300. Recruitment Settings and Procedures
Updated July 1, 2019
Recruitment is generally the first contact between researchers and prospective participants (whether through materials or face-to-face) and is a prelude to the informed consent process. Researchers should use fair and equitable recruitment practices in research and avoid practices that place participants
at risk for coercion or undue influence.
An important ethical principle that is relevant to the recruitment process is Respect for Persons as described in the Belmont Report.
Investigators and the IRB must consider the characteristics of the sample population, and where, when, and how subjects will be recruited to ensure recruitment practices are both ethical and equitable. The IRB review considers whether recruitment processes
- are likely to result in impartial and justifiable selection of research participants;
- minimize the potential for bias;
- protect individual rights to privacy;
- are free from coercion and influence; and
- allow sufficient time for prospective participants to consider whether or not they are interested in proceeding to the consent process.
NOTE: The proximity in time of the recruitment to the informed consent process and research interventions should reflect the degree of risk. For example, the greater the risk, the more time prospective participants may need to consider their decisions about participating. Research posing more than minimal risk may require time be allotted for individuals to consult with family members, their physicians, or others.
Considerations for Recruitment Settings
Recruitment activities must be carried out in settings that are free of situational or circumstantial influences or intimidations but that allow researchers to target the population of interest to the research.
Consider the following sample questions when selecting recruitment locations:
- Will the recruitment setting uphold each prospective participant's right to choose or offer subtle inducements to participate? For example, recruitment that takes place in a group setting such as a classroom or an office in the presence of peers or superiors must be planned carefully to ensure the right to choose and minimize situational influences.
- Should a person be recruited to take part in a research study when in a stressful location (e.g., emergency department)?
- Should researchers approach prospective participants in public settings for recruitment into research involving topics that may be stigmatizing (e.g., HIV research)?
- Is the setting conducive to assessing that prospective participants are lucid and capable of making independent decisions (when warranted)?
Considerations for Recruitment Time Frames
Consider the following sample questions when establishing recruitment times:
- Will the time between recruitment, and the consent process and research interventions be sufficient for individuals to consider their participation in the study?
- Is the timetable commensurate with the risks and effort associated with participation (e.g., greater risk may require more time for participants to consider their involvement)?
- Should a person be invited to take part in research immediately after the individual has been diagnosed with a serious disease, condition, or disorder?
- Should a person be recruited to take part in a research study when in a strained state of mind, (e.g., imminent delivery of a baby, just informed of a loved one's diagnosis of a serious disease)?
Considerations for Recruitment Methods/Procedures
Who May Recruit?
Persons involved in the recruitment process must have sufficient knowledge of the study to answer questions about the research or be able to refer a recruit to the researcher for questions about the study. Recruiters should be able to refer recruits to RI for questions about participants' rights.
Common Recruitment Venues
- Flyers or advertisements
- Emails or letters
- Scripted presentations
- Direct Person-to-person contact with prospective participants
- SONA (for University researchers)
- Third party assistance and snowball sampling
- Existing records
- Recruitment lists, databases, and repositories
NOTE: Regardless of venue, recruitment materials must comply with the IRB policy for recruitment materials to ensure required content is provided and disallowed content is not used, and text and graphics are used appropriately. The final versions of all flyers must be Added to the project/package in IRBNet at the time of submission.
Recruitment in which researchers contact prospective participants without prior agreement (i.e., "cold calling") may not always be welcome. To prevent future unwelcome emails, researchers who routinely employ "cold" e-mailing, telephoning, messaging, or mailing must provide recipients the option to join a "no-contact" list. Before sending unsolicited recruitment advertisements or messages, researchers must first check the no-contact list and exclude those not wishing to be contacted from the distribution list. The initial contact should provide a telephone number or other means that the prospective participant can use to verify the study constitutes University research.
Using Flyers/Advertisements to Recruit
In the IRB application, researchers are to identify locations where flyers or advertisement will be placed or aired. As applicable, location information may be provided in in general terms (e.g., public billboards on University campus, public libraries, coffeehouses, local radio station) or with more specificity (e.g., subject-specific list-serves or websites).
Researchers must adhere to the requirements of the location/site.
Using E-mail to Recruit Participants
Researchers wishing to use emails obtained from private organizations must obtain permission and abide by the requirements of the holder of the e-mail distribution list.
Researchers may use emails obtained from public sources with no additional permissions.
Researchers planning to use University emails must abide by University requirements for use of computing resources (including email accounts). The University requires that such uses be ethical, respect individual privacy, and minimize the effect of the usage on the work of those affected. University faculty, students, and staff may only access those computer accounts they are authorized to use and must use the accounts only for the authorized purposes. For example, professors may not use student or employee email addresses to recruit for research studies without explicit permission from the appropriate administrator or the individuals involved, and IRB approval.
As a courtesy, e-mail recruitment messages should include information about how the recipients' e-mail addresses were obtained.
When recruitment plans include sending multiple messages, researchers should tell recipients the number of messages that will be sent and when possible, provide the recipient with the option of not receiving future e-recruitment solicitations.
Research Recruitment Using Official University E-Mail Lists
Use of official, institutional e-mail lists such as faculty or staff lists, or those maintained by the Dean's office or department require approval by the appropriate office official. Generally, projects must be deemed to be relevant to the University's mission or which show a legitimate need that cannot be met through other contacting methods to be approved by University administrators.
Using Scripted Presentations to Recruit
Researchers must identify all off-site organizations, establishments, or institutions where recruitment presentations will be given and provide the IRB with written permission from an authorized representative of the organization or site. Recruitment in UNR classrooms does not require written permission.
