Model Of Informed Consent Research Articles

Current modalities and concepts on access and use of biospecimen samples and associated data for research from human biobanks

It is accepted worldwide that biospecimen and data sharing (BDS) play an essential role for the future of medical research to improve diagnostics and prognostics, e.g. by validated biomarkers. BDS is also pivotal to the development of new therapeutic treatments and for the improvement of population health. Human biobanks can generate an added value to this need by providing biospecimens and/or associated data to researchers. An inspection of several examples of epidemiological as well as clinical/disease-oriented biobanks in Germany shows that best practice procedures (BPP) that are internationally agreed on are being installed for biospecimen and/or data access. In general, fair access is aimed at requiring a written application by the requesting scientist, which is then peer-reviewed for scientific and ethical validity by the Biobank. Applied BPP take into account (i) patient education/agreement according to the informed consent model, (ii) privacy protection, (iii) intellectual property rights, the (iv) notification obligation of health-related findings (including incidental findings), the (v) use of material (MTA) and data transfer agreements (DTA) for mutual legal security, the avoidance of conflicts of interests, as well as for cost recovery/fee for service as a basis for sustainability of the biobank. BPP are rooted in the self-regulation efforts of life sciences and are supported by parent ethics committees in Germany. Central biobank registries displaying aggregated information on biospecimens stored and the research foci constitute an important tool to make biobanks that are scattered across the country visible to each other, and, can thus promote access to hitherto unknown biospecimen and data resources.

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

BackgroundThe rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by...

Patient feedback and early outcome data with a novel tiered-binned model for multiplex breast cancer susceptibility testing.

The risks, benefits, and utilities of multiplex panels for breast cancer susceptibility are unknown, and new counseling and informed consent models are needed. We sought to obtain patient feedback and early outcome data with a novel tiered-binned model for multiplex testing. BRCA1/2-negative and untested patients completed pre- and posttest counseling and surveys evaluating testing experiences and cognitive and affective responses to multiplex testing. Of 73 patients, 49 (67%) completed pretest counseling. BRCA1/2-negative patients were more likely to proceed with multiplex testing (86%) than those untested for BRCA1/2 (43%; P < 0.01). Many patients declining testing reported concern for uncertainty and distress. Most patients would not change anything about their pre- (76%) or posttest (89%) counseling sessions. Thirty-three patients (72%) were classified as making an informed choice, including 81% of those who proceeded with multiplex testing. Knowledge increased significantly. Anxiety, depression, uncertainty, and cancer worry did not significantly increase with multiplex testing. Some patients, particularly those without prior BRCA1/2 testing, decline multiplex testing. Most patients who proceeded with testing did not experience negative psychological responses, but larger studies are needed. The tiered-binned approach is an innovative genetic counseling and informed consent model for further study in the era of multiplex testing.Genet Med 18 1, 25-33.

Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

BackgroundThe development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. ObjectivesTo explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. MethodsA cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. ResultsThe majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and respondents with degree-level education, respectively. Those who reported being aware of EHRs were less likely to say they expected explicit consent to be sought before use of their de-identified record. ConclusionsA large number of patients remain unaware of EHRs, while preference for implicit consent is stronger among those who report previous awareness. Differences in awareness levels and consent expectations between groups with different socio-demographic characteristics suggest that public education and information campaigns should target specific groups to increase public awareness and ensure meaningful informed consent mechanisms.

Why is it hard to make progress in assessing children's decision-making competence?

