Despite a tendency to react otherwise, there is no obvious reason to believe that economically disadvantaged people ought not to be exposed to the same levels of research risk as the rest of the population.
Research in the PED and PICU is essential to medical understanding of the efficacy of emergency interventions. Researchers must minimize the additional stress that consent and participation in research entail for pediatric patients and their families.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
This process of developing EBM-based guidelines and applying them to clinical care highlights the tension between generating unbiased knowledge based on statistical aggregation and the application of this information to individual patients.
Elderly persons should not be excluded from participation in clinical trials for cardiovascular drugs since that population comprises the largest number of patients with cardiovascular disease.
The FDA's decision to put a black-box warning on antidepressant labels may be misleading because it implies that antidepressants have definitely been found to increase suicidality in adolescents, when in fact there is merely a lack of clear evidence about their safety.
CBP researchers are challenged to think strategically about ways to convey their accomplishments and educate their non-CBPR peers about the nature of their research, processes not required of traditional researchers.
Specific advocate guidelines are needed for the protection of children in state custody who are potential research subjects in trials that would expose them to greater-than-minimal risk but also hold the prospect of direct benefit.
In “Ethics of International Research: What Does Responsiveness Mean?” Christine Grady explains how developing countries are vulnerable to exploitation by researchers and explores what “responsiveness” to the needs of those populations might entail.
Strengthened NIH policies of inclusion have resulted in more NIH-funded research including more women and other underrepresented population groups as subjects in medical research.