Incomplete ethical statements were included in the published version of the following articles that appeared in previous issues of Gastro Hep Advances.
The appropriate ethical information, provided by the Authors, are included below:
1. “Impact of the Sessile Serrated Polyp Pathway on Predicted Colorectal Cancer Outcomes” [Gastro Hep Advances, 2022;1(1): 55-62] https://doi.org/10.1016/j.gastha.2021.10.007
Additional Ethical Information: This manuscript was based on a computer simulation model which used inputs from the published literature and did not involve any human subjects (no living individuals, no identifiable private information, nor identifiable biospecimens). As such, this work meets exemption criteria under HHS OHRP 45 CFR 46 and is not considered human subjects research.
2. “Enabling Transition Service Delivery in a General Gastroenterology Clinic via the Electronic Health Record and System Supports” [Gastro Hep Advances, 2022;1(1): 4-6] https://doi.org/10.1016/j.gastha.2021.08.002
Additional Ethical Information: This project was a Quality Improvement project and was deemed exempt by our IRB.
3. “Increasing Incidence of Intrahepatic Cholangiocarcinoma Relative to Hepatocellular Carcinoma in the United States” [Gastro Hep Advances, 2022;1(2): 121-124] https://doi.org/10.1016/j.gastha.2021.10.010
Additional Ethical Information: The study was exempted from Institutional Review Board review since it involved the analysis of a de-identified dataset.
4. “Systemic Activin Is Elevated in Patients With Severe Alcoholic Hepatitis” [Gastro Hep Advances, 2022;1(2): 147-149] https://doi.org/10.1016/j.gastha.2021.12.004
Additional Ethical Information: For the AUD and control samples: The protocol was approved by the Ethics Committee of the University of California San Diego. Patients were enrolled after written informed consent was obtained from each patient.
For the sAH STOPAH: The trial was conducted and reported with fidelity to the protocol, the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended in 2006, the European Union Clinical Trials Directive (Directive 2001/20/EC) guidelines, the principles of the International Conference on Harmonisation Good Clinical Practice under the oversight of University Hospital Southampton NHS Foundation Trust, and the provisions of the Declaration of Helsinki. The written informed consent from each patient was obtained or from their legal representative until such time as the patient recovered mental capacity.
5. “Avoidant/Restrictive Food Intake Disorder Characteristics and Prevalence in Adult Celiac Disease Patients” [Gastro Hep Advances, 2022;1(3): 321-327] https://doi.org/10.1016/j.gastha.2022.01.002
Additional Ethical Information: This study was IRB approved by the Vanderbilt Medical Center IRB. IRB approval number 201859.
6. “Master Transcription Regulators and Transcription Factors Regulate Immune-Associated Differences Between Patients of African and European Ancestry With Colorectal Cancer” [Gastro Hep Advances, 2022;1(3): 328-341] https://doi.org/10.1016/j.gastha.2022.01.004
Additional Ethical Information: As the study only used data from published sources (the cancer genome atlas) which is freely available for anyone to download and analyze, no ethical approval was required.
7. “Association of Pancreatic Fatty Infiltration With Age and Metabolic Syndrome Is Sex-Dependent” [Gastro Hep Advances, 2022;1(3): 344-349] https://doi.org/10.1016/j.gastha.2022.01.007
Additional Ethical Information: ORA #: 22020806-IRB01. An exemption was granted in accordance with 45 CFR 46.104(d)(4).
8. “Complexity of Secretory Chemokines in Human Intestinal Organoid Cultures Ex Vivo” [Gastro Hep Advances, 2022;1(3): 457-460] https://doi.org/10.1016/j.gastha.2022.02.009
Additional Ethical Information: Study design and protocols were approved by the Emory University Institutional Review Board committee.
9. “Truncating SOX9 Alterations Are Heterozygous Null Alleles in Genome-Stable Colorectal Cancer” [Gastro Hep Advances, 2022;1(5): 709-713] https://doi.org/10.1016/j.gastha.2022.04.011
Additional Ethical Information: The study was approved by the Howard University IRB, approval number 12-CMED-76.
10. “Histopathological Features of Monogenic Inflammatory Bowel Disease: Subanalysis of Systematic Review” [Gastro Hep Advances, 2022;1(5): 679-681] https://doi.org/10.1016/j.gastha.2022.05.011
Additional Ethical Information: As this study is a review of published material, it did not require the approval of an institutional review board.
11. “Productivity Loss and Indirect Burden of Cyclic Vomiting Syndrome in the United States” [Gastro Hep Advances, 2022;1(6): 954-962] https://doi.org/10.1016/j.gastha.2022.06.017
Additional Ethical Information: All database records are de-identified and fully compliant with United States patient confidentiality requirements, including the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Because this study uses only de-identified patient records and does not involve the collection, use, or transmittal of individually identifiable data, the data does not involve human subjects (per the definition of human subjects in the Code of Federal Regulations (CFR) Title 45 Part 46.102(e)). Thus, this study was exempted from Institutional Review Board (IRB) approval.
12. “Development of Inflammatory Bowel Disease in HIV Patients: A Danish Cohort Study (1983–2018) With American Validation (1999–2018)” [Gastro Hep Advances, 2022;1(6): 1114-1121] https://doi.org/10.1016/j.gastha.2022.08.003
Additional Ethical Information: Due to the study being undertaken not directly involving human subjects in the data collection process (Danish national health registries and US insurance claims databases were the only sources of data used), ethical approval was not required to undertake this work.
13. “One-year Increment Staging Incidence of Esophageal Adenocarcinoma With Enhanced Ethnicity Surveillance, Epidemiology, and End Results Program 18 Sampling, 2000–2017” [Gastro Hep Advances, 2023;2(1): 5-7] https://doi.org/10.1016/j.gastha.2022.08.009
Additional Ethical Information: This study was performed using SEER databases. This does not record any patient information and is exempt from IRB.
14. “CYP2C19 Genotype Is Not Associated With the Risk of Microscopic Colitis” [Gastro Hep Advances, 2023;2(2): 242-243] https://doi.org/10.1016/j.gastha.2022.09.013
Additional Ethical Information: This study was approved by the UNC Institutional Review Board (Risk Factors for Microscopic Colitis, IRB# 14-3156).
15. “It Is Time for a Simplified Approach to Hepatitis B Elimination” [Gastro Hep Advances, 2023;2(2): 209-218] https://doi.org/10.1016/j.gastha.2022.10.004
Additional Ethical Information: The study did not require the approval of an institutional review board.