Factors linked to the increased vulnerability of research subjects

Lima, Sandro Gonçalves de; Maia, Luna Gama; Dourado, Aline Tenório; Silva, Lívia Cristina Gomes; Lima, Tatiana Albuquerque Gonçalves de; Medeiros, Zulma Maria de; Feitosa, Saulo Ferreira; Oliveira, Daniel Alexandre de; Welkovic, Stefan

doi:10.1590/1983-80422017252196

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Research • Rev. Bioét. 25 (2) • May-Aug 2017 • https://doi.org/10.1590/1983-80422017252196 copy

Factors linked to the increased vulnerability of research subjects

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

A cross-sectional study was carried out that aimed to assess the prevalence of factors associated with the increased vulnerability of research subjects. A total of 116 patients and 18 doctors were interviewed. A proportion of 15% of patients were illiterate, 27% did not know the reason for their hospitalization and 45% did not know what treatment they were receiving. Of the total sample, 43% were from rural areas and 70% had at most an elementary level education, factors that make this population especially vulnerable. The percentage of correct answers on issues related to the understanding of free and informed consent and prescriptions were 12% and 7%, respectively. Among the doctors, 44% were not aware of all the research projects being carried out in the ward for which they were responsible, and 17% said that the hospital stays of patients participating in research were longer. The prevalence of factors that increased the vulnerability of subjects in medical research was high.

Health vulnerability; Ethics, research; Humans; Literacy-Comprehension

Variable	n	%
Schooling
Illiterate	17	15
Up to 5 years of study	32	28
Between 6 and 9 years of study	33	28
Between 10 and 12 years of study	30	26
Higher and post-graduate	4	3
Residence
Masonry	115	99
Mud	1	1
Phone
Yes	95	83
No	20	17
Form of transport to hospital
Public transport	56	49
Own car/ride from other	23	20
On foot	25	22
Other	11	9
Individual income
Below 1 minimum salary*	44	38
> 1 and < 2 minimum salaries	66	57
Two or more minimum salaries	6	5
Family income
No income	14	13,1
> 1 and < 2 minimum salaries	71	66,3
Two or more minimum salaries	22	20,6
Knew reason for hospitalization
Yes	85	73
No	31	27
Knew about treatment that was receiving
Yes	63	55
No	52	45
Knew about main pathology and associated illnesses
Yes	53	46
No	62	54
Was accompanied during hospitalization
Yes	70	61
No	45	39
Knew name of doctor providing care
Yes	61	53
No	54	47
Described relationship with doctor as
Excellent	42	37
Good	62	54
Poor	2	2
Indiffirent	8	7
Knew name of hospital
Yes	101	88
No	13	11
Knew that was hospitalized in teaching hospital
Yes	93	82
No	21	18

Variables	n	%
Understanding of participation in research
Correct	13	18
Errado	60	82
Understanding ofthe voluntary nature of research participation
Correct	70	96
Errado	3	4
Understanding of the confidentiality of personal information
Correct	54	74
Errado	19	26
Understanding of the lack of financial reward for participating in the research
Correct	71	97
Incorrect	2	3
Understanding of the lack of financial expense in participating in the research
Correct	71	97
Incorrect	2	3
Understanding of the possibility of withdrawing consent at any time
Correct	54	74
Incorrect	19	26
Overall evaluation
1 to 3 correct understandings	9	12
4 to 5 correct understandings	55	75
All correct	9	12
Understanding of the number of medications prescribed
Correct	38	52
Incorrect	35	48
Understanding of the dosage of the first medication prescribed
Correct	51	70
Incorrect	22	30
Understanding of the dosage of the second medication prescribed
Correct	9	12
Incorrect	64	88
Understanding of the dosage of the third medication prescribed
Correct	52	71
Incorrect	21	29
Overall Evaluation
All incorrect	11	15
1 to 2 correct understandings	23	32
3 correct understandings	34	47
All correct	5	7

Variables	n	%
Know about all the research studies in the ward for which they are responsible
Yes	10	56
No	8	44
Hospital treats adverse effects arising from research studies
Yes	12	67
No	2	11
Don’t know	4	22
Are there professionals trained to treat patients presenting adverse effects arising from research studies
Yes	15	83
No	1	6
Don’t know	2	11
Duration of hospitalization of research participants in relation to patients who did not participate in studies
Semelhante	10	56
Menor	1	6
Maior	3	17
Don’t know	4	22

Conselho Federal de Medicina SGAS 915, lote 72, CEP 70390-150, Tel.: (55 61) 3445-5932, Fax: (55 61) 3346-7384 - Brasília - DF - Brazil
E-mail: bioetica@portalmedico.org.br

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[1] Correspondência Sandro Gonçalves de Lima – Rua Frei Jaboatão, 180/2.802, Torre CEP 50710-030. Recife/PE, Brasil.