Introduction

Recruitment

The recruitment section should clarify all aspects regarding how participants will be engaged within the study.

• Describe the location (e.g., university campus, hospital, community, city, zipcode area, etc.) of recruitment.
• Update this document describing the strategy for participant recruitment. Please beware that local ethical review boards may have some guidelines regarding the conditions that apply to recruitment tools and procedures. Some example strategies of recruitment are:
  • Consecutive ongoing recruitment through principal investigator in daily clinical practice.
  • Participant recruitment through referring physician.
  • Advertisement/flyer (in this case, add the corresponding files under assets/ and link them from the body of this document).
• Describe whether participants' information will be pulled from some existing database, or collected into a newly created database. If a database or will be used, describe how to gain access to it and how to operate it.
• Describe the mechanisms to contact participants:
  • If contact if over telephone, write down a script for the call
  • If contact is over e-mail or postal mail, write down the communication template

Screening

Every new candidate participant must be screened to assess they meet all the inclusion criteria of your study, as well as do not meet any of the exclusion criteria.

Your SOPs should clearly state:

• Refer to the inclusion and exclusion criteria of the study protocol, highlighting important aspects of the study (e.g., we are only investigating twins).
• Describe how the screening must be conducted.
• Prepare a checklist with all the elements that the candidate participant must be walked through if they accept to participate, for example:
• Confirm that participant does not have any contraindications
  • List of obvious implants and medical devices (e.g., peacemaker in an MRI experiment)
  • List of less-obvious circumstances that may disqualify participation, such as non-removable orthodontia, or home-made tattoos. Please note that minor implants (such as metal braces, retainers and some palatal expanders) that are sufficiently secured to the body may be safe on clinical MR scanners at 1.5T and 3T (tesla). However, these implants may originate artifacts on the generated images if they cause large-enough discontinuity of magnetic properties.
• Confirm that participant will accept the participation conditions described in the informed consent form, for example:
  • If they will be required to abstain from eating, consuming coffee or smoking within a window of time prior to the exam.
  • If their data will be openly shared after proper privacy protection measures.
  • If they want to be informed about relevant incidental findings (and whether they can give up on their right to learn about them).
  • Report life events that are relevant to the experiment and may be cause of stopping the participation for safety and health reasons (e.g., pregnancy) or other reasons (i.e., incompatibility with the study).
  • Remind participant of any incompatibilities with the experiment that may apply (e.g., jewelry, removable orthodontics, some hairstyling products, etc.).
  • If allowed to wear street clothes, remind participant to avoid clothing with metal or that would uncomfortable to lie in for the duration of the scan
  • If participant has indicated nervousness or history of claustrophobia, or they belong to a population at risk (e.g., infants), anticipate the scheduling of a preparation session on a mock scanner prior to the first acquisition.

Scheduling

Participants will likely need to visit your facilities for the development of the study in one or more occasions.

• State the number and nature of each of the sessions.
• Indicate how the scheduling should be conducted with each participant.
• Establish a system to store and share the information on how the research team will be made aware of the schedule and its changes
• Clearly explain how to book shared resources utilized by the study (e.g., MRI scanner).