Despite the developing influence of the Internet as a tool for reaching potential subjects, little empirical information exits on how individuals are recruited to participate in clinical research via the Internet or on what type of information clinical trial Web sites provide. This study revealed that roughly half of the sites failed to mention study risks or specific details about what the study required on the part of participants, while nearly three-quarters described incentives to participate. Moreover, for-profit entities (...) were more likely to be the sponsors of Web sites that did not appear to provide balanced information. These data suggest that policy-makers and IRBs should increase oversight of current online recruitment practices. (shrink)

(2001). How Should IVF Programs Handle Initial Disclosure of Information to Prospective Ovum Donors? The American Journal of Bioethics: Vol. 1, No. 4, pp. 23-25.

Increasing emphasis on genetic research means that growing numbers of human research projects in Australia will involve complex issues related to genetic privacy, familial information and genetic epidemiology. The Office of Population Health Genomics (Department of Health, Western Australia) hosted an interactive workshop to explore the ethical issues involved in the disclosure of genetic information, where researchers and members of human research ethics committees (HRECs) were asked to consider several case studies from an ethical perspective. Workshop participants (...) used a variety of approaches to examine the complex ethical issues encountered, but did not consistently refer to the values and principles outlined in the National Statement on Ethical Conduct in Human Research (NHMRC 2007) or apply rational ethical approaches. Overall, the data suggested that both researchers and HREC members may benefit from further education and support regarding the application of ethical frameworks to the issues encountered in genetic research. (shrink)

There has been much discussion about what, if any, legal and moral duties professionals have to disclose relevant genetic information to the family members of someone with an identified disease predisposing mutation. Here, we present a case report where dissemination of such a genetic test result did not take place within a family. In contrast to previous literature, there appeared to be no deliberate withholding of information, instead distant relatives were unable to communicate relevant information appropriately. When (...) communication was facilitated through the follow-up of a chance remark, the patient was able to avoid planned major surgery, with its attendant morbidity, and her high anxiety levels were much reduced. We believe this case highlights the need for an ongoing debate on how genetic services can best support patients and their families with disclosing relevant genetic information to other family members. (shrink)

The requirement for disclosure of risks of treatment as part of informed consent came before the Supreme Court of Canada in two 1980 cases. The Court found the duty of disclosure of risks to be based in negligence and not battery. The scope of the duty is not to be determined by medical evidence alone and requires the physician to disclose the nature of the proposed treatment, its gravity, any material risks and any special or unusual risks as (...) well as answering in a reasonable way all specific questions asked by the patient. Whether the patient would have decided differently if all the information were known is an objective test, based on what the reasonable person in the patient's particular circumstance would do. (shrink)

One of the major puzzles in evolutionary theory is how communication and information transfer are possible when the interests of those involved conflict. Perfect information transfer seems inevitable if there are physical constraints, which limit the signal repertoire of an individual, effectively making bluffing an impossibility. This, I argue, is incorrect. Unfakeable signals by no means guarantee information transfer. I demonstrate the existence of a so-called pooling equilibrium and discuss why the traditional argument for perfect information (...) transfer does not hold in all cases. Additionally, I demonstrate that deception is possible at equilibrium despite the fact that signals are impossible to fake. (shrink)

This paper investigates potential motivations for late adopting U.S. companies to begin disclosing environmental liability amounts in their financial statements. Based on a review of 10-K reports filed from 1998 through 2012, inclusive, we identified 55 firms initiating environmental liability disclosure over the period, with all but three doing so by 2006. Focusing on the disclosers up through 2006, we argue that the companies may have used the disclosure as a tool of impression management to avoid potential stakeholder (...) mis-estimation of previously undisclosed liability exposures. We first compute tests to identify firms that may have begun the disclosure due to (1) materiality and (2) concerns of having proprietary costs imposed upon them due to changes in their environmental media coverage and environmental performance, and we find very few cases where these explanations might hold. For the remaining companies, we compared their newly disclosed liability amount, on average, with the mean level of environmental liability being disclosed by other firms in the year prior to the sample companies’ initiation, and find that it is significantly smaller, thus supporting our impression management argument. Finally, we find that overall level of environmental liability amounts was consistently decreasing over the time frame examined, suggesting that earlier adoption would have made more sense. However, it may also explain why almost no new firms began disclosing after the mid-2000s. (shrink)

