A case study of a single ethics committee for multicentre trials

This article describes an approach to enhancing the value of case study material in teaching professional ethics in psychology. The mock committee approach involves a series of hearings convened fry students who rotate membership on a class ethics committee. Members of the class participate randomly as psychologists accused of various ethical violations. While the class observes, formal complaint hearings occur that result in official rulings and the setting of appropriate penalties and remedial requirements. The larger class then joins in active feedback and exchange with the committee to highlight and discuss salient ethical issues. We present and discuss student evaluation data for this technique and comment on the potential advantages of this teaching approach.

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Why Did You Not Act on Our Suggestion? Regulatory and Growth-Oriented Opportunities During Ethical Review: A Case Study

SAGE Open ◽

10.1177/2158244020920587 ◽

2020 ◽

Vol 10 (2) ◽

pp. 215824402092058

Author(s):

Sean G. Dicks ◽

Ian J. Pieper ◽

Holly L. Northam ◽

Frank M. P. van Haren ◽

Douglas P. Boer

Keyword(s):

Research Ethics ◽

Ethics Committee ◽

Ethical Review ◽

Human Research Ethics ◽

Apply Research ◽

Differences Of Opinion ◽

Research Plan ◽

Conducting Research ◽

Human Participants

In Australia, before conducting research with human participants, researchers must have their research plan reviewed by a Human Research Ethics Committee (HREC) to ensure that proposed methods meet ethical requirements and protect the welfare of participants. In addition, it has been proposed that HRECs can contribute to a novice researcher’s ethical mindfulness. To explore this suggestion, the current self-reflective case study examines the dialogue between a PhD candidate and the HREC that reviewed his proposed study of family bereavement in the context of the potential for organ donation. Findings suggest that when a respectful, problem-solving attitude is adopted by both parties, a learning environment evolves where diverse views, differences of opinion, and novel solutions are tolerated. In this context, the research plan is improved and the novice researcher’s ability to apply research ethics is developed. Simultaneously, members of the HREC gain practice in the identification of ethical dilemmas and the application of ethical principles that help resolve those dilemmas.

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Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

Journal of Empirical Research on Human Research Ethics ◽

10.1177/15562646211068316 ◽

2022 ◽

pp. 155626462110683

Author(s):

Katherine Christian ◽

Carolyn Johnstone ◽

Jo-ann Larkins ◽

Wendy Wright

Keyword(s):

Informed Consent ◽

Research Ethics ◽

Ethics Committee ◽

University Staff ◽

Institutional Approval ◽

Human Research ◽

Human Research Ethics ◽

Risk Research ◽

Case Basis

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

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Treatment preferences for preventive interventions for rheumatoid arthritis: protocol of a mixed methods case study for the Innovative Medicines Initiative PREFER project

BMJ Open ◽

10.1136/bmjopen-2020-045851 ◽

2021 ◽

Vol 11 (4) ◽

pp. e045851

Author(s):

Marie Falahee ◽

Gwenda Simons ◽

Rachael L DiSantostefano ◽

Larissa Valor Méndez ◽

Christine Radawski ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Life Cycle ◽

Mixed Methods ◽

Patient Preferences ◽

Ethics Committee ◽

Nominal Group ◽

Preventive Interventions ◽

The Public ◽

Trade Offs

IntroductionAmidst growing consensus that stakeholder decision-making during drug development should be informed by an understanding of patient preferences, the Innovative Medicines Initiative project ‘Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle’ (PREFER) is developing evidence-based recommendations about how and when patient preferences should be integrated into the drug life cycle. This protocol describes a PREFER clinical case study which compares two preference elicitation methodologies across several populations and provides information about benefit–risk trade-offs by those at risk of rheumatoid arthritis (RA) for preventive interventions.Methods and analysisThis mixed methods study will be conducted in three countries (UK, Germany, Romania) to assess preferences of (1) first-degree relatives (FDRs) of patients with RA and (2) members of the public. Focus groups using nominal group techniques (UK) and ranking surveys (Germany and Romania) will identify and rank key treatment attributes. Focus group transcripts will be analysed thematically using the framework method and average rank orders calculated. These results will inform the treatment attributes to be assessed in a survey including a discrete choice experiment (DCE) and a probabilistic threshold technique (PTT). The survey will also include measures of sociodemographic variables, health literacy, numeracy, illness perceptions and beliefs about medicines. The survey will be administered to (1) 400 FDRs of patients with RA (UK); (2) 100 FDRs of patients with RA (Germany); and (3) 1000 members of the public in each of UK, Germany and Romania. Logit-based approaches will be used to analyse the DCE and imputation and interval regression for the PTT.Ethics and disseminationThis study has been approved by the London-Hampstead Research Ethics Committee (19/LO/0407) and the Ethics Committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg (92_17 B). The protocol has been approved by the PREFER expert review board. The results will be disseminated widely and will inform the PREFER recommendations.

