The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.
ethics; law; research; tissue
Objective. To define current use patterns of Facebook and Twitter among pharmacy preceptors and assess perceptions regarding use of social media within professional practice.
Methods. An electronic survey instrument was sent to 315 pharmacists registered as advanced pharmacy practice experience (APPE) preceptors for Purdue University College of Pharmacy.
Results. Approximately 60% of the 155 respondents used a Facebook account and 9% used a Twitter account. Respondents were willing to complete continuing education (CE) credit (46%) using social media, and were interested in following professional organizations (39%) on social media; however, the majority were not interested in obtaining drug or disease-state information, identifying employment opportunities, or participating in clinical discussion forums via social media.
Conclusion. Despite the growing popularity of social media across multiple disciplines, the majority of pharmacy preceptors surveyed were not willing to use these venues in professional practice.
social networking; Facebook; Twitter; technology; advanced pharmacy practice experience
Social networking site use is increasingly common among emerging medical professionals, with medical schools even reporting disciplinary student expulsion. Medical professionals who use social networking sites have unique responsibilities since their postings could violate patient privacy. However, it is unknown whether students and residents portray protected health information and under what circumstances or contexts.
The objective of our study was to document and describe online portrayals of potential patient privacy violations in the Facebook profiles of medical students and residents.
A multidisciplinary team performed two cross-sectional analyses at the University of Florida in 2007 and 2009 of all medical students and residents to see who had Facebook profiles. For each identified profile, we manually scanned the entire profile for any textual or photographic representations of protected health information, such as portrayals of people, names, dates, or descriptions of procedures.
Almost half of all eligible students and residents had Facebook profiles (49.8%, or n=1023 out of 2053). There were 12 instances of potential patient violations, in which students and residents posted photographs of care they provided to individuals. No resident or student posted any identifiable patient information or likeness in text form. Each instance occurred in developing countries on apparent medical mission trips. These portrayals increased over time (1 in the 2007 cohort; 11 in 2009; P = .03). Medical students were more likely to have these potential violations on their profiles than residents (11 vs 1, P = .04), and there was no difference by gender. Photographs included trainees interacting with identifiable patients, all children, or performing medical examinations or procedures such as vaccinations of children.
While students and residents in this study are posting photographs that are potentially violations of patient privacy, they only seem to make this lapse in the setting of medical mission trips. Trainees need to learn to equate standards of patient privacy in all medical contexts using both legal and ethical arguments to maintain the highest professional principles. We propose three practical guidelines. First, there should be a legal resource for physicians traveling on medical mission trips such as an online list of local laws, or a telephone legal contact. Second, institutions that organize medical mission trips should plan an ethics seminar prior the departure on any trip since the legal and ethical implications may not be intuitive. Finally, at minimum, traveling physicians should apply the strictest legal precedent to any situation.
Protected health information, medical missions, Internet
To assess pharmacy students' Facebook activity and opinions regarding accountability and e-professionalism and determine effects of an e-professionalism education session on pharmacy students' posting behavior.
A 21-item questionnaire was developed, pilot-tested, revised, and administered to 299 pharmacy students at 3 colleges of pharmacy. Following a presentation regarding potential e-professionalism issues with Facebook, pharmacy students with existing profiles answered an additional question concerning changes in online posting behavior.
Incoming first-year pharmacy students' Facebook usage is consistent with that of the general college student population. Male students are opposed to authority figures' use of Facebook for character and professionalism judgments and are more likely to present information they would not want faculty members, future employers, or patients to see. More than half of the pharmacy students planned to make changes to their online posting behavior as a result of the e-professionalism presentation.
There is high social media usage among pharmacy students and many do not fully comprehend the issues that arise from being overly transparent in online settings. Attitudes toward accountability for information supplied via social networking emphasize the need for e-professionalism training of incoming pharmacy students.
online social networking; e-professionalism; Facebook; technology; professionalism
Emerging genetic information and the availability of genetic testing has the potential to increase understanding of the disease and improve clinical management of some types of epilepsy. However, genetic testing is also likely to raise significant ethical, legal, and social issues for people with epilepsy, their family members, and their health care providers. We review the genetic and social dimensions of epilepsy relevant to understanding the complex questions raised by epilepsy genetics.
