Reviews the book, Discovering existence with Husserl by Emmanuel Levinas, translated by Richard A. Cohen and Michael B. Smith. The work of Emmanuel Levinas represents one of the most innovative and influential expositions of twentieth-century phenomenology. His thought represents a radically new interpretation of the phenomenological project, the meaning of ethics, and the role of ontology and metaphysics in our discussion of the Other and the Good. 2012 APA, all rights reserved).

The Quality Attestation Presidential Task Force has made a thoughtful and thorough contribution to the establishment of clinical ethics consultation as a professional field. As Eric Kodish, Joseph J. Fins, and colleagues indicate, quality attestation is another step in bringing greater accountability and transparency to CEC. To complete this process, however, the work of the QAPTF must be situated within a larger project. As the field further develops, there will be a move toward restricting CEC to those who (...) have demonstrated, by means of this version of the quality attestation or an eventual iteration of it, that they are capable of conducting an ethics consultation with the skill, knowledge, and rigor necessary. This raises the question of how potential consultants will gain the experience required to produce a portfolio of cases when only those who are qualified are permitted to perform CECs, either by their institution or by some external evaluator, such as The Joint Commission. Now may be the time to begin thinking about further developments in the field that will complement both current academic training programs and the quality attestation process. For this, we might look to the Association for Clinical Pastoral Education for its model for certifying educators of chaplains who wish to become professionals. (shrink)

BackgroundInternationally, clinical ethics support has yet to be implemented systematically in community health and care services. A large-scale Norwegian project attempted to increase ethical competence in community services through facilitating the implementation of ethics support activities in 241 Norwegian municipalities. The article describes the ethics project and the ethics activities that ensued.MethodsThe article first gives an account of the Norwegian ethics project. Then the results of two online questionnaires are reported, characterizing the scope, activities and organization of the ethics activities (...) in the Norwegian municipalities and the ethical topics addressed.ResultsOne hundred and thirty-seven municipal contact persons answered the first survey, whereas 217 ethics facilitators from 48 municipalities responded to the second. The Norwegian ethics project is vast in scope, yet has focused on some institutions and professions whilst seldom reaching others. Patients and next of kin were very seldom involved. Through the ethics project employees discussed many important ethical challenges, in particular related to patient autonomy, competence to consent, and cooperation with next of kin. The “ethics reflection group” was the most common venue for ethics deliberation.ConclusionsThe Norwegian project is the first of its kind and scope, and other countries may learn from the Norwegian experiences. Professionals have discussed central ethical dilemmas, the handling of which arguably makes a difference for patients/users and service quality. The study indicates that large scale implementation of CES structures for the municipal health and care services is complex, yet feasible. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome Project and BioethicsEric T. Juengst, Ph.D. (bio)The fifteen-year "human genome project" at the National Institutes of Health and the Department of Energy officially began on October 1, 1990. With it began a new dimension in federally supported scientific research: concurrent funding for work to anticipate the social consequences of the project's research and to develop policies to guide the use of the knowledge it produces. As (...) a result, the National Center for Human Genome Research (NCHGR) at NIH will support the largest public investment in bioethical analysis to date.NCHGR was established to work with other federal, private, and international organizations on the scientific effort to characterize the form and content of the human genome. The research will yield information—high-resolution genetic linkage and physical maps of all the human chromosomes as well as human DNA sequence data—that will be a resource for studies of gene structure and function. It will greatly increase our understanding of the genetic aspects of human health and disease. That increased understanding will eventually provide insights into the prevention and treatment of the 3,000 known inherited disorders, and of conditions caused by our (gene-governed) physiological reactions to pathogens, toxins, and mutagens of external origin.It has been clear since the conception of the human genome project, however, that professional and public deliberations concerning the responsible use of genetic information must be a part of the process. The most immediate consequence of genome research will be the development of new diagnostic and predictive tests, well in advance of corresponding therapeutic or curative advances. The implications of acquiring and using that knowledge about individuals raise policy questions at many levels within society. The primary purpose of the Ethical, Legal and Social Implications Program at the NCHGR is to anticipate and address these questions early in the life of the scientific project, to help optimize the [End Page 71] benefits to human welfare and opportunity from the new knowledge, and to guard against its misuses.The program has identified three sets of questions as particularly important to pursue as the genome initiative proceeds:1.Issues involved in the integration of new genetic tests into medical practice. Human genome research is expected to increase greatly the number of gene-based diagnostic and prognostic tests available to health professionals. The bioethical policy problems involved in integrating those tests effectively into medical practice include developing standards for:— accuracy and quality control of genetic tests;— medical indications for testing and design of testing protocols;— professional responsibilities of clinicians who perform tests;— confidentiality of information obtained from testing;— access to and use of test results by third parties, such as health insurers; and— reimbursement for testing and test-related counseling.These are problems for both those charged with regulating the use of new genetic tests and for those establishing the standards of practice within the health professions. Thus, in addition to soliciting and funding scholarly research proposals on both the factual and normative questions raised by these problems, the program is commissioning a major new study by the National Academy of Sciences/Institute of Medicine aimed at providing professional guidelines for the integration of genetic services into mainstream medical practice.2. Issues involved in educating and counseling individuals about genetic test results. The primary risk that health professionals will face in using genetic tests is the misinterpretation of their findings and the resulting potential for psychological trauma, stigmatization, and discrimination. Sometimes, out of ignorance, patients, families, and social institutions already stigmatize genetic disorders and treat those with them unfairly. This risk broadens as the genetic elements of more health problems are uncovered and gene-based tests for susceptibilities and carrier states are developed.To protect against these risks, NCHGR is soliciting and supporting projects aimed at improving professional and public understanding of these tests and their implications. For example, a philosopher is leading a team of geneticists and physicians in a scholarly effort to clarify [End Page 72] concepts of genetic susceptibility and draw out the social meaning of their different interpretations. Other projects involve social scientific studies of genetic risk perceptions, stigmatization, and discrimination. The conclusions of these studies, and... (shrink)

