Comparison of conflict of interest policies and reported practices in academic medical centers in the United States

The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.     

Editorial

VOLUNTAS: International Journal of Voluntary and Nonprofit Organizations -     

Ethics in population-based genetic research

Population-based genetic research, including genetic epidemiology, shows tremendous potential to elucidate the role of genes as causal factors in complex and common human diseases. Like all research with human subjects, full realization of these benefits requires careful attention to its ethical conduct, establishing an appropriate balance between individual protections and the advancement of scientific and medical knowledge. This article reviews the growing literature on genetics research and ethics to describe some of the fundamental ethical issues in population-based genetics research, including research design, recruitment and informed consent, and dealing with research results. Its focus is on areas where consensus is forming and where future work is needed.     

Marital Shopping and Epidemic AIDS

HIV risks decline sharply at age 30 for women in South Africa, long before coital frequencies or pregnancies decrease. I evaluate several prominent behavioral models of HIV, and find that these do not suggest sharply decreasing risks with age. I formulate a model of spousal search and find that “marital shopping” can generate epidemic HIV prevalence despite low transmission rates because search behavior interacts with dynamics of HIV infectiousness. The implied age-infection profile closely mimics that in South Africa, and the suggested behavior matches that reported by South Africans. Condom use in new relationships and transmission rate reductions are both found to be effective policies and, when used together, eliminate the potential of spousal search to spread HIV. In contrast, antiretroviral treatment is found to have only a minimal effect on the epidemic.     

Social Networks and Support,Gender, and Racial/Ethnic Disparities in Hypertension Among Older Adults

Using data from the 2001 NHIS and the 2005–2006 and 2007–2008 NHANES, we examine how self-reporting a previous diagnosis of hypertension among adults aged 65+ differs by race/ethnicity for men and women; we explore the extent to which disparities are driven by group differences in social risk factors, particularly social support and integration; and last, whether these relationships mimic patterns seen for measured hypertension at interview. Findings indicate that rates of ever-diagnosed hypertension in both samples are highest among black seniors and older women and lowest among Mexican-American men, with the gender gap lowest among whites and substantially higher among blacks and Mexican-Americans. However, replication analyses of NHANES models using measured hypertension, instead of a self-report of having ever been diagnosed with hypertension, suggests that reporting bias and measurement error contribute to observed disparities, as racial/ethnic differences in hypertension rates are smaller when measured hypertension is examined, especially among women. Logistic regression models also show that while adjusting for group differences in measures of support and integration mediates some of the disparity in measured hypertension between Mexican-American and white seniors, adjusting for support and integration amplifies black-white disparities in both ever diagnosed and measured hypertension—driven primarily by adjustment for attendance at religious services, which reduces hypertension risk for all older adults but is more commonly reported among black seniors, especially women.     

Adolescent Secretive Behavior: African American and Hmong Adolescents' Strategies and Justifications for Managing Parents' Knowledge About Peers

Drawing upon the expectancy violation‐realignment theory of autonomy development, this qualitative study examined African American and Hmong adolescent autonomy‐seeking behaviors and parent–child communication about activities and relationships with peers. Twenty‐two African American and 11 Hmong adolescents in grades 6–12 and 14 African American and 8 Hmong primary caregivers were interviewed. Participants discussed their perspectives on adolescent information management regarding activities with friends. Four categories of information management strategies and four primary types of adolescent justifications were identified. Adolescents were pragmatic in their decisions about secretive behaviors but also considered the impact of their behaviors on their relationships with parents. Adolescent strategies were consistent across ethnic groups, whereas justifications for secretive behaviors were embedded within cultural and family experiences.     

Blazing new trails or opportunity lost? Evaluating research at the intersection of leadership and entrepreneurship

More than a decade ago, scholars formally conceptualized the potential synergy between leadership and entrepreneurship scholarship. Our work highlights research accomplishments occurring at the interface of these two intellectual areas as well as identifying untapped possibilities for continued research. We highlight how recent efforts have witnessed a mutual exchange of ideas that present opportunities benefiting both fields. Drawing from four key domains of entrepreneurship previously proposed to mutually inform future leadership research efforts, we make suggestions for integrating entrepreneurial opportunities, the roles of individual and entrepreneurial teams, the modes of organizing entrepreneurial ventures, and differing entrepreneurial environments with key trends important to leadership research, such as servant leadership and leader-member exchange theory. Overall, our work provides an assessment of the state of the art surrounding the coalescence of leadership and entrepreneurship research and sets an agenda for the next decade of research at this intersection.     

The Rheumatoid Arthritis Drug Development Model: a case study in Bayesian clinical trial simulation

The development of a new drug is a major undertaking and it is important to consider carefully the key decisions in the development process. Decisions are made in the presence of uncertainty and outcomes such as the probability of successful drug registration depend on the clinical development programmme. The Rheumatoid Arthritis Drug Development Model was developed to support key decisions for drugs in development for the treatment of rheumatoid arthritis. It is configured to simulate Phase 2b and 3 trials based on the efficacy of new drugs at the end of Phase 2a, evidence about the efficacy of existing treatments, and expert opinion regarding key safety criteria. The model evaluates the performance of different development programmes with respect to the duration of disease of the target population, Phase 2b and 3 sample sizes, the dose(s) of the experimental treatment, the choice of comparator, the duration of the Phase 2b clinical trial, the primary efficacy outcome and decision criteria for successfully passing Phases 2b and 3. It uses Bayesian clinical trial simulation to calculate the probability of successful drug registration based on the uncertainty about parameters of interest, thereby providing a more realistic assessment of the likely outcomes of individual trials and sequences of trials for the purpose of decision making. In this case study, the results show that, depending on the trial design, the new treatment has assurances of successful drug registration in the range 0.044–0.142 for an ACR20 outcome and 0.057–0.213 for an ACR50 outcome. Copyright © 2009 John Wiley & Sons, Ltd.