Principle Of Respect For Persons Research Articles

Responsible Conduct of Radiology Research

The purpose of the articles in this series is to explain the ethical and legal basis for responsible conduct of radiology research. In the current article, the regulatory framework of human research is explained. There is no overall regulatory process for protecting the rights and welfare of humans participating in research. Instead, legal protections in the United States are an amalgam of regulations from multiple federal and state agencies. The key regulations are from the Department of Health and Human Services, the Food and Drug Administration, and the Federal Privacy Rule of the Health Insurance Portability and Accountability Act. Which of these apply in any situation depends on many factors, including the funding source of the research, the site of the research, and the items being tested. Radiologists conducting human research need to know which regulations apply and how to comply with them. The regulations represent a set of rules based on the ethical principles of respect for persons, beneficence, and justice. Radiologists should understand these ethical principles for situations when the regulations are silent, ambiguous, or incomplete. (c) RSNA, 2005.

Scaling up HIV Testing: Ethical Issues

H 1IV testing is not an end in itself. It is instead a means to an end, in which the ethically acceptable ends are care and access to treatment for people found to be infected and access to adequate preventive means for those who are uninfected. It is obvious that testing is required in order to know who is eligible for treatment. Critical to the testing process, however, is systematically linking testing with existing or planned treatment or prevention programs. Failure to do so would be to treat the individuals tested merely as a means, which would be a violation of the ethical principle of respect for persons. When individuals consent to undergo HIV testing, and their consent appears to be both voluntary and properly informed, the situation seems to be one in which they are serving their own ends by agreeing to be tested. In principle, that may well be true, but additional conditions have to be met. These include adequate information provided in pretest counseling; full voluntariness of consent to be tested; and accurate understanding and expectations on the part of individuals tested. If these conditions are fulfilled, then individuals are serving their own ends in agreeing to be tested. These conditions are necessary for testing to be ethically sound, but they are not sufficient. The major benefit to individuals' learning that they are HIV-positive is access to anti-retroviral therapy (ART), if they meet the medical eligibility criteria and if ART is available. Without the likelihood of receiving treatment, however, being informed of an

The Quality of Informed Consent in a Clinical Research Study in Thailand

btaining the informed consent of participants in clinical studies is a fundamental requirement for ethical research.' Based on the principle of respect for persons, potential research subjects are provided with relevant information about a study so that they can make an informed and voluntary decision about participation. Skepticism and controversy exists, however, about informed consent from research participants in developing countries. In addition to concepts about research and individual choice that might be unfamiliar, developing country participants may be plagued by poverty, illiteracy, and limited access to health care services that make it difficult for them to give valid informed consent.2 Most agree that following the provision of adequate and accurate information about a study, valid informed consent requires at least some knowledge of the study details and a voluntary decision to enroll.3 Evaluation of the quality of informed consent therefore should attempt to measure what participants understand and how freely they made the enrollment decision. A small yet increasing number of studies using quantitative or qualitative methods to evaluate participants' informed consent or to test informed consent interventions have been reported. Yet, only a few published studies from Thailand,4 South Africa,s The Gambia,6 Bangladesh,7 and Haiti,8 have used quantitative methods to survey research participants in developing countries about the informed consent process. Although the results of these studies show mixed comprehension, the paucity and small size of these studies make it difficult to say much about the quality of informed consent in developing countries or to compare it to the quality of informed consent in developed countries. This difficulty is compounded by methodological limitations in the studies that have been conducted in both settings. For example, in some studies the time period between the informed consent process and the administration of the informed consent questionnaire varied from respondent to respondent, even extending to several months.9 In other studies, crucial domains, such as the degree to which subjects felt pressured to participate in the clinical research, were excluded. 10 To assess the quality of informed consent in a developing country while avoiding some of these methodological limitations, we interviewed 141 individuals immediately after they consented to participate in a randomized HIV study in Bangkok, Thailand. In Thai culture, individuals often defer to the authority of the health care professional. However, because there has been a considerable volume of clinical research in Thailand including HIV research, Thai citizens may be more familiar with and experienced in research overall than people in other resource poor countries. Very little is known, however, about the quality of informed consent given by Thai subjects in HIV studies. In this study, individuals were surveyed about their experience with the informed consent process, their understanding of the information they were given about the trial, and the voluntary nature of their decision to join.

