SciELO - Scientific Electronic Library Online

vol.25 número2Problemas éticos e justiça social na Estratégia Saúde da FamíliaRelação médico-paciente nos pareceres-consultas enviados ao Cremesp índice de autoresíndice de assuntospesquisa de artigos
Home Pagelista alfabética de periódicos  

Serviços Personalizados




Links relacionados


Revista Bioética

versão impressa ISSN 1983-8042versão On-line ISSN 1983-8034

Rev. Bioét. vol.25 no.2 Brasília maio/ago. 2017 


Factors linked to the increased vulnerability of research subjects

Sandro Gonçalves de Lima1 

Luna Gama Maia2 

Aline Tenório Dourado3 

Lívia Cristina Gomes Silva4 

Tatiana Albuquerque Gonçalves de Lima5 

Zulma Maria de Medeiros6 

Saulo Ferreira Feitosa7 

Daniel Alexandre de Oliveira8 

Stefan Welkovic Junior9 

1. Doutor – Universidade Federal de Pernambuco (UFPE)

2. Graduada – UFPE

3. Graduada – UFPE

4. Graduada – UFPE

5. Mestre – UFPE

6. Doutora – UFPE

7. Doutor – UFPE, Recife/PE

8. Graduando – Centro Universitário Maurício de Nassau (Uninassau)

9. Graduando – Uninassau, Recife/PE, Brasil.


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.

Key words: Health vulnerability; Ethics, research; Humans; Literacy-Comprehension

CNS Resolution 466/2012, which discusses ethical aspects of research involving human beings in Brazil, has been in force since June 13 2013. It defines “vulnerability”, in Item II.25, as the state of persons or groups who, for any reason or motive, have their capacity for self-determination reduced or impeded, or are in any way prevented from resisting, especially with regard to free and informed consent 1.

In addition, it also incorporates, from the point of view of individuals and communities, references to bioethics - autonomy, non-maleficence, beneficence, justice and equity - and aims to ensure the rights and duties of research participants, the scientific community and the state. However, research involving human beings is an example of an activity in which consent is a necessary condition, but is insufficient for ethical practice.

Vulnerability has been increasingly associated not only with the conditions of the individual itself, but with surrounding conditions (environmental, social or otherwise), and so it is necessary to incorporate sociocultural aspects into the understanding of the concept. Therefore, it should be noted that there are at least two types of human vulnerability: anthropological, understood as a condition of fragility intrinsic to the human being as it is biological and psychic; and socio-political, when an individual belongs to a group, gender, locality, culture, environment or socioeconomic condition that makes them vulnerable.

Vulnerability refers not only to the biological dimension, but also to the individual’s history in relation to others and to the harm caused by a relationship with others, which has been called “social vulnerability.” The latter presupposes anthropological vulnerability, but intensifies it due to environmental or social factors that are interrelated to the point of making the attribution of damage to a single cause highly complex 2. Taking this broader concept of the concept, Article 8 of the Universal Declaration of Bioethics and Human Rights (UDBHR) determines that in applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. 3.

In addition, it insists on the observance of specificities, demonstrating the importance of the consideration of the peculiarities inherent to each research participant. For this reason, the same article establishes that individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected 3. Behind this manifest preoccupation with the individual and the community is the respect for human dignity, a principle adopted by UDBHR and which supports all the recommendations contained in the text, in order to extend the protection and ensure the autonomy of the research participants.

It is based on the premise that the patient cared for by public health care services, even if able to consent to participate in a given research project, is more susceptible to harm as a result of factors linked to the environment in which they live, including the health service itself. Thus, the objective of this study was to evaluate the socioeconomic and cultural conditions of the patients and the institutional characteristics that might put an individual hospitalized in a public university hospital in conditions of greater vulnerability in medical research.


A cross-sectional study was carried out in which 116 hospitalized individuals aged over 18 years, without cognitive or verbal expression difficulties, and 18 doctors, each of whom was responsible for a ward used for the hospitalization of adults, were consecutively interviewed. The interviews were carried out between April and June 2014 in the hospital wards using a questionnaire of open and closed questions. The inpatient sample was obtained by convenience, and those who agreed to participate signed a free and informed consent form (FICF), an instrument responsible both for clarifying the objectives and procedures of the research and for guaranteeing the rights of confidentiality, withdrawal, care and compensation of the participant, among others.

