American Indian and Alaska Native Programs, University of Colorado Health Sciences Center, Nighthorse Campbell Native Health Building, Mail Stop F800, P.O. Box 6508, Aurora, CO 80045-0508, USA. spero.manson@uchsc.edu
OBJECTIVE: To illustrate successful strategies in working with American Indian (AI) and Alaska Native (AN) communities in aging and health research by emphasizing access, local relevance, and decision-making processes. METHODS: Case examples of health studies involving older AIs (greater than or equal to 50 years) among Eastern Band Cherokee Indians, a federally recognized reservation; the Cherokee Nation, a rural, nonreservation, tribal jurisdictional service area; and Lakota tribal members living in Rapid City, South Dakota. RESULTS: Local review and decision making reflect the unique legal and historical factors underpinning AI sovereignty. Although specific approval procedures vary, there are common expectations across these communities that can be anticipated in conceptualizing, designing, and implementing health research among native elders. CONCLUSIONS: Most investigators are unprepared to address the demands of health research in AI communities. Community-based participatory research in this setting conflicts with investigators' desire for academic freedom and scientific independence. Successful collaboration promises to enhance research efficiencies and move findings more quickly to clinical practice.
Members of racially and ethnically diverse groups have been persistently underrepresented in biomedical research in general, possibly due to mistrust with the medical and research community. This article describes the perceptions, understandings, and expectations of Alaska Native people about research involving the collection and storage of biological specimens.
Stratified focus groups.
Twenty-nine focus groups with Alaska Native people (n = 178) were held in 14 locations using a semi-structured moderator guide. ATLAS.ti was used for thematic analysis through iterative readings and coding. Alaska Native peoples' perceptions, understandings, and expectations of researcher beneficence, informed consent processes, and provision of research findings were elicited.
Alaska Native people desired extensive disclosure of information beyond that typically provided in consent and results dissemination processes. Information germane to the motivation and intent of researchers and specifics of specimen storage and destruction were specifically requested. A clear and extensive process of informed consent and continued improvements in sharing results may enhance the transparency of research intent, conduct, and use of obtained results among Alaska Native people. Meeting expectations may improve relationships between researchers and the Alaska Native population which could result in increased research participation. Our findings offer a guide for researchers and communities when planning and implementing research with biological specimens.
Notes
Cites: Scand J Public Health. 2004;32(3):224-915204184
Alzheimer disease ethics--informed consent and related issues in clinical trials: results of a survey among the members of the Research Ethics Committees in Sweden.
The rapid advances in biomedical sciences have induced special moral and ethical attitudes, which ought to be taken into account. One of the most essential issues is the principles for participation in research of subjects with reduced decision-making capacity. We conducted a questionnaire survey among members of the research ethics committees in Sweden to find out their attitudes to a range of ethical issues related to research on subjects with Alzheimer's disease. One hundred thirty-six of those approached responded (66%), and 117 of the responses (56%) were considered substantially complete. There were 16 questions with fixed reply alternatives. Some central questions concerned the informed consent process. With a few exceptions, there were no significant differences in attitudes between the experts and laypersons, between persons of different ages, and between men and women. However, women and laypersons were in general keener to preserve the patient's integrity and the experts were more willing than the laypersons to allow participation of subjects with dementia in placebo-controlled trials.
Xenotransplantation, or the use of animal cells, tissues and organs for humans, has been promoted as an important solution to the worldwide shortage of organs. While scientific studies continue to be done to address problems of rejection and the possibility of animal-to-human virus transfer, socio-ethical and legal questions have also been raised around informed consent, life-long monitoring, animal welfare and animal rights, and appropriate regulatory practices. Many calls have also been made to consult publics before policy decisions are made. This paper describes the Canadian public consultation process on xenotransplantation carried out by the Canadian Public Health Association in an arm's length process from Health Canada, the ministry overseeing government health policy and regulation. Focusing on six citizen for a conducted around the country patterned after the citizen jury deliberative approach, the paper describes the citizen panelists' recommendations to hold off on proceeding with clinical trials and the rationales behind this recommendation. The consultation process is discussed in the context of constructive technology assessment, a framework which argues for broader input into earlier stages of technology innovation, particularly at the technology design stage.
Centre for Education and Research on Aging and Health, and School of Social Work, Lakehead University, 955 Oliver Road, Thunder Bay, Ontario, Canada P7B 5E1. hprince@lakeheadu.ca
To investigate compliance with applicable regulations by Canadian human embryonic stem cell (hESC) researchers and fertility clinics involved in providing embryos for their research, and to ascertain actual consent practices in the hESC research context.
Telephone interviews were conducted with all hESC researchers, and email interviews were conducted with fertility clinics that provide embryos to these researchers. Consent forms currently used for donation of embryos to hESC research were reviewed. Separate questionnaires were used for the researchers and clinics.
Three of four clinics responded. Of the clinics that responded, each had provided embryos for hESC research to at least one of the researchers. Despite considerable policy attention given to hESC research, very few researchers and clinics are actually involved in the research in Canada. Only cryopreserved embryos are currently being used in hESC research, but one researcher has applied to use fresh embryos. Fertility clinics play a primary role in the consent process, and researchers have no contact with patients/donors. Although representations have been made in academic literature and the popular press suggesting a lack of compliance by Canadian hESC researchers, researchers and clinics report that they are in substantial compliance with applicable regulations. The researchers appear to be very conscious of the ethics of hESC research. In addition, they state that they are willing to follow the rules, but they are frustrated by the lack of regulatory clarity and by delays in the research oversight process.
Empirical research on perceptions other stakeholders (donors, research ethics boards etc.) have of the hESC research process appears essential.
