As described in the Declaration of Helsinki, consent is an integral part of modern medical research involving humans. Respect for the autonomy of each and every individual assumes that explicit permission be sought for enrolling a patient in research of any sort. Valid consent requires that the person consenting:

  • Have capacity to make the decision
  • Be provided with all the necessary information, in a form that they are able to understand
  • Not suffer any undue influence or fear repercussions from their decision
  • Is informed of any conflict of interest of the researcher

It is the responsibility of the researcher to provide sufficient information to study participants to make their decision. This information is typically provided on the same form which is then signed by the participant to indicate their consent. This form is known as the Patient Information Sheet and Consent Form (PISCF).

The PISCF should address the following issues in terms that the typical patient can understand:

  1. What is this study about?
  2. What will happen to me if I enter? Eg. what treatment will I receive, how often, for how long, and how will it be allocated?
  3. What data will be collected? Who will have access to it?
  4. What are the risks of participation? Eg. side effects of treatment, effect on other treatments?
  5. What are the benefits of participation?
  6. Who is organising and funding the research?
  7. Do I have to participate?
  8. What if I change my mind about participation?
  9. What happens when the study ends?
  10. Will/can I be informed of the outcome of the research?
  11. Who can I contact for more information?

Participants should be given as much time as they wish to review the information and consider their decision.

Modification to the consent process

Trials in specific settings with vulnerable populations (such as in paediatrics, emergency medicine, intensive care) must have special consent process. Usually informed consent from patient’s legal representatives is sought, and if the patient can later agree to participate in the trial they must do so. In some circumstances, consent may be simplified or waived completely. Simplified consent includes ‘opt-out’ consent, meaning that participants are provided with information and the opportunity to choose not to participate, but that unless they sign and return the form or otherwise indicate, they are assumed to consent and will be included in the study. Such deviation from standard informed consent is supported only when obtaining consent is especially impractical and when study participation poses no or little risk to participants. Approval from an Ethics Committee or Institutional Review Board is still required to conduct a study under simplified or waiver of consent. Researchers must prove that the only way the study can be practically performed is to simplify or waive consent.