A Survey of Researchers[rquo] Practice in Returning Research Results To Research Participants. Oral Abstracts Presented at ASH Annual Meeting 2003.

Background: Offering research results to study participants is increasingly considered an ethical obligation founded on the principle of respect for persons. This practice acknowledges the importance of the participant's contribution in the study and, in some instances, enables the participant to benefit directly from the health information derived from the research. Recent studies have established that there is growing support for this practice among investigators and study participants in highly selected populations. The frequency and means of this practice is unknown in the broader national and international research community.Methods: We pilot-tested a questionnaire, which we designed for this study. It had a high content validity. The questionnaire was designed to document the frequency with which researchers offer return of results to research participants, the means by which researchers offer results, the role of Research Ethics Boards (REBs) in the return of research results, and the demographics of the study participants.We classified all 887 abstracts presented at the American Society of Hematology Annual Meeting in December 2003 according to study type. Only those abstracts involving human subjects were included. Of the 478 eligible abstracts, email addresses for 472 (98.7%) first or senior authors were found using public web sites. The investigators were sent the 4–5 minute survey by email. Two reminders were sent to non-respondents. Responses were downloaded to a secure server and analyzed by descriptive and Chi squared techniques.Results: Interim results were obtained 11 days after initiating the survey. Complete responses were received from 84 of the 471 (18%) investigators. Most responders were physicians (n=68; 81%) and almost half (n=40; 47%) received Research Ethics Board (REB) approval for their study in the United States. Only 23 (27%) investigators had a formal plan for the return of results to study participants. No clear preference for any one means of returning research results was indicated. The majority (n=18; 78%) indicated that they would provide the participant with a choice of whether or not to receive research results and most (n=14; 61%) indicated that they would provide an overall summary of results rather than an overall summary plus individual level results. Reasons for not returning research results included: did not consider it (n=25), contact difficulties (n=22), and participant difficulty in understanding results (n=19). Cost and concern for the patient regarding adverse effects of receiving results were infrequently cited. Only 2 (2%) of investigators reported that their REB mandated the offer of return of research results to all participants. 55 researchers (66%) supported or strongly supported the return of results to participants, 27 (32%) were neutral, and only 2 (2%) opposed or strongly opposed this practice. Updated data and further analyses will be reported at the annual meeting.Conclusion: Investigators in the international research community infrequently offer to return results to research participants, and REBs rarely mandate this practice. Our study reaffirms the findings of other studies that indicate a high level of support for this practice among researchers. Further work is needed to assess participant needs and concerns, and how to bridge the gap between the expressed attitudes of researchers and actual practice.

The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis.

We perform an ethical analysis of European Union Directive 2001/20/EC on the simplification and harmonization of guidelines regarding good clinical practice in the conduct of clinical trials involving drugs. The Directive provides guidance on protecting incapacitated subjects who participate in drug clinical trials. Such guidance promotes society's obligations of beneficence because the participation of incapacitated subjects in research is crucial in advancing the understanding and treatment of serious diseases. The Directive requires proxy consent for incapacitated subjects which adheres to the principle of respect for persons. The Directive also recommends additional safeguards to further protect subjects against exploitation and harm. These include respect for the assent and dissent of incapacitated subjects and the "necessity" and "subject-condition" requirements. While these essential protection mechanisms are commendable, the Directive fails to endorse other safeguards that have been recommended by other research ethics guidelines, especially for riskier research. The Directive's silence regarding research in the emergency setting frustrates the principle of beneficence because the lack of guidance might prove to be a barrier for the conduct of such potentially beneficial research. We conclude that the European Directive fails in many respects to promote several important ethical principles in research involving incapacitated subjects.

The quest for legitimacy: comment on Cox Macpherson's 'To strengthen consensus, consult the stakeholders'.

In this issue of Bioethics, Cheryl Cox Macpherson is critical of the failure of the Council for International Organizations of Medical Sciences (CIOMS) to engage in broad public and stakeholder consultation in the latest revision of the International Ethical Guidelines for Biomedical Research Involving Human Subjects.1 The critique of the CIOMS process is two-fold. First, by not engaging in broad consultation, CIOMS violated the principle of respect for persons and its own requirement that researchers consult with communities. As a result, ‘CIOMS may lose credibility for holding what appears to be a double standard.’2 Second, CIOMS as an ‘organisation that aims to represent either society in general, or a particular constituency’, has an obligation to seek to build a broad consensus on moral issues through public debate.3 CoxMacpherson concludes that ‘CIOMS and similar organisations must put more emphasis on consulting stakeholders, and on globally promoting ethical guidelines and dialogue.’4 Bioethics ISSN 0269-9702 (print); 1467-8519 (online) Volume 18 Number 3 2004

Ethics in Violence Against Women Research: The Sensitive, the Dangerous, and the Overlooked

Traditional disciplinary guidelines are inadequate to address some of the ethical dilemmas that emerge when conducting research on violence against women and girls. This article is organized according to the ethical principles of respect for persons, privacy and confidentiality, justice, beneficence, and nonmaleficence. In the article, I describe dilemmas involved in cross-cultural research, research on children, informed consent, voluntariness, coercion, deception, safety, mandated reporting, and dissemination. In the article, I include examples from qualitative and quantitative studies in many nations. I also offer suggestions for researchers and institutional review boards.

The legacies of liberalism and oppressive relations: facing a dilemma for the subject of moral education

In modern Western moral and political theory the notion of the liberal subject has flourished as the locus of moral experience, interpretation and critique. Through this conceptual lens on subjectivity, individuals are enabled to shape and regulate their interactions in arguably desirable ways, e.g. through principles of respect for persons and the constraints of reciprocal rights, and moral education has largely adopted this perspective. However, this article argues that some kinds of morally significant relations—those framed by social groups related to each other through structures of hierarchical power—constitute a different kind of subjectivity that needs more theoretical and empirical attention. In contrast to four core characteristics of liberal subjectivity, a view of subjectivity that can be located in how individuals are members of particular kinds of social groups is offered. It is argued that unless it can accommodate working with attention to this form of subjectivity as well, moral education runs the risk of itself contributing to forms of oppression such as racism, instead of being a means of combating them.

Critical Thinking, Autonomy and Practical Reason

This article points out an internal tension, or even conflict, in the conceptual foundations of Harvey Siegel’s conception of critical thinking. Siegel justifies critical thinking, or critically rational autonomy, as an educational ideal first and foremost by an appeal to the Kantian principle of respect for persons. It is made explicit that this fundamental moral principle is ultimately grounded in the Kantian conception of autonomous practical reason as normatively and motivationally robust. Yet this Kantian conception openly conflicts with Siegel’s own two-component theory of critical thinking, which on close inspection turns out to be a version of the Humean conception of instrumental practical reason as normatively and motivationally powerless. It is concluded that Siegel cannot have it both ways: he cannot appeal both to means-end and to robust rationality. Siegel’s Kantian justification of the critical thinking educational ideal is, therefore, found wanting in terms of his own Humean premises.

Guidelines for adolescent health research*1

A.There is a critical need for adolescent health research in order to enhance adolescent health and well-being. Both biomedical research and behavioral research have contributed significantly to adolescent health and continue to offer great opportunities to improve adolescent health promotion and disease prevention.B.Adolescents comprise a distinct group, between childhood and adulthood, characterized by developing cognitive capacities and judgment. These emerging abilities directly affect adolescents' capacity to be involved independently in the research process. The arbitrary age threshold used to define majority, usually age 18 years does not adequately consider these emerging abilities. The protection of adolescents in the research process should be informed by a scientific understanding of adolescent cognitive, psychologic, and social development.C.Adolescents best achieve a full and integrated maturity when they are grounded in a supportive and loving family. Adolescents require a secure adult base as they explore the attitudes, values, and beliefs of the larger society. Ideally, no adult is better suited to provide this base than the adolescent's parent. The role of the parent in protecting the adolescent's interests must be honored and facilitated whenever possible and appropriate.D.Risks and benefits to the individual adolescent and adolescents as a group should be considered in evaluating proposed research. The risks and benefits to adolescents of not performing the research should also be considered. Adolescent minors should not be excluded solely because of age from participation in research that might benefit them.E.Researchers generally should involve members of the study population or community in the formulation of research priorities, the purposes and procedures of the study, the safeguards to protect privacy and confidentiality, and the possible applications of the study's findings. Researchers should also provide feedback on research results in a timely fashion.F.Current federal regulations (45 CFR Part 46) and the underlying principles of respect for persons, beneficence, and justice provide an appropriate framework for evaluating the circumstances under which adolescent minors can be involved as subjects in research. These research guidelines are intended to interpret and amplify the current federal regulations in order to facilitate the involvement of adolescents in the research process.G.Institution Review Board (IRB) members and investigators involved in adolescent health research would benefit from guidance in interpreting the regulations as they apply to adolescents with respect to the protection of the rights and welfare of adolescents as research subjects.

