Data Ownership and Management
Data Management Ethics(Annotated Bibliography for Years 1978 – 2015)
1) Anderson, Nicholas R., E. Sally Lee, J. Scott Brockenbrough, Mark E. Minie, Sherrilynne Fuller, James Brinkley, and Peter Tarczy-Hornoch. "Issues in biomedical research data management and analysis: needs and barriers." Journal of the American Medical Informatics Association 14, no. 4 (2007): 478-488.
Abstract: Themes identified in this study suggest that at least some common data management needs will best be served by improving access to basic level tools such that researchers can solve their own problems. Additionally, institutions and informaticians should focus on three components: 1) facilitate and encourage the use of modern data exchange models and standards, enabling researchers to leverage a common layer of interoperability and analysis; 2) improve the ability of researchers to maintain provenance of data and models as they evolve over time though tools and the leveraging of standards; and 3) develop and support information management service cores that could assist in these previous components while providing researchers with unique data analysis and information design support within a spectrum of informatics capabilities.
2) Anderson, Philip C. "The Patchwork Mouse." JAMA 236, no. 2 (1976): 205-205.
Abstract: Over two years ago, selected New York science writers were summoned to a big story concerning the new director of Memorial Sloan-Kettering Cancer Center, Dr Robert Good, whose protege had falsified some highly touted research concerning graft immunology. The protege, William Summerlin, was suspended during a review of his case and then dismissed with a year's salary paid. Throughout the affair, center stage was accorded to Dr Good who, an innovative Minnesotan, was coming into the highly political New York research community and the desirable directorship at Memorial Sloan-Kettering. Readers may be disappointed that this book does not set forth new key issues from this brief, awkward incident after two years of study; validate some conclusion about biomedical ethics; or suggest some elegant way to prevent such falsifications of research data. The analysis is thorough, concerning only small scandal at Memorial Sloan-Kettering.
3) Beckett, Robert. "Communication ethics: Principle and practice." Journal of Communication Management 8, no. 1 (2004): 41-52.
Abstract: Communication ethics, this paper argues, is a discipline ready for application to communication management and is particularly relevant as we enter an “age of information”. With a moral foundation firmly set in the social and human sciences, communication ethics offers managers a means to face unpredictable futures with greater certainty and purpose. This paper outlines an approach in which all decision making and its communication are understood as having an ethical grounding. Such an application empowers managers to act with integrity across the spectrum of their varied communication roles: through management and internal communications, public affairs and marketing; in advertising, media and publishing, and in the use of information technology. Positioned independently from the professional bodies of communication, an interdisciplinary ethics offers practitioners skills and moral frameworks that can be shared across professions and used to compare and evaluate their practice. This paper concludes by presenting a model of communication ethics that individual managers can use to prescribe a more sensitive and dynamic human‐ethical environment.
4) Beyrer, Chris, and Nancy E. Kass. "Human rights, politics, and reviews of research ethics." The Lancet 360, no. 9328 (2002): 246-251.
Abstract: Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review—the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations—can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.
5) Borgman, Christine L. "The conundrum of sharing research data." Journal of the American Society for Information Science and Technology 63, no. 6 (2012): 1059-1078.
Abstract: Researchers are producing an unprecedented deluge of data by using new methods and instrumentation. Others may wish to mine these data for new discoveries and innovations. However, research data are not readily available as sharing is common in only a few fields such as astronomy and genomics. Data sharing practices in other fields vary widely. Moreover, research data take many forms, are handled in many ways, using many approaches, and often are difficult to interpret once removed from their initial context. Data sharing is thus a conundrum. Four rationales for sharing data are examined, drawing examples from the sciences, social sciences, and humanities: (1) to reproduce or to verify research, (2) to make results of publicly funded research available to the public, (3) to enable others to ask new questions of extant data, and (4) to advance the state of research and innovation. These rationales differ by the arguments for sharing, by beneficiaries, and by the motivations and incentives of the many stakeholders involved. The challenges are to understand which data might be shared, by whom, with whom, under what conditions, why, and to what effects. Answers will inform data policy and practice.
6) Blumenthal, David, Eric G. Campbell, Melissa S. Anderson, Nancyanne Causino, and Karen Seashore Louis. "Withholding research results in academic life science: evidence from a national survey of faculty." Jama 277, no. 15 (1997): 1224-1228.
Abstract: Objectives —To identify the prevalence and determinants of data-withholding behaviors among academic life scientists.
