Supporting Hamilton’s inclusive fitness theory, archival analyses of inheritance patterns in wills have revealed that people invest more of their estates in kin of closer genetic relatedness. Recent classroom experiments have shown that this genetic relatedness effect is stronger for relatives of direct lineage (children, grandchildren) than for relatives of collateral lineage (siblings, nieces, nephews). In the present research, multilevel modeling of more than 1,000 British Columbian wills revealed a positive effect of genetic relatedness on proportions of estates allocated to (...) relatives. This effect was qualified by an interaction with lineage, such that it was stronger for direct than for collateral relatives. Exploratory analyses of the moderating role of benefactors’ sex and estate values showed the genetic relatedness effect was stronger among female and wealthier benefactors. The importance of these moderators to understanding kin investment in modern humans is discussed. (shrink)

The relationship between corporate social responsiveness and profitability is investigated in a sample of corporate directors. The findings show there is no relationship between the level of director social responsiveness and corporate profitability. The implications of these results are discussed, especially as they relate to concerns about corporate governance.

Patronizing the Public is the first detailed and comprehensive examination of how American philanthropy has transformed culture, communication, and the humanities. Drawing on an impressive range of archival and secondary sources, the chapters in the volume shed light on philanthropic foundations have shaped numerous fields, including film, television, radio, journalism, drama, local history, museums, as well as art and the humanities in general.

One of the leading cognitive models of auditory verbal hallucinations (AVHs) proposes such experiences result from a disturbance in the process by which inner speech is attributed to the self. Research in this area has, however, proceeded in the absence of thorough cognitive and phenomenological investigations of the nature of inner speech, against which AVHs are implicitly or explicitly defined. In this paper we begin by introducing philosophical phenomenology and highlighting its relevance to AVHs, before briefly examining the evolving literature (...) on the relation between inner experiences and AVHs. We then argue for the need for philosophical phenomenology (Phenomenology) and the traditional empirical methods of psychology for studying inner experience (phenomenology) to mutually inform each other to provide a richer and more nuanced picture of both inner experience and AVHs than either could on its own. A critical examination is undertaken of the leading model of AVHs derived from phenomenological philosophy, the ipseity disturbance model. From this we suggest issues that future work in this vein will need to consider, and examine how interdisciplinary methodologies may contribute to advances in our understanding of AVHs. Detailed suggestions are made for the direction and methodology of future work into AVHs, which we suggest should be undertaken in a context where phenomenology and physiology are both necessary, but neither sufficient. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of Health and (...) Human Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