We reviewed two literatures: (a) research on the genetics of epilepsy, and (b) social science research on the social experience and social consequences of epilepsy. For each, we note key empiric findings and discuss their implications with regard to the consequences of emerging genetic information about epilepsy. We also briefly review available principles and guidelines from professional and advocacy groups that might help to direct efforts to ascertain and address the ethical, legal, and social dimensions of genetic testing for epilepsy.
Genetic information about epilepsy may pose significant challenges for people with epilepsy and their family members. Although some general resources are available for navigating this complex new terrain, no guidelines specific to epilepsy have yet been developed to assist people with epilepsy, their family members, or their health care providers.
Research is needed on the ethical, legal, and social concerns raised by genetic research on epilepsy and the advent of genetic testing. This research should include the perspectives of people with epilepsy and their family members, as well as those of health care professionals, policymakers, and bioethicists.
Epilepsy; Genetics; Genetic testing; Stigma; Discrimination
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.
Prenatal/preconceptional and newborn screening programs have been a focus of recent policy debates that have included attention to ethical, legal, and social issues (ELSIs). In parallel, there has been an ongoing discussion about whether and how ELSIs may be addressed in health technology assessment (HTA). We conducted a knowledge synthesis study to explore both guidance and current practice regarding the consideration of ELSIs in HTA for prenatal/preconceptional and newborn screening. As the concluding activity for this project, we held a Canadian workshop to discuss the issues with a diverse group of stakeholders. Based on key workshop themes integrated with our study results, we suggest that population-based genetic screening programs may present particular types of ELSIs and that a public health ethics perspective is potentially highly relevant when considering them. We also suggest that approaches to addressing ELSIs in HTA for prenatal/preconceptional and newborn screening may need to be flexible enough to respond to diversity in HTA organizations, cultural values, stakeholder communities, and contextual factors. Finally, we highlight a need for transparency in the way that HTA producers move from evidence to conclusions and the ways in which screening policy decisions are made.
Ethical, legal, and social issues (ELSIs); Genetic screening; Health technology assessment; Neonatal screening; Prenatal screening; Public health ethics
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.
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.
Ethical; Islamic perspective; legal; Nigeria; organ transplantation
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.
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.
Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated.
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.
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.
This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.
bioethics; biological specimen banks; cord-blood stem cell transplantation; ethics; informed consent; legislation
Although immunization is one of the most important health interventions of the 20th century, cases of infectious disease continue to occur. There are parents who refuse immunization for their children, creating a dilemma for the primary care physician who must consider the best interest of the individual child as well as that of the community. Some physicians, when faced with parents who refuse immunization on behalf of their children, choose to dismiss these families from their practice. Given the existing shortage of primary care physicians across Canada, this decision to dismiss families based on vaccine refusal has far-reaching implications. The present article explores this issue in the Canadian context from a legal, ethical and public health perspective.
Ethics; Health law; Patient dismissal; Public health; Vaccination
Objective To consider issues related to research with youth on social networking sites online. Methods Description of the data collection process from 1,588 participants in a randomized controlled trial testing the efficacy of HIV prevention education delivered on Facebook. Using respondent-driven sampling, staff-recruited participants are encouraged to recruit up to three friends to enroll in the study. Results Researchers should (a) consider whether an online social networking site is an appropriate place to implement a research study; (b) offer opportunities to review informed consent documents at multiple times and in multiple locations throughout the study; and (c) collect data outside the social networking site and store it behind secure firewalls to ensure it will not be accessible to any person on the social networking site. Conclusions Online social networks are growing in popularity. Conducting research on social media sites requires deliberate attention to consent, confidentiality, and security.
ethical issues; health behavior; research design and methods
One way to ensure that social and ethical implications (SEI) of nanotechnology research are taken into consideration early in research projects is to incorporate ethical concepts into university science education. In this paper, we describe an interdisciplinary nanotechnology university science course and the ways in which the opinions of students regarding the ethical implications of nanotechnology research were influenced by the course. From an SEI perspective, there is value in scientists being aware of the need to make explicit the uncertainties that always exist in scientific and technological research and development. By the end of the class, a majority of the students felt that risks and ethical issues are not well understood by scientists working in nanomaterials, and ethical training was recommended for these scientists. Findings from this study speak to the importance of this type of interdisciplinary class in preparing students for collaborative research and making them aware of issues important to the general public who someday will become consumers of products derived from nanotechnology research.
