Public preferences and the challenge to genetic research policy

Modern genetic research requires scientists to collect, store, and study DNA samples and health information from thousands of people. Longstanding policy allows researchers to use samples and information without a person''s informed consent as long as the person''s identity is protected. Under existing policy, researchers must neither disclose study results to interested research participants nor compensate people who contribute to genetic research. Research and ethics experts developed these policy approaches without input from the people whose contributions are essential to the genetic research enterprise. A growing body of evidence shows that many research participants and would-be participants disagree with the current policy approaches. For ethical and practical reasons, participants should have a greater role in determining how genetic research is conducted.     

Informed consent elements. Final rule

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.     

Reactions to participating in dating violence research: are our questions distressing participants?

In recent years, there has been increased research focus on dating violence, producing important information for reducing these violent relationships. Yet Institutional Review Boards (IRBs) are often hesitant to approve research on dating violence, citing emotional distress of participants as a possible risk of participation. However, no known research has examined the reactions of research participants to questions about dating violence. The current study examined the reactions among college students to completing a self-report measure on dating violence. Results showed that participants reported numerous positive experiences as a result of their research participation, with only mildly increased negative emotional reactions evident for some. Findings are discussed in relation to IRB proposals and appropriate informed consent for research participants.     

The genomic data deficit: On the need to inform research subjects of the informational content of their genomic sequence data in consent for genomic research

Research subject consent plays a significant role in the legitimation of genomic research in Europe – both ethically and legally. One key criterion for any consent to be legitimate is that the research subject is ‘informed’. This criterion implies that the research subject is given all relevant information to allow them to decide whether engaging with a genomic research infrastructure or project would be normatively desirable and whether they wish to accept the risks associated with engagement. This article makes the normative argument that, in order to be truly ‘informed’, the research subject should be provided with information on the informational content of their genomic sequence data. Information should be provided, in the first instance, prior to the initial consent transaction, and should include: information on the fact that genomic sequence data will be collected and processed, information on the types of information which can currently be extracted from sequence data and information on the uncertainties surrounding the types of information which may eventually be extractable from sequence data. Information should also be provided, on an ongoing basis, as relevant and necessary, throughout the research process, and should include: information on novel information which can be extracted from sequence data and information on the novel uses and utility of sequence data. The article argues that current elaborations of ‘informed’ consent fail to adequately address the requirements set out in the normative argument and that this inadequacy constitutes an issue in need of a solution. The article finishes with a set of observations as to the fora best suited to deliver a solution and as to the substantive content of a solution.     

Informed consent utilizing satellite imagery in forestry carbon trading with North Korea

Informed consent can assist in mitigating investment risks associated with forestry carbon trading in North Korea by supporting corporate responsibility. Scientific developments for collecting information necessary to informed consent far outpace the development of inter-Korean regulatory frameworks. This paper seeks to identify how the intersection of legal and technological disciplines can foster informed consent, through the responsible application of satellite data. The permanent record of standard satellite remote-sensing systems demonstrates its capability of presenting area-wide visual evidence of forest conditions. Such data are essential to initiating informed consent, establishing a carbon stock baseline, detecting and quantifying rates of land-cover change, and quantifying above-ground biomass stocks as specified in the Kyoto Protocol. This research could be a valuable reference for utilizing the capabilities of satellites with informed consent obligations in North Korea by suggesting the provision of realistic informed consent mechanisms.     

Ethical and legal issues in suicide research

Moralist, libertarian and relativist ethical positions concerning suicide and its prevention are presented in order to clarify premises upon which ethical issues in suicide research may be resolved. Ethical concerns are differentiated from legal considerations and the implications of the vulnerability of suicidology research participants are discussed. Specific issues that arise in design, choice of participants, interpretation, diffusion of results and evaluative research are treated. These include: experimental methodologies, obtaining informed consent, deception and disclosure, studying innovative and unproven interventions, unknown consequences of participation, rescue criteria, disclosure of information to third parties, research with special populations, risks in publicizing results and measuring the value of human life. When specific legal obligations are lacking, ethical premises concerning the acceptability of suicide and obligations to intervene may influence research protocols.     

Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.     

Research With Cognitively Impaired Participants

Illnesses that cause cognitive impairment are a considerable health problem in the United States. These include Alzheimer's disease, Huntington's chorea, cerebrovascular disease, psychiatric disorders, chronic alcoholism, and AIDS dementia complex. Illness associated with cognitive impairment may cause great suffering to the affected patients and their families. Research involving individuals who may be at risk for or have cognitive impairment is necessary to improve our understanding of these illnesses. For example, this may occur during efforts to develop effective therapies to treat them. However, research with participants who have cognitive impairment presents additional ethical concerns because they may be vulnerable to coercion. Therefore, nurse researchers must not only understand the principles of informed consent (i.e., autonomy, beneficence, nonmaleficence, and justice), but also the additional safeguards provided in the common rule to protect cognitively impaired participants in research. These safeguards include advanced informed consent, legal representative, and assent. Gaps exist in federal regulations related to adhering to these safeguards such as how to assess for decision-making capacity and variations on who can be a legal representative. The nurse researchers have potential roles as educators and advocates in research involving participants with cognitive impairment.     

Research on medical records without informed consent

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.     

Understanding incidental findings in the context of genetics and genomics.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, "incidental" or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power afforded by new genomic analyses may lead to findings of statistical, but not necessarily clinical, significance. This paper addresses the issues to be considered in deciding whether and how to disclose "incidental" findings or other findings of clinical significance that arise in the course of human genomic and genetic research. What research results should be offered, and what should not be offered? For which research should individual results be offered to research participants, when should they be offered, how, and to whom?     

Cervical manipulation--how might informed consent be obtained before treatment?

This article discusses methods and mediums of obtaining informed consent in physiotherapy clinical practice, specifically in relation to cervical manipulation. Whilst cervical manipulation is a useful method of treatment for spinal joint pain and dysfunction, it has also been shown to be ineffective or even positively harmful. Legal precedents have set boundaries for informing patients of such adverse consequences. However, a degree of uncertainty exists in the physiotherapy profession, as in other health care professions, as to how to obtain informed consent in a busy clinical setting in order to discharge the legal duties owed. Obtaining meaningful informed consent in clinical practice raises issues of patient comprehension, memory and decision-making capacity. A large quantity of research directed at enhancing patient understanding has been undertaken in recent years. The important findings are that a variety of communication methods and mediums need to be employed in both providing information and assessing patient understanding. A combination of verbal, written and audiovisual information provides patients with maximum opportunity to be involved in treatment decisions.     

The law of incidental findings in human subjects research: establishing researchers' duties

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.     

The Future of Incidental Findings: Should They be Viewed as Benefits?

This paper argues against considering incidental fndings (IFs) as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated (e.g., results of testing to determine study eligibility), those that can reasonably be characterized in terms of their nature and frequency of generation (e.g., misattributed parentage), and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit.     

The capacities of minors to exercise voluntariness in medical treatment decisions

The legal standard for informed consent to medical treatment requires that the consenter be informed, competent, and acting voluntarily. The voluntary requirement of a valid consent was investigated by comparing forty 9- and 10-year-old children and forty 14- and 15-year-old adolescents (both generally presumed to be incapable of voluntary consent) with 47 young adults ranging in age from 21 to 25 (legally presumed to be deciding voluntarily) on responses to three hypothetical medical decision vignettes. The degree of parental influence was varied within each vignette to study the salience of parental influence in medical decision making. In two of three medical decision vignettes, most participants were deferent to parental wishes and few differences were found between children, adolescents, and young adults in their responses to parental influence. Differences between age groups were found in response to a kidney donation vignette. Children were significantly more likely to defer to parents than either adolescents or young adults. Adolescents were more likely to defer to parents than young adults, although this finding only approximated statistical significance. Implications of these findings for legal authorities, social policy makers, and families are discussed.     

