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Research 101: A process for developing local guidelines for ethical research in heavily researched communities.

ABSTRACT: BACKGROUND:Marginalized communities often attract more than their share of research. Too often, this research benefits researchers disproportionately and leaves such communities feeling exploited, misrepresented, and exhausted. The Downtown Eastside (DTES) neighborhood of Vancouver, Canada, has been the site of multiple public health epidemics related to injection drug use as well as the site of much community-led resistance and struggle that has led to the development of cutting-edge harm reduction interventions (e.g., North America's first supervised injection facility, Insite) and a strong sense of community organization. This background has made the DTES one of the most heavily researched communities in the world. Amidst ongoing experiences of unethical or disrespectful research engagement in the neighborhood, a collaboration between local academic researchers and community representatives developed to explore how we could work together to encourage more respectful, community-responsive research and discourage exploitative or disrespectful research. METHODS:We developed a series of six weekly workshops called "Research 101." These workshops brought together approximately 13 representatives from peer-based organizations in the DTES with a variety of experiences with research. Research 101 created space for community members themselves to discuss the pitfalls and potential of research in their neighborhood and to express community expectations for more ethical and respectful research. RESULTS:We summarized workshop discussions in a co-authored "Manifesto for Ethical Research in the Downtown Eastside." This document serves as a resource to empower community organizations to develop more equitable partnerships with researchers and help researchers ground their work in the principles of locally developed "community ethics." Manifesto guidelines include increased researcher transparency, community-based ethical review of projects, empowering peer researchers in meaningful roles within a research project, and taking seriously the need for reciprocity in the research exchange. CONCLUSIONS:Research 101 was a process for eliciting and presenting a local vision of "community ethics" in a heavily researched neighborhood to guide researchers and empower community organizations. Our ongoing work involves building consensus for these guidelines within the community and communicating these expectations to researchers and ethics offices at local universities. We also describe how our Research 101 process could be replicated in other heavily researched communities.

SUBMITTER: Neufeld SD

PROVIDER: S-EPMC6604375 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Research 101: A process for developing local guidelines for ethical research in heavily researched communities.

Neufeld Scott D SD Chapman Jule J Crier Nicolas N Marsh Samona S McLeod Jim J Deane Lindsay A LA

Harm reduction journal 20190701 1

<h4>Background</h4>Marginalized communities often attract more than their share of research. Too often, this research benefits researchers disproportionately and leaves such communities feeling exploited, misrepresented, and exhausted. The Downtown Eastside (DTES) neighborhood of Vancouver, Canada, has been the site of multiple public health epidemics related to injection drug use as well as the site of much community-led resistance and struggle that has led to the development of cutting-edge ha ...[more]

PMID: 31262305

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Project description:BACKGROUND:Regenerative medicine plays a major role in biomedicine, and given the ever-expanding boundaries of this knowledge, numerous ethical considerations have been raised. MAIN TEXT:Rapid advancement of regenerative medicine science and technology in Iran, emerged the Iranian National Committee for Ethics in Biomedical Research to develop a comprehensive national ethical guideline. Therefore, the present ethical guideline which comprises eleven chapters was developed in 2019 and approved in early 2020. The titles of these chapters were selected based on the ethical considerations of various aspects of the field of regenerative medicine: (1) ethical principles of research on stem cells and regenerative medicine; (2) ethical considerations for research on stem cells (embryonic stem cells, epiblast stem cells, tissue-specific stem cells, stem cells derived from transdifferentiation, induced pluripotent stem cells [iPSCs], germline pluripotent stem cells, germline stem cells, and somatic cell nuclear transfer [SCNT] stem cells); (3) ethical considerations for research on somatic cells in regenerative medicine (adult somatic cells, fetal tissue somatic cells, and somatic cells derived from pregnancy products [other than fetus]); (4) ethical considerations for research on gametes in regenerative medicine; (5) ethical considerations for research related to genetic manipulation (human and animal) in regenerative medicine; (6) ethical considerations for research on tissue engineering in regenerative medicine; (7) ethical considerations for pre-clinical studies in regenerative medicine; (8) ethical considerations for clinical trials in regenerative medicine; (9) ethical considerations for stem cells and regenerative medicine bio-banks; (10) ethical considerations for privacy and confidentiality; and (11) ethical considerations for obtaining informed consent. CONCLUSION:This article discusses the process of developing the present ethical guidelines and its practical points. We hope that it can play an important worldwide role in advancing ethics of research on stem cells and regenerative medicine.

Project description:The use of animals in research entails a range of societal and ethical issues, and there is widespread consensus that animals are to be kept safe from unnecessary suffering. Therefore, harm done to animals in the name of research has to be carefully regulated and undergo ethical review for approval. Since 2013, this has been enforced within the European Union through Directive 2010/63/EU on the protection of animals used for scientific purposes. However, critics argue that the directive and its implementation by member states do not properly consider all aspects of animal welfare, which risks causing unnecessary animal suffering and decreased public trust in the system. In this pilot study, the ethical review process in Sweden was investigated to determine whether or not the system is in fact flawed, and if so, what may be the underlying cause of this. Through in-depth analysis of 18 applications and decisions of ethical reviews, we found that there are recurring problems within the ethical review process in Sweden. Discrepancies between demands set by legislation and the structure of the application form lead to submitted information being incomplete by design. In turn, this prevents the Animal Ethics Committees from being able to fulfill their task of performing a harm-benefit analysis and ensuring Replacement, Reduction, and Refinement (the 3Rs). Results further showed that a significant number of applications failed to meet legal requirements regarding content. Similarly, no Animal Ethics Committee decision contained any account of evaluation of the 3Rs and a majority failed to include harm-benefit analysis as required by law. Hence, the welfare may be at risk, as well as the fulfilling of the legal requirement of only approving "necessary suffering". We argue that the results show an unacceptably low level of compliance in the investigated applications with the legal requirement of performing both a harm-benefit analysis and applying the 3Rs within the decision-making process, and that by implication, public insight through transparency is not achieved in these cases. In order to improve the ethical review, the process needs to be restructured, and the legal demands put on both the applicants and the Animal Ethics Committees as such need to be made clear. We further propose a number of improvements, including a revision of the application form. We also encourage future research to further investigate and address issues unearthed by this pilot study.