Design —Mailed survey of 3394 life science faculty in the 50 universities that received the most funding from the National Institutes of Health in 1993. Participants —A total of 2167 faculty responded to the survey, a 64% response rate. Outcome Measures —Whether respondents delayed publication of their research results for more than 6 months and whether respondents refused to share research results with other university scientists in the last 3 years.
Results —A total of 410 respondents (19.8%) reported that publication of their research results had been delayed by more than 6 months at least once in the last 3 years to allow for patent application, to protect their scientific lead, to slow the dissemination of undesired results, to allow time to negotiate a patent, or to resolve disputes over the ownership of intellectual property. Also, 181 respondents (8.9%) reported refusing to share research results with other university scientists in the last 3 years. In multivariate analysis, participation in an academic-industry research relationship and engagement in the commercialization of university research were significantly associated with delays in publication. Odds ratios (ORs) and 95% confidence intervals (Cls) were 1.34 (1.07-1.59) and 3.15 (2.88-3.41), respectively. Variables associated with refusing to share results were conducting research similar to the Human Genome Project (OR, 2.09; 95% CI, 1.75-2.42), publication rate (OR, 1.02; 95% CI, 1.01-1.03), and engagement in commercialization of research (OR, 2.45; 95% CI, 2.08-2.82). Conclusions —Withholding of research results is not a widespread phenomenon among life-science researchers. However, withholding is more common among the most productive and entrepreneurial faculty. These results also suggest that data withholding has affected a significant number of life-science faculty and further study on data-withholding practices is suggested.
7) Brandt, Allan M. "Racism and research: the case of the Tuskegee Syphilis Study." Hastings Center Report 8, no. 6 (1978): 21-29.
Abstract: The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African-American men in Alabama. They were told that they were receiving free health care from the U.S. government. The Public Health Service started working on this study in 1932 during the Great Depression, in collaboration with the Tuskegee Institute, a historically black college in Alabama. Investigators enrolled in the study a total of 600 impoverished sharecroppers from Macon County, Alabama. Of these men, 399 had previously contracted syphilis before the study began, and 201 did not have the disease. The men were given free medical care, meals, and free burial insurance for participating in the study. None of the men infected were ever told they had the disease, nor were any treated for it with penicillin after this antibiotic became proven for treatment. According to the Centers for Disease Control, the men were told they were being treated for "bad blood", a local term for various illnesses that include syphilis, anemia, and fatigue. The 40-year study was controversial for reasons related to ethical standards, primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. Revelation in 1972 of study failures by a whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent communication of diagnosis, and accurate reporting of test results.
8) Chalmers, Iain. "Preventing scientific misconduct." The Lancet 368, no. 9534 (2006): 450.
Abstract: Given the likely extent of scientific misconduct, new ideas for preventing it are welcome. However, more thought needs to be given to how to rank the elements of the “slippery slope between honest errors and intentional fraud” proposed by Magne Nylenna and Sigmund Simonsen (June 10, p 1882),1 at least as far as clinical research is concerned. If one assesses the sins they have ranked in terms of their potential for doing harm to patients, biased reporting of research surely has far more serious practical consequences than undeserved authorship and plagiarism.
9) Daley, Kathryn. "The wrongs of protection: Balancing protection and participation in research with marginalised young people." Journal of Sociology (2013): 1440783313482365.
Abstract: Protecting participants – especially the vulnerable and/or young – is essential to respecting individuals and doing so upholds the merit and integrity of research. Research is a way of improving the lives of the vulnerable as research informs policy and service provision. Research participants need to be protected, but as their right, they also need to be able to participate in research as a way of being heard on matters which affect them. This article argues that ethical review of research is so heavily focused on minimising risk that young people’s right to participate in discussion is often overlooked. I use my own research with young people who have experienced problematic substance use as a running case study to discuss the tension between balancing protection and participation in research design and offer strategies for balancing the two when designing research.
10) De Vries, Raymond, Melissa S. Anderson, and Brian C. Martinson. "Normal misbehavior: Scientists talk about the ethics of research." Journal of Empirical Research on Human Research Ethics 1, no. 1 (2006): 43-50.
Abstract: Those concerned with protecting the integrity of science generally focus on the serious but rare infractions of falsification, fabrication, and plagiarism (FFP). While the violations of FFP are clear threats to the quality of scientific work and public trust in science, are they the behaviors that researchers themselves find most troubling? Noticing that scientists seldom are asked to report their perceptions of the behaviors that pose problems for the enterprise of science, we conducted six focus groups with researchers from major research universities. A total of 51 scientists participated in our focus-group discussions, which lasted from 1.5 to 2 hours each. We found that while researchers were aware of the problems of FFP, in their eyes misconduct generally is associated with more mundane, everyday problems in the work environment. These more common problems fall into four categories: The meaning of data, the rules of science, life with colleagues, and the pressures of production in science. Focus on the “normal misbehaviors” that are part of the ordinary life of researchers allows us to see the way the organization of science generates both compliance and deviance from ethical norms.
