Recruitment and informed consent procedure template
This is a recruitment and informed consent procedure template endorsed by the European Union Clinical Trials Coordination and Advisory Group to support implementation of Regulation (European Union) No 536/2014 on clinical trials of medicinal products for human use. It is intended for use when describing both recruitment arrangements and informed consent procedures and is aligned with the content required in Annex I of the EU Regulation. It is most relevant for teams planning a clinical trial of a medicinal product in the EU or EEA under this Regulation and seeking a concise, structured checklist of what ethics committees and competent authorities expect for recruitment and informed consent, including special populations and situations such as emergency research or cluster trials. It is less likely to be needed where the study does not fall under the EU Clinical Trial Regulation or where a national template already in use clearly covers the same requirements.
The document is structured as a set of questions with free text fields to complete for a specific trial. It can be used as a standalone description or as a guide for what needs to be included in the trial protocol. Sections that are not relevant for a particular trial can be deleted or explicitly marked as not appropriate.
The template covers:
- All clinical trials
- How potential participants will be identified, including whether existing lists or other identifiable information will be used.
- Which recruitment materials and channels will be used, and how they will be presented to potential participants.
- Who will approach potential participants and who will obtain informed consent, including their professional role and any existing clinical relationship.
- When, where and under what conditions informed consent will be obtained, how privacy will be protected and how much time will be given to decide.
- How the researcher will check that information has been understood and that consent is truly informed.
- Arrangements for people who do not speak the national language.
- How participants can withdraw consent at any time and what the consequences will be for data and participation.
- A field to define the first act of recruitment if the form is also used to describe recruitment arrangements.
- Clinical trials that recruit incapacitated adults
- Justification for including adults who cannot consent for themselves and why similar data cannot be obtained from adults who can consent.
- How capacity to consent will be assessed and by whom.
- How people with fluctuating or borderline capacity will be involved in the decision and how they will be re consented if they regain capacity.
- How the legally designated representative will be identified and which roles can act in this function.
- Clinical trials involving minors
- Justification for including minors in the trial.
- How minors will be involved in the decision to participate, including how assent will be sought and recorded.
- Who will obtain consent and which training or experience they have with children.
- How the legal representative will be identified.
- How participants will be consented to continue in the trial once they reach the age at which they can legally consent.
- Clinical trials using an impartial witness
- Why an impartial witness is expected to be required, for example when participants cannot write.
- How an impartial witness will be identified.
- How the researcher and witness will confirm and document that the participant has given informed consent.
- Clinical trials in emergency situations
- Why it is not possible to obtain consent from the participant or the legal representative before inclusion.
- How informed consent will be obtained as soon as possible afterwards, from the participant or from a legal representative.
- How it will be checked that the participant has not previously expressed an objection to taking part in such a trial.
- Cluster clinical trials
- How simplified informed consent will be obtained in trials that randomise groups rather than individuals, where this is compatible with national law and where the medicinal product is used as authorised with no additional interventions beyond standard treatment.
- A reminder that the justification for simplified consent must also be described in the protocol.