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Health promotion of the triad mother-child and family and the nursing diagnosis of ineffective breastfeeding in childcare consultation

Revista de Enfermagem UFPE on line ◽

10.5205/reuol.1262-12560-1-le.0508201124 ◽

2011 ◽

Vol 5 (8) ◽

pp. 1995

Author(s):

Susy Maria Feitosa de Melo Freitas ◽

Adriana Gomes Nogueira Ferreira ◽

Cibele Almeida Torres ◽

Fabiane Do Amaral Gubert ◽

Kelanne Lima da Silva ◽

...

Keyword(s):

Health Promotion ◽

Qualitative Study ◽

Prenatal Care ◽

Ethics Committee ◽

Clinical Factors ◽

Nursing Diagnosis ◽

Knowledge Deficit ◽

Study Type ◽

Estudio De Caso

ABSTRACTObjective: to describe the socio-demographic and clinical factors that interfere with the satisfactory practice of breastfeeding in seven triads (mother-child and family) assisted in childcare consultation. Method: qualitative study, of the case study type carried out in April 2009, with seven triad (mother-child and family) assisted in childcare consultation with the maximum age of six months and registered in the unit, through interviews with questions based on defining characteristics and factors related to the Nursing Diagnosis "Ineffective Breastfeeding", observation and verification of prenatal card and of child. The analysis was performed through study and transcription of the answers in the form of cases, later the set of common and divergent characteristics presented by the triad was discussed based on the existing literature. The study was approved by the Ethics Committee of the Federal University of Ceara, with protocol number 36/09. Results: it was verified a higher frequency of conditions related to the incorrect attachment, anomaly of mother's breast, inadequate emptying of breast and knowledge deficit. Conclusion: it was noticed insufficient approach on breastfeeding during prenatal care, a fact that highlights the need to promote this practice seeking the adherence and maintenance of effective breastfeeding. Descriptors: nursing; breastfeeding; nursing diagnosis.RESUMOObjetivo: descrever os fatores sociodemográficos e clínicos que interferem na prática satisfatória da amamentação. Método: estudo qualitativo, no formato de estudo de caso, realizado em abril de 2009, junto a sete trinômios (mãe-filho e família) atendidos em consulta de puericultura, com idade máxima dos lactentes de seis meses e cadastro na unidade, por meio de entrevista com questões baseadas nas características definidoras e fatores relacionados ao Diagnóstico de Enfermagem “Amamentação Ineficaz”, observação e verificação do cartão do pré-natal e da criança. A análise foi realizada por meio de estudo e transcrição das respostas em forma de casos, posteriormente, o conjunto de características comuns e divergentes apresentado pelos trinômios foi discutido à luz da literatura existente. O estudo foi aprovado pelo Comitê de Ética da Universidade Federal do Ceará, número de protocolo n°36/09. Resultados: observou-se maior frequência de condições relacionadas à pega inadequada, à anomalia do peito materno, ao esvaziamento insuficiente da mama e ao déficit de conhecimento. Conclusão: percebeu-se abordagem insuficiente sobre aleitamento materno no pré-natal, fato que evidencia a necessidade da promoção desta prática com vistas à adesão e manutenção da amamentação eficaz. Descritores: enfermagem; aleitamento materno; diagnóstico de enfermagem. RESUMENObjetivo: describir los factores sociodemográficos y clínicos que interfieren en la práctica de la lactancia materna satisfactoria con siete tríada (madre-niño y familia) atendidos en consulta de puericultura. Método: estudio cualitativo realizado, estudio de caso, realizado en abril/2009, con siete trinomios (madre-hijo y familia) atendidos en consulta de puericultura, con edad máxima de seis meses de los bebés y registro en la unidad, a través de entrevistas con preguntas basadas en las características definidoras y en los factores relacionados al Diagnóstico de Enfermería "Lactancia materna ineficaz", observación y verificación del cartón del prenatal y del niño. El análisis se realizó mediante estudio y transcrición de las respuestas en forma de casos, después, el conjunto de características comunes y divergentes presentado por el trinomio fue discutido a la luz de la literatura existente. El estudio fue aprobado por el Comité de Ética de la Universidad Federal del Ceará, bajo número de protocolo 36/09. Resultados: Se observó una mayor frecuencia de condiciones relacionadas con la pega incorrecta, anomalía del pecho materno, vaciamiento insuficiente de la mama y déficit de conocimiento. Conclusión: se percibió enfoque insuficiente acerca de la lactancia durante la atención prenatal, hecho que pone de relieve la necesidad de promover esta práctica para el mantenimiento de la adhesión y eficacia de la lactancia materna. Descriptores: enfermería; lactancia materna; diagnóstico de enfermería.