A resurgence of interest in inner speech as a core feature of human experience has not yet coincided with methodological progress in the empirical study of the phenomenon. The present article reports the development and psychometric validation of a novel instrument, the Varieties of Inner Speech Questionnaire , designed to assess the phenomenological properties of inner speech along dimensions of dialogicality, condensed/expanded quality, evaluative/motivational nature, and the extent to which inner speech incorporates other people’s voices. In response to findings that (...) some forms of psychopathology may relate to inner speech, anxiety, depression, and proneness to auditory and visual hallucinations were also assessed. Anxiety, but not depression, was found to be uniquely positively related to both evaluative/motivational inner speech and the presence of other voices in inner speech. Only dialogic inner speech predicted auditory hallucination-proneness, with no inner speech variables predicting levels of visual hallucinations/disturbances. Directions for future research are discussed. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A New Look at Animal-to-Human Organ TransplantationCharles R. McCarthy (bio)The acute shortage of organs available for transplantation into human beings combined with a new scientific understanding of the immune systems of both humans and animals make it probable that animal-to-human solid organ transplants (xenografts) may soon be attempted at a frequency rate unknown in the past. 1 Optimism about successful animal-to-human organ transplantation is greater than at any (...) previous time. The creation of a reliable supply of animal organs appears to be technically feasible. At least five major transplant centers in the United States are currently considering plans to pursue xenotransplantation. Although, at the time of this writing, no federal guidelines prohibit animal-to-human organ transplantation, the institutions considering such programs are awaiting deliberations on the subject by the Institute of Medicine (IOM), the Food and Drug Administration (FDA), and the Department of Health and Human Services (DHHS).The demand for organs suitable for transplantation into human beings greatly exceeds the supply. According to the United Network for Organ Sharing (UNOS 1996a), approximately 44,000 patients in the United states awaited organ transplantation at the end of 1995. In 1994, more than 3,000 patients died while on the transplant waiting list, and the demand for transplantable organs increases annually (UNOS 1996b). The figures do not include the hundreds or perhaps thousands of patients who could profit from a transplant, but who do not meet the requirements of the UNOS waiting list. Even if efforts to persuade persons to donate organs are redoubled, and even if the consent to donate organs should become a legal presumption, there is little prospect of developing a sufficient supply of transplantable human organs to meet the growing demand.As technical and biological barriers to successful animal-to-human xenografts are lowered, the prospect of raising dedicated colonies of animals, genetically altered to reduce the chances that human hosts will reject organs derived from them, is being seriously discussed. 2 Such colonies do not exist at the present time. [End Page 183] However, if new techniques for animal-to-human transplantation prove successful, it is likely that animal colonies will be established to provide a ready and predictable supply of organs for transplantation to humans. Some believe that commercial investment in colonies of purpose-bred animals to serve as a source of transplantable organs is close at hand (Leventhal 1994).New drugs and new combinations of existing drugs have improved the chances of successful medical outcomes for patients who receive solid organ transplants. It is now recognized that serial application of immunosuppressive drugs can reduce the likelihood of both short- and long-term organ rejection (Makowka 1994). Improved understanding of both human and animal immune systems, insights into histocompatibility, new agents to control graft-versus-host disease, animal breeding programs for the production of transgenic animals, and improved surgical techniques have opened, as never before, the possibility of successful transfer of organs from animals to humans. Some rate the chances of good patient outcomes (usually measured in terms of time of patient survival) as high, others make more conservative predictions, but virtually all experts believe that the chances for successful human patient outcomes resulting from xenotransplantation are improved. Because many patients face immanent death unless their organs can be replaced, there can be little doubt that many humans will readily consent to xenotransplantation.History Suggests CautionDespite the advances in immunosuppression, the frequency of failure in past animal-to-human xenograft attempts should temper the optimism of the transplant community. To date, all efforts to prolong human life by implanting solid organs from animals into human recipients have failed. The first attempts at animal-to-human xenotransplantation early in the twentieth century resulted in the early death of all recipients (Neuhof 1923). More sophisticated efforts at xenotransplantation occurred in the late 1960s and early 1970s, a period when anti-rejection drugs began to make allografts more feasible. Although one human recipient of a xenograft survived for nine months (with poor quality of life), most patients died within a matter of minutes, hours, or a few days following the transplantation of organs from chimpanzees or baboons (Starzl... (shrink)

A classic work of the European Enlightenment--and one of the most popular, if scandalous, in its day--the Persian Letters captures, in an engaging epistolary format, the transformational spirit of the era. Amid an ongoing tale rife with sex, violence, and wit, the work addresses a diverse range of topics from human nature and the origins of society, to the nature and role of religious belief, the role of women, statecraft, justice, morality, and human identity. With skill and artistry, Raymond (...) MacKenzie’s stunning new translation accurately reflects the mood and character of the work. In his richly conceived Introduction, MacKenzie seamlessly weaves together an overview of the period with details of Montesquieu’s life, including the influences that inspired the _Persian Letters_, the character and power of the book, and its reception. This edition also includes a Calendar of the _Persian Letters_, a Bibliography of Works in English, and a Bibliography of Works in French. Related texts provide insight into the legacy of the _Persian Letters_. They include selections from works by George Lyttelton, Voltaire, Oliver Goldsmith, and Maria Edgeworth. (shrink)

The article offers a proposal about natural law inquiry in terms of knowledge attendant in the practices of a craft. We begin by discussing Aristotle’s analogical use of crafts in considering knowledge of ethics and politics in the Nicomachean Ethics. We inquire further into craft as a way of knowing by consulting the works of psychologist Mihaly Csikszentmihalyi and sociologist Richard Sennett. The framework of a craft is connected to moral realism through an analysis of works by Iris Murdoch and (...) Simone Weil. Finally we provide a proposal for natural law inquiry in relation to the embodied and embedded nature of craft. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

