Volume 26, Issue 3 - Observational Studies
Registration and ethics committee approval for observational studies: Current status and way forward
Abstract
Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer such questions as they are based upon real data obtained from patient healthcare records, medical databases, and registries. Literature review has shown that observational studies are as important as RCTs and should be considered when making any clinical decisions. However, there is a lack of standard guidelines for registering and reporting observational studies, which may contribute to publication and reporting bias. Furthermore, guidelines differ on the ethical considerations for observational studies. This article discusses these issues, focusing on the current situation and gaps in the registration, ethics approval, and publication of observational studies.
Download the full article
References
-
Song JW, Chung KC. Observational studies: cohort and case-control studies. Plast Reconstr Surg 2010;126:2234-42.
Available from: http://
-
Silverman SL. From randomized controlled trials to observational studies. Am J Med 2009;122:114-20.
Available from: http://
-
Mariani AW, Pêgo-Fernandes PM. Observational studies: why are they so important? Sao Paulo Med J 2014;132:1-2.
Available from: http://
-
Schillaci G, Battista F, Pucci G. Are observ - ational studies more informative than randomized controlled trials in hypertension? Con side of the argu ment. Hypertension 2013;62:470-6.
Available from: http://
-
Benson K, Hartz AJ. A comparison of observational studies and randomised, controlled trials. N Engl J Med 2000;342:1878-86.
Available from: http://
-
Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-92.
Available from: http://
-
Grant WB. Using findings from observational studies to guide vitamin D randomized controlled trials. J Intern Med 2015;277:83-6.
Available from: http://
-
Faraoni D, Schaefer ST. Randomized controlled trials vs. observational studies: why not just live together? BMC Anesthesiol 2016;16:102.
Available from: http://
-
Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv 2008;1:211-7.
Available from: http://
-
FDA. Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine). 2017 [cited 2017 June 07]. Available from:
Available from: https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070263
-
Morton SC, Costlow MR, Graff JS, Dubois RW. Standards and guidelines for observational studies: quality is in the eye of the beholder. J Clin Epidemiol 2016;71:3-10.
Available from: http://
-
AHRQ Methods for Effective Health Care. Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, editors. Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 [cited 2017 June 07]. Available from:
Available from: https://www.ncbi.nlm.nih.gov/pubmed/23469377
-
Berger ML, Martin BC, Husereau D et al. A questionnaire to assess the relevance and credibility of observational studies to inform health care decision making: an ISPOR-AMCP-NPC good practice task force report. Value Health 2014;17:143-56.
Available from: http://
-
The European Network of Centres for Pharmacoepidemiology and Pharma - covigilance (ENCePP). ENCePP Checklist for study protocols (revision 3). 2017 [cited 2017 June 07]. Available from:
Available from: http://www.encepp.eu/encepp/openAttachment/methodologicalDeclaration/19034;jsessionid=8FX83-nDtJBQU68dzHjDZj-TG4Z_eH1Qto6W0iqP5tEamNws3gbL!298584184
-
The European Network of Centres for Pharmacoepidemiology and Pharma - covigilance (ENCePP). Guide on Methodological Standards in Pharma - coepidemiology (revision 5). 2017 [cited 2017 June 07]. Available from:
Available from: http://www.encepp.eu/standards_and_guidances/documents/ENCePPGuideofMethStandardsinPE_Rev5.pdf
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment. 2007 [cited 2017 June 07]. Available from:
Available from: https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126834.pdf
-
Dreyer NA, Velentgas P, Westrich K, Dubois R. The GRACE checklist for rating the quality of observational studies of comparative effectiveness: a tale of hope and caution. J Manag Care Spec Pharm 2014;20:301-8.
Available from: http://
-
The GRACE Initiative. GRACE principles: Good ReseArch for Comparative Effectiveness. 2017 [cited 2017 June 07]. Available from:
Available from: https://www.pharmacoepi.org/pub/1c29f69f-2354-d714-5100-1ef2b0e9abd9
-
Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomised studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report – Part I. Value Health 2009;12:1044-52.
Available from: http://
-
Patient-Centered Outcomes Research Institute (PCORI). PCORI Methodology Standards. 2017 [cited 2017 June 07]. Available from:
Available from: http://www.pcori.org/research-results/about-our-research/research-methodology/pcorimethodology-standards
-
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191-4.
Available from: http://
-
Loder E, Groves T, MacAuley D. Registration of observational studies. BMJ. 2010;340(2):c950.
-
ClinicalTrials.gov. FDAAA 801 Requirements. 2017 [cited 2017 June 07]. Available from:
Available from: https://clinicaltrials.gov/ct2/manage-recs/fdaaa
-
Williams RJ, Tse T, Harlan WR, Zarin DA. Registration of observational studies: is it time? CMAJ 2010;182:1638-42.
Available from: http://
-
ClinicalTrials.gov. ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies. 2017 [cited 2017 June 07]. Available from:
Available from: https://prsinfo.clinicaltrials.gov/definitions.html
-
The European Network of Centres for Pharmacoepidemiology and Pharma - covigilance (ENCePP). The European Union electronic Register of Post- Authorisation Studies (EU PAS Register). 2017 [cited 2017 June 07]. Available from:
Available from: http://www.encepp.eu/encepp_studies/indexRegister.shtml
-
Boccia S, Rothman KJ, Panic N et al. Registration practices for observational studies on ClinicalTrials.gov indicated low adherence. J Clin Epidemiol 2016;70: 176-82.
Available from: http://
-
Rasmussen LS, Gisvold SE, Wisborg T. Ethics Committee approval for observational studies. Acta Anaesthesiol Scand 2014;58:1047-8.
Available from: http://
-
Perlman M. Ethical issues in ‘observational research’. Paediatr Child Health 2000;5:89- 90.
Available from: http://
-
Kıraç FS. Is Ethics Approval Necessary for all Trials? A Clear But Not Certain Process. Mol Imaging Radionucl Ther. 2013;22(3):73-5.
Available from: http://
-
Orchard J. For debate: should observational clinical studies require ethics committee approval? J Sci Med Sport 2008;11:239-42.
Available from: http://
-
Moser B, Röggla G. Should observational clinical studies require ethics committee approval? J Sci Med Sport 2008;11:518.
Available from: http://
-
Claudot F, Alla F, Fresson J, Calvez T, Coudane H, Bonaïti-Pellié C. Ethics and observational studies in medical research: various rules in a common framework. Int J Epidemiol 2009;38:1104-8.
Available from: http://
-
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 2007;147:573-7.
Available from: http://
-
International Committee of Medical Journal Editors (ICMJE). Preparing for Submission. 2016 [cited 2017 June 07]. Available from:
Available from: http://www.icmje.org/recommendations/browse/manuscriptpreparation/preparing-for-submission.html#d
-
The BMJ. Ethics approval of research. 2017 [cited 2017 June 07]. Available from:
Available from: http://www.bmj.com/aboutbmj/resources-authors/formspolicies-andchecklists/ethics-approvalresearch
-
The JAMA Network. Instructions for Authors. 2017 [cited 2017 June 07]. Available from:
Available from: http://jamanetwork.com/journals/jama/pages/instructions-for-authors
-
PLOS ONE. Submission Guidelines. 2017 [cited 2017 June 07]. Available from:
Available from: http://journals.plos.org/plosone/s/submission-guidelines#loc-observationaland-field-studies
-
The Lancet. Instructions for Authors. 2017 [cited 2017 June 07]. Available from:
Available from: http://www.thelancet.com/pb/assets/raw/Lancet/authors/lancet-information-forauthors.pdf
-
Springer. Publishing ethics. 2017 [cited 2017 June 07]. Available from:
Available from: https://www.springer.com/gp/authorseditors/journal-author/journal-authorhelpdesk/publishing-ethics/14214
-
Committee on Publication Ethics (COPE). Ethics committee approval. 2015 [cited 2017 June 07]. Available from:
Available from: https://publicationethics.org/case/ethicscommittee-approval
-
Committee on Publication Ethics (COPE). Seeking retrospective ethics approval. 2011 [cited 2017 June 07]. Available from:
Available from: https://publicationethics.org/case/seeking-retrospective-ethics-approval