BackgroundFor decades, the discussion on children’s competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children’s interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children’s competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children’s competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children’s medical decision-making competence.DiscussionUnderstanding children’s competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child’s decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children’s competency, in which the most prominent question concerns the lack of a clear operationalization of children’s competence to consent. Empirical data are needed to substantiate the discussion.SummaryThe empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

The iterative informed consent model for the feedback of incidental findings in human health research using WGS procedures

The iterative informed consent model for the feedback of incidental findings in human health research using WGS procedures

Management of Incidental Findings from Genetic Tests: Perspectives of Ethics Committee Members

New genomic technologies, whilst allowing comprehensive and cost-effective access to disease-causing mutations, also increase the possibility of incidental findings unrelated to the original research question. These findings may have health, reproductive or familial implications for the research participant concerned. There are diverse opinions regarding the obligations of researchers and appropriate management strategies regarding how or whether to return this information to research participants. As the empirical data on which these arguments are based is still fairly limited, we undertook a qualitative study, using a thematic analysis approach, to explore the topic further. We interviewed members of UK NHS research ethics committees to ascertain their experiences regarding genetic incidental findings, as well as their opinions regarding future challenges and management. The interviews were transcribed, coded and analysed for common themes. Three themes emerged; facilitating participant consent, supporting the validity of consent, and risks and rights. Ethics committee members were aware of the issues raised by genetic incidental findings despite limited practical experience in the projects they have assessed. There was no consensus as to how information should be presented to potential participants during recruitment for research involving genome-wide technologies, or whether blanket or checklist-based consent was most useful. Participants also discussed the difficulties in balancing the rights and obligations of research participants, their families, researchers and clinicians when considering the return of incidental findings. Some supported overruling patient consent in order to return clinically actionable incidental findings. In the absence of national guidance on these issues, the lack of consensus evident in this study could potentially lead to disparity between research ethics committees in the way genetic research studies are appraised. A wider discussion on the suitability of the current informed consent model for complex genomic research may also be required.

A randomized controlled trial of an electronic informed consent process.

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study.

Informed consent, and an ethico- legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study

Birth cohort studies are important tools for life-course epidemiology, given the spectrum of the environmental, behavioural, and genetic factors that should be considered when making judgements on human health. Biobanks are valuable components of studies designed to investigate the genetic variability of diseases and improve phenotypic characterisation. In studies involving vulnerable populations and biobanks, it is essential to provide ethical reasoning and analyse the legal requirements. We describe the processes and the tools used in the iterative design of an appropriate informed consent model and the ethico-legal framework of the Piccolipiù study. The Piccolipiù study is a prospective population-based study funded by the Italian Ministry of Health that intends to enrol 3,000 newborns and their mothers in five Italian cities, and to store biological samples for future use. To realise these objectives, we performed a thorough evaluation of the literature, of national and international guidelines, and of the impact of the Italian legal requirements for research biobanking. Discussions among stakeholders facilitated the design of the informed consent and the ethico-legal framework. Several topics are addressed, including the suitability of a broad informed consent for paediatric biobanks, infant vulnerability, access to and sharing of data, and the disclosure of individual's genetic results. Discussion of the ethical and legal procedures adopted in epidemiological biobanking might be a fruitful ground for comparison both at the national level, where standardization and homogeneity are lacking, and at the international level, where different regulatory issues are often in the background and might hamper research biobanks networking.

Imperfect informed consent for prenatal screening: Lessons from the Quad screen

Objective The study evaluated patient informed consent (IC) for the Quad screen and examined differences in IC between test acceptors and test refusers. A multidimensional model of IC was used. Methods Women seeking prenatal care at nine obstetrics clinics in a large Midwestern city completed surveys between February and December 2006. Surveys contained measures for three dimensions of IC: intention, understanding and controlling influence. Results 56.2% of women did not meet criteria for all three of our dimensions of IC and therefore failed to give it. The failure rate was higher among women who choose to screen (72.6%) than women who choose not screen (50%) (p &lt; 0.001). Women who met all criteria for IC were over three times less likley to choose to screen (or = 0.32, CI 0.17–0.62 ( p &lt; 0.01)) than women who did not meet criteria for IC. Conclusion The decision to screen for fetal anomalies is less of a deliberated action than the decision not to screen. Women who lack a fundamental understanding of the purpose and nature of the screen may be operating on the belief that the screen is part of standard care and presents no need to deliberate.

