Beyond the informed consent procedure: continuing consent in human research

Mueller, Mary-Rose; Instone, Susan

doi:10.1590/s1413-81232008000200013

Cited by 14 publications

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“…This document explains in accessible language the research details to ensure that that the subject understands the procedures, risks, discomforts, benefits and rights involved and makes an autonomous decision [15,16]. …”

Section: Introductionmentioning

confidence: 99%

Motives for participating in a clinical research trial: a pilot study in Brazil

2013

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BackgroundIn the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil.MethodsMixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing.ResultsThe motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study.ConclusionsThe present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

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Section: Introductionmentioning

confidence: 99%

Motives for participating in a clinical research trial: a pilot study in Brazil

2013

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“…[13] In general, informed consent is taken initially and then repeated whenever there are amendments to the consent document. In psychiatry, however, continued consent has an important role.…”

Section: Informed Consentmentioning

confidence: 99%

Challenges in conducting psychiatry studies in India

Kharawala

Dalal

2011

Perspect Clin Res

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A large number of psychiatry studies are conducted in India. Psychiatry studies are complex and present unique challenges in the Indian setting. Ethical issues pertaining to the risk of worsening of illness, use of placebo and validity of informed consents are commonly faced. Site selection can be difficult due to the relative paucity of ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) trained psychiatry investigators in India. Recruitment can be challenging due to issues such as strict eligibility criteria, (lack of) availability of caregiver, illness-related considerations, etc. Assessment of the consent capacity of patients is not simple, while structured assessments are not commonly employed. As the illness fluctuates, the consent capacity may change, thus requiring continued assessment of consent capacity. Study patients run the risk of worsening of illness and suicide due to exposure to inactive treatments; this risk is counterbalanced by use of appropriate study designs, as well as the indirect psychotherapeutic support received. Psychiatry studies are associated with a high placebo response. This necessitates conduct of placebo-controlled studies despite the attendant difficulties. Also, the high placebo response is often the cause of failed trials. Rating scales are essential for assessment of drug response. Some rating instruments as well as some rater training procedures may not be suitable for the Indian setting. Technological advancements may increase the procedural complexity but improve the quality of ratings. Psychiatry studies present monitors and auditors with unique scenarios too. Utilization of psychiatry specific training and expertise is recommended to ensure successful conduct of these studies in India.

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“…Participants may forget relevant information over the course of their research participation, such as the right to withdraw. Changes also may occur after participants have enrolled: new options may become available, participants’ health may decline, their diseases may progress [15]. …”

Section: Introductionmentioning

confidence: 99%

Empirical evaluation of the need for ‘on-going consent’ in clinical research

Smith

Grady

Krohmal

et al. 2011

Aids

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Objective Some commentators argue that informed consent for clinical research should be an on-going process, which begins, rather than ends, with participants’ initial consent. Lacking, however, are empirical data on whether there is a need for ‘on-going consent’. Design Two self-administered surveys—a baseline survey at initial consent and a follow-up survey 2-3 years later—to assess whether participants remain informed over time. Methods Respondents were adults with HIV disease from Argentina, Brazil and Thailand enrolled in a long-term clinical trial. Results Respondents overall were well informed at baseline. At follow-up, many reported being not informed about aspects of the study central to their on-going participation. With respect to the possibility of withdrawal, 38.5% of respondents at follow-up reported being “not at all” informed. At follow-up, 71.1% wanted more information. Yet, 62.8% had not asked any questions during the entire study. Reasons for not asking questions included not having an opportunity (16.4%) and not knowing whom to ask (15.5%). Conclusions The standard consent process resulted in participants being well informed at enrollment. Yet, this process was not sufficient to keep them informed about aspects of the study central to their on-going participation. In addition, participants who wanted more information often did not ask for it. These findings provide empirical support for recommendations that clinical trials should consider including a process of ‘on-going consent’.

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Beyond the informed consent procedure: continuing consent in human research

Abstract: An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol re

Cited by 14 publications

References 10 publications

Motives for participating in a clinical research trial: a pilot study in Brazil

Motives for participating in a clinical research trial: a pilot study in Brazil

Challenges in conducting psychiatry studies in India

Empirical evaluation of the need for ‘on-going consent’ in clinical research

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