Informed consent guidance

Having gained permission to access a setting, whether formally or as a courtesy, your next responsibilities in your recruitment of participants are to provide information and gain their consent. It is important to ensure that consent to participate in a research project is effective, ongoing and freely given. These three criteria respect the basic rights of people to autonomy.

The level and form of consent to participate in research should be appropriate to the nature of the research topic, design and the participants. It should recognise, in particular, the:

• sensitivity or personal nature of the research, anticipation of the potential for distress from whatever source or the basis on which a participant is being asked to engage;
• wide variety of data types, ranging from anonymised-at-source, secondary data sources, non-sensitive data through to video recorded, identity-capturing data on sensitive topics;
• age and abilities of participants to understand and communicate their wishes.

Secure records should be kept which clearly demonstrate participants pathways to consent to engage in all aspects of the research journey, as relevant to the research design. For young people under the legal age of consent as appropriate to the research context and others whose particular needs affect their ability to consent, assent should be sought. In addition, consent should be gained from parents, guardians or others who have legal responsibilities for supporting the participant.

Further guidance specifically for children and young people is available

Effective and ongoing consent

Effective informed consent relies on providing sufficient information to potential participants prior to the research commencing. Participant information is the basis of informed consent, often provided as a participant information sheet (PIS), but could also be offered on a website or comprise audio or video communications. Giving potential participants sufficient information about the research in an understandable form requires careful drafting. Information should be provided and available to participants for their continuing reference. The journey of ongoing assent/consent is one of providing the right information for the participant at the right time, ie when the participant can most easily understand what is being asked of them and the consequences of their participation.

If the research relies on information being withheld either about the topic, because of the methods or other reason important to the integrity of the research, a researcher should make this case to the Human Research Ethics Committee (HREC). This should explain how the researcher is exercising the principle of minimising harm and maximising the benefits of the project. Any information withheld and the delay in disclosing the withheld information should be kept to the minimum necessary. A clear plan should be outlined of how and when these decisions will be communicated to the participants, which might involve a stage of debriefing.

Freely given consent

It is important that participation in a research study is not coerced. Coercion can come about in many ways, not just through the offering of rewards for consenting or disincentives for not consenting. Power dynamics often exist in relationships within the research settings, all of which might not be immediately obvious. Researchers have a responsibility to become aware of the potential for coercion and minimise the potential impact on participants. This covers the rights of gatekeepers and participants to take part in research as well as to decline the invitation.

It is important that no reward, actual or implied, is offered over and above reasonable recompense for travel, other incurred costs and the time and inconvenience of participation. Overly remunerating could encourage participation that is not driven by motivations to contribute to the aims of the study. Alternative forms of recognition to money or vouchers to offer thanks for the contributions could include digital badges or certificates of participation.

Forms and evidence of consent

Consent, whether in a verbal recording, electronic or hard copy form, should include an explicit statement that it confirms that the information about the research has been given to the participant and understood. To be inclusive, a researcher may engage a parent, guardian or other who have legal responsibilities for supporting the participant. There may be occasions when a researcher wants to provide a safe space for children, young people or vulnerable adults to reflect on their home experiences. After discussing with gatekeepers of settings who support such individuals, and other researchers, it might be that other adults ‘in loco parentis’ could be considered as appropriate to negotiate consent for the inclusion of their participation. Decisions would be best made based on maximising opportunities for voice whilst minimising the chance of risk of harm. In all such cases, assent should also be sought directly from the individuals participating.

Evidence of consent and assent should be recorded and form part of the data management plan which should include research-related documentation. Data management plans are now mandatory and advice about what to include and how to develop a plan can be found on the OU's Library Research Support site. You might also find it useful to refer to the FAQ on the HREC website with advice on the storage of consent forms.