Public preferences regarding informed consent models for participation in population-based genomic research

Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, whereas others reconsent for specific new studies. Understanding research participants' attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support. An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy and the value of research, and the perceived trustworthiness of researchers. Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among black non-Hispanic respondents and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those who would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved. These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent.

Abstract FO03-01: Cancer epidemiology consortia and international cohorts: Challenges and opportunities

Abstract Throughout the last two decades, studies based on cancer epidemiology cohorts have helped to better understand the complex etiology of cancer. By providing fundamental insights into key environmental, lifestyle, and genetic determinants of this disease, cohort-based research has contributed evidence to design cancer control measures for groups and populations at risk. In addition, specific follow-up of affected individuals are beginning to generate insights on outcomes and response to therapy in cancer survivors. More recently, the advent of new genotyping, next-generation sequencing and other high-throughput molecular technologies has enhanced the requirement for extremely large numbers to address large-scale gene discovery, to examine interactions between genes, pathways and the environment, or to focus on defined cancer subtypes and special populations. Consequently, the research approach has shifted away from single investigators research to a consortial approach, where multiple cohorts at the international level combine their population infrastructures and interdisciplinary expertise to address investigations not easily approachable by a single cohort or group (http://epi.grants.cancer.gov/Consortia/cohort.html). The establishment of these networks has challenged established paradigms at both academic institutions and funding agencies. NCI recognizes that CECs are valuable resources that benefit the entire cancer research community. However, the continued support of a comprehensive cohort infrastructure requires careful review to maintain balanced representation and state-of-the art methodology. To this extent, the Epidemiology and Genomic Research Program (EGRP) has sponsored several initiatives to support the establishment and maintenance of cohorts and consortia infrastructures and research (http://epi.grants.cancer.gov/gameon/; http://grants.nih.gov/grants/guide/pa-files/PAR-11-167.html). The purpose of this forum presentation is to give an overview of current cancer epidemiology cohorts supported by the EGRP and discuss the the opportunities and challenges posed by the evolution of the current model of population-based cohort(s) toward a fully collaborative Cohort Consortium (or “synthetic cohort”) encompassing the complete characterization of participants across the age and ethnicity spectrum at the clinical, molecular and epidemiological level. Topics include the utilization of contemporary approaches (internet/wireless technologies) and real-time feedback for exposure assessment; the assembly of associated high quality biobanks; the incorporation of state-of-the art molecular technologies; the optimization of data harmonization, management and distribution; the enhancement of communication strategies for diffusion and dissemination of results; and the evaluation of the impact of research results on health, lifestyle and clinical practices Access and informed consent models to make data available to a wider community of interested investigators for integrative analyses of increasing complexity as well as publication policies will also be discussed. Citation Format: Daniela Seminara. Cancer epidemiology consortia and international cohorts: Challenges and opportunities. [abstract]. In: Proceedings of the Eleventh Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2012 Oct 16-19; Anaheim, CA. Philadelphia (PA): AACR; Cancer Prev Res 2012;5(11 Suppl):Abstract nr FO03-01.

Use of the Informed Consent Model in the Provision of Cross-Sex Hormone Therapy: A Survey of the Practices of Selected Clinics

ABSTRACT Introduction: Some clinics have developed models for the initiation of cross sex hormone therapy (csHT) without an in-depth mental health evaluation and referral. These approaches have also been referred to as the informed consent (IC) model. Aims: (a) Survey practice characteristics of clinics utilizing the IC care model; (b) assess potential legal risks to clinics utilizing the IC care model; and (c) assess for any known cases of regret by patients with respect to csHT. Methods: (a) Convenience sample survey instrument distributed at professional conferences and online and (b) thorough online legal literature search. Results: Responses were obtained from 12 unique U.S. sites. Seventeen known cases of regret were reported across all sites. No cases of malpractice claims or judgments relating to regret about the use of csHT were reported. Only 4 of 12 sites required any contact with a mental health provider prior to initiation of csHT. A minimum number of visits prior to beginning treatment was required by only 5 clinics. The literature review yielded no related legal actions.

