BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//IBSAL - ECPv6.17.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:IBSAL
X-ORIGINAL-URL:https://ibsal.es/en/
X-WR-CALDESC:Events for IBSAL
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:UTC
BEGIN:STANDARD
TZOFFSETFROM:+0000
TZOFFSETTO:+0000
TZNAME:UTC
DTSTART:20250101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20260211
DTEND;VALUE=DATE:20260312
DTSTAMP:20260123T092047Z
CREATED:20260123T092047Z
LAST-MODIFIED:20260123T092047Z
UID:25252-1770768000-1773273599@ibsal.es
SUMMARY:AES 2026 - Independent Clinical Research Projects 2026
DESCRIPTION:Purpose\nThe purpose of this initiative\, launched by the Carlos III Health Institute (ISCIII)\, is to promote independent clinical research involving drugs for human use and/or advanced therapies by funding projects not sponsored by the pharmaceutical industry. \nProjects of proven quality aimed at conducting clinical trials with drugs for human use and/or advanced therapies (defined as gene therapy\, cell therapy\, or tissue engineering) that lead to tangible improvements for patients and provide evidence to health authorities for their implementation in the National Health System (SNS). Active pharmaceutical ingredients that are currently under protection (patent or data protection) and have a single marketing authorization holder are expressly excluded.  \nProject content must relate to the following priority thematic areas: \n\nClinical research involving advanced therapies\, where the patent—if any—is majority-owned by an entity within the National Health System\, including cell therapy\, gene therapy\, and tissue engineering.\nClinical research on orphan drugs.\nClinical research and studies on the therapeutic or diagnostic repurposing of drugs.\nClinical research aimed at reducing antibiotic resistance.\nClinical research with drugs in special populations\, particularly in the pediatric population or populations that are underrepresented in commercial clinical trials.\nClinical research on approved drugs under real-world conditions\, including pharmacoepidemiological and clinical safety studies.\nClinical research and comparative studies of medications in the context of control strategies\, with an impact on public health for the National Health System (SNS).\nClinical trials\, including pharmacogenetic studies\, aimed at identifying populations with varying degrees of response—in terms of efficacy and/or safety—to drugs of clinical and therapeutic relevance in healthcare practice.\n\nThe projects submitted must be clinical trials in the field of independent clinical research\, preferably in phases I\, II\, or III; however\, other types of clinical trials may also be funded\, including those that require completion of the final phases of the preclinical stage prior to the start of the clinical trial\, if adequately justified. \nIn general\, research projects may be submitted under one of the following categories: \n\nIndividual projects: Submitted by an applicant institution and to be carried out at a single site by a research team led by one or two principal investigators (PI and Co-PI) who are civil servants\, statutory employees\, or staff members of the applicant institution.\nMulticenter projects: Conducted in accordance with a single protocol at more than one site. Each project will have a team and will be led by one or two principal investigators (PI and co-PI). For this type of project\, applicants may choose one of the following options:\n\nMulticenter study design with a single grant recipient institution. Submission of a single application by the institution to which the principal investigator(s) (PI and co-PI\, if applicable) are affiliated\, who act as project coordinators\, with all collaborating researchers listed as part of the same team\, regardless of the institution from which they participate.\nMulticenter study design involving several grant-receiving centers. Each participating center must submit an application\, with one or two principal investigators (PI and co-PI\, as applicable) and a research team for each application submitted. One of the projects will also serve as the coordinator\, and its PI or\, where applicable\, its two PIs\, will be responsible for the scientific coordination and oversight of the project as a whole. \n\n\n\nSpecial consideration will be given to projects led by two principal investigators who indicate in their application report their intention to initiate a leadership transition process between the two\, with one being a senior researcher and the other a young researcher. In these projects\, the co-PI will be the senior researcher\, while the PI will be the person to whom the transition is being made; both CVs will be given equal weight during the evaluation.  \nClinical trials requested through the CIBER will only be eligible for the multicenter project category if they have a single beneficiary center and must include researchers from at least two CIBER thematic areas. \n  \nRequirements\nRequirements for applicants: \n\n\n\n\nThe following may be eligible for this program: \n\nHealth research institutes accredited by ministerial order (IIS).\nPublic health entities and institutions with clinical assistance activities.\nPublic health entities and institutions without a health activity license\, but with demonstrable R+D+I activity in the area of knowledge of Public Health.