Project description:BACKGROUND:The rapid expansion of direct-to-consumer wearable fitness products (eg, Flex 2, Fitbit) and research-grade sensors (eg, SenseCam, Microsoft Research; activPAL, PAL Technologies) coincides with new opportunities for biomedical and behavioral researchers. Underserved communities report among the highest rates of chronic disease and could benefit from mobile technologies designed to facilitate awareness of health behaviors. However, new and nuanced ethical issues are introduced with new technologies, which are challenging both institutional review boards (IRBs) and researchers alike. Given the potential benefits of such technologies, ethical and regulatory concerns must be carefully considered. OBJECTIVE:Our aim was to understand potential barriers to using wearable sensors among members of Latino, Somali and Native Hawaiian Pacific Islander (NHPI) communities. These ethnic groups report high rates of disparate health conditions and could benefit from wearable technologies that translate the connection between physical activity and desired health outcomes. Moreover, these groups are traditionally under-represented in biomedical research. METHODS:We independently conducted formative research with individuals from southern California, who identified as Latino, Somali, or Native Hawaiian Pacific Islander (NHPI). Data collection methods included survey (NHPI), interview (Latino), and focus group (Somali) with analysis focusing on cross-cutting themes. RESULTS:The results pointed to gaps in informed consent, challenges to data management (ie, participant privacy, data confidentiality, and data sharing conventions), social implications (ie, unwanted attention), and legal risks (ie, potential deportation). CONCLUSIONS:Results shed light on concerns that may escalate the digital divide. Recommendations include suggestions for researchers and IRBs to collaborate with a goal of developing meaningful and ethical practices that are responsive to diverse research participants who can benefit from technology-enabled research methods. TRIAL REGISTRATION:ClinicalTrials.gov NCT02505165; https://clinicaltrials.gov/ct2/show/NCT02505165 (Archived by WebCite at http://www.Webcitation.org/6r9ZSUgoT).

Project description:BackgroundAlthough in recent years there has been a strong increase in published research on theories (e.g. realist evaluation, normalization process theory) driving and guiding process evaluations of complex interventions, there is limited guidance to help rehabilitation researchers design and carry out process evaluations. This can lead to the risk of process evaluations being unsystematic. This paper reports on the development of new consensus guidelines that address the specific challenges of conducting process evaluations alongside clinical trials of rehabilitation interventions.MethodsA formal consensus process was carried out based on a modified nominal group technique, which comprised two phases. Phase I was informed by the findings of a systematic review, and included a nominal group meeting with an expert panel of participants to rate and discuss the proposed statements. Phase II was an in depth semi-structured telephone interviews with expert panel participants in order to further discuss the structure and contents of the revised guidelines. Frequency of rating responses to each statement was calculated and thematic analysis was carried out on all qualitative data.ResultsThe guidelines for carrying out process evaluations within complex intervention rehabilitation research were produced by combining findings from Phase I and Phase II. The consensus guidelines include recommendations that are grouped in seven sections. These sections are theoretical work, design and methods, context, recruitment and retention, intervention staff, delivery of the intervention and results. These sections represent different aspects or stages of the evaluation process.ConclusionThe consensus guidelines here presented can play a role at assisting rehabilitation researchers at the time of designing and conducting process evaluations alongside trials of complex interventions. The guidelines break new ground in terms of concepts and theory and works towards a consensus in regards to how rehabilitation researchers should go about carrying out process evaluations and how this evaluation should be linked into the proposed trials. These guidelines may be used, adapted and tested by rehabilitation researchers depending on the research stage or study design (e.g. feasibility trial, pilot trial, etc.).

Project description:OBJECTIVE: To explore how survey respondents perceived their experiences and the impact of participating in a survey, and to assess adverse consequences resulting from participation. DESIGN: Qualitative study involving purposefully selected participants who had participated in a household-based survey. METHODS: This qualitative study was nested within a survey that investigated the prevalence of gender-based violence perpetration and victimization with adult men and women in South Africa. 13 male- and 10 female-in-depth interviews were conducted with survey respondents. RESULTS: A majority of informants, without gender-differences, perceived the survey interview as a rare opportunity to share their adverse and or personal experiences in a 'safe' space. Gender-differences were noted in reporting perceptions of risks involved with survey participation. Some women remained fearful after completing the survey, that should breach of confidentiality or full survey content disclosure occur, they may be victimized by partners as a punishment for survey participation without men's approval. A number of informants generally discussed their survey participation with others. However, among women with interpersonal violence history or currently in abusive relationships, full survey content disclosure was done with fear; the partner responses were negative, and few women reported receiving threatening remarks but none reported being assaulted. In contrast no man reported adverse reaction by others. Informants with major life adversities reported that the survey had made them to relive the experiences causing them sadness and pain at the time. No informant perceived the survey as emotionally harmful or needed professional support because of survey questions. Rather the vast majority perceived benefit from survey participation. CONCLUSION: Whilst no informant felt answering the survey questions had caused them emotional or physical harm, some were distressed and anxious, albeit temporarily. Research protocols need to put in place safeguards where appropriate so that this group receives support and protection.

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Research 101: A process for developing local guidelines for ethical research in heavily researched communities.

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Research 101: A process for developing local guidelines for ethical research in heavily researched communities.

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