11) Drahos, Peter. "INDIGENOUS KNOWLEDGE, INTELLECTUAL PROPERTY AND BIOPIRACY: IS A GLOBAL BIO." EIPR 22, no. 6 (2000): 245-250.
Abstract: Problems of uncertainty and enforcement confronting contracting parties over use of knowledge of indigenous groups about plant material and role global bio collecting society could play in addressing problems. The economics of knowledge in the emerging global knowledge society has seen some life sciences companies enter into partnerships with indigenous groups over the use of knowledge that those groups possess in relation to plant material. [FN1] It is an intriguing and potentially unstable combination--some of the world's most globalised and hypermodern companies seeking deals with some of the world's most local and traditional people. Finding ways in which to encourage mutually satisfactory contractual arrangements between life sci- ences companies and indigenous groups over the use of indigenous knowledge has become a major regulatory challenge. Part of the solution, it will be argued, lies in the creation of a global bio-collecting society ("GBS"). A GBS will overcome some of the problems of uncertainty and enforcement that confront contracting parties in this area. The second section of this opinion outlines the role that the GBS could play. The first section sketches the problems that need to be addressed.
12) Eisen, Arri, and Roberta M. Berry. "The absent professor: Why we don't teach research ethics and what to do about it." The American Journal of Bioethics 2, no. 4 (2002): 38-49.
Abstract: Research ethics education in the biosciences has not historically been a priority for research universities despite the fact that funding agencies, government regulators, and the parties involved in the research enterprise agree that it ought to be. The confluence of a number of factors, including scrutiny and regulation due to increased public awareness of the impact of basic research on society, increased public and private funding, increased diversity and collaboration among researchers, the impressive success and speed of research advances, and high-profile cases of misconduct, have made it necessary to reexamine how the bioscience research community at all levels provides ethics education to its own. We discuss the need to and reasons for making ethics integral to the education of bioscientists, approaches to achieving this goal, challenges this goal presents, and responses to those challenges.
13) Engler, Robert L., James W. Covell, Paul J. Friedman, Philip S. Kitcher, and Richard M. Peters. "Misrepresentation and responsibility in medical research." The New England journal of medicine 317, no. 22 (1987): 1383-1389.
Abstract: Early in 1985, after being questioned about duplicate data in two of his papers, Robert A. Slutsky, M.D., resigned his appointments as a radiology resident (trainee) and nonsalaried associate clinical professor in the Department of Radiology at the University of California, San Diego. During the following year, faculty committees investigated Slutsky's entire bibliography of 137 articles published in seven years; 77 (including reviews) were classified as valid, 48 were judged questionable, and 12 were deemed fraudulent. The majority of these papers were published while Slutsky was a research or clinical trainee in cardiology, nuclear medicine, and then radiology. Our analysis of this case leads us to conclude that research fraud, although probably rare, in view of the size of the research establishment, may evade detection, and that there are scientists prepared to run the appreciable risk of submitting inaccurate statements for publication. Sophisticated dishonesty can escape detection by peer review and replication. The emphasis on competition and the pressure to produce, while intended to advance the discovery of truth, may foster a conflict between personal career goals and the intellectual motivation of scientists to seek the truth. The scientific community needs to address the issues raised by recent reports of fraud. Each institution and granting agency must have procedures for investigating suspected fraud or unethical practices, procedures that protect both the person who reports such practices and the accused person from premature disclosure. As we heighten awareness, we must avoid a "witch hunt." Deterrence of research fraud is clearly needed, but institution of practices that might stifle originality or discourage cooperative research would be counterproductive.
14) Fishbein, Estelle A. "Ownership of research data." Academic Medicine 66, no. 3 (1991): 129-33.
Abstract: The author reviews the conventional "works for hire" principle that an institution, not its employees, owns the rights to its employees' written products or other forms of expression, including primary research data. This principle is not open to debate as a legal matter. The tough problems giving rise to debates regarding data ownership and access are ethical problems rather than legal ones; these will remain unsettled for some time because at present there is no consensus concerning what constitutes ethical conduct among scholars and scientists and how seriously and in what manner to penalize breaches of that conduct. Access to data is a thorny issue; case histories illustrate the legal and ethical difficulties involved in questions of who has access to information compiled in the course of academic inquiry, and for what purpose. Much depends on the ethics and established procedures of the employing institution, but current case law suggests that a faculty member or institutional researcher does not have any legal right to review the data developed by a colleague. The author recommends that institutions clearly state their policies regarding ownership of data, and presents guidelines for such a policy.
