Characterize your target population by defining your 1⁰ and 2⁰ audience
Use this checklist to organize your criteria.
Software that you may use in your "prep to research" for cohort identification activities. I2b2, an acronym that stands for "Informatics for Integrating Biology and the Bedside“, is an NIH-funded National Center for Biomedical Computing (NCBC) based at Partners HealthCare System in Boston, Massachusetts. Since 2004, more than 100 academic medical institutions have adopted i2b2 for a variety of research uses.
Enterprise health data warehouse headquartered on the University of Colorado Anschutz Medical Campus. We are jointly sponsored by the University of Colorado School of Medicine, University Physicians, Inc., University of Colorado Health, and Children’s Hospital Colorado.
It is very helpful to forecast your research participant recruitment timelines by plotting out the expected or targeted number of participants recruited compared to the actual number of participants recruited. Download a recruitment Accrual Planning Spreadsheet.
Be sure to have a system in place to track the responses you will get as a result of your outreach efforts.
A recruitment timeline spreadsheet will also be helpful to get a better idea of site resource load per week and the expected number of subject visits and types of visits.
Successful clinical trial recruitment involves the development and implementation of a well-managed plan. Subject recruitment efforts should be evaluated throughout the recruitment process and new strategies should be implemented as needed.
Innovation for Multi-site Studies: Participant Recruitment
CTSA Accrual to Clinical Trials (CTSA ACT)
Initiative to develop a nationwide network of sites using data from the Electronic Health Record (EHR) to identify potential trial participants meeting entry criteria.
SHRINE queries all network institutions and provides an approximate number of participants at each site who meet the criteria.
CTSA Network Recruitment Innovation Centers (RICs)
Initiative to build national recruitment capacity using data from the Electronic Health Record (EHR) to find potential trial participants who meet entry criteria.
The National Cancer Institute (NCI) developed AccrualNet to provice a growing, searchable database of hundreds of journal articles with easy-to-read summaries, helpful tools, sample materials, and training resources. Learn more about AccrualNet
|Tool||Cost||Time to Implement||Target|
|Craigslist||Free||~ 1 week or less||General Public|
|Campus emails||Free||~ 1 week or less||Faculty, staff, patients|
|Flyers||$||~ 1 week or less||General Public|
|Direct Patient letter||$||~ 1 - 2 months||Diagnosis specific|
|Clinic recruitment||$||~ 1 – 2 months||Diagnosis specific|
|Health Fairs||$ - $$||~ 1 – 2 months||General Public/Diagnosis Specific|
|Foundations||$ - $$||~ 1 – 2 months||General Public/Diagnosis Specific|
|Newspapers (neighborhood)||$$||~2 – 4 weeks||General Public|
|Social Media (Facebook, Twitter, Google ads)||$$||~1 week or less||General Public|
|Newspapers (city)||$$ - $$$||~ 1 week or less||General Public|
|Mass Mailing Service||$$$||~ 1 – 2 months||General Public|
|Radio ads||$$$||~2 – 4 weeks||General Public|
Paid Advertising Resources
Experienced media buyer who can help build a paid advertising plan and place advertising in market on behalf of a client.
Advertising representative for print and digital advertising opportunities with the Denver Post.
Advertising representative for print and digital advertising opportunities with the Aurora Sentinel.
Advertising representative for on-air and digital advertising opportunities with Entercom, parent company of Alice 105.9; The Mountain; KS107.5; Cruisin’ 1430 and Comedy 103.1.
Kroenke Sports Entertainment
Advertising representative for on-air and digital advertising opportunities on KOOL 105, The Wolf, and Mix 100 radio stations.
Research Ethics Consult Service is a free service sponsored by the CCTSI. It is available to all biomedical and behavioral researchers at the University of Colorado Denver, as well as its clinical affiliates, who seek advice about ethically complex aspects of their research, including recruitment of research participants.
The following methods of recruiting subjects have been used in studies being conducted at the University of Colorado Denver and its affiliated institutions. Depending on circumstances, any of these methods may be in compliance with both the federal Common Rule (45 CFR 46) and the federal HIPAA Privacy Rule (45 CFR 164), but there also may be ethical and practical problems with any of the methods. The methods of recruitment must be outlined in the COMIRB application, and all materials distributed to potential research participants must also be approved by the COMIRB prior to use.
Who May Recruit
Individuals initiating contact (in person or by phone) with potential subjects must have basic knowledge about the study (so they can answer questions) and training in the voluntary nature of research participation. They also should be prepared to provide prospective subjects with:
For purposes of recruitment, people are considered "involved in the patient’s care" (and therefore eligible to review HIPAA-protected information without an authorization or waiver) if they are:
The purposes of the CCTSI Study Monitoring Committee (SMC) include:
CCTSI SMC Committee
The CCTSI SMC consists of SARC members as follows: (1) CCTSI Research Subject Advocate, (2) biostatistician, (3) physicians, and (4) senior research scientists. The goals of the CCTSI SMC include:
Active studies on the CTRC shall undergo at least annual review by the SMC for safety based on risk assessment.
Study monitoring requirements will vary depending on the nature and structure of the study to be undertaken. Minimal or low risk studies can be monitored appropriately for safety by the investigator. Moderate and high risk studies require a level of oversight other than can be provided by the investigator. These studies will utilize, in addition to the investigator, additional monitoring such as a safety officer or DSMB.
The extent of SMC safety monitoring for CCTSI studies will be based upon a risk assessment. Factors to be taken into account include the following:
Delays in recruiting participants to clinical studies are a major barrier to progress in clinical research. Initially, it is important to develop realistic recruitment goals and have a means of tracking enrollment. Recruitment milestones are expected to be met by the investigators at specific time periods. It will be the responsibility of the CCTSI SMC to ensure the timely assessment of recruitment milestones. If, at any time, recruitment falls significantly below the milestones projected by the principal investigator, the CCTSI will consider taking one or more actions, depending on the severity and duration of the recruitment shortfall. The CCTSI SMC generally will work with the investigtor to correct the deficiencies before taking action.
The researcher and the study team members should consider the following ethical questions when evaluating a recruitment strategy:
Potential subjects cannot be specifically identified or contacted until COMIRB approval for the research has been obtained. It is possible to obtain general data relating to the availability of a specific population to ascertain the feasibility of the study.
There are a number of ways to recruit subjects:
Students as Subjects
When UCD students and/or employees are being recruited as potential subjects, researchers must ensure that there are additional safeguards for these subjects. The voluntary nature of their participation must be primary and without undue
influence on their decision. Researchers must emphasize to subjects that neither their academic status nor grades or their employment will be affected by their participation decision.
To minimize coercion, investigators should avoid, whenever possible, the use of their students and employees in procedures which are neither therapeutic nor diagnostic. In these latter situations, investigators should solicit subjects through means such as bulletin board notices, flyers, advertisements in newspapers, and announcements in classes other than their own. When entering a classroom to recruit students and conduct research, e.g. administer a survey, investigators must do so at the end of the class period to allow non-participating students the option of leaving the classroom, thereby alleviating pressure to participate.
Finder's Fees and Incentives
Finder’s fees include any payment or gift to an individual who identifies a prospective subject. Principal Investigators and research personnel may not individually receive incentive payments or finder’s fees on a per participant
basis. PIs may accept monetary rewards that are offered by
the sponsor only after the research is closed to enrollment and only if the reward is directed to the research team as a whole (e.g. funds allocated for purchasing educational materials or to support attendance at educational conferences).
Note: For Faculty and staff employed by the Denver VA: Questions regarding finder's fees and incentives involving VA studies should be directed to the Denver VA Research office or VA regional counsel.
The investigator will provide the COMIRB with all recruiting materials to be used in identifying participants including: the information contained in the advertisement, the mode of its communication; the final copy of printed advertