doi:10.4103/1117-6806.103103
PMCID: PMC3762001  PMID: 24027394
Ethical; Islamic perspective; legal; Nigeria; organ transplantation
15.  Ethical and legal implications of the risks of medical tourism for patients: a qualitative study of Canadian health and safety representatives’ perspectives 
BMJ Open  2013;3(2):e002302.
Objectives
Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism.
Design
We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically.
Participants
Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated.
Results
Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making.
Conclusions
Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose significant public health risks.
doi:10.1136/bmjopen-2012-002302
PMCID: PMC3586128  PMID: 23396563
Qualitative Research
16.  Legal Considerations in End-of-Life Decisionmaking in Louisiana 
The Ochsner Journal  2011;11(4):330-333.
End-of-life directives are among the most difficult decisions that a patient or a patient's family makes because of the many moral, ethical, legal, and practical considerations. This article addresses the basic legal framework in Louisiana for end-of-life directives. Although Louisiana law provides a framework for addressing end-of-life issues, the law does not dictate outcomes or decisions. The law is often the refuge of last resort, providing unsatisfactory results. End-of-life care decisions are generally most productive when they are based on discussions between patients, their families, and their care team regarding the patient's wishes.
PMCID: PMC3241065  PMID: 22190883
Do not resuscitate; end of life; law; Louisiana
17.  Four phases of checks for exclusion of umbilical cord blood donors 
Blood Transfusion  2011;9(3):286-291.
Aim
The aim of this study was to analyse umbilical cord blood (UCB) collection over 1 year between October 2008 and September 2009, seeking ways to improve the number of suitable banked UCB units. Four phases of the process were investigated, from the consent form to the banking procedure, paying attention to the discarded UCB units.
Material and methods
We recruited couples at 35 weeks of gestation and took an accurate history, focusing on genetic, immunological and infectious diseases. We collected UCB from pregnant women who delivered vaginally or by Caesarean section between the 37–41+6 weeks of gestation. Some units were discarded on the basis of the patients' history, obstetric events or biological criteria. In utero collection was the preferred method of collection.
Results
During the study period, between October 2008 and September 2009, there were 1,477 deliveries in our unit. The number of couples interested in UCB donation was 595 (40.2%-595/1,477). We collected 393 UBC units. We excluded 122 patients at the phase of the history taking, counselling and informed consent (first phase check). Of the 393 units collected, 162 (41.3%) were banked whereas 231 (58.7%) were discarded because they did not fulfil biological criteria (third phase check). The volume of UCB units collected after Caesarean section was greater than the volume of units collected after vaginal delivery (95.4 mL versus 85.0 mL, respectively; p <0.01). The UCB units collected after vaginal delivery contained a higher number of total nucleated cells compared to the units collected after Caesarean section (970x106 cells versus 874x106 cells, respectively; p=0.037). None of the banked UCB units was discarded at the clinical check 6 months after delivery (fourth phase check).
Conclusions
Our study shows that strict observance of each of the checks and the collection strategy is important to guarantee the safety of the UCB units and to maximise the cost-benefit ratio. After the appropriate checks we banked UCB units from only 27.2% (162/595) of the couples who gave consent to the procedure and from only 11% (162/1,477) of all the deliveries in the 12 month study period, as 59.8% of couples were not properly informed about UCB donation.
doi:10.2450/2011.0038-10
PMCID: PMC3136596  PMID: 21627927
cord blood; obstetric factors; stem cells
18.  Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial 
BMC Medical Ethics  2012;13:17.
Background
Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
Findings
In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
Conclusion
The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
doi:10.1186/1472-6939-13-17
PMCID: PMC3521203  PMID: 22818109
19.  Definitions of genetic testing in European legal documents 
Journal of Community Genetics  2012;3(2):125-141.
The definition of “genetic testing” is not a simple matter, and the term is often used with different meanings. The purpose of this work was the collection and analysis of European (and other) legislation and policy instruments regarding genetic testing, to scrutinise the definitions of genetic testing therewith contained the following: 60 legal documents were identified and examined—55 national and five international ones. Documents were analysed for the type (context) of testing and the material tested and compared by legal fields (privacy and confidentiality, data protection, biobanks, insurance and labour law, forensic medicine); some instruments are very complex and deal with various legal fields at the same time. There was no standard for the definitions used, and different approaches were identified (from wide general, to some very specific and technically based). Often, legal documents did not contain any definitions, and many did not distinguish between genetic testing and genetic information. Genetic testing was more often defined in non-binding legal documents than in binding ones. Definitions are core elements of legal documents, and their accuracy and harmonisation (particularly within a particular legal field) is critical, not to compromise their enforcement. We believe to have gathered now the evidence for adopting the much needed differentiation between (a) “clinical genetics testing”, (b) “genetics laboratory-based genetic testing” and (c) “genetic information”, as proposed before.
Electronic supplementary material
The online version of this article (doi:10.1007/s12687-012-0077-1) contains supplementary material, which is available to authorized users.
doi:10.1007/s12687-012-0077-1
PMCID: PMC3312943  PMID: 22278813
Legislation; Definition; Genetic test; Genetic information; EuroGentest
20.  Ethical, social, and legal issues surrounding studies of susceptible populations and individuals. 
Environmental Health Perspectives  1997;105(Suppl 4):837-841.
Calls for professional accountability have resulted in the development of ethics guidelines by numerous specialty and subspecialty groups of scientists. Indeed, guidelines among some health professions now address vulnerable and dependent groups: but these are silent on issues related to biomarkers. In parallel, attention has been drawn to human rights concerns associated with attempts to detect hypersusceptible workers, especially in democratic countries. Despite this, concern for vulnerable populations grows as advances in biomarker technology make the identification of genetic predisposition and susceptibility markers of both exposure and outcome more attainable. In this article, the principles derived from the ethical theory of utilitarianism provide the basis for principle-based ethical analysis. In addition, the four principles of biomedical ethics--respect for autonomy, beneficence, nonmaleficence, and social justice--are considered for biomarker studies. The need for a context in which ethical analysis is conducted and from which prevailing social values are shown to drive decisions of an ethical nature is emphasized; these include statutory regulation and law. Because biomarker studies can result in more harm than good, special precautions to inform research participants prior to any involvement in the use of biomarkers are needed. In addition, safeguards to maintain the privacy of data derived from biomarker studies must be developed and implemented prior to the application of these new technologies. Guidelines must be expanded to incorporate ethical, social, and legal considerations surrounding the introduction of new technologies for studying susceptible populations and individuals who may be vulnerable to environmental exposures.
PMCID: PMC1470036  PMID: 9255569
21.  Embryo futures and stem cell research: the management of informed uncertainty 
Sociology of Health & Illness  2012;34(1):114-129.
In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.
doi:10.1111/j.1467-9566.2011.01367.x
PMCID: PMC3378712  PMID: 21812792
embryo donation; futures; human embryonic stem cell research; restricted consent; informed uncertainty
22.  Ethical and legal issues in aesthetic surgery 
Rapid growth and expansion of plastic surgery in general and aesthetic surgery in particular in the past decade has brought in its wake some confusions particularly raising questions for the surgeons conduct towards his colleagues and the patients in the light of ethical requirements. Some thoughts from eminent thinkers form a backdrop to consideration of theories of medical ethics. In this article raging and continuous debates on these subjects have been avoided to maintain the momentum. Apart from the western thoughts, directions from our old scriptures on ethical conduct have been included to accommodate prevelant Indian practices. The confusion created by specialists advertising their abilities directly to the lay public following removal of ethical bars by the American Courts as also latitudes allowed by the General Medical Council of Great Britain have been discussed. The medical fraternity however has its reservations. Unnecessary skirmishes with the law arose in cosmetic surgery from the freedom exercised by the police to file criminal proceedings against attending doctors in the event of a patient's death with or without any evidence of wrong doing. This has now been curtailed in the judgement of the Supreme Court of India[1] where norms have been laid down for such prosecution. This has helped doctors to function without fear of harassment. An effort has been made to state a simple day-to-day routine for an ethical doctor-patient relationship.
doi:10.4103/0970-0358.105973
PMCID: PMC3580358  PMID: 23450235
Aesthetic surgery; legal; medical ethics
23.  Biobanks for Genomics and Genomics for Biobanks 
Biobanks include biological samples and attached databases. Human biobanks occur in research, technological development and medical activities. Population genomics is highly dependent on the availability of large biobanks. Ethical issues must be considered: protecting the rights of those people whose samples or data are in biobanks (information, autonomy, confidentiality, protection of private life), assuring the non-commercial use of human body elements and the optimal use of samples and data. They balance other issues, such as protecting the rights of researchers and companies, allowing long-term use of biobanks while detailed information on future uses is not available. At the level of populations, the traditional form of informed consent is challenged. Other dimensions relate to the rights of a group as such, in addition to individual rights. Conditions of return of results and/or benefit to a population need to be defined. With ‘large-scale biobanking’ a marked trend in genomics, new societal dimensions appear, regarding communication, debate, regulation, societal control and valorization of such large biobanks. Exploring how genomics can help health sector biobanks to become more rationally constituted and exploited is an interesting perspective. For example, evaluating how genomic approaches can help in optimizing haematopoietic stem cell donor registries using new markers and high-throughput techniques to increase immunogenetic variability in such registries is a challenge currently being addressed. Ethical issues in such contexts are important, as not only individual decisions or projects are concerned, but also national policies in the international arena and organization of democratic debate about science, medicine and society.
doi:10.1002/cfg.333
PMCID: PMC2447308  PMID: 18629026
24.  Biobank research and ethics: the problem of informed consent in Polish biobanks 
Introduction
The dynamic development of biobanks causes some ethical, social, and legal problems. The most discussed problems are obtaining informed consent, especially for future research, from minors and from deceased people. The aim of this article is to present the current standards held by Polish biobanks concerning obtaining a participant's informed consent in some aspects.
Material and methods
Survey was carried out by anonymous questionnaire among 59 institutions which deal with the collecting and storage of human cells and tissues in the year 2008. Twenty four filled-in copies of the questionnaires were sent back (return=41%).
Results
Almost every institution (92%) obtains written consent, but a third of the surveyed institutions (29%) do not obtain consent for the future use of the samples. The majority of the respondents (83%) support the idea of using biological materials for research purposes of a donor who died if he did not leave any written objection to such practices and 46% of respondents stated that biobanks should obtain the consent from the already mature donor who gave their samples as a child.
Conclusions
The practice and rules for obtaining informed consent for the scientific research require improvement. The possibility to use the human materials in the future, conditions for getting access to the data, the possibility of their withdrawal from the database and using the materials and data after the death of the donor should be clearly determined when the informed consent to collect the material is obtained.
doi:10.5114/aoms.2011.25568
PMCID: PMC3258806  PMID: 22291838
biobanks; research ethics; informed consent; genetic collection; management
25.  The legal risks of returning results of genomics research 
Published guidelines suggest that research results and incidental findings should be offered to study participants under some circumstances. Although some have argued against the return of results in research, many cite an emerging consensus that there is an ethical obligation to return at least some results; the debate quickly turns to issues of mechanics (e.g., which results? who discloses? for how long does the obligation exist?). Although commentators are careful to distinguish this as an ethical rather than legal obligation, we worry that return of results may unjustifiably become standard of care based on this growing “consensus,” which could quickly lead to a legal (negligence-based) duty to offer and return individualized genetic research results. We caution against this and argue in this essay that the debate to date has failed to give adequate weight to a number of fundamental ethical and policy issues that should undergird policy on return of research results in the first instance, many of which go to the fundamental differences between research and clinical care. We confine our comments to research using data from large biobanks, the topic of the guidelines proposed in this symposium issue.
doi:10.1038/gim.2012.10
PMCID: PMC3779603  PMID: 22323070
biobanking; ethics; genetics; law; policy; return of results

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