MUOT IRB POLICY ON RECRUITMENT
OF RESEARCH STUDY SUBJECTS
1. Recruitment Procedures:
Patient-physician confidentiality and the absolutely voluntary nature of participation in research protocols must be considered and maintained when recruiting potential subjects.
a) Publicly placed flyers, posters, brochures, and advertisements in newspapers and other such publications are good means for recruitment that avoid any possibility of coercion and promote voluntary participation. See below for further details on such instruments.
b) Review of departmental log books, medical charts, and databases for potential subjects is not an acceptable practice prior to IRB review and approval. It is acceptable to request information on the number of cases that might fit the criteria an investigator wants to study in order to determine whether there is an adequate population size to support a research study. Such a request must not include patient identifiers. Persons with access to patient names and diagnoses should not, nor should they be asked to, provide such lists for an investigator to use to contact potential participants, who could view such an unexpected communication to be an invasion of privacy and a breach of doctor-patient confidentiality.
If an investigator plans to recruit subjects that are not his/her own patients, he or she should enlist the assistance of the potential participants' own physicians to introduce the study. An invitational, informational letter from the personal physician or clinic doctor to the potential participants should be used to explain that there is a research study being conducted and state by whom, what the study is designed to investigate, why they are being asked to participate (medical diagnosis, age/sex criteria, caregiver to someone with a specific condition, and such), and whom to contact if interested in learning more details. In the letter, the potential participants may also be asked to give permission for the investigator(s) to make direct contact. The personal physician would then relay the names of the "positive" responders to the investigator.
A draft of this letter must be submitted to the IRB with the rest of the application materials.
2. Recruitment Instruments (e.g. Advertisements, Flyers, etc.):
ALL forms of advertisement to recruit human subjects for research studies (including, but not limited to, newspaper ads, television and radio ads, flyers, posters, e-mail, web sites, telephone ads and other such announcements) must be submitted to the MUOT IRB for review and approval prior to their use or publication. They should be submitted as a part of the original protocol application whenever possible.
The following information may be included in the recruiting material:
a) the name and address of the investigator and/or research facility
b) the condition under study and/or the purpose of the research
c) in summary form, the eligibility criteria that will be used to admit subjects into the study
d) a straightforward and truthful description of the benefits to the subject for participation in the study, e.g., no charge for taking part in the study, no-cost health examination, and/or the incentives to subjects such as payments for participation (the amount should not be stated)
e) the time or other commitment required of the participants
f) the location of the research
g) the person or office to contact for further information
research@meduohio.edu