Recruitment and Informed Consent
Recruitment is often an iterative process. It is a good idea to document the effectiveness of individual recruitment techniques in case they are not working. You can use this data to change course later if needed.
Some funding agencies and industry sponsors require that you submit a list of potential participants screened as part of the recruitment process, along with documentation of why ineligible individuals did not meet study criteria. They may provide you with a screening log to submit, or you may need to create your own.
Once you have confirmed that an individual is interested in learning more about the study, you can proceed to conduct informed consent discussion. You will need to obtain documentation of informed consent as required by the Institutional Review Board-approved consent procedures. There may be multiple consent and assent forms, along with translated consent forms, depending on the study population. It may be necessary to tailor your consent discussion for each population involved, and to arrange for interpretation services.
Provide copies of the signed consent and HIPAA forms to participants, but keep the originals in your files. Check your Institutional Review Board approval to see if you described how to file documents that contain participant identifiers, and follow the process as approved.