Research Roadmap

Recruitment

Subjects can be recruited in a variety of manners. The recruitment strategy depends on the type of subject sought and the time available to recruit the subjects. In most cases, recruitment is done by the treating physician through the clinic (inpatient or outpatient). Other recruitment methods include the use of advertisements, internet sites, folders or other tools.

All recruitment activities, regardless of the strategy selected, must be approved by the MREC.

Any questions concerning the manner of recruitment may be submitted to the MREC Amsterdam UMC.

Screening

An anonymous screening must be maintained when screening for potential subjects. This is a list of all potential subjects who are/are not participating in the research and why. Noting the reasons for non-participation by potential subjects (e.g. did not meet inclusion and exclusion criteria or did not provide consent) makes it possible to demonstrate that no selection bias occurred.

Informed consent procedure

To inform potential subjects, all study-specific information must be submitted. This includes, but is not limited to, information sheets with consent forms, advertising and recruitment texts, study brochures, patient diaries and questionnaires. National templates per specific study type and age groups are available via the CCMO website.

An Amsterdam UMC procedure (GCT SOP 01 Informed Consent Procedure) has been established in order to ensure that the IC process for various target groups is implemented according to the applicable legislation, regulations and local requirements.

If you have any questions about the applicability of this procedure, specifically for your research project, contact the MREC.

Some main concerns:

• This information must be given in language that is easy to understand (language level B1), so that it
  can be reasonably assumed that the potential participant has understood the content of the study. This is mostly done in writing through an information letter and occasionally orally (when available the possibility of oral consultation must be offered).  
• The reviewing committee (MREC or CCMO) only assesses the Dutch information sheet and consent form. However, every test subject must be able to make well-informed decisions about participating in a study. If a person not sufficiently proficient in Dutch, is asked to participate in a study, the subject information sheet must be available in a language that the person is proficient in. As a standard, the study's sponsor is responsible for a good translation. The review committee does not require the translated subject information sheet; however  the corresponding translation certificate must be submitted. 
• Use the most recent approved version of the subject information letter and informed consent form.
• Note the individual steps of the informed consent proces in the source documentation (medical status) of the potential participant. When a participant (patient and healthy volunteer) is linked to the relevant study in Epic (instruction for patients and instructions for healthy volunteers), the different steps can be indicated in a drop-down menu. Smartphrases are also available*.
• Give the potential participant and/or his/her legal representative(s) sufficient time to reflect.
• Go through all parts that describe what the participant gives permission for.
• Verify if the participant has understood all aspects of the study and check to see if there are any questions left.
• Ask the participant and/or his/her legal representative(s) to sign and date the informed consent form and if applicable, if the participant cannot write and/or read, after verbal consent from the participant, have it signed by the independent witness. It is important that the participant and/or his/her legal representative(s) sign first, followed by the investigator or his/her delegate.
• Provide the participant and/or his/her legal representative(s) a copy of the informative letter and
  signed informed consent form or have 2 copies signed.

*For non-WMO research, it is not mandatory to link study participants to a study file in Epic. However, it can sometimes be wise to make this consideration. You can ask yourself the following questions:

• Is participation possibly directly relevant to other practitioners in the context of patient safety?
• Can you reach the participants for feedback, incidental findings, referral or follow-up questions if necessary?
• Is the inclusion and informed consent procedure outside Epic well maintained and documented?
• Are the study activities, data and/or material collected outside of Epic and (possibly) carried out on a study budget? Then the Principle Investigator itself is responsible for the storage and possible reuse of (pseudonymised/anonymous) data and material in accordance with the applicable laws and regulations and for the declaring of study expenses incurred.

Revision of the PIF/ICF during the study and re-consent

During the study, it may be necessary to revise a Subject Information Letter or Informed Consent Form (e.g. due to the availability of new safety information or changes in study procedures). A revised Subject Information Letter or Informed Consent Form must always* be submitted for approval to the MREC or competent authority) by means of a substantial amendment. The rule is that the new version of the Subject Information Letter or Informed Consent Form may not be used until it has been approved by the MREC (and the competent authority, if applicable).

Implementation without approval is allowed only if the revised or new information is relevant to the immediate safety of subjects. Only in that case may the change be implemented immediately, but permission must still be requested after the fact from the MREC and, if applicable, the competent authority.

GCT SOP 01  Informed Consent Prodecure  describes when consent should be requested again from subjects who have already granted consent (the ‘re-consent’ proces). You can also find this information om the CCMO website.

* Exceptions to this rule include the correction of typing and spelling errors or other minor changes (e.g. address details). In case of doubt, the first step should always be to contact the MREC.