These guidelines are intended to cover all subjects, so they are fairly general and are grouped under some main concepts.
Respect for the autonomy and dignity of persons
Respect for autonomy means that researchers should make sure that research participants are entirely free to make a choice about their participation in a study. In order to be in a position to make such a choice they must be given enough information about the research and what participation involves, they have to be sufficiently competent to understand this information and to understand it to their own satisfaction. They must also be free from influence or coercion. In ethical terms this means that researchers have to obtain informed consent and provide assurance that non-participation or withdrawal from participation can occur with no adverse consequences for the participants. A template form for routine use is available in Appendix 10 of the GCU research ethics booklet.
A lot has been written about Informed consent and it needs careful consideration. Researchers who are working with vulnerable people such as children, prisoners, those with some form of mental illness or incapacity or the very sick or old will need to pay particular attention to the way in which they gain informed consent. The process of gaining informed consent from young people and children is complex and must take into account current legislation (BMA 2000). Guidance on consent procedures is available on the following websites:
- GMC Learning Disabilities and the RCN policy on shared decision making and people with learning disabilities
- MPS guidance on children and the GMC's 0-18 Years : guidance for doctors
- Older people
- People in prison
This guidance focuses on clinical practice, but be aware that legally the principles that apply to clinical practice also apply to research.