Evaluation of a rapid serological test for detection of IgM and igG antibodies against SARS-CoV-2 under field conditions.

Objective: To determine the additional diagnostic performance of a rapid serological test for detection of IgM and IgG antibodies compared to the real-time polymerase chain reaction (RT-PCR) test; for detection of SARS-CoV-2.

Materials And Methods: A cross-sectional study was carried out including patients hospitalized for COVID-19 in 3 hospitals, health workers exposed to the infection and outpatients who met suspicious case criteria, all of which underwent the molecular test (RT-PCR) and the rapid serological test. The additional diagnostic performance of rapid serological test was evaluated in comparison to molecular tests.

A Missing Piece in Clinical Trial Inspections in Latin America: Interviews With Research Subjects in Peru.

Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs.

Ethical problems in health research with indigenous or originary peoples in Peru.

The varied, abrupt and amazing geography of the land of Peru is home of one of the major concentrations of indigenous peoples in the world. The asymmetry of power, however, in their relationship with the rest of society and the State is still very evident in their social exclusion, their gap in social and economic development, barriers in their access to health services as well as their marginalization and exploitation as subjects of health research. In this paper, we analyse two cases of research on indigenous populations in Peru, discuss them from the point of view of bioethics and reflect on important issues for researchers, research participants and the society, such as the need to respect different cultures, the need that the research being done is relevant to the needs of the population in which it is conducted and the necessity to empower indigenous communities in participatory research, to strengthen the institutions and to protect human rights, namely through ethics committees for research and the free, informed and meaningful informed consent.

[Strategy to strengthen health research capabilities in regional public universities: the role of the Mining Canon and the Instituto Nacional de Salud].

The development of scientific health research requires a sustained and articulated research system that is consistent with the research priorities, as well as both internal and external funding, and availability of competent human resources. The Mining Canon, a constitutional right, has been partly used to foster applied scientific research in public universities (PU). In addition, the National Health Institute (INSTITUTO NACIONAL DE SALUD - INS) is devoted, among others, to promoting, managing and disseminating health research development at a national level.

[Role of the state as regulatory authority of clinical trials in Peru].

This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory authority that has strengthened its steering and its main objective of protecting the rights, safety and welfare of human subjects in clinical trials.

[Characteristics of clinical trials authorized in Peru: 1995-2012].

Objective: To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012.

Material And Methods: Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. We performed a descriptive analysis of the states of the CT approval and other characteristics.

[Towards a national commission on health research ethics in Peru: reflections on the routes and processes comparing viewpoints].

We performed a review of the constitution processes and functions of national commissions on health research ethics in Latin America and Europe countries, which are characterized by its relation with the legislation and governmental structures in health sector, but, especially, in almost totality of cases for being linked by the functioning of the Research Ethics Committees. On the basis of this review there are realized an initial balance sheet and perspectives of the conformation of a National Commission on Health Research Ethics in Peru.