Research on informed consent

Background and Objectives: Federal regulations require that research subjects provide informed consent for their participation in biomedical research. Before giving consent, subjects are presented with information about study procedures, risks, benefits, and alternatives. Although investigators have assessed subjects' retention of consent material, little is known about how participants view methodologic dimensions of biomedical research, such as placebos and randomization, or the distinction between medical treatment in a research protocol versus personal health care. These issues were examined with a qualitative interview study.

Psychosomatics

Psychiatric and addictive disorders are often considered contraindications to hepatitis C virus (HCV) treatment. In this pilot study, the ability of 30 veterans to provide informed consent for combined antiviral HCV therapy was examined with a mental health assessment protocol specifically geared to evaluate capacity in this area. The results showed that subjects lacked essential knowledge regarding the course of the disease and the nature of antiviral treatment despite receiving prior counseling. Informed consent assessments of candidates for HCV treatment may identify deficits that are responsive to intervention, thereby allowing patients with comorbid psychiatric and addictive disorders to receive effective HCV treatment.

Genetics in Medicine, 2012

In 2006, the Department of Veterans Affairs launched the Genomic Medicine Program with the goal of using genomic information to personalize and improve health care for veterans. A step toward this goal is the Million Veteran Program, which aims to enroll a million veterans in a longitudinal cohort study and establish a database with genomic, lifestyle, military-exposure, and health information. Before the launch of the Million Veteran Program, a survey of Department of Veterans Affairs patients was conducted to measure preferences for opt-in and opt-out models of enrollment and consent. methods: An online survey was conducted with a random sample of 451 veterans. The survey described the proposed Million Veteran Program database and asked respondents about the acceptability of opt-in and opt-out models of enrollment. The study examined differences in responses among demographic groups and relationships between beliefs about each model and willingness to participate. Results: Most respondents were willing to participate under both opt-in (80%) and opt-out (69%) models. Nearly 80% said they would be comfortable providing access to residual clinical samples for research. At least half of respondents did not strongly favor one model over the other; of those who expressed a preference, significantly more people said they would participate in a study using opt-in methods. Stronger preferences for the opt-in approach were expressed among younger patients and Hispanic patients. conclusion: Support for the study and willingness to participate were high for both enrollment models. The use of an opt-out model could impede recruitment of certain demographic groups, including Hispanic patients and patients under the age of 55 years.

Neuropsychopharmacology, 2001

Sociology Compass, 2008

The dual concepts of ‘consent’ and ‘informed consent’ continue to have three evolutions. The primary evolution of consent in the patient–physician relationship began in Great Britain in 1767 in the British case, Slater v. Baker and Stapleton, in the judge-made law of consent. The term ‘informed consent’ within the patient–physician relationship entered the judicial lexicon in the 1957 California appellate case, Salgo v. Leland Stanford Junior University. In its second evolution within research on humans following the Nuremberg trials that included experimental atrocities on humans, there is a key focus on clarifying the purpose of research and specifying the reasons for the need for an even more extensive risk disclosure to individuals considering volunteering for study participation. This second evolution continues with the further refinement of the Declaration of Helsinki and, within the USA, a focus on the Belmont Report. In its third evolution in research in the social science, there has been a recognition of problems with informed consent to questionnaire research. When questionnaires involve patients with moderate or severe posttraumatic stress disorder or abused individuals, there needs to be intense consideration focused on how to best protect the participants with these conditions during the questionnaire study.

2018

Informed and voluntary consent are important aspects when conducting human research and is an area that is frequently talked about particularly since the atrocities of the World War II. Since, there have been numerous legal additions to safeguard research volunteers and ethics approval also incorporates this process. This is therefore one of the nuts and bolts in research methodology. This article looks at the informed consent process and how this is obtained. It discussed how research informed consent varied from consent for a clinical procedure and looks at occasions when this important aspect can be waived.

Social Science & Medicine, 1983

Patient consent to medical treatment has been a subject of concern within the United States professional communities for over two decades. This paper traces the development of research literature on patient decision making and informed consent to medical treatment in three fields of research: medicine, law and the social sciences. A general model for stages in the development of scientific specialties is applied as a test for the development of informed consent as a specialty interest in each research field. Results indicate a relatively advanced stage of development within medicine and law. Research in the social science disciplines tend to lag behind in terms of cumulative number of publications. In addition. social science research which is potentially relevant to the ethical and policy issues of consent in medical treatment appears to lack a clear programmatic thrust. with little attention given to the policy implications of the work. In contrast. the medical and legal literatures indicate a direct concern with social policy and reflect attempts on the part of physicians and lawyers to influence the policy making process.

Pain Practice, 2008

Informed consent is important: in research, it allows subjects to make an informed and voluntary choice to participate--or refuse to participate--in a project where they will be asked to take risks for the benefit of others. In both research and clinical care, informed consent represents a permission to intervene on a person's private sphere. The elements of informed consent are usually described as disclosure, understanding, decision-making capacity, and voluntariness. Each poses distinct difficulties, and can be amenable to improvements. However, research on the quality of informed consent and on strategies intended to improve it have only become the object of research relatively recently. In this article, we describe some results of this research, and outline how they can be relevant to informed consent in research and clinical care. Although much of the data suffers from limitations, it does suggest that disclosure has improved, but is still uneven, comprehension is often poor, for both patients and research subjects. Moreover, trust is a motivating factor for research participation, and thus we run risks if we allow false expectations and prove ourselves unworthy of this trust. Although improving consent forms does not have a clear effect on understanding, improving the consent process may help. Finally, better information may decrease anxiety and seems to have at most a small negative effect on research recruitment.

2015

Bulletin of the World Health Organization, 2015

We conducted a literature search of PubMed and Scopus using the following terms: "informed consent [mh] AND (comprehension[mh] OR decision making[mh] OR knowledge[mh] OR perception[mh] OR communication[mh] OR understanding) AND (randomized controlled trials as topic[mh] OR clinical trial as topic [mh])". In addition, in a simple search of Scopus, we used: "allintitle: understanding OR comprehension OR knowledge OR decision OR perception OR communication "informed consent"." In Google Scholar, we used the keywords "informed consent" as the exact phrase and "understanding, comprehension, knowledge, decision, perception, communication" with the option with at least one of the words and selected "where my words occur in the title of the article". The search strategy was developed as previously described. The searches covered all data entered up to Objective To estimate the proportion of participants in clinical trials who understand different components of informed consent. Methods Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity. Findings The analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study's purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years. Conclusion The proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding.