Secondary Logo

Journal Logo

Editorial

Observational study design

Extending the standard

Bhatia, Pradeep; Mohammed, Sadik

Author Information
Journal of Anaesthesiology Clinical Pharmacology: July–September 2021 - Volume 37 - Issue 3 - p 317-318
doi: 10.4103/joacp.JOACP_453_21
  • Open

Observational studies form an important part of medical research, particularly in situations where randomized controlled trials (RCT) are not feasible or are unethical. However, lately, we have observed a large increase in the number of observational studies submitted to the journal. One reason appears to be the requirement of clearance from the Institute Ethical Committee, the need to register with Clinical Trial Registry, and complying with CONSORT guidelines in interventional studies. Many studies where these requirements are not fulfilled are submitted to the journals under the guise of observational studies as it is widely believed that observational studies, particularly retrospective, are not required to follow the abovementioned processes.

The Declaration of Helsinki clearly specifies that research involving human subjects must be approved by a research ethics committee (in order to prevent the exploitation of patients) before the study commences.[1] This recommendation is strictly adhered to in an RCT, but the situation is less straightforward for an observational study (as there is no experimental intervention), and even more confusing for a retrospective observational study. There is no uniformity regarding the requirement of approval from the Ethical Committee for an observational study design among scientific journals. A few journals require it even for case reports, or case series, while others do not require it even for prospective observational studies. We are of the opinion that every research protocol must be submitted to the Ethical Committee for approval, and the correspondence letter from the Ethical Committee (even if the committee has waived off the approval) must be uploaded along with the manuscript during submission to medical journals. The recommendation by the World Association of Medical Journals states that “documented review and approval from a formally constituted review board (Institutional Review Board or Ethics Committee) should be required for all studies involving people, medical records, and human tissues. Researchers who do not have access to formal ethics review committees should adhere to the principles outlined in the Helsinki Declaration. A statement from the committee should be submitted if an observational study is exempted from ethical approval.”[2] Similarly, informed consent by participants should always be sought irrespective of the study design. The institute may have a policy to take the informed consent at the time of their treatment/admission to use the data for the scientific research so that all the retrospective observational studies have the necessary consent. In case this is not possible, the institutional review board must decide if the study is ethically acceptable.

Because there are no regulations governing the prospective registration of observational studies, their overall validity is jeopardized.[34] The rationale for the prospective registration of clinical trials[5] also applies to the registration of observational studies.[6] The most recent revision of the Declaration of Helsinki (2013) stating that “every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject” further strengthens the requirement for registration of observational studies.[1] An increasing number of clinical trial registries, including Clinical Trial Registry, India, allow prospective registration of prospective observational studies; however, there is no provision for registration of retrospective observational studies. A few journals (e.g. BMJ and Lancet) encourage or require registration of prospective observational studies for consideration for publication. Registration of all prospective observational studies is a step forward for improving transparency. However, complete transparency can be ensured by allowing registration of all types (prospective as well as retrospective) of observational studies. The Journal of Anesthesiology Clinical Pharmacology (JOACP) also encourages observational studies to be registered with Clinical Trial Registry.

Another important step toward improving the standard for observational studies is adherence to the reporting guidelines [Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)].[7] A growing number of biomedical journals endorse these guidelines and require that the authors must complete the STROBE checklist not only with page references but also with sufficient text excerpted from the manuscript to explain how they accomplished all applicable items. This requirement is clearly mentioned in the “Instructions for Authors” page of the JOACP website.[8]

The Editorial Board of the JOACP strives to improve the standards of observational studies. We request the authors/researchers to obtain ethical approval for their work, get the same registered, and follow the STROBE checklist before submitting an observational study to the journal.

1. [Last accessed on 2021 Sep 15] Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
2. [Last accessed on 2021 Sep 15] Available from: https://wame.org/recommendations-on-publication-ethics-policies-for-medical-journals
3. Dickersin K, Min YI, Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards JAMA. 1992;267:374–8
4. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research Lancet. 1991;337:867–72
5. Krleza-Jeric K, Chan AW, 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;330:956–8
6. Loder E, Groves T, Macauley D. Registration of observational studies BMJ. 2010;340:950
7. [Last accessed on 2021 Sep 15] Available from: https://www.equator-network.org/?post_type=eq_guidelines&eq_guidelines_study_design=observational-studies&eq_guidelines_clinical_specialty=0&eq_guidelines_report_section=0&s=+&eq_guidelines_study_design_sub_cat=0
8. [Last accessed on 2021 Sep 15] Available from: https://journals.lww.com/joacp/pages/instructionsforauthors.aspx
© 2021 Journal of Anaesthesiology Clinical Pharmacology | Published by Wolters Kluwer – Medknow