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Guidance on the assessment of the biological relevance of data in scientific assessments

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Guidance on the assessment of the biological relevance of data in scientific assessments. / Hardy, Anthony; Benford, Diane; Halldorsson, Thorhallur; Jeger, Michael John; Knutsen, Helle Katrine; More, Simon; Naegeli, Hanspeter; Noteborn, Hubert; Ockleford, Colin; Ricci, Antonia; Rychen, Guido; Schlatter, Josef R; Silano, Vittorio; Solecki, Roland; Turck, Dominique; Younes, Maged; Bresson, Jean-Louis; Griffin, John; Hougaard Benekou, Susanne; van Loveren, Henk; Luttik, Robert; Messean, Antoine; Penninks, André; Ru, Giuseppe; Stegeman, Jan Arend; van der Werf, Wopke; Westendorf, Johannes; Woutersen, Rudolf Antonius; Barizzone, Fulvio; Bottex, Bernard; Lanzoni, Anna; Georgiadis, Nikolaos; Alexander, Jan.

In: EFSA Journal, Vol. 15, No. 8, 04970, 08.2017.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Hardy, A, Benford, D, Halldorsson, T, Jeger, MJ, Knutsen, HK, More, S, Naegeli, H, Noteborn, H, Ockleford, C, Ricci, A, Rychen, G, Schlatter, JR, Silano, V, Solecki, R, Turck, D, Younes, M, Bresson, J-L, Griffin, J, Hougaard Benekou, S, van Loveren, H, Luttik, R, Messean, A, Penninks, A, Ru, G, Stegeman, JA, van der Werf, W, Westendorf, J, Woutersen, RA, Barizzone, F, Bottex, B, Lanzoni, A, Georgiadis, N & Alexander, J 2017, 'Guidance on the assessment of the biological relevance of data in scientific assessments', EFSA Journal, vol. 15, no. 8, 04970. https://doi.org/10.2903/j.efsa.2017.4970

APA

Hardy, A., Benford, D., Halldorsson, T., Jeger, M. J., Knutsen, H. K., More, S., Naegeli, H., Noteborn, H., Ockleford, C., Ricci, A., Rychen, G., Schlatter, J. R., Silano, V., Solecki, R., Turck, D., Younes, M., Bresson, J-L., Griffin, J., Hougaard Benekou, S., ... Alexander, J. (2017). Guidance on the assessment of the biological relevance of data in scientific assessments. EFSA Journal, 15(8), [04970]. https://doi.org/10.2903/j.efsa.2017.4970

Vancouver

Hardy A, Benford D, Halldorsson T, Jeger MJ, Knutsen HK, More S et al. Guidance on the assessment of the biological relevance of data in scientific assessments. EFSA Journal. 2017 Aug;15(8). 04970. https://doi.org/10.2903/j.efsa.2017.4970

Author

Hardy, Anthony ; Benford, Diane ; Halldorsson, Thorhallur ; Jeger, Michael John ; Knutsen, Helle Katrine ; More, Simon ; Naegeli, Hanspeter ; Noteborn, Hubert ; Ockleford, Colin ; Ricci, Antonia ; Rychen, Guido ; Schlatter, Josef R ; Silano, Vittorio ; Solecki, Roland ; Turck, Dominique ; Younes, Maged ; Bresson, Jean-Louis ; Griffin, John ; Hougaard Benekou, Susanne ; van Loveren, Henk ; Luttik, Robert ; Messean, Antoine ; Penninks, André ; Ru, Giuseppe ; Stegeman, Jan Arend ; van der Werf, Wopke ; Westendorf, Johannes ; Woutersen, Rudolf Antonius ; Barizzone, Fulvio ; Bottex, Bernard ; Lanzoni, Anna ; Georgiadis, Nikolaos ; Alexander, Jan. / Guidance on the assessment of the biological relevance of data in scientific assessments. In: EFSA Journal. 2017 ; Vol. 15, No. 8.

Bibtex

@article{1c5a804d8a734a419f460518eb6f2c99,
title = "Guidance on the assessment of the biological relevance of data in scientific assessments",
abstract = "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.",
keywords = "biological relevance, adverse effect, beneficial effect, size of the effect, nature of the effect, scientific assessment",
author = "Anthony Hardy and Diane Benford and Thorhallur Halldorsson and Jeger, {Michael John} and Knutsen, {Helle Katrine} and Simon More and Hanspeter Naegeli and Hubert Noteborn and Colin Ockleford and Antonia Ricci and Guido Rychen and Schlatter, {Josef R} and Vittorio Silano and Roland Solecki and Dominique Turck and Maged Younes and Jean-Louis Bresson and John Griffin and {Hougaard Benekou}, Susanne and {van Loveren}, Henk and Robert Luttik and Antoine Messean and Andr{\'e} Penninks and Giuseppe Ru and Stegeman, {Jan Arend} and {van der Werf}, Wopke and Johannes Westendorf and Woutersen, {Rudolf Antonius} and Fulvio Barizzone and Bernard Bottex and Anna Lanzoni and Nikolaos Georgiadis and Jan Alexander",
year = "2017",
month = aug,
doi = "10.2903/j.efsa.2017.4970",
language = "English",
volume = "15",
journal = "EFSA Journal",
issn = "1831-4732",
publisher = "John Wiley & Sons, Ltd",
number = "8",

}

RIS

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 -