- Last updated:
Recruiting human subjects
Identifying potential subjects, contacting, and screening
- Guidance Contact:
IU Human Research Protection Program (HRPP)
Recruitment is the process of identifying potential subjects, contacting those individuals (if applicable), and screening, which involves making the final determination about whether a subject meets the inclusion/exclusion criteria for the study, and any procedures necessary to get the information needed to make that determination.
Common recruitment methods include:
- Recruitment by interactions with individuals. For example, posters, flyers, or advertisements designed to inform the public of the study and to get subjects to contact the study team;
- Recruitment by third parties, such as doctors in other departments of a hospital, or clinics or private practices that refer potential subjects to contact the research team;
- Accessing existing data or biospecimens for the purpose of determining whether an individual or his/her data or specimen may be included in a study.
Recruitment is considered the beginning of the informed consent process; as such, study teams are required to describe their recruitment plan to the IRB in the human subjects application. For studies that only involve secondary use of data or specimens, the recruitment plan describes where the data or specimens are located and how they will be accessed by the study team.
Please see the IU HRPP Policy on Recruitment of Human Subjects for specific requirements. Additional guidance on some topics is provided below.
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.