HUMAN RESEARCH ETHICS

INTRODUCTION TO RESEARCH ETHICS: ISSUES, GUIDELINES, PRINCIPLES AND VALUES

PART A:
Achievement Test

The following questions are designed to enable you to show that you have understood the essential features of the philosophical basis and origins of human research ethics and of the objectives and scope of the National Statement.

Feedback is provided on your answers. Where this indicates that you have not selected the optimal answer, you will be directed to review this Part and answer the question a second time.

A1. Why were human research ethics committee systems established?

Select which of the following you regard as the best answer.

     

because of the atrocities revealed in the Nuremberg war trials


This is not the best answer. Although the judgment from this trial included the Nuremberg code contained important ethical principles for human research, the judgment did not propose committee review. Please review the material in this Part and answer the question again.

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because of the United States government's response to the disclosure of the Tuskegee syphilis study

This is the best answer. It was the 1974 US government response to the 1972 disclosure of the Tuskegee study that triggered the enactment of the regulations requiring institutions receiving Federal research funds to establish institutional review boards to review all federally funded projects. It is likely that this was the origin of the requirement in the 1976 Australian Statement on Human Experimentation that review of human research by an institutional ethics committee was required.

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because of the provision of the 1964 Declaration of Helsinki

This is not the best answer. The Declaration of Helsinki required only that a project be referred to a "specially appointed independent committee fort consideration, comment and guidance." It is not clear form the text whether this was intended to be a scientific or ethical review - or both. Please review the material in this Part and answer the question again.


A2 What is the process in Australia that aims to ensure that all human research projects meet acceptable ethical standards?

Select which of the following you regard as the best answer.

     

All projects are required by law to be reviewed by committees established by institutions conducting research.

This is not the best answer. There is no law in Australia that requires ALL human research projects to be reviewed by institutional committees. Please review the material in this Part and answer the question again.

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All projects are designed by suitably trained and experienced investigators and are reviewed by a committee of the investigator's peers.

This is not the best answer. The peer review of research projects is used to assess their scientific validity and/or their suitability for funding. Such reviews are not required to assess the ethical aspects of the projects and those reviews do not meet the national requirements of ethical review of human research projects. Please review the material in this Part and answer the question again.

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All projects are designed by suitably trained and experienced investigators and, before commencement, are reviewed, approved and periodically monitored by a human research ethics committee.

This is the best answer.


A3 What is the origin of the ethical standards that should be used by committees that review the ethical acceptability of human research projects?

Select which of the following you regard as the best answer.

     

the combined ethical sensitivities, ideas and values of the committee members.

This is not the best answer. Ethics committee members do draw on their own experience in their work, but the origins of the standards they should apply are not merely personal morality or prejudice. Please review the material in this Part and answer the question again.

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The provisions of the applicable national or international guidelines.

This is not the best answer. The guidelines are only the source of the standards in a formal way: they state the standards. The standards are ethical standards and their origin lies in the nature of ethics as an historical and cultural and intellectual process. Please review the material in this Part and answer the question again.

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The cumulative historical reflection on ethical standards of conduct on which contemporary societies draw in developing national and international guidelines on the ethics of the conduct of human research.

This is the best answer. Ethical standards share the historical, cultural and intellectual nature of ethics.