With an increasing number of individuals living with chronic illness and pain, integrative approaches offering self-management support are needed. This book proposes a multi-layered framework integrating the body/self/environment that cultivates wholeness as an authentic embodied presence in alignment with a reflexive self.

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings (...) in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

BackgroundThe boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and (...) determination of risk level across a broad range of projects and health-related contexts. This paper describes the development of the Public Health Ontario Risk Screening Tool.MethodDevelopment of the PHO Risk Screening Tool included: preparation of a draft risk tool ; expert appraisal; internal stakeholder validation; external validation; pilot testing and evalution of the draft tool; and revision after 1 year of testing.ResultsA risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.ConclusionsThe PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions. (shrink)

The study examines the attitudes among physicians regarding acceptance of gifts, sponsorships, and drug samples in response to marketing efforts of pharmaceutical companies in India. The research also attempts to study physicians’ perceptions of the Medical Council of India (MCI) guidelines on the code of conduct for pharmaceutical marketing practices and the influence of these guidelines on physicians’ actions. A structured questionnaire was developed for collecting primary data regarding exposure of physicians to promotional tools and physicians’ attitudes and practices with (...) regard to various professional ethical issues. One thousand physicians from private and government hospitals located in a metropolitan area were approached personally or through email for getting the questionnaire filled. A total of 189 completed and usable questionnaires could be obtained which is a response rate of approximately 20 %. Respondents in the study indicate being offered samples, sponsorship, and gifts by pharmaceutical companies with a frequency of at least once a month. Thus, many pharmaceutical firms are not following the code of conduct issued by the Department of Pharmaceuticals, Govt. of India. Further, though almost all physicians report being aware of the guidelines issued by the MCI, yet as many as 69 % of the sample admitted to be accepting gifts and sponsorships offered by the pharmaceutical firms. Educational programs were found to be influencing physician prescription behavior to a greater extent when compared with gifts. Frequency of offers made for gifts and sponsorships were found to be dependent upon physicians’ practice (number of prescriptions written) and the type of hospital they are associated with (private or government). The study focuses on sensitive yet critical ethical issues related to the promotional practices of pharmaceutical firms in India and physicians’ responses with regard to these promotional practices in the context of the guidelines of the Medical Council of India and the Department of Pharmaceuticals. (shrink)