Guidelines for adolescent health research

A.There is a critical need for adolescent health research in order to enhance adolescent health and well-being. Both biomedical research and behavioral research have contributed significantly to adolescent health and continue to offer great opportunities to improve adolescent health promotion and disease prevention.B.Adolescents comprise a distinct group, between childhood and adulthood, characterized by developing cognitive capacities and judgment. These emerging abilities directly affect adolescents' capacity to be involved independently in the research process. The arbitrary age threshold used to define majority, usually age 18 years does not adequately consider these emerging abilities. The protection of adolescents in the research process should be informed by a scientific understanding of adolescent cognitive, psychologic, and social development.C.Adolescents best achieve a full and integrated maturity when they are grounded in a supportive and loving family. Adolescents require a secure adult base as they explore the attitudes, values, and beliefs of the larger society. Ideally, no adult is better suited to provide this base than the adolescent's parent. The role of the parent in protecting the adolescent's interests must be honored and facilitated whenever possible and appropriate.D.Risks and benefits to the individual adolescent and adolescents as a group should be considered in evaluating proposed research. The risks and benefits to adolescents of not performing the research should also be considered. Adolescent minors should not be excluded solely because of age from participation in research that might benefit them.E.Researchers generally should involve members of the study population or community in the formulation of research priorities, the purposes and procedures of the study, the safeguards to protect privacy and confidentiality, and the possible applications of the study's findings. Researchers should also provide feedback on research results in a timely fashion.F.Current federal regulations (45 CFR Part 46) and the underlying principles of respect for persons, beneficence, and justice provide an appropriate framework for evaluating the circumstances under which adolescent minors can be involved as subjects in research. These research guidelines are intended to interpret and amplify the current federal regulations in order to facilitate the involvement of adolescents in the research process.G.Institution Review Board (IRB) members and investigators involved in adolescent health research would benefit from guidance in interpreting the regulations as they apply to adolescents with respect to the protection of the rights and welfare of adolescents as research subjects.

Informed Consent and the Capacity for Voluntarism

Objective: Informed consent is built upon the elements of information, decisional capacity, and voluntarism. Of these elements, voluntarism in clinical and research consent is the least well understood. This has interfered with the ability to resolve key ethical problems faced by the field of psychiatry. Method: The author suggests that voluntarism encompasses an individual’s ability to act in accordance with one’s authentic sense of what is good, right, and best in light of one’s situation, values, and prior history. Voluntarism further entails the capacity to make this choice freely and in the absence of coercion. Deliberateness, purposefulness of intent, clarity, genuineness, and coherence with prior life decisions are implicitly emphasized in this construction. Results: The author offers and illustrates a framework for voluntarism in clinical and research consent decisions, focusing on four domains of potential influence: 1) developmental factors, 2) illness-related considerations, 3) psychological issues and cultural and religious values, and 4) external features and pressures. Conclusions: It is hoped that improved understanding of voluntarism will help in our efforts to fulfill the principle of respect for persons in clinical care and research.

Research Subject Advocate: A New Protector of Research Participants

In 2001, the National Center for Research Resources (NCRR) directed the 78 General Clinical Research Centers (GCRC) to develop a Research Subject Advocate (RSA) position. The RSA would report directly to the Principal Investigator (PI) of each GCRC and assure compliance of studies conducted on the GCRC with federal regulations and policies. Seven RSAs agreed to be interviewed about their new role. Website documents, electronic correspondence, and presentations at the first annual national meeting of RSAs were scrutinized using discursive analysis to shed light on this new organizational form and its potential for increased protection of human research participants. The RSA role actualizes the ethical principles of respect for persons, justice, and beneficence that are the foundation of the protection of research participants. The results also reveal the regulatory, institutional, collegial, and personal resources and barriers that assist the RSA in the successful implementation of the RSA role. In addition, issues important to the RSAs are described.