All the doctors responsible for adult wards agreed to participate in the study and were included. The research was conducted in a public university hospital with exclusive access through the Unified Health System. The hospital is considered to be large, with 411 beds and mainly outpatient, surgical and intensive care services. The questions addressed to the patients were related to demographic characteristics, socioeconomic conditions, level of knowledge regarding the disease and comorbidities that led to hospitalization, the relationship with the attending doctor, the length of stay and current or previous participation in clinical research trials.

Such trials are defined as any research involving humans that aim to discover or verify the pharmacodynamic, pharmacological, clinical and/or other effects of products and/or identify adverse reactions to products under investigation for the purpose of ascertaining their safety and/or efficacy 4. The questions addressed to the physicians were regarding their knowledge of the research carried out in the ward, the care given to the research participants and the level of preparation of the medical team to treat patients with adverse reactions arising from a study performed in the hospital.

According to the good clinical practice manual, any unanticipated harmful response is considered to be an adverse reaction in any dose to a new medicinal product. In relation to already marketed medicinal products, an adverse reaction is considered a harmful and unintended response that occurs at doses normally used in humans for prophylaxis, diagnosis or treatment of diseases or to modify physiological function 5.

Literate individuals were divided into two groups according to the number of correct answers to five questions related to the comprehension of a section of the FICF and four questions about medical prescriptions, typed on a prescription form to avoid problems related to calligraphy. The demographic, socioeconomic and cultural conditions were evaluated as independent variables between the groups with and without errors in the understanding of the FICF and the prescription, establishing a value of p <0.05 as statistically significant.


The sample consisted of 81 women (70%) and 35 men (30%), whose average age was 43 years (18-84 years), with the majority (57%) from urban areas. In terms of religion, 54 (47%) were evangelicals, 48 (41%) were Catholic, five (4%) did not profess to any religion, two (2%) were spiritists and seven (6%) belonged to other faiths. The mean hospital length of this population was 13 days (1 to 210 days). Table 1 shows the level of schooling, the housing and communication conditions, the means of transportation used to travel to the hospital, and the average monthly income of the population studied. Data on the patient’s knowledge about the pathology that led to their hospitalization, the treatment they were receiving at the hospital and their relationship with the institution and the health team are also shown in Table 1.

Table 1 Distribution of hospitalized patients according to socioeconomic and cultural conditions 

Variable n %
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
Masonry 115 99
Mud 1 1
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

*Brazil (2013) = R$ 678.00

Among the individuals in this sample, 32 out of 114 (28%) reported having previously participated in scientific research. Only 9 of 31 (29%) were able to identify the research they had participated in. Of the individuals who had already signed a FICF for participating in research, 9 (out of 12, or 75%) said they understood the content of the document. The majority (17 of 19, 89%) did not receive any compensation for having participated in trials. The data resulting from the evaluation of the understanding by the interviewees with more than five years of schooling of a section of the FICF and their understanding of a prescription on a prescription form are shown in Table 2.

Table 2 Distribution of hospitalized patients according to their understanding of a section of a FICF and a medical prescription 

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

n = 73 (number of interviewed people)

Among those who demonstrated that they understood all the medical prescription information, the majority had an individual monthly income less than a minimum wage (p = 0.044). No other statistically significant associations were found between the number of correct answers in the questions related to the FICF and prescription (Table 2) and the other socioeconomic and cultural variables studied. Of the 18 physicians responsible for the wards in which the patients who composed the study sample were hospitalized, only six (33%) performed exclusively academic research (without the participation of the drug industry). Regarding the research designs, observational studies were most often performed by seven of the doctors (39%), while six (33%) undertook clinical trials with the participation of the pharmaceutical industry. Table 3 shows the responses of these doctors to the surveys conducted in the sectors for which they are responsible.

