Consent Procedures Research Articles

PF751 POST-TRANSPLANT CYCLOPHOSPHAMIDE AND SIROLIMUS IN HAPLOIDENTICAL TRANSPLANT WITH PBSC GRAFTS: RESULTS IN 151 PATIENTS

Background: The use of haploidentical hematopoietic stem cell transplantation (HSCT) with post- transplant cyclophosphamide (PT-Cy) and calcineurin inhibitors (CNI) as graft-versus-host disease (GVHD) prophylaxis is rapidly increasing. Aims: Herein we describe long-term outcomes of haploidentical HSCT from PBSC grafts, using intensified myeloablative conditioning, and GVHD prophylaxis with PT-Cy and sirolimus. Methods: From 2012 to 2017, 151 adult patients received haploidentical HSCT for high-risk hematological malignancies, mainly acute myeloid leukemia (n = 92). Disease risk index (DRI; Armand et al) was low-intermediate in 52, high in 64 and very high in 35 patients. At HSCT, 58% of patients were not in CR; 25% of patients received a previous allogeneic HSCT. Conditioning was myeloablative in 123 and reduced-intensity in 28 patients. It was based on treosulfan-fludarabine, and 116 patients receive a regimen intensified by a 2nd alkylating agent (melphalan or thiotepa). The majority of patients (n = 148) received unmanipulated PBSCs. All pts received PT-Cy (50 mg/kg/day) on days 3 and 4. Sirolimus was given from day 5, and withdrawn 3 months after HSCT. Mycophenolate mofetil (MMF) was initiated on day 5, and withdrawn on day 30. All patients were treated according to current institutional programs upon written informed consent for transplant procedures and for the use of medical records for research. Results: Median follow up was 26 months (3–68). Median PBSC graft CD34+ and CD3+ cell doses were respectively 6x10^6/Kg (range, 5–8) and 2x10^8/Kg (range, 0.8–4.8). The majority of patients reached the neutrophil (86%) and platelet (77%) engraftment within 30 and 90 days after HSCT, respectively. Post-HSCT recovery of lymphocyte subsets was broad and fast, reaching more than 100/ml CD3+ T cells within a median of 33 days (20–799). Clinically relevant CMV and HHV-6 infections occurred in 63 and 60 patients, respectively. Invasive fungal diseases were reported in 14 cases. The cumulative incidence of grades II-IV and III-IV acute GVHD at 100 days was 35% and 20%, respectively. The cumulative incidence of chronic GVHD was 42% at 3 years; we observed severe chronic GVHD only in 16% of pts. The cumulative incidences of relapse and non-relapse mortality (NRM) were respectively 35% and 27% at 3 years. Three-year overall survival (OS) was 44% and progression free survival (PFS) 38%. The composite end point of GVHD-free/relapse-free survival (GRFS) was 24% at 3 years. Multivariate analysis confirmed the effect of DRI on transplant outcomes, with worse PFS in high and very high compared to low-intermediate DRI population. Summary/Conclusion: Extended follow-up in 151 high-risk patients confirms that Sirolimus and PT-Cy association as GvHD prophylaxis is feasible in haploidentical HSCT based on unmanipulated PBSC graft; DRI is still a major issue for transplant long-term outcome.

Ensuring Effective Utilization of Biospecimens: Design, Marketing, and Other Important Approaches.

A number of studies have shown that underutilization of biospecimens from bioresources (biobanks and biorepositories) is a significant concern. In addition, biospecimen underutilization has been identified as an ethical as well as practical concern. The utilization of biospecimens is affected by many factors, including the establishment of a scientific need for the biospecimens, the design of the bioresource, strategic planning, biospecimen quality and fitness for purpose, informed consent considerations, access policies and procedures, and marketing. This article discusses the impact of these factors on biospecimen utilization and provides suggestions for how bioresources can optimize biospecimen utilization from their collections.

Knowledge, motivations, expectations, and traits of an African, African-American, and Afro-Caribbean sequencing cohort and comparisons to the original ClinSeq® cohort

Racial minority populations are underrepresented in genomics research. This study enrolled African-descended individuals in a sequencing study and reported their characteristics. We purposively recruited 467 individuals self-identified as African, African American, or Afro-Caribbean to the ClinSeq® study and surveyed them about knowledge, motivations, expectations, and traits. Summary statistics were calculated and compared with data from the study's original cohort, which was primarily White and self-referred. Recruitment took five years and 83% of enrollees completed the survey. Participants had modest knowledge about benefits and limitations of sequencing (x̅s = 5.1, ranges: 0-10), and less than the original cohort (x̅ = 7.5 and 7.7, respectively). Common motivations to enroll were learning information relevant to personal health (49%) or family members' health (33%), and most had realistic expectations of sequencing. Like the original cohort, they had high levels of optimism, openness, and resilience. Early adopters may have relatively consistent personality traits irrespective of majority/minority status and recruitment methods, but high levels of genomics knowledge are not universal. Research should determine whether recruitment and consent procedures provide adequate education to promote informed choices and realistic expectations, which are vital to ethical research and increasing genomics research participation in underrepresented communities.

Coping strategies of patients affected by rare diseases – A qualitative focus group study

Fifty-one patients from open-label pilot trials have been transplanted in Huntington's disease (HD) using human fetal cells; clinical data and follow-up are available in 30 of them. These open-label studies were mostly designed for safety and feasibility. However, signs of long-term efficacy have been reported in 4 out of 30 patients, differences in tissue preparation, surgical procedure, patients characteristics, immunosuppression regimens, clinical, and imaging assessments, makes it difficult to define the optimal procedure for future trials. Forty-five patients have now been grafted in the multicentric intracerebral grafting trial in Huntington's in France (MIG-HD) and Belgium, and 22 in Germany in a randomized delayed start design. Whereas the 10 patients published from the German cohort showed no improvement, the results from the MIG-HD trial are still under analysis. However, the MIG-HD trial has already changed cell transplantation for HD by showing alloimmunization with graft rejection in one patient and HLA antibodies against the transplant in others. Moreover, MIG-HD has established a new surgical procedure to avoid subdural hematoma, the most frequent adverse effect in transplant in HD, and a surgical strategy to eradicate eventual choroid cysts. By reviewing all the published results, new avenues are provided for optimization for cell preparation, delivery methods, standardization of clinical assessment, and surgical procedure with blind video scoring, imaging, and electrophysiology. Future trials should capitalize on a new CAPIT-HD2 battery to determine efficacy with sufficiently long pre and postgraft follow-up, using patient stratification and randomization, control of alloimmunization, HLA monitoring, and standardization of the consent procedure.

Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

What is in a Name? Parent, Professional and Policy-Maker Conceptions of Consent-Related Language in the Context of Newborn Screening.

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents (n = 32), healthcare professionals (n = 19) and policy decision makers (n = 17) in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information attainment. Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities (including disclosure of information and time to review); parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs.

Pulled away: the experience of bilingual nurses as ad hoc interpreters in the emergency department

ABSTRACT This study aimed to understand the experiences of bilingual nurses asked to interpret in the Emergency Department (ED), and the subsequent impact on safety climate. Australian ED clinicians assess and treat high numbers of linguistically diverse patients, many with limited English proficiency. New South Wales Health policy mandates the use of accredited interpreters when collecting personal and health information, and when obtaining consent for medical procedures. Semi-structured interviews with 12 nurses (representing 12 languages) from two metropolitan EDs were audio-recorded and analysed using qualitative content analysis, guided by Glendon & Stanton’s model of organisational climate and culture. Analysis revealed widespread underlying assumptions that engaging interpreters is difficult, time-consuming and costly. Bilingual ED nurses with variable language fluency were used across organisations as the first choice due to clinical urgency, task urgency, and hospital workflow pressures. While the use of nurse interpreters facilitated timely assessment for the benefit of patients, it equally led to increased nurse workload, missed or misinterpreted information and subsequent perceived clinical risk. These practices were supported and facilitated by unit level managerial and multidisciplinary team practices, physician pressure and the nurses’ own values and beliefs. While some, (but not all) participants were aware of the interpreter policy, they were torn between their acknowledgement of risky translation practices and their desire to support their colleagues to provide timely, culturally-competent assessment and care. Findings suggests a ‘top-down’ approach to translation policy has failed to influence the local safety culture and practices and does not address a climate created by clinical urgency and workflow. Formal training and accreditation of bilingual nurses, and/or embedded interpreters for common language groups may reduce risks for non-English speaking patients.

Mobile applications for client use: Ethical and legal considerations.

Mobile applications (apps) to support behavioral health are increasing in number and are recommended frequently by medical providers in a variety of settings. As with the use of any adjunct tool in therapy, psychologists adopting new technologies in clinical practice must comply with relevant professional ethics codes and legal standards. However, emerging technologies can outpace regulations regarding their use, presenting novel ethical considerations. Therefore, it is incumbent upon providers to extrapolate current ethical standards and laws to new technologies before they recommend them as adjuncts to face-to-face treatment. This article identifies best practices for incorporating apps into treatment, including competence in the use of smartphones in general and familiarity with the specific apps recommended. Psychologists must conduct informed consent procedures in accordance with existing evidence, as well as privacy and security concerns relating to a particular app, in order to mitigate potential liability regarding the collection of client-generated data. Psychologists also should be prepared to educate clients about how best to safeguard their data, such as through encryption, password protection, or remote deletion of data. By doing so, psychologists can balance potentially competing demands of leveraging emerging technology to improve care while simultaneously ensuring ethical and legal compliance in these new areas. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Dilemmas of Ethics in Practice in Longitudinal Health Research: Identifying Opportunities for Widening Participation of Residents.

Background: Mechanisms for widening participation of local participants in research studies can improve governance of public health research. Research conducted in longitudinal health study areas depends on there being mutual trust and respect over time between the local residents and researchers. Ethics in practice needs consideration alongside procedural ethics. By widening participation of the experimental public—local residents and resident service providers—ethics in practice and accountability are strengthened.Methods: The study was undertaken in a longitudinal health study area in rural South Africa using multiple qualitative methods. The sample included 35 individual and five group interviews with resident local leaders and service providers, 24 individual and eight group interviews with residents of the study area, and ten researchers' reflections on two critical incidents from ethnographic field notes on dilemmas of ethics in practice. The interviews were all audio-recorded (besides one where consent to record was not given) and then transcribed verbatim and translated from Shangaan into English. Thematic analysis was conducted.Results: Residents requested the reporting back of personal screening test results from research studies, and raised informed consent issues. Researchers recognized the importance of mechanisms to increase their accountability to residents throughout the research process, and the complexity of informed consent and fieldwork procedures within research studies.Conclusion: This study elicited the views of residents and researchers in a longitudinal health study area to seek guidance on how to strengthen participation in research governance. Three strategies were identified by participants to widen participation of the experimental public. Firstly, increasing study budgets so that individual screening test results could be personally delivered back to participants. Secondly, more rigorous field staff training in informed consent and study procedures with ongoing monitoring and supervision from researchers. Thirdly, increased earlier involvement of residents in research protocol development through study advisory groups. Additional strategies include deeper involvement of Community Advisory Groups and more focused dissemination of research results to specific audiences. In general, there is a need to identify strategies for increased accountability of researchers and participatory governance through involvement of the experimental public in all aspects of longitudinal public health research as part of the ethics in practice and democratization of science.

Preference for caesarean and attitudes toward birth in a Chilean sample of young adults

BackgroundLittle empirical research exists about what motivates birth mode preferences, and even less about this topic in Latin America, where obstetric interventions and caesareans are some of the highest worldwide. AimTo identify factors associated with caesarean preference among Chilean men and women who plan to have children and to inform childbirth education and informed consent procedures. MethodsAn online cross-sectional survey measuring attitudes toward birth was administered to graduate students at a large public university in Chile. Eligible students were under the age of 40 and had no children but intended to have children. Logistic regression modelling was used to determine which sociodemographic factors, knowledge and beliefs were associated with caesarean preference. FindingsAmong eligible students, 730 responded and 664 provided complete answers to the variables of interest. Respondents had a mean age of 28.8; 38% were male and 62% female. Positive attitude toward technological intervention (Odds Ratio 7.4, 95% Confidence Interval 3.9–14.0), high risk perception of vaginal birth (Odds Ratio 1.8, 95% Confidence Interval 1.1–2.8), family history of caesarean (Odds Ratio 1.9, 95% Confidence Interval 1.0–3.8) and high fear of birth (Odds Ratio 3.7, 95% Confidence Interval 2.0–6.8) were associated with caesarean preference. DiscussionPreference for caesarean birth was highly associated with positive attitudes toward technological intervention and may be related to a lack of knowledge about the realities of caesarean and vaginal birth. ConclusionsPatient-centered education on the relative benefits and risks of birth modes has the potential to influence preferences toward vaginal birth.

Feasibility of pharmacists to contribute to multicenter emergency medicine research

ObjectivesA flexible, rapid, and scalable multicenter network is needed for pharmacotherapy research in emergency medicine (EM). The objective of this study was to evaluate the types of studies EM pharmacists are willing to conduct in multicenter research.MethodsThis was a cross‐sectional national survey conducted in the United States. The survey was developed using an iterative process to establish face and content validity. Members of the American College of Clinical Pharmacy EM Practice and Research Network were invited to complete the survey using Research Electronic Data Capture. Online consent was obtained prior to survey completion. The survey consisted of 14 questions, which was expected to take less than 5 minutes to complete. Data were descriptively evaluated.ResultsThere were a total of 637 potentially eligible participants for the survey. Of these, 98 completed the survey (15% response rate). In terms of types of studies, 91 (93%) would participate in studies involving retrospective acquisition of data, 83 (85%) in observational studies not requiring patient consent, 48 (49%) in observational studies involving a patient consent procedure, and 26 (27%) in implementing and conducting a clinical trial. Overall, 85 (87%) would participate without funding and 66 (67%) would participate without receiving authorship.ConclusionsA substantial number of EM pharmacists are willing to participate in multicenter research. The number of participants decreases without provision of authorship or for studies involving patient consent.

Does using anatomical models improve patient satisfaction in orthopaedic consenting? Single-blinded randomised controlled trial

BackgroundPatient satisfaction in consenting is a major pillar of clinical governance and healthcare quality assessment. The purpose was to observe the effect of using 3D anatomical models of knee and shoulder joints on patient satisfaction during informed consent in the largest single-blinded randomised controlled trial in this field. Methods52 patients undergoing elective knee or shoulder surgery were randomised into two groups when being consented. The intervention group (n = 26) was shown an anatomical model of the knee/shoulder joint while the control group (n = 26) was given only a verbal explanation without a model. Patients rated their satisfaction on the validated Medical Interview Satisfaction Scale (MISS-26) questionnaire. Semi-structured interviews were analysed for specific themes to determine key factors that influenced patient satisfaction. The mean score ±SD were calculated with significance set at p < 0.05. ResultsThere was a significant difference in the overall satisfaction between the control and intervention cohorts (MISS-26 score 4.33 [86.6%] ± 0.646 vs 4.70 [94.0%] ± 0.335 respectively, 7.4% improvement, 8.5% difference, p = 0.01). Behavioural criteria showed a 13% increase in satisfaction (p = 0.02). Semi-structured interviews determined that the factors influencing satisfaction included the surgeon's interpersonal manner, the use of the visual aid and seeing the consultant surgeon in clinic. All patients in the intervention cohort identified factors contributing to their satisfaction, whereas a fifth of the control cohort claimed nothing at all made them feel satisfied. ConclusionAnatomical models as visual aids significantly increased patient satisfaction during the consenting process and played an integral part of the surgeon's explanation. Patients exposed to anatomical models also claimed to be more satisfied with the surgeon's inter-personal skills. This study recommends the use of anatomical models, which are both cost-effective and easily implementable, during explanation and consent for orthopaedic procedures.

PO 8538 STRENGTHENING SOCIAL STRATEGIES TO ENGAGE SUB-SAHARAN AFRICAN SOCIETIES TO VALUE CLINICAL RESEARCH: THE EXPERIENCE IN CONDUCTING CLINICAL TRIALS IN LAMBARéNé

BackgroundOver the last two decades, clinical research activities have increased significantly in sub-Saharan Africa but societal engagement to make research socially and economically valuable is limited. Thus, engaging communities when designing clinical research and promoting social impacts of research are becoming key objectives among stakeholders involved in clinical research in sub-Saharan Africa. However, there is a need to define concepts and indicators to assess the strength of community engagement as well as the social impacts of clinical research.Here, we hypothesised that the social meanings of willingness to participate and compliance to clinical trial procedures are relevant indicators to assess community engagement.MethodsWe conducted a retrospective, prospective case study of clinical trials conducted in CERMEL between 1995 and 2017. We performed a social meaning framework analysis of the following processes: protocol design, ethical and regulatory clearance, informed consent and medical study procedures. We identified the social meanings of each procedure according to the involvement of social components (actors, ideas, communication strategies).ResultsA total of 42 clinical trials were identified in the ClinicalTrials.gov and Pan-African Clinical Trials Registry databases and confirmed by the top management of CERMEL. Between 1995 and 2004, there was little social meaning connected to trial procedures. This period was associated with poor compliance to study procedures. Between 2005 and 2017, compliance to study procedures improved. Detailed results will be presented during the meeting.ConclusionThe rise in willingness to participate in clinical research and improved compliance with study procedures were associated with the introduction of social components to medical procedures. Both indicators may be relevant to assess the strength of community engagement.

Use of broad consent and related procedures in genomics research: Perspectives from research participants in the Genetics of Rheumatic Heart Disease (RHDGen) study in a University Teaching Hospital in Zambia

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use.

The nocebo effect as a source of bias in the assessment of treatmenteffects.

The term nocebo effect refers to the harmful outcomes that result from people's negative beliefs, anticipations, or experiences related to the treatment rather than the pharmacological properties of the treatment. These outcomes may include a worsening of symptoms, a lack of expected improvement, or adverse events, and they may occur after the active treatment and the placebo that is supposed to imitate it. The nocebo effect is always unwanted and may distort estimates of treatment effectiveness and safety; moreover, it may causediscontinuation of therapy or withdrawal from a trial. The nocebo effect may be unintentionally evoked by the explanations given by healthcare professionals during a clinical consultation or consent procedures, or by information from other patients, the media, or the Internet. Moreover, it may be a consequence of previous bad experiences with the treatment, through learning and conditioning, and the conditioning may happen without patients' conscious awareness. In trial settings, a study design, for example lack of blinding, may introduce bias from the nocebo effect. Unlike the placebo effect, which is usually taken into consideration while interpreting treatment outcomes and controlled for in clinical trials, the nocebo effect is under-recognised by clinical researchers and clinicians. This is worrying, because the nocebo phenomenon is common and may have potentially negative consequences for the results of clinical treatment and trials. It is therefore important that doctors and medical researchers consider any potential nocebo effect while assessing the treatment effect and try to minimise it through careful choice and phrasing of treatment-related information given to patients.

Medical Malpractice of Vestibular Schwannoma: A 40-Year Review of the United States Legal Databases.

To analyze medical malpractice lawsuit trends pertaining to cases of vestibular schwannomas (VS). Two major computerized legal databases (LexisNexis and WestLaw) were queried and reviewed for evaluation of all the US state and federal court records from civil trials alleging malpractice between 1976 and 2016. A total of 32 VS cases were identified. Allegations were divided into four categories: misdiagnosis/delayed diagnosis (47%), postoperative complications (44%), failure of informed consent or information sharing (16%), and other (3%). Postoperative complications included facial nerve paralysis, myocardial infarction, meningitis, and intracranial hemorrhage. Judgment amounts ranged from $300,000 to $2,000,000. The specialist type was specified for 24 of the 32 cases (75%): neurosurgeons (n = 9; 37%), neurotologists (n = 6; 25%), general otolaryngologists (n = 5; 21%), primary care physicians (n = 4; 17%), neurologists (n = 3; 12%), radiologists (n = 3; 12%), anesthesiologists (n = 2; 8%), radiation oncologists (n = 1; 4%), and general surgeon (n = 1; 4%). Of these 24 cases, (n = 9; 37%) two or more physicians were named as defendants in the lawsuit. Enhanced physician-patient communication, ensuring proper and adequate patient consent procedures, and proper documentation are good practices that may decrease the likelihood of lawsuits.

Ethical issues of the informed consent procedure in schizophrenia patients in view of cognitive dysfunction

Te procedure of obtaining the informed consent plays the crucial role in biomedical studies. Psychiatric patients refer to the vulnerable category of subjects, as there is an obvious conflict exists between the necessity of compliance to the subject’s autonomy rules and the restrictions of this autonomy caused by the illness. Schizophrenia patients suffer from cognitive dysfunction in different domains, which influence their ability to comprehend the information and to make decisions. From the other hand, arguing the appropriateness of informed consent obtaining in patients with severe mental disorders (e.g. with schizophrenia) and, thus, limitation of their ability to participate in clinical trials, can be considered as an equitable limitation of their access to the latest achievements of medical science. Potential difculties in obtaining informed consent in schizophrenia subjects can be divided into three categories: 1) subject related; 2) protocol related; 3) investigator/physician related; Both the investigators and the physicians must be acquainted with the potential ethical issues that can influence the decision making ability in schizophrenia subjects due cognitive dysfunction and the decline in subject’s autonomy level.

Integrating Parents in Neonatal and Pediatric Research

Background: Parents and their infants are the beneficiaries of neonatal and pediatric research, but in the past they have been excluded from most stages of research projects. As a result, many projects may fail to produce the most worthwhile information for parents and families. Lately, veteran resource parents and patients have been increasingly integrated in research initiatives. Methods: Benchmarking of neonatal and pediatric research initiatives where resource parents and/or ex neonatal patients have helped to optimize pediatric research. We review ways in which resource parents/patients can be involved in research, with examples and practical ideas of how to proceed. Results: Resource parents/patients can be collaborators in research and be integrated in many steps: prioritizing research projects, designing trials, determining the outcomes of interest, ethics review, developing and improving consent procedures, collection and interpretation of data, participation in data safety monitoring committees, publication of results, and presentation to peer groups. Some of the strategies for integration of stakeholders in clinical research are more complex, may involve risk and require more training than others. Conclusion: We suggest that groups wanting to involve parents in their research endeavors start with simpler tasks that entail less risk and develop teams of resource parents who have differing interests and abilities. Quality control of programs is essential, such as frequently giving and obtaining feedback from resource parents/patients and researchers. In the future, integration of resource parents/patients into every step of clinical research will be essential to ensure that parent and family important outcomes are examined.

Autonomy Challenges in Epigenetic Risk-Stratified Cancer Screening: How Can Patient Decision Aids Support Informed Consent?

Information of an individual’s epigenome can be useful in cancer screening to enable personalised decision making on participation, treatment options and further screening strategies. However, adding this information might result in complex risk predictions on multiple diseases, unsolicited findings and information on (past) environmental exposure and behaviour. This complicates informed consent procedures and may impede autonomous decision-making. In this article we investigate and identify the specific features of epigenetic risk-stratified cancer screening that challenge the current informed consent doctrine. Subsequently we describe current and new informed consent models and the principle of respect for autonomy and argue for a specific informed consent model for epigenetic risk-stratified screening programmes. Next, we propose a framework that guides the development of Patient Decision Aids (PDAs) to support informed consent and promote autonomous choices in the specific context of epigenetic cancer screening programmes.

Understanding Respondents’ Attitudes Toward Web Paradata Use

The collection and use of paradata is gaining in importance, especially in web surveys. From a research ethics’ perspective, respondents should be asked for their consent to the collection and use of web paradata. In this context, a positive attitude toward paradata use has been deemed to be a prerequisite for respondents’ willingness to share their paradata. The present study aimed to identify factors affecting respondents’ attitudes toward paradata use. Our findings revealed that adequately informing survey respondents about what paradata are and why they are used was an important determinant of their attitudes toward paradata use. Moreover, we found that respondents with a positive attitude toward the survey were more likely to have a favorable opinion of paradata use. Our findings suggest that a thorough understanding of the factors that contribute to a positive attitude toward paradata use provides the basis for improved paradata consent procedures, which in turn will increase rates of consent to paradata use and help attenuate the risk of consent bias in web surveys.