Bridging consent: from toll bridges to lift bridges?

BackgroundThe ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Although informed consent often does not anticipate such cross-domain sharing, it is important to examine its plausibility. The purpose of this study was to explore the feasibility of bridging consent between disease-specific and population-based research. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted.DiscussionEthical and legal frameworks governing consent dissuade cross-domain data sharing. Paradoxically, analysis of consent models for disease-specific and population-based research reveals such a high degree of similarity that bridging consent could be possible if additional information regarding bridging was incorporated into consent forms. We submit that bridging of consent could be supported if current trends endorsing a new interpretation of consent are adopted. To illustrate this we sketch potential bridging consent scenarios.SummaryA bridging consent, respectful of the spirit of initial consent, is feasible and would require only small changes to the content of consents currently being used. Under a bridging consent approach, the initial data and samples collection can serve an identified research project as well as contribute to the creation of a resource for a range of other projects.

Elements of Psychological Maturity and Its Influence on Antisocial and Criminal Behavior

Insights from developmental psychology provide a useful perspective from which to understand why young people might engage in higher levels of antisocial behavior than adults. They can also be useful in term of highlighting which aspects of development result in young people making less mature judgments. Yet despite this extensive body of knowledge, there is no psychological or legal definition of maturity that can be applied to legal decision making. Within a criminal context, investigations of adolescent immaturity have emphasized cognitive factors, influenced by the informed consent model which places a premium on factors such as “knowledge” and “competence”, with an emphasis on cognitive functioning (e.g., thinking, reasoning, and understanding). This approach has been criticized for failing to adequately illustrate differences between adolescent and adult decision making. This paper reviews the notion of psychological maturity and comments on the importance of a broader assessment that includes psychosocial factors in the face of a growing trend in many jurisdictions to transfer juvenile offenders to the adult jurisdiction based on the severity of crime committed rather than their level of culpability.

Desperation May Affect Autonomy but Not Informed Consent

Desperation May Affect Autonomy but Not Informed Consent

Informed Consent in High-Risk Renal Transplant Recipients

Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words— informed and consent—are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.

Prescribing placebos ethically: the appeal of negatively informed consent

Kihlbom has recently argued that a system of seeking negatively informed consent might be preferable in some cases to the ubiquitous informed consent model. Although this theory is perhaps not...

Information preferences of high literacy pregnant women regarding informed consent models for genetic carrier screening

Objective With the increasing carrier screening options being offered to pregnant women, it is critical to consider what information women want in an informed consent process, and how they make decisions regarding screening. Methods We surveyed 201 pregnant women. Results Subjects prefer “to have as much information as possible” (84%), and valued their physician's recommendations (82%) regarding screening. After reviewing two hypothetical scenarios, 71% of participants preferred more information about genetic carrier screening; however, some participants expressed concern that too much information can also lead to anxiety. When specifically asked about components of a potential informed consent process, the highest preferences were to include: the chance of having a child with the disorder (97%), the options for carriers (93%), the value and purpose of testing (91%), and the prognosis if a child has the disease (94%); preference for “symptoms” information differed based on scenario preference ( p < 0.001). Conclusion This study is the first to document variation in patients’ views regarding the information desired as part of the informed consent process. Practice implications Providers should consider ways to ascertain their patients’ preferred informational style, and how to provide information in the amount and style that patients find useful in making decisions.

Torts to contract¿ moving from informed consent to shared decision‐making

Many claims of medical malpractice arise from a breakdown in communication between physician and patient. As a result, medical decision-making may change from an informed consent model to a shared decision-making strategy. Shared decision-making, a contract derivative, will trigger contract obligations and change the face of medical malpractice from tort to contract.