The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by them, so that they can make the voluntary decision regarding ‘to’ or ‘not to’ participate in the research study.
(Nijahwan 2013, p. 134–140)

Participation in a research project must be entirely voluntary. In order for potential participants to make a decision whether or not to participate, it is important to fully inform them about the project. Ensuring that they are well informed allows people to weigh up the risks and benefits of participating in the project (Iphofen, 2005).

Obtaining informed consent to participate in a study often happens in two stages:

Stage 1: Participants receive an ‘information sheet’ with information about:

  • aim and objectives of the research project (i.e., what the research expects to achieve)
  • research process (e.g., location of data collection, methods of data collection, what participants will be asked to do)
  • risks and benefits of taking part (e.g., the risk of re-traumatisation or the benefit of receiving psychosocial support)
  • confidentiality and anonymity (i.e., a promise to protect the identity of the participant)
  • right to refuse and withdraw (i.e., participants should be able to end their participation during or after data collection without any fear of reprisal)
  • data handling and data protection (e.g., how data will be stored and protected to ensure privacy, confidentiality and anonymity of participants)
  • usage of data (e.g., publications, presentations, film screening, exhibition)

You need to present the information in an accessible way to potential participants, so it is important that you take their age, language competency and cognitive abilities into account. After you present the information to them, participants should be given  several days to reflect on the information they have received. They should be under no pressure to respond to the researcher right away. Rather, another consultation takes place during which people can ask you questions about the project.

Stage 2: Once people feel fully informed and have had their questions answered, they can officially agree to participate in the research by providing ‘informed consent’. In this case, you need to give them another document, the ‘consent form’. The consent form repeats the terms of the research in separate bullet points. The person then agrees to each term by giving explicit consent before consenting to participate in the project as a whole.

Written or Oral Consent?

Informed consent is mostly obtained in writing. However, there can be instances when it is not feasible to do so, and oral consent must be obtained instead. Oral consent is appropriate where:

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

In whichever way consent is obtained, you should never assume people are unable to make their own decisions, no matter how vulnerable or cognitively impaired they may be.

Consent as a Process 

Giving consent is increasingly seen as a process rather than a one-off event of signing a consent form. If participants are involved in a project over a longer period, it is especially advisable to inquire regularly whether they are still happy to be involved in the project.

It is also important to note that even after giving informed consent, participants are not obligated to participate in your study. They can withdraw their consent at any time without giving a reason. However, you can include a consent withdrawal deadline after which it is not possible to withdraw consent because data might have been analysed and impossible to remove from the now fully anonymised dataset.

(Author: Jonny (Jonathan) Adams and Bwalya Mulenga)

What is it?


Consent – UK Research and Innovation by UKRI

This website answers frequently asked questions about informed consent in research including health-related research.

(Academic reference: UK Research and Innovation (2022). Consent.

Online Courses:

Introduction to informed consent by the Global Health Training Centre

This free online course introduces the history of informed consent. It also describes informed consent regulations, guidelines and processes.

(Academic reference: The Global Health Network (n.d.) Introduction to informed consent.


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What is informed consent // Informed consent training by ELLICSR: Health, Wellness & Cancer Survivorship

This video introduces the concept of informed consent. It also outlines some of the challenges of informed consent in research studies.

(Academic reference: ELLICSR: Health, Wellness & Cancer Survivorship Centre (2017, July 18). What is informed consent // Informed consent training [Video]. YouTube.

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Basics – Part 9 – Informed consent by GCP-Mindset – All About Clinical Research published in 2020

This video discusses the importance and process of getting informed consent in clinical trials.

(Academic reference: GCP-Mindset – All About Clinical Research (2020, December 17). Basics – Part 9 – Informed consent [Video]. YouTube.


The ethics of research related to healthcare in developing countries. Chapter 6: Consent. By Nuffield Council on Bioethics

This report provides detailed information about the elements of informed consent and its important in research in developing countries.

(Academic reference: Nuffield Council on Bioethics (2002). The ethics of research related to healthcare in developing countries (pp. 71-83).

The process of informed consent. What’s at stake? by Arlene Katz and Kenneth Fox

This detailed article presents findings from a study of the informed consent process and makes recommendations for its improvement.

(Academic reference: Katz, A., Fox, K. (2004). The Process of Informed Consent. What’s at Stake?

How is it done?


Model participant information sheet and guidance by UCL Research Ethics

This template provides practical information for completing a participant information sheet.

(Academic reference: UCL Research Ethics. Guidance on Completing a Participant Information Sheet.

Informed consent form template for qualitative studies by the World Health Organisation

This is an informed consent template for qualitative studies which use questionnaires, in-depth interviews or focus group discussions.

(Academic reference: World Health Organization Research Ethics Review Committee. Informed consent form template for qualitative studies.