Human genome and philosophy: what ethical challenge will human genome studies bring to the medical practices in the 21st century?

A human being or person cannot be reduced to a set of human genes, or human genome. Genetic essentialism is wrong, because as a person the entity should have self-conscious and social interaction capacity which is grown in an interpersonal relationship. Genetic determinism is wrong too, the relationship between a gene and a trait is not a linear model of causation, but rather a non-linear one. Human genome is a complexity system and functions in a complexity system of human body and a complexity of systems of natural/social environment. Genetic determinism also caused the issue of how much responsibility an agent should take for her/his action, and how much degrees of freedom will a human being have. Human genome research caused several conceptual issues. Can we call a gene 'good' or 'bad', 'superior' of 'inferior'? Is a boy who is detected to have the gene of Huntington's chorea or Alzheimer disease a patient? What should the term 'eugenics' mean? What do the terms such as 'gene therapy', 'treatment' and 'enhancement' and 'human cloning' mean etc.? The research of human genome and its application caused and will cause ethical issues. Can human genome research and its application be used for eugenics, or only for the treatment and prevention of diseases? Must the principle of informed consent/choice be insisted in human genome research and its application? How to protecting gene privacy and combating the discrimination on the basis of genes? How to promote the quality between persons, harmony between ethnic groups and peace between countries? How to establish a fair, just, equal and equitable relationship between developing and developed countries in regarding to human genome research and its application?     

Public Opinion about the Importance of Privacy in Biobank Research

Concerns about privacy may deter people from participating in genetic research. Recruitment and retention of biobank participants requires understanding the nature and magnitude of these concerns. Potential participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted. Ninety percent of respondents would be concerned about privacy, 56% would be concerned about researchers having their information, and 37% would worry that study data could be used against them. However, 60% would participate in the biobank if asked. Nearly half (48%) would prefer to provide consent once for all research approved by an oversight panel, whereas 42% would prefer to provide consent for each project separately. Although 92% would allow academic researchers to use study data, 80% and 75%, respectively, would grant access to government and industry researchers. Concern about privacy was related to lower willingness to participate only when respondents were told that they would receive $50 for participation and would not receive individual research results back. Among respondents who were told that they would receive $200 or individual research results, privacy concerns were not related to willingness. Survey respondents valued both privacy and participation in biomedical research. Despite pervasive privacy concerns, 60% would participate in a biobank. Assuring research participants that their privacy will be protected to the best of researchers'' abilities may increase participants'' acceptance of consent for broad research uses of biobank data by a wide range of researchers.     

Is Consent Based on Trust Morally Inferior to Consent Based on Information?

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust‐based consent is morally inferior to information‐based consent. We analyse the moral values essential to valid consent – autonomy, voluntariness, non‐manipulation, and non‐exploitation – and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust‐based consent if not morally inferior to information‐based consent.     

Comparing plant and animal extracellular matrix-cytoskeleton connections — are they alike?

Summary Cell adhesion and communication is one of the most fascinating fields of modern biology. How do cells receive information from the environment and from neighboring cells? How does this information elicit morphogenesis, cell division and migration? The recent identification of the surface molecules involved in these events in animal systems is beginning to disclose that a continuum, extracellular matrix-plasma membrane-cytoskeleton, may be a common structure present in all eukaryotic cells. In this article we compare current knowledge on this complex structure in animal systems to the emerging data on plants. We point out the areas that need additional research to fully understand the role of the cell wall-cytoskeleton continuum in plants.Abbreviations ABP actin-binding protein - AGP arabinogalactan proteins - CTK cytoskeleton - ECM extracellular matrix - FN fibronectin - hFN human fibronectin - HRGP hydroxyproline-rich glycoproteins - hVN human vitronectin - PM plasma membrane - SAM substrate adhesion molecule - VN vitronectin Dedicated to Professor Dr. Hartmut K. Lichtenthaler on the occasion of his 60th birthday     

Quality control of human tissues-experience from the Indiana University Cancer Center-Lilly Research Labs human tissue bank

