Informed consent in experimental research

Informed Consent in Experimental Research

For templates, click here.

In order for a potential subject to make an informed decision as to their participation in any research, the subject must be made aware of the nature, purpose and duration of the research, the method by which the research is to be conducted, and any risks or benefits which may come from participation in the research.

The information provided to the subject should be written at an appropriate level and should avoid the use of jargon or technical terminology.

The information provided to the subject should include the following:

  1. A statement that the study involves research
  2. An explanation of the purpose of the research
  3. The expected duration of the subject’s participation
  4. A description of the procedures to be followed
  5. A description of any reasonably foreseeable risks or discomforts to the subject
  6. A description of any benefits to the subject or to others which may reasonably be expected from the research
    If the subject will not derive any direct benefit from participating in the research, this should be made clear. You may suggest possible benefits to others that the study may have, however you may not make unfounded claims regarding the potential benefit of the study.
  7. A statement describing the extent to which, and the way in which, subject anonymity and the confidentiality of subject records will be maintained
  8. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights
  9. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subjects may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
  10. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
    A researcher has the right to refuse to allow a subject to participate in a study, or to discontinue testing of a subject after testing has commenced. Common reasons include consideration of the wellbeing of the subject (e.g., if the subject feels unwell or uncomfortable with the testing situation but has not asked for the testing to stop), failure to meet testing criteria or failure to follow test instructions.
  11. Any additional costs to the subject that may result from participation in the study; any payment that the subject may receive for participation in the study
  12. A statement indicating either (i) the body that has given ethical approval for the study, or (ii) the set of ethical guidelines which the researcher(s) have undertaken to follow
    Click on the links below to find appropriate ethical guidelines:
    British Psychological Society – code of ethics and conduct
    Medical Research Council – guidance on good research practice
    British Sociological Association – statement of ethical practice (pdf)
    British Association for Applied Linguistics – recommendations on good practice (pdf) (Check out the student version too: British Association for Applied Linguistics – recommendations for student projects [pdf])
  13. A place for the subject/caregiver to indicate their consent.

In some cases, you may believe that you cannot provide one or more of the above pieces of information to the subject, e.g., you feel it would influence their behaviour in a way that would prejudice the research. Please see the page on deception vs. incomplete disclosure for guidance.