Leading research projects are evidence of the growing public interest in genetic diagnosis and treatment. In this context, disclosure of genetic information to relatives has become a prominent issue. However, this involves patient confidentiality, which is grounded in law and conflicts with disclosure to relatives. When conducting a legal and bioethical discussion in this context, it is first necessary to examine how clinicians perceive the role of law in their practice and how they interpret it. A qualitative (...) study was therefore conducted among clinicians in Israel. The findings indicate that the clinicians’ approach is more relational than that of the law, in view of their pro-active steps to ensure that familial information reaches the relatives when the patient is reluctant to convey this information themselves. In light of these findings the authors argue that the law can resolve situations of explicit and implicit refusal to inform relatives. (shrink)

This study explores the rationality behind firms’ decision to admit or deny their involvement in bribery when responding to confidential surveys conducted by international agencies. Specifically, we posit that firms’ reluctance to provide accurate information about their engagement in bribery is at least to some extent contingent on certain situational factors. In other words, we claim that this behavior is context dependent. The paper uses the notions provided by the theory of planned behavior to understand the way in which (...) the corruption of the legal environment, the intensity of market competition, and identification risk influence firms’ decision to lie about their involvement in bribery. To test these notions, we use databases from the fifth wave of the EBRD-World Bank Business Environment and Enterprise Performance Survey, country-level data from the Kauffman Foundation and macroeconomic information from the World Bank database. We run ordinary least squares with geographic region-clustered standard errors on data from 30 countries and 6122 individual firms during the period 2012–2013. Consistent with our expectations, the results indicate that firms operating within more corrupt legal environments, facing more competition, and bearing a higher risk of being identified are less likely to deny their involvement in bribery. We conclude that not all firms have the same incentives to lie about their participation in bribery, and therefore, identifying the drivers of this heterogeneity may help policymakers better assess the reliability of bribery information collected through confidential surveys. (shrink)

Confidentiality is a cornerstone of the physician-patient relationship. Breaches of confidentiality in the context of genetic testing are of particular concern for a number of reasons. First, genetic testing reveals information not only about a particular patient, but also about his or her family members. Second,genetic testing can label healthy people as “at risk,” subjecting them to possible stigmatization or discrimination by third parties. Third, as genetic testing becomes more widespread and is incorporated into primary care, breaches of confidentiality (...) might inadvertently occur more frequently because primary care providers may not be trained to understand the uniqueness of genetic information. Until now, genetic services have been provided primarily by medical geneticists and genetic counselors. However, with the proliferation of new genetic presymptomatic and carrier tests, primary care physicians are going to become increasingly involved in genetic testing. Currently, little is known about physicians’ attitudes toward disclosure of confidential genetic information to third parties. (shrink)

Confidentiality is a cornerstone of the physician-patient relationship. Breaches of confidentiality in the context of genetic testing are of particular concern for a number of reasons. First, genetic testing reveals information not only about a particular patient, but also about his or her family members. Second,genetic testing can label healthy people as “at risk,” subjecting them to possible stigmatization or discrimination by third parties. Third, as genetic testing becomes more widespread and is incorporated into primary care, breaches of confidentiality (...) might inadvertently occur more frequently because primary care providers may not be trained to understand the uniqueness of genetic information. Until now, genetic services have been provided primarily by medical geneticists and genetic counselors. However, with the proliferation of new genetic presymptomatic and carrier tests, primary care physicians are going to become increasingly involved in genetic testing. Currently, little is known about physicians’ attitudes toward disclosure of confidential genetic information to third parties. (shrink)

