Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study

Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

doi:10.1371/journal.pone.0157056

Cited by 18 publications

(26 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Most of the in-depth and key informants, however, preferred oral consent while even they agreed to participate in the study. This finding was concurring with the studies conducted in different parts of Ethiopia [ 17 , 27 , 29 , 30 ]. The participants relate signature with legal accountability and could hinder participants from responding freely for any question [ 27 , 30 ].…”

Section: Discussionsupporting

confidence: 92%

See 1 more Smart Citation

Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia

et al. 2018

Self Cite

View full text Add to dashboard Cite

BackgroundRapid 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.MethodsQualitative 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.ResultsPerceived 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.ConclusionsVoluntary 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.

show abstract

Section: Discussionsupporting

confidence: 92%

“…The term “cancer” is considered fatal and incurable disease by both the cancer patients and relatives interviewed. This view was also documented in a study conducted in Northern Ethiopia [ 27 ]. As a result of this, it was not simple to use the word cancer while interviewing some of the breast and cervical cancer patients.…”

Section: Discussionsupporting

confidence: 70%

Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia

et al. 2018

Self Cite

View full text Add to dashboard Cite

show abstract

“…Studies in sub-Saharan Africa have shown that low community awareness about health research and the participants’ perception that signing consent forms is not a good approach due to the potential legal accountability decrease research acceptance and participation rates [35]. Therefore, trained data enumerators, who were bilingual (English and Luganda) explained the study to participants in either English or Luganda through a plain language statement.…”

Section: Methodsmentioning

confidence: 99%

Sexual, Reproductive Health Needs, and Rights of Young People in Slum Areas of Kampala, Uganda: A Cross Sectional Study

et al. 2017

View full text Add to dashboard Cite

BackgroundYoung people in Uganda face various sexual and reproductive health risks, especially those living in urban slums. The aim of this study was to examine factors associated with comprehensive categories of sexual and reproductive health, including sexual behaviours; sexual education and access to contraceptive services; family planning; prevention of STDs; sexual consent as a right; gender based violence; as well as HIV testing, counselling, disclosure and support.MethodsThe study was cross-sectional in design and was carried out in July 2014 in Makindye and Nakawa Divisions of Kampala City, Uganda. Using systematic random sampling, data were collected on 663 participants aged between 13 and 24 years in Kampala’s urban slums.ResultsSixty two percent of participants reported having ever had sex and the mean age of sexual debut was 16 years (95%CI: 15.6, 16.4 years, range: 5–23 years). The odds of reporting ever having had sexual intercourse were higher among respondents living alone (OR: 2.75; 95%CI: 1.35, 5.61; p<0.01) than those living in a nuclear family. However, condom use was only 54%. The number of sexual partners in the last 12 months preceding the survey averaged 1.8 partners (95%CI: 1.7, 1.9; range 1–4) with 18.1% reporting an age gap of 10 years or older. More than three quarters (80.6%) of sexually active participants reported that their first sexual encounter was consensual, suggesting that most young people are choosing when they make their sexual debut. Low prevalence of willing first sexual intercourse was associated with younger age (OR = 0.48, 95%CI: 0.25, 0.90, p<0.05), having a disability (OR = 0.40, 95%CI: 0.16, 0.98, p<0.05), living with non-relatives (OR = 0.44, 95%CI: 0.16, 0.97, p<0.05), and being still at school (OR = 0.29, 95%CI: 0.12, 0.67, p<0.01). These results remained significant after adjusting for covariates, except for disability and the age of participants. The proportion of unwilling first sexual intercourse was significantly higher among women for persuasion (13.2% vs. 2.4%, p<0.001), being tricked (7.1% vs 2.9%, p<0.05) and being forced or raped (9.9% vs 4.4%, p<0.05) than men. A high level of sexual abuse emerged from the data with 34.3% affirming that it was alright for a boy to force a girl to have sex if he had feelings for her; 73.3% affirming that it was common for strangers and relatives to force young females to have sexual intercourse with them without consent; 26.3% indicating that it was sometimes justifiable for a boy to hit his girlfriend, as long as they loved each other.ConclusionThis study has explored current sexual practice among young people in a specific part of urban Kampala. Young people’s sexual and reproductive health remains a challenge in Uganda. To address these barriers, a comprehensive and harmonised sexual and reproductive health system that is youth friendly and takes into account local socio-cultural contexts is urgently needed.

show abstract

“…Whereas few were unsure about ease of withdrawal from the study, the majority were aware of risks associated with use of the contraceptives, but few could actually understand the level of risk of pregnancy while using the experimental contraceptive. In a study that assessed the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study in healthy pregnant women [ 34 ], awareness about health research, rights of participants, and the condition being studied was low. Besides, while most participants were skeptical and afraid of signing consent forms for research, others believed that they had an obligation to participate.…”

Section: Main Textmentioning

confidence: 99%

Why ‘understanding’ of research may not be necessary for ethical emergency research

Kaye

2020

Philos Ethics Humanit Med

View full text Add to dashboard Cite

Background: Randomized controlled trials (RCTs) are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented. Methods: Conceptual review. Discussion: Research is necessary to identify how the illnesses may be prevented, to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the 'understanding' of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research. Conclusion: While participant 'understanding' of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered.

show abstract

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study

Cited by 18 publications

References 21 publications

Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia

Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia

Sexual, Reproductive Health Needs, and Rights of Young People in Slum Areas of Kampala, Uganda: A Cross Sectional Study

Why ‘understanding’ of research may not be necessary for ethical emergency research

Contact Info

Product

Resources

About