Table 2.

Comparison of consent refusals between studies on the basis of study type, design, and the risk stratification and gradation

Scientific title of the study	Sponsor	Type of the study	Risk stratification of the study (As per ICMR guidelines)	Study rank as per risk gradation by the Investigator	Consent refusals (n/ Total counseled) (%)
Evaluation of host immune responses and parasite proteome in healthy participants	Investigator-initiated	Observational	Minimal risk	1	0/50
Evaluation of host immune responses and parasite proteome in patients with severe/complicated malaria	Investigator-initiated	Observational	Minimal risk	2	0/80
A prospective study to assess the correlation between genotype, phenotype and Prakriti of an individual on Phenytoin monotherapy	Investigator-initiated	Observational	Minimal risk	3	35/337 (10.38)
Three way, three period, cross over bioequivalence study of single oral dose of three brands of 300mg Phenytoin sodium tablets marketed in India, on healthy Indian human volunteers	Investigator-initiated	Interventional (Phase IV)	Minimal risk	4	2/24 (8.33)
A phase III, open label, randomized, parallel group, multicentric trial comparing the safety and efficacy of fixed dose combination tablets of arterolane maleate and piperaquine phosphate (PQP) with chloroquine tablets in patients with acute uncomplicated Plasmodium vivax malaria	Pharmaceutical-sponsored	Interventional (Phase III)	More than minimal risk	5	93/145 (64.14)
A randomized, double blind, multicentric, placebo controlled, phase II study assessing the safety and efficacy of intraarticular ex-vivo cultured adult allogeneic mesenchymal stem cells in patients with osteoarthritis of knee	Pharmaceutical-sponsored	Interventional (Phase II)	More than minimal risk	6	0/11 (0)
A phase II/III, randomized, multi-centric, comparator-controlled Study of the safety and neutralizing activity of a human monoclonal antibody to rabies (SII RMAb) administered in conjunction with rabies vaccine for post-exposure prophylaxis in patients following potential rabies exposure	Pharmaceutical-sponsored	Interventional (Phase II/III)	More than minimal risk	7	34/91 (37.36)
A phase 1, prospective, randomized, two-arm, active controlled, double-blind study to evaluate the safety and tolerability of Serum Institute of India’s 10-valent pneumococcal conjugate vaccine (SIILPCV10) in healthy Indian young adults	Pharmaceutical-sponsored	Interventional (Phase I)	More than minimal risk	8	26/60 (43.33)
Pharmacokinetics of colistin, after intravenous administration of colistimethate sodium in subjects with nosocomial infections caused by multidrug resistant, gram negative bacilli	Pharmaceutical-sponsored	Interventional (Phase IV)	More than minimal risk	9	0/16 (0)
Open-label, randomized, dose escalation phase I study in healthy adult volunteers to evaluate the safety and pharmacokinetics of a human monoclonal antibody to rabies (SII RMab) in comparison to human rabies immune globulin administered in conjunction with rabies vaccine (RABIVAX®)	Pharmaceutical-sponsored	Interventional (Phase I)	More than minimal risk	10	16/162 (9.88)