Recruitment and inclusion

  • WMO
  • Non-WMO

Recruitment

Participants can be recruited through various methods, depending on the target population and the available timeframe. In most cases, recruitment is conducted by the treating physician within the clinical setting (inpatient or outpatient). Other recruitment methods include advertisements, websites, brochures, or other tools.

Regardless of the chosen strategy, all recruitment activities must be approved by the review committee (CCMO or MREC).

Screening

An anonymous screening log must be maintained when identifying potential participants. This is a list of all potential participants, including those who do/do not enroll in the study and why.

Documenting reasons for non-enrollment - such as not meeting inclusion/exclusion criteria or not providing consent - demonstrates that no selection bias has occurred.

All study-specific information provided to potential participants must be submitted for approval to the review committee. This includes, but is not limited to, the subject information sheet (PIF) and informed consent form (ICF), advertising and recruitment texts, study brochures, patient diaries and questionnaires.
The CCMO provides national templates for the PIF and ICF on their website, for both adults and children.

At Amsterdam UMC, the standard procedure for obtaining informed consent is described in GCT SOP 01 Informed Consent Procedure to ensure that it is conducted in accordance with applicable legislation, regulations, and local requirements.

Key considerations:

  • Study-specific information must be written in clear, easy to understand language (level B1) to reasonably assume that participants understand the content of the study. Information is primarily provided in writing (via the PIF) and, when possible, oral consultation must be offered;
  • The review committee only assesses the Dutch version of the PIF and ICF. However, every potential participant must be able to make an informed decision. If a potential participant is not proficient in Dutch, the PIF must be available in a language they understand. The study sponsor is responsible for providing a certified translation. While the review committee does not require the translated PIF itself, the corresponding translation certificate must be submitted;
  • Always use the most recent, approved version of the PIF and ICF;
  • Record each step of the informed consent proces in the source documentation (medical record) of the participant. If a participant (see instructions for patients or healthy volunteers) is linked to the relevant study in Epic, steps can be documented using the drop-down menu. Smartphrases are also available*;
  • The potential participant and/or their legal representative(s) must be given sufficient time to consider their participation;
  • Carefully go through all sections detailing what the participant is consenting to;
  • Verify that the participant has understood all aspects of the study and address any remaining questions;
  • Ask the participant and/or their legal representative(s) to sign and date the ICF.
    If the participant cannot write or read, verbal consent may be obtained in the presence of an independent witness, who must then sign the ICF;
  • The participant/legal representative(s) must sign first, followed by the investigator or their delegate;
  • Provide the participant and/or their legal representative(s) with a copy of the signed PIF and ICF. Alternatively, have two copies signed so they kan keep one.

*For non-WMO research, linking participants to a study in Epic is not mandatory. However, it may still be beneficial to consider the following:

  • Is participation relevant to other healthcare providers in terms of patient safety?
  • Can participants be contacted for feedback, incidental findings, referrals, or follow-up questions if necessary?
  • Is the inclusion and informed consent process well maintained and documented outside of Epic?
  • Are study activities, data, and/or biological materials collected outside of Epic and (possibly) managed within a study budget? If so, the principal investigator is responsible for data storage and possible reuse of pseudonymised/anonymous data and materials, in compliance with applicable laws and regulations. The principal investigator must also ensure that study expenses are properly declared.

Revision of the PIF/ICF and re-consent

During the study, it may be necessary to revise the PIF or ICF - for example, due to new safety information or changes in study procedures.

A revised PIF or ICF must always* be submitted for approval to the review committee via a substantial amendment. The updated version cannot be used until it has been approved.

*Implementation without prior approval is allowed only if the revised or new information is critical to the immediate safety of participants. In such cases, the change may be implemented immediately, but approval must still be requested retrospectively from the review committee.

Certain minor changes, such as spelling errors or updating address details, do not require approval from the review committee. These changes can be submitted via a non-substantial amendment, allowing the review committee to take note for information purposes.

In case of doubt, always consult the review committee first.

Re-consent process

GCT SOP 01  Informed Consent Prodecure describes when re-consent should be requested from participants who have already provided consent.

If you have any questions about recruitment methods, the informed consent procedure, or revisions of the PIF and ICF, contact the MREC Amsterdam UMC.