Principles of Consent

The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it (NS 2.2.1). This information must be presented in ways suitable to each participant (NS 2.2.3). The process of communicating information to participants and seeking their consent should not be merely a matter of satisfying a formal requirement. The aim is mutual understanding between researchers and participants. In some research, consent may need to be renegotiated or confirmed from time to time, especially where projects are complex or long-running, or participants are vulnerable (NS 2.2.8).
Participants must be given a Participant Information Statement (PIS) except in exceptional circumstances where consent is to be obtained orally and a written script to be read to participants instead. (See “Exceptions to written consent”.)

Participant Information Statement and Consent Form

Participants must be given a Participant Information Statement (PIS) except in exceptional circumstances where consent is to be obtained orally and a written script to be read to participants instead. (See “Exceptions to written consent”.)
In almost all cases a Participant Consent Form (PCF) should be given to participants to sign. For exceptions please see “Exceptions to written consent” and “Waiver of Consent”.

Have you prepared a Participant Information Statement in appropriate lay language and suitable for the target audience? Information must be presented in a way that is clear and likely to be understood. Have you prepared a Participant Consent Form? If not, how will you document and record informed consent? Consent must be voluntary and free of coercion.

The PCF should:

  • be a separate document which outlines clearly what is being consented to.
  • ask consent for any specific tasks and/or risks.
  • ask for specific consent if participants are to be identifiable in any publication.
  • ask for consent for the use of the data in future research if this is likely.

Participant Information Statement and Consent form templates

Please make sure that you upload the PIS and PCF under the "Documents" tab before submitting your application