Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

Human projects and ethical approval

All human interaction, including human research, has ethical dimensions. Responsibility for the ethical design, review and conduct of human research is exercised at many levels. While the processes of ethical review are important, individual researchers and the institutions within which they work hold primary responsibility for ensuring that their research is ethically acceptable.

Examples of activities that do require ethics approval are research projects which include:

  • Student projects at both undergraduate or postgraduate level
  • Staff projects
  • Questionnaires
  • Findings that will be reported or published externally

Activities that do not require ethics approval are those which:

  • Audits or end-of-course evaluations of teaching programmes delivered in the RCSI (e.g. questionnaires to test current course content, or ask for comments regarding possible changes).*
  • Findings which will not be reported or published externally

For example, RCSI staff members do not need to obtain ethics approval if they are conducting a research audit for the purpose of reviewing current teaching programs, courses, services, policies, procedures, or for quality improvement purposes, provided the nature of the research is non-invasive and the findings will not be published or presented externally.

*Evaluation and feedback from RCSI students is part of the normal curriculum cycle and is considered as recommended ongoing quality assurance of routinely collected data from the College courses. Since the information collected within this type of evaluation is not obtained for research, rather it is the routinely collected educational data and information from RCSI students that makes up the educational assessment, this type of study does not require ethical approval. However all formal studies of this nature must be planned in a thorough and professional manner, should be proposed to and approved by the Dean (undergraduate studies) and the equivalent relevant senior person in postgraduate settings, and follow the recommended policy for curriculum evaluation in the College as follows:

  • Data should not be reviewed by non-RCSI staff (this can only take place when a duty of confidentiality has been put in place)
  • Any data collected should be anonymised wherever possible, removing identifying information such as name, student number, address, date of birth, etc. All data must be kept secure, ensuring that only relevant RCSI professionals are able to access this data. All electronic data must be stored on the RCSI server on password protected files.
  • Data must only be collected for the stated purpose of audit and only that which you need to answer your audit objectives (keeping in mind the Data Protection Principle 'Adequate, relevant and not excessive').
  • The Data Protection Act (1988 & 2003):There are eight principles that we are required to comply with to ensure that information is handled appropriately. Someone who determines the purposes and the way in which any personal data is processed, has to keep to these principles.

     

    These being that data is:

    1. Fairly and lawfully processed
    2. Processed for limited purposes
    3. Adequate, relevant and not excessive
    4. Accurate
    5. Not kept for longer than is necessary
    6. Processed in line with your rights
    7. Secure
    8. Not transferred to countries without adequate protection

However, please do not assume that you do not require ethical approval and please ensure that your project is not actually research. In cases where there is uncertainty about whether a project is audit or research please contact the Research Ethics Committee at recadmin@rcsi.ie for advice.

Remember that research projects will always require ethical approval.