Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes.

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.

Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study.

Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.

Assessing training needs in health research ethics: a case study from the University of Zambia School of Medicine.

In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM) using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee. Seventy-five faculty members of various ranks completed the questionnaire. It was found that 31% of the faculty had not received any research ethics training. Of those who had received training, most of them had received it through short workshops of five days or less (57.4%, n = 31), while only 27.7% received ethics training as a component of an academic degree and 22.2% obtained it through electronic web-based courses. While most faculty (70.7%) reported being well-prepared to guide their students in developing a research methods section of a research protocol, only 25.3% felt they were well-prepared to guide on ethical considerations. This study has demonstrated gaps in research ethics training among faculty members at UNZASoM. Mandatory instruction in research ethics among faculty and students is recommended.

Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda.

BACKGROUND: Lack of data for timely decision-making around the prevention and control of non-communicable diseases (NCDs) presents special challenges for policy makers, especially in resource-limited settings. New data collection methods, including pre-recorded Interactive Voice Response (IVR) phone surveys, are being developed to support rapid compilation of population-level disease risk factor information in such settings. We aimed to identify information that could be used to optimize consent approaches for future mobile phone surveys (MPS) employed in Uganda and, possibly, similar contexts. METHODS: We conducted an in-depth qualitative study with key stakeholders in Uganda about consent approaches, and potential challenges, for pre-recorded IVR NCD risk factor surveys. Semi-structured interviews were conducted with 14 key informants. A contextualized thematic approach was used to interpret the results supported by representative quotes. RESULTS: Several potential challenges in designing consent approaches for MPS were identified, including low literacy and the lack of appropriate ways of assessing comprehension and documenting consent. Communication with potential respondents prior to the MPS and providing options for callbacks were suggested as possible strategies for improving comprehension within the consent process. "Opt-in" forms of authorization were preferred over "opt-out". There was particular concern about data security and confidentiality and how matters relating to this would be communicated to MPS respondents. CONCLUSIONS: These local insights provide important information to support optimization of consent for MPS, whose use is increasing globally to advance public health surveillance and research in constructive ways.

The features and qualities of online training modules in research ethics: a case study evaluating their institutional application for the University of Botswana.

Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then assembled Focus Group Discussions (FGDs) to engage the UB community to select the best 2-3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions.

Ethics challenges and guidance related to research involving adolescent post-abortion care: a scoping review.

INTRODUCTION: An increase in post abortion care (PAC) research with adolescents, particularly in low- and middle-income countries, has brought to attention several associated research ethics challenges. In order to better understand the ethics context of PAC research with adolescents, we conducted a scoping review of published literature. METHODS: Following a systematic search of PubMed, HINARI, and Google Scholar, we analysed articles meeting inclusion criteria to determine common themes across both the ethical challenges related to PAC research with adolescents and any available guidance on the identified challenges. RESULTS: The literature search identified an initial 3321 records of which 14 were included in analysis following screening. Several ethical challenges stem from abortion being a controversial, sensitive, and stigmatized topic in many settings. Ethical dilemmas experienced by researchers conducting adolescent PAC research included: difficulties in convincing local health providers to permit PAC research; challenges in recruiting and seeking consent due to sensitivity of the subject; effectively protecting confidentiality; managing negative effects of interventions; creating a non-prejudicial atmosphere for research; managing emotional issues among adolescents; and dealing with uncertainty regarding the role of researchers when observing unethical health care practices. Suggested strategies for addressing some of these challenges include: using several sources to recruit study participants, using research to facilitate dialogue on abortion, briefing health workers on any observed unethical practices after data collection, fostering a comprehensive understanding of contextual norms and values, selecting staff with experience working with study populations, and avoiding collection of personal identifiers. CONCLUSION: Addressing ethical challenges that researchers face when conducting PAC research with adolescents requires guidance at the individual, institutional, community, and international levels. Overall, despite the documentation of challenges in the published literature, guidance on handling several of these ethics challenges is sparse. We encourage further research to clarify the identified challenges and support the development of formal guidance in this area.

Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research.

