3rd session of the Debate Forum - Clinical Research: pandemic-time procedures
On May 29, the third session of the Debate Forum dedicated to the theme "Clinical investigation: pandemic-time procedures" is held, with the intervention of Dr. Joel Passarinho, director of the clinical trials unit of Infarmed and Prof. Maria Alexandra Ribeiro, Interim President of CEIC.
This session is initiated by the project coordinator, Professor Maria do Céu Patrão Neves, who welcomes all participants and introduces the theme. Mr. Joel Passarinho begins by describing the procedures required by Infarmed with regard to conducting clinical trials in pandemic conditions. These guidelines aim to ensure that health professionals can be focused on their clinical activities and consequently simplify some procedures in the conduct of clinical trials, while ensuring the protection of participants. According to infarmed's instructions, it was left to the prosecutor's consideration in conjunction with the researchers to adopt procedures appropriate to each situation. These guidelines include, for example, the possibility of immediate suspension of clinical trials, adjustment of scheduled patient visits, remote monitoring, or even the dispensing of home study medications, among others. In the context of the Provisions of Infarmed, immediate notification is provided for in situations of interruption of the treatment of participants; in the remaining cases, a final report is requested with impact assessment to be submitted after the end of the pandemic. Then, Professor Maria Alexandra Ribeiro refers that CEIC has similar procedures, differing essentially in the need for timely notification of all changes to the conduct of the study resulting from the pandemic that would allow a regular monitoring and evaluation of the measures implemented.
2nd session of the Discussion Forum – Informed consent in pandemic time: clinical assistance and biomedical research
On May 22, the second session of the Discussion Forum takes place, this time dedicated to the theme "Informed consent in pandemic time: clinical assistance and biomedical research", with the intervention of Professor M. Patrão Neves, coordinator of the BERC-Luso Project, and Professor Maria Alexandra Ribeiro, interim President of CEIC.
The session begins to recall the realm of Informed Consent as an ethical process, which cannot be reduced to a legal act. In this context, the essence of informed consent is based on a match between professionals and patients and on the commitment of the former to listen to and meet the needs, expectations and desires of the latter. In emergency situations, such as the current pandemic, the requirements of informed consent are maintained, both in the care plan and in clinical research, in the transmission of relevant information, in listening patients/volunteers and in signing a written document. However, recognizing that it is not always possible to fully comply with all the requirements, it is emphasized that: in the care plan, alternative formats of assent should be opted for and, when not possible, the principle of beneficence prevails; in the practice of clinical research, obtaining informed consent for studies for COVID-19, given its exceptional nature of the disease, it may be acceptable to obtain informed consent by simplified means such as obtaining an oral consent, thus replacing the classic and written form usually required in the context of research. On the other hand, the ethics committee must adopt operational procedures that respond quickly, making processes more flexible, but without reducing the ethical requirements prior to the approval of the project.
BERC-Luso project organizes webinar “International best practices in pandemic times"
The pandemic situation that the world is going through has led to profound changes in all categories of individual and social activity, forcing a constant effort to adapt to new realities and respond to current needs. The BERC-Luso also follows this dynamic. In this context, BERC-Luso, faithful to its design of ethical and regulatory training in the field of biomedicine and wanting to contribute to the better response of partners to the extraordinary demands of pandemic times, organizes a thematic Debates Forum, under the common name “ Best practices in pandemic times ”.
The webinar will contain a brief thematic introduction by the person in charge of the session in question, followed by debate between all participants.
May 15(12 pm- 13pm /Lisbon)
–Community masks: manufacture, access and use -
Mr. Jorge Batista and Professor Patrão Neves
May 22 (12 pm-13 pm /Lisbon)
– Informed consent in pandemic time: clinical assistance and biomedical research -
Professor Patrão Neves and Professor Alexandra Ribeiro
May 29 (12 pm-13pm/Lisboa)
– Clinical research: pandemic-time procedures -
Mr. Rui Ivo and Professor Alexandra Ribeiro
June 5 (12pm-13pm/Lisbon)
– Clinical research and innovation -
Professor Ana Paula Martins and Professor Helder Mota Filipe
Discussion Forum - Community masks: manufacture, access and use
On May 15, the first webinar "Best International Practices in Pandemic Time" takes place, with the theme "Community masks: manufacture, access and use". The session takes place with the participation of 15 trainees of the BERC-Luso Project, and consists of a short intervention by Professor Maria do Ceu Patrão Neves, coordinator of BERC-Luso and Mr. Jorge Batista, Executive Manager of the Project BERC-Luso Project, on the use of masks in the context of the COVID-19 pandemic, followed by a debate that will count with all the participants present at the event. The intervention focuses on the differences between the numerous types of protective masks, medical devices, personal protective equipment and textile articles, their usage and indications. Subsequently, information on community masks or social masks is then presented, including their correct use, certification and widespread use in the population, including resources available in Portuguese from the Directorate-General for Health of Portugal and INFARMED.
