Skip Navigation Links.
Collapse <span class="m110 colortj mt20 fontw700">Volume 12 (2024)</span>Volume 12 (2024)
Collapse <span class="m110 colortj mt20 fontw700">Volume 11 (2023)</span>Volume 11 (2023)
Collapse <span class="m110 colortj mt20 fontw700">Volume 10 (2022)</span>Volume 10 (2022)
Collapse <span class="m110 colortj mt20 fontw700">Volume 9 (2021)</span>Volume 9 (2021)
Collapse <span class="m110 colortj mt20 fontw700">Volume 8 (2020)</span>Volume 8 (2020)
Collapse <span class="m110 colortj mt20 fontw700">Volume 7 (2019)</span>Volume 7 (2019)
Collapse <span class="m110 colortj mt20 fontw700">Volume 6 (2018)</span>Volume 6 (2018)
Collapse <span class="m110 colortj mt20 fontw700">Volume 5 (2017)</span>Volume 5 (2017)
Collapse <span class="m110 colortj mt20 fontw700">Volume 4 (2016)</span>Volume 4 (2016)
Collapse <span class="m110 colortj mt20 fontw700">Volume 3 (2015)</span>Volume 3 (2015)
Collapse <span class="m110 colortj mt20 fontw700">Volume 2 (2014)</span>Volume 2 (2014)
Collapse <span class="m110 colortj mt20 fontw700">Volume 1 (2013)</span>Volume 1 (2013)
American Journal of Public Health Research. 2022, 10(2), 42-52
DOI: 10.12691/AJPHR-10-2-2
Review Article

Ethical Considerations in Clinical Research: A Comprehensive Review

Venkataramana Kandi1, and Sabitha Vadakedath1

1Prathima Institute of Medical Sciences, Telangana, India

Pub. Date: March 01, 2022

Cite this paper

Venkataramana Kandi and Sabitha Vadakedath. Ethical Considerations in Clinical Research: A Comprehensive Review. American Journal of Public Health Research. 2022; 10(2):42-52. doi: 10.12691/AJPHR-10-2-2

Abstract

Clinical studies involve research that is carried out in human beings and has direct implications on the health of people who participate in it as study subjects. Moreover, clinical trials are performed on healthy and diseased human subjects, wherein the safety and efficacy of a novel drug/device are tested. Therefore, the study design and the subject recruitment assumes increased significance. In this review we attempt to comprehensively discuss the importance of ethics in clinical research and specific ethical considerations concerning the evaluation of medical products, epidemiological studies, human genetics, and genomic research, transplantation studies, reproductive procedures/interventions, research among geriatric and pediatric populations and research involving the development of vaccines and diagnostic devices.

Keywords

clinical studies, clinical research, human subjects, ethics, ethical considerations, vaccines, devices, medical products

Copyright

Creative CommonsThis work is licensed under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

References

[1]  Muthuswamy V. Ethical issues in clinical research. Perspect Clin Res. 2013; 4(1): 9-13.
 
[2]  Reviewing Clinical Trials: A Guide for the Ethics Committee. https://www.pfizer.com/files/research/research_clinical_trials/ethics_committee_guide.pdf.
 
[3]  Raj GM, Priyadarshini R. The new Indian ethical guidelines for biomedical and health research-delving new vistas. J Pharmacol Pharmacother 2018; 9: 56-61.
 
[4]  Ediger AD, Limbach B and Dannhorn D. FDA Requirements for Clinical Investigations of Medical Devices: A Review for European Manufacturers. Qual Assur J 2003; 7: 32-40.
 
[5]  Radhadevi N, Balamuralidhara V, Pramod Kumar TM, Ravi V. Regulatory guidelines for medical devices in India: An overview. Asian J Pharm 2012; 6: 10-7.
 
[6]  Coughlin SS. Ethical issues in epidemiologic research and public health practice. Emerg Themes Epidemiol. 2006; 3: 16. Published 2006 Oct 3.
 
[7]  Hyder AA, Rattani A, Krubiner C, Bachani AM, Tran NT. Ethical review of health systems research in low- and middle-income countries: a conceptual exploration. Am J Bioeth. 2014; 14(2): 28-37.
 
[8]  Barata Rita Barradas. Ethics in epidemiological research. Ciênc. saúde coletiva [Internet]. 2008 Apr [cited 2020 Mar 14] ; 13(2): 453-548.
 
[9]  Mathaiyan J, Chandrasekaran A, Davis S. Ethics of genomic research. Perspect Clin Res. 2013; 4(1): 100-104.
 
