Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

BackgroundInformed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent.MethodsThe objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa.ResultsThe median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001).ConclusionsThis study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.

[1]  F. V. Oosten.  The Doctrine of Informed Consent in Medical Law , 1991 .

[2]  N. Sewankambo,et al.  Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study , 2012, BMC medical ethics.

[3]  R. Faden,et al.  Research and informed consent in Africa--another look. , 1992, The New England journal of medicine.

[4]  J. E. Kerrich.  Statistics in South Africa , 1968 .

[5]  E. Ezeome,et al.  Informed consent practices in Nigeria. , 2009, Developing world bioethics.

[6]  Z. Bankowski,et al.  Council for International Organizations of Medical Sciences , 1991 .

[7]  M. Jukič,et al.  Knowledge and practices of obtaining informed consent for medical procedures among specialist physicians: questionnaire study in 6 Croatian hospitals. , 2009, Croatian medical journal.

[8]  N. Kass,et al.  Post-consent assessment of dental subjects' understanding of informed consent in oral health research in Nigeria , 2009, BMC medical ethics.

[9]  Ulrich Rendtel,et al.  Editorial , 2014, Journal of basic microbiology.

[10]  A. Schlemmer,et al.  The effects of a language barrier in a South African district hospital. , 2006, South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde.

[11]  Jonathan Gorman,et al.  Rights and Reason: United Nations Universal Declaration of Human Rights , 2003 .

[12]  E F Cook,et al.  Quality of informed consent: a new measure of understanding among research subjects. , 2001, Journal of the National Cancer Institute.

[13]  J. Watt.  Sidaway v the Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital , 1996 .

[14]  R. Worthington.  Clinical issues on consent: some philosophical concerns , 2002, Journal of medical ethics.

[15]  B. Gordijn,et al.  Empirical Ethics and its Alleged Meta-Ethical Fallacies , 2009, Bioethics.

[16]  G. Barnes,et al.  Putting the ‘informed’ into ‘consent’: A matter of plain language , 2003, Journal of paediatrics and child health.

[17]  S. Mhlongo,et al.  Informed consent. Informed consent is light years away for black African patients. , 1997, BMJ.

[18]  Vincent T. Maphai.  Affirmative action in South Africa ‐a genuine option? , 1989 .

[19]  Craig G. A. Jones,et al.  From research to practice , 2013, Addiction Science & Clinical Practice.

[20]  Robert Edson,et al.  Evaluating the quality of informed consent , 2005, Clinical trials.

[21]  Andra le Roux-Kemp.  Foundational Principles of South African Medical Law, Pieter Carstens and Debbie Pearmain : book review , 2008 .

[22]  W. Hanekom,et al.  Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting , 2008, BMC medical ethics.

[23]  J. Dow,et al.  Mental Capacity Act , 2008 .

[24]  J. Youngleson.  Informed consent--a survey of doctors' practices in South Africa. , 1996, South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde.

[25]  L. Richter,et al.  HIV vaccine trials: critical issues in informed consent. , 2000, South African journal of science.

[26]  Maria Fenech Adami,et al.  The use of triangulation for completeness purposes. , 2005, Nurse researcher.

[27]  Victoria A. Miller,et al.  The Concept of Voluntary Consent , 2011, The American journal of bioethics : AJOB.

[28]  D. Canning.  Informed consent for neonatal circumcision: an ethical and legal conundrum. , 2002, The Journal of urology.

[29]  C. Rotimi,et al.  Tailoring Consent to Context: Designing an Appropriate Consent Process for a Biomedical Study in a Low Income Setting , 2009, PLoS neglected tropical diseases.

[30]  E. Sturman,et al.  The capacity to consent to treatment and research: a review of standardized assessment tools. , 2005, Clinical psychology review.

[31]  Glyn Hughes,et al.  Shortage of Doctors , 1962 .

[32]  G. Annas,et al.  Human rights and maternal-fetal HIV transmission prevention trials in Africa. , 1998, American journal of public health.

[33]  D. Irabor,et al.  Local attitudes, moral obligation, customary obedience and other cultural practices: their influence on the process of gaining informed consent for surgery in a tertiary institution in a developing country. , 2009, Developing world bioethics.

[34]  M. Jefford,et al.  Improvement of informed consent and the quality of consent documents. , 2008, The Lancet. Oncology.

[35]  Glenn Flores,et al.  Language barriers to health care in the United States. , 2006, The New England journal of medicine.

[36]  P. Appelbaum.  Clinical practice. Assessment of patients' competence to consent to treatment. , 2007, The New England journal of medicine.

[37]  Claire Gilbert Foster,et al.  International ethical guidelines for biomedical research involving human subjects , 1994 .

[38]  M. Ranney,et al.  Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa , 2006, Clinical trials.

[39]  D. Birnbacher.  Ethics and Social Science: Which Kind of Co-operation? , 1999 .

[40]  Bo Qing.  International ethical guidelines for biomedical research involving human subjects , 2003 .

[41]  C. Adebamowo,et al.  Surgeons' opinions and practice of informed consent in Nigeria , 2010, Journal of Medical Ethics.

[42]  W. Stevens.  Thirteen Ways of Looking at a Blackbird , 1917 .

[43]  Paul S Appelbaum,et al.  Voluntariness of consent to research: a preliminary empirical investigation. , 2009, IRB.

[44]  J. Leventhal,et al.  The interpreter as cultural educator of residents: improving communication for Latino parents. , 2006, Archives of pediatrics & adolescent medicine.

[45]  Pascal Borry,et al.  What is the role of empirical research in bioethical reflection and decision-making? An ethical analysis , 2004, Medicine, health care, and philosophy.

[46]  J. Zauszniewski,et al.  Methodological triangulation: an approach to understanding data. , 2012, Nurse researcher.