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Conflict of
interest
Objective
Work Plan
Young
researchers
Achivemen
t Research
group
Uni /
multicenter
study
RESEARCH TEAM
DEVELOPMENT
RESULTS AND
DISSEMINATION
Incidents
Paper
Safety
Folow up
report
Interpretation
Analysis
Recruitment
Privacy
policy
Funding
Biological
samples
Budget
Subject
Informatio
n sheet
Disseminati
on plan
Researchers
Commitment
ETHICAL/LEGAL
Review
Translati
on
IMPLEMENTATION
Statistical
Plan
Impact
assessment
Patients
opinion
Priority
area
Patients
APPROVALS
Clinician
opinion
PRELIMINARY REPORT
RESEARCH TRAINING ACCREDITATION
Bias
DATA SHARING
Evidence
EQUATOR CHECK UP
Data
collection
PROTOCOL FILE
METHODOLOGICAL
DESIGN
RESEARCH QUESTION
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
GOOD RESEARCH PRACTICE TRAINING ACCREDITATION
Rationale: Good Clinical Practice recommendations indicate that all the health professionals must be trained for every
aspect of their work, including research. Clinical research may involve risk to participants.
Research Unit actions: Principal Investigators of a new project must have “IP Txartela” (PI card). It will be given if they
have a large experience or they attend the following courses: “Ethical and legal issues in biomedical research” and
“Good Practice for data management workshop”
Information: Clinical Research Training Program, secretary at Araba Research Unit :
[email protected]
1 General Medical Council (2013) Good medical practice. www.gmc-uk.org/gmp
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
PRELIMINARY REPORT
Rationale: the relevance and suitability of the research question and the background of the research team must be the
key point of the adequacy of the study. This may be helpful as a first step to elaborate the research report in order to
get financial support or future publication.
Research Unit actions: a) To create a template for the preliminary report; b) Check and register reports.
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
PROTOCOL REGISTRY
Rationale: it is believed that registry of clinical trials may reduce the risk of selective publication and increase
transparency in research, thus both funding agencies and journal editors and managers are demanding registration of
research1. Recently, new empirical evidence has been published that suggests inverse association between study
registration and positive findings2. Although the greatest part of available evidence refers to clinical trials, there is no
reason to think this could not be applied to other type of studies.
Research Unit actions: a) To elaborate a template for presenting any type of study; b) To write a complete research
report following Araba Research Unit template or, if applicable, using available guidelines: SPIRIT –clinical trials,
PRISMA-P –systematic reviews; c) Registry of research protocol and/or report in Araba Research Unit, leaving proof of
date and last version; d) Registry in clinicaltrials.com or other similar approved registries.
1 Krleza-Jerić K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from
human trials of health related interventions: Ottawa statement (part 1). BMJ. 2005;330 (7497):956-958.
2 Emdin C, Odutayo A, Hsiao A, Shakir M, Hopewell S, Rahimi K, Altman D. Association of Cardiovascular Trial Registration With Positive Study
Findings: Epidemiological Study of Randomized Trials (ESORT). JAMA Int Med. 2014. Published online December 29, 2014
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
LAW REQUIREMENTS
Rationale: biomedical research with human beings is regulated by a complex legal and ethical framework in order to
protect research participants. Clinical Research Ethical Committees guarantee that research is conducted applying
ethical regulations. In Alava region, these committees are Araba University Hospital Clinical Research Ethical
Committee and Basque Country Clinical Research Ethical Committee.
Research Unit actions: a) To verify all required permissions are applied for according to the study scope and type of
research design; b) if necessary, to advice with process paperwork.
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
EQUATOR STATEMENT AND APPROVAL OF RESEARCHERS
Rationale: Although it has been discussed in the ‘preparation of the study’ stage, the tasks undertaken by each team
member have to be updated and therefore, so have the roles regarding the authorship. This implies rechecking the
ICMJE authorship criteria. For authorship to be considered, it is necessary to: 1) substantially contribute to the
conception and design, data collection, or analysis and interpretation; 2) contribute to the manuscript or to critically
revise it with a relevant intellectual component; 3) give final approval of the version to be published. Prior to
submission each author should check for correctness of its name, initials, affiliation…
Research Unit actions: a) Declaration of the PI of having filtered and adequated the manuscript to the criteria of the
corresponding EQUATOR statement; b) Archive the manuscript provided with version number and signed approval of
all the researchers.
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
DATA SHARING
Rationale: The sharing of data from clinical studies will accelerate new discoveries avoiding, for example, study
duplication and will optimize the profit devived from the effort of researchers. There are also some risks and
challenges such as maintaining the privacy of the participants, protecting the rights of the promoters or guaranteeing
the validity of subsequent studies1. According to the report of the IOM, these principles should be followed: 1) to
maximize the benefits of the clinical studies while minimizing the risks of information sharing; 2) to respect the rights
of the participants; 3) to increase the confidence of public opinion in public research; 4) to share the data in a
reasonable and transparent manner.
Research Unit actions: a) Raw data from study’s main article will be hosted in the research unit (RU) and will be
available to researchers upon request for a maximum period of six months after publication; b) All the data collected
during the study will be hosted in the RU and will be available to researchers upon request after a maximum period of
18 months after completion of the study; c) The RU will host all the documents generated throughout the course of
the study which may contain information necessary for optimal understanding of the research and for an unbiased
interpretarion of findings. This encompasses documents not routinelly available such as reports submitted to
committees or regulatory agencies to justify the study, or the reviews made by the journals to which manuscripts
about the study have been sent.
1 Institute
of Medicine (IOM). 2015. Sharing clinical trial data: Maximizing benefits, minimizing risk. Washington, DC: The National Academies Press
et al.: Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers.
Trials 2010 11:9.
2 Hrynaszkiewicz
RESEARCH TEAM
RESEARCH QUESTION
METHODOLOGY
ETHICS/ LEGAL
FIELD WORK
RESULTS &
DISSEMINATION
IMPLEMENTATION OF FINDINGS
Rationale: The strategy to implement the findings into the practice should consider, at the very least, the following
aspects: the key audiences for the research, the implementation outcome variables, the implementation strategies
that will support the delivery of health services.1
Research Unit actions: a) Rating joint research-innovation-BIOEF-OSTEBA alternatives for optimal implementation of
the research results; b) Implementation of the procedures for legal protection of research results and, where
appropriate, of the products corresponding transfer.
1 Peters
DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: what it is and how to do it. BMJ 2013;347:f6753 doi: 10.1136/bmj.f6753
(Published 20 November 2013)