- Rosana Soibelmann Glock 1, Jos Roberto Goldim21 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 Clnicas de Porto Alegre/Brazil. Corresponding author: Rosana Soibelmann Glock
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 1. Goldim JR. O Consentimento Informado e a adequao de seu uso na pesquisa em seres humanos [dissertation]. Porto Alegre: Universidade Federal do Rio Grande do Sul; 1999. 2. Bellino F. Fundamentos de Biotica. Bauru: EDUSC; 1997. 3. Seidman MD, Shapiro DP, Shirwany NA. Ethical issues for otolaryngology and surgery in the elderly. ENTJ. 1999;78(6):422-8. 4. Clotet J, Goldim JR, Francisconi CF. Consentimento Informado e a sua prtica na assistncia e pesquisa no Brasil. Porto Alegre: EDIPUCRS; 2000. 5. Habiba MA. Examining consent within the patient-doctor relationship. J Med Ethics. 2000;26:183-187. 6. Veatch RM. Medical Ethics. Sudbury: Jones and Bartlett Publishers; 1997. 7. Kirby M. Consent and the doctor-patient relationship. In: Gillon R, ed. Principles of health care ethics. London: Wiley; 1994:445-456. 8. Schwartz M. Lies sobre amar e viver. Rio de Janeiro: Sextante; 1999. 9. Hayflick L. Como e por que envelhecemos. Rio de Janeiro: Campus; 1997. 10. Henley EC, Twinble RL, Kremer L. Programas de promoo da sade. In: Pickles B, Compton A, Cott CA, Simpson JM, Vandervoort AA, eds. Fisioterapia na terceira idade. So Paulo: Santos; 2000:171-186. 11. Weston A. A practical companion to ethics. New York: Oxford; 1997. 12. Lohfeld LH, Brazil K. Understanding the collaborative experience between researchers and health care practitioners: Implications for gerontological nursing practice. Educational Gerontology. 2000;26:1-13. 13. Akabayashi A, Fetters MD. Paying for informed consent. J Med Ethics. 2000;26:212-214. 14. Wolf AM, Schorling JB. Does informed consent alter elderly patients' preferences for colorectal cancer screening? Results of a randomized trial. J Gen Intern Med. 2000;15:24-30. 15. Goldim JR. Biotica e envelhecimento. In: Freitas EV, Py L, Neri AL, Canado FAX, Gorzoni ML, Rocha SM, eds. Tratado de geriatria e gerontologia. Rio de Janeiro: Guanabara Koogan; 2002:85-90. 16. Statistical Information System of World Health Organization. Available at: http://www3.who.int/whosis/menu.cfm. Accessed July 5, 2002. 17. Price GD. The easiest way to improve your writing. 2nd ed. San Francisco: Reference; 1990.