Process for Obtaining Informed Consent: Women’s Opinions

Bento, Silvana Ferreira; Hardy, Ellen; Osis, Maria José Duarte

doi:10.1111/j.1471-8847.2006.00183.x

Cited by 12 publications

(10 citation statements)

References 17 publications

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“…29 The study also showed that 62% (25/40; 95% CI 47.5% to 77.5%) wanted results of previous studies of safety and 45% (18/40; 95% CI 29.5% to 60.4%) of efficacy, and 15% (6/40; 95% CI 3.9% to 26.1%) wanted to know if study medication had been approved for clinical use 29 The one qualitative study showed that participants wanted to know how to use the intervention 21 Continued 23 31 32 Pooled results of the two quantitative studies 20 30 suggest that 57% (95% CI 7% to 98%) wanted to know about study benefits Two studies provided relevant data relating to specific benefits. 29 How data will be collected, stored, what it will be used for, who will have access to it, how long it will be retained for and how it will be disposed of 2 23 32 Pooled results showed that 44% (95% CI 10% to 82%) participants wanted to be given information about confidentiality and the protection of their privacy Continued What will happen to the results of the research, if it is intended to be published and how results will be made available to participants and that they will not be identified in any publication 3 28 30 33 Pooled results showed that 91% (95% CI 85% to 95%) wanted to know about study results Specific information types varied considerably between studies, so no meaningful pooled results could be calculated.…”

Section: Resultsmentioning

confidence: 99%

What potential research participants want to know about research: a systematic review

et al. 2012

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ObjectiveTo establish the empirical evidence base for the information that participants want to know about medical research and to assess how this relates to current guidance from the National Research Ethics Service (NRES).Data sourcesMedline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information Consortium, Cochrane Library, thesis index's, grey literature databases, reference and cited article lists, key journals, Google Scholar and correspondence with expert authors.Study selectionOriginal research studies published between 1950 and October 2010 that asked potential participants to indicate how much or what types of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information were included.Study appraisal and synthesis methodsStudies were appraised based on the generalisability of results to the UK potential research participant population. A metadata analysis using basic thematic analysis was used to split results from papers into themes based on the sections of information that NRES recommends should be included in a participant information sheet.Results14 studies were included. Of the 20 pieces of information that NRES recommend should be included in patient information sheets for research pooled proportions could be calculated for seven themes. Results showed that potential participants wanted to be offered information about result dissemination (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), potential benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). The level of detail participants wanted to know was not explored comprehensively in the studies. There was no empirical evidence to support the level of information provision required by participants on the remaining seven items.ConclusionsThere is limited empirical evidence on what potential participants want to know about research. The existing empirical evidence suggests that individuals may have very different needs and a more tailored evidence-based approach may be necessary.

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Section: Resultsmentioning

confidence: 99%

What potential research participants want to know about research: a systematic review

et al. 2012

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“…For those who did agree to participate, an appointment was made at a convenient date and time for each woman. Since the interviews were conducted by telephone, informed consent was given verbally and recorded after any doubts were clari ed (10).…”

Section: The Cross-sectional Qualitative Studymentioning

confidence: 99%

“Preterm birth risk, me?” Women risk perception about premature delivery – a qualitative analysis

Silva

Bento

Katz

et al. 2020

Preprint

Self Cite

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Background: Risk perception is based on collective indicators, but it is influenced by the individual’s self-perception of his health-disease process. This study aims to investigate the risk perception of pregnant who were identified as high-risk for premature birth and to seek strategies for better management of such cases. Methods: This is a cross-sectional study where women who had completed their participation in P5 trial were contacted and invited to answer a structured questionnaire with open questions. Data were collected by telephone and analyzed using thematic analysis. The analysis categories were defined, and all the answers were reviewed, categorized, grouped, and a descriptive summary was prepared. Results: 208 Brazilian women have participated.Three categories were identified: 1) Risk perception mediated by health professionals; 2) Self-perception of risk through personal experiences and relationships; 3) Perception of treatment success. After receiving an explanation from a healthcare professional about short cervix and premature birth, women understood the risk of premature delivery, recognizing the importance of early diagnosis to prevent premature birth. Unsuccessful previous experiences in prior pregnancies influenced women's risk perception. Patients believed in the success of the treatment performed, placing their hopes on the treatment even without research guarantees about benefits. Conclusion: Pregnant women’s risk perception regarding prematurity is based partly on personal and family experiences but mainly on information given by healthcare professionals. The risk perception about preterm birth may contribute to healthy pregnancy, guiding necessary interventions and preventing adverse outcomes. Prevention studies on prematurity should thus focus on neonatal outcomes.

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“…Throughout the course of the therapeutic relationship, it is important that informed consent is obtained if there are any changes in intervention(s) along the way. This can be effectively accomplished if it is integrated into the therapeutic process from beginning at the first point of contact and to continue to the end (Bento, Hardy, & Osis, 2008). Once a client's consent is obtained, which is his or her willingness to participate in the therapeutic process after understanding their rights; the nature of the process, and being able to make decisions throughout the process, informed consent can be viewed to be valid (Vitello, 2008).…”

Section: What Is Informed Consent Process?mentioning

confidence: 99%

“…From the three stages of obtaining informed consent, which include preconditioning, elements, and elements of consent, the required components of the informed consent process have to be included in order to achieve a successful outcome (Bento, Hardy, & Osis, 2008). For any informed consent that is related to research, therapy, assessment, consultation, the nature, purpose and anticipated course (duration), etc., should be provided to the patient.…”

Section: Basic Elements Of Informed Consent Processmentioning

confidence: 99%

The History and Current Status of Informed Consent

Farinde¹

2014

IJSW

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The purpose of this article is to examine the process of informed consent as it relates to the practice of psychology and as a part of Human relations Standards (3.10) of the American Psychological Association Ethical Principles of Psychologists and Code of Conduct. Before a psychologist provides any type of psychological service to a client/patient, whether it involves conducting research, administering a test or assessment/ therapy, counseling, clinical supervision, or providing consulting services, he or she must ensure that informed consent is obtained (oral, written, or other methods). This information must be delivered using language that is reasonably understandable to a competent individual. The term reasonably understandable describes the level of complexity and completeness that is required of psychologist when obtaining informed consent. The process of informed consent implies that a patient/client is made fully aware of the purpose as to why a service is being provided, the intended use of the information, and the benefits and risks associated with the process, involvement of any third parties, and limits and risks of confidentiality. It is recognized as a decision-making process where a psychologist communicates sufficient information to a potential client/patient so that he or she is able to make a well-informed decision as to whether they will participate in the professional relationship. If any information is taken during the session whether it is written, video, or audio, the client/patient is to be made aware of how this information will be used, if it will be released or disclosed to others a formal writing is to be provided indicating who these individuals will be. While the informed consent process is recognized as an important aspect for any psychologist to cover when it involves providing any type of service to a client this can often times be neglected which places the psychologists in jeopardy for lawsuits or loss of licensure. The informed consent process, is just that, a process, and not a single event not only protects the privacy rights of the client/patient but safeguards the psychologist from being liable in the case that a client/patient reports they were not adequately informed about a psychological service.

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Process for Obtaining Informed Consent: Women’s Opinions

Cited by 12 publications

References 17 publications

What potential research participants want to know about research: a systematic review

What potential research participants want to know about research: a systematic review

“Preterm birth risk, me?” Women risk perception about premature delivery – a qualitative analysis

The History and Current Status of Informed Consent

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