Current methods of obtaining an informed consent leave much to be desired. Patients rarely read consent forms or understand all of the risks, benefits, or alternatives associated with their treatment. Evaluating the advantages and disadvantages of treatment options often presents a more significant challenge for patients with lower levels of health literacy. This article reviews the evidence of shortcomings in our informed consent system and then explores the potential for a new approach to engage patients at all levels (...) of health literacy in their treatment decisions. Specifically, the article will examine the potential of shared decision-making to bridge gaps in knowledge, increase patient adherence to treatment, and improve health outcomes in low health literacy patient populations. Leveling barriers to treatment information for disadvantaged populations should be a public health imperative, especially if it can be shown to improve health outcomes and reduce health disparities. (shrink)

Current methods of obtaining an informed consent leave much to be desired. Patients rarely read consent forms or understand all of the risks, benefits, or alternatives associated with their treatment. Evaluating the advantages and disadvantages of treatment options often presents a more significant challenge for patients with lower levels of health literacy. This article reviews the evidence of shortcomings in our informed consent system and then explores the potential for a new approach to engage patients at all levels (...) of health literacy in their treatment decisions. Specifically, the article will examine the potential of shared decision-making to bridge gaps in knowledge, increase patient adherence to treatment, and improve health outcomes in low health literacy patient populations. Leveling barriers to treatment information for disadvantaged populations should be a public health imperative, especially if it can be shown to improve health outcomes and reduce health disparities. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

ObjectiveInformed consent is a prerequisite for caesarean section, the commonest surgical procedure in low- and middle-income settings, but not always acquired to an appropriate extent. Exploring perceptions of health care workers may aid in improving clinical practice around informed consent. We aim to explore health workers’ beliefs and experiences related to principles and practice of informed consent.MethodsQualitative study conducted between January and June 2018 in a rural 150-bed mission hospital in Southern Malawi. Clinical observations, semi-structured interviews and a (...) focus group discussion were used to collect data. Participants were 22 clinical officers, nurse-midwives and midwifery students involved in maternity care. Data were analysed to identify themes and construct an analytical framework.ResultsDefinition and purpose of informed consent revolved around providing information, respecting women’s autonomy and achieving legal protection. Due to fear of blame and litigation, health workers preferred written consent. Written consent requires active participation by the consenting individual and was perceived to transfer liability to that person. A woman’s refusal to provide written informed consent may pose a dilemma for the health worker between doing good and respecting autonomy. To prevent such refusal, health workers said to only partially disclose surgical risks in order to minimize women's anxiety. Commonly perceived barriers to obtain a fully informed consent were labour pains, language barriers, women’s lack of education and their dependency on others to make decisions.ConclusionsHealth workers are familiar with the principles around informed consent and aware of its advantages, but fear of blame and litigation, partial disclosure of risks and barriers to communication hamper the process of obtaining informed consent. Findings can be used to develop interventions to improve the informed consent process. (shrink)

There are some paradoxes in the way doctors and patients make medical decisions today. Today's patients are more empowered than were patients in the past. They have the right to see their medical records. The law requires doctors to obtain their informed consent for treatment. Patients are told about the options for treatment and the risks and benefits of each option. Their values and preferences are elucidated in order to guide the treatments that are provided.

This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of IVF treatment, (...) and the tendency for patients to overestimate their chances of success prior to the experience of treatment. Once in active treatment, however, patients identify their oöcytes as both precious and precarious. We argue that it is necessary to formally include embodied experience as a source of knowledge in informed consent procedures, both for gratuitous donation and for egg-sharing regimes. We recommend that at least one full cycle of IVF be completed before approaching women to divert eggs away from their own fertility treatment. (shrink)