To protect individual privacy, it is preferable to include a mechanism for prospective participants to obtain more information about the study or to volunteer to participate outside of the group setting. For example, business cards or simple handouts may be provided for interested persons to contact the researchers. Alternatively, prospective participants may complete individual contact cards for researchers to use to contact them.
Group sign-up sheets raise concerns about individual privacy and are NOT acceptable.
Using Direct Person-to-Person Contact to Recruit
Researchers must identify all settings where prospective participants will be directly approached. For private or business settings, researchers must obtain and provide the IRB with written permission from an authorized representative of the location.
To protect individual privacy, it is preferable to include a mechanism for prospective participants to obtain more information about the study or to volunteer to participate individually. For example, business cards or simple handouts may be provided for interested persons to contact the researchers. Alternatively, prospective participants may complete individual contact cards for researchers to use to contact them.
Using a University SONA Subject Pool to Recruit
University students and students enrolled in other institutions within the Nevada System of Higher Education (NSHE) (e.g., TMCC ) may be offered the opportunity to participate in research for credit as part of a course requirement via the University Psychology and Social Psychology Subject Pools. (NOTE: For all NSHE institutions other than the University of Nevada, Reno, requirements for obtaining site permission apply. Researchers are advised to contact the authorized representative for other NSHE institutions for information about obtaining site permission.)
Researchers planning to recruit subjects via one of the SONA Subject Pools are advised to familiarize themselves with the standard procedures for posting studies, scheduling participants, determining credit amounts, and notifying professors of earned credits.
The IRB reviews research involving recruitment through SONA with the understanding that the standard procedures will be followed. Deviations from the standard SONA procedures must be described in the IRB application.
Using a "Third Party" or "Snowball Sampling" to Recruit
Researchers sometime opt to use a third party to invite prospective participants to consider participation in a research study.
Examples of third parties:
- Physicians, school administrators, or local service providers who agree to act on behalf of the researchers by providing recruitment information;
- Commercial entities hired to aid in recruiting research volunteers; and
- Research participants who tell friends, acquaintances, or co-workers about a research study (i.e., snowball sampling).
Researchers should provide third-party or snowball recruiters with an IRB-approved script, written handout, or flyer to be used during the recruitment process. Third-party or snowball recruiters must agree to limit their remarks to the information provided to them by the researcher, and to refer all other questions to the researcher. The recruitment materials should include instructions for interested individuals to contact the researcher to ask questions or to enroll in the study. Allowing interested individuals to initiate contact with the researchers enhances privacy and minimizes potential for coercion or influence.
Third parties recruiting on behalf of researchers may NOT collect research-related information to determine eligibility or for research records, or obtain consent.
Using Existing Records to Identify and Contact Eligible Individuals
IRB review and approval is required before a researcher may review existing data sets to identify individuals who may be eligible to participate in a research study or to obtain information for contacting prospective participants.
The exception is the cursory review of records to determine the feasibility of conducting a research study (e.g., identify number of patients with a specific disease). This is permissible only under the following circumstances:
- The individuals reviewing the records are eligible to review private information by virtue of their position in the facility to which the records belong;
- No Protected Personally Identifiable Information is recorded; and
- The individuals whose records were reviewed are NOT contacted until after the project (and recruitment processes) have been approved by the IRB).
Data sources that are not publicly available may be subject to additional institutional or regulatory requirements prior to access. Researchers are responsible for identifying and complying with all such additional requirements to use existing records for recruitment purposes. The IRB considers HIPAA requirements for research uses of Protected Health Information (PHI); FERPA requirements for research uses of academic records; and other requirements as applicable before approving a project.
When planning research that may require use of existing records to identify people who are eligible for the study or obtain contact information, researchers and the IRB should consider if prospective participants would be upset that their private information was shared with or viewed by investigators for research purposes and when applicable, address this concern in the privacy section of the IRB application.
Requirements for Using Student Directory Information
IRB policy provides information about the FERPA exception for disclosure of student directory information.
Researchers interested in using student directory information for recruitment (or research) must obtain permission from the University Office of Admissions and Records. The Office considers requests for release of directory information on a case-by-case basis.
Requirements to Use Records to Assess for Eligibility Prior to Recruitment
Sometimes, a researcher must use existing data to identify individuals who may be eligible to participate in a study but it isn't always feasible to inform all of the individuals to whom the records apply of this use of their private information. In such cases, the researchers must request, justify, and obtain IRB approval for a waiver of the consent process. If the records include PHI, a waiver of HIPAA authorization is also required.
When persons are identified without their knowledge as possibly qualifying for a research project, it is preferable for an individual known to the prospective participants to make the initial contact. For example, the treating clinician or other health care provider would contact persons identified through a review of clinical records; school personnel would contact students identified through the directory information obtained from academic records. When it is not practical to have prospective participants contacted by an individual known to them, researchers may contact prospective participants directly but the IRB may require justification for such cold calling.
Creating and Using Lists, Databases, or Repositories to Recruit
Investigators may create and maintain lists of research participants who previously took part in research or were screened for but deemed ineligible for other research studies, when these individuals expressly consent to having their theirs name and contact information retained for recruitment for future research participation. However, the creation and maintenance of such lists requires IRB approval.
The IRB must assess and approve the type of information to be retained and procedures for insuring confidentiality of the information before researchers may develop and use recruiting lists, databases or repositories.
Investigators may contact individuals on IRB-approved recruiting lists about research studies in accordance with the agreement between the researcher and the prospective participant.
Investigators must provide a mechanism for each person on the list to remove her/his name and information from the list at any time.