Table 3 Distribution of doctors responsible for clinical and surgical wards according to the knowledge of the research carried out in the hospital 

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



The socioeconomic and cultural conditions of this population place it in additional situations of vulnerability, in terms of participation in medical research. Most of the individuals studied had individual and family incomes below two minimum wages, which were below the national average (2.46 minimum wages, according to the 2010 Census 6). In addition to the risks arising strictly from the procedures used in the surveys which would affect any individual, it is necessary to consider those that place participants in particular conditions of vulnerability.

For example, a lack of access to emergency medical care in the event of adverse effects arising from clinical research or a lack of guidance from the researcher in charge of the study because of the unavailability of telephone communication increases the vulnerability of the participant. The distance between the municipality where the participant resides and the place where they receive medical care and participate in research, plus the lack of knowledge about the illness that affects them, the treatment they receive and the name of the treating doctor or hospital in question also influences conditions of vulnerability.

We consider that the risks to which individuals are subject, even in case of mathematically low percentages for some variables, are significant for research participants as an additional risk to their basic condition and, therefore, a factor of increased vulnerability. Conditions such as these serve to support arguments by some authors who argue that participants from developing nations need additional guarantees to protect them against harm or exploitation in research 7.

Often it is the characteristics that make a particular population particularly vulnerable that make it the preferred target in clinical trials with placebo. An example of this was a study conducted in South Africa and other developing countries involving poor women led by researchers who stated that research could only be conducted among women with few choices regarding the treatment they would be offered 8. In Brazil, according to Resolution CNS 466/2012, a new therapeutic method should be tested in comparison to the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebos or any treatment in studies that do not have proven methods of prophylaxis, diagnosis or treatment 1.

Health care is more accessible in urban areas than in rural areas because of the greater availability of health institutions and specialized professionals. Moving to and even within urban centers may be difficult for some individuals, which makes them even more vulnerable. A very high percentage of individuals in this research came from the rural area (43%): almost half of the population studied depended on public transport, which in Brazil is still lacking, with irregular, overcrowded lines, expensive fares, and insufficient access for those with locomotion difficulties 11.

More than 20% of individuals interviewed walked to the hospital. If we consider that the majority of research participants are not compensated for the expenses they incur through transport to the hospital, this data assumes even greater relevance.

Garrafa and Lorenzo 12 emphasize the importance of guidelines that require proof that the medical centers responsible for the clinical supervision of participants are able to treat them in a timely manner and at levels of complexity appropriate to the risks. In addition, they must have rapid and adequate means of transferring patients and maintain efficient communication with the network offered to participants included in clinical trials living in the outskirts and poor neighborhoods of large Latin American cities.

Researchers are advised to provide a telephone number on the FICF so that research participants can contact them. According to our results, 17% of the interviewees are in a situation of greater vulnerability because they do not have a telephone, through which they could receive guidance from the person in charge of the research. More than 70% of the sample population attended elementary education at most, making them particularly vulnerable as education has the potential to protect against risks arising from any research. This percentage is well above the national average (50.2%) reported by the 2010 Census 6.

This low level of schooling reflects the high degree of disinformation about their own health conditions, the treatment established for the illness that led to their hospitalization, and even more elementary information, such as the name of the attending physician and the hospital where they are hospitalized. As already mentioned, although some of the percentages of the analyzed variables are low, it is considered that the risks of harm to which the participants are subject are significant.

It is, of course, the duty of the health professional to provide information to the patient in clear language and to help establish a relationship in which the patient participates in decisions about their health and treatment. However, it is expected that the patient themselves play an active role, by taking an interest in this information. The hypothesis that disinformation results from social and economic conditions can be corroborated by the high percentage of patients who described their relationship with the attending physician as excellent or good.

The question culturally rooted in the idea of “the doctor is the person who asks, and the patient is the one who answers” can justify part of the results. Some authors point out that effective communication with the participant is also a way of enhancing the protective action of the FICF 13,14. It is likely that both social and cultural conditions have a similar influence on the high percentage of individuals who are unable to identify the surveys in which they participated and therefore do not know how to assess the risks to which they were subjected.