\nPrivate healthcare entities and institutions that are licensed to provide healthcare services and are affiliated with or have agreements with the National Health System (SNS).\nThe OPIs (Public Research Organizations).\nPublic universities and private universities with proven R&D capacity and activity.\nState-level technology centers and state-level centers for supporting technological innovation that are registered in the Registry of Centers established by Royal Decree 2093/2008\nOther public R&D\, research and knowledge dissemination centers and research infrastructures\, with their own legal personality\, linked to or dependent on the General State Administration or the rest of the Public Administrations and their agencies.\nPublic and private non-profit entities that carry out and/or manage R&D activities\, generate scientific or technological knowledge or facilitate its application and transfer.\nPublic consortia and state public consortia with R&D&I activities in Biomedicine or Health Sciences and Technologies.\nOther units of the health administration\n\nIn the projects submitted\, the role of sponsor must rest exclusively and solely with the managing entity of the applicant institution; projects or clinical trials in which the sponsor is a researcher are expressly excluded\, regardless of whether the researcher holds this position individually or even as a co-sponsor with the applicant center. \n  \nPI requirements: \n\n\n\nHave a formal civil service\, statutory\, or employment relationship with the applying institution or the institution where the project will be carried out. The research institution must engage in clinical and patient care activities or have demonstrable capacity so that\, in the absence of the former\, there are no limitations on the project’s implementation. Special consideration will be given to projects led or co-led by researchers engaged in clinical and patient care activities who were born in 1981 or later.  \nNot currently enrolled in a Specialized Health Training (FSE) program\, not under a pre-doctoral training contract\, and not employed as part of a research project.\nNot be the principal investigator of a project that has received funding through the grant calls for Independent Clinical Research Projects in 2023\, 2024\, or 2025.\n\n\nRequirements for Researchers\n\n\nAll members of the research team must have a formal civil service\, statutory\, employment\, or paid training relationship with any of the entities eligible to submit applications for this initiative for at least the entire period between the deadline for submitting applications and the final decision on the award.\nParticipation in the projects covered by this initiative will be compatible with submitting applications and participating in other PEICTI calls for proposals.\nNo researcher acting as the sponsor of the clinical trial that is the subject of this action may apply for this call for proposals; the role of co-sponsor is expressly excluded.\nResearchers participating in this initiative may not be listed on more than one application.\n\n\n\n\n\n  \nApplication\nApplications and all other required documentation must be submitted exclusively through the  ISCIII’s online portal.   \nApplications must be accompanied by the following documentation: \n\nApplication Form. A single application must be submitted for each project proposed. For multicenter projects with multiple beneficiary centers\, a complete application must be submitted for each of the\nsubprojects.  \nResearch project report using exclusively the standardized form corresponding to AES 2026\, completed in English or Spanish. For multicenter projects with multiple participating centers\, a complete application must be submitted for each subproject. \nAbbreviated Curriculum Vitae (CVA)\, automatically generated by the FECYT’s CVN editor for the principal investigator or principal investigators in applicable projects (applications with a principal investigator and co-principal investigators). Once completed—in either Spanish or English—it must be attached to the application via the online system. \nResearch track record of the research teams\, completed in English or Spanish.\nAll clinical and healthcare centers participating in the project that is the subject of this application and that are not directly publicly owned must submit a commitment signed by their legal representative\, which must include an obligation not to bill participating patients for any type of service\, including emergency care\, unscheduled or unforeseen care\, regardless of the nature of such care\, as well as a commitment to inform participating patients of this requirement. There must be an explicit reference to this commitment in the patient information sheet. \nA commitment issued by the applicant organization and signed by its legal representative\, in which the organization assumes the unequivocal obligation to act as the sole sponsor of the clinical trial should the grant that is the subject of this action be awarded.\nIn multicenter projects involving multiple participating centers\, the standard-format coordination report must also be completed.\n\n  \nCall for Applications Guidelines\nThe complete terms and conditions of the call for applications can be viewed by clicking  here. \n  \n 
URL:https://ibsal.es/en/evento/aes-2026-independent-clinical-research-projects-2026/
CATEGORIES:Calls for research
END:VEVENT
END:VCALENDAR