Venkataramana Kandi and Sabitha Vadakedath. Ethical Considerations in Clinical Research: A Comprehensive Review.
. 2022; 10(2):42-52. doi: 10.12691/AJPHR-10-2-2
clinical studies, clinical research, human subjects, ethics, ethical considerations, vaccines, devices, medical products
This work is licensed under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit
[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. |
|