Recently, scholars have argued that disclosure of personal information is an effective mechanism for building high-quality relationships. However, personal information can focus attention on differences in demographically diverse teams. In an experiment using 37 undergraduate teams, we examine how sharing personal information by ethnically similar and ethnically distinct newcomers to a team affects team perceptions, performance, and behavior. Our findings indicate that the disclosure of personal information by ethnically distinct newcomers improves team performance. However, (...) the positive impact on team performance comes at a cost to the newcomers, who are perceived as less competent by others and experience heightened social discomfort in team interactions. Ironically, what benefits the ethnically diverse team may undermine its ethnically distinct members. This study highlights how the management of diversity may sometimes require making trade-offs between individual interests and those of the team. (shrink)

When considering the principle of medical confidentiality, disclosure of genetic information constitutes a special case because of the impact that this information can have on the health and the lives of relatives. The aim of this study is to explore the attitudes of Turkish physicians and patients about sharing information obtained from genetic tests.

Ten years after the enactment of the Biologics Price Competition and Innovation Act, competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem (...) to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act, which is administered by the Environmental Protection Agency. The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets. (shrink)

As global warming continues to attract growing levels of attention, various stakeholders have put climate change on corporate agendas and expect firms to disclose relevant greenhouse gas information. In this paper, we investigate the consistency of the GHG information voluntarily disclosed by French listed firms through two different communication channels: corporate reports and the Carbon Disclosure Project. More precisely, we contrast the amounts of GHG emissions reported and the methodological explanations provided in each channel. Consistent with a (...) stakeholder theory perspective, we find that GHG amounts are significantly lower in the CR than in the CDP. We also find that firms increase the CR figures’ traceability when there is a discrepancy between disclosures in the two channels. We suggest that the aim of this greater traceability is to enhance information credibility across the different channels used. (shrink)

Based on the institutional theory, this article attempts to examine two consecutive questions regarding the impact of various factors on corporate decision in environmental information disclosure (EID): (1) whether or not to disclose; and (2) the level of disclosure. The relevance of these factors is empirically tested using data collected from publicly listed manufacturing companies from 2006 to 2008 in China. Some interesting findings appear. We find that firms that are state-owned, those that operate in environmentally sensitive (...) industries, those having more industrial peers engaged in EID, and those with better reputation are more likely to disclose environmental information. When it comes to the content of EID, variables that attempt to capture external institutional pressures exhibit either no or weak explanatory power. Only the variable of organizational image and reputation is demonstrated to have a significant impact on both the act and the content of EID. This study provides a snapshot of the dialogues between constituencies in the organizational field and EID development. (shrink)

The ideal moral standard for surgical informed‐consent calls upon surgeons to carry out a disclosure dialogue with patients so they have as full as possible an understanding of the procedure before they sign the informed‐consent form. This study is the first to empirically explore patient preferences regarding disclosure dialogue. Twelve Israelis who underwent life‐saving surgeries participated in a narrative study. Three themes emerged from the analysis: objectification of patients, anxiety provoking processes and information, and lack of (...) class='Hi'>information that was essential for patients. Findings contribute to existing debates among surgeons regarding the scope and importance of some disclosure components. Analysis led to our formulation of an augmented subjective model of information disclosure that participants prefer, which extends beyond the immediate present of the surgery to the period after discharge, and until return to routine. Surgeons should be aware of patient preferences in disclosure, and gaps between perceptions of surgeons, and preferences and needs of patients. (shrink)

Enactment of mandated pre-procedure disclosures in abortion and assisted reproductive technology services has swelled in recent years. Calls to equally regard these mandates as neutral tools in furtherance of patient protection fail to acknowledge key substantive and structural differences in these reproduction-affecting mandates. While ART mandates permit physicians to use their medical judgment to protect presumptively vulnerable egg donors and gestational carriers, abortion disclosures impart scientifically suspect messaging aimed at dissuading women from pursuing pregnancy termination. These and other distinctions counsel (...) in favor of regarding and analyzing abortion and ART mandated disclosures as separate and distinguishable informed consent tools. (shrink)