The success of molecular research and its applications in both the clinical and basic research arenas is strongly dependent on the collection, handling, storage, and quality control of fresh human tissue samples. This tissue bank was set up to bank fresh surgically obtained human tissue using a Clinical Annotated Tissue Database (CATD) in order to capture the associated patient clinical data and demographics using a one way patient encryption scheme to protect patient identification. In this study, we determined that high quality of tissue samples is imperative for both genomic and proteomic molecular research. This paper also contains a brief compilation of the literature involved in the patient ethics, patient informed consent, patient de-identification, tissue collection, processing, and storage as well as basic molecular research generated from the tissue bank using good clinical practices. The current applicable rules, regulations, and guidelines for handling human tissues are briefly discussed. More than 6,610 cancer patients have been consented (97% of those that were contacted by the consenter) and 16,800 tissue specimens have been banked from these patients in 9 years. All samples collected in the bank were QC’d by a pathologist. Approximately 1,550 tissue samples have been requested for use in basic, clinical, and/or biomarker cancer research studies. Each tissue aliquot removed from the bank for a research study were evaluated by a second H&E, if the samples passed the QC, they were submitted for genomic and proteomic molecular analysis/study. Approximately 75% of samples evaluated were of high histologic quality and used for research studies. Since 2003, we changed the patient informed consent to allow the tissue bank to gather more patient clinical follow-up information. Ninety two percent of the patients (1,865 patients) signed the new informed consent form and agreed to be re-contacted for follow-up information on their disease state. In addition, eighty five percent of patients (1,584) agreed to be re-contacted to provide a biological fluid sample to be used for biomarker research.     

Research, Informed Consent, and the Limits of Disclosure

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers' personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects' autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers' job and (ii) that subjects should be told of researchers' views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.     

Health migration from Norway to Spain – ambiguous belonging

Abstract

In line with Gustafson (2008), most studies of transnationalism have investigated migration from south to north. This article examines health-, welfare- and lifestyle-related migration from Norway to Spain. The phenomenon is increasing, with consequences for national and municipal policies. The focus is on how Norwegian health migrants cope. Based on anthropological fieldwork and life story interviews we ask: Who are these migrants? How did the migration step come into being? How do they cope when the decision is effectuated? What kind of identity-related challenges do they face? The article also discusses implications for future comparative research on the phenomenon.     

The adequacy of informed consent forms in genetic research in Oman: a pilot study

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman. The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review. Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms. Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms.     

WHAT SHOULD RESEARCH PARTICIPANTS UNDERSTAND TO UNDERSTAND THEY ARE PARTICIPANTS IN RESEARCH?

To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution : those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship : the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact : the extent to which participating in the study will alter what participants do and what happens to them.     

Limiting Factors Impacting on Voluntary First Person Informed Consent in the Philippines

How well can institutional guidelines help ensure the dignity, rights, safety and well being of research participants in an underdeveloped country? In this paper I describe the limits of informed consent as an instrument for the protection of participants in the context of the Philippines. I bring to this paper my experiences as an advocate of rights, a member of an ethics review board, a researcher on the ethics of research and as an observer of the dynamics of clinical practice in an academic public teaching hospital of the University of the Philippines where I am professor.     

The consent problem within DNA biobanks

Large prospective biobanks are being established containing DNA, lifestyle and health information in order to study the relationship between diseases, genes and environment. Informed consent is a central component of research ethics protection. Disclosure of information about the research is an essential element of seeking informed consent. Within biobanks, it is not possible at recruitment to describe in detail the information that will subsequently be collected because people will not know which disease they will develop. It will also be difficult to describe the specific research that will be performed using the biobank, other than to stipulate categories of research or diseases that are not included. Potential subjects can only be given information about the sorts of research that will be performed and by whom. Organisations responsible for biobanks usually argue that this disclosure of information is adequate when seeking informed consent, especially if coupled with a right to withdraw, as it would not be feasible or it would be too expensive to seek consent renewal on a regular basis. However, there are concerns about this 'blanket consent' approach'. Consent waivers have also been proposed in which research subjects entrust their consent with an independent third party to decide whether subsequent research using the biobank is consistent with the original consent provided by the subject.     

Rethinking counselling in prenatal screening: An ethical analysis of informed consent in the context of non-invasive prenatal testing (NIPT)

Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non-invasive prenatal testing (NIPT) in first-trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent compared to informed choice, and for a focus on value-consistent choices and personalized informational preferences. We argue for a three-step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical-technical information and are asked to make a decision about screening; (3) during post-test counselling, women are supported in decision-making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre-test) counselling, where techniques for expanding genome analysis and burdensome test-outcomes challenge counselling of patients.     

Informed consent in clinical research at a general hospital in Mexico: opinions of the investigators

In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,(1) 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work.     

The Role of Regret in Informed Consent

Informed consent to medical procedures tends to be construed in terms of principle-based ethics and one or other form of expected utility theory. These constructions leave problems created by imperfect communication; subjective distress and other emotions; imperfect knowledge and incomplete understanding; complexity, and previous experience or the lack of it. There is evidence that people giving consent to therapy or to research participation act intuitively and assess consequences holistically, being influenced more by the magnitude of outcomes than their probability. People avoid decisions they may regret, but modern regret theory has received little attention in discussions of informed consent. This essay suggests ways in which regret may be acknowledged in the consent process and in the assessment of the information that is an intrinsic part of it.     

Social Standards as Stabilizing Factors of the "Social Mind"

In our everyday lives we constantly encounter phenomena that, through facts of the behavior of particular individuals, cannot be understood merely by a psychological analysis of an isolated human being. We read that "the collective was seized by the enthusiasm of labor," or "the stadium began to hoot indignantly," or "the spectators jumped up from their seats as a man," etc. A psychological analysis of such phenomena immediately raises a number of complex problems. What is the nature of these common psychological manifestations? How do they embrace many people? How do they affect the mind of each discrete individual?     

Tangles of neurogenetics, neuroethics, and culture

Neurogenetics promises rich insights into how the mind works. Researchers investigating the range of topics from normal brain functioning to pathological states are increasingly looking to genetics for clues on human variability and disease etiology. Is it fair to assume this interest in neurogenetics is universal? How should researchers and clinicians approach ideas of consent to research or prediction of disease when a subject or patient understands the mind with concepts or language incompatible with neurogenetics? In this paper we consider how non-Western philosophies bring complexity to ideas of individual and community consent and confidentiality in the context of neurogenetics.     

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.     

Respecting the autonomy of cancer patients when talking with their families: qualitative analysis of semistructured interviews with patients.

OBJECTIVE: To discover cancer patients'' views about disclosure of information to their family, their family''s influence over the information given them, and their preferences for doctors'' behaviour if they and their family disagree, as a complement to applied ethical theory. DESIGN: Semistructured interviews followed by qualitative content analysis. SETTING: Mainly urban British general practice. SUBJECTS: 30 patients in whom cancer, excluding basal and squamous cell skin carcinomas, was diagnosed 1-7 years earlier. RESULTS: All subjects wished doctors to respect their views rather than those of their family, should they differ. With their consent, subjects favoured close family receiving information about their illness, all but one mentioning advantage to their family. Without such consent, six unconditionally favoured disclosure of information to their family while seven unconditionally opposed disclosure. Seventeen participants restricted their approval for such disclosure to specific circumstances. Only two participants approved of their family influencing the information that they received about their illness; all but seven wished to receive full information, the exceptions relating to information about bad prognosis. CONCLUSIONS: Subjects favoured openness with their family but most rejected unconditional disclosure of information without their consent and their family influencing what information they would be given. They valued respect for their autonomy more highly than beneficence and considered that their own needs took priority over those of their family.     

The Principle of Caveat Emptor: Confidentiality and Informed Consent as Endemic Ethical Dilemmas in Focus Group Research

Informed consent and confidentiality supposedly minimize harm for research participants in all qualitative research methodologies, inclusive of one-on-one unstructured interviews and focus groups. This is not the case for the latter. Confidentiality and informed consent uniquely manifest themselves as endemic ethical dilemmas for focus group researchers. The principle of caveat emptor (let the buyer beware) may be a more useful tool for those involved in focus group research: that is, let the researcher, the participants and the ethics committee beware that the only ethical assurance that can be given to focus group participants is that there are few ethical assurances. These ethical dilemmas are not sufficiently realized in the literature, and if they are discussed, they are often dealt with within the focus group moderator’s preamble to the group discussion. This paper encourages the mandatory use of a participant information sheet sufficiently detailed to engender the participant’s active consent. Sufficient here means the participant must be made adequately aware of these endemic ethical dilemmas in advance, to allow them to consent to share responsibility for any ensuing harm. The focus group moderator is not their sole protector.     

Giving addicts their drug of choice: the problem of consent

Researchers working on drug addiction may, for a variety of reasons, want to carry out research which involves giving addicts their drug of choice. In carrying out this research consent needs to be obtained from those addicts recruited to participate in it. Concerns have been raised about whether or not such addicts are able to give this consent. Despite their differences, however, both sides in this debate appear to be agreed that the way to resolve this issue is to determine whether or not addicts have irresistible cravings for drugs – if they do, then they cannot consent to this type of research; if they do not, then they can. This I will argue is a mistake. Determining whether or not addicts can say 'No' to offers of drugs will not help us to make much progress here. Instead we need to look at the various ways in which different types of research may undermine an addict's competence to give consent. What we will find is that the details of the research make a big difference here and that, as such, we need to steer a course between, on the one hand, painting all addicts as being unable to consent to research which involves providing them with drugs, and, on the other, maintaining that there are no problems in obtaining consent from addicts to take part in such research.