A heated debate surrounds the significance of reproducibility as an indicator for research quality and reliability, with many commentators linking a "crisis of reproducibility" to the rise of fraudulent, careless and unreliable practices of knowledge production. Through the analysis of discourse and practices across research fields, I point out that reproducibility is not only interpreted in different ways, but also serves a variety of epistemic functions depending on the research at hand. Given such variation, I argue that the (...) uncritical pursuit of reproducibility as an overarching epistemic value is misleading and potentially damaging to scientific advancement. Requirements for reproducibility, however they are interpreted, are one of many available means to secure reliable research outcomes. Furthermore, there are cases where the focus on enhancing reproducibility turns out not to foster high-quality research. Scientific communities and Open Science advocates should learn from inferential reasoning from irreproducible data, and promote incentives for all researchers to explicitly and publicly discuss their methodological commitments, the ways in which they learn from mistakes and problems in everyday practice, and the strategies they use to choose which research component of any project needs to be preserved in the long term, and how. (shrink)

While cadaver dissection remains an unmatched learning tool for structural anatomy, recent shifts in medical culture and pedagogy indicate that developing humanistic practices and fostering empathic responses are crucial components of early medical education. The Donor Letter Project was designed to accompany a traditional dissection curriculum, and the pilot, described here, tested its quality and efficacy. In 2017, family members of recently deceased donors to the Colorado State Anatomical Board were invited to submit letters about their loved ones, and (...) forty-seven first-year medical students at the University of Colorado School of Medicine volunteered to read the letters after their human anatomy course. The students then completed a survey about their experience. Because student and donor family responses to the DLP were overwhelmingly positive, the DLP will be repeated with incoming medical school classes, and an addendum to the State Anatomical Board donation application will invite donors to submit letters along with their enrollment materials that may be read by students at the time of donation. (shrink)

Motivation plays an immense role and is one of the key factors for successful and qualitative performance in all spheres of personal and professional engagement of individuals. Therefore, educational institutions, including academia, pay special attention to finding tools for motivating students, but also for motivation of their academic staff. Increased motivation has shown to lead to better performance and better performance inevitably contributes to quality enhancement at both individual and institutional level. The aim of this paper is to present (...) an institutional Ranking and Remuneration Policy based on Key Performance Indicators in four areas identified as the most crucial for successful operation of a higher education institution: teaching and learning, research, staff digital profile, service to society and project-based activities. Southeast European University in North Macedonia has developed KPIs in these four areas through an inclusive and transparent process based on its unique Total Quality Management approach. The policy has been created after many consultations, trials and simulations and its main objective is to enhance institutional academic productivity and effectiveness through a human resource vibration that starts from individual evaluation, motivation and performance differentiation and leads to stimulation for achieving excellence. It is at an initial stage and if tested well in practice, it can serve as a model for other higher education institutions in the country and wider. (shrink)