The ethical standard for informed consent is fostered within a shared decision-making process. SDM has become a recognized and needed approach in health care decision-making. Based on an ethical foundation, the approach fosters the active engagement of patients, where the clinician presents evidence-based treatment information and options and openly elicits the patient’s values and preferences. The SDM process is affected by the context in which the information exchange occurs. Rural settings are one context (...) that impacts the delivery of health care and SDM. Rural health care is significantly influenced by economic, geographical and social characteristics. Several specific distinctive features influence rural health care decision-making—poverty, access to health care, isolation, over-lapping relationships, and a shared culture. The rural context creates challenges as well as fosters opportunities for the application of SDM as a natural dynamic within the rural provider–patient relationship. To fulfill the ethical requirements of informed consent through SDM, it is necessary to understand its inherent challenges and opportunities. Therefore, rural clinicians and ethicists need to be cognizant of the impact of the rural setting on SDM and use the insights as an opportunity to achieve SDM. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Living Organ Donors’ Stories: (Unmet) Expectations about Informed Consent, Outcomes, and CareElisa J. Gordon, Symposium EditorKeywordsEthics, informed consent, kidney, liver, living donor, narrative, transplantationLiving donor organ transplantation has become standard treatment for patients with end-stage kidney or end-stage liver disease. Live donors comprised approximately 5,769 (34%) and 247 (4%) of all kidney and liver transplants in 2011, respectively (OPTN/UNOS). The reasons why people donate, the perception that (...) donating does not entail a decision per se, and the attendant fears and anxieties living donors feel about donating, have all been previously well investigated (Lennerling, Forsberg, Meyer, & Nyberg, 2004; Papachristou, Walter, Frommer, & Klapp, 2010). But much less is known about how donors experienced the overall donation process including the donor evaluation, preparation, appreciation of risks, decision-making, informed consent, post-operative, recovery processes, and the impact of donating on all aspects of their life, from their point of view. Thus, a narrative approach is essential for gaining insights into these less well known phenomena.There is good reason to remain concerned about the safety and ethical basis of living donation considering that living donors undergo serious health risks for no direct medical benefit to themselves (Ethics Committee of the Transplantation Society, 2004; Laird, 2012; Neergaard, 2011; Ratner & Sandoval, 2010; Shelton, 2011). The situation raises serious ethical questions specifically about nonmaleficence and informed consent, and more broadly about using people as a means to an end. The absence of long-term information may not undermine a willing donor’s commitment to save a loved one’s life, but is certainly cause for concern among transplant clinicians who want to be sure to disclose information that may be material for donors in order to provide adequate informed consent. In other words, the disjuncture between what transplant clinicians find important to disclose to donors and what prospective donors need to know—which follows along the lines of what Elliot Mishler referred to as the ‘voice of medicine’ versus the ‘voice of the lifeworld’(1984)—seems to complicate donors’ preparation for donation. Donors’ stories are important for addressing these concerns by identifying risks that typically do not get reported in the scientific literature—perhaps owing to a different [End Page 1] conceptualization of what should be construed as noteworthy risks—as well as by demonstrating how personal situations can enhance or detract from the experience overall.This issue of Narrative Inquiry in Bioethics (NIB) affords a unique entrée into both the often heard and unheard stories of living organ donors. A set of topical areas were presented for the authors’ consideration that relate to the donation process in general and the informed consent process more specifically: whether donors were prepared to donate; comprehended what they were told; could have understood the process better, as well as, the impact of donation on health, employment, finances, and personal relationships (Table 1). When soliciting donors’ stories, every effort was made to include a full range of experiences—both good and bad—from a variety of donors: kidney donation, liver donation, adult-to-adult and adult-to-child donation, related, unrelated, directed and anonymous (also known as ‘altruistic’ or ‘good Samaritan’ donors), paired chain exchange, and list exchange (Table 2)—in order to present a balanced perspective on live donation. Additionally, this issue includes a full breadth of stories about the donor experience, ranging from positive to mixed to negative (Table 3). While donors were given tremendous leeway in what stories they told, they were asked to focus their narratives on the lesser known dimensions of donation—the experience of it. While additional stories from liver donors would have helped to underscore common concerns among liver donors, we only received a few. Some of the donors are themselves health care professionals, active in the United Network for Organ Sharing (UNOS) or their local OPO, or have leveraged their experiences to help others by becoming a donor buddy or donor advocate. Given that we received more stories than Click for larger view View full resolutionTable 1.Topical areas to address[End Page 2] Click for larger view View full resolutionTable 2.Forms of Living Donation Click for larger view View... (shrink)

