Human Research Ethics Committee

Clinical trials in which registered or listed medicines (or medical devices) are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence. 

Acknowledgments The authors would like to thank all University of Sydney students who agreed to participate in this study. Data collections described in this work were authorised by the University of Sydney Human Research Ethics Committee, project reference numbers 04-2004/7353 and 08-2005/4/8461. 

Ethical approval for the 1998—1999 and 2000—2001 surveys was granted by the University of Tasmania Human Research Ethics Committee and for the post-intervention surveys in 2003, 2004, 2005 and 2007 by the Southern Tasmanian Health and Medical Human Research Ethics Committee and the Department of Educations Office of Educational Review. Individual informed consent was obtained from a patent/guardian of each child for all surveys. 

The study was approved by the University of Queensland Human Research Ethics Committee (reference 2011001430). 

The issue of (informed) consent looms large in discussions of the ethics of research involving human subjects and is a principal concern of the Research Ethics Committees that are now the norm in medical research. 

Under US regulations, each institution conducting research with human subjects must have its own IRB. These perform the same functions as the Independent Ethics Committees in Europe, and should contain at least five members, one of which should be independent of the institution. There should be available a mixture of scientific and non-scientific expertise capable of assessing research proposals from legal, ethical and scientific perspectives. The IRB must grant written authorisation to the investigator before a study can commence. They are also responsible for on-going reviews of research, and must report to the FDA ... 

Army Medical Research and Development Command Contract Review Board and the Surgeon General s Human Use Committee and Clinical Investigation Committee, to insure uniform application of ethical standards for human research studies conducted within or sponsored by the Army Medical Department and other Army Agencies. 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

A principal committee of the NHMRC, the Australian Health Ethics Committee (AHEC), provides guidance and support for HRECs in Australia, and is responsible for developing and publishing the National Statement on the Ethical Conduct of Research Involving Humans 1999, which replaced the previous NHMRC Statement on Human Experimentation and Supplementary Notes 1992. ... 

The IRB, also known as the ethics committee or human subjects committee, originally was established to protect people confined to hospitals, mental institutions, nursing homes, and prisons who may be used as subjects in clinical research. In the United States any institution conducting clinical studies supported by federal funds is required to have proposed studies reviewed and approved by an IRB. 

The goal of the IRB (known also as the Independent Ethics Committee, or IEC) is the protection of the rights, safety, and welfare of human subjects involved in clinical research investigations. The review board is, therefore, primarily responsible for the evaluation of the proposed research. All evaluations should have the following objectives (a) to determine that the research is properly designed (b) to determine that the benefit of the intended therapy will outweigh the potential risk and (c) to determine that the patient will be provided with adequate information to enable him or her to make an informed decision regarding participation in the clinical trial. 

The primary reason for the presence of GCP is to safeguard human rights, as the welfare of current study subjects and future patients is at stake. Therefore, systems must be in place (such as ethics committee review and informed consent) to protect study subjects. Collecting honest and accurate data is also a major objective of GCP to ensure that data have integrity and that valid conclusions may be drawn from those data. Further, data should be reproducible, that is if the study were to be conducted in a similar population using the same procedures, the results should be the same. To assure the integrity and reproducibility of research... 

Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects, Royal College of Physicians of London, 1997. 

If local institutions receive any federal research money, all human research must be approved by the IRB. This is not the basis for IRB review but provides the incentive for local institutions to conduct studies that are ethical. The committee becomes involved in matters such as confidentiality, anonymity, and moral issues related to experimental activities. Approval from an IRB, however, does not relieve the principal investigator from the basic responsibility of safeguarding the health and welfare of participating individuals. This is a moral and professional responsibility that cannot be delegated. 

Before commencing human SCNT experiments, approval for the study was obtained from the Institutional Review Board on Human Subjects Research and Ethics Committees of Hanyang University Hospital, Seoul, Korea. 

In 1971, in a move to affirm the Declaration of Helsinki, and further guarantee the protection of research subjects, the US Department of Health, Education and Welfare (DHEW) issued The Guide to DHEW Policy on Protection of Human Subjects. This publication required every institution receiving DHEW funds for research to establish a committee to monitor the ethical integrity of that institution s human research, and made both the institution and the investigator responsible for violations. 

Human experimentation is limited by statute and by ethical considerations to studies in which there is no prospect of permanent harm to the volunteers participating in the study. This obviously limits the scope of the results obtained by this route, although it can be employed to detenrane the onset of early symptoms or to determine threshold levels for detection of odors or irritation as a potential warning mechanism. Any experiment of this type must be carefully reviewed by a human subject review committee of the institution or corporate research facility where the research is being contemplated. Any subject of such experimentation must be fuUy informed of any risks or benefits and normally must be given an opportunity to withdraw at any point. However, even with this restriction, many experiments using volunteers have been conducted and significant data have been obtained on symptoms initiated by modest levels of... 

As elderly people are perceived to be a frail population, European regulation requires presentation of the research protocol to an ethics committee. Directive 2001/20/EC regulates and harmonizes ethical rules governing clinical trials in Europe. The ethics committee is an independent body made up of healthcare professionals and nonmedical members. Its responsibility is to protect the rights, safety and well-being of human subjects involved in a clinical trial, and to control the protocol, the suitability of investigators and the documents used to inform the subjects. Consequently, it is the responsibility of each investigator to ensure compliance of the sensory studies with the ethics laws of his country. 

April 2014 by the new Regulation No 536 014 which is to come into force no earlier than 28th May 2016), which deals with the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [56]. Each specific investigation has to be approved by an Ethics Committee. In the Netherlands, a national committee for clinical research has to assign a certificate of incorporation. Research with a non-licensed medicine without such an approval is not allowed. In Switzerland, a new act on human research entered into force as from 2014. It inserts an article into the Swiss Federal Constitution, recently voted and approved by the Swiss nation in 2010 [57]. 

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