Qualitative Research in Sport Sciences: Is the Biomedical Ethics Model Applicable?

Research in sports science has historically been grounded in positivist traditions. This means that ethics committees may not be adequately sensitized to the ethical problems posed by qualitative research. Qualitative researchers may thus be disadvantaged in the research approval process. Our paper argues that the traditional biomedical ethics model may not always be appropriate in evaluating qualitative proposals. Due to the nature of its methods, qualitative work may have emergent and ongoing ethical issues that require consultation and resolution. We argue that, contrary to the judgements of many ethics committees, methods such as deception and covert observation can be justified if certain conditions are met. In reaffirming a commitment to the overarching ethical principle of respect for persons, we conclude that researchers need to recognize and plan for ethical issues in their work. Likewise, ethics committees need to recognize that qualitative work poses unique problems, but that these need not necessarily be insurmountable obstacles to project approval.

Informed consent and the capacity for voluntarism.

Informed consent is built upon the elements of information, decisional capacity, and volunteerism. Of these elements, voluntarism in clinical and research consent is the least well understood. This has interfered with the ability to resolve key ethical problems faced by the field of psychiatry. The author suggests that voluntarism encompasses an individual's ability to act in accordance with one's authentic sense of what is good, right, and best in light of one's situation, values, and prior history. Voluntarism further entails the capacity to make this choice freely and in the absence of coercion. Deliberateness, purposefulness of intent, clarity, genuineness, and coherence with prior life decisions are implicitly emphasized in this construction. The author offers and illustrates a framework for voluntarism in clinical and research consent decisions, focusing on four domains of potential influence: 1) developmental factors, 2) illness-related considerations, 3) psychological issues and cultural and religious values, and 4) external features and pressures. It is hoped that improved understanding of voluntarism will help in our efforts to fulfill the principle of respect for persons in clinical care and research.

Ethical issues in human genome epidemiology: a case study based on the Japanese American Family Study in Seattle, Washington.

Recent completion of the draft sequence of the human genome has been greeted with both excitement and skepticism, and the potential of this accomplishment for advancing public health has been tempered by ethical concerns about the protection of human subjects. This commentary explores ethical issues arising in human genome epidemiology by using a case study approach based on the ongoing Japanese American Family Study at the University of Washington in Seattle (1994-2003). Ethical issues encountered in designing the study, collecting the data, and reporting the study results are considered. When developing studies, investigators must consider whether to restrict the study to specific racial or ethnic groups and whether community involvement is appropriate. Once the study design is in place, further ethical issues emerge, including obtaining informed consent for DNA banking and protecting the privacy and confidentiality of family members. Finally, investigators must carefully consider whether to report genotype results to study participants and whether pedigrees illustrating the results of the study will be published. Overall, the promise of genomics for improving public health must be pursued based on the fundamental ethical principles of respect for persons, beneficence, and justice.

Aspectos éticos de la investigación biomédica: Conceptos frecuentes en las normas escritas

Most codes and declarations pertaining to the ethics of research involving human subjects have been formulated in response to specific events mostly of a painful or embarrassing nature. Several concepts appearing repeatedly in their texts are highlighted in this paper: principles of respect for persons, beneficence and justice, vulnerability and research propriety. Along with some comments on current revisions of many international guidelines and the role of bioethics committees, a plea is made to have a proactive rather than a reactive stance in ethical regulation of biomedical research.

