ArticleBMC medical ethics2006
Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.
Article in BMC medical ethics, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.
- Audio-visual presentation of information for informed consent for participation in clinical trials.The Cochrane database of systematic reviews · 2014Pooled it
- How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.BMC medical ethics · 2010Trial
- Radiation therapy for prostate cancer in Syrian refugees: facing the need for change.Frontiers in public health · 2023Article
- Article
- Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities.The oncologist · 2019Review
- Bioethical reflexivity and requirements of valid consent: conceptual tools.BMC medical ethics · 2019Article
- Biomedical research ethics in Cameroon: a survey to assess training needs of medical residents and students.BMC medical education · 2019Article
- Challenges of Obtaining Informed Consent in Emergency Ward: A Qualitative Study in One Iranian Hospital.The open nursing journal · 2017Article
- Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study.PloS one · 2016Article
- Why are clinical trials necessary in India?Perspectives in clinical research · 2014Article
- Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand.BMC medical ethics · 2013Article
- Vulnerable population and methods for their safeguard.Perspectives in clinical research · 2013Article
- Aspects of vulnerable patients and informed consent in clinical trials.German medical science : GMS e-journal · 2013Review
- Violation of ethical principles in clinical research. Influences and possible solutions for Latin America.BMC medical ethics · 2012Article
- Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience.BMC medical ethics · 2012Article
- Are women who work in bars, guesthouses and similar facilities a suitable study population for vaginal microbicide trials in Africa?PloS one · 2010Article
- Understanding of research: a Sri Lankan perspective.BMC medical ethics · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important.
methodsTo gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale.
resultsThirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade.
conclusionThe results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.