Informed Consent in Gerontology

- Rosana Soibelmann Glock 1, JosŽ Roberto Goldim2

1 MSc, Biomedical Gerontology Post-Graduate Program, Pontificial Catholic University of Rio Grande do Sul/Brazil, Ethics Committee.

2 MSc, PhD, Biomedical Gerontology Post-Graduate Program, Pontificial Catholic University of Rio Grande do Sul/Brazil, Ethics Committee, Graduate Research Group, Hospital de Cl’nicas de Porto Alegre/Brazil.

Corresponding author: Rosana Soibelmann Glock
Comit de ƒtica em Pesquisa da PUCRS

Ave. Ipiranga, 6690, 90619-900 Porto Alegre, RS - Brazil

E-mail: goldim@vortex.ufrgs.br Eubios Journal of Asian and International Bioethics 13 (2003), 6-8.
Abstract

   
The aim of this study was to assess the use and adequacy of informed consent in research involving the elderly in Brazil. Using a reading index, we observed that in 83% of informed consent forms, the text was considered difficult, and demanded a higher schooling level than that presented by the subjects. Whereas 100% of the investigators considered the text in informed consent forms accessible, 75% of the subjects considered it hard to understand. This difference was statistically significant. 94% percent of the elderly participating in research protocols made the decision to participate in the study before reading the term of consent. More attention should be given both to the writing of informed consent forms and to the entire informed consent process, which, in gerontology research, should be reviewed at each encounter with study participants.

Key Words: Bioethics; Gerontology; Informed Consent; Aged; Elderly.

Introduction

Research is essential in the search for health prevention, treatment and rehabilitation solutions. The first goal of research should be to diminish human suffering and to promote the rescue of happiness.1 Ethical assessment has become an essential part of scientific investigation,2 so as to ensure that human beings are respected in terms of their dignity and values, and so that they not are used merely as a means towards an end.3

Informed consent is indispensable for research with human beings.4,5 Such research is, at the same time, necessary and problematic, socially commendable but ethically dangerous.6

Studies about the adequacy of the informed consent process in trials with humans1 have demonstrated the importance of ethics committees in the assessment of research protocols. One essential aspect of this evaluation is the review of all stages involved in obtaining informed consent, including the adequacy of the terms used. The participants in a study must understand all information concerning the study and their rights, and must have permanent access to the investigator (so that any eventual doubts can be cleared). Therefore, serious reflection regarding all aspects of the informed consent process is required.

The information used in the term of consent must be appropriate to the individual's developmental level, as well as to his/her comprehension level.7

It is fundamental that information be adequately provided, with clear explanations and answers to eventual doubts.4 In addition, there must be room for emotion while each participant reflects on these questions8 while deciding whether or not to enroll. Considering that elderly people show more individual variation than young adults, and that age is not reliable to predict the behavior of elderly individuals,9 since this group encompasses a wide range, between 60 and 100 years ,10 the information provided must be especially adapted.4

When ethical values are considered, differences may coexist, and prejudice, stereotypes and labels are left behind.11

Consent is a process of decision-making,4 in which the expectations about the significance of research results must be considered.12

It is important that participants see the investigator as a person they can trust. Informed consent may be an important element for the establishment of an adequate bond between researcher and participants. The investigator should be helpful to all participants and provide all the information needed, so that each individual is able to make their own decision, according to their personal concerns.4,13,14

Active participation of the elderly in the decision-making process is often inadequately curtailed by the family or by institutional limitations.15 However, there is a dearth of studies focusing on research in gerontology to identify the singular aspects of the relationship between investigator and elderly subjects.

Therefore, the aim of the present study was to evaluate the use and adequacy of informed consent in research carried out with the elderly in the South of Brazil.

Method

Researchers and subjects involved in clinical trials with the elderly were interviewed. All participants in the present study were engaged in research projects carried out at the Institute of Geriatrics and Gerontology (IGG) of the Catholic University of Rio Grande do Sul (PUCRS), Southern Brazil, a World Health Organization and Pan-American Health Organization Collaborating Center for Prevention of Pathological Aging and Associated Chronic Degenerative Diseases.

We considered as elderly those people aged 60 years or older.16 We evaluated the informed consent terms used in the six different research projects between September 2001 and January 2002, that were in the process of enrollment and selection of participants. The level of difficulty associated with the reading of each term of informed consent was assessed by the Index of Legibility of Flesch-Kincaid (ILFK) and the Index of Flesch (IF).17 Both indices have been validated for Brazilian Portuguese.1

This project was approved by the ethics committee at PUCRS. The analysis of results was performed with statistical tests,18 using the software SPSS 9.0 for Windows and Epi Info 2000.

Results

Thirty-two elderly participants of the six ongoing trials in gerontology and the six principal investigators were interviewed.

Most participants were female (75%). Mean age was 75.4 years ± 10.0 years (median = 71 years). Concerning educational level, participants ranged from illiteracy to having completed high school. None of the subjects interviewed had college-level education or higher. In the six trials, the number of procedures involved varied from two to nine, with a median of 2.5 procedures. The mean number of risky situations described was 2. One term of consent did not report any risk. The number of benefits described varied from 0 to 5, with a median of 1.5.

Values obtained with ILFK showed that the understanding of the terms of consent required from 9 to 17 years of schooling (mean of 14.6 and median of 15.5 years of schooling). IF results ranged from 33% to 54%. Five terms of informed consent were considered difficult to read, or near the limit of very difficult. The mean IF was 38.83% (median 37%). This value indicates that taken together, the six terms were difficult to read.

Usually, investigators read the term along with the patient or aloud; however, all 32 subjects interviewed reported a preference for having the investigator read the informed consent form aloud to them. The reasons pointed out by them included not having to bring glasses; not having patience to read; not knowing how to read. Some subjects also reported that they trusted the investigator and therefore did not feel the need to read the term before signing in, and that it was sufficient to read it later at home. Other subjects reported just giving the document to their family to read, despite having already given their consent.

The majority of the elderly, 94%, had agreed to participate in the study before going through the informed consent process. Many individuals had already accepted the invitation to participate even before knowing which trials they would be involved in.

In terms of informed consent, 5% of the elderly reported having received information prior to signing the form. In 91% of the cases, subjects reported not having any doubts concerning the studies, although 72% could not remember the term of informed consent they had signed. In addition, 75% did not find the text accessible.

All investigators reported that, from their point of view, the texts were accessible to the subjects. In 88% of the cases, the elderly understood the information described. The statistical analysis showed a significant difference (P < 0.05) between the schooling level of participants and the level demanded by the texts of all the terms of informed consent analyzed. At the same time, the perception of investigators and participants regarding the degree reading difficulty differed (P < 0.05).

 

Conclusions

Research ethics committees base their assessment on the terms of informed consent. The majority of the subjects declared that they had decided to participate before reading the document, based only on the information provided by the investigator. Our study demonstrates the need to build new parameters for the informed consent: This process must ensure an effective interaction between possible participants in the trial and investigators. Information should be shared, and the consent must be founded on a relationship of mutual trust.

 

References

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15. Goldim JR. BioŽtica e envelhecimento. In: Freitas EV, Py L, Neri AL, Canado FAX, Gorzoni ML, Rocha SM, eds. Tratado de geriatria e gerontologia. Rio de Janeiro: Guanabara Koogan; 2002:85-90.

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http://www3.who.int/whosis/menu.cfm. Accessed July 5, 2002.

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