INTRODUCTION: Traditional informed consent approaches, involving separate discussions and lengthy consent forms, may be an imperfect fit for comparative effectiveness research (CER) that is integrated into usual care and compares non-investigational treatments. However, systematic efforts to collect broad stakeholder perspectives about alternative streamlined approaches to disclosure and consent in this context have been limited. METHODS: We used a deliberative engagement method to solicit the views of a multi-stakeholder group regarding 3 alternative models of disclosure, consent, and authorization in CER studies: Opt-In, Opt-Out, and "General Approval". Participants considered the acceptability of these 3 models for observational and randomized CER studies of hypertension medications and for alternative treatments for spinal stenosis, all conducted in the context of a learning health care system. RESULTS: Fifty-eight stakeholders participated in the all-day deliberative engagement session. Following deliberation, a majority of stakeholders (67%) liked the General Approval model for the observational hypertension study, more than the number who reported liking Opt-Out or Opt-In (45% and 36%, respectively). Support was lower for General Approval model in the context of a randomized hypertension study, with 80% liking a traditional Opt-In approach, compared with 54% liking Opt-Out, and 11% liking General Approval. Similarly, for the spinal stenosis CER studies, while most stakeholders preferred a streamlined Opt-Out approach for the observational design, most preferred a traditional Opt-In approach for the randomized version. CONCLUSIONS: This multi-stakeholder group was more favorable towards streamlined models for disclosure and authorization for observational CER than randomized designs. These findings are consistent with arguments that informed consent requirements should be tailored to the context of the research design, rather than a standard "one size fits all" approach.

Ethical challenges in research on post-abortion care with adolescents: experiences of researchers in Zambia.

Post-abortion care (PAC) research is increasingly being conducted in low- and middle-income countries (LMICs) to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion and community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents' right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance.

Bioethics training programmes for Africa: evaluating professional and bioethics-related achievements of African trainees after a decade of Fogarty NIH investment.

OBJECTIVES: Our primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioethics training programmes (Fogarty bioethics training programmes, FBTPs) that trained individuals from Africa over the programme's first 10 years to examine changes between pretraining and post-training in individual achievement and to document any associations between individual, training programme and post-training accomplishments. DESIGN: We surveyed trainees from the 10 bioethics programmes funded by NIH Fogarty International Center from 2000 to 2011 that included African trainees. McNemar's and Wilcoxon signed rank-sum tests were used to analyse pre-post levels of general and bioethics-related professional achievement. Likelihood of specific post-training achievement outcomes was measured using logistic regression including demographic, pretraining and intratraining variables. SETTING: 10 different FBTPs that trained individuals from Africa from 2000 to 2011. PARTICIPANTS: Of 253 eligible respondents, 171 completed the survey (response rate 67.6%). PRIMARY OUTCOME MEASURES: Pre-post comparisons of professional achievement indicators (eg, serving in leadership roles, teaching, publishing manuscripts); likelihood of specific post-training achievement outcomes. RESULTS: Post-training, respondents were significantly more likely to report serving in a leadership role, being an investigator on a research grant, serving on international committees, serving as a mentor, and publishing manuscripts than at pretraining. Post-training, significantly greater numbers of respondents reported bioethics-related achievements including being a bioethics instructor, serving on an Institutional Review Board (IRB), being an investigator on a bioethics grant and publishing bioethics-related manuscripts than pretraining. Controlling for other factors, there were no significant differences by gender in the post-training success of these participants in terms of leadership roles, being instructors, investigators on grants and holding IRB roles. CONCLUSIONS: African trainees who participated in FBTPs reported significantly higher levels of professional achievement after training. There was no single factor-either demographic, related to a trainee's professional background, or in programme design-that consistently predicted greater levels of post-training achievement.

Exploring Institutional Research Ethics Systems: A Case Study From Uganda.

BACKGROUND: The increasing globalization of research drives a need for greater research ethics capacity in low resource countries. Several programs have attempted to expand research ethics capacity by training individuals, but few have focused on broader research ethics systems and institutions. This study describes and applies an institutional research ethics model to assess the institutional research ethics capacity of Makerere University College of Heath Sciences (MakCHS) in 2011. METHODS: Internal and external stakeholders conducted the assessment of MakCHS using the multidimensional Octagon framework. Five methods were used to collect data on current ethical processes and institutional relationships. RESULTS: MakCHS scored in the mid range on all Octagon domains, with some variation between external and internal assessments. The external Octagon scores suggest that MakCHS's areas of strengths are in identity, structure, relevance, target groups, and working environment; needs are greater in the areas of production, competence, and systems of finance and administration. Discrepancies in external and internal assessment can serve as a useful platform to shape ongoing discussions and strategic efforts. CONCLUSIONS: The assessment identified strengths, opportunities, and challenges for institutional research ethics capacity at MakCHS. We believe this systematic approach was helpful in evaluating research ethics needs and provides a benchmark for institutions to measure progress over time.

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

BACKGROUND: Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. METHODS: Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. RESULTS: 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. CONCLUSIONS: Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples.