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Stakeholder attitudes towards the role and application of informed consent for newborn bloodspot screening: a study protocol.

ABSTRACT: Newborn bloodspot screening (NBS) involves testing a small sample of blood taken from the heel of the newborn for a number of serious and life-limiting conditions. In Canada, newborn screening programmes fall under provincial and territorial jurisdiction with no federal coordination. To date, we know very little about the underlying beliefs around different consent practices or how terminology is interpreted by different individuals. Differences in attitudes may have important healthcare consequences. This study will provide empirical data comparing stakeholder opinions on their understanding of consent-related terminology, the perceived applicability of different consent approaches to newborn screening, and the requirements of these different approaches.Parents, healthcare professionals and policymakers will be recruited in the provinces of Ontario and Newfoundland and Labrador. Parents will be identified through records held by each provincial screening programme. Healthcare professionals will be purposively sampled on the basis of engagement with newborn screening. Within each province we will identify policymakers who have policy analysis or advisory responsibilities relating to NBS. Data collection will be by qualitative interviews. We will conduct 20 interviews with parents of young children, 10 interviews with key healthcare professionals across the range of appropriate specialties and 10 with policymakers at each site (40 per site, total, N=80). The examination of the transcripts will follow a thematic analysis approach. Recruitment started in June 2014 and is expected to be complete by June 2015.This study received ethics approval from the Ottawa Health Science Network Research Ethics Board, the Children's Hospital of Eastern Ontario Research Ethics Board (both Ontario), and the Health Research Ethics Authority (Newfoundland and Labrador).These will be reported in peer-reviewed publications and conference presentations. The results will have specific application to the development of parent education materials for newborn screening.

SUBMITTER: Nicholls SG

PROVIDER: S-EPMC4244491 | biostudies-other | 2014 Nov

REPOSITORIES: biostudies-other

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Stakeholder attitudes towards the role and application of informed consent for newborn bloodspot screening: a study protocol.

Nicholls S G SG Tessier L L Etchegary H H Brehaut J C JC Potter B K BK Hayeems R Z RZ Chakraborty P P Marcadier J J Milburn J J Pullman D D Turner L L Wilson B J BJ

BMJ open 20141124 11

<h4>Introduction</h4>Newborn bloodspot screening (NBS) involves testing a small sample of blood taken from the heel of the newborn for a number of serious and life-limiting conditions. In Canada, newborn screening programmes fall under provincial and territorial jurisdiction with no federal coordination. To date, we know very little about the underlying beliefs around different consent practices or how terminology is interpreted by different individuals. Differences in attitudes may have importa ...[more]

PMID: 25421341

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Project description:BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.

Project description:Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence.The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof.Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought.Outcome will be published in a scientific journal.NTR5374; Pre-results.

Project description:BackgroundThe legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists' attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice.Methods155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent.ResultsAmong the surveyed psychotherapists, there was a high consensus on important information that should be communicated to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists' age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent.ConclusionsThe present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective.

Project description:Background:The integration of digital treatments into national mental health services is on the agenda in the European Union. The E-COMPARED consortium conducted a survey aimed at exploring stakeholders' knowledge, acceptance and expectations of digital treatments for depression, and at identifying factors that might influence their opinions when considering the implementation of these approaches. Method:An online survey was conducted in eight European countries: France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland and The United Kingdom. Organisations representing government bodies, care providers, service-users, funding/insurance bodies, technical developers and researchers were invited to participate in the survey. The participating countries and organisations reflect the diversity in health care infrastructures and e-health implementation across Europe. Results:A total of 764 organisations were invited to the survey during the period March-June 2014, with 175 of these organisations participating in our survey. The participating stakeholders reported moderate knowledge of digital treatments and considered cost-effectiveness to be the primary incentive for integration into care services. Low feasibility of delivery within existing care services was considered to be a primary barrier. Digital treatments were regarded more suitable for milder forms of depression. Stakeholders showed greater acceptability towards blended treatment (the integration of face-to-face and internet sessions within the same treatment protocol) compared to standalone internet treatments. Organisations in countries with developed e-health solutions reported greater knowledge and acceptability of digital treatments. Conclusion:Mental health stakeholders in Europe are aware of the potential benefits of digital interventions. However, there are variations between countries and stakeholders in terms of level of knowledge about such interventions and their feasibility within routine care services. The high acceptance of blended treatments is an interesting finding that indicates a gradual integration of technology into clinical practice may fit the attitudes and needs of stakeholders. The potential of the blended treatment approach, in terms of enhancing acceptance of digital treatment while retaining the benefit of cost-effectiveness in delivery, should be further explored. Funding:The E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 603098.

Dataset Information

Stakeholder attitudes towards the role and application of informed consent for newborn bloodspot screening: a study protocol.

Publications

Stakeholder attitudes towards the role and application of informed consent for newborn bloodspot screening: a study protocol.

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