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Results for “ETHICS, PHARMACEUTICAL”

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At least 1,135 records · Page 63Linked to original sources
PubMed2005

Paying research participants: a study of current practices in Australia.

OBJECTIVE: To examine current research payment practices and to inform development of clearer guidelines for researchers and ethics committees. DESIGN: Exploratory email based questionnaire study of current research participant reimbursement practices. A diverse sample of organisations and individuals were targeted. SETTING: Australia. PARTICIPANTS: Contacts in 84 key research organisations and select electronic listservers across Australia. A total of 100 completed questionnaires were received with representations from a variety of research areas (for example, market, alcohol and drug, medical, pharmaceutical and social research). MAIN MEASUREMENTS: Open-ended and fixed alternative questions about type of research agency; type of research; type of population under study; whether payment is standard; amounts and mechanisms of payment; factors taken into account when deciding on payment practices; and whether payment policies exist. RESULTS: Reimbursement practice is highly variable. Where it occurs (most commonly for drug dependent rather than health professional or general population samples) it is largely monetary and is for time and out-of-pocket expenses. Ethics committees were reported to be often involved in decision making around reimbursement. CONCLUSIONS: Research subject payment practices vary in Australia. Researchers who do provide payments to research participants generally do so without written policy and procedures. Ethics committees have an important role in developing guidelines in this area. Specific guidelines are needed considering existing local policies and procedures; payment models and their application in diverse settings; case study examples of types and levels of reimbursement; applied definitions of incentive and inducement; and the rationale for diverse payment practices in different settings.

Australia↗
PubMed2001

Ethical issues related to retrospective drug utilization studies in South Africa.

PURPOSE: The purpose of the manuscript is to discuss the ethical issues related to pharamacoepidemiological research in South Africa, with specific emphasis on three recently performed retrospective drug utilization studies. METHODS: Ethical considerations relating to three retrospective drug utilization studies on hyperlipidaemia, diabetes and tricyclic antidepressants are discussed. RESULTS: Computerized medication records were obtained from three different organizations after formal proposals had been submitted. The information contained in the data sets varied, and in some instances, a fair amount of manual coding had to be performed to make the data useable for research purposes. The research was not sponsored by the private pharmaceutical sector and this minimized the potential for any bias in the studies. Data privacy and confidentiality were maintained at all times. No patient could be traced, and it was also not possible to determine which medical practitioners were involved in the prescribing of the drugs. CONCLUSIONS: Retrospective drug utilization studies are a relatively easy, inexpensive and uncomplicated method to comment on the prescribing of drugs in large patient populations provided that ethical principles related to confidentiality and data privacy are adhered to.

Bioethics↗