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Research in prison
Published in Joanne Brooke, Dementia in Prison, 2020
The Declaration of Helsinki was first adopted by the World Medical Association (WMA) in 1964, with amendments agreed in 1975, 1983, 1989, 1996, 2000, 2008 and 2013. The declaration applies to all medical research involving human subjects, including research on identifiable human material and data, and was originally written for physicians, but all healthcare professionals are recommended to adopt these principles. The declaration contains a number of sections including general principles risks, burdens and benefits; vulnerable groups and individuals, scientific requirements and research protocols; research ethics committees; privacy and confidentiality; informed consent; use of placebo; post-trial provisions; research registration and public dissemination of results; and unproven interventions in clinical practice. Although the WMA states that the declaration should be read and applied in full, for this section, elements particularly relevant to prison research will be discussed.
Health Impairment Process in Human Service Work
Published in Dorota Żołnierczyk-Zreda, Emotional Labour in Work with Patients and Clients, 2020
A cross-lagged, one-year measurement interval study was conducted in the period from September to November 2017 and 2018 by trained research assistants at the study participants’ employment premises. All participants were treated in compliance with the ethical guidelines of the Declaration of Helsinki. Participants received a hard copy of the questionnaires along with a letter explaining the purpose of the study. Full data confidentiality and anonymity were ensured. Participants were asked to fill out the questionnaires and seal them in envelopes, which were subsequently collected by the research assistants. Out of 500 distributed questionnaires, 358 (72%) were returned and 200 (40% of the original pool) were at least 75% complete and subsequently used for data analysis.
The TRIPS regime for test data protection and access to medicines
Published in Olasupo Owoeye, Intellectual Property and Access to Medicines in Africa, 2019
There are also ethical issues involved in allowing generic manufacturers to rely on the originator’s test data. Clinical trials generally involve the use of both human and animal research subjects5 and requiring generic manufacturers to duplicate clinical results will entail very onerous consequences for the research subjects. Paragraph 12 of the World Medical Association Declaration of Helsinki is particularly instructive in relation to the ethical issues involved in clinical trials. It provides: Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
The clinical features and outcomes of systemic light chain amyloidosis with hepatic involvement
Published in Annals of Medicine, 2022
Liang Zhao, Guisheng Ren, Jinzhou Guo, Wencui Chen, Weiwei Xu, Xianghua Huang
Retrospectively we reviewed 88 cases of patients with AL amyloidosis and predominant hepatic involvement who were newly diagnosed in our institution between June 2004 and January 2019. The diagnosis and type of AL was histologically confirmed (Congo-red, immunofluorescence). The histologic specimens were obtained by using at least one of the following biopsies: abdominal skin and fat, rectum mucosa, bone marrow, renal or liver. Plasma cell dyscrasia was documented by serum immunofixation electrophoresis and serum-free light chain test. Patients with ATTR, AA, familial or localized (including dialysis-related) amyloidosis were excluded. This study followed the Declaration of Helsinki Ethical Principles for Medical Research involving human subjects. Informed consent was obtained from each participant to have their medical records reviewed, and the study was approved by the institutional ethics review board of Jinling Hospital.
Orbital abscess: 20 years’ experience at a tertiary eye care center
Published in Orbit, 2022
Md Shahid Alam, Varsha Backiavathy, Veena Noronha, Bipasha Mukherjee
A retrospective review of all patients with the ICD codes 376.00 and 376.01 (version 9) from January 2000 – January 2020 was done at Medical Research Foundation, Sankara Nethralaya, Chennai. The ICD code corresponds to acute inflammation of orbit/ orbital cellulitis. There is no specific ICD code for orbital abscess. Patients fulfilling the inclusion criteria for orbital abscess being radiological evidence of abscess formation in the orbital fat were included in the study. Cases of orbital cellulitis without an orbital abscess and those with subperiosteal abscess were excluded. The diagnosis was based on magnetic resonance imaging or computed tomography of the orbit. The scans were reviewed by a single in – house radiologist with an experience of over 20 years in our institute. The data analyzed included demographic information, predisposing factors, clinical and radiological features, microbiological profile, interventions, management outcomes, and complications. Institutional review board approval and ethical clearance were obtained and the study adhered to the tenets of the declaration of Helsinki.
Lacrimal gland pleomorphic adenoma with extensive necrosis
Published in Orbit, 2022
Micheal A. O’Rourke, Penelope A. McKelvie, Christopher M. Angel, Alan A. McNab
Lacrimal gland pleomorphic adenoma (LGPA) accounts for over one fifth of LG epithelial tumours.1 This benign mixed tumour usually presents with slowly progressive unilateral painless proptosis arising most commonly from the orbital lobe of the lacrimal gland.2–4 These tumours are akin to such tumours occurring in other salivary glands such as the parotid and sub-mandibular glands. Diagnosis of LGPA can be difficult and atypical presentations are well recognised.5,6 The clinician should be aware of the potential for atypical presentations as the choice of biopsy versus primary gland excision remains open for discussion.7,8 Although rare, spontaneous infarction in salivary gland pleomorphic adenomas has been reported.9–12 Necrosis can mimic carcinoma leading to misinterpretation as a malignancy in an otherwise benign lacrimal gland neoplasm. We present a case of necrosis in LGPA initially diagnosed as adenocarcinoma. This report adhered to the ethical principles outlined in the Declaration of Helsinki. Written consent for clinic photographs was obtained and is archived by the authors.