It is expected that the likelihood of research-related harm will be lower for participants accompanied by family or friends during hospitalization. The mean age of the population surveyed may justify the absence of accompanying persons during the hospitalization of almost 40% of the patients, as, in general, they are allowed to stay only with children or the elderly.

The FICF, as the basic instrument that ethically grounds the respondent’s rights and agreement to participate in the research in question, must be clearly understood by the research participant. Problems related to the extent of the TCLE, the sophistication of some information, and the participants’ capacity to understand are some challenges to obtaining consent in an appropriate manner, which has generated opinions that while the FICF is useful and valuable, and a necessary condition, it is not enough 15.

Our data show that a very low percentage of respondents (12%) understood all the questions in the section of the FICF presented to them. We consider that, regardless of the deficiencies of understanding or the question addressed, this percentage of understanding indicates a considerable increase in the vulnerability of all the others.

The high percentage of people who did not understand what their participation in the research would involve was notable not only because of its magnitude (82%), but because of the importance of the question. The possibility that the agreement to participate derives from irresistible indirect compensations – the guarantee of care, the access to complementary exams and medications, for example - cannot be discarded, especially in relation to low income populations and those with difficulty in access to health services, such as the group studied. In developing countries, people are more likely to participate in studies, as they have low economic and educational status, little ability to understand risks and report complaints or to take legal action in case of loss 16,17.

However, one of the basic requirements for participating in research is that consent is given only if there is an adequate understanding of the risks of the study 18. In this respect, under no circumstances should it be assumed that ignorance about science results in an inability to understand or pass judgment 19. More dangerous may be the situation where the researcher is unable to understand the community or selected population 20. Some studies have shown that people often participate in research without properly understanding the purpose and risks of the study 21-24, and that a lack of understanding correlates with the educational level 25,26.

However, a better understanding of scientific terms leads to greater resistance to participating in research, as shown in a study in which only 19% of doctors were willing to participate in research, compared to 50% approval among lay people 27. Still, some authors have reported that the understanding of the FICF is insufficient even among culturally enlightened individuals with better socioeconomic conditions 21,28,29.

The present study identified an even lower percentage (7%) of individuals who demonstrated an understanding of all the medical prescription items. Considering that only individuals with at least five years of study responded to these questions, the percentages of errors in each of the prescription items reveal an alarming problem and serious repercussions for the health of the participant. The vulnerability expressed in this issue also goes beyond the question of research involving humans, and provides an explanation for the lack of adherence to the prescribed treatment and for the lack of response to treatment and the “inefficacy” of medications.

Data from the Instituto Brasileiro de Geografia e Estatística (the Brazilian Institute of Geography and Statistics) (IBGE) revealed that approximately 62% of the population of Brazil can be considered functionally illiterate, that is, are unable to interpret texts correctly 6. The lack of association between the majority of the variables studied in the with and without errors groups in the understanding of the FICF and the prescriptions may be related to the few individuals who answered all the questions, which may have biased the results. An individual income significantly lower than one minimum wage among those who answered all the questions can corroborate this hypothesis.

If, on the one hand, the conditions of the research participants put them in a greater degree of vulnerability, on the other, those connected with the institution are not much different. Data from the interviews with the doctors responsible for the wards show that disinformation related to the topic “research with human beings” is not exclusive to the participants. A significant percentage (8 out of 18, about 44%) of research is developed without the knowledge of those in charge of the ward. These data are even more relevant if analyzed taking into account the information that more than 30% of research studies performed in the hospital are intervention studies with the significant participation of the drug industry.

Finally, we know that a longer period of hospitalization results in greater risks to the patient’s health. As 17% of the doctors interviewed stated that research participants are hospitalized for a longer period of time, it can be concluded that the study population is even more vulnerable. Although there are differences between institutional vulnerability and the vulnerability of the individual, especially regarding risks to the health and life of the research participants, we must recognize that the hospital institution is also in a worrying condition of vulnerability.

The percentage of those responsible for the wards who reported not being aware of the research carried out in such locations and not knowing whether the hospital treats adverse effects resulting from research reveals institutional vulnerability. At the same time, it shows that it is more a factor of vulnerability of the participating patients, which further compromises their autonomy.