Social and Ethical Implications; Multidisciplinary Course; Nanotechnology Curriculum
Data on human genetic variation help scientists to understand human origins, susceptibility to illness and genetic causes of disease. Destructive episodes in the history of genetic research make it crucial to consider the ethical and social implications of research in genomics, especially human genetic variation. The analysis of ethical, legal and social implications should be integrated into genetic research, with the participation of scientists who can anticipate and monitor the full range of possible applications of the research from the earliest stages. The design and implementation of research directs the ways in which its results can be used, and data and technology, rather than ethical considerations or social needs, drive the use of science in unintended ways. Here we examine forensic genetics and argue that all geneticists should anticipate the ethical and social issues associated with nonmedical applications of genetic variation research.
The National Institute of Environmental Health Sciences is supporting a multiyear research initiative examining genetic influences on environmental response. Proponents of this new initiative, known as the Environmental Genome Project, hope that the information learned will improve our understanding of environmentally associated diseases and allow clinicians and public health officials to target disease-prevention strategies to those who are at increased risk. Despite these potential benefits, the project presents several ethical and social challenges. Of immediate concern is the protection of individual research participants. Other ethical issues relate to the application of research results and how study findings could affect social priorities. Clarifying these emerging areas of concern, many of which have not received adequate attention in the existing bioethics literature, is an important step toward minimizing potential research-related risks and defining research needs.
There is substantial evidence that methylphenidate (MPH; Ritalin), is being used by healthy university students for non-medical motives such as the improvement of concentration, alertness, and academic performance. The scope and potential consequences of the non-medical use of MPH upon healthcare and society bring about many points of view.
To gain insight into key ethical and social issues on the non-medical use of MPH, we examined discourses in the print media, bioethics literature, and public health literature.
Our study identified three diverging paradigms with varying perspectives on the nature of performance enhancement. The beneficial effects of MPH on normal cognition were generally portrayed enthusiastically in the print media and bioethics discourses but supported by scant information on associated risks. Overall, we found a variety of perspectives regarding ethical, legal and social issues related to the non-medical use of MPH for performance enhancement and its impact upon social practices and institutions. The exception to this was public health discourse which took a strong stance against the non-medical use of MPH typically viewed as a form of prescription abuse or misuse. Wide-ranging recommendations for prevention of further non-medical use of MPH included legislation and increased public education.
Some positive portrayals of the non-medical use of MPH for performance enhancement in the print media and bioethics discourses could entice further uses. Medicine and society need to prepare for more prevalent non-medical uses of neuropharmaceuticals by fostering better informed public debates.
The global malaria situation, especially in Africa, and the problems frequently encountered in chemical control of vectors such as insecticide resistance, emphasize the urgency of research, development and implementation of new vector control technologies that are applicable at regional and local levels. The successful application of the sterile insect technique (SIT) for the control of the New World screwworm Cochliomyia hominivorax and several species of fruit flies has given impetus to the use of this method for suppression or elimination of malaria vectors in some areas of Africa including Northern State of Sudan. The research and development phase of the Northern State feasibility study has been started. Sudanese stakeholders are working side-by-side with the International Atomic Energy Agency in the activities of this important phase. Several ethical, legal and social issues associated with this approach arose during this phase of the project. They need to be seriously considered and handled with care. In this paper, these issues are described, and the current and proposed activities to overcome potential hurdles to ensure success of the project are listed.
The described interdisciplinary course helped a mixed population of in-service secondary English and biology teacher-participants increase their genetics content knowledge and awareness of Ethical, Legal, and Social Implications (ELSI) that arose from discoveries and practices associated with the Human Genome Project. This was accomplished by applying a critical literacy approach that allows people develop cognitive skills such that they are able to “read the world” (Wink, 2004). The approach is one that permits readers to go beyond the literal text to examine what is present as well as what is missing as it relates to issues of equity and fairness. Becoming critically literate enabled these teacher-participants to challenge the subtle attitudes, values, and beliefs conveyed by a range of written and oral texts. The teacher-participants in this course improved their critical literacy skills by actively reading, critically writing about, and using evidence to support their conclusions about issues arising from advances in human genetics. A biologist, a linguist, and an educator collaboratively designed and taught the course. The personalized focus on the integration of thoughtful reading and writing in this class enhanced the teacher-participants' (n = 16) professional and intellectual development and will potentially improve learning in their biology and English classrooms in the future.
Social media now complements many parts of our lives. Facebook, Twitter, YouTube and many other social networking sites allow users to share and interact with online content and to connect with like-minded people. Its strengths – rapid dissemination and amplification of content and the ability to lead informal conversations – make it a powerful tool to use in a professional context. This commentary explains the overall concept of social media and offers suggestions on usage and possible types of scientific content. It advises researchers on the potential benefits and how to take a strategic approach towards building a social media presence. It also presents examples of effective social media use within the plant science community. Common reasons for scientists to not engage with social media include the fear of appearing unprofessional, posting something wrong or being misunderstood, or a lack of confidence in their computer skills. With the rapid changes in academic publishing, dissemination and science communication, as well as the rise of ‘altmetrics’ to track online engagement with scientific content, digital literacy will become an essential skill in a scientist’s tool kit.
Social media; Social networking; Hashtag; Blogging; Science communication
Electronic health records (EHRs) facilitate several innovations capable of reforming health care. Despite their promise, many currently unanswered legal, ethical, and financial questions threaten the widespread adoption and use of EHRs. Key legal dilemmas that must be addressed in the near-term pertain to the extent of clinicians' responsibilities for reviewing the entire computer-accessible clinical synopsis from multiple clinicians and institutions, the liabilities posed by overriding clinical decision support warnings and alerts, and mechanisms for clinicians to publically report potential EHR safety issues. Ethical dilemmas that need additional discussion relate to opt-out provisions that exclude patients from electronic record storage, sale of deidentified patient data by EHR vendors, adolescent control of access to their data, and use of electronic data repositories to redesign the nation's health care delivery and payment mechanisms on the basis of statistical analyses. Finally, one overwhelming financial question is who should pay for EHR implementation because most users and current owners of these systems will not receive the majority of benefits. The authors recommend that key stakeholders begin discussing these issues in a national forum. These actions can help identify and prioritize solutions to the key legal, ethical, and financial dilemmas discussed, so that widespread, safe, effective, interoperable EHRs can help transform health care.
electronic health records; ethics; medical; confidentiality
The legal requirements and justifications for collecting patient‐identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population‐based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 (DPA1998) and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient‐identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient‐identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient‐identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support.
Since fisal year 1991, the U.S. Human Genome Project has spent $170.6 million in federal funds to help isolate genes associated with Huntington's disease, amyotrophic lateral sclerosis, neurofibromatosis types 1 and 2, myotonic dystrophy, and fragile X syndrome and to localize genes that predispose people to breast cancer, colon cancer, hypertension, diabetes, and Alzheimer's disease. Now comes the hard part. Biology's 21st century megaproject starts to look relatively manageable compared to another challenge facing the enterprise: sorting out ethical, legal, and social issues associated with using this information. "The Human Genome Project," wrote Senior Editor Barbara Jasny in the October 1 Science editorial, stretches "the limits of the technology and the limits of our ability to ethically and rationally apply genetic information to our lives."
Review of the legal and ethical basis for reproductive endocrinologists to refuse ovulation induction to patients with diminished ovarian reserve.
The Lexis-Nexis search engine was used to perform a legal review pertaining to refusal of treatment. Ethical opinions of medical organizations were also reviewed.
Federal antidiscrimination laws provide legal recourse for patients with diminished ovarian reserve who are denied ovulation induction. However, the same laws also permit refusal of care when there is bona fide medical justification to decline services. In addition, the codes of ethics for relevant professional organizations support physicians’ decisions to refuse treatment when treatment is futile.
Although it is ethically and legally permissible to deny ovulation induction to patients with diminished ovarian reserve when medically justified, refusal may invite retaliatory litigation. Counseling remains a cornerstone in directing these patients to options with more potential for success, such as donor eggs and adoption.
Ethics; Diminished ovarian reserve; Ovulation induction; Discrimination; Liability
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.
Eggs; Ethics; Export; Gametes; Import; Legal; Sperm