(Inviting Participation in the Research)
Initial Contact with and Recruitment of Participants
Participant recruitment is the process of inviting individuals from the target population to consider participating in the research project. The process begins with the initial contact with potential participants, whether that be in person, by email, over the telephone, or on the web, and whether it be directly by the investigator or by someone else acting on behalf of the investigator. During the recruitment process, potential participants receive information about the study that will help them decide if they wish to learn more and possibly become involved in the study. Therefore, the IRB must review these procedures before they are implemented and as a general rule, investigators may not have any contact whatsoever with potential participants prior to IRB review of the study.
In order to review the procedures, the PI must provide a copy of the information being provided to potential participants as part of the recruitment process. The recruitment language, whether it is the form of an email, an oral script, a letter, or a flyer, must be provided with the IRB application. The information provided at recruitment is typically not as extensive as that provided at the consent phase. (See the IRB recruitment guidance (PDF) for more information on the items that must be included in recruitment messages.) Sometimes, the recruitment and consent processes occur simultaneously (such as in telephone interviews), in which case, this must be explained in the IRB application. Missing recruitment information, such as the recruitment email or script, is a common cause of delay in the review process.
When the study sample is very targeted and relatively small, the investigator may wish to have very preliminary contact with potential participants in order to determine the feasibility of the research prior to fully developing the study design and IRB application. In this situation, the investigator should first contact the IRB Administrator or Chair and confirm the appropriateness of the preliminary contact.
In service or educational programs, the service provider (who may also be the researcher) may sometimes need to invite participation in the program prior to inviting participation in the research aspects of the project. This is permissible, provided that a) the program is not part of the research; in other words, the service or training would take place with or without the research component; and b) any information about the research is only referred to in general terms (e.g., “at a later date, you will receive an invitation to participate in research associated with this program, but your involvement in the program will not be affected by whether or not you decide to participate in the research”).
Undue Influence and Indirect Recruitment
Undue influence occurs most commonly when the researcher is in a formal position of power over the potential participants –supervisor/employee, counselor/client, teacher/student. It is best to avoid these situations whenever possible. For example, investigators should try to avoid using their current students in their research projects. If current students must be used, it must be made clear to the participants that the decision to participate will have no effect upon their grades or other standing in the course. Typically this means that someone other than the investigator must recruit the participant and/or collect the data so that the investigator has no knowledge of who did or did not participate until after the end of the semester, or that consent to use student work be obtained at the end of the semester or school year when the instructor no longer has a differential power relationship with the participants. Investigators should be aware that the IRB will not approve a study when coercion or undue influence is present, even if no adequate alternative design is available, unless the IRB is satisfied that voluntary consent can be obtained and undue influence or coercion to participate has been mitigated by the study procedures.
A common method for mitigating undue influence during recruitment is to use indirect recruitment procedures. Direct recruitment involves asking potential participants face-to-face or over the telephone to participate. With indirect recruitment, contact is less personal. This could include having a third party invite individuals to participate, hanging flyers with information so that participants can make contact if interested, or in some cases, sending emails. Note that the IRB generally does not approve direct recruitment of individuals with whom the researcher has a personal or professional relationship, especially when a power differential exists.
It is permissible, and in fact advisable, for researchers to have contact prior to IRB review with cooperating organizations and research sites regarding their willingness to play a role in the project. If external sites are involved in the study, the IRB will require documentation of permission from at least one research site prior to approving the study. (See Study Site Cooperation for further details.)
If the individual in authority at the prospective site is also a possible participant in the study, investigators should be careful not to confuse requesting permission to conduct the study at that site with inviting the individual’s participation as a possible subject in the study. This can happen, for example, when the purpose of the study is to interview school administrators, including superintendents and principals. In this case, the PI should wait and first submit for IRB review a special letter of invitation for the top administrator in each school or system that requests permission to conduct the study as well as a personal solicitation to participate as a subject. The IRB would then approve the study contingent on receiving letters of cooperation from each of the sites, and the PI would then proceed to seek formal consent and otherwise collect data from that individual and all of the other administrators in that location. As with all consent documents, the consent form signed by the participant-administrators would not be provided to the IRB, only that initial letter/email of cooperation on behalf of the organization. A parallel situation could arise for studies involving other organizations or companies, and the same process should be considered in those circumstances as well.