Brody (2011) claims that clarifying conflict of interest (COI) is important for several reasons. Brody's paper seems to focus on the importance of raising awareness of the impact of COI and the nee...

There are now at least two different views that fall under the heading of the “fair benefits” approach (FBA) to international research. These views share a number of important commitments, such as...

In the target article “Universal and Uniform Protections of Human Subjects in Research,” Shamoo and Schwartz (2008) argue for state action to address the fact that significant numbers of human-rese...

The growing importance of health systems research has opened debate about appropriate ethical frameworks and guidelines for the ethical review and conduct of health systems research. In this article we consider a detailed proposal from Hyder et al. and consider it in relation to the conventional criteria for ethics review of clinical research outlined by Emanuel et al. and argue that the Emanuel criteria can be usefully applied to the review of health systems research to supplement the Hyder et al. (...) proposals. We argue further that health systems researchers and reviewers would benefit from many of the debates that have characterized the ethics of clinical research over the past three decades. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 27-29, June 2011.

At the end of a paper on international research ethics published in the July-August 2010 issue of the Hastings Center Report, London and Zollman argue the need for grounding our duties in international medical and health-related research within a broader normative framework of social, distributive, and rectificatory justice. The same goes for Thomas Pogge, who, in a whole range of publications during the past years, has argued for a human-rights-based approach to international research. In a thought-provoking paper in the June (...) 2010 issue of the American Journal of Bioethics, Angela J. Ballantyne argues that “the global bioethics priority” in medical and health-related research ethics today is how to do research fairly in an unjust world. (shrink)

Background: Informed consent is a legal as well as ethical prerequisite in clinical research. For dementia research, informed consent can be a problem if subjects with dementia, whose capacity for understanding and thus also decision making might be limited, are to be exam- ined. This might result in exclusion of dementia patients from research, as capacity for understanding and decision making are often equated with the ability for rational decision making. However, this valuation has been criticized at times for attaching (...) too much impor- tance to the cognitive aspect of decision making. -/- Methods: This qualitative study investigates the actual consent procedure of a clini- cal research study in Germany with regard to dementia patients’ subjective and objective understanding of informed consent information. Research participants were ten dementia patients, who volunteered in two clinical research studies, as well as their caregivers. Data were collected by use of semi-structured interviews. -/- Results: It was determined that the patients’ comprehension of informed consent infor- mation was rather limited. However, a number of patients were quite aware of this. In con- trast, all caregivers claimed to have fully understood the provided information, while their objective comprehension was also incomplete. Several participants indicated that they did not attach much importance to the information given in the consent procedure and that their consent did not primarily depend on this information. Rather, participation in the research study for them seemed to be more of a problem-focused coping strategy for dealing with their diagnosis of dementia. -/- Conclusion: For research ethics these results raise the question whether the currently prevailing emphasis on the cognitive aspect of autonomous decision making, i.e., compre- hension, may be too one-sided, and to what extent the “volitional” aspect in giving consent should be given greater consideration. (shrink)

Phishing is a fraudulent form of email that solicits personal or financial information from the recipient, such as a password, username, or social security or bank account number. The scammer may use the illicitly obtained information to steal the victim’s money or identity or sell the information to another party. The direct costs of phishing on consumers are exceptionally high and have risen substantially over the past 12 years. Phishing experiments that simulate real world conditions can provide cybersecurity experts with (...) valuable knowledge they can use to develop effective countermeasures and prevent people from being duped by phishing emails. Although these experiments contravene widely accepted informed consent requirements and involve deception, we argue that they can be conducted ethically if risks are minimized, confidentiality and privacy are protected, potential participants have an opportunity to opt out of the research before it begins, and human subjects are debriefed after their participation ends. (shrink)

Social justice has been identified as a foundational moral commitment for global health research ethics. Yet what a commitment to social justice means for community engagement in such research has not been critically examined. This paper draws on the rich social justice literature from political philosophy to explore the normative question: What should the ethical goals of community engagement be if it is to help connect global health research to social justice? Five ethical goals for community engagement are proposed that (...) promote well-being, agency, and self-development, particularly for those considered disadvantaged and marginalized. The paper also considers how key terms used in the proposed goals should be defined using existing theories of health and social justice. This analysis is done to give global health researchers and their partners a better idea of what the ethical goals mean. Patterns of convergence amongst different theories are identified that support relying on particular definitions of key terms. (shrink)

It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join with a (...) very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that (...) is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders’ perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research. Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research. (shrink)

Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully talks through (...) the most important points, and gives him time to ask questions. Though it is a Phase 1 study and the chance that he will benefit is very low, Miguel happily agrees to take part. A week later, after the first experimental injection, she asks him if he is worried about the risks. “Risks?” he asks. “I’m sure this is safe—you’re a doctor, after all!”. (shrink)

Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE (...) study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. (shrink)

In this Symposium on the Ethics and Epistemology of Big Data, we present four perspectives on the ways in which the rapid growth in size of research databanks—i.e. their shift into the realm of “big data”—has changed their moral, socio-political, and epistemic status. While there is clearly something different about “big data” databanks, we encourage readers to place the arguments presented in this Symposium in the context of longstanding debates about the ethics, politics, and epistemology of biobank, database, genetic, and (...) epidemiological research. (shrink)

Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and benefits of attempting such (...) an exercise are identified, and suggestions on ways to avoid some of the challenges are proposed. I argue that disseminating the findings of genomic research to participating communities should be seen as sharing knowledge rather than returning results. Calling the dissemination of aggregate, population level information returning results can be confusing and misleading as participants might expect to receive individual level information. Talking about sharing knowledge is a more appropriate way of expressing and communicating the outcome of population genomic research. Considering the knowledge produced by genomics research a worthwhile output that should be shared with the participants and approaching the exercise as a ‘sharing of knowledge’, could help mitigate the risks of unrealistic expectations and misunderstanding of findings, whilst promoting trusting and long lasting relationships with the participating communities. (shrink)

The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. (...) The oversight system is based on a foundation, first implemented by the U.S. Public Health Service in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report. (shrink)

Zu den elementaren Rechtfertigungsbedingungen der medizinischen Forschung an und mit Menschen zählt die informierte Einwilligungserklärung („informed consent“) des Probanden/Patienten. Für die Gewährleistung eines „informed consent“ sind dem potenziellen Studienteilnehmer u. a. qualitativ hochwertige schriftliche Aufklärungsmaterialien zur Verfügung zu stellen. Wir entwickelten eine Liste von Prüfpunkten, um mit ihnen die Qualität schriftlicher Aufklärungsmaterialien zu bestimmen und zu bewerten. Mithilfe eines Kriterienkataloges bestehend aus über 100 Prüfpunkten wurde die Qualität von 128 zufällig ausgewählten schriftlichen Aufklärungsmaterialien zu Forschungsvorhaben beurteilt, die der Ethikkommission der (...) Universität zu Lübeck im Jahr 2006 vorgelegt worden waren. Jeder Prüfpunkt ist einem von sechs Qualitätsbereichen zugeordnet (z. B. Lesbarkeit und Verständlichkeit, Nutzen-/Schadenpotenziale). Die untersuchten Aufklärungsmaterialien erfüllten im Durchschnitt die Hälfte der 117 abgefragten Qualitätskriterien, die Spannweite reichte dabei von 20 % bis 76 %. Der höchste Qualitätsscore wurde für den Bereich „Einwilligungserklärung“ beobachtet (64 % der Kriterien erfüllt), am schlechtesten schnitt der Bereich „Nutzen- und Schadenpotenziale“ ab (35 % der Kriterien erfüllt). Aufklärungsmaterialien zu klinischen Prüfungen von Arzneimitteln zeigten dabei eine signifikant höhere Qualität als die Aufklärungsmaterialien zu anderen Studientypen. Nur 21 der 117 analysierten Qualitätskriterien wurden in mehr als 80 % der einschlägigen Aufklärungsmaterialien umgesetzt. Die vorliegende Arbeit zeigt deutliche Defizite in der Qualität der untersuchten Aufklärungsmaterialien auf. Forscherinnen und Forscher benötigen Hilfestellung bei der Erstellung von Materialien, die eine informierte Entscheidung für oder gegen eine Studienteilnahme ermöglichen. Der von uns eingesetzte Kriterienkatalog könnte u. a. im Rahmen von Doktorandenseminaren dazu genutzt werden, den Blick für die Vielfalt der Anforderungen zu schärfen. (shrink)

Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive — they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At (...) the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research. (shrink)

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed (...) plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”. (shrink)

This paper gives an introduction to the interdisciplinary special section. Against the historical and ethical background of reproductive technologies, it explores future scenarios of human reproduction and analyzes ways of mutual engagement between fictional and academic endeavors. The underlying idea is that we can make use of human reproduction scenarios in at least two ways: we can use them to critique technologies by imagining terrible consequences for humanity but also to defend positions that favor scientific and technological development.

During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance on researchers as virtuous and caring physicians. (...) This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics and the compilation of the first set of national ethical guidelines on biomedical research–one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, ‘period 3’ is on its way. It is predictable from the obvious trends toward performance of high-quality clinical research and the appearance of a highly educated new generation, especially among women. (shrink)