Health research raises profound concerns of an ethical and legal nature — concerns primarily centered on how to balance researchers’ quest for scientific discovery against societal interest in protecting individuals whose participation makes the discovery possible. Particularly in a country such as Nigeria, which, not too long ago, suffered major abuse of research subjects, deploying a robust ethicolegal regime capable of curbing excesses and protecting research participants whilst contemporaneously not frustrating scientific progress is not an easy task. This is even (...) more critical in the context of novel scientific endeavors, such as biobanking and genomic research, particularly when a significant pool of potential donors are inadequately informed about the processes involved in their participation or the result. (shrink)

Not many African countries have been able to develop a robust system for regulating health research within their respective jurisdictions, particularly in the realm of biobanking and genomics. This is not without reason. Aside from underdevelopment and all that it entails or perhaps in consequence thereof, countries in the region have been unable to make significant strides in medical research. But there are exceptions. Amongst the few seeming success stories is Uganda. Nonetheless, although the country has developed what appears to (...) be a functional framework to govern genomic research and biobanking, the consistency of key provisions with international standards, especially those pertaining to privacy of research participants and confidentiality of their health information, is not at all clear. Yet, making this determination – the main objective of this article – is critical in determining the adequacy of protection available to human research subjects in the country. (shrink)

The Human Heredity and Health in Africa Consortium is a conglomeration of research and infrastructure projects spread throughout Africa whose aim is to apply genomic methodology to diseases affecting the people in the region. Its operation is innovative in the sense that it is doing something new; that is, filling a hitherto existing void in genomic research capability of African scientists and infusing resources and manpower to institutions and investigators across Africa. But aside from developing and sustaining capacity in genomic (...) research and biorepositories, H3Africa is also invested in developing appropriate ethical regulatory regime to govern research in these areas. This latter concern –research ethics governance – is the major subject of this paper. Specifically, the paper discusses protection of research participants as envisaged by H3Africa in the area of consent, safeguarding privacy, maintaining confidentiality of health information and sharing of data/biospecimens. The ultimate goal is to determine whether H3Africa initiatives and processes are consistent or at odds with international guidelines and best practices. (shrink)

BackgroundInvolvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational (...) new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda.MethodsFrom August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions.ResultsMost community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention.ConclusionsStakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining adolescents in HIV clinical trials and identifying practical strategies to ensure high ethical standards during trial implementation. (shrink)

Monetary intelligence theory asserts that individuals apply their money attitude to frame critical concerns in the context and strategically select certain options to achieve financial goals and ultimate happiness. This study explores the dark side of monetary Intelligence and behavioral economics—dishonesty. Dishonesty, a risky prospect, involves cost–benefit analysis of self-interest. We frame good or bad barrels in the environmental context as a proxy of high or low probability of getting caught for dishonesty, respectively. We theorize: The magnitude and intensity of (...) the relationship between love of money and dishonest prospect may reveal how individuals frame dishonesty in the context of two levels of subjective norm—perceived corporate ethical values at the micro-level and Corruption Perceptions Index at the macro-level, collected from multiple sources. Based on 6382 managers in 31 geopolitical entities across six continents, our cross-level three-way interaction effect illustrates: As expected, managers in good barrels, mixed barrels, and bad barrels display low, medium, and high magnitude of dishonesty, respectively. With high CEV, the intensity is the same across cultures. With low CEV, the intensity of dishonesty is the highest in high CPI entities —the Enron Effect, but the lowest in low CPI entities. CPI has a strong impact on the magnitude of dishonesty, whereas CEV has a strong impact on the intensity of dishonesty. We demonstrate dishonesty in light of monetary values and two frames of social norm, revealing critical implications to the field of behavioral economics and business ethics. (shrink)

Monetary Intelligence theory asserts that individuals apply their money attitude to frame critical concerns in the context and strategically select certain options to achieve financial goals and ultimate happiness. This study explores the bright side of Monetary Intelligence and behavioral economics, frames money attitude in the context of pay and life satisfaction, and controls money at the macro-level and micro-level. We theorize: Managers with low love of money motive but high stewardship behavior will have high subjective well-being: pay satisfaction and (...) quality of life. Data collected from 6586 managers in 32 cultures across six continents support our theory. Interestingly, GDP per capita is related to life satisfaction, but not to pay satisfaction. Individual income is related to both life and pay satisfaction. Neither GDP nor income is related to Happiness. Our theoretical model across three GDP groups offers new discoveries: In high GDP entities, “high income” not only reduces aspirations—“Rich, Motivator, and Power,” but also promotes stewardship behavior—“Budget, Give/Donate, and Contribute” and appreciation of “Achievement.” After controlling income, we demonstrate the bright side of Monetary Intelligence: Low love of money motive but high stewardship behavior define Monetary Intelligence. “Good apples enjoy good quality of life in good barrels.” This notion adds another explanation to managers’ low magnitude of dishonesty in entities with high Corruption Perceptions Index. In low GDP entities, high income is related to poor Budgeting skills and escalated Happiness. These managers experience equal satisfaction with pay and life. We add a new vocabulary to the conversation of monetary intelligence, income, GDP, happiness, subjective well-being, good and bad apples and barrels, corruption, and behavioral ethics. (shrink)

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect (...) it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation. (shrink)

Corruption involves greed, money, and risky decision-making. We explore the love of money, pay satisfaction, probability of risk, and dishonesty across cultures. Avaricious monetary aspiration breeds unethicality. Prospect theory frames decisions in the gains-losses domain and high-low probability. Pay dissatisfaction (in the losses domain) incites dishonesty in the name of justice at the individual level. The Corruption Perceptions Index, CPI, signals a high-low probability of getting caught for dishonesty at the country level. We theorize that decision-makers adopt avaricious love-of-money aspiration (...) as a lens and frame dishonesty in the gains-losses domain (pay satisfaction-dissatisfaction, Level 1) and high-low probability (CPI, Level 2) to maximize expected utility and ultimate serenity. We challenge the myth: Pay satisfaction mitigates dishonesty across nations consistently. Based on 6500 managers in 32 countries, our cross-level three-dimensional visualization offers the following discoveries. Under high aspiration conditions, pay dissatisfaction excites the highest- (third-highest) avaricious justice-seeking dishonesty in high (medium) CPI nations, supporting the certainty effect. However, pay satisfaction provokes the second-highest avaricious opportunity-seizing dishonesty in low CPI entities, sustaining the possibility effect—maximizing expected utility. Under low aspiration conditions, high pay satisfaction consistently leads to low dishonesty, demonstrating risk aversion—achieving ultimate serenity. We expand prospect theory from a micro and individual-level theory to a cross-level theory of monetary wisdom across 32 nations. We enhance the S-shaped Curve to three 3-D corruption surfaces across three levels of the global economic pyramid, providing novel insights into behavioral economics, business ethics, the environment, and responsibility. (shrink)