15) Foote, MaryAnn. "Review of current authorship guidelines and the controversy regarding publication of clinical trial data." Biotechnology annual review 9 (2003): 303-313.
Abstract: Publication of clinical trial data is the final step in the scientific method and an important method by which pharmaceutical and biotechnology companies, i.e., drug sponsors, disseminate information about their products. Because of the nature of large, multicenter trials, multiple investigators from many institutions may be considered as authors of these papers. Controversy concerning the rights of academic institutions and the rights of drug sponsors has been widely debated. This chapter summarizes the controversy and the current policies.
16) Holden, Constance. "NIMH finds a case of" serious misconduct."." Science (1987).
Abstract: Reports that an investigation conducted for the National Institute of Mental Health (NIMH) revealed that S. E. Breuning, a prominent investigator of the uses of psychoactive drugs with the mentally retarded, is the perpetrator of a deliberate case of scientific fraud. The draft report outlines what appears to have been a career of chronically doctored research results and reports of research not conducted at all. The NIMH review panel was able to authenticate little of the research Breuning claimed to have conducted at institutions where he worked. Breuning is currently reviewing the draft of the report but has denied any wrongdoing beyond some minor errors. The report will not be released and possible sanctions will not be considered until the comments have been received and the final version has been reviewed by the Director of the Alcohol, Drug Abuse and Mental Health Administration. (0 ref) (PsycINFO Database Record (c) 2012 APA, all rights reserved)
17) Linda Hyde, RHIA; Theresa Rihanek, MHA, RHIA, CCS; Terry Santana-Johnson, RHIT, CDIP, CCS, CCS-P; Rita Scichilone, MHSA, RHIA, CCS, CCS-P; Cortnie Simmons, MHA, RHIA, CCS; Jane Beth Turner, RHIA; Wendy Zumar, MA, RHIA, CCS. “Data Mapping and Its Impact on Data Integrity.” American Health Information Management Association (2013).
Abstract: The current rise in data mapping projects is the result of the need to link disparate electronic data systems in a rapidly changing environment. Mapping projects are valuable in a variety of situations where data elements from one code or data set are compared to another set and evaluated for equivalence of meaning to accomplish a defined “use case.” Code sets related to health information functions include CPT and its modifiers, ICD-9-CM, ICD-10-CM/PCS, and HCPCS level II, as well as LOINC, Rx NORM, and SNOMED CT®. Additionally, quality measures such as those used by the Agen- cy for Healthcare Research and Quality and National Quality Forum are frequently linked to these code sets and may require internal mapping to ensure accurate measurement. Data mapping is not limited to just these code sets; there are many different types of maps in the healthcare realm.
The increased demands for data sharing and interoperability, especially across different practice settings and different classification systems, increase reliance on data mapping tools and techniques. The use of these tools requires frequent integrity checks. Understanding the role and context of data maps, as well as their strengths and weaknesses, is essential in ensuring the reliability of the data entries derived from maps. Data mapping tasks may be as simple as matching a provider’s administrative codes for disposition to an external standard such as UB-04 or taking a more complex clinical condition and creating a standard representation across different standardized representations. In all situations employing maps, processes and guidelines must be clearly defined and documentation prepared to explain how the map was created, tested, and performing correctly for its intended use case.
18) Kleppner, Daniel. "Ensuring the integrity, accessibility, and stewardship of research data in the digital age." (2010).
Abstract: Research data, methods, and other information integral to publicly reported results should be publically accessible. The research enterprise as a whole is moving toward expanded access and sharing. Change should be led by researchers, but journals, sponsors and other can have significant leverage. Researchers that lack standards for sharing research data should develop them.
19) Last, Robert L. "Sandbox ethics in science: sharing of data and materials in plant biology." Plant physiology 132, no. 1 (2003): 17-18.
Abstract: As much as anyone, those of us doing scientific discovery really do stand on the shoulders of giants—breakthroughs occur at an increasing rate because there is so much information and materials to build upon (prior art, in legalese). Overall scientific progress is fastest when knowledge and materials are freely accessible in the literature, in stock centers, from colleagues, and from commercial vendors at reasonable prices.
But there is a fundamental problem: On the one hand, I can make the most rapid progress in my own research if I have unconstrained and immediate access to your biomaterials and ideas. On the other hand, you have an obligation to the people in your group and other collaborators to make sure that they can accomplish their research goals without undue pressure from me and my colleagues. You also have a legal obligation to your employer to protect the potential monetary value of the intellectual property that you have generated. Clearly, this is a reciprocal arrangement—your research would progress fastest by knowing all that is going on in my research, yet I have obligations to my employer, students, and collaborators.
This tension takes on a greater dimension if you or I are employed by a for-profit institution or are doing research sponsored by a company. The concepts don't change much—you still want to make the fastest progress possible, and you have explicit legal obligations to the employer. However, unlike the not-for-profit institution, which generally places a high value on scholarship and training, the corporation is only successful if it can convert its know-how into commercially valuable products, pay its employees, and provide value to investors. Sharing has an unacceptably high cost if it prevents your employer from marketing a valuable product because it cedes rights to its own intellectual property. In addition, it would take a crystal ball for corporate scientists and business people to predict which disclosures would be safe and which ones will compromise the company's future freedom to operate. The fear of the unknown generally mutes a corporation's willingness to take risks.
20) Macfarlane, Bruce. Researching with integrity: The ethics of academic enquiry. Routledge, 2009.
Abstract: There is increased emphasis internationally on ethically sound research, and on good training for research supervisors. Researching with Integrity aims to identify what and how research can be undertaken ethically and with ‘virtue’ from initial conception of ideas through to dissemination. It outlines the context in which academics engage in research, considering the impact of discipline and institutional culture, the influence of government audit of research ‘quality’, the role of government and quangos, professional organisations and business sponsors, and examines the effects of the increasing power and influence of funding bodies, university ethics committees and codes of practice.
Based on the notion of ‘virtue’ ethics, this book proposes an alternative approach to research, which focuses not only on ethical rules and protocol to avoid unethical research, but encourages academic, professional and character development and allows for the exercise of personal judgement.
21) Marco, Catherine A., and Gregory L. Larkin. "Research ethics: ethical issues of data reporting and the quest for authenticity." Academic Emergency Medicine 7, no. 6 (2000): 691-694.
Abstract: The search for truth and its unbiased reporting are ultimate goals of conducting scientific research. Ideally, the reporting of research data ought to be an objective task. In practice, however, it is fraught with numerous statistical and ethical pitfalls, seldom addressed in formal emergency medicine training. The lure of academic celebrity and related influences may persuade researchers to report results in ways that make data appear more interesting, or worthy of publication. Several examples of potentially misleading data reporting are illustrated, including using inappropriate statistical tests, neglecting negative results, omitting missing data points, failing to report actual numbers of eligible subjects, using inappropriate graph labels or terminology, data dredging, and others. Although potentially inaccurate or inflated methods of data reporting may not constitute overt scientific misconduct, the intentional misrepresentation of data is a form of fraud or deception. Publicly funded academic inquiry is a privilege and honor enjoyed by a trusted few. Regardless of outcome, every effort should be made to report data in the most scientifically accurate method. To this end, the Society for Academic Emergency Medicine Code of Conduct and American College of Emergency Physicians Code of Ethics provide important guidance toward the accurate, compassionate, competent, impartial, and honest conduct of scientific research. Accuracy and authenticity in data reporting are first and foremost a matter of individual integrity, and are crucial to the preservation of academic credibility, the protection of future patients, and the public's trust in the medical research enterprise.
22) Martinson, Brian C., Melissa S. Anderson, and Raymond De Vries. "Scientists behaving badly." Nature 435, no. 7043 (2005): 737-738.
Abstract: To protect the integrity of science, we must look beyond falsification, fabrication and plagiarism, to a wider range of questionable research practices, argue Brian C. Martinson, Melissa S. Anderson and Raymond de Vries. Serious misbehaviour in research is important for many reasons, not least because it damages the reputation of, and undermines public support for, science. Historically, professionals and the public have focused on headline-grabbing cases of scientific misconduct, but we believe that researchers can no longer afford to ignore a wider range of questionable behaviour that threatens the integrity of science.
23) Merriam, Sharan B. Qualitative Research and Case Study Applications in Education. Revised and Expanded from" Case Study Research in Education.". Jossey-Bass Publishers, 350 Sansome St, San Francisco, CA 94104, 1998.
Abstract: This book offers a resource guide for qualitative researchers in education, discussing data collection techniques, data analysis, reporting, and the issues of validity, reliability, and ethics. Part 1 reviews the nature and design of qualitative research; it discusses various types of qualitative research (including case studies), and how to design a qualitative study, including problem formation and sample selection. Differentiating case study techniques from other qualitative approaches, the book discusses concepts, theories, and techniques taken from anthropology, history, sociology, and psychology. Part 2 covers the collection of qualitative data; chapters cover conducting effective interviews, being a careful observer, mining data from documents, and the interactive nature of data collection in case studies. Part 3 covers the analysis and reporting of qualitative data, and discusses analytic techniques and data management, levels of analysis, the increasing role of computers, and strategies for dealing with validity, reliability, and ethics. A final chapter looks at writing up research results, with emphasis on the particular requirements of the case study report.
24) Mgbeoji, Ikechi. Global biopiracy: patents, plants, and indigenous knowledge. Ubc Press, 2007.
Abstract: Legal control and ownership of plants and traditional knowledge of the uses of plants (TKUP) is a vexing issue. The phenomenon of appropriation of plants and TKUP, otherwise known as biopiracy, thrives in a cultural milieu where non-Western forms of knowledge are systemically marginalized and devalued as "folk knowledge" or characterized as inferior. Global Biopiracy rethinks the role of international law and legal concepts, the Western-based, Eurocentric patent systems of the world, and international agricultural research institutions as they affect legal ownership and control of plants and TKUP.
The analysis is cast in various contexts and examined at multiple levels. The first deals with the Eurocentric character of the patent system, international law, and institutions. The second involves the cultural and economic dichotomy between the industrialized Western world and the westernizing, developing world. The third level of analysis considers the phenomenal loss of human cultures and plant diversity. Exhaustively researched and eloquently argued, Global Biopiracy sheds new light on a contentious topic. The impact of intellectual property law on indigenous peoples and informal or traditional innovations is a field of study that currently includes only a handful of scholars. Biopiracy will be an invaluable resource for students, teachers, and legal practitioners.
25) Miller, Franklin G., Donald L. Rosenstein, and Evan G. DeRenzo. "Professional integrity in clinical research." Jama 280, no. 16 (1998): 1449-1454.
Abstract: In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.
26) Mitcham, Carl. "Co-responsibility for research integrity." Science and Engineering Ethics 9, no. 2 (2003): 273-290.
Abstract: To enlarge the discussion of scientific responsibility for research integrity, this paper offers two historico-philosophical observations. First, in the broad history of ideas, modern ethics replaces social role responsibility with appeals to abstract principles; by contrast, discussions within the scientific community of responsibility for research integrity constitute a rediscovery of the continuing vitality of role responsibility. This is a rediscovery from which philosophy itself may benefit. Second, within the context of scientists’ concerns, the idea of role responsibility has undergone significant evolution from “collective responsibility” to the notion of responsibility resting with a “trans-scientific community.” Further challenges nevertheless remain in order to relate scientific role responsibility for scientific integrity to the relationship between science and society. To promote a notion of integrity not just in science but in the science-society relationship, it may be useful to think in terms of a “co-responsibility” for scientific integrity.
27) McGuire, Amy L., Timothy Caulfield, and Mildred K. Cho. "Research ethics and the challenge of whole-genome sequencing." Nature Reviews Genetics 9, no. 2 (2008): 152-156.
Abstract: The recent completion of the first two individual whole-genome sequences is a research milestone. As personal genome research advances, investigators and international research bodies must ensure ethical research conduct. We identify three major ethical considerations that have been implicated in whole-genome research: the return of research results to participants; the obligations, if any, that are owed to participants' relatives; and the future use of samples and data taken for whole-genome sequencing. Although the issues are not new, we discuss their implications for personal genomics and provide recommendations for appropriate management in the context of research involving individual whole-genome sequencing.
28) National Commission for the Proptection of Human Subjects of Biomedical and Behavioral Research, Bethesda, MD. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. ERIC Clearinghouse, 1978.
Abstract: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
29) Payne, G. Tyge, and R. Duane Ireland. "It Takes a Village Ethical Publishing of Family Business Research." Family Business Review (2015): 0894486515574193.
Abstract: This editorial explores key issues regarding ethics in family business research – particularly that surrounding the evaluation and publication process – and advocates creating a stronger and more knowledgeable community of scholars to overcome the many challenges facing responsible research. Rather than only discussing the various types of ethical problems in research such as plagiarism, unprincipled data manipulation, and falsification of data, we expand the conversation to include the role the scholarly community – including researchers, reviewers, editors, and institutional leaders – plays in dealing with ongoing ethical concerns in scholarly publishing. We offer a few pragmatic suggestions for improving some processes, but primarily make a broad call for building a stronger (global) community of family business researchers that supports and promotes ethical conduct in publishing research through increased dialogue and interaction.
