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Module 3: Conducting Research Responsibly – Protecting Yourself, Your Research, and Your University

3.4 Ethics and biosafety clearances and committees

Many of the interactions that a researcher has with research subjects or research materials are carefully regulated by society. Society's involvement has come about primarily because human subjects can and have been harmed by research. Research involving human subjects – whether gathering information, administering tests, or administering agents; collecting tissue, blood, or other body fluids; or using archived material where the subject is identified –requires considerations of recruitment and consent, and all of this stems from a need to demonstrate respect for persons. The ethical principles underlying this are now well described and accepted, but historically they follow in the wake of a record of failure which no researcher of integrity could now support. In the additional reading material you may wish to review the material that led to the establishment of the Nuremberg Code, the Declaration of Helsinki, or the initial and subsequent NHMRC National Statements.

Researchers must also consider regulations regarding the use of animals in research, and the use of chemical and biological agents, both of which can affect the environment of the researcher and the wider community. All institutions which receive funding from the NHMRC or ARC are required to follow the existing codes for the use of human subjects and the use of animals in research; they must also establish appropriately constituted ethics committees which review research before it commences, while it is happening, and at its completion. These codes are:

Additionally, researchers may need approval for:

You may also be required to comply with your university's requirements when:

Robust research practice requires that these considerations be built into your research planning. Research integrity requires that you can identify the risks involved in any planned research and have in place mechanisms to protect research subjects and your research colleagues.

The instances when you will require ethical approval are described briefly below:

  • Research involving human participation. All research involving human participation – in any of its many forms, including interviews and the completion of questionnaires – requires clearance from your institution's Human Ethics Review Committee. Student projects must also be cleared before commencement.
  • Research involving the use of animals. All work involving the use of animals must be reviewed by an Animal Ethics Committee and no animal experimentation can take place without a current animal ethics clearance.
  • Biosafety. Appropriate biosafety approvals must be obtained from your institution's Biosafety Committee prior to commencement of the research project, and the first-named chief investigator must ensure that project staff and students are qualified, trained, and appropriately supervised. There are potential health risks in using chemicals and biohazardous materials in the workplace, and all personnel working with such material should be familiar with and comply with regulatory authorities and internal university requirements in this area.

Time lag between application and approval of clearances. Ethical and biosafety review committees have a high workload and each application needs to be carefully scrutinised. It is no surprise, therefore, that it can take some time to obtain ethics or biosafety approval, delaying the commencement of your project. To avoid delays you should lodge your application for ethics or biosafety clearance at the same time as you submit your grant application. By doing this you will not only be able to make a start on preliminary work, but you will also be able to commence your project as soon as the funding agreement has been signed.

 

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