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King’s College London Student Clinical Ethics Committee case discussion: An elderly patient wants to go home following inpatient treatment, but it is thought she may be at risk in her own home and her discharge is delayed

Clinical Ethics ◽

10.1177/1477750916657667 ◽

2016 ◽

Vol 11 (4) ◽

pp. 210-213

Author(s):

Carolyn Johnston ◽

Michael Baty ◽

Patricia Kelly

Keyword(s):

Clinical Ethics ◽

Inpatient Treatment ◽

Elderly Woman ◽

Ethics Committee ◽

Health Care Teams ◽

Case Discussion ◽

Clinical Ethics Committee ◽

King's College ◽

Potential Risks

The Student Clinical Ethics Committee considered the case of an elderly woman who remained in hospital for 2 months after treatment, despite being considered medically fit for discharge, causing her great distress. The committee considered the justifications for keeping the patient on the ward in order to determine whether she was fit to be discharged to her home. The case study summarises the reflections of the committee and focuses on the capacity of the patient to make the decision to go home, the potential risks and consequences of discharging her, the concerns of the health care teams and their responsibility to make a decision.

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Father Figure and Relationship with Mother of Individual Who Experiences Possession Disorder

10.31124/advance.7440803 ◽

2019 ◽

Author(s):

Siswanto Siswanto ◽

Subandi Subandi ◽

ira paramastri

Keyword(s):

Informed Consent ◽

Data Collection ◽

Research Ethics ◽

Structured Interview ◽

Ethics Committee ◽

Father Figure ◽

Research Ethics Committee ◽

Minimal Data

The method applied is a case study, supported by three participants, they are all women who have experienced possession disorder twice for minimal. Data collection obtained by interviewing the participants and participant’s friend or family using semi-structured interview followed by SSCT test. All participants have obtained informed consent and expressed their willingness to become participants.<p></p> This study also received approval from the Research Ethics Committee of the Faculty of Psychology, Gadjah Mada University No. 4204/SD/PL.03.01/XI/ 2017

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Father Figure and Relationship with Mother of Individual Who Experiences Possession Disorder

10.31124/advance.7440803.v1 ◽

2019 ◽

Author(s):

Siswanto Siswanto ◽

Subandi Subandi ◽

ira paramastri

Keyword(s):

Informed Consent ◽

Data Collection ◽

Research Ethics ◽

Structured Interview ◽

Ethics Committee ◽

Father Figure ◽

Research Ethics Committee ◽

Minimal Data

The method applied is a case study, supported by three participants, they are all women who have experienced possession disorder twice for minimal. Data collection obtained by interviewing the participants and participant’s friend or family using semi-structured interview followed by SSCT test. All participants have obtained informed consent and expressed their willingness to become participants.<p></p> This study also received approval from the Research Ethics Committee of the Faculty of Psychology, Gadjah Mada University No. 4204/SD/PL.03.01/XI/ 2017

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