Respect for humans
All research and scholarship involving children under 18 years of age must be of a design that minimises predictable risk to the researcher and to the research subjects. The project must be seen to be beneficial to society and non-exploitative, either of human or animal subjects, or the environment. Accordingly, all researchers and scholars must:
- Inform individuals about all aspects of the proposed research
- Secure their voluntary agreement to participate - the principle of
- Handle and store personal information under conditions of the highest
- Use such information exclusively for the purposes of the research.
Research Involving Human Participants or Biological Samples
Researchers must ensure that informed consent is received and documented from all human subjects involved in the study or their legal guardians. They must be fully informed about the procedures and the purpose of the research. All material obtained from or about a subject should be treated as confidential and fully protected, and the researcher must fulfill any legal requirements such as those of the Data Protection Acts and the Freedom of Information Acts.The health and welfare of the subjects and the researchers is deemed to be paramount at all times.
In addition to ethical approval from DIT, approval must also be sought, where appropriate, from the relevant hospital or other relevant Research Ethics Committees and from other regulatory bodies as relevant, and as required by individual sponsors (eg the Wellcome Trust).
Researchers have a duty of care to their subjects, and should be cognisant of the following:
- The researcher has a duty of care to those discovered to be at risk if the research uncovers information about individual subjects that might have a bearing on their wellbeing
- Diagnostic tests and procedures should only be used if they are specific to the research questions asked, and should only be analysed by persons with the appropriate qualifications and competence to interpret the results. Duty of care may require feedback to the individual concerned or to someone responsible for the individual if the individual is identified as being at risk
- When feedback to an individual or legal guardian is warranted, extreme care is necessary to avoid possible negative consequences
- The researchers' duty of care to participants pertains only to the information that is central to the purpose of the research.
Research Involving Children and Other 'Less Powerful' Individuals
All research and scholarship involving children under 18 years of age must only be conducted when their participation is indispensable, the methodology is appropriate, and the circumstances in which the research is conducted provides for their physical, emotional and psychological safety. The emphasis is on ensuring children are seen as bona fide research players and decision makers, and that they are legitimised as such throughout the whole research cycle.
Researchers must be mindful of the more intrusive nature of some methodologies which involve children than other methods such as observation. In reducing the potential impact of this intrusiveness, the researchers must:
- explain the purpose of the interview to the children in a way in which they can understand.
- use language which takes account of the children's verbal abilities.
- choose a physical setting for the interview with which the children are
familiar and in which they feel comfortable.
- be sensitive in responding to the children's verbal and non-verbal
- give more/less time to the interview as the children dictate.
Using photography as a method for gathering information requires careful consideration of ethical issues. Among the most pertinent of these are issues concerning consent by the children themselves, ownership of the electronic images, how the images will be used and who will have access to them.
It is mandatory to obtain the informed written consent from the parent or legal guardian. The assent of the child/young person should be obtained to the degree possible dependent on the age of the child/young person. If none of the above is possible, an explanation must be given to the DIT Research Ethics Committee.
Similar guidelines are required when conducting research with other 'less powerful' individuals, eg the elderly, people in care, in hospital or in prison.
Information on consent forms and statements is given here...
Medicinal Products for Human Use
The Minister of Health and Children has made Regulations (European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004) (S.I. 190 of 2004) implementing the EU Clinical Trials Directive. The Regulations came into force on 1st May 2004. More information on clinical trials guidelines available here...
Any researcher involved in any testing of medicinal products must apply to one of the research ethics committees approved by the Department of Health and Children and to the Irish Medicine's Board for approval.