scholarly journals The regulation of informed consent to participation in clinical research by mentally ill persons: An overview

2010 ◽  
Vol 16 (4) ◽  
pp. 6
Author(s):  
A Nienaber

The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft) regulations, and the South African Constitution.

2020 ◽  
Vol 20 (3) ◽  
pp. 256-283
Author(s):  
Himani Bhakuni

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.


Obiter ◽  
2021 ◽  
Vol 42 (1) ◽  
pp. 148-161
Author(s):  
Shannon Hoctor

Once a crime has been committed, full repentance and restoration do not have any bearing on liability, but may be taken into account in mitigation of sentence. On the other hand, there is no question of criminal liability ensuing for an attempt at a crime if there is a withdrawal from the envisaged crime while still in the stage of preparation, and before, in South African law, reaching the watershed moment of the “commencement of the consummation”. However, what occurs between the moment when the attempt begins, and the moment when the crime has been completed, where there has been a withdrawal from the criminal purpose, is more contested terrain. The disagreement does not apparently arise in the South African case law, where the few judgments that refer to this question have consistently held that where the accused withdraws after the commencement of the consummation of the crime, there will be attempt liability and, at best, the accused may rely on the abandonment as a mitigating factor in sentencing. However, as is discussed, prominent South African academic commentators, along with comparative sources in both the civil-law and common-law jurisdictions, demur from such an “unyielding analysis”, and would regard such withdrawal as giving rise to a defence to criminal liability. Which approach ought to be applied in South African law?  The question may be posed as to how to categorise a defence of voluntary withdrawal? It is neither a justification ground nor a ground excluding fault, but rather a ground excluding punishment. The uniqueness of the defence is demonstrated in that the accused has already met all the requirements for liability, and thus it is not an intending criminal, but an actual criminal who is being considered. This is at least true of the common-law approach (also adopted by South African law), where a two-stage approach is applied to the trial, relating first to establishing criminal liability and followed, if guilt is so established, by an inquiry into sentence. At the outset, it may be stated that the view that is taken in the discussion that follows is that there is no good reason to treat voluntary abandonment as a special defence. As Yaffe has stated, to grant a defence on the basis of abandonment is to mistake the absence of a reason to issue a particular sanction rather than a lower one for a sufficient reason to issue no sanction at all.In the discussion that follows, the current case law is examined, whereafter the alternative approach contended for by some academic writers (and used in other jurisdictions) is discussed; the arguments for and against a renunciation defence are set out, before these aspects are drawn together in a final concluding analysis.


2013 ◽  
Vol 21 (1) ◽  
pp. 16-27 ◽  
Author(s):  
Shirley T Bristol ◽  
Rodney W Hicks

Successful clinical research outcomes are essential for improving patient care. Achieving this goal, however, implies an effective informed consent process for potential research participants. This article traces the development of ethical and legal requirements of informed consent and examines the effectiveness of past and current practice. The authors propose the use of innovative monitoring methodologies to improve outcomes while safeguarding consent relationships and activities. Additional rigorous research will help direct policy efforts at standardizing quality improvement processes.


Author(s):  
Anatoliy Lytvynenko

The given article deals with the Canadian legacy of civil actions on negligence and technical assault or battery involving an unauthorizedmedical interference to plaintiff. In modern doctrine and case-law, the given concept is named “informed consent”, upon whichthe patient is not a mere subject of medical treatment, but has a substantial set of patient rights, involving the informational ones, whichincludes his right to be informed on further invasive treatment and thus to be able to assent or decline it. The doctrine of informed consent,arising from actions on unauthorized medical treatment in both common law and civil law jurisdictions, has a centuryfold historyin the jurisprudence. In the common-law world, it was bred in the end of the 19th century primarily in the jurisprudence of Americancourts, but still has its distinct peculiarities in the common law of Canada throughout the twentieth century. The span on the researchedjurisprudence embraces the time period of 1899 (judgment of Parnell, which was the first case to deal with the subject) to 1980 (caseof Reibl v. Hughes), where the Canadian Supreme Court has firmly recognized the principle of informed consent in the acting commonlaw. In the 1990s, the principles of informed consent had been codified. The author has investigated on the evolvement of the conceptof patient’s right to autonomy in the state from the very beginning to the judgment of Reibl v. Hughes in 1980, and has researched theroots of the “right to autonomy” as an extension of the right to privacy, which has penumbrally existed in Canadian jurisprudence forover a century, despite having been recognized as such relatively recently, despite an existence of various early case-law legacy. Apartfrom the abovesaid, the author aimed to define the authorities used by Canadian courts in the earlier cases dealing with unconsentedsurgery, which involves judgments from other jurisdictions as well as professional legal and medical textbooks.


