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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Guidance on the assessment of the biological relevance of data in scientific assessments
AU - Hardy, Anthony
AU - Benford, Diane
AU - Halldorsson, Thorhallur
AU - Jeger, Michael John
AU - Knutsen, Helle Katrine
AU - More, Simon
AU - Naegeli, Hanspeter
AU - Noteborn, Hubert
AU - Ockleford, Colin
AU - Ricci, Antonia
AU - Rychen, Guido
AU - Schlatter, Josef R
AU - Silano, Vittorio
AU - Solecki, Roland
AU - Turck, Dominique
AU - Younes, Maged
AU - Bresson, Jean-Louis
AU - Griffin, John
AU - Hougaard Benekou, Susanne
AU - van Loveren, Henk
AU - Luttik, Robert
AU - Messean, Antoine
AU - Penninks, André
AU - Ru, Giuseppe
AU - Stegeman, Jan Arend
AU - van der Werf, Wopke
AU - Westendorf, Johannes
AU - Woutersen, Rudolf Antonius
AU - Barizzone, Fulvio
AU - Bottex, Bernard
AU - Lanzoni, Anna
AU - Georgiadis, Nikolaos
AU - Alexander, Jan
PY - 2017/8
Y1 - 2017/8
N2 - Abstract EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered.
AB - Abstract EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered.
KW - biological relevance
KW - adverse effect
KW - beneficial effect
KW - size of the effect
KW - nature of the effect
KW - scientific assessment
U2 - 10.2903/j.efsa.2017.4970
DO - 10.2903/j.efsa.2017.4970
M3 - Journal article
VL - 15
JO - EFSA Journal
JF - EFSA Journal
SN - 1831-4732
IS - 8
M1 - 04970
ER -