Due to the associated factors, we identified a relevant aspect that needs to be properly considered in research: communication. We know that health communication is a strategic tool both for the interpersonal relationship between professionals and patients and for the promotion of public health. The same degree of importance of communication must be recognized in the conduct of research.

Good communication between the members of an institution, researchers, and research participants can reduce vulnerability. Information is one of the components of communication, but it does not represent its entirety. In the same way, the good relationship between doctor and patient, while a necessary condition to establish communicability, does not in itself ensure its concretization.

In order for there to be good communication it is important that a dialogical process is structured among all those involved. This process must be permanent and dynamic, as it results from a joint construction. This requires time, dedication and the ability to listen - the latter especially among health professionals in relation to those who are in a vulnerable condition. Listening helps to improve the self-esteem of vulnerable individuals and contributes to their empowerment. In the present case, it means diminishing the relational asymmetry between researchers and research participants, strengthening the autonomy of the latter as they acquire the necessary conditions to manifest their will.

Given the high percentage of patients that come from rural areas, the communicability to be developed should take into account the characteristics of the cultures of the rural populations. For this, it is not enough to ensure good spelling and the use of more accessible vocabulary. In rural communities, orality predominates. As memorization, apprehension and transmission of knowledge are intrinsically linked to daily practices in the oral tradition, it is important that communicative strategies with research participants be used as instruments and forms of communication that are as close as possible to their cultural realities. This is a challenge to be faced.

Final considerations

After analyzing the results, it was verified that the frequency of factors related to the research participant and the hospital institution that increase the vulnerability of the participants of clinical studies is high in all the variables evaluated in this study. This compromises the autonomy of the participants. This situation demands more dedication and attention to the patients involved and to the projects in execution from researchers and the institution. The results of the present study corroborate the belief that the vulnerability condition of the participants makes the FICF insufficient. Although this instrument is essential and of great importance, we cannot under any circumstances conceive it as the only necessary tool capable of ensuring the autonomy of volunteers and promoting their protection.


1. Conselho Nacional de Saúde. Resolução CNS nº 466, de 12 de dezembro de 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. [Internet]. Diário Oficial da União. Brasília; n. 12, p. 59. 13 jun 2013 [acesso 9 maio 2017]. Seção 1. Disponível: ]

2. Feito L. Vulnerabilidad. An Sist Sanit Navar. 2007;30(Suppl 3):7-22. [ Links ]

3. Organização das Nações Unidas para Educação, Ciência e a Cultura. Declaração universal sobre bioética e direitos humanos. [Internet]. Paris: Unesco; 2006 [acesso 14 dez 2016]. Disponível: ]

4. European Medicines Agency. Guideline for good clinical practice E6(R2). [Internet]. London: EMA; 1º dez 2016 [acesso 9 maio 2017]. Disponível: ]

5. Organização Pan-Americana da Saúde. Boas práticas clínicas: documento das Américas [Internet]. IV Conferência Pan-Americana para Harmonização da Regulamentação Farmacêutica. República Dominicana: Opas; 2005 [acesso 9 maio 2017]. Disponível: ]

6. Instituto Brasileiro de Geografia e Estatística. Pesquisa nacional por amostra de domicílios. Brasília: IBGE; 2011. [ Links ]

7. Resnik DB. Research subjects in developing nations and vulnerability. Am J Bioeth. 2004;4(3):63-4. [ Links ]

8. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997;337(12):853-6. [ Links ]

9. Kassouf AL. Acesso aos serviços de saúde nas áreas urbana e rural do Brasil. Rev Econ Sociol Rural. 2005;43(1):29-44. [ Links ]

10. Pinheiro RS, Viacava F, Travassos C, Brito AS. Gênero, morbidade, acesso e utilização de serviços de saúde no Brasil. Ciênc Saúde Coletiva. 2002;7(4):687-707. [ Links ]

11. Gomide AA. Transporte urbano e inclusão social: elementos para políticas públicas. Brasília: Ipea; 2003. [ Links ]

12. Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cad Saúde Pública. 2008;24(10):2219-26. [ Links ]

