A Review of Evidence on Consent Bias in Research

Emam, Khaled El; Jonker, Elizabeth; Moher, Ester; Arbuckle, Luk

doi:10.1080/15265161.2013.767958

Cited by 24 publications

(22 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In the case of our cross-sectional study, which sought to examine the association between sexual behaviors (exposure) and testing newly positive for HIV (outcome), our data suggest that the risk of consent bias for a study with this exposure and outcome is probably minimized; we observed significant differences between enrollees and nonenrollees with regard to sexual behaviors, but the HIV test positivity of the two groups was approximately equal. Though the importance of consent bias is somewhat debatable (26)(27)(28), our findings are reassuring to researchers in clinical settings where broader issues of selection bias are already of concern.…”

Section: Discussionmentioning

confidence: 59%

Evaluation of a Computer-Based Recruitment System for Enrolling Men Who Have Sex With Men Into an Observational HIV Behavioral Risk Study

Khosropour¹,

Dombrowksi²,

Manhart³

et al. 2016

Am. J. Epidemiol.

View full text Add to dashboard Cite

Enrolling large numbers of high-risk men who have sex with men (MSM) into human immunodeficiency virus (HIV) prevention studies is necessary for research with an HIV outcome, but the resources required for in-person recruitment can be prohibitive. New methods with which to efficiently recruit large samples of MSM are needed. At a sexually transmitted disease clinic in Seattle, Washington, in 2013-2014, we used an existing clinical computer-assisted self-interview that collects patients' medical and sexual history data to recruit, screen, and enroll MSM into an HIV behavioral risk study and compared enrollees with men who declined to enroll. After completing the clinical computer-assisted self-interview, men aged ≥18 years who reported having had sex with men in the prior year were presented with an electronic study description and consent statement. We enrolled men at 2,661 (54%) of 4,944 visits, including 1,748 unique individuals. Enrolled men were younger (mean age = 34 years vs. 37 years; P < 0.001) and reported more male sex partners (11 vs. 8; P < 0.001) and more methamphetamine use (15% vs. 8%; P < 0.001) than men who declined to enroll, but the HIV test positivity of the two groups was similar (1.9% vs. 2.0%; P = 0.80). Adapting an existing computerized clinic intake system, we recruited a large sample of MSM who may be an ideal population for an HIV prevention study.

show abstract

Section: Discussionmentioning

confidence: 59%

Evaluation of a Computer-Based Recruitment System for Enrolling Men Who Have Sex With Men Into an Observational HIV Behavioral Risk Study

Khosropour¹,

Dombrowksi²,

Manhart³

et al. 2016

Am. J. Epidemiol.

View full text Add to dashboard Cite

show abstract

“…They can also lead to selection bias-the systematic distortion of research results due to statistically irremediable deviations from a normal sample-which can seriously reduce the reliability of research. [15][16][17] Significantly, both ethics and the law allow for consent waivers to avoid these problems if the research in question can be shown to involve only minimal risks. 18 Using blockchain-based data access management system and multiparty secure computing could reduce the risks of much non-interventional research to minimal, since data would remain at its origin and not be subject to additional breach risks.…”

Section: Consent Minimal Risk and Default Permissionsmentioning

confidence: 99%

Blockchain, consent and prosent for medical research

et al. 2020

View full text Add to dashboard Cite

Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances—blockchain technologies—and argues that they can be used to share medical data in a secure and auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion.

show abstract

“…This cannot be done if some do not consent, because those who do not consent are not included. Two systematic reviews have shown differences between consenters and non-consenters [31,32]. In one of these, researchers compared the age, sex, race, education, income and health status of persons who did and did not consent with observational research on their medical records across 17 studies [32].…”

Section: Informed Consent and Selection Biasmentioning

confidence: 99%

“…They found that non-consenters differed from consenters on all six measures in an unpredictable way that could not be corrected for statistically. A more recent review supplemented these findings with 21 additional studies and three further outcome measures (mental health status, functioning and lifestyle factors) [31]. It found overwhelming evidence that consent and the type of consent do have an impact on the characteristics of the individuals who are included in clinical research studies, adding that ‘[it] is difficult to dispute this evidence’ [31].…”

Section: Informed Consent and Selection Biasmentioning

confidence: 99%

See 1 more Smart Citation

Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue

Mann

Savulescu

Sahakian

2016

Phil. Trans. R. Soc. A.

View full text Add to dashboard Cite

Advances in data science allow for sophisticated analysis of increasingly large datasets. In the medical context, large volumes of data collected for healthcare purposes are contained in electronic health records (EHRs). The real-life character and sheer amount of data contained in them make EHRs an attractive resource for public health and biomedical research. However, medical records contain sensitive information that could be misused by third parties. Medical confidentiality and respect for patients' privacy and autonomy protect patient data, barring access to health records unless consent is given by the data subject. This creates a situation in which much of the beneficial records-based research is prevented from being used or is seriously undermined, because the refusal of consent by some patients introduces a systematic deviation, known as selection bias, from a representative sample of the general population, thus distorting research findings. Although research exemptions for the requirement of informed consent exist, they are rarely used in practice due to concerns over liability and a general culture of caution. In this paper, we argue that the problem of research access to sensitive data can be understood as a tension between the medical duties of confidentiality and beneficence. We attempt to show that the requirement of informed consent is not appropriate for all kinds of records-based research by distinguishing studies involving minimal risk from those that feature moderate or greater risks. We argue that the duty of easy rescue—the principle that persons should benefit others when this can be done at no or minimal risk to themselves—grounds the removal of consent requirements for minimally risky records-based research. Drawing on this discussion, we propose a risk-adapted framework for the facilitation of ethical uses of health data for the benefit of society.This article is part of the themed issue ‘The ethical impact of data science’.

show abstract

A Review of Evidence on Consent Bias in Research

Cited by 24 publications

References 9 publications

Evaluation of a Computer-Based Recruitment System for Enrolling Men Who Have Sex With Men Into an Observational HIV Behavioral Risk Study

Evaluation of a Computer-Based Recruitment System for Enrolling Men Who Have Sex With Men Into an Observational HIV Behavioral Risk Study

Blockchain, consent and prosent for medical research

Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue

Contact Info

Product

Resources

About