Informed consent forms have been useful in clinical practice and they constitute a part of the shared decision making in the informed consent process. They provide information to patients about clinical procedures and techniques. They also act as a remainder of the information discussed after the medical interview. Sometimes these documents are not readable to everybody. Belgian law specifies that all information that patients receive has to be proportionate verbally, but written information is also handled. (...) The present research analyzes the readability of the Flemish informed consent forms located in the webs of all General Hospitals using a simple random sample of 75 informed consent forms. By using the Douma tool, which bases its analysis in the length of words and sentences, the readability mean of the sample was 46, level “Difficult”. The 59% of them had a difficult level. The 11% were normal. It is a fact, then, that the 59% of the informed consent forms evaluated in this study are not suitable for everybody in Flanders, especially those people with low literacy. There were some researches made in other countries that agreed with these results. Written clinical information was poorly written so the informed consent forms were not working helping patients to recall information nor helping patients to become a part in the shared decision making about their health. The use of readability formulas represented a simple way to discriminate those informed consent forms that had normal readability scores from those that should be adapted. (shrink)

Resnik and Pugh recently explored the ethical implications of routinely integrating environmental concerns into clinical decision-making. While we share their concern for the holistic well-being of patients, our response offers a different clinical and bioethical stance on green informed consent and patient autonomy. Contrary to the authors’ lack of data to support their concerns about provider and patient willingness to engage in climate-related conversations, we provide evidence supporting their sustainability engagement and stress the importance of a proactive, (...) anticipatory approach in healthcare to align with evolving societal values. If climate change is perceived as a politicised issue, though it is not inherently so, healthcare providers are professionally trained to address sensitive subjects and have a duty to inform patients about potential health risks. Recognising the environmental crisis as a health crisis underscores the direct connection between environmental hazards and patients’ well-being. Our perspective advocates for integrating individual considerations, societal responsibilities and systemic changes to promote environmentally sustainable healthcare. (shrink)

A cross-sectional study to ascertain what the Singapore population would regard as material risk in the anaesthesia consent-taking process and identify demographic factors that predict patient preferences in medical decision-making to tailor a more patient-centered informed consent. A survey was performed involving patients 21 years old and above who attended the pre-operative evaluation clinic over a 1-month period in Singapore General Hospital. Questionnaires were administered to assess patients’ perception of material risks, by trained interviewers. Patients’ demographics (...) were obtained. Mann–Whitney U test and Kruskal-Wallis one-way analysis of variance was used. Statistical significance was taken at p < 0.05. Four hundred fourteen patients were eligible of which 26 refused to participate and 24 were excluded due to language barrier. 364 patients were recruited. A higher level of education, being employed and younger age group are factors identified in patients who wanted greater participation in medical decisions. Gender, marital status, type of surgery, and previous surgical history did not affect their level of participation. The complications most patients knew about were Nausea, Drowsiness and Surgical Wound Pain. Patients ranked Heart Attack, Death and Stroke as the most significant risks that they wanted to be informed about in greater detail. Most patients wanted to make a joint decision with the anaesthetist, instead of letting the doctor decide or deciding for themselves. Discussion with the anaesthetist is the preferred medium of communication compared to reading a pamphlet or watching a video. Age and educational level can influence medical decision-making. Despite the digital age, most patients still prefer a clinic consult instead of audio-visual multimedia for pre-operative anaesthetic counselling. The local population appears to place greater importance on rare but serious complications compared to common complications. This illustrates the need to contextualize information provided during informed consent to strengthen the doctor-patient relationship. (shrink)

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

The medical decision-making process is currently in flux. Decisions are no longer made entirely at the physician's discretion: patients are becoming more and more involved in the process. There is a great deal of discussion about the ideal of ‘informed consent’, that is that diagnostic and therapeutic decisions should be made based on an interaction between physician and patient. This means that patients are informed about the advantages and disadvantages of a treatment as well as alternatives (...) to the treatment; then, based on this information they can decide whether or not they want to undergo the treatment. However, recent studies show that the realisation of the ideal of ‘shared decision-making’ faces a number of difficulties related to the fact that patients are not provided with complete and accurate information. Using the example of breast cancer screening, this article examines the question of whether, in light of these difficulties, the ideal of informed decision-making is only an illusion or whether concrete steps can be taken towards the realisation of this ideal. (shrink)

Decision making is a key activity, perhaps the most important activity, in the practice of healthcare. Although physicians acquire a great deal of knowledge and specialised skills during their training and through their practice, it is in the exercise of clinical judgement and its application to individual patients that the outstanding physician is distinguished. This has become even more relevant as patients become increasingly welcomed as partners in a shared decision making process. This book translates (...) the research and theory from the science of decision making into clinically useful tools and principles that can be applied by clinicians in the field. It considers issues of patient goals, uncertainty, judgement, choice, development of new information, and family and social concerns in healthcare. It helps to demystify decision theory by emphasizing concepts and clinical cases over mathematics and computation. (shrink)

Genetic testing has led to the establishment of the concept of the “previvor”: someone who is not yet sick, but who has a genetic predisposition to disease. The previvor experience demonstrates how the practice of medicine and medical decision making is evolving to render current law and policy increasingly inapplicable to modern medical practice. The introduction of previvorship to the medical landscape raises special issues for the physician-patient relationship and the legal doctrine of informed consent. It challenges (...) some of the most basic assumptions underlying the doctrine, is representative of the doctrine’s declining utility, and is illustrative of the need to transition to a shared decision-making model. Thus, we should begin to envision a legal doctrine that supports a robust shared decision-making approach to address individual preferences and values, the increasing complexity of risk/benefit assessment, and inherent (and sometimes irreducible) uncertainty. Such an approach should emphasize a new, more expansive, and inclusive model of illness. (shrink)

Objectives: To determine the effects of risk and payment on subjects’ willingness to participate, and to examine how payment influences subjects’ potential behaviours and risk evaluations.Methods: A 3 × 3 , between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from (...) hypothetical biomedical research projects. Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating.Results: Monetary payment had positive effects on respondents’ willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents’ potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents’ propensity to neglect to tell researchers about negative effects.Conclusions: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns—notably the potential for payments to diminish the integrity of a study’s findings. Future research is critical to make sound decisions about the payment of research subjects. (shrink)

Standard versions of the requirement of informed consent state that patients who are offered to enter a clinical trial of a medical procedure should be informed about risks and possible benefits of this procedure (compared to available alternatives) in order to facilitate a rational decision whether or not to participate. However, in many real cases where new medical procedures are to be clinically tested for the first time the information available for such communication to prospective patients is (...) very scarce, vague and/or uncertain. This phenomenon is illustrated by the clinical introduction of new procedures in reproductive medicine, such as preimplantation genetic diagnosis (PGD). Regarding such procedures, it has ben argued that, in such cases, the quality of the available information may be too low for the obtaining of informed consent to be possible, even if it is successfully communicated. Others, instead, holds that informed consent may always be obtained regardless of the quality of the available information. Unfortunately, the standard litterature on informed consent give no clue as to which of these interpretations is correct. This issue is explored by connecting the concept of informed consent to ethical ideas of respect for autonomy and ideas of rational decision making. It is argued, first, that low quality of available information regarding the risks and possible benefits of a medical procedure may indeed make the obtaining of informed consent from patients to undergo this procedure impossible even in theory. However, it is also argued that whether or not this is the case must be relativized to the actual needs and deires of individual patients. Thus, regarding one and the same procedure, informed consent may be impossible to obtain from some patients due to the low quality of the available information regarding this procedure, but still be possible to obtain from other patients. (shrink)