Background The consistency of codes governing disclosure of terminal illness to patients and families in Islamic countries has not been studied until now. Objectives To review available codes on disclosure of terminal illness in Islamic countries. Data source and extraction Data were extracted through searches on Google and PubMed. Codes related to disclosure of terminal illness to patients or families were abstracted, and then classified independently by the three authors. Data synthesis Codes for 14 Islamic countries were (...) located. Five codes were silent regarding informing the patient, seven allowed concealment, one mandated disclosure and one prohibited disclosure. Five codes were silent regarding informing the family, four allowed disclosure and five mandated/recommended disclosure. The Islamic Organization for Medical Sciences code was silent on both issues. Conclusion Codes regarding disclosure of terminal illness to patients and families differed markedly among Islamic countries. They were silent in one-third of the codes, and tended to favour a paternalistic/utilitarian, family-centred approach over an autonomous, patient-centred approach. (shrink)

The Securities and Exchange Commission requires publicly held US corporations to disclose all information, whether it is positive or negative, that might be relevant to an investor's decision to buy, sell, or hold a company's securities. The decisions made by corporate managers to disclose such information can significantly affect the judgments and decisions of investors. This paper examines academic accounting research on corporate managers' voluntary disclosures of earnings forecasts and non-GAAP earnings measures. Much of the evidence from this (...) research indicates that some managers engage in opportunistic disclosure behavior that often benefits one group (managers and shareholders) at the expense of other groups (often other investors). The paper concludes by discussing the ethical implications of this behavior. (shrink)

PEOPLE WITH MENTAL HEALTH conditions are often required to address the question of whether they should disclose information about their mental health. Should they inform their employers, colleagues, friends, family, neighbors, and so on, that they have a mental health condition? Should they be encouraged by others to do so? There has been a recent move to promote disclosure as a way to increase the empowerment and decrease the self-stigma of people with mental health conditions. For instance, a (...) three-week intervention, Coming Out Proud, has been devised to inform people about the costs and benefits of disclosure, forms of disclosure, and helpful ways to tell... (shrink)

Is self-disclosure of negative information a viable strategy for a company to lessen the damage done to consumer responses? Three experiments assessed whether self-disclosing negative information in itself lessened the damaging impact of this information compared to third-party disclosure of the same information. Results indicated that mere self-disclosure of a negative event positively affected consumers’ choice behavior, perceived company trustworthiness, and company evaluations compared to third-party disclosure. The effectiveness of the self-disclosure (...) strategy was moderated by the initial reputation of a company, such that its impact was only observed for companies that had a poor reputation at the outset. For them, self-disclosure considerably lessened the impact of negative information compared to third-party disclosure. For companies that enjoyed a positive reputation, type of disclosure did not affect consumer responses. Mediation analysis showed that perceptions of company trustworthiness underlie the effects of the self-disclosure strategy on consumer judgment. (shrink)

Objectives Disclosures of funding sources and conflicts of interests (COI) in published peer-reviewed journal articles have recently begun to receive some attention, but many critical questions remain, for example, how often such reporting occurs concerning research conducted in the developing world and what factors may be involved. Design Of all articles indexed in Medline reporting on human subject HIV research in 2007 conducted in four countries (India, Thailand, Nigeria and Uganda), this study explored how many disclosed a funding source and (...) COI, and what factors are involved. Results Of 221 articles that met the criteria, 67.9% (150) disclosed the presence or absence of a funding source, but only 20% (44) disclosed COI. Studies from Uganda were more likely, and those from Nigeria were less likely to mention a funding source (p<0.001). Of articles in journals that had adopted International Committee of Medical Journal Editors (ICMJE) guidelines, 56% did not disclose COI. Disclosure of funding was more likely when: ≥50% of the authors and the corresponding author were from the sponsoring country, the sponsor country was the USA, and the articles were published in journals in which more of the editors were from the sponsoring countries. Conclusions Of the published studies examined, over a third did not disclose funding source (ie, whether or not there was a funding source) and 80% did not disclose whether COI existed. Most articles in ICMJE-affiliated journals did not disclose COI. These data suggest the need to consider alteration of policies to require that published articles include funding and COI information, to allow readers to assess articles as fully as possible. (shrink)