13. Lacativa PGS, Szrajbman M, Silva DASM, Melazzi ACC, Gregório LH, Russo LAT. Perfil de sujeitos de pesquisa clínica em um centro ambulatorial independente. Ciênc Saúde Coletiva. 2008;13(3):1023-32. [ Links ]

14. Goldim JR, Pithan CF, Oliveira JG, Raymundo MM. O processo de consentimento livre e esclarecido em pesquisa: uma nova abordagem. Rev Assoc Med Bras. 2003;49(4):372-4. [ Links ]

15. Organisation for Economic Co-Operation and Development. Creation and Governance of Human Genetic Research Database. Paris: OECD; 2006. p. 90. [ Links ]

16. Grady C. Vulnerability in research: individuals with limited financial and/or social resources. J Law Med Ethics. 2009;37(1):19-27. [ Links ]

17. World Health Organization. Operational guidelines for ethics committees that review biomedical research. Geneva: WHO; 2000. [ Links ]

18. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? Jama. 2000;283(20):2701-11. [ Links ]

19. Segre M. Reflections on bioethics: consolidation of the principle of autonomy and legal aspects. Cad Saúde Pública. 1999;15(Suppl 1):91-8. [ Links ]

20. Cabral MML, Schindler HC, Abath FGC. Regulamentações, conflitos e ética da pesquisa médica em países em desenvolvimento. Rev Saúde Pública. 2006;40(3):521-7. [ Links ]

21. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772-7. [ Links ]

22. Sastry J, Pisal H, Sutar S, Kapadia-Kundu N, Joshi A, Suryavanshi N et al. Optimizing the HIV/AIDS informed consent process in India. BMC Med. 2004;2:28. [ Links ]

23. Fitzgerald DW, Marotte C, Verdier RI, Johnson Jr WD, Pape JW. Comprehension during informed consent in a less-developed country. Lancet. 2002;360(9342):1301-2. [ Links ]

24. Kass NE, Maman S, Atkinson J. Motivations, understanding, and voluntariness in international randomized trials. IRB. 2005;27(6):1-8. [ Links ]

25. Mandava A, Pace C, Campbell B, Emanuel E, Grady C. The quality of informed consent: mapping the landscape: a review of empirical data from developing and developed countries. J Med Ethics. 2012;38(6):356-65. [ Links ]

26. Bajotto AP, Goldim JR. Consentimento informado: cuidados para o recrutamento de populações vulneráveis. Rev. bioét. (Impr.). 2012;20(2):226-31. [ Links ]

27. Kottow M. Modelos de evaluación y situaciones especiales: curso de ética de la investigación en seres humanos. Programa de Educación Permanente en Bioética – UNESCO; 2008. Módulo 2. [ Links ]

28. Robinson EJ, Kerr C, Stevens A, Lilford R, Braunholtz D, Edwards S. Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials. Soc Sci Med. 2004;58(4):811-24. [ Links ]

29. Santos ML, Emmerich A. O consentimento livre e esclarecido e a vulnerabilidade do sujeito de pesquisa. Rev. bioét. (Impr.). 2011;19(2):553-61. [ Links ]


Questionnaire for patients

1) Gender:

( ) Female ( ) Male

2) What is your age?


3) In which city and state do you live?

State: ________________________________________________________________________________________

City: _________________________________________________________________________________________

If you live in Recife, in which neighbourhood do you live? _______________________________________________

If you live in another city, do you live in:

( ) an urban area ( ) a rural area

4) Type of residence:

( ) Brick house ( ) Mud house

5) What is your level of schooling?

( ) Illiterate

( ) Literate only

( ) Incomplete primary (up to 3th grade of elementary school)

( ) Complete primary (completed 4th grade of elementary school)

( ) Incomplete elementary school (up to 7th grade of elementary school)

( ) Complete elementary school (completed 8th grade of elementary school)

( ) Incomplete high school (up to 2th grade of high school)

( ) Complete high school (completed 3th grade of high school)

( ) Incomplete higher

( ) Complete higher

( ) Pos-graduate (master/doctorate)

6) What is your monthly individual income?


