Informed Consent Policy

From Top Italian Scientists Journal

TISJ treats Informed Consent as one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.

Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.

There are two distinct stages to a standard consent process for competent adults:

  • Stage 1 (giving information): the person reflects on the information given; they are under no pressure to respond to the researcher immediately.
  • Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.

Researchers should ensure that they comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if they will be collecting 'special category' (ie sensitive) data or personal data in the course of their research (also refer to the advice on consent in research involving children).

Written or oral consent – which process suits your project?

Which process to use depends on the research project (its context, design and participants), though an oral process is usually only appropriate where a written process is not feasible.

Any consent process must be understandable to the participants concerned. Please see the sections below to find out about different processes which may be used depending on the context.

Written informed consent process

A written process is used where:

  • Reading and signing forms is not problematic.
  • The research is complex or has multiple stages.
  • First access to the research participants is by providing written information.

Though opinions differ about the legal force of signed consent forms, they provide extra proof that the terms of consent have been understood. This can be especially important when seeking consent for copyright over data, or for future uses of data. Also, future funders or regulators may want written proof of the terms of original consent.

For literate participants who are not put off by written information, a written process is often a straightforward way of communicating the 'research contract'.

Between the provision of information and obtaining consent, the participant should be given a reasonable amount of time to consider whether to consent and to ask questions, though the time given depends on the project design, the context of the research and the participants.

Oral informed consent process

An oral consent process is where researcher and participant have a conversation to give information and obtain consent. There is no paper form to sign. It is normally used:

  • where literacy is a problem
  • where there are cultural or political concerns with signing contract-like documents
  • where either the researcher and/or the participant could be put at risk by existence of a paper record
  • where time for consent is limited, eg a chance interaction between researcher and participant (although you should not use an oral process merely to correct poor planning of research)
  • for research conducted via remote video conferencing software

It may also be more appropriate when interviewing elite participants as part of the research.

For all other research, how you arrange the oral process depends on how you will encounter your participants (for example email, phone, an on-the-street-meeting by chance). Between the information-giving and consent stage the participant should be given a reasonable amount of time to consider whether to consent, though this depends on the project design, the type of participants and the context of the research.

When obtaining oral consent, please ensure you are recording the consent process either using a recording device (for example audio recorder if you are conducting an interview that needs to be recorded) or, if participants do not agree to audio recording or if using or keeping audio records is unsafe, by using a researcher record of oral consent template or completing a written consent form on their behalf.