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Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.

ABSTRACT: Controlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop "Ethical Approval for CHIM Clinical Trial Protocols", which took place on May 30-31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteria for CHIM and the role(s) of CHIM in pharmaceutical development. The discussions led to several recommendations, including continued assurance that routine ethical requirements are met, assurance that participants are well-informed, and that preparation of study documents must be both ethically and scientifically sound from an early stage. Study applications must clearly state the rationale for the challenge compared to alternative study designs. ECs need to have clear guidance and procedures for evaluating social value and assessing third-party risks. Among other things, public trust in research requires minimisation of harm to healthy volunteers and third-party risk. Other important considerations include appropriate stakeholder engagement, public education, and access to health care for participants after the study.

SUBMITTER: Jamrozik E

PROVIDER: S-EPMC11004724 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.

Jamrozik Euzebiusz E Littler Katherine K Meln Irina I Van Molle Wim W Morel Sandra S Olesen Ole F OF Rubbrecht Michelle M Balasingam Shobana S Neels Pieter P

Biologicals : journal of the International Association of Biological Standardization 20240212

Controlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop "Ethical Approval for CHIM Clinical Trial Protocols", which took place on May 30-31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteri ...[more]

PMID: 38350349

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Project description:BackgroundResearch engagement contributes to the improvement of patient care. A systematic review is a suitable first scholarly activity because it entails summarization of publicly available data and usually requires neither rigorous ethical review nor research funding.MethodsThis study aimed to develop a model workshop for healthcare staff to acquire skills in creating systematic review protocols based on their own clinical questions at teaching hospitals. We used an action research method to create a model workshop at four hospitals in Japan from April 2015 to March 2017. To improve the program, we solicited reflections using participant questionnaires for each lecture and examined the quality of homework submitted by participants after each lecture. We administered a revised final version of the workshop at five hospitals from April 2016 to March 2017. We evaluated the participants' scholarly productivity related to these workshops. The observation period was a minimum of 2 years following the workshops.ResultsMost participants had never developed a formal clinical research protocol and voluntarily participated in the workshop. The action research was developed and implemented at nine teaching hospitals in Japan, including one university hospital. The study developed a model nine-step workshop curriculum: 1) Research question development, 2) Search strategy development, 3) Search strategy brush-up, 4) Exclusion and inclusion criteria development, 5) Risk of bias assessment planning, 6) Meta-analysis planning, 7) Subgroup and sensitivity analysis planning, 8) Planning the presentation of results, and 9) Presentation protocols. A total of 233 participants, including medical doctors and other health professionals, produced 414 research questions. Seventy-nine participants (34%) completed the workshop, and 47 review teams accomplished systematic review protocols. The participants published 13 peer-reviewed articles as a result of the workshop.ConclusionsWe developed a structured scholarly productive model workshop for healthcare staff working at hospitals. We found healthcare staff with clinical subspecialties were able to develop an unexpectedly high number of research questions through this workshop. Medical teachers at hospitals with prior systematic review experience could teach how to develop systematic review protocols using this model. Further research is needed to increase the academic productivity of such workshops.Trial registrationUMIN (https://www.umin.ac.jp/ctr/), UMIN000017107 (4/15/2015), UMIN000025580 (1/10/2017).

Project description:BackgroundControversial results have been reported regarding the impact of photobiomodulation (PBM) on orthodontically induced inflammatory root resorption (OIIRR). The aim of this study was to evaluate the influence of two PBM protocols, one of them requiring a high application frequency (on days 0, 3, 7, 14, then every 2 weeks), while the second requires less frequent applications (every 3 weeks), on OIIRR accompanying orthodontic treatment.MethodsTwenty female patients were recruited for this randomized controlled trial, requiring the therapeutic extraction of maxillary first premolars, and they were randomly divided into 2 equal groups. In Group A, one side of the maxillary arch randomly received PBM on days 0, 3, 7, 14, and every 2 weeks thereafter, while in Group B, one side was randomly chosen to receive PBM every 3 weeks. The laser applied was a Diode laser with a wavelength of 980 nm, in a continuous mode. Canine retraction in both groups was carried out using closed-coil springs, delivering 150 g of force, and the force level was checked every 3 weeks, over a 12-week study period. Pre-retraction and post-retraction cone-beam computed tomography (CBCT) was done for the evaluation of OIIRR.ResultsNo significant differences in the amount of OIIRR have been reported between the laser and control sides in both groups A and B. Also, no significant differences have been reported between the laser sides in both groups.ConclusionsPhotobiomodulation does not affect OIIRR, whether by increasing or decreasing its occurrence, with both laser application protocols. Therefore, it can be stated that PBM does not result in root resorption less than the commonly observed range elicited with conventional orthodontic treatment, and that it has no effect on OIIRR. Trial registration Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction (NCT04926389), 15/06/2021-retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04926389 .

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Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.

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Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.

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