In February 1993, Judge Charles R. Richey of the United States District Court issued a summary judgment in the case of Animal Legal Defense Fund, et al. v. The Secretary of Agriculture, et al. The decision, which was in favor of the Animal Legal Defense Fund, requires the U.S. Department of Agriculture to withdraw its current regulations governing exercise for dogs and the psychological well-being of nonhuman primates used for biomedical research and to issue new regulations containing only minimum, (...) measurable standards. Both plaintiffs and defendants contended that they were seeking the best interests of the laboratory animals. The issue at stake is whether animals are better protected if the government establishes limited minimal standards or is allowed to require institutions to provide additional standards, which will be judged on the basis of their effectiveness in maintaining healthy animals. The Court avoided this dispute, however, by placing primary emphasis on applying the Administrative Procedures Act and stating that it was merely interpreting the "plain meaning" of the Animal Welfare Act, as amended. In this article, arguments are presented for interpreting the law in a far more flexible way than Judge Richey did. The conclusion is also reached that there were no winners in the Animal Legal Defense Fund case and that the real losers are the laboratory animals. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When OPRR Comes Calling:Enforcing Federal Research RegulationsCharles R. Mccarthy (bio)In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted—contrary to federal regulations—without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in many (...) institutions, including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation?Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.1BackgroundThe Department of Health and Human Services (DHHS) is the largest supporter of biomedical and behavioral research in the world. Somewhere between 25 and 33 percent of its medical research budget is devoted to the support of research involving human subjects. In accordance with the Public Health Service Act, DHHS has issued Regulations for the Protection of Human Subjects (45 CFR 46). The DHHS Secretary has delegated responsibility for promulgating and administering the regulations to the Office for Protection from Research Risks (OPRR), which is located within the National Institutes of Health.When an institution receives an award from a DHHS agency to carry out research involving human subjects, it is required to negotiate, or to have on file, an "assurance of compliance" document that provides detailed information [End Page 51] specifying how the institution plans to comply with the regulations for the protection of human subjects. Most major research institutions in the country have on file a "multiple project assurance" (MPA) document, which extends DHHS regulations to all human subjects research conducted or sponsored by that institution, irrespective of the source of funding. The regulations and the assurance of compliance require any research project involving human subjects to be reviewed and approved by an institutional review board (IRB) prior to initiation of the research. In addition, the project must be re-reviewed by the IRB at appropriate intervals—in no case, less than once a year. Institutional compliance with these and other requirements of the regulations has improved during the last 30 years and appears to be at a high level. However, from time to time, allegations of noncompliance arise, as they did in the George Washington University embryo-splitting experiment, and set in motion the review process described below.How do Allegations of Noncompliance Arise?Allegations or indications of noncompliance with federal regulations for the protection of human subjects may come from a variety of sources. Most commonly, the institution's IRB discovers that research involving humans is going forward without the required prior IRB review and approval, or that approved research is being conducted in a way that is contrary to the stipulations of the IRB. The Hall-Stillman case came to the attention of George Washington University's IRB because the research protocol was submitted to the IRB after the research had been carried out. In this case, there could be no doubt that an infraction had occurred.Information about possible noncompliance also frequently derives from a funding agency's Initial Review Group (IRG) (commonly called a Study Section) when it has reason to suspect noncompliance in a project it is reviewing for possible funding. An actual case that occurred some years ago involved a research application that proposed to perform brain biopsies on normal volunteers. The IRG that reviewed the application lost little time in questioning whether an IRB had approved the protocol. In this case, it was not enough for the IRG to recommend disapproval of the proposal for funding; it also was obliged to report the possible infraction to OPRR.Whistleblowers, including research subjects, nurses, students, members of the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Update on Waiving Informed Consent in Emergency ResearchCharles R. McCarthyMadam: The closing statement of my article on Waiving Informed Consent in Emergency Research published in the June 1995 issue of the Kennedy Institute of Ethics Journal was: "No doubt we shall hear more of this issue."Indeed, we have heard much more on this issue. (1) In May 1995, after my article had already gone to press, the Food and (...) Drug Administration (FDA) and the National Institutes of Health (NIH) jointly published a report on the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. (2) On July 26, 1995, the Department of Health and Human Services (HHS) published in the Federal Register a Notice of Action Related to Emergency Research Activity (60 FR 38353-54). This action constituted a waiver of the requirement to obtain prior informed consent from subjects, as required by the Department's Regulations for the Protection of Human Subjects (45 CFR 46), for one specific NIH-funded project under strictly defined circumstances. (3) On September 21, 1995, FDA published a proposed rule to amend its current informed consent regulations (21 CFR 50) to permit harmonization of federal policies on emergency research and to reduce confusion as to when such research can proceed without obtaining prior informed consent from research subjects. The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human research subject.The HHS waiver (a harbinger of a proposed amendment to its regulations) and the FDA proposed rule are intended to be harmonized so that an Institutional Review Board (IRB) in compliance with one set of regulations relative to the waiver of informed consent will be, ipso facto, in compliance with the other set of regulations.In brief: The FDA proposed amendments will allow an IRB to waive informed consent in emergency situations when:1. The human subjects are in a life threatening condition;2. Obtaining informed consent is not feasible because: (i) the subjects will not be able to provide consent because of their medical condition, (ii) the intervention must be administered before consent from legally authorized representatives is feasible, (iii) there is no reasonable way to identify prospectively the individuals likely to become eligible for the research because the emergence of the condition to be studied cannot be predicted reliably in particular individuals; [End Page 385]3. The opportunity to participate is in the interest of the subjects because: (i) a life threatening situation necessitates intervention, (ii) the risk of the intervention is reasonable in the light of what is known about the medical condition and the patient, the risks and benefits of current therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;4. The research could not practicably be carried out without the waiver;5. Additional protection of the rights and welfare of the subjects will be provided including, at least: (i) consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn, (ii) public disclosure prior to commencement of the study sufficient to describe the study and its risks and benefits, (iii) public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results, and (iv) the establishment of an independent data and safety monitoring board;6. The IRB has reviewed and approved an informed consent document for use with subjects or legal representatives in situations in which obtaining such consent may be feasible for some subjects.The preamble to the proposed amendments to the regulations and the amendments themselves contain much more information than is presented here. Readers are therefore encouraged to study the proposals carefully. The public comment period ended November 6, and the FDA is expected to issue a final rule in 1996.Charles R. McCarthyKennedy Institute of Ethics Georgetown University Washington, DCCopyright © 1995 The Johns Hopkins University Press... (shrink)