Shared decision-making involves health professionals and patients/clients working together to achieve true person-centred health care. However, this goal is infrequently realized, and most barriers are unknown. Discussion between philosophers, clinicians, and researchers can assist in confronting the epistemic and moral basis of health care, with benefits to all. The aim of this paper is to describe what shared decision-making is, discuss its necessary conditions, and develop a definition that can be used in practice to (...) support excellence in maternity care. Discussion between the authors, with backgrounds in philosophy, clinical maternity care, health care management, and maternity care research, assisted the team to confront established norms in maternity care and challenge the epistemic and moral basis of decision-making for caesarean section. The team concluded that shared decision-making must start in pregnancy and continue throughout labour and birth, with equality in discourse facilitated by the clinician. Clinicians have a duty of care for the adequacy of women's knowledge, which can only be fulfilled when relevant knowledge is offered freely and when personal beliefs and biases that may impinge on decision-making (defeaters) are disclosed. Informed consent is not shared decision-making. Key barriers include existing cultural norms of “the doctor knows best” and “patient acquiescence” that prevent defeaters being acknowledged and discussed and can lead to legal challenges, overuse of medical intervention and, in some areas, obstetric violence. Shared decision-making in maternity care can thus be defined as an enquiry by clinician and expectant woman aimed at deciding upon a course of care or none, which takes the form of a dialogue within which the clinician fulfils their duty of care to the client's knowledge by making available their complete knowledge (based on all types of evidence) and expertise, including an exposition of any relevant and recognized potential defeaters. Research to develop measurement tools is required. (shrink)

IntroductionInformed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia.MethodA cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in SPSS version 23.ResultsA total of (...) 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process.ConclusionThis research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent. (shrink)

For more than sixty years, surgeons have used bioethical strategies to promote patient self‐determination, many of these now collectively described as “informed consent.” Yet the core framework—understanding, risks, benefits, and alternatives—fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will “fix” the problem. They omit critical information about the goals and downsides of surgery and present untenable (...) options as a matter of patient choice. We propose a novel framework called “better conversations.” Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment. (shrink)

Background Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo effects. Methods We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. (...) In both groups, patients received an open-label placebo pill instead of their sleeping medication. Results No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter. Conclusion In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. Trial registration Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered. (shrink)

Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. (...) Methods We sought to use mabaraza , traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research. (shrink)

Shared Decision Making (‘SDM’) is one of the most significant developments in Western health care practices in recent years. Whereas traditional models of care operate on the basis of the physician as the primary medical decision maker, SDM requires patients to be supported to consider options in order to achieve informed preferences by mutually sharing the best available evidence. According to its proponents, SDM is the right way to interpret the clinician-patient relationship because it fulfils (...) the ethical imperative of respecting patient autonomy. However, there is no consensus about how decisions in SDM contexts relate to the principle of respect for autonomy. In response, I demonstrate that in order to make decisions about what treatment they will or will not receive, patients will be required to meet different conditions depending on the approach proponents of SDM take to understanding personal autonomy. Due to the fact that different conceptions of autonomy yield different obligations, I argue that if physicians and patients satisfied all the conditions described in standard accounts of SDM, then SDM would undermine patient autonomy. (shrink)

The necessity of consent is widely justified on the basis of the principle of respect for autonomy. Also, it is widely believed that shared decision making (SDM) is the practical device to seek patients’ consent for medical treatment. In this essay, I argue that SDM, while necessary, is insufficient for consent; because, in the paradigm of evidence-based medicine, SDM is contingent upon other practices to identify appropriate treatments that form the subjects of SDM. Indeed, case law emphasises (...) normative decision-making practices that precede SDM. Furthermore, case law supplies a nuanced understanding of SDM, which includes not only exchange of information but also attention to human vulnerability that persists despite formal retention of decision-making capacity. In addition, the law marks out a space in which people with capacity are absolutely entitled to self-determination. Thus, a four-step framework of decision making can be induced from legal doctrine. This legal framework corresponds to a construct of respect for autonomy that draws upon feminist theory. Feminist scholars have objected to the focus on individuals in traditional theories of autonomy; instead, they insist that people have to be considered in the context of their social influences and relationships. Feminists separate out four ideas of autonomy, and these ideas can be used to construct a four-layered model of respect for autonomy, in which each layer corresponds sequentially to a step in the legal framework of decision making. This model of respect for autonomy provides both conceptual clarity and theoretically robust justification for doctors’ various obligations in decision-making practices for consent. (shrink)

