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The US government recently updated the Common Rule, a set of federal regulations to ensure the ethical conduct of human subjects research. The new regulations require that consent documents provide information that is clear and concise enough to enable truly informed consent. This study explores potential American Indian research participants' understanding and perceptions of an example consent document, focusing on possible improvements to better serve the requirements of the revised Common Rule. Participants completed a survey that collected demographic data and measured health literacy, numeracy, and comprehension of the example document. Next, they participated in focus groups to answer open-ended questions regarding their views on the example document. We calculated mean scores and frequencies of response to analyze quantitative survey data and performed a qualitative thematic analysis of focus group transcripts. Results demonstrated that American Indian participants with relatively strong health literacy skills clearly understood key elements of the consent document, including the purpose of signing it, confidentiality, compensation, and whom to contact for questions. However, they were overwhelmed by details on research procedures and were concerned about the document's layout. To make consent documents more readily comprehensible, participants recommended the addition of headings, bullets, graphics, and relevant pictures. They also recommended a two-step consent process, comprising a short introduction to the research project followed by a longer explanation of procedures. These results illustrate the potential advantages of community engagement in drafting consent materials. Health researchers would likely benefit from documents adherent to the revised Common Rule.

AbstractIn 1984, Hrubec and Robinette published what was arguably the first review of the role of twins in medical research. The authors acknowledged a growing distinction between two categories of twin studies: those aimed at assessing genetic contributions to disease and those aimed at assessing environmental contributions while controlling for genetic variation. They concluded with a brief section on recently founded twin registries that had begun to provide unprecedented access to twins for medical research. Here we offer an overview of the twin research that, in our estimation, best represents the field has progress since 1984. We start by summarizing what we know about twinning. We then focus on the value of twin study designs to differentiate between genetic and environmental influences on health and on emerging applications of twins in multiple areas of medical research. We finish by describing how twin registries and networks are accelerating twin research worldwide.

AbstractProlonged fatigue equal to or greater than 1 month duration and chronic fatigue equal to or greater than 6 months duration are both commonly seen in clinical practice, yet little is known about the etiology or epidemiology of either symptom. Chronic fatigue syndrome (CFS), while rarer, presents similar challenges in determining cause and epidemiology. Twin studies can be useful in elucidating genetic and environmental influences on fatigue and CFS. The goal of this article was to use biometrical structural equation twin modeling to examine genetic and environmental influences on fatigue, and to investigate whether these influences varied by gender. A total of 1042 monozygotic (MZ) twin pairs and 828 dizygotic (DZ) twin pairs who had completed the University of Washington Twin Registry survey were assessed for three fatigue-related variables: prolonged fatigue, chronic fatigue, and CFS. Structural equation twin modeling was used to determine the relative contributions of additive genetic effects, shared environmental effects, and individual-specific environmental effects to the 3 fatigue conditions. In women, tetrachoric correlations were similar for MZ and DZ pairs for prolonged and chronic fatigue, but not for CFS. In men, however, the correlations for prolonged and chronic fatigue were higher in MZ pairs than in DZ pairs. About half the variance for both prolonged and chronic fatigue in males was due to genetic effects, and half due to individual-specific environmental effects. For females, most variance was due to individual environmental effects.

AbstractObjectives. To compare cancer care among American Indian and Alaska Native (AIAN) patients with other racial groups. Methods. We used Washington State cancer registry records to identify 33,624 patients < age 65 diagnosed with local and regional stage breast, colorectal, and lung cancer from 1997 to 2003. Records were linked with regional tribal registry and Medicaid records to identify AIAN. Results. Enrollment in Medicaid at or after diagnosis was 50% for AIAN, 34% for Hispanic, 33% for black, and 18% for Asian/Pacific Islander compared to 13% of white cancer patients. AIAN were equally as likely as whites and other minority groups to receive surgery for breast and colorectal cancer, but significantly less likely (OR = 0.67) to receive surgery for lung cancer. Medicaid patients in general were less likely to receive surgery within 2 months of diagnosis, but AIAN were no less likely to receive timely surgery compared to other racial groups. Conclusion. AIAN rely more heavily than other racial groups on Medicaid for insurance after they are diagnosed with cancer. Issues associated with Medicaid enrollment, as well as non‐insurance related factors may account for delays in time to surgery and lower rates of lung cancer surgery among AIAN.