Preparing the Next Generation of Oral Historians is an invaluable resource to educators seeking to bring history alive for students at all levels. Filled with insightful reflections on teaching oral history, it offers practical suggestions for educators seeking to create curricula, engage students, gather community support, and meet educational standards. By the close of the book, readers will be able to successfully incorporate oral history projects in their own classrooms.

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (...) (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)

PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against (...) providing results; and barriers to providing results. RESULTS: Four hundred nine parents (including 19 of deceased children) and 86 adolescents responded. Most parents (n = 385; 94.2%) felt that they had a strong right to research results. For positive results, most wanted a letter or e-mail summary (n = 238; 58.2%) or a phone call followed by a letter (n = 100; 24.4%). If the results were negative, phone call (n = 136; 33.3%) or personal visits (n = 150; 36.7%) were preferred. Parents wanted the summary to include long-term sequelae and suggestions for participants (n = 341; 83.4%), effect on future treatments (n = 341; 83.4%), and subsequent research steps (n = 284; 69.5%). Understanding the researcher was a main concern about receiving results (n = 145; 35.5%). Parents felt that results provide information to support quality of life (n = 315; 77%) and raise public awareness of research (n = 282; 68.9%). Adolescents identified similar preferences. CONCLUSION: Parents of children with cancer and adolescents with cancer feel strongly that they have a right to be offered research results and have specific preferences of how and what information should be communicated. (shrink)

This study analyzes a series of complex, ambivalent literary responses to the decades of civil turmoil in seventeenth-century England that simultaneously demanded public commitment and prompted private withdrawal. From their various perspectives the Royalist writers raised in the humanist tradition are shown to appreciate anew the value of patient fortitude.