Can Broad Consent be Informed Consent?

Sheehan, Mark

doi:10.1093/phe/phr020

Cited by 129 publications

(94 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As specific information about future projects is not available at the time of consent, there is much ethical controversy about the type of informed consent that can permit biobank-based genomic research. 3,9,10,12,19,59 Some argue that consent is not valid if it does not offer specific information. Therefore, either a narrow or specific type of consent or obtaining new consent from participants for each new project is demanded.…”

Section: Type Of the Consentmentioning

confidence: 99%

Stakeholders’ perspectives on biobank-based genomic research: systematic review of the literature

et al. 2015

View full text Add to dashboard Cite

The success of biobank-based genomic research is widely dependent on people's willingness to donate their tissue. Thus, stakeholders' opinions should be considered in the development of best practice guidelines for research and recruiting participants. We systematically analyzed the empirical literature describing different stakeholders' views towards ethical questions with regard to type of consent, data sharing and return of incidental findings. Patients are more open to one-time general consent than the public. Only a small proportion desires recontact if the research aim changed. A broad consent model would prevent only a small proportion of patients from participating in research. Although professionals are concerned about a risk of reidentification, patients and the public support data sharing and find that the benefit of research outweighs the potential risk of reidentification. However, they desire detailed information about the privacy protection measures. Regarding the return of incidental findings, the public and professionals focus on clinically actionable results, whereas patients are interested in receiving as much information as possible. For professionals, concrete guidelines that help managing the return of incidental findings should be warranted. For this it would be helpful addressing the different categories -actionable, untreatable and inheritable diseases -upfront with patients and public. European Journal of Human Genetics (2015Genetics ( ) 23, 1607Genetics ( -1614 doi:10.1038/ejhg.2015; published online 4 March 2015 INTRODUCTIONTechnical advances in whole-genome sequencing enable the identification of genomic variations involved in the development of diseases, such as acquired mutations that are causally linked to cancer. 1,2 Improvements in disease prevention as well as diagnostic and therapeutic strategies may eventually lead to more precise, individually stratified health care. As most diseases are complex, which means that they are caused by multiple genomic factors, research is often based on large numbers of samples representing large numbers of individuals to arrive at statistically significant conclusions. In addition, genetic susceptibility alone is not sufficient to induce a complex disease; the causes also include different lifestyle and environmental factors. Therefore, to study complex diseases the interplay of all of these factors has to be considered. An efficient tool to achieve this is the creation of biobanks. Biobanks are defined as organized collections of human biological specimens comprised of cells, tissues, blood or DNA, which could be linked to clinical data and detailed individual lifestyle. Biobanks vary with respect to types and sources of samples and size, as well as research focus. Biobanks can be disease-specific or population-based, ranging from small collections to large-scale repositories. [3][4][5][6][7] Linking biological materials to personal data for enabling biobankbased genomic research raises several ethical questions that are currently debated. Th...

show abstract

Section: Type Of the Consentmentioning

confidence: 99%

Stakeholders’ perspectives on biobank-based genomic research: systematic review of the literature

et al. 2015

View full text Add to dashboard Cite

show abstract

“…3,14,22 The autonomous choice presupposes the capacity of voluntary decision, i.e., free from coercion or manipulation by third parties, and suffi cient and understandable information to support it. 14,22 The informed consent creates the opportunity for research subjects to consider, according to their perceptions, the risks and potential benefi ts of the research, thus contributing to reduce potential damages. 14,22 Subjects should understand procedures, risks, discomforts, benefi ts and rights involved in their participation in the research.…”

Section: Right To Autonomy and Informed Consentmentioning

confidence: 99%

“…14,22 The informed consent creates the opportunity for research subjects to consider, according to their perceptions, the risks and potential benefi ts of the research, thus contributing to reduce potential damages. 14,22 Subjects should understand procedures, risks, discomforts, benefi ts and rights involved in their participation in the research. 11 However, some studies have shown limited knowledge about the research among individuals that had consented to participate, 13 which may be due to the research subjects' conscious choice to disregard information, or to failures in the communication process.…”

Section: Right To Autonomy and Informed Consentmentioning

confidence: 99%

“…In this context, the requirement of consent to use identifi ed secondary data has been a hotly debated topic. 15,18,22 Subjects' consent to access functional and health records has been considered a fundamental condition to participate in the study, as this information is essential to investigate the outcomes 2 and, consequently, to fulfi ll the objectives of a longitudinal study. Therefore, the following sentence was included in the document's fi nal statement, after the general agreement with the conditions to participate in the study: "I state that I authorize the researchers of the Brazilian Longitudinal Study for Adult Health -ELSA-Brasil, to obtain information on my health history from health institutions, medical records at outpatient clinics, emergency services and/or hospitals, according to the specifi c situation.…”

Section: Right To Autonomy and Informed Consentmentioning

confidence: 99%

See 1 more Smart Citation

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

et al. 2013

View full text Add to dashboard Cite

The debate about ethics in research with human beings has historically emphasized experimental studies because of their greater potential to harm the subjects involved. However, observational studies also include risks and relevant questions to be discussed. This article aims to present and discuss the ethical aspects involved in the implementation of ELSA-Brasil (Brazilian Longitudinal Study for Adult Health), a longitudinal multicenter study, with public funding, in which the research subjects and investigators are employees of the same institutions. The procedures adopted to meet the ethical requirements and commitments are described, as well as the casuistics that guided the actions according to their guiding principles (benefi cence, autonomy and social justice). We present some moral problems that required consideration of risks and benefi ts at the confl uence with the study's objectives, and we conclude with comments on the peculiarities and the potential benefi ts of a longitudinal study.

show abstract

“…The overall rationale of biobanks is to house and facilitate ongoing research on human biological material (Sheehan, 2011). They vary according to the type and number of tissues stored, the extent of genetic, clinical and personal data and the permitted use of the samples and data.…”

Section: Biobanksmentioning

confidence: 99%

Consent in psychiatric biobanks for pharmacogenetic research

Baan

Bernabe

Bredenoord

et al. 2013

International Journal of Neuropsychopharmacology

View full text Add to dashboard Cite

In psychiatric practice, pharmacogenetics has the potential to identify patients with an increased risk of unsatisfactory drug responses. Genotype-guided treatment adjustments may increase benefits and reduce harm in these patients; however, pharmacogenetic testing is not (yet) common practice and more pharmacogenetic research in psychiatric patients is warranted. An important precondition for this type of research is the establishment of biobanks. In this paper, we argue that, for the storage of samples in psychiatric biobanks, waiving of consent is not ethically justifiable since the risks cannot be considered minimal and the argument of impracticability does not apply. An opt-out consent procedure is also not justifiable, since it presumes competence while the decisional competence of psychiatric patients needs to be carefully evaluated. We state that an enhanced opt-in consent procedure is ethically necessary, i.e. a procedure that supports the patients' decision-making at the time when the patient is most competent. Nevertheless, such a procedure is not the traditional exhaustive informed consent procedure, since this is not feasible in the case of biobanking.

show abstract

Can Broad Consent be Informed Consent?

Cited by 129 publications

References 31 publications

Stakeholders’ perspectives on biobank-based genomic research: systematic review of the literature

Stakeholders’ perspectives on biobank-based genomic research: systematic review of the literature

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

Consent in psychiatric biobanks for pharmacogenetic research

Contact Info

Product

Resources

About