According to agency theory, agents base their economic decisions on self-interests when adverse selection conditions exist. However, cognitive moral development theory predicts that ethics/morals may influence decision-makers not to behave egoistically. Rutledge and Karim, 173-184) find both the moral reasoning level of the managers and an adverse selection condition affect a manager's project evaluation decisions significantly. Since prior studies have shown that national culture might influence the application of agency theory in project evaluation, this current study uses a different moral (...) development measurement to reexamine Rutledge and Karim's hypotheses in another culture. A total of 73 Taiwanese executive MBA students with an average of 12.17 years work experience participated in this study. We found that both moral development level and adverse selection conditions significantly affect managers' project continuance decisions. The interaction effect of these two factors indicates that, when adverse selection conditions exist, participants with a high level of moral development exhibit less of a tendency to continue an unprofitable project than those with a low level of moral development. With subjects from a different culture, our results confirm the findings of Rutldege and Karim. That is, the effects of moral development and adverse selection conditions on managers' project continuance decisions are robust and can be generalized to different cultures. Implications of the findings of this study to multinational firms are also discussed. (shrink)

Regularly, the question on the quality of philosophical practice is raised. Practicing philosophers, policy makers, scientists and last but not least clients wonder how to assess the quality of philosophical practice. Professionals want to value the format of different practices and clients want to know what to expect from visiting a philosophical practice. Understanding the quality of philosophical practice is important for determining its value and its role in society. Quality indicators can provide such information. A (...) quality indicator is not a norm or criterion. A quality indicator is a sign or signal evoking reflection on the structure and process of the philosophical practice and the outcomes of the philosophizing that takes place there. As quality is an abstract phenomenon related to the way or how a philosophical practice is, the quality indicator should inform us on “the how”of a philosophical practice. With respect to the philosophizing in philosophical practice, reflexivity seems to be essential for recognizing it as philosophy. Just like the color of a litmus paper points at the presence or absence of an acid in a solution, the presence or absence of reflexivity informs us about the quality of the dialogue in philosophical practice. Reflexivity deepens such a dialogue every time it is applied. When applied consciously by the philosophical practitioner it can be called intentional depth. This intentional depth determines the quality of a philosophical practice. (shrink)

Background Consent policies for post-mortem organ procurement (OP) vary throughout Europe, and yet no studies have empirically evaluated the ethical implications of contrasting consent models. To fill this gap, we introduce a novel indicator of governance quality based on the ideal of informed support, and examine national differences on this measure through a quantitative survey of OP policy informedness and preferences in seven European countries. -/- Methods Between 2017–2019, we conducted a convenience sample survey of students (n = (...) 2006) in Austria (AT), Belgium (BE), Denmark (DK), Germany (DE), Greece (GR), Slovenia (SI) and Spain (ES), asking participants about their donation preferences, as well as their beliefs and views about the policy in place. From these measures, we computed indices of informedness, policy support, and fulfilment of unexpressed preferences, which we compared across countries and consent systems. -/- Results Our study introduces a tool for analyzing policy governance in the context of OP. Wide variation in policy awareness was observed: Most respondents in DK, DE, AT and BE correctly identified the policy in place, while those in SI, GR and ES did not. Respondents in opt-out countries (AT, BE, ES and GR) tended to support the policy in place (with one exception, i.e., SI), whereas those in opt-in countries (DE and DK) overwhelmingly opposed it. These results reveal stark differences in governance quality across countries and consent policies: We found a preponderance of informed opposition in opt-in countries and a general tendency towards support–either informed or uninformed–in opt-out countries. We also found informed divergence in opt-in countries and a tendency for convergence–either informed or uninformed–among opt-out countries. -/- Conclusion Our study offers a novel tool for analyzing governance quality and illustrates, in the context of OP, how the strengths and weaknesses of different policy implementations can be estimated and compared using quantitative survey data. (shrink)

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

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

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such (...) risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval. (shrink)

This paper makes a contribution to ongoing debates about whether and how we can empirically assess the potential, limitations, and actual impacts of public-private partnerships in developing countries. Several United Nations and bilateral aid agencies have called for the development of impact assessment methodologies that can help clarify when, how, where, and for whom partnerships work. This paper scrutinizes some of the key assumptions underlying this debate, arguing that no objective ' truth' about the effects of PPPs can be discovered (...) through the use of such methodologies. The paper then investigates what can actually be known about a PPP's effects by testing a PPP IA framework that is recommended by the Organization for Economic Cooperation and Development. This is done using a case study from Pakistan. The paper shows that IA methodology may provide an indication of how well a PPP has fared, but not why the PPP has turned out the way it has. At the same time, win-win and win-lose outcomes may exist simultaneously, even for the same stakeholder in the PPP. While the importance of ensuring proper design, monitoring, and IA of PPPs cannot be denied, their effects must be seen as an outcome of struggles between a variety of actors over the distribution of social and environmental hazards associated with broader processes of economic development and industrialization. (shrink)

The inclusion of stakeholders and knowledge systems is increasingly valued in research to address complex socio-ecological challenges around the world. Often these projects take place in cross-cultural setting where external researchers risk perpetuating historically extractive research models that not only harm local communities but damage the validity of research projects. Responsible community engagement is increasingly recognized as a practice that can improve researcher-community relationships and research quality by incorporating principles of ethics, reciprocity, and power sharing. In partnership with local (...) community leaders, researchers from a U.S. university coded 76 research articles for indicators of responsible community engagement conducted in the Samburu, Kenya community since 2000. Findings from this study suggest that most of the research in Samburu has followed extractive models. Of the 76 articles reviewed many failed to acknowledge ethical protocols, did not address relevance of the study to the local community, and did not report any indication of outreach or community change as a result of the research. While a portion of articles showed evidence of community involvement in the studies, the involvement was primarily limited to secondary roles with little to no shared decision-making power over the research process. We discuss methodological considerations for future research and steps that must be taken in order to shift the norm and practice of academic research in sites such as Samburu, Kenya. (shrink)

Chronic deficiencies of the Greek welfare state and the introduction of austerity measures as part of the international financial bailout agreements have created an explosive cocktail of poverty and social exclusion that severely tested the resilience of the frail social safety net and the demands of equity. The score on the indicators of social quality has worsened considerably as the Greek welfare system was overhauled. This article examines the four conditional factors of social quality from the viewpoint of (...) socio-economic policies and everyday experiences in Greece during the crisis. (shrink)

More and more businesses are aligning their activities with the principles of sustainable development. Therefore they need to adapt their ways of measuring corporate performance. However, it includes issues which may be outside the direct control of the organisation, that are difficult to characterise and often are based on value judgements rather than hard data. The difficulty in measuring performance is further complicated by the fact that many corporations have a complex organisational structure, with different business streams, functions and projects. (...) This paper has used two case studies to explore how the appropriate use of indicators can be a powerful tool in addressing the sustainability of businesses both at a corporate wide level and at a project level. (shrink)

There is an expectation that all researchers will act ethically and responsibly in the conduct of research involving humans and animals. While research ethics is mentioned in quality indicators and codes of responsible researcher conduct, it appears to have little profile in doctoral assessment. There seems to be an implicit assumption that ethical competence has been achieved by the end of doctoral candidacy and that there is no need for candidates to report on the ethical dimensions of their study (...) nor for examiners to assess this integral aspect of researcher development. In the context of ensuring that institutions are fulfilling their responsibility of producing ethically sensitive and competent researchers, it is salient to investigate whether doctoral thesis examiners make comment about ethical issues in their reports. This study analysed an archive of examiner reports to identify the frequency, magnitude and nature of examiner comment about ethics. Although comment was rare examiners provided: prescriptive instruction on ethical review processes; formative instruction on the design, conduct, and reporting of research projects; and positive or negative judgments about a candidate's ethical competence, the latter often aligned with meeting, or not meeting, 'doctoral standards'. The scarcity of ethics in examination criteria and examiner reports implies a silence that needs to be addressed to ensure graduating candidates are prepared to conduct ethical and responsible research. (shrink)

The purpose of the study is to scientifically and technically substantiate the mechanism for the development of food systems within the framework of building an algorithm for ensuring the availability of food products, taking into account the interests of the most vulnerable segments of society. The article focuses on the presence of a variety of available tools in solving the problems of ensuring economic accessibility and assortment sufficiency of food products. However, the authors revealed that the problem of balanced nutrition (...) of children and adolescents has not been worked out due to the presence of both socio-economic and cultural-historical problems. Scientific novelty lies in the development of the theoretical foundations for building the food system of the state based on the application of the Innocenti concept, taking into account the interests of all sectors of society. As a result of the analysis, the need to amend the current legislation aimed at improving the quality of food products is argued. (shrink)

