Response

2000 ◽  
Vol 27 (1) ◽  
pp. 28-28
Author(s):  
David Wyatt Seal ◽  
Frederick R. Bloom ◽  
Anton M. Somlai
Keyword(s):  
Research Ethics ◽  
Applied Field ◽  
Ethical Dilemmas ◽  
Real Life ◽  
Field Research ◽  
Institutional Review Board ◽  
Board Governance ◽  
Practical Application ◽  
Multiple Strategies ◽  
Institutional Review

Lew Margolis’s commentary on our discussion of field dilemmas delineates the basic tenets of research ethics and presents the historical backdrop for Institutional Review Board governance of the conduct of scientific research. Margolis’s commentary also highlights two important points: (1) within broad boundaries, multiple strategies may exist for resolving ethical dilemmas, and (2) field judgments about the best strategy for resolving ethical dilemmas may sometimes appear less than optimal with hindsight. These emphases reinforce the critical need for continued dialogue about the practical application of research ethics in applied field settings. We further emphasize the importance of conducting this dialogue not only in community forums but in academic arenas. The professional expertise of field researchers often is derived from direct experience with or membership in the communities being studied. For academic discussion of research ethics to have real-life utility, it is essential that conceptual discussion be translated into discussion of these issues as they apply to real-life situations demanding real-life solutions. We invite others to continue this dialogue about the practical application of research ethics to dilemmas that have been encountered during the conduct of applied field research.

scholarly journals 489 TWT-101: a phase 1 study of the novel HPK1 inhibitor CFI-402411 in patients with advanced cancer

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A519-A519
Author(s):  
Omid Hamid ◽  
Johanna Bendell ◽  
Siqing Fu ◽  
Kyriakos Papadopoulos ◽  
Judy Wang ◽  
...  
Keyword(s):  
T Cells ◽  
T Cell ◽  
Research Ethics ◽  
Potent Inhibitor ◽  
Phase 1 ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Research Ethics Board ◽  
Grade 3 ◽  
Advanced Tumors

BackgroundCFI-402411 is an orally available small molecule potent inhibitor of HPK1 (Hematopoietic progenitor kinase 1). T-cells are negatively-regulated at different junctures of cancer-immunity cycle by this regulatory kinase. HPK1, (also mitogen activated protein kinase kinase kinase kinase 1 (MAP4K1)) is a protein serine/threonine kinase predominantly expressed in hematopoietic cells. In T-cells, following T-cell receptor activation, HPK1 is recruited to the plasma membrane where it phosphorylates the adapter protein SH2 domain-containing leukocyte protein of 76 kDa (SLP-76), down-regulating signaling events required for T cell activation and proliferation. Selected for development based on its pharmacologic properties and preclinical activity in a variety of syngeneic cancer models and assays, with an IC50 = 4.0±1.3 nM, CFI-402411 is expected to relieve HPK1-mediated inhibition of T and B cells, facilitating an anti-tumor immune response.MethodsPhase 1, 3 + 3 design in patients. Patients have acceptable laboratory, other parameters for study entry. Single agent dose daily oral escalation cohort (A1) in advanced tumors, then dose expansion (A3) with biomarker backfill (A2) in select advanced tumors; combination with PD-1 Inhibitor (pembrolizumab) (B1, pembrolizumab eligible tumors with no prior grade >=3 related to CPI)) and expansion (B2, PD-1/PD-L1 naïve pembrolizumab eligible tumors). DLT defined as any grade >=3 toxicity in first cycle of therapy (21d cycles). Standard assessments for response per RECIST v1.1 or iRECIST. The starting dose level was 80mg.ResultsAt 10 June 2021 data is available for 12 patients from A1. Median age 61.5 years (range 33–73), 8 patients female, and 10 white. Diagnoses were pancreatic cancer, colorectal (3 pts), ovarian, basal cell, cholangiocarcinoma, sigmoid, salivary and breast cancer (1 pt). Six patients (50%) had 4 prior therapies, 1 patient (basal cell) had prior treatment with immune checkpoint inhibitor, pembrolizumab. Four doses studied: 80, 120, 180 and 270mg. TEAEs across all CTCAE grades, (in >2 patients) were diarrhea (6 patients), nausea (4 patients), dyspepsia (3 patients), fatigue (3 patients). No related grade 3–5 events, one immune related event (grade 1, weight loss). 3 grade 3 events all unrelated to study drug - pleural effusion, rash, thromboembolic event. Discontinuation due to disease progression was main reason (7 patients). PK and PD assessments will be updated at time of presentation.ConclusionsCFI-402411 is a potent inhibitor of HPK1 that is well tolerated with a manageable adverse event profile and dose escalations continue. Further safety and efficacy results will be presented at the meeting including additional cohorts if available.AcknowledgementsTreadwell Therapeutics thanks all sites, importantly their patients and their families.Trial RegistrationClinicalTrials.gov Identifier: NCT04521413Ethics ApprovalThis study obtained has obtained ethics approvals at multiple institutions globally including;USAWCG IRB - Western Institutional Review Board - MOD00002618 (Submission ID)IntegReview Institutional Review Board - N/AAdvarra Central IRB - SSU00130103IntegReview Institutional Review Board N/AAdvarra Central IRB - SSU00137751Advarra Central IRB - SSU00143275The University of Texas MD Anderson Cancer Center Institutional Review Board - 2020–0678 (IRB ID Number)Hong KongJoint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee - 2020.367 (Ref Number)CanadaOntario Cancer Research Ethics Board - 3320 (Project ID)Health Research Ethics Board of Alberta, HREBA Cancer Committee - HREBA.CC-20–0504 (Ethics ID Number)South KoreaimCORE - Seoul National University Hospital Institutional Review Board - H-2012-094-1182 (IRB Number)National Cancer Institute Review Board - 2020–0525–0001 (Receipt Number)All participants gave informed consent before taking part in this clinical trial.