30) Price, James H., Joseph A. Dake, and Rafat Islam. "Selected ethical issues in research and publication: perceptions of health education faculty." Health education & behavior 28, no. 1 (2001): 51-64.
Abstract: A national random sample of 195 university health education faculty at graduate degree–granting programs completed a 31-item survey with regard to their perceptions of ethical issues in research and publishing. Most respondents were male (57%), tenured (75%), had graduate faculty status (92%), had presented original research at conferences (85%), and had published articles in health education journals (89%). Faculty members were requested to assess whether 21 scenarios dealing with ethical issues in research and publishing were ethical, unethical, questionable, or not an ethical issue. Of the scenarios, 3 were considered ethical and 7 unethical by the majority of respondents. The perceptions of how ethical the remaining 11 scenarios were varied considerably. Perceptions of the ethical scenarios did not differ among respondents by sex, academic rank, years taught as a faculty member, whether the department taught units/classes on research ethics, or whether the respondents were from doctoral-level versus master’s-level programs.
31) Rennie, Drummond, Veronica Yank, and Linda Emanuel. "When authorship fails: a proposal to make contributors accountable." Jama 278, no. 7 (1997): 579-585.
Abstract: A published article is the primary means whereby new work is communicated, priority is established, and academic promotion is determined. Publication depends on trust and requires that authors be held to standards of honesty, completeness, and fairness in their reporting, and to accountability for their statements. The system of authorship, while appropriate for articles with only 1 author, has become inappropriate as the average number of authors of an article has increased; as the work of coauthors has become more specialized and relationships between them have become more complex; and as both credit and, even more, responsibility have become obscured and diluted. Credit and accountability cannot be assessed unless the contributions of those named as authors are disclosed to readers, so the system is flawed. We argue for a radical conceptual and systematic change, to reflect the realities of multiple authorship and to buttress accountability. We propose dropping the outmoded notion of author in favor of the more useful and realistic one of contributor. This requires disclosure to readers of the contributions made to the research and to the manuscript by the contributors, so that they can accept both credit and responsibility. In addition, certain named contributors take on the role of guarantor for the integrity of the entire work. The requirement that all participants be named as contributors will eliminate the artificial distinction between authors and acknowledgees and will enhance the integrity of publication.
32) Rhodes, Rosamond. "Rethinking research ethics." The American Journal of Bioethics 5, no. 1 (2005): 7-28.
Abstract: Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.
33) Rogozea, Liliana, Gabriela Sechel, and Andreea Fleancu. "Ethical aspects in bioengineering research." In WSEAS International Conference. Proceedings. Mathematics and Computers in Science and Engineering, edited by Shengyong Chen, no. 8. World Scientific and Engineering Academy and Society, 2009.
Abstract: This paper presents the ethical standards for carrying out bioengineering research in correlation with human subjects and according to the Declaration of Helsinki, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the WHO and ICH Guidelines for Good Clinical Practice. Knowing and developing the ethical standards in this field is connected with the assurance of the dignity, rights, safety, and well- being and with the scientific progress. Developing the research in bioengineering must be predominantly motivated by the concern for the community benefit, for all people without any discrimination of age, gender, economic status, cultural or ethnic considerations.
34) Shiva, Vandana, and Heather Eaton. "[Biopiracy: The Plunder of Nature & Knowledge]." Resources for Feminist Research 26, no. 1/2 (1998): 122.
Abstract: Vandana Shiva has provided a research document about the tangle of issues that are creating and supporting the global exploitation, and ultimate destruction of life itself. Although Biopiracy is a continuation of Shiva's work, it provides more substantive examples to her theoretical stances on the role of Western science and Eurowestern imperialism than in other works.
Biopiracy begins by presenting the history of patents, something that most of us take for granted and know little about. Shiva reviews the theory behind patents, which then opens a window onto the discussion of the global exploitation of life itself. Patents developed into Intellectual Property Rights (IPRs), Trade Related Property Rights (TRIPs), free-trade agreements, and are an integral part of the economic -- exploitative -- globalization process.
Shiva traces the rise of reductionist science through the development of patents and their sequels, to the theoretical stance whereby all life is reduced to genes. From here it is an extremely distressing unfolding of events: genetic manipulation and engineering of micro organisms, plants and animals, and human genes. Shiva provides myriad examples of bioengineering disasters, which involve every level of life-systems and the food chain.
