- Description of the procedures that will be applied to effectively recruit the study population described in the protocol: where, how, by whom. This should include justification for the possible recruitment of participants who are unable to give their consent (due to "incapacity of will" or "urgency of inclusion"). Please provide this information in a separate document.
- If recruitment material (poster, leaflet, advertisement, website, etc....) is used, it should also be submitted under this folder.
Guidelines advertisement/recruitment for clinical studies
- The Ethics Committee should always be informed of the means used to announce a study. These include both "traditional" channels (posters, leaflets, etc.) and various forms of advertising via the internet (website, social media, etc.). The necessary documents must be submitted for approval with the submission dossier.
- Advertising is strictly limited to publicising a study through the above-mentioned channels.
- Regarding the content of advertisements (through traditional channels, or over the internet), the following is emphasised:
- Brief, objective and neutral information (no marketing or promotional language).
- Always referral to the general practitioner / treating physician: often the demand for participation in a study arises within the framework of the doctor-patient relationship. However, following new forms of advertising (especially via the Internet), studies are increasingly being "offered" by third parties (firms, association) through channels that reach potential participants directly, outside the doctor-patient relationship. However, it remains important that the potential participant is explicitly encouraged to discuss possible participation with his/her own doctor in the first instance.
- No list of purely medical inclusion/exclusion criteria (these are intended for the physician and could be misinterpreted).
- If applicable, it may state that a "reasonable fee" is provided, or state per study visit, but not the total amount.
- Mentioning of government (if applicable) and ethics committee approval, including the study's S number (or MP number if it is a study reviewed by the OBC).
- The contact details of the researcher(s) may be mentioned on the recruitment materials
- Disclosure of studies should not involve the collection of identifying and/or confidential (medical) data. These data belong to the context of the doctor-patient relationship (or researcher/trial subject) and should not be requested through other channels.
Social media recruitment guidelines
When advertising via social media, there is a risk that confidential (medical) data may end up in the hands of unauthorised individuals (sponsor, Facebook, etc.) and may be used for other purposes. In particular, when an individual may "like", comment or share an advertisement, this person may be identifiable and linked to (participation in/interest in) a clinical study or pathology.
For these reasons, EC continues to warn about the dangers of social media in participant recruitment but can agree to use social media when it can be done in a highly secure framework.
We therefore draw your explicit attention to the following points:
- Blocking all social links such as "like, comment, share" in the advertisement avoids collecting identifying and/or confidential (medical) data outside the context of the doctor-patient relationship.
- Direct contact between companies (or their representatives) and potential participants is not allowed and therefore no link to online exploratory queries (preliminary screening) of potential candidates is provided. It is up to the potential candidate to take the initiative whether or not to contact doctor/study centre regarding a particular study.
Furthermore, we ask that the following points be mentioned when using a website/social media:
- Clear statement that the potential participant should contact the clinical trial site/investigator(s) and not the sponsor
- Contact details for the participant
- Details about the study (purpose, title, duration of participation, inclusion/exclusion criteria, no additional costs...)
- Ethics committee approval stating that this should not be seen as an incentive to participate
- Indication that data will be treated confidentially in accordance with the AVG
More information can be accessed via the following link.