Recruitment and Quality Assurance Program (RQP)
The HSC Recruitment & Quality Assurance Program (RQP) assists investigators by streamlining the participant-recruitment process and facilitating inclusion of diverse participant groups in the database, with particular emphasis on recruitment of individuals with developmental language disorders. The RQP also works to assist investigators with compliance and supports the preparation of IRB and NIH reports.
Streamlined Participant Recruitment
To streamline participant recruitment, the RQP provides research staff with access to a recruitment database, as well as specific support for individual labs' recruitment needs. The RQP efforts related to the database include extensive efforts to enroll community members in the database and trainings for lab staff on how to utilize the database.
Boys Town National Research Hospital has a unique research volunteer database of over 10,000 potential participants that is maintained by the RQP. Researchers use Query, a secure web-based tool, to search the recruitment database and find potential participants that are a good match for their study. Use of the database and Query, as well as training in use of Query, are a standard service available to all research labs.
The RQP recruits adults and children into the recruitment database through multiple methods, including hearing and language screenings at health fairs and other community events and through Boys Town Hospital clinical services. When a potential participant enrolls, they provide their contact information and a brief overview of their hearing, balance, language and emotional/behavioral status. Additionally, if they are a Boys Town Hospital patient, their clinical audiology test results are imported into the recruitment database.
Research labs also assist in growing the recruitment database and keeping it current by electronically enrolling participants and administering an optional across-lab intake form during the consent process. In order to help researchers further refine their search for participants, research results for standardized hearing, language and cognitive results are also submitted by research lab staff and included in the database.
Recruitment Database Infographic
To find appropriate potential participants in the recruitment database, researchers have the ability to enter search parameters in Query including age, hearing status and specific degrees and configurations of hearing loss, vestibular diagnoses and speech/language screening results, among many other search parameters. In addition to helping researchers recruit potential research participants for current projects, Query can also be used to determine the number of potential volunteers for future projects.
Recruitment for Individual Lab Needs
The RQP helps COBRE PIs and other PIs with their participant recruitment efforts. Upon request, the RQP can assess the recruitment needs for a protocol and provide a consultation that will include specific recruitment suggestions and Query search strategies. The RQP also maintains information about labs' recruitment needs and creates general recruiting marketing materials that enroll participants in the recruitment database.
Scheduling and Sign Language Interpreting
COBRE PIs can also receive the added benefit of RQP scheduling and sign language interpreting services. RQP scheduling services include contacting, screening and scheduling participants. Attempts are made to coordinate research appointments across labs and for multiple family members, resulting in increased efficiency of data collection and satisfaction of participants.
Quality Assurance and Compliance
To support labs with meeting IRB and NIH quality assurance regulatory requirements, the RQP provides consent training, consent review and tracking, audit assistance, enrollment reporting, planned enrollment preparation and research participant experience survey data.
Consent Training and Process Observation
The RQP provides consenting training to new lab staff. Consenting forms, procedures, guidelines and tips for consenting participants in person, by phone and online are reviewed. Additionally, the RQP offers new lab staff members the opportunity to do a mock consenting interview that provides practice and feedback before they begin to consent participants.
A consenting process observation is completed annually for each protocol that is currently testing participants. A PI can also request additional observations to help newer staff members improve their consenting skills. The results of the observation are shared with the PI and staff member.
Consent Database Services
The RQP maintains a consent database. If labs choose to make use of the consent database, the RQP can provide a number of services, including consents review, generation of enrollment reports and support of the lab during internal protocol audits. If errors are noted on the consent forms, the lab is notified. Paper consent forms can also be stored in the RQP office.
The RQP also generates IRB and NIH enrollment reports from the consent database for each protocol. Additionally, the RQP sends quarterly enrollment reports to each lab to ensure that there are no discrepancies between the consent database and lab records. During an internal protocol audit, the RQP provides consent documentation to the auditor and answers questions about the paper consents on file.
Upon request from PIs, the RQP can prepare planned enrollment tables for grant proposals based on the number of anticipated research participants and census data. The RQP can also provide PIs with information on the number of possible participants that fit their criteria who are already enrolled in the recruitment database.
Research Participant Experience Survey
PIs can choose to offer participants an optional research participant experience survey at the conclusion of both in-person and remote research appointments. Participants' responses remain anonymous. The short survey includes multiple-choice questions pertaining to the research experience and the option to provide comments. The RQP compiles the survey data quarterly and sends a report to the PI. PIs have the option to add questions that are specific to their protocol/lab, if they choose.