Evaluation of reasons for participation refusal among pregnant women in a perinatal outcome research

Vijayan Sharmila, Thirunavukkarasu Arun Babu


Background: The number of protocol-eligible patients, refusing to participate in a biomedical research is often not mentioned in the results of the studies. There are no studies that have looked at the data on willingness to participate in a research among pregnant women in India. The aim of this study is to report the number of pregnant women who refused to participate and to evaluate the reasons for not participating in a research that was concerned with swabbing of the genital tract for culture.

Methods: A prospective research study was done among healthy pregnant women, that required collection of vaginal swabs for culture to study the vaginal flora. The women eligible to participate in the study were approached for their willingness to participate in the study. The details of women who refused to participate in the study and the various self-reported reasons for their refusal were documented and analysed.

Results: A total 48.2% of the total protocol-eligible group refused to participate in the study and the refusal rate was alarmingly higher than expected. Some of the common responses for their refusal include reasons such as the study involved tests from their private parts, lack of interest to participate and the need to discuss with their partner or that their partner wound not allow them to participate in research.

Conclusions: It is important for research studies to include data on the refusal to participate and also the reasons why people refuse to participate in research so as to formulate strategies to improve the acceptance rate for participation in research.



Participation in research, Participation refusal, Pregnant women, Reasons for refusal, Self-reported reasons

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McCall N, Khatutsky G, Smith K, Pope GC. Estimation of non-response bias in the Medicare FFS HOS. Health Care Financing Rev. 2004;25(4):27.

Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Social Sci Med. 2004;58(9):1689-97.

The Belmont report. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979.

Brody JL, Waldron HB. Ethical issues in research on the treatment of adolescent substance abuse disorders. J Addict Behav. 2000;25(2):217-28.

Smith A, King E, Hindley N, Barnetson L, Barton J, Kim A. The experience of research participation and the value of diagnosis in dementia: implications for practice. J Mental Health. 1998;7:309-21.

Farre M, Lamas X, Cami J. Sensation seeking amongst healthy volunteers participating in phase I clinical trials. Br J Clin Pharmacol. 1995;39:405-9.

Harrison DA. Volunteer motivation and attendance decisions: competitive theory testing in multiple samples from a homeless shelter. J Appl Psychol. 1995;80:371-85.

Ygge BM, Arnetz JE. A study of non-response in a questionnaire survey of parents' views of paediatric care. J Nurs Manag. 2004;12:5-12.

Khalil SS, Silverman HJ, Raafat M, El-Kamary S, El-Setouhy M. Attitudes, understanding, and concerns regarding medical research amongst Egyptians: a qualitative pilot study. BMC Med Ethics. 2007;8(9):1472.

Almeida CH, Marques RD, Reis DC, Melo JM, Diemert D, Gazzinelli MF. Scientific research in health: an analysis of the participation of vulnerable populations. Texto and Contexto-Enfermagem. 2010;19(1):104-11.

Guimarães NS, Greco DB, Fausto MA, Kakehasi AM, Guimarães MM, Tupinambás U. Prevalence and reasons for refusal to participate in clinical research. Rev Bioét. (Impr). 2016;24(2):286-91.

Mfutso-Bengo J, Masiye F, Molyneux M, Ndebele P, Chilungo A. Why do people refuse to take part in biomedical research studies? Evidence from a resource-poor area. Malawi Med J. 2008;20(2):57-63.