Informed consent is ethically incomplete and should be redefined as empowered consent. This essay challenges theoretical assumptions of the value of informed consent in light of substantial evidence of its failure in clinical practice and questions the continued emphasis on autonomy as the primary ethical justification for the practice of consent in health care. Human dignity—rather than autonomy—is advanced from a nursing ethics perspective as a preferred justification for consent practices in health care. The adequacy of an ethic (...) of obligation (namely, principlism) as the dominant theoretical lens for recognising and responding to persistent problems in consent practices is also reconsidered. A feminist empowerment framework is adopted as an alternative ethical theory to principlism and is advanced as a more practical and complete lens for examining the concept and context of consent in health care. To accomplish this, the three leading conceptions of informed consent are overviewed, followed by a feminist critique to reveal practical problems with each of them. The need for a language change from informed to empowered consent is strongly considered. Implications for consent activities in clinical practice are reviewed with focused discussion on the need for greater role clarity for all involved in consent—beyond and inclusive of the patient‐physician dyad, as the practice and improvement of consent is necessarily a transdisciplinary endeavour. Specific concrete and practical recommendations for leveraging nursing expertise in this space are presented. Perhaps what is most needed in the discourse and practice of consent in health care is nursing. (shrink)

BackgroundThe psychological burden possibly deriving from not immediately undergoing radical treatment for prostate cancer could be a potential disadvantage of active surveillance, especially in the eve of some relevant clinical exams [i.e., re-biopsy, prostate-specific antigen test, and medical examination]. Even if it is known from the literature that the majority of PCa men in AS do not report heightened anxiety, there is a minority of patients who show clinically significant levels of anxiety after diagnosis. The present study aimed to (...) investigate if demographic, clinical, and psychological variables at the entrance in AS were associated with the risk of developing clinically significant PCa-related anxiety 2 months before the first re-biopsy and to offer psychological support to improve quality of life.Materials and MethodsA total of 236 patients participated in the PCa Research International: AS protocol and in PRIAS-QoL study. Demographic/clinical features, health-related QoL domains, coping with cancer, PCa-related anxiety [Memorial Anxiety Scale for PCa ], personality traits, and decision-making-related factors were assessed at T0. MAX-PC was also administered at T1. PCa-related anxiety at T1 was considered to be of clinical significance if the MAX-PC score was ≥1.5. Multivariable logistic regression coupled to bootstrap was used to detect factors associated with high levels of anxiety.ResultsThe median age was 64.4 years. Fifty-six patients reported MAX-PC total score above the cutoff. Three factors were associated with a high level of PCa anxiety at T1: anxious preoccupation [odds ratio = 4.36], extraversion, and prostate-related symptoms. Physical well-being was associated with a low PCa anxiety subscale ; neuroticism and functional well-being were associated with PSA anxiety. Neuroticism and helplessness/hopelessness were associated with fear of progression.ConclusionOnly a partial portion of the sample experienced significant levels of anxiety after 10 months. Psychological assessment should be routinely conducted to detect risk factors for increased anxiety, offering tailored psychological interventions aimed at promoting interpersonal awareness and emotional well-being. (shrink)

BackgroundThe participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study (...) requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants’ motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi.MethodsWe conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation.FindingsThe findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role.ConclusionThese findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants’ concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants’ needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups.Trial Registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451). (shrink)

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries (...) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. (shrink)

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to (...) limited abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

Volume 20, Issue 6, June 2020, Page W1-W5.

This paper discusses the use of deep brain stimulation for the treatment of neurological and psychiatric disorders in children. At present, deep brain stimulation is used to treat movement disorders in children and a few cases of deep brain stimulation for psychiatric disorders in adolescents have been reported. Ethical guidelines on the use of deep brain stimulation in children are therefore urgently needed. This paper focuses on the decision-making process, and provides an ethical framework for (future) treatment decisions (...) in pediatric deep brain stimulation. I defend a shared decision-making model in case of deep brain stimulation for neurological and psychiatric disorders in children. To protect the vulnerable child patient, a dual consent process is needed where parents or parental guardians give their consent, and the child gives his/her assent. (shrink)