Competence to give informed consent for medical procedures

This study shows that referrals to psychiatry for evaluation for competence to give informed consent generally were made on patients who refused medical treatment. In this sample of referred patients, the only patients found to be incompetent to give informed consent were those with organic brain syndromes. No one with either schizophrenia or depression was found to be incompetent. It is possible that schizophrenic and depressed patients may generally be competent to give informed consent to medical treatment. This finding might be true notwithstanding the fact that many such patients have been found in other studies to be incompetent to consent to voluntary psychiatric treatment. For example, a patient may have delusions that others can read his mind and thoughts, but he still can understand that he needs dialysis for renal failure. Alternatively, it may be relatively rare that an emergency procedure is necessary before a patient's psychosis can be brought under control and consequently internists and surgeons themselves may prefer to wait. The significance of the results is unclear. Because of active interest in the doctrine of informed consent for psychiatric and medical patients by both physicians and attorneys and the few studies within this population, there is a strong need for more study regarding competence to give informed consent. Further study is especially important for psychotic patients for whom psychiatric consultation is not requested.(ABSTRACT TRUNCATED AT 250 WORDS)     

Incidental findings in pediatric research

The approach to incidental research findings in children emerges by considering the child-parent relationship and balancing divergent interests and preferences. Incidental findings with clear and proximate clinical importance should be disclosed to both. We recommend that particularly sensitive or private information (e.g., pregnancy or drug use) should be disclosed to the adolescent first, while particularly serious information (e.g., cancer) should first be disclosed to the parent. These approaches allow the researcher to form an alliance with one party prior to engaging the other. However, unlike clinical settings, where there may be presumptive expectations of confidentiality about sharing information within the family, in most research settings it is reasonable to plan to disclose such information to both parties. It is important to communicate this plan during the informed consent process separately to adolescents to avoid enrolling adolescents when sensitive incidental findings such as pregnancy and drug use may be detected. The approach to incidental findings without clear and proximate benefit is challenging. Researchers should plan more limited disclosure of such incidental findings for pediatric participants than for adult participants.     

Informed consent issues in the cardiac transplantation evaluation

As consultation-liaison psychiatrists to a cardiac transplantation team, we have observed various informed consent issues that are particularly associated with evaluation for cardiac transplantation. We discuss complicating factors that relate to each component of informed consent and present the defense mechanism of denial as a barrier to making the decision to accept or refuse transplantation. Changes in the evaluation protocol could preclude existing impediments to provision of information and patient autonomy; however, certain intrapsychic issues must be recognized as ongoing clinical realities to be addressed as the doctrine of informed consent continues to evolve.     

Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

论患者隐私权保护——兼论侵害“告知后同意”之请求权基础

隐私权已从传统消极防御面向发展到兼具积极支配面向,主要包括四项权能:隐私隐瞒权、隐私利用权、隐私维护权和隐私支配权.《侵权责任法》第62条、第61条、第55条和第56条对应以上四种权能并共同构筑了患者隐私权范畴.患者隐私支配权需要借助于对患者的“告知后同意”实现,告知的内容应当包括医师同时兼具的研究者身份与潜在利益冲突.“告知后同意”虽然可以作为一种法益或者注意义务之违反得到救济,但作为某种权利得到保护系必然趋势,这种权利应是隐私权而非自主权.侵害患者“告知后同意”之隐私权的请求权基础应为第6条第1款,涉及赔偿责任时应适用特别规定第55条第2款,所涉损害主要系精神损害.     

The conduct of socially sensitive research: sex offenders as participants

This article examines some extra-research variables inherent in conducting community-based research with child molesters and other sex offenders. These include such issues as informed consent with court-referred participants, confidentiality when interagency collaboration is necessary, and duty to take proper care. Methods for establishing the scientific credibility of the project, responding to client grievances, dealing with client crises, and protecting staff and the surrounding community also are addressed. Adopting procedures similar to those described here could be an important step in ensuring the viability of other socially sensitive research projects.