关键词: Cancer patients Consent process Ethiopia Rapid ethical assessment Research ethics

Mesh : Adult Aged Biomedical Research / ethics Ethics Consultation Ethiopia Female Humans Informed Consent / ethics Longitudinal Studies Medical Oncology / ethics Middle Aged Neoplasms / therapy Patient Selection / ethics Prohibitins Young Adult

来  源:   DOI:10.1186/s12910-018-0328-8   PDF(Sci-hub)   PDF(Pubmed)

Abstract:
Rapid Ethical Assessment (REA) is an approach used to design context tailored consent process for voluntary participation of participants in research including human subjects. There is, however, limited evidence on the design of ethical assessment in studies targeting cancer patients in Ethiopia. REA was conducted to explore factors that influence the informed consent process among female cancer patients recruited for longitudinal research from Addis Ababa Population-based Cancer Registry.
Qualitative study employing rapid ethnographic approach was conducted from May-July, 2017, at the Tikur Anbessa Specialized Referral Hospital. In-depth and key informants\' interviews were conducted among purposively selected 16 participants. Regular de-briefings among the study team helped to identify emerging themes and ensure saturation. Interviews and debriefings were tape recorded in Amharic, and transcribed and translated to English. Coding of the transcripts was facilitated by use of NVivo software. Thematic analysis was employed to respond to the initial questions and interpret findings.
Perceived barriers to voluntary study participation included lack of reporting back study results of previous studies, the decision making status of women, hopelessness or fatigue in the patients, shyness of the women, data collectors approach to the patient, and patient\'s time constraints. Most of the patients preferred oral over written consent and face-to-face interview over telephone interview. Provision of detail information about the study, using short and understandable tool, competent, compassionate and respectful enumerators of the same gender were suggested to assure participation. Due to the perceived severity, the use of the term \"cancer\" was associated with fear and anxiety. Alternatively, uses of phrases like \"breast or cervical illness/disease\" were suggested during patient interviews.
Voluntary participation is not straight forward but affected by different factors. Using competent, compassionate and respectful enumerators, short and precise questioning tools to limit the time of the interview could improve voluntary participation. Moreover, careful consideration of the patients and families concept of the disease such as wording and information has to be taken into account. This assessment helped in improving the consent process of the ongoing project on breast and cervical cancer patients.
摘要:
快速道德评估(REA)是一种用于设计上下文量身定制的同意过程的方法,以使参与者自愿参与包括人类受试者在内的研究。有,然而,在埃塞俄比亚针对癌症患者的研究中,关于伦理评估设计的证据有限。进行REA以探索影响从亚的斯亚贝巴基于人群的癌症登记处招募进行纵向研究的女性癌症患者知情同意过程的因素。
从5月至7月进行了采用快速人种学方法的定性研究,2017年,在TikurAnbessa专业转诊医院。在有目的地选择的16名参与者中进行了深入和关键的线人访谈。研究小组的定期汇报有助于确定新出现的主题并确保饱和。采访和汇报用阿姆哈拉语录音,并转录并翻译成英语。通过使用NVivo软件促进转录物的编码。采用主题分析来回答最初的问题并解释发现。
自愿参与研究的障碍包括缺乏报告以前研究的研究结果,妇女的决策地位,病人的绝望或疲劳,女人的羞怯,数据收集器接近病人,和病人的时间限制。大多数患者更喜欢口头而不是书面同意,面对面采访而不是电话采访。提供有关研究的详细信息,使用简短易懂的工具,主管,建议同性别的富有同情心和尊重的调查员确保参与。由于感知的严重性,“癌症”一词的使用与恐惧和焦虑有关。或者,在患者访谈中建议使用诸如“乳房或宫颈疾病/疾病”之类的短语。
自愿参与不是直截了当的,而是受到不同因素的影响。使用称职的,富有同情心和尊重的列举者,简短而精确的提问工具来限制面试时间可以提高自愿参与。此外,必须仔细考虑患者和家庭对疾病的概念,例如措辞和信息。这项评估有助于改善正在进行的乳腺癌和宫颈癌患者项目的同意过程。
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