Background One of the biggest challenges of practicing medicine in the age of informational technology is how to conciliate the overwhelming amount of medical-scientific information with the multiple patients’ values of modern pluralistic societies. To organize and optimize the the Decision-Making Process of seriously ill patient care, we present a framework to be used by Healthcare Providers. The objective is to align Bioethics, Evidence-based Practice and Person-centered Care. Main body The framework divides the DMP into four steps, each (...) with a different but complementary focus, goal and ethical principle. Step 1 focuses exclusively on the disease, having accuracy is its ethical principle. It aims at an accurate and probabilistic estimation of prognosis, absolute risk reduction, relative risk reduction and treatments’ burdens. Step 2 focuses on the person, using empathic communication to learn about patient values and what suffering means for the patient. Emphasis is given to learning and active listening, not taking action. Thus, instead beneficence, we trust comprehension and understanding with the suffering of others and respect for others as autonomous moral agents as the ethical principles of Step 2. Step 3 focuses on the healthcare team, having the ethics of situational awareness guiding this step. The goal is, through effective teamwork, to contextualize and link rates and probabilities related to the disease to the learned patient’s values, presenting a summary of which treatments the team considers as acceptable, recommended, potentially inappropriate and futile. Finally, Step 4 focuses on provider-patient relationship, seeking shared Goals of Care, for the best and worst scenario. Through an ethics of deliberation, it aims for a consensus that could ensure that the patient’s values will be respected as well as a scientifically acceptable medical practice will be provided. In summary: accuracy, comprehension, understanding, situational awareness and deliberation would be the ethical principles guiding each step. Conclusion Hopefully, by highlighting and naming the different perspectives of knowledge needed in clinical practice, this framework will be valuable as a practical and educational tool, guiding modern medical professionals through the many challenges of providing high quality person-centered care that is both ethical and evidence based. (shrink)

Medical paternalism has long been a common medical practice. However, patient autonomy in healthcare has been recently adopted by doctors and patients alike. This study explored whether doctors and patients in a tertiary care hospital in Saudi Arabia preferred autonomy or paternalism in shared decision‐making. A total of 118 participants (51 patients requiring total knee replacement, owing to stages 3–4 of osteoarthritis, and 67 doctors) from the Eastern province, Saudi Arabia. responded to a 17‐question category‐based questionnaire involving (...) four scales of autonomy. Descriptive statistics and chi‐square test results revealed that in this hospital, patients preferred a paternalistic approach toward their medical care along with a full disclosure of the risks related to surgical procedures. We recommend health education regarding the specific autonomy subscales (doctor knows best, patient should decide, right to non‐participation, and obligatory risk information), and the implementation of protocols that protect patients' rights and enhance personal autonomy. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present a (...) case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present a (...) case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent (...) and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent (...) and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Clinical evidence suggests that many patients undergo surgery that they would decline if fully informed. Failure to communicate the relevant risks, benefits, and alternatives of a procedure violates medical ethics and wastes medical resources. Integrating shared decision-making, a method of communication between provider and patient, into medical decisions can satisfy physicians' ethical obligations and reduce unwanted procedures. This article proposes a three-step process for implementing a nationwide practice of shared decision-making: create model integration (...) programs; provide legal incentives to ease the transition; and incorporate shared decision-making into medical necessity determinations. (shrink)

In the U.S. there has been considerable interest in connecting low-income households to alternative food networks like Community Supported Agriculture. To learn more about this possibility we conducted a statewide survey of CSA members in California. A total of 1149 members from 41 CSAs responded. Here we answer the research question: How do CSA members’ socioeconomic and demographic backgrounds, household conditions potentially interfering with membership, and CSA membership experiences vary between lower-income households and higher-income households? We divided members into LIHHs (...) and HIHHs. We present comparisons of LIHHs’ and HIHHs’ employment, race/ethnicity, household composition and education, use of food support, and enjoyment of food-related activities; conditions interfering with membership and major life events; and sources of information influencing decision to join, reasons for joining, ratings of importance of and satisfaction with various CSA attributes, gaps between importance of and satisfaction with various CSA attributes, valuing of the share and willingness to pay more, and impacts of membership. We find that LIHHs are committed CSA members, often more so than HIHHs, and that CSA members in California are disproportionately white, but that racial disproportionality decreases as incomes increase. We conclude by considering: the economic risks that LIHHs face in CSA membership, the intersection of economic risks with race/ethnicity and cultural coding in CSA; and the possibilities of increasing participation of LIHH in CSA. (shrink)