Non-recent (historic) childhood sexual abuse is an important issue to research, though often regarded as taboo and frequently met with caution, avoidance or even opposition from research ethics committees. Sensitive research, such as that which asks victim-survivors to recount experiences of abuse or harm, has the propensity to be emotionally challenging for both the participant and the researcher. However, most research suggests that any distress experienced is usually momentary and not of any clinical significance. Moreover, this type of research offers (...) a platform for voices which have often been silenced, and many participants report the cathartic effect of recounting their experiences in a safe, non-judgemental space. With regard to the course of such research, lines of inquiry which ask adult participants to discuss their experiences of childhood sexual abuse may result in a first-time disclosure of that abuse by the victim-survivor to the researcher. Guidance about how researchers should respond to first-time disclosure is lacking. In this article, we discuss our response to one research ethics committee which had suggested that for a qualitative study for which we were seeking ethical approval (investigating experiences of pregnancy and childbirth having previously survived childhood sexual abuse), any disclosure of non-recent (historic) childhood sexual abuse which had not been previously reported would result in the researcher being obliged to report it to relevant authorities. We assess this to be inconsistent with both law and professional guidance in the United Kingdom; and provide information and recommendations for researchers and research ethics committees to consider. (shrink)

BackgroundIn Saudi clinical settings, benevolent family care that reflects strongly held sociocultural values is commonly used to justify overriding respect for patient autonomy. Because the welfare of individuals is commonly regarded as inseparable from the welfare of their family as a whole, these values are widely believed to obligate the family to protect the welfare of its members by, for example, giving the family authority over what healthcare practitioners disclose to patients about their diagnoses and prognoses and preventing them from (...) making informed decisions about their healthcare.DiscussionFamily dominance over the healthcare decisions of competent patients is ethically problematic when the family prevent healthcare practitioners from disclosing diagnoses and prognoses to patients who have the capacity to consent and make decisions in their own best interests. Thus, the author holds that sociocultural values ought to be respected only when they do not prevent competent patients from knowing their diagnoses and prognoses or prevent them from making their own decisions.ConclusionHealthcare practitioners should not allow patients’ families to control what can or cannot be disclosed to competent patients. This is particularly important when patients are approaching death so that they may address their material and spiritual wishes—among other needs—as they prepare for death. Justification for this position is drawn from the Maqasid Al-Shariah-based Islamic bioethics approach, from which it is possible to argue that the harm of withholding diagnoses and prognoses from patients who are imminently dying outweighs the potential benefits. (shrink)

ABSTRACTGenetic testing results and research findings raise concerns about access to genetic information by insurers. Recently, the Canadian Life and Health Insurance Association reaffirmed its prerogative to request, for underwriting purposes, the disclosure of clinical and research genetic test results if the participant/patient or his physician has knowledge of the results. Studies have shown that access to genetic information to determine insurability can, in limited instances, lead to actual, or fear of, genetic discrimination, result in individuals refusing (...) to undergo testing or declining participation in genomic research, and being asked to pay higher premiums or denied access to certain types of insurance. Obtaining informed consent for genetic testing and genomic research is crucial and should take into account the potential need to disclose possible insurability risks to patients and participants. Our study analyzed clinical and research consent forms, templates and guidelines from Quebec to investigate two questions: whether consent forms include clauses providing information on potential insurability risks and when such potential risks are included, what information is provided and how it is formulated. Our findings show that current information on insurability risks in Quebec’s forms/guidelines lack coherence, potentially resulting in patients/participants receiving inconsistent information. (shrink)

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the (...) informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. RESULTS: The authors received (...) replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated. (shrink)

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the (...) rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully. (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)