Organic farming is expected to contribute to conserving national biodiversity on farms, especially remnant, old, and undisturbed small biotopes, forests, and permanent grassland. This objective cannot rely on the legislation of organic farming solely, and to succeed, farmers need to understand the goals behind it. A set of indicators with the purpose of facilitating dialogues between expert and farmer on wildlife quality has been developed and tested on eight organic farms. “Weed cover in cereal fields,” was used as an (...) indicator of floral and faunal biodiversity in the cultivated land, and “uncultivated biotope area” on the farm was used as a general measure of wildlife habitats. Functional grouping of herbaceous plants (discriminating between “high conservation value” plant species and “competitive”/“ruderal” species) and low mobility butterflies were used as indicators of conservation value, especially focusing on the few sites left with considerable remnant conservation value. The dialog processes revealed that the organic farmers’ ideas and goals of conservation of wildlife quality were not necessarily the same as for biologists; the farmers expressed very different opinions on the biological rooted idea, that wildlife quality is related to the absence of agricultural impact. However, farmers also stated that the information given by the indicators and especially the dialogue with the biologist had influenced their perception and awareness of wildlife. We conclude that, combined with a dialogue process, using these indicators when mapping wildlife quality could be an important key component of a farm wildlife management advisory tool at farm level. (shrink)

The Clinical Ethics Credentialing Project (CECP) was intiated in 2007 in response to the lack of uniform standards for both the training of clinical ethics consultants, and for evaluating their work as consultants. CECP participants, all practicing clinical ethics consultants, met monthly to apply a standard evaluation instrument, the “QI tool”, to their consultation notes. This paper describes, from a qualitative perspective, how participants grappled with applying standards to their work. Although the process was marked by resistance and disagreement, it (...) was also noteworthy for the sustained engagement by participants over the year of the project, and a high level of acceptance by its conclusion. (shrink)

In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care through the health care spectrum. Within (...) the guidelines there are eight domains to the provision of palliative care. This article focuses on the last, but very significant Domain 8—Ethical and Legal Aspects of Care. (shrink)

Objective: The establishment of patient-centered measures capable of empirically determining meaningful cognitive change after surgery can significantly improve the medical care of epilepsy patients. Thus, this study aimed to develop reliable change indices (RCIs) and standardized regression-based (SRB) change norms for a comprehensive neuropsychological test battery in the German language. Methods: Forty-seven consecutive patients with temporal lobe epilepsy underwent neuropsychological assessments, both before and 12 months after surgery. Practice-effect-adjusted RCIs and SRB change norms for each test score were computed. To (...) assess their usefulness, the presented methods were applied to a clinical sample, and binary logistic regression analyses were conducted to model the odds of achieving improvement in quality of life (QOL) after surgery. Results: The determined RCIs at 90% confidence intervals, and the SRB equations for each test score included in the test battery are provided. Cohen’s kappa analyses revealed a moderate mean agreement between the two measures, varying from slight to almost perfect agreement across test scores. Using these measures, a negative association between improvement in QOL and decline in verbal memory functions after surgery was detected. Significance: To the best of our knowledge, this study is the first to provide RCIs and SRB change norms necessary for the objective determination of neuropsychological change in a comprehensive test battery in the German language, facilitating the individual monitoring of improvement and decline in each patients’ cognitive functioning and psychosocial situations after epilepsy surgery. The application of the described measures revealed a strong negative association between improvement in QOL and decline in verbal memory functions after surgery. (shrink)

The evaluation of the European Moral Case Deliberation Outcomes project (Euro-MCD) has resulted in a revised evaluation instrument, knowledge about the content of MCD (moral case deliberation), and the perspectives of those involved. In this paper, we report on a perspective that has been overlooked, the facilitators’. We aim to describe facilitators’ perceptions of high-quality moral case deliberation and their Euro-MCD sessions. The research took place in Norway, Sweden, and the Netherlands using a survey combined with interviews with 41 (...) facilitators. Facilitators’ perceived that attaining a high-quality MCD implies fostering a safe and respectful atmosphere, creating a wondering mode, being an attentive authority, developing moral reflective skills, reaching a common understanding, and ensuring organisational prerequisites for the MCD sessions. Our central conclusion is that efforts at three levels are required to attain a high-quality MCD: trained and virtuous facilitator; committed, respectful participants; and organizational space. Furthermore, managers have a responsibility to prepare MCD participants for what it means to take part in MCD. (shrink)