This “Legal Briefing” column covers recent legal developments involving patient decision aids. This topic has been the subject of recent articles in JCE. It is included in the 2010 Patient Protection and Affordable Care Act. And it has received significant attention in the biomedical literature, including a new book, a thematic issue of Health Affairs, and a recent article in the New England Journal of Medicine. Moreover, physicians and health systems across the United States are increasingly integrating decision (...) aids into their clinical practice. Both federal and state laws play a significant role in promoting this expanded use. On the other hand, concerns about liability could stymie development and implementation. We categorize legal developments concerning patient decision aids into the following five sections:1. Development of decision aids2. Effectiveness of decision aids3. Federal regulation of decision aids4. State regulation of decision aids5. Legal concerns regarding decision aids. (shrink)

We read commentaries on our feature article ‘The ethics of consent during labour and birth: episiotomies’1 with gratitude and interest. Nearly all commenting authors agree that consent for in-labour procedures is necessary and ideally given at the point of intervening. Both Shalowitz & Ralston and Stirrat note that this is already required by professional statements and guidelines in the USA2 and UK3, respectively, but also note that practice does not yet conform. The Americans authors helpfully emphasise the importance of multilevel (...) institutional measures for closing this gap, including consent policies and reporting mechanisms, as well as ongoing education.2 The UK writer seconds the role for education within wider shared decision-making and informed choice approaches, and generously commends our paper for close study by all maternity care providers. Others add a cautionary note. Lee applauds all our recommendations, but notes our proposals cannot fully secure autonomy because of, among others, epistemic injustice and other power differentials.4 Kumar-Hazard and Dahlen worry that opt-out consent is equal to substitute decision-making; weakens women’s rights; and is open to abuse.5 Nelson and Clough object to our willlingness to work within a flawed conceptual framework, which ought to be challenged.6 We agree that there are limits to what our proposal can do. It cannot rectify unequal distributions of epistemic credibilities, either in general or in any particular interaction. Risk communication is never neutral;7 “even the most well-meaning healthcare professionals could unwittingly wield influence over birthing women’s …. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and (...) to discuss it with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

The Canadian law governing informed consent was significantly influenced by the decision of its Supreme Court in Reibl v. Hughes, a case that involved a physician’s failure to warn the patient about the risk of stroke after carotid endarterectomy. Even though most Canadian plaintiffs after Reibl have continued to lose informed consent cases, it is likely that the judgement in this case has significantly influenced the manner in which physicians now approach the discussion of risk (...) while obtaining consent not only in Canada but also in several other jurisdictions.The development of informed consent law in the United States similarly became one of the drivers for change in physicians’ practices of information disclosure to their patients. The effect of Reibl on clinical practice is an outstanding example of the law’s positive influence on medical practice, especially in protecting patient autonomy during collaborative medical decision-making. (shrink)

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a (...) qualitative focus group study at the National Center for Tumor Diseases. Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, establishing independent governance entities in order to minimize the informational risks of genomic research, and implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research. (shrink)

Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT (...) participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334).Main Outcome Measures Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Results Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Conclusions and Relevance Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. (shrink)

Motivations and decision-making styles that influence participation in biomedical research vary across study types, cultures, and countries. While there is a small amount of literature on informed consent in non-western cultures, few studies have examined how participants make the decision to join research. This study was designed to identify the factors motivating people to participate in biomedical research in a traditional Nigerian community, assess the degree to which participants involve others in the decision-making process, (...) and examine issues of autonomy in decision-making for research. A descriptive cross-sectional study was conducted with 100 adults (50 men, 50 women) in an urban Nigerian community who had participated in a biomedical research study. Subjects were interviewed using a survey instrument.Two-thirds of the respondents reported participating in the biomedical study to learn more about their illness, while 30% hoped to get some medical care. Over three-quarters (78%) of participants discussed the enrolment decision with someone else and 39% reported obtaining permission from a spouse or family member to participate in the study. Women were more than twice as likely as men to report obtaining permission from someone else before participating. More specifically, half of the female participants reported seeking permission from a spouse before enrolling. The findings suggest that informed consent in this community is understood and practised as a relational activity that involves others in the decision making process. Further studies are needed in non-Western countries concerning autonomy, decision-making, and motivation to participate in research studies. (shrink)