7) What is the monthly income of your family? _____________________________ (Including all the people who live with you)

8) How many people contribute to this income? ____________________________

9) What is your religion?

( ) Catholics

( ) Spiritists

( ) Evangelical

( ) Afro-Brazilian religious syncretism

( ) Not religious

( ) Other

10) Do you have home or cell phone?

( ) Yes ( ) No

11) How did you usually get to the hospital or health service?

( ) Bus

( ) Taxi

( ) Own car

( ) Motorbike

( ) Bicycle

( ) On foot

( ) Ride from others (neighbours etc.)

( ) Others

12) Do you know what disease is the reason for your hospitalization?

( ) Yes ( ) No

13) Do you know what treatment is being used against your illness?

( ) Yes ( ) No

14) Do you have some other associated disease (besides that which caused hospitalization), such as hypertension, diabetes, asthma, renal failure, chronic obstructive pulmonary disease, etc.?

( ) Yes ( ) No ( ) Don’t know

15) How long have you been hospitalized for?


16) Is there a friend or relative to accompany you during your hospitalization? (Not including visitors)

( ) Yes ( ) No

17) Do you know the name of your attending doctor?

( ) Yes ( ) No

18) How would you classify your relationship with your attending doctor?

( ) Excellent

( ) Good

( ) Poor

( ) Indifferent

19) Do you know the name of the hospital where you are hospitalized?

( ) Yes ( ) No

20) Do you know if the hospital where you are hospitalized is a teaching hospital for students and recently qualified doctors?

( ) Yes ( ) No

21) Do you know if you are taking part in or of if you have already taken part in scientific research during your hospitalization or during treatment received from the outpatient clinic?

( ) Yes ( ) No

Do you know what the research studies were?

( ) Yes ( ) No

If yes, in which studies did you take part?


22) Before taking part in the study, did you sign a free and informed consente form (which is a document where you give authorize your participation)?

( ) Yes ( ) No

23) Do you think you understood all the infomation contained in the consente form?

( ) Yes ( ) No

24) Do you receive any form of compensation or pagament for participating in the study?

( ) Yes ( ) No

25) Have you ever suffered some kind of adverse effect resulting from a study in which you’ve taken part?

( ) Yes ( ) No

26) Have you ever received guidance as to what to do if you experience any side effects?

( ) Yes ( ) No

27) Who were you advised to contact in the event of experiencing a side effect?

( ) The researcher

( ) The attending doctor

( ) The hospital

( ) I wasn’t told who to contact

( ) Others

28) Were you given a gurantee that following the end of the study, you would be able to use the medications and/or exams used, either for free or at a lower price?

( ) Yes ( ) No

Questionnaire for the doctor responsible for the ward

1) What type of research is carried out in the hospital?

( ) Drug industry research protocols

( ) Exclusively academic research

( ) Both

( ) Don’t know

2) What types of study designs are most frequently used in the research carried out in the hospital?

( ) Observational

( ) Clinical trials

( ) Evaluation of diagnostic methods

( ) Don’t know

( ) Others: ______________________________________

3) Are you aware of all the studies that are carried out in the ward for which you are responsible?

( ) Yes ( ) No

4) Does the hospital treat patients whose condition arises from a consequence of the study?

( ) Yes ( ) No

5) Are the health professionals in the hospital trained to treat patients who exhibit adverse effects arrising from the study?

( ) Yes ( ) No

6) Are patients who participate in a research study hospitalized for a similar length of time to those who do not participate in such studies?

( ) Yes

( ) No, for longer

( ) No, for less time

( ) Don’t know

Received: September 18, 2016; Revised: May 11, 2017; Accepted: May 15, 2017

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

Declaram não haver conflito de interesse.

Participation of authors

Sandro Gonçalves de Lima conceived the project. Luna Gama Maia, Aline Tenório Dourado and Lívia Cristina Gomes Silva collaborated in data collection. All the authors contributed to data analysis and the writing of the article.

Aprovação CEP-UFPE 062/11, CAEE 0044.0.172.000-11

Creative Commons License  This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.