Participants from each country can share their national experiences, regarding the national certification of these articles, the policies implemented in each country, as well as access to these products.
Finally, and responding to a previous request from the participants, a set of resources on the role of pharmacists played in the COVID-19 pandemic is shared, disseminating the Resources in Portuguese of the International Pharmaceutical Federation (FIP), consisting of health promotion material, intervention protocols and evidence material on SARS-CoV-2 infection.
BERC-Luso coordination meets with the trainees of the Republic of Angola
The BERC-Luso coordination meets on the 7th of May 2020 with the trainees of the Republic of Angola, via electronic platform, with the presence of Ms. Jocelyne Vasconcelos, Ms. Isabel Malungue and Mr. Adelino Quiteque.
The goal of the meeting is to listen to the necessities of the partner countries in this phase of combat to the new coronavírus, maintaining a link between partner countries and the BERC-Luso project.
The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, maintaining a link between partner countries and the BERC-Luso project, and to promote webinars aiming at discussing relevant topics.
BERC-Luso coordination meets with the trainees of the Republic of Guinea Bissau
The BERC-Luso coordination meets on the 6th of May 2020 with the trainees of the Republic of Guinea Bissau, via electronic platform, with the presence of Ms. Zeferina Costa, Mr. Mouhammed Ahmed and Mr. Cesário Martins.
The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, as well as maintaining contact between partner countries and the BERC-Luso project, promoting the development of thematic webinars.
BERC-Luso coordination meets with the trainees of the Republic of Cape Verde
The BERC-Luso coordination meets on the 6th of May 2020 with the trainees of the Republic of Cape Verde, via electronic platform, with the presence of Ms. Maria de Lourdes Monteiro, Ms. Lenira Centeio, Ms. Ester Oliveira, Ms. Sheila Monteiro and Ms. Maria do Céu Teixeira.
The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, as well as the promotion of webinars aiming at discussing relevant topics to all partner countries.
The BERC-Luso coordination meets with the trainees of the Democratic Republic of São Tomé e Príncipe
BERC-Luso coordination meets on the 5th of May 2020 with the trainees of the Democratic Republic of São Tomé e Príncipe, via electronic platform, with the presence of Mrs. Semôa Espírito Santo and Mr. Jeryson Ramos.
The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, as well as the promotion of webinars aiming at discussing relevant topics to all partner countries, whilst maintaining a link of communication between countries.
Conclusion of Commitment brings together partner countries of BERC-Luso, WHO and UNESCO
On the afternoon of the last day of work, on 22nd February, takes place the Commitment Celebration Session of the Training Action of the BERC-Luso Project. The main objective of this session is to celebrate the commitment of all participants from BERC-Luso partner countries, in relation to the best practices in healthcare and clinical research, to be implemented in the present and in the future, formulated under the designation of the “Declaration of Commitment ”.
The Session begins with a debate moderated by Professor Helder Mota Filipe and welcoming Mr. Andreas Reis, representative of the World Health Organization (WHO) and Professor Dafna Feinholz, representative of UNESCO. Participants from partner countries thus have the opportunity to clarify questions about the activities of these organizations and explore possible points of collaboration.
Subsequently, representatives of the BERC-Luso partner countries present the Declarations of Commitment: Mr. Mamba Sampaio (Angola), Mr. Victor Gomes (Guinea Bissau), Mrs. Telma Chicuamba (Mozambique), Mrs. Semôa Sousa (São Tomé and Príncipe), and by Cape Verde Mrs. Lenira Centeio, Mrs. Maria de Lourdes Monteiro and Professor Antonieta Martins. These Declarations of Commitment reflect a set of actions to be developed in the various countries, with the aim of improving the conditions and installed capacity for the development of biomedical research and clinical trials.
The trainees from all countries formally deliver to the WHO and UNESCO representatives, Mr. Andreas Reis and Professor Dafna Feinholz, respectively, a partnership proposal for support and training in the areas of ethical and regulatory review, as well as requesting support in concrete actions. The representatives of international institutions formally present to all training professionals a document containing a set of publications and teaching material, fundamental for the training of these professionals and their countries. The partnership between Angola, Cape Verde, Guinea Bissau, Mozambique, São Tomé and Príncipe, the World Health Organization and UNESCO, will allow the establishment of direct contact points with support for the continuation of training initiatives in the area of ethical and regulatory review in the various countries.
The Closing session is done by the Coordinator of BERC-Luso, Professor Maria do Céu Patrão Neves, and the Executive Project Manager, Mr. Jorge Batista.