Ethical Risk Self Assessment

It can prove useful to conduct an assessment of 'ethical risk' prior to making an application to a research ethics committee, and to re-assess ethical risk when making an amendment to an ongoing study.

This Ethical Risk Self Assessment Tool which was developed by the HSE Research and Development Team for the purposes of assessing which studies might be suitable for expedited review is a helpful tool for researchers and research ethics committees.

This tool was developed with research studies which seek to survey, interview or observe HSE staff in mind, hence, would need to be modified for studies involving patients - while some research studies involving patients seek to survey, interview or observe, many will involve a diagnostic test, medical exam, medical procedure, sample collection, sample analysis etc, etc....

The four key ethical principles to keep in mind are:

  • Beneficence - do good
  • Non-maleficence - do no harm
  • Respect Autonomy - obtain consent
  • Justice - be fair

Each research study brings benefits, and carries risks of harm. Researchers aim to minimise the risks of harm, while fully informing participants, allowing them to make an informed decision as to whether they wish to take part in a research study or not. Researchers aim to be fair and just in allowing access to the opportunity to take part in research, and access to the benefits of research in general.

Each research study builds on the knowledge previously published in a particular field of study, with the ultimate aim of finding information or developing a tool which will help current patients, or the next generation of patients.

Some research studies are conducted by students, and the goal of the study may be simply to teach and train the student in how to conduct research.