35) Skloot, Rebecca, and Bahni Turpin. The immortal life of Henrietta Lacks. New York: Crown Publishers, 2010.
Abstract: Rebecca Skloot's debut book, The Immortal Life of Henrietta Lacks, defies easy classification. With a sensitive heart, a knowledge of science, an investigative reporter's zeal, and a novelist's skill, Skloot combines biography, medicine, science, detective thriller, social critique, and medicolegal inquiry. This layered approach is at once moving, sad, funny, and deeply unsettling. The book is not perfect, but ultimately it is an irresistible read.
At the center of the book is the HeLa cell line. The story of HeLa begins in 1951, when Henrietta Lacks, a 31-year-old black mother of 5, received treatment at Johns Hopkins Hospital for cervical cancer. Without telling her, physicians removed a dime-sized slice of Lacks' tumor and sent it to a hospital laboratory, where George Gey had for years been unsuccessfully trying to grow human cells outside the body. The cells were marked “HeLa” for Henrietta Lacks, and as he had done with other cells he had received from the hospital, Gey placed them onto clots of chicken blood in test tubes and covered them with culture medium to determine if they would grow.
36) Whittemore, Robin, Susan K. Chase, and Carol Lynn Mandle. "Validity in qualitative research." Qualitative health research 11, no. 4 (2001): 522-537.
Abstract: Much contemporary dialogue has centered on the difficulty of establishing validity criteria in qualitative research. Developing validity standards in qualitative research is challenging because of the necessity to incorporate rigor and subjectivity as well as creativity into the scientific process. This article explores the extant issues related to the science and art of qualitative research and proposes a synthesis of contemporary viewpoints. A distinction between primary and secondary validity criteria in qualitative research is made with credibility, authenticity, criticality, and integrity identified as primary validity criteria and explicitness, vividness, creativity, thoroughness, congruence, and sensitivity identified as secondary validity criteria.
37) Wing, Steve. "Social responsibility and research ethics in community-driven studies of industrialized hog production." Environmental Health Perspectives 110, no. 5 (2002): 437.
Abstract: Environmental health research can document exposures and health effects that result from inequitable relationships between communities of low income or people of color and the institutions that derive benefits (profits, federal and state funding or services, avoidance of wastes) from activities and policies that burden these communities. Researchers, most of whom work in relatively privileged institutions, are placed in situations of conflicting loyalties if they conduct research in collaboration with, or on behalf of, communities burdened by environmental injustices. These conflicts can threaten the self-interest of researchers and may raise social and ethical issues that do not typically arise in research projects that respond to the agendas of institutions. This article describes how we addressed issues of research ethics and social responsibility in environmental health research on industrialized hog production in North Carolina. Researchers and institutional review boards are not well prepared to address ethical issues when interests of entire communities, as well as individual research participants, are involved. Community-driven research partnerships can help address problems in research ethics and can enhance the social responsibility of researchers and their institutions.
Data Management Bibliography before 2010
The Akwesasne Research Advisory Committee. (1996). The good mind research protocol. Akwesasne Notes New Series 2, 94-9.
DeWolf, V., Sieber, J., Steel, P., & Zarate, A. (2006). Part III: meeting the challenge when data sharing is required. IRB: Ethics and Human Research, 10-15.
Gillett, G. & McKergow, F. (2007). Genes, ownership, and indigenous reality. Social Science & Medicine 65, 2093-2104.
Gbadegesin, S. & Wendler, D. (2006). Protecting Communities in Health Research from Exploitation. Bioethics 20, 248-253.
Horner, J. & Minifie, F. (2011). Research ethics II: mentoring, collaboration, peer review, and data management and ownership. Journal of Speech, Language, and Hearing Research 54, S330-345.
Joshi, M. & Krag, S. (2010). Issues in data management. Science and Engineering Ethics 16(4), 743-8.
Lounsbury, D., Reynolds, T., Rapkin, B., Robson, M., & Ostroff, J. (2007). Protecting the privacy of third-party information: Recommendations for social and behavioral health researchers. Social Science & Medicine 64, 213–222.
Moodie, S. (2010). Power, rights, respect and data ownership in academic research with indigenous peoples. Environmental Research 110, 818-820.
Schinasi, L., Horton, R., & Wing, S. (200). Data completeness and quality in a community-based and participatory epidemiologic study. Progress in Community Health Partnerships: Research, Education, and Action 3.2, 179-190.