This paper analyses the way articles are published in scientific journals in the field of law in the Republic of Moldova, including an experiment with a previously published article. Lack of compliance with journal publishing standards, including peer reviewing of articles, leads to the fact that virtually any article can be published. The examined journals do not perform their natural functions, but are rather used by researchers to report that they have scientific outcomes. The study allows us to consider that (...) publishing in scientific journals is an indicator of the quality of scientific research, as well as an indicator of compliance with scientific research ethical principles. Scientific misconduct and lack of scientific meritocracy that are characteristic of some of the post-Soviet science, are very well reflected in the law field in the Republic of Moldova. (shrink)

This study aims to examine the relationship between public financial management and indicators of well-being among 29 Economic Co-operation and Development (OECD) countries using a balanced panel dataset over the period between 2005 and 2019. This study used a matrix of seven proxy measures of public financial management, which works as an integrated financial system to improve the objective quality of well-being measured by employment, education level, productivity, and wages. Using the generalised method of moments, the estimator's results, indicate (...) that higher government revenues, expenses (% of GDP) lead to lower well-being while the higher net lending /net borrowing, cost of business start-up procedures, and adjusted gross savings (% of GNI) lead to increase well-being measured by spending on education. The higher government revenues, regulatory quality, government effectiveness, and higher net lending /net borrowing lead to improved well-being, while the higher cost of business start-up procedures (% of GNI per capita) leads to lower well-being measured by wages. The higher government revenues, government effectiveness, and higher net lending/net borrowing lead to increased well-being. In contrast, the higher expense (% of GDP) leads to lower well-being measured by productivity labor. The higher government revenues, government effectiveness, regulatory quality, net lending /net borrowing and adjusted gross savings lead to lower well-being, while the higher cost of business start-up procedures leads to increased well-being measured by employment rates. The OECD countries should prepare fiscal policies to ensure the sustainability of public finances in the long run and identify emergency response mechanisms to overcome the challenges of improving the objective quality of well-being. (shrink)

The Clinical Ethics Credentialing Project (CECP) was intiated in 2007 in response to the lack of uniform standards for both the training of clinical ethics consultants, and for evaluating their work as consultants. CECP participants, all practicing clinical ethics consultants, met monthly to apply a standard evaluation instrument, the QI tool , to their consultation notes. This paper describes, from a qualitative perspective, how participants grappled with applying standards to their work. Although the process was marked by resistance and disagreement, (...) it was also noteworthy for the sustained engagement by participants over the year of the project, and a high level of acceptance by its conclusion. (shrink)

Bioethics education has remarkably grown across the globe in the last few decades. The data of the UNESCO Global Ethics Observatory proves that bioethics education is a global phenomenon with various bioethics institutions, teaching programs, and academicians. However, this situation does not mean that bioethics education has reached a stable and flawless level. Especially, the effectiveness of bioethics programs or their quality assessment is a major area that should be analyzed through more academic works. For filling that gap, this (...) article aims to formulate a general framework to address the quality standards and indicators in bioethics education. The article adapts Donabedian’s three approaches—structure, process, and outcome— as three levels to measure quality in bioethics education. The proposed model considers the indicators the ultimate quantifiable points by creating a sequential classification as the three levels, main categories, standards, and indicators, which means that it applies an inductive approach following a path from the indicators to the standards, from the standards to the main categories, and from the main categories to the levels in order to reach a conclusion about the effectiveness of each level. (shrink)

The structure and expectations of societies are constantly changing, developing, and advancing as time demands. Accordingly, the vision, mission, purpose, and objectives of educational institutions are changing and are shaped according to the expectations of the society. School Directors, teachers, and families, briefly the community, should know that schools are institutions that best fulfill children’s learning, and make them feel happy and safe. A cheerful and peaceful school environment always brings academic success. Children who have a quality school life (...) are aware of the responsibility for their behaviors as well as the social responsibilities for their environment. Thus, students who are closely interested in social responsibility projects are not just academically developed; at the same time, their social, emotional, and mental development increases, and their social cohesion and awareness develop. This research aims to examine ways to improve the quality of social life in schools through social responsibility projects to be started as well as opinions by School Directors. In this study, the qualitative method and case study design were used. The study group of this research consisted of 15 teachers working in primary schools affiliated with the Department of Primary Education of the Ministry of National Education. The participants were interviewed through live connections. The findings revealed that students are very willing to take part in social responsibility projects, and significant improvements have been made in their academic achievement; they attended more willingly, and there have been noticeable changes in the quality of the school. (shrink)