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Epidemiol Prev ; 44(5-6 Suppl 2): 113-118, 2020.
Article in English | MEDLINE | ID: covidwho-2243433


BACKGROUND: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. OBJECTIVES: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. DESIGN: cross-sectional survey. SETTING AND PARTICIPANTS: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. MAIN OUTCOME MEASURES: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. RESULTS: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. CONCLUSIONS: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.

COVID-19 , Ethics Committees , Pandemics , Quarantine , SARS-CoV-2 , COVID-19/epidemiology , COVID-19/prevention & control , Ethics Committees/statistics & numerical data , Ethics Committees, Research , Ethics, Research , Health Care Surveys , Humans , Italy/epidemiology , Outcome Assessment, Health Care , Physical Distancing , Workload
Res Dev Disabil ; 108: 103816, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-939236


The COVID-19 pandemic imposed dramatic changes to everyone's daily routines, but especially to children with developmental disabilities. The Robert Hollman Foundation decided not to interrupt its service to all the visually impaired children and initiated a Distance Support Project. It was an online process covering all aspects of support for the children and involving audio-video calls, videos and tailored-made multisensory material created specifically for each child. A questionnaire, carried out after the 5-month project duration, was created to collect feedback from parents and professionals to understand the impact this project had on everyone involved. Overall both parents and professionals indicated high levels of satisfaction, but in a significant number of questions parents reported consistently higher levels of satisfaction (p-value <0.001). It was shown that parents felt reassured at this otherwise very difficult time because their children were able to continue their treatment, even if in a very different way. This fact encourages us to consider enriching our existing programmes of support and care, integrating this online approach when necessary. At the same time, it seems clear that the responses of the professionals indicate their belief that the benefits of the traditional ways of working remain of unquestionable importance for children with sight deprivation.

COVID-19 , Internet-Based Intervention , Patient Care Management/organization & administration , Psychosocial Support Systems , Telemedicine/methods , Visually Impaired Persons , Audiovisual Aids/trends , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/psychology , Child , Family Health/trends , Female , Humans , Male , Organizational Innovation , Parents/psychology , Patient Care Management/trends , SARS-CoV-2 , Visually Impaired Persons/psychology , Visually Impaired Persons/rehabilitation