Informed consent in clinical research at a general hospital in mexico: Opinions of the investigators

Developing World Bioethics

Volumn 6, Issue 1, 2006, Pages 41-51

  Vargas Parada, Laura ^b   Kawa, Simon ^b   Salazar, Alberto ^b   MazÖn, Juan José ^b   Flisser, Ana ^a  

^a HOSPITAL GENERAL DR MANUEL GEA GONZÁLEZ   (Mexico)

^b NONE

Author keywords

Clinical trials; Consent; General hospital; Information supplied in informed consent; Investigators; Mexico; Research protocols

Indexed keywords

PLACEBO;

ADULT; CLINICAL RESEARCH; DECISION MAKING; DEVELOPING COUNTRY; FEMALE; GENERAL HOSPITAL; HOSPITALIZATION; HUMAN; INFORMATION; INFORMED CONSENT; MALE; MEDICAL ETHICS; MEXICO; NORMAL HUMAN; PATIENT; PHYSICIAN; PRIORITY JOURNAL; REVIEW; WORK;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

ATTITUDE; CLINICAL TRIALS; COMPREHENSION; DISCLOSURE; ETHICS, MEDICAL; HUMANS; INFORMED CONSENT; MEXICO; PHYSICIAN-PATIENT RELATIONS; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RISK ASSESSMENT;

EID: 33645100026     PISSN: 14718731     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1471-8847.2006.00135.x     Document Type: Review

References (16)

1. Mexican General Law of Health, 2000. See appendix.
2. The Nuremberg Code (1949). In: Doctors of Infamy: The Story of the Nazi Medical Crimes. A. Mitscherlich & F. Mielke. New York: Schuman: xxiii-xxv.
3. E. Shuster. Fifty Years Later: The Significance of the Nuremberg Code. NEJM. 1997; 337: 1436-1440; World Medical Association (WMA). Helsinki Declaration VI. Bull Med Ethics 2000; 162: 8-11; Council for International Organizations of Medical Sciences (CIOMS). 1993. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. CIOMS; Pan American Health Organization (PAHO). 2000. Ethical Guidelines for Research Involving Human Subjects. Washington, DC. PAHO; General Law of Health of the United States of Mexico (1984, revised in 2000).
4. Mexican General Law of Health, 2000. Second Title Of Ethical Aspects of Research in Human Beings. Chapter 1, articles 20 and 21. See appendix.
5. E. Lazcano-Ponce et al Ethics and Communication between Physicians and their Patients with Cancer, HIV/AIDS, and Rheumatoid Arthritis in Mexico Arch Med Res 2004 35 66 75
6. F. Verheggen R. Jonkers G. Kok Patients' Perceptions on Informed Consent and the Quality of Information Disclosure in Clinical Trials Patient Educ Couns 1996 29 137 153
7. P.R. Ferguson Information Giving in Clinical Trials: The Views of Medical Investigators Bioethics 2003 17 101 111
8. Ibid. p. 101.
9. F. Alvarez Castillo Limiting Factor Impacting on Voluntary First Person Informed Consent in the Philippines Developing World Bioeth 2002 2 21 27
10. K.M. Taylor, R.G. Margolese & C.L. Soskolne. Physicians' Reasons for not Entering Eligible Patients into a Randomized Clinical Trial of Surgery for Breast Cancer. NEJM 1984; 310: 1363-1367; K.M. Taylor et al. Physician Response to Informed Consent Regulations for Randomized Clinical Trial. Cancer 1987; 60: 1415-1422; Ferguson, op. cit. note 7, pp. 105-107.
11. Guidelines for the General Rights of the Patients. As part of the National Campaign for a Health System of Quality, the Health Ministry issued the following Decalogue, which has legal founding on the different legal ordinances of the Mexican Law. This Decalogue should be displayed in a visible place at all public health institutions. The patient has the right to: (i) receive adequate medical attention, (ii) receive a dignified and respectful treatment, (iii) receive sufficient, unambiguous, opportune, and truthful information, (iv) decide without coercion about his treatment, (v) give or not his informed consent, (vi) be treated confidentially, (vii) receive all the facilities to obtain a second opinion, (viii) receive immediate medical attention in the case of an emergency, (ix) have a clinical file and (x) dispose of legal assistance in case of non conformity with the medical staff.
12. E. Hardy S. Ferreira Bento M.J. Duarte Osis Consentimento Livre e Esclarecido: Experiencia de Pesquisadores Brasileiros na área da Begulação da Fecundidade Cad Saude Publica 2004 20 216 223
13. P.L. Knudson Ethical Issues in Human Subject Research. Informed Consent to Participate in Research Arch Med Res 2002 33 88 89
14. P.S. Applebaum L.H. Roth C. Lidy The Therapeutic Misconception: Informed Consent in Psychiatric Research Int J Law Psychiatry 1982 5 319 329
15. Verheggen, op. cit. note 6.
16. Ferguson, op. cit. note 7.