Regulation Of Medical Research Research Articles

Conditions of Legality of Medical Human Subject Research

The article examines international acts and national legislation and highlights the conditions for the legality of medical research with human participation.
 The provisions of the Nuremberg Code (1947), the Helsinki Declaration of the World Medical Association «Ethical principles for medical research involv- ing human subjects» (1964), the Universal Declaration on the Human Genome and Human Rights (1997), the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997) and the Addi- tional Protocols to the Convention, Regulation of the European Parliament and of the Council (EU) No 536/2014. The support of the recommendation to ratify the Convention on Human Rights and Biomedicine and its additional protocols in Ukraine has been expressed.
 It has been established that international acts stipulate that the design and implementation of each human subject research must be clearly described in the research protocol. In addition, research protocols must be subject to prior review by the Ethics Committees.
 It has been substantiated that international acts set for medical research standards, which are based on the principles of respect for dignity and human rights, the priority of interests of the person over the interests of society or sci- ence, compliance with safety requirements and prevention of harm to humans, mandatory permission to conduct medical examination, research and control- lability of the research process and its results, compensation for any damage caused by medical research.
 Conditions of legality of medical research can be divided into general (obser- vance of which is always necessary if a person participates in experiments) and special (additional conditions of legality, which are put forward depend- ing on the field or object of research, namely in the field of experiments com- bined with medical care , human genome research, in vitro embryo research, in the field of clinical trials of drugs).

Abstract PR004

Background & Objectives: Critically ill patients in the Intensive Care Unit (ICU) often lose their capacity for legal consent during part or all of their stay there, posing serious difficulties for enrolment in research into therapies which may improve their outcome. Although the insistence of strict consent requirements originates from the need to protect these vulnerable patients from possible exploitation, the unintended result might well be that of an impoverished evidence base from which to direct therapy. Can alternative approaches to consent balance the need for protection from exploitation with sufficient leeway to allow participation in therapeutic research which can expand the evidence base for Intensive Care medicine? Materials & Methods: Alternative approaches were identified from published studies in the Intensive Care field, proposals for advanced or proxy decision making for the mentally incapacitated and traditional bedside approaches. They are assessed with regard to autonomy, beneficence and non-maleficence of the four principles approach. Additional consideration is given to cultural context, conflict of interest of stakeholders, etc. Results: Traditionally the family is often involved on an everyday clinical basis. However, that completely disregards the autonomy of the patient, and the possibility of conflict of interest also exists. Often this approach is not formalized and considerable variation may occur. However, in countries and regions with a strong Confucian background (such as Japan and Korea), this approach is culturally acceptable and appropriate. Advanced medical directives and living wills appointing proxy decision makers are common approaches to the problem of decision-making for the mentally incapacitated patient, but are usually applied to therapeutic interventions rather than therapeutic research. There is acknowledgement of patient autonomy, but the possibility of conflict of interests always exists where a proxy is involved. The 2006 report of the Hong Kong Law Reform Commission noted that England and Scotland had made proposals regarding the regulation of medical research in mentally incapacitated persons, but it was also obvious that this was not common amongst the other jurisdictions reviewed. Delayed consent was used in the Australian SAFE study on the use of albumin in Intensive Care. Element of presumed consent somewhat disregards autonomy of the patient. Presumed consent would expose patient to risks before chance to refuse was presented. Conclusion: The approaches evaluated present few definitive advantages as they stand at present. In areas with a large Confucian influence, approaching the family might be a culturally appropriate way forward. Advance medical directives and living wills with proxy decisions makers can offer a way forward if further development on its application to therapeutic medical research in further undertaken. Disclosure of Interest: None declared

Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was <30 days, 16% had >89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects.

Does the Regulation of Medical Research in the Netherlands Adequately Protect Privacy Rights After Death?

There is a growing interest in scientific research using data and bodily material for medical purposes. In 2007 and 2011, results were published of studies on the genetic properties of the DNA of a deceased person. This case raises the question whether a deceased is entitled to legal protection, more specifically privacy protection in scientific research in the Netherlands. This article outlines the Dutch legal framework for scientific research involving historical data and bodily material as well as bodily material and parts of the deceased. These considerations do indicate that further legislation will be required, specifically with respect to the proper use of bodily material of the deceased and subsequent publication of the results.

Conference on emerging issues in ethics and regulation of medical research

Conference on emerging issues in ethics and regulation of medical research

Incommensurable worldviews? Is public use of complementary and alternative medicines incompatible with support for science and conventional medicine?

Proponents of controversial Complementary and Alternative Medicines, such as homeopathy, argue that these treatments can be used with great effect in addition to, and sometimes instead of, ‘conventional’ medicine. In doing so, they accept the idea that the scientific approach to the evaluation of treatment does not undermine use of and support for some of the more controversial CAM treatments. For those adhering to the scientific canon, however, such efficacy claims lack the requisite evidential basis from randomised controlled trials. It is not clear, however, whether such opposition characterises the views of the general public. In this paper we use data from the 2009 Wellcome Monitor survey to investigate public use of and beliefs about the efficacy of a prominent and controversial CAM within the United Kingdom, homeopathy. We proceed by using Latent Class Analysis to assess whether it is possible to identify a sub-group of the population who are at ease in combining support for science and conventional medicine with use of CAM treatments, and belief in the efficacy of homeopathy. Our results suggest that over 40% of the British public maintain positive evaluations of both homeopathy and conventional medicine simultaneously. Explanatory analyses reveal that simultaneous support for a controversial CAM treatment and conventional medicine is, in part, explained by a lack of scientific knowledge as well as concerns about the regulation of medical research.

Protection of Incapacitated Elderly in Medical Research

The widened scope of medical research has resulted in the establishment of multiple international, European and national rules and norms. Firm regulation of medical research is especially important when vulnerable people like incapacitated elderly are involved. The protection of incapacitated elderly is at stake when rules and norms are multi-interpretable, unclear and conflicting.

The bonfire of the regulators: a phoenix from the ashes?

Jean McHale considers the implications of the Government's recent report, Liberating the NHS: Report of the arm's-length bodies review. The report proposes to abolish a number of regulatory and other arm's-length bodies: does this restructuring offer an opportunity to rationalize the regulation of medical research in the UK?

Study of medical research regulation announced

Study of medical research regulation announced

The CNEP trial: how a good trial was turned rotten

The CNEP trial: how a good trial was turned rotten

Medical Research on Minors in Finland

This article concerns the legal regulation of medical research on children in Finland. The topic is covered by the Medical Research Act of 1999 and by the Recommendations issued by the Working group on medical research on children in 2003. The Decisions of the Parliamentary Ombudsman also play an important role in this area in Finland. The article focuses on two specific issues: involvement of guardians in decision-making for the child, and the expansion of the right to self-determination of minors. Two case examples on these topics are also discussed. Overall, the author comes to the conclusion that the Finnish legislation, policy-makers, investigators and the industry have succeeded well in taking into account international legislation in this area, although there is also room for improvement.

Information disclosure, subject understanding, and informed consent in psychiatric research.

Investigator information disclosure and subject understanding are examined in four psychiatric studies using data drawn from observation of 88 consent sessions. In an attempt to determine if subjects' understanding of research can be improved, three experimental methods of information giving (including the use of independent subject educators) are compared to standard investigator disclosure. Findings indicate that the use of experimental techniques generally increases the quality of information delivered to prospective subjects, with disclosures by subject educators generating the most complete information. Subject understanding was also found to be significantly associated with the quality of information provided. Diagnosis and level of psychopathology, however, were found to be the most important predictors of subject understanding, with schizophrenics and the highly impaired most likely to demonstrate poor comprehension. These results suggest that the degree of improvement in understanding obtainable for severely disordered subjects is substantially lower than it is for others. The implications of these findings for informed consent, the regulation of medical research, and the protection of human subjects are discussed.