scholarly journals Institutional Review Board and International Field Research in Conflict Zones

2014 ◽  
Vol 47 (04) ◽  
pp. 840-844 ◽  
Author(s):  
Srobana Bhattacharya
Keyword(s):  
Human Subjects ◽  
Social Science Research ◽  
Field Research ◽  
Science Research ◽  
Political Conflict ◽  
Institutional Review Board ◽  
Biomedical Sciences ◽  
Conflict Zones ◽  
Institutional Review ◽  
The Many

ABSTRACTResearch on political conflict can benefit immensely from fieldwork. However, the Institutional Review Board (IRB) process is elaborate and daunting that discourages rather than encourages this type of research. Existing policies often are insensitive to the many uncertainties related to field research abroad, especially in conflict zones. Three reasons for this are identified in this article. First, the federal regulations to protect human subjects of social science research are most suitable for biomedical sciences. Second, there is huge gap between “procedural ethics” and “ethics in practice.” Third, there is a lack of communication or dialogue between researchers and IRBs. After discussing these reasons, I offer the following suggestions: bridging the gap between the researcher and the IRB; reducing delays in the IRB approval and revision process; encouraging collaboration and dialogue among researchers; and advocating a proactive stance by academic associations.

Qualitative research ethics on the spot

2015 ◽  
Vol 23 (4) ◽  
pp. 455-464 ◽  
Author(s):  
Christine Øye ◽  
Nelli Øvre Sørensen ◽  
Stinne Glasdam
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethical Dilemmas ◽  
Institutional Review Boards ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Institutional Review ◽  
Review Boards

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.

scholarly journals Negotiating the Ethical Conduct of Educational Research in an Institutional Review Board Space: Perspectives from a University in Ethiopia

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ashenafi Alemu
Keyword(s):  
Research Ethics ◽  
Educational Research ◽  
Ethical Issues ◽  
Behavioral Science ◽  
Institutional Review Board ◽  
Ethical Review ◽  
National Guidelines ◽  
African Countries ◽  
Institutional Review ◽  
Éthique De La Recherche

Some international researchers assume that there is a lack of ethical review of research in many countries of the Global South. However, numerous African countries have recently introduced local and national research ethics guidelines. This article unpacks how ethical reviews of research in education are negotiated in a higher education institution in Ethiopia. It employs a critical analytical lens to challenge some of the assumptions of Beaty’s (2010) Institutional Review Board (IRB) stakeholder model. The article begins with a discussion of the limitations inherent in the IRB model. Critical analyses of institutional documents and non-confidential, off-the-shelf IRB minutes are also conducted. The analysis shows that researchers within the medical and health sciences disciplines have well established organizational engagement when it comes to handling issues related to research ethics. However, the limited representation of the educational and social and behavioral science disciplines remains a challenge. Furthermore, ethical issues in conducting educational research are hardly addressed in the national guidelines for granting research ethics approval. This results in further marginalisation of the contributions of educational research to knowledge production. Certains chercheurs internationaux présument un manque de suivi éthique de la recherche dans plusieurs pays du Sud. Cependant, de nombreux pays d’Afrique ont récemment mis en place des recommandations au niveau local et national en ce qui concerne l’éthique de la recherche. Le présent article analyse comment le suivi éthique de la recherche en sciences de l’éducation est mené dans un établissement d’enseignement supérieur en Ethiopie. Adoptant un point de vue analytique critique, il remet en question certains présupposés du modèle de l’Institutional Review Board (IRB – comité d’éthique de la recherche) de Beaty (2010) basé sur la théorie des parties prenantes. L’article commence par considérer les limites du modèle de l’Institutional Review Board. Des analyses critiques sont également menées à partir de documents institutionnels et de comptes-rendus disponibles et non confidentiels de réunions de l’Institutional Review Board. Cette recherche démontre que les chercheurs en médecine et sciences de la santé ont des positions clairement établies et propres aux organismes auxquels ils appartiennent, qui leur permettent de faire face aux questions d’éthique de la recherche. Cependant, la sous-représentation des sciences de l’éducation, des sciences sociales et des sciences comportementales demeure problématique. De plus, les questions éthiques qui se posent dans la recherche en sciences de l’éducation sont à peine abordées dans les directives nationales qui permettent d’obtenir l’approbation du comité d’éthique de la recherche. Cela a pour conséquence d’éloigner un peu plus les contributions de la recherche en sciences de l’éducation de la production du savoir.

scholarly journals 545 A phase 2 study of retifanlimab in patients with advanced or metastatic merkel cell carcinoma (MCC) (POD1UM-201)

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A574-A575
Author(s):  
Giovanni Grignani ◽  
Piotr Rutkowski ◽  
Celeste Lebbe ◽  
Natalie Prinzi ◽  
Jean-jaques Grob ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Research Ethics ◽  
Health Research ◽  
Institutional Review Board ◽  
Phase 2 ◽  
Merkel Cell ◽  
Institutional Review ◽  
Phase 2 Study ◽  
Research Ethics Board ◽  
Grade 3

BackgroundRetifanlimab (INCMGA00012) is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ), anti-programmed cell death protein (PD)-1 monoclonal antibody with safety and clinical pharmacology that are characteristic for the class. Evaluation of retifanlimab in solid tumors is under investigation in phase 2 and 3 studies. POD1UM-201 is an open-label, single-arm, multicenter, phase 2 study evaluating the efficacy and safety of retifanlimab in patients with chemotherapy-naïve or chemotherapy-refractory advanced/metastatic Merkel cell carcinoma (MCC). Updated results from the chemotherapy-naïve cohort are reported here.MethodsEligible patients were ≥18 years of age, had metastatic or recurrent unresectable loco-regional MCC, Eastern Cooperative Oncology Group performance status ≤1, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and had not received prior systemic treatment for MCC. Retifanlimab 500 mg IV every 4 weeks (Q4W) was administered for up to 2 years. The primary endpoint was overall response rate (ORR) assessed by independent central review per RECIST v1.1. Secondary endpoints included duration of response, disease control rate (DCR; defined as proportion of patients with either an objective response or stable disease lasting at least 6 months), progression-free survival, overall survival, safety, and pharmacokinetics.ResultsAs of April 16, 2021, 87 patients with chemotherapy-naïve advanced/metastatic MCC had received retifanlimab. Per protocol, the primary efficacy analyses are based on the first 65 patients assessed. At the data cutoff, 34 of these 65 patients (52.3%) were on treatment; 4 (6.2%) had completed treatment; and 27 (41.5%) had discontinued treatment for reasons including disease progression (18 [27.7%]), adverse event (AE; 7 [10.8%]), death (1 [1.5%]), and physician decision (1 [1.5%]). The ORR in these patients was 46.2% (n=30: complete response, 8 [12.3%]; partial response, 22 [33.8%]). The DCR was 53.8% (n=35). Other secondary efficacy results are not yet mature. Among all treated patients (n=87), 66 (75.9%) had a treatment-emergent AE (TEAE), 25 (28.7%) had a grade ≥3 TEAE, and 12 (13.8%) had a grade ≥3 treatment-related AE. Twenty-three patients (26.4%) had an immune-related AE (irAE), and 8 (9.2%) had a grade ≥3 irAE. Four patients (4.6%) discontinued treatment due to irAEs (peripheral sensorimotor neuropathy, pancreatitis, eosinophilic fasciitis, and polyarthritis [each n=1]). One patient (1.1%) had a grade 3 infusion reaction.ConclusionsThese data from the POD1UM-201 trial show that retifanlimab monotherapy at 500 mg Q4W continues to demonstrate promising clinical activity and safety in patients with advanced/metastatic chemotherapy-naïve MCC. Updated results will be presented at the meeting.AcknowledgementsThe study is sponsored by Incyte Corporation (Wilmington, DE). Statistical support was provided by Xiaohan Xu of Incyte Corporation. Editorial assistance was provided by Matthew Bidgood of Envision Pharma Group (Philadelphia, PA, USA).Trial RegistrationClinicaltrials.gov NCT03599713; EudraCT 2018-001627-39Ethics ApprovalThe study was approved by institutional review boards or independent ethics committees in Canada (McGill University Health Center-Research Ethics Board [MP-37-2019-5103, MEO-37-2019-1616]; Ontario Cancer Research Ethics Board [1728]; Health Research Ethics Board of Alberta – Cancer Committee [HREBA.CC-19-0004, HREBA.CC-19-0020]); Czech Republic (Eticka komise Fakultni nemocnice Kralovske Vinohrady, Eticka komise IKEM a FTNsP, Eticka komise Nemocnice Na Bulovce, Statni ustav pro kontrolu leciv, Eticka komise FN a LF UP Olomouc [169/18MEK24, LEK/04/07/2018, (L-18-85) 8522/23.3.2021, 22.3.2021/9965/EK-Z]); France (Comité de Protection des Personnes Ile de France X [CNRIPH : 18.11.19.49212/Id. 2043]; Agence Nationale de Sécurité du Médicament et des Produits de Santé); Germany (Ethik-Kommission der Medizinischen Fakultaet der Universitaet Duisburg-Essen [18-8371-AF]; Bundesamt fuer Strahlenschutz; Paul-Ehrlich Institute); Hungary (Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga [IV/2407-0/2021-EKL, OGYÉI/11697-2/2021]; Orszagos Gyogyszereszeti es Elelmezes-egeszsegugyi Intezet); Italy (Comitato Etico IRCCS Pascale Napoli [116/21 E - 87/18]; Comitato Etico IRCCS di Candiolo [232/2021]; Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari [736/CE]; Comitato Etico Locale per la Sperim. Clin. dei Medicinali dell’Az. Osp.ra Univ.ria Senese di Siena [14107]; Comitato Etico dell’IRCCS Istituto Nazionale per la Ricerca sul Cancro di Genova [389/2018 - 24/05/2021]; Comitato etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino [IEO 948 - RE3065/IB Edition 7 dated 10Nov2020 (SA7)]; Comitato Etico, Fondazione IRCCS Istituto Nazionale dei Tumori, .c. Medicina Oncologica 1 – Fondazio [INT 01/19]; Comitato Etico IRCCS Istituto Oncologico Veneto di Padova [EM 109/2021]; Comitato Etico dell’IRCCS Istituto Dermopatico dell’Immacolata Ospedale Generale S. Carlo di Roma [550/7]; AIFA – Agenzia Italiana del Farmaco [0040152-01/04/2021-AIFA-AIFA_USC-P]; Comitatao Etico Policlinico di Modena [1017/2018/FARM/AOUMO - EMENDAMENTO SOSTANZIALE IB EDIZIONE 7 DEL 10/11/20 (201800162739-010) (p. 9869/21)]); Poland (Komisja Bioetyczna przy Centrum Onkologii [no. 55/2019]; Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [UR/DBL/D/328/2019]); Spain (CEIC Hospital General Universitario Gregorio Marañon [280/18]; Agencia Española del Medicamento y Productos Sanitarios); Switzerland (Kantonale Ethikkommission Zürich (KEK-Zürich) [2019-00200]; Swissmedic [2019DR2035]); United Kingdom (North East – York Research Ethics Committee [248465]; Medicines and Healthcare products Regulatory Agency; Health Research Authority); United States (Copernicus Group IRB; Western Institutional Review Board [20181738, Work order number -– IQV1-18-309]; Roswell Park Cancer Institute IRB [STUDY00000802/P 75918]; Inova Institutional Review Board, Human Research Protection Program; Stanford IRB Research Compliance Office [48198]; Rush University Medical Center [18072304-IRB01]; University of Miami IRB; Mayo Clinic IRB – Rochester).

scholarly journals Research Ethics Step by Step

2020 ◽  
pp. 227-273
Author(s):  
Jaap Bos
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Institutional Review Board ◽  
Consent Form ◽  
List Type ◽  
General Knowledge ◽  
Know How ◽  
Institutional Review ◽  
Informed Consent Form ◽  
Research Designs

After Reading This Chapter, You Will: Have a general knowledge of Institutional Review Board (IRB) procedures Have the capacity to anticipate the basic ethical pitfalls in research designs Know how to counter common ethical objections Be able to design an informed consent form

Reforming Institutional Review Board Policy: Issues in Implementation and Field Research

2008 ◽  
Vol 41 (03) ◽  
pp. 483-494 ◽  
Author(s):  
Dvora Yanow ◽  
Peregrine Schwartz-Shea
Keyword(s):  
Political Science ◽  
Field Research ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Policy Issues ◽  
Regulatory Policies ◽  
Institutional Review ◽  
Review Boards ◽  
Sense Of Urgency

Political science as a discipline has largely ignored research regulatory policies associated with institutional review boards (IRBs). Many political scientists—especially those in the senior ranks—are either oblivious to the existence of IRBs or actively decide to sidestep them by not submitting their proposals for review. Based on research conducted since 2004, we hold that APSA members at all ranks of the profession, along with political scientists worldwide, need to be concerned, not to say alarmed, about IRB policy. Why this sense of urgency, and why now?

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