Ethical medical care of pregnant women in Australia should include the real provision of information regarding the risks and benefits of vaginal birth. Routinely obtaining consent for the different ways in which childbirth is commonly intervened on and the assistance involved (such as midwife-led care or a planned caesarean section) and providing sufficient information for women to evaluate the harms and benefits of the care on offer, would not only enable the empowerment of women but would align with (...) the current standard of care as established by Rogers v Whittaker. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to (...) understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective (...) manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means. (shrink)

Each year individuals are required to execute millions of authorizations for the release of their health records as a condition of employment, applying for various types of insurance, and submitting claims for benefits. Generally, there are no restrictions on the scope of information released pursuant to these compelled authorizations, and the development of a nationwide system of interoperable electronic health records will increase the amount of health information released. After quantifying the extent of these disclosures, this article discusses (...) why it is important to limit disclosures of health information for nonmedical purposes as well as how it may be possible to do so. (shrink)

In 2013, following the leaks by Edward Snowden, The Guardian published a number of classified NSA documents. Both leaking and publishing leaks violate the law prohibiting unauthorized disclosures. Accordingly, there are two potential targets for prosecution: the leakers and the press. In practice, however, only the leakers are prosecuted: Snowden is facing a threat of 30 years’ imprisonment; no charges have been made against The Guardian. If both leaking and publishing leaks violate the law, why prosecute only the leakers and (...) not the press? I consider and reject two arguments. The first claims that the press has special moral claims by virtue of its rights or its role. The second argument states that the leakers commit a greater wrong than the press. I conclude that the current prosecution practice is inconsistent: prosecutors should either prosecute both or neither. (shrink)

This article explores the hypothesis that third parties are motivated to seek information about agents who have behaved unethically in the past, even if the agent and available information are irrelevant to the third parties’ goals and interests. We explored two possible motives for this information seeking behavior: deonance, or the motive to care about ethics and justice simply for the sake of ethics and justice, and distrust-based threat monitoring. Participants in a consumer decision task were found (...) to seek out information about an agent who had behaved unethically even when the agent was explicitly excluded from the task; there were no intentions to purchase from the agent; performance expectations for the agent’s product were low; the information that could be sought was non-diagnostic, redundant or irrelevant to an ethical judgment; and alternatives in the market offered as good or better value as the unethical agent. Critically, this information seeking took place even when the observer could disengage from and was not vulnerable to the agent. The findings are discussed in terms of third party information seeking and its effects on ethical behavior in the marketplace. (shrink)

A cardinal rule of academic research with human participants is to protect their confidentiality. While there are limits to confidentiality, universities and researchers will make strenuous efforts...

Clozapine is a very effective drug with both significant benefits and significant risks in treatment-resistant schizophrenia. Informed consent is generally accepted as both desirable and necessary in order to ensure that the patient’s human rights and dignity are respected. Disclosure is a key element of informed consent. It is unclear if the adequate documentation of disclosure is standard practice before initiation of clozapine. The aim of this study was to assess the adequacy of the documentation of disclosure (...) in consent to clozapine treatment in an adult mental health service and to develop guidelines on disclosure. The method was a retrospective analysis of charts of patients given clozapine who received the drug through the pharmacy of a single North Dublin psychiatric hospital. Results show that current practice has evident gaps. The professional, ethical and legal issues are discussed. (shrink)

BackgroundHospitals face a disclosure dilemma when large-scale adverse events affect multiple patients and the chance of harm is extremely low. Understanding the perspectives of patients who have received disclosures following such events could help institutions develop communication plans that are commensurate with the perceived or real harm and scale of the event.MethodsA mailed survey was conducted in 2008 of 266 University of Washington Medical Center (UWMC) patients who received written disclosure in 2004 about a large-scale, low-harm/low-risk adverse event (...) involving an incomplete endoscope cleaning process. The survey measured patients’ satisfaction with this disclosure, their concerns about healthcare outcomes, and their recommendations for future communication, given similar circumstances.ResultsSurveys were received from 127 of 266 (48 percent) of eligible respondents; 98 percent thought that UWMC was right to inform them about this event, and mean satisfaction with the disclosure was 7.7 on a 0 to 10 scale. Of the 127 respondents, 64 percent were somewhat or very concerned that the endoscope cleaning problem might cause them health problems; 60 percent reported their impressions of UWMC’s honesty and integrity had increased; 31 percent said their perceptions of the quality of care had increased; 94 percent agreed that institutions should tell patients about any error in their care, even when the risk of harm was low, although 28 percent agreed that such notifications would make them anxious. Respondents who reported concern that the event could cause them health problems were less likely to be satisfied with the institution’s disclosure. Patients cited their right to know information material to their own health and healthcare as an important reason for disclosure.ConclusionRecipients of disclosure of a large-scale, low-harm/low-risk event overwhelmingly supported being told of the event and endorsed notification of patients for similar events in the future. Although informing patients may cause concern for some, institutions should ensure their disclosure policies and procedures reflect their patients’ preferences. (shrink)

The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in (...) medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent. This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis. (shrink)

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of (...) applicable government regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research. (shrink)

Self-disclosure is the key prerequisite for the provision of help and professional intervention in the case of mental difficulties. Self-harming behaviour is a problem in this area that has been a remarkably strong taboo, and as such, this form of behaviour is often hidden. The most at risk category in this context are adolescents who demonstrably receive the least psychological intervention and for whom self-harm is a high-risk behaviour. This study observes the prevalence of self-harming behaviour in a sample (...) of 2,210 adolescents aged from 11 to 19, and subsequently observes the willingness of the subjects to self-disclose self-harming behaviour in a sample subset of 1,002 self-harming adolescents. 55.2% of self-harmers were willing to provide data on this topic; and only 51.5% of them stated that they had disclosed their self-harming behaviour to someone else, most frequently to their peer. Female subjects disclosed this information significantly more often than men and were significantly more willing to provide data about their behaviour in this area. There were no age specificities observed in the self-disclosure by self-harming adolescents. The analysis of the results suggests a need to provide the target group of adolescents with information regarding the help available to self-harming individuals as well as a need of further scientific observation of possible barriers, facilitators or interventional variables. (shrink)

Incidental findings and secondary findings, being results that are unrelated to the diagnostic question, are the subject of an important debate in the practice of clinical genomic medicine. Arguments for reporting these results or not doing so typically relate to the principles of autonomy, non-maleficence and beneficence. However, these principles frequently conflict and are insufficient by themselves to come to a conclusion. This study investigates empirically how ethical principles are considered when actually reporting IFs or SFs and how value conflicts (...) are weighed. A qualitative focus group study has been undertaken, including a multidisciplinary group of professionals from Belgian centres for medical genetics. The data were analysed thematically. All eight Belgian centres participated in this study. Ethical values were frequently referred to for disclosure policies on IFs and SFs. Participants invoked respect for patient autonomy to support the disclosure of IFs and opt-out options for IFs and SFs, non-maleficence for the professional delineation of reportable IFs and opt-out options for IFs and SFs and beneficence for the mandatory reporting of actionable IFs, the delineation of reportable IFs and a current decline of actively pursued SFs. Professional assumptions about patients’ genetic literacy were an important factor in the weighing of values. In line with the traditional bioethical discourse, the mandatory reporting of actionable IFs might be interpreted as a “technological, soft paternalism”. Restricting patients’ choices might be acceptable, but then its motives should be valid and its beneficent outcomes highly plausible. Hence, the presuppositions of technological, soft paternalism - patients’ inability to make informed decisions, normative rationality, the efficacy of beneficent outcomes and the delineated spectrum of beneficence - should be approached critically. Moreover, distributive justice should be considered an important value in the delineation of the current scope of the ethical debate on IFs and SFs. This study of guiding values may stimulate the debate on the ethical grounds for a solid policy on IFs and SFs internationally. (shrink)