TY - JOUR
T1 - Retrospective observational studies
T2 - Lights and shadows for medical writers
AU - International Network of Clinicians for Endocrinopathies in Thalassemia Adolescence Medicine (ICET-A)
AU - de Sanctis, Vincenzo
AU - Soliman, Ashraf T.
AU - Daar, Shahina
AU - Tzoulis, Ploutarchos
AU - Fiscina, Bernadette
AU - Kattamis, Christos
AU - Banchev, Atanas
AU - Stoyanova, Denka
AU - Angastiniotis, Michael
AU - Christou, Soteroula
AU - Elsedfy, Heba
AU - El Kholy, Mohamed
AU - Khater, Doaa
AU - Kattamis, Antonis
AU - Delaporta, Polyxeni
AU - Bozorgi, Haleh
AU - Karimi, Mehran
AU - Campisi, Saveria
AU - Di Maio, Salvatore
AU - Fortugno, Carmelo
AU - Concetta, Maria
AU - Raiola, Giuseppe
AU - Al Jaouni, Soad K.
AU - Wali, Yasser
AU - Yassin, Mohamed A.
AU - Corrons, Joan Lluis Vives
AU - Kottahachchi, Dulani
AU - Canatan, Duran
N1 - Publisher Copyright:
© Mattioli 1885.
PY - 2022/10/26
Y1 - 2022/10/26
N2 - A retrospective study (by definition non-interventional) is a purely observational review and/ or reassessment of database records with the aim of analyzing previous events of interest. The ethical and scientific standards for conducting biomedical research with humans have been established in international guidelines. Nevertheless, the reporting of ethical considerations in human research is not yet agreed upon globally, although some progress has been made in recent years. If a study has been granted exemption from ethics approval, this should be indicated in the manuscript (including the reasons for the exemption) and, if formal review by an ethics committee is not available, a statement should be included indicating that the research was conducted according to the principles of the Declaration of Helsinki. Editors play an important role in adherence to these ethical requirements for all submitted and published research papers in their journals. This short review paper focuses on the main lights and shadows of ethical aspects for conducting retrospective observational studies in humans and implications for medical writers. (www.actabiomedica.it).
AB - A retrospective study (by definition non-interventional) is a purely observational review and/ or reassessment of database records with the aim of analyzing previous events of interest. The ethical and scientific standards for conducting biomedical research with humans have been established in international guidelines. Nevertheless, the reporting of ethical considerations in human research is not yet agreed upon globally, although some progress has been made in recent years. If a study has been granted exemption from ethics approval, this should be indicated in the manuscript (including the reasons for the exemption) and, if formal review by an ethics committee is not available, a statement should be included indicating that the research was conducted according to the principles of the Declaration of Helsinki. Editors play an important role in adherence to these ethical requirements for all submitted and published research papers in their journals. This short review paper focuses on the main lights and shadows of ethical aspects for conducting retrospective observational studies in humans and implications for medical writers. (www.actabiomedica.it).
KW - Ethical Committee
KW - exemption
KW - human
KW - ICET-A survey
KW - international variation
KW - low-risk research
KW - Retrospective studies
KW - Informed Consent
KW - Medical Writing
KW - Humans
KW - Biomedical Research
KW - Retrospective Studies
UR - http://www.scopus.com/inward/record.url?scp=85141130846&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85141130846&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/d28fb426-982a-30bb-8a58-70d5b3a9f884/
U2 - 10.23750/abm.v93i5.13179
DO - 10.23750/abm.v93i5.13179
M3 - Review article
C2 - 36300226
AN - SCOPUS:85141130846
SN - 0392-4203
VL - 93
JO - Acta Biomedica
JF - Acta Biomedica
IS - 5
M1 - e2022319
ER -