2018 ◽  
Vol 32 (1&2) ◽  
Author(s):  
Chuks Okpaluba

In order to accomplish its objectives of extensively regulating rights and obligations, the 1996 Constitution of South Africa similarly provides for the enforcement of those rights by the courts. In turn, it has, in the said enforcement provisions, invested in the courts enormous discretionary powers to enable them to effectively deal with breaches of the entrenched fundamental rights as well as all constitutional rights violations. That the Constitutional Court has purposefully interpreted and made optimum use of the expressions: ‘appropriate relief’ and ‘just and equitable’ order in developing the constitutional remedies jurisprudence is crystal clear from a wealth of available case law. It is also not in doubt that the contributions of Justice Ngcobo (later Chief Justice) in this regard are intellectually gratifying. This presentation singles out for discussion and analysis the judgment of Ngcobo J in Hoffman v South African Airways 2001 (1) SA 1 (CC) which not only typifies judicial activism at its acme; it has also introduced into the South African public and labour laws, the novel remedy of ‘instatement.’ Apparently drawn from the analogy of the labour law remedy of reinstatement, ‘instatement’ is akin to the remedy of mandamus in public law, and specific performance in the law of contract. This article moves from the premise that this innovation is one of its kind in contemporary common law jurisprudence and one which courts in the common law jurisdictions world would no doubt emulate one fine day.


1979 ◽  
Vol 7 (4) ◽  
pp. 479-491 ◽  
Author(s):  
Mary C. Sherman ◽  
F.S. Abuzzahab

Psychiatry and the law interface on the issue of informed consent in a singular way, because of the nature of the psychiatric patient. In the 1970's, with the increase in societal consciousness about psychiatric treatment and commitment procedures, principles regarding informed consent in psychiatric practice have been enunciated in case law. Some fundamental conflicts between psychiatry and the law remain, however, leaving the patient in the middle. No methods of care have been designed by religious and professional groups who oppose psychiatric treatment for those patients who “refuse” treatment. Systematic research is needed to test methods of consent and contents of consent disclosure.


1978 ◽  
Vol 133 (4) ◽  
pp. 366-369 ◽  
Author(s):  
I. G. Pryce

The ProblemOver the last two decades increasing attention has been paid to the rights and safety of the subjects of clinical research. A key safeguard against any abuse has been the requirement to obtain the subject's informed, valid or true consent, which has been defined by the Medical Research Council as ‘consent freely given with proper understanding of the nature and consequences of what is proposed’ (M.R.C., 1962–3). However, it has been recognized by the M.R.C. that it may not be possible to obtain such consent from, among others, some subjects who are mentally ill. Whether or not a research project should be carried out on such subjects should depend, they say, on whether or not ‘there are reasonable grounds for believing that a particular new procedure will contribute to the benefit of that particular patient…’, and further, ‘when true consent cannot be obtained, procedures which are of no direct benefit and which might carry a risk of harm to the subject should not be undertaken’ (M.R.C., 1962–3).


Author(s):  
Kate J O'Regan

The relationship between the Bill of Rights in the South African Constitution of 1996 and the common law is analyzed in this paper. "Common law" is understood broadly to include not only the Roman-Dutch law, but also the wide variety of legal sources and traditions which make up South African law, including African tradition, Muslim practice and the English law heritage.Firstly an exposition of the chief characteristics of the hybrid system of South African common law is given. It is shown that the common law is not codified; that it is a living and organic system of law constantly under legislative and judicial review; that its sources vary from judicial precedent to civilian authorities, English, indigenous customary and Muslim law; that the style of litigation and adjudication is English rather than Continental in Character and that when a common law rule is modified, it is done retrospectively in conflict with principles of legal certainty.Secondly the chief constitutional provisions relating to the relationship between the Constitution and the common law are considered. The supremacy clause (section 2) renders a common law rule which is inconsistent with the Constitution invalid from the date of the Constitution unless a court gives a different ruling in accordance with justice and equity. Courts have the inherent power to develop the common law, but the Constitutional Court may do so only in constitutional matters. Two forms of constitutional normative effects may be distinguished: direct (as in sections 2 and 8(1)) and indirect (as in section 39(2)). In terms of the latter the spirit, purport and objects of the Bill of Rights are to guide the development of the common law.Thirdly the interaction between the common law and the Constitution is thoroughly explored with reference to common law rules that are in conflict with the Constitution as well as where the common law already provides protection for the rights provided by the Bill of Rights. These matters are explored with reference to a number of recent judgments of the Constitutional Court, in some of which the common law was effectively developed.It is concluded that the firm normative thrust of the Constitution may well prove to be a rich source of principle for the development of the common law and that the flexibility of the common law may facilitate a cross-pollination between it and the Constitution.


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