A Sociological Account of the Growth of Principlism

Bioethicists' attraction to principlism is rooted in a Western view of how matters that affect public ought to be deliberated and decided: their resolution ought to be so structured and constrained that it can be understood and verified even by those at a remove from circumstances of problem. That view of deliberation, itself fostered by Western view of government, has encouraged principlism to spread from its source in human subjects research into other areas of bioethics discourse. The three principles of respect for persons, beneficence, and justice first articulated in Belmont Report and four similar principles published in Beauchamp and Childress's Principles of Biomedical Ethics have structured decisionmaking in bioethics.[1] In this paper I do not address whether these principles are or apply them to problems. Nor do I explain why certain principles have become institutionalized rather than others. Rather, I engage in an investigation of principlism from perspective of sociology of knowledge: Why has use of a small set of principles--whichever they may be--become common in bioethics? The sociology of knowledge assumes that decisionmaking systems, such as principlism, do not become influential because they are the best or correct, but rather because social conditions are right for those promoting system to defeat champions of competing ideas. That an idea is most coherent, for example, is important in this competition only if people in authority to judge legitimacy of ideas agree that coherence is important. Everyone recognizes that to understand dominance of principlism we must go back in history, perhaps to Nuremberg trial. I propose that to understand social determinants of principlism we must go back much farther, to 1494, when first textbook for double-entry bookkeeping was written. This form of bookkeeping is tabulation that any department chair is familiar with: What are our costs for next year; what is our income? And more specifically, are costs associated with this component of business generating returns that justify costs? This process is taken so much for granted it is hard to imagine an alternative. Before invention of this system, however, accounts from businesses were basically a rambling story with that served to assist memory of businessman, but not help with evaluation of businessman's actions.[2] For example, an account from early 14th century England stated: Account of Maurice Hunter and Fynlay Sutor, balies of burgh of Stivelyn, given up at Dunbretan on twenty-fifth day of January, ... of fermes of said burgh for two terms of this account. They charge themselves with .36 [pounds sterling] received on account of fermes of said burgh for year of their account. Whereof, for their superexpenses made in preceding account 40 s. 1 d halfpenny. And in duties to abbot of Cambuskyneth and Dunfermelyn, ... during time of account, 23 [pounds sterling]., 5 s. 4 d. And to Friars Preachers of Stivelyn. .. (p. 40) Double-entry bookkeeping was a major innovation in economic history. Two changes in accounts system also transformed it into a procedure that allowed for calculability, efficiency, and predictability in human action, paving way for modern capitalism. The first change was that new system was a means of discarding information deemed to be extraneous to decisionmaking. After all, does it matter to calculation of profit that Hunter and Sutor live in burgh of Stivelyn? This could be put in an address book. The new accounting just had numbers, with all other information removed. The second change was that these numbers took on a new degree of calculability. Instead of putting proceeds on one list (the account above) and costs on another, these two were translated into a common metric called profit, making an evaluation of each action much more precise. …

Informed Consent and Assent in Human Subject Research

Informed consent is an important aspect of human subject research, designed to uphold individual autonomy and the moral principle of respect for persons. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research articulates three distinct elements of informed consent as "information, comprehension, and voluntariness." These elements are discussed as they apply to informed consent. This article then discusses the concept of child assent. Finally, informed consent as it applies to public health research is discussed.

The ethical basis of psychiatric research: Conceptual issues and empirical findings

The study objective was to clarify the ethical basis of psychiatric research by outlining conceptual issues and empirical findings related to the ethics of human experimentation. A systematic review of scholarly and empirical literature covering three decades was performed. The ethics of human research has come to be understood in relation to the principles of respect for persons, beneficence, justice, and the ideal of informed consent. Subjects who cannot fully participate in informed-consent processes are especially vulnerable to exploitation. Current dilemmas stem from insufficient attention to the vulnerabilities of mentally ill research participants, problems in applying ethical concepts and guidelines to psychiatric research, and claims of research misconduct. Empirical studies indicate that (1) psychiatric symptoms significantly affect informed consent, (2) psychiatric patients may possess certain strengths with respect to research involvement, (3) proxy decision-making is problematic, (4) informed consent is also difficult to attain with the medically ill and others, (5) patients are motivated to participate in research by the hope of personal benefit, (6) ethical aspects of research are poorly documented, and (7) institutional review processes may not be adequate to protect vulnerable subjects. Psychiatric research can be performed ethically, according to standards set throughout the biomedical and behavioral sciences, so long as researchers and institutions are respectful of special ethical issues in human experimentation and strive to include vulnerable study participants fully in research decisions. However, many gaps in the empirical literature exist regarding the specific nature and implementation of ethics principles in psychiatric research. Efforts to advance both science and ethics, including the study of ethical dimensions of human research itself, are essential for the future of psychiatry.