This section will provide some brief guidance and things to consider when working with human participants. You may need to consult other areas of the Toolkit to find more detailed information on working with, for example, children & young adults, vulnerable adults, those lacking capacity, crime research, internet research, research within an organisation/workplace, and medical research.
Human participants (or subjects) are defined as including living human beings, human beings who have recently died (cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids, and human data and records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements).
No doubt, at the outset of a project the researcher has an idea of who they need to recruit in order to adequately fulfil their research aims. However, additional thought should also be given to how participants and/or their data will be recruited. Will it be a targeted, direct approach; via gatekeeper; through random survey, etc.
The researcher must provide a detailed recruitment protocol that includes a justification for the approach proposed, a flow diagram of the stages of recruitment and a consideration of the measures in place to manage the risks to the participant.
A gatekeeper is any person or institution that acts as an intermediary between a researcher and potential participants, a gatekeeper may also have the power to grant or deny permission for access to potential research participants. Examples of where the use of a gatekeeper may be necessary include: where a researcher does not have legitimate access to personal data (names and contact details) of potential participants then it will be mandatory to use a gatekeeper who does have such access to make the first contact on behalf of the researcher. In other cases it may not be mandatory but good etiquette to use a gatekeeper.
Examples of gatekeepers include health and social care professionals, such as those working with patients, children or elderly. Gatekeepers may also be community leaders, elders of a community or clergy. Researchers must describe their recuitment strategy within the research protocol and give full consideration as to whether their is a need for a gatekeeper or not.
In all cases of research, researchers should inform participants of their right to refuse to participate or withdraw from the investigation whenever and for whatever reason they wish. Refusal to partcipate, or withdrawal from a study must be without prejudice to the participant. There should be no coercion of research participants to take part in the research. Adult research participants, however, may be given appropriate monetary reimbursement for their time and expenses involved. In some instances, it may be justified to use techniques such as a free prize draw or book vouchers, to encourage survey responses. Respondents must not be required to do anything other than agree to participate or return a questionnaire to be eligible to a free prize draw, and incentives must not be offered that require the respondent to spend any money. Where children are involved, it is often appropriate to acknowledge their help with gifts to participating schools and/or personal gifts such as book tokens. In short, incentives may be permissible, but anything which implies coercion is not.
In all cases of research, researchers should inform participants of their right to refuse to participate or withdraw from the investigation whenever and for whatever reason they wish. There should be no coercion of research participants to take part in the research see CIOMS guideline 7 (pdf)
Research involving human tissue (including blood) is subject to the 2004 Human Tissue Act, (or The Human Tissue (Scotland) Act 2006 (HT (Scotland) Act) as appropriate) and should adhere to the Codes of Practice issued by the Human Tissue Authority. Ethics approval should be obtained from an NRES research ethics committee.
Where research involves the need to secure tissue samples (including blood), participants should be informed of their rights over such samples and data derived from them. The researcher should justify their approach to the use and retention of tissues within the research protocol and they should provide clear and unambiguous information for research participants regarding their right to withdraw from the study and whether there are any limitations on the right to completely withdraw their sample and associated data.