[10]  Emerson C, James S, Littler K, Randazzo S. Principles for gene drive research. Science 2017: 358 (6367): 1135-1136.
 
[11]  Dunstan GR. The ethics of organ donation. Bnhih Medical Bulletin 1997^3 (No 4) 921-939.
 
[12]  Richard J. Howard and Danielle L. Cornell (December 29th 2016). Ethical Issues in Organ Procurement and Transplantation, Bioethics - Medical, Ethical and Legal Perspectives, Peter A. Clark, IntechOpen,
 
[13]  Brezina PR, Zhao Y. The Ethical, Legal, and Social Issues Impacted by Modern Assisted Reproductive Technologies. Obstetrics and Gynaecology International 2012; Article ID 686253.
 
[14]  Malhotra N, Shah D, Pai R, Pai HD, Bankar M. Assisted reproductive technology in India: A 3 year retrospective data analysis. J Hum Reprod Sci. 2013; 6(4): 235-240.
 
[15]  Shenoy P, Harugeri A. Elderly patients' participation in clinical trials. Perspect Clin Res. 2015; 6(4): 184-189.
 
[16]  Cerreta, F., Temple, R., Asahina, Y. et al. Regulatory activities to address the needs of older patients. J Nutr Health Aging 19, 232-233 (2015).
 
[17]  Sampson MR, Benjamin DK, Cohen-Wolkowiez M. Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health. Expert Rev Clin Pharmacol. 2012; 5(5): 525-531.
 
[18]  Shakhnovich V, Hornik CP, Kearns GL, Weigel J, Abdel-Rahman SM. How to Conduct Clinical Trials in Children: A Tutorial. Clin Transl Sci. 2019; 12(3): 218-230.
 
[19]  Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian J Anaesth. 2017; 61(3): 192-199.
 
[20]  WHO GUIDELINES ON CLINICAL EVALUATION OF VACCINES: REGULATORY EXPECTATIONS https://www.who.int/biologicals/publications/clinical_guidelines_ecbs_2001.pdf?ua=1.
 
[21]  Terwindt C. Health Rights Litigation Pushes for Accountability in Clinical Trials in India. Health and Human Rights Vol. 16, No. 2, Health Rights Litigation (December 2014), pp. 84-95.
 
[22]  Nardini C. The ethics of clinical trials. Ecancermedicalscience. 2014; 8: 387. Published 2014 Jan 16.
 
[23]  Lim CY, In J. Randomization in clinical studies [published correction appears in Korean J Anesthesiol. 2019 Aug;72(4):396]. Korean J Anesthesiol. 2019;72(3): 221-232.
 
[24]  Vyas N, Jadhav P, Sane R. Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors. Natl J Physiol Pharm Pharmacol. 2020; 10(1): 54-58.
 
[25]  Meher BR. Materiovigilance: An Indian perspective. Perspect Clin Res. 2018; 9(4): 175-178.
 
[26]  Lairumbi, G.M., Parker, M., Fitzpatrick, R. et al. Stakeholders understanding of the concept of benefit sharing in health research in Kenya: a qualitative study. BMC Med Ethics 12, 20 (2011).
 
[27]  Benatar M. (2006). Basic Principles of Epidemiology and Biostatistics. In: Benatar M. (eds) Neuromuscular Disease. Humana Press.
 
[28]  Ibnas M, Asim M, Mekkodathil A, Sathian B. Practical challenges and Obligations for conducting Clinical Trial in Nepal: A call for improvement. Nepal J Epidemiol. 2019; 9(3): 769-771. Published 2019 Sep 30.
 
[29]  Ali F, Gajera G, Gowda GS, Srinivasa P, Gowda M. Consent in current psychiatric practice and research: An Indian perspective. Indian J Psychiatry. 2019; 61(Suppl 4): S667-S675.
 
[30]  Borysowski J, Ehni HJ, Górski A. Ethics review in compassionate use. BMC Med. 2017; 15(1): 136. Published 2017 Jul 24.
 
[31]  Manti S, Licari A. How to obtain informed consent for research. Breathe (Sheff). 2018; 14(2): 145-152.
 
[32]  Chandy A, Waanbah B, Yadav B, Kunjummen AT, Riley DJS, Kamath MS. Knowledge and attitudes of subfertile couples towards disposition of supernumerary cryopreserved embryos: an Indian perspective. Reprod Biomed Soc Online. 2019; 9: 11-16. Published 2019 Oct 27.
 
[33]  Ruiter R, Burggraaf J, Rissmann R. Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database. Br J Clin Pharmacol. 2019; 85(4): 838-844.