Recruiting human subjects

Recruitment materials must be reviewed and approved by the IRB. Examples of recruitment materials include:

• Posters, flyers, brochures
• Published advertisements
• Direct mail and/or email scripts
• Verbal scripts
• Website advertisements
• Social media advertisements

The following are not considered to be advertisements, and do not require submission to the IRB for approval:

• Recruitment materials not directed to potential subjects (e.g., materials given to health care providers, teachers, or schools who will facilitate recruitment of subjects)
• News articles not intended for recruitment
• Financial page information for investors
• Listings on clinical trial websites which provide basic information (i.e., title, purpose, study summary, basic eligibility criteria, locations, contact information)

Advertisements should be limited to some or all of the following information to determine eligibility and interest:

• The name and address of the investigator and/or research facility
• The condition being studied and/or the purpose of the research
• In summary form, the criteria that will be used to determine eligibility for the study
• A brief list of participation benefits, if any (e.g., a no-cost health examination)
• Time or other commitment required of subjects (e.g., number of visits and total duration of participation)
• The location of the research and the person or office to contact for further information

The IRB evaluates recruitment materials under the IU HRPP Policy on Recruitment of Human Subjects. Recruitment materials cannot emphasize payment to subjects in any way (e.g., larger, bold, or highlighted text, pictures or arrows, etc.).

Use of official IU or department logos for advertisements may require special approval through the school or department. See IU’s Brand Guidelines for more information. You may also need to contact the Public or Media Relations Department of your school or entity.

When appropriate, a potential subject should be encouraged to consult his/her physician prior to enrollment.

When doing research within a community group or organization, a person authorized to speak for the group should be approached for permission to recruit from that group or organization.

Persons with the following study-related responsibilities should not participate as subjects in the research study:

• data collection or other direct access to study data;
• direct subject contact and/or care;
• distribution and/or monitoring of investigational agents or study interventions.

For research conducted at the Roudebush VAMC, initial contact with potential subjects cannot be made via phone. Research personnel may consider sending an introductory letter to potential subjects, then following up via phone.

For research subject to Department of Justice regulations and conducted within the Bureau of Prisons (BoP), the selection of subjects within any one organization must be equitable. Incentives may not be offered to help persuade inmate subjects to participate. However, soft drinks and snacks to be consumed at the test setting may be offered. Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research subjects who are no longer in BoP custody and participating in authorized research being conduct by BoP employees or contractors.

Payment arrangements are often part of the recruitment and consent process. Inappropriate payment arrangements can place subjects at risk of coercion or undue influence; therefore, the IRB needs to assess the amount of payment and the proposed method and timing of disbursement.

Generally, credit for payment should accrue as a study progresses and not be contingent upon a subject completing the entire study. Any amount paid as a bonus for completion needs to be reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.

All information concerning payment, including the amount and schedule of payments, should be described in the informed consent document and recruitment materials, as applicable.

When recruiting employees as subjects, steps must be taken to protect them from coercion and undue influence, whether real or perceived. Coercion can occur when an employee feels that refusal to participate in the employer’s research may negatively impact their employment status or treatment at work.  Undue influence can arise when an employer offers incentives for participating in their research, which could include, but are not limited to, career advancement or favorable performance evaluations. Despite these concerns, the IRB also recognizes that out of respect for subject autonomy, employees generally should not be excluded from participating in research merely because they are under the  direct supervision of the investigator. 

Supervisors should avoid directly interacting with their employees during recruitment and throughout the study, as even approaching an employee to participate in research may be perceived by an employee as creating pressure to enroll.  Employees should be recruited through general announcements or advertisements/flyers displayed in neutral locations, and informed consent should be obtained by a research assistant or someone other than the supervisor.  Additionally, the supervisor should not access their employees’ identifiable information or identifiable biospecimens, if possible.  Rather, identifiable information and biospecimens should be collected by another member of the study team and de-identified before the supervisor accesses the information. 

In situations where research interaction between the supervisor and employee is unavoidable, particularly during recruitment and consent, the IRB will determine if this allowable. The IRB application should outline the precautions that will be taken to minimize the possibility of coercion or undue influence as a result of these direct interactions.  The IRB may require the supervisor to provide explicit assurances to the employees that their participation in the study, or lack of participation, will not impact their job in any way.