Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

AKACHA, M. & BRANSON, J. et al. (2020): Challenges in assessing the impact of the COVID-19 pandemic on the integrity and interpretability of clinical trials. In: Statistics in Biopharmaceutical Research, 12(4), pp. 419–426. [online] [Retrieved August 20, 2021] Available at: https://www.tandfonline.com/doi/full/10.1080/19466315.2020.1788984?src=recsys10.1080/19466315.2020.1788984 Search in Google Scholar

BEAUCHAMP, T. L. & CHILDRESS, J. F. (2019): Principles of Biomedical Ethics, 8th ed. New York: Oxford University Press. Search in Google Scholar

CODE OF FEDERAL REGULATIONS, 21 CFR 312: TITLE 21, FOOD AND DRUGS, CHAPTER I, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER D - DRUGS FOR HUMAN USE. [online] [Retrieved August 18, 2021] Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312 Search in Google Scholar

CODE OF FEDERAL REGULATIONS, 21 CFR 56.108: TITLE 21, FOOD AND DRUGS, CHAPTER I, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER A - GENERAL. [online] [Retrieved August 18, 2021] Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=56. 108 Search in Google Scholar

DELDEN, J. J. M. (2016): Revising the 2002 CIOMS Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS. [online] [Retrieved August 20, 2021] Available at: https://cioms.ch/revising-2002-cioms-ethical-guidelines-biomedical-research-involving-human-subjects/ Search in Google Scholar

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE (1979): Belmont report. [online] [Retrieved August 30, 2021] Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xethical Search in Google Scholar

EMA (2014): REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. [online] [Retrieved August 10, 2021] Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&from=EN Search in Google Scholar

EMA (2016): Guideline for good clinical practice E6(R2). [online] [Retrieved August 10, 2021] Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf Search in Google Scholar

EMA (2020): ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. [online] [Retrieved August 10, 2021] https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf Search in Google Scholar

EMA (2021): Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic. Version 4. [online] [Retrieved August 10, 2021] Available at: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol10/guidanceclinicaltrials_covid19_en.pdf Search in Google Scholar

EMANUEL, E. J. & WENDLER, D. et al. (2000): What makes clinical research ethical? In: JAMA, 283(20), pp. 2701–2711. Search in Google Scholar

FDA (2010): Information Sheet guidance for sponsors, clinical investigators, and IRBs. [online] [Retrieved August 15, 2021] Available at: https://www.fda.gov/media/78830/download Search in Google Scholar

FDA (2020): Conduct of clinical trials of medical products during the COVID-19 public health emergency. [online] [Retrieved August 15, 2021] Available at: https://www.fda.gov/media/136238/download Search in Google Scholar

GEIJO, F. & RUIZ, X. (2020): Remote audits in clinical investigation. Learning from the COVID-19 pandemic. Telstar. [online] [Retrieved August 10, 2021] Available at: https://www.telstar.com/wp-content/uploads/2020/08/EN-Telstar-WP-Remote-Audit2020.pdf Search in Google Scholar

HAWILA, N. & BERG, A. (2021): Assessing the impact of COVID-19 on registered interventional clinical trials. In: Clinical and Translational Science, 14(3), pp. 1147–1154. [online] [Retrieved August 20, 2021] Available at: https://doi.org/10.1111/cts.1303410.1111/cts.13034 Search in Google Scholar

HEADS OF MEDICINES AGENCIES (2020): National guidance on CT management during the COVID-19 pandemic. [online] [Retrieved August 10, 2021] Available at: https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_03_CTFG_Link_to_National_guidance_on_CT_managmant_during_the_COVID-19_pandemia.pdf Search in Google Scholar

JEDLIČKOVÁ, A. (2015): Podvod v klinickém hodnocení léčiv z pohledu etiky a práva [Fraud in clinical trials in terms of ethics and law]. Praha: Univerzita Karlova, Fakulta humanitních studií. Search in Google Scholar

NARDINI, C. (2014): The ethics of clinical trials. In: Ecancermedicalscience, 8(387) [online] [Retrieved August 30, 2021] Available at: https://doi.org/10.3332/ecancer.2014.38710.3332/ecancer.2014.387 Search in Google Scholar

NICHOLLS, S. G. & CARROLL, K. et al. (2019): The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders. In: Trials, 20(1), p. 765. [online] [Retrieved August 30, 2021] Available at: https://doi.org/10.1186/s13063-019-3899-x10.1186/s13063-019-3899-x Search in Google Scholar

OFFICE FOR HUMAN RESEARCH PROTECTIONS (2015): Attachment A: Recommended guidance on minimal risk research and informed consent. [online] [Retrieved August 31, 2021] Available at: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2015-september-28-attachment-a/index.html Search in Google Scholar

TALJAARD, M. & WEIJER, C. et al. (2018): Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol. In: Trials, 19(1), p. 525. [online] [Retrieved August 31, 2021] Available at: https://pubmed.ncbi.nlm.nih.gov/30261933/. doi: 10.1186/s13063-018-2895-x10.1186/s13063-018-2895-x Search in Google Scholar

TSUTSUMI, N. & MATSUYAMA, K. et al. (2021): A study on a strategic model to implement remote auditing. In: Clin Eval, 49(1). [online] [Retrieved August 31, 2021] Available at: http://cont.o.oo7.jp/49_1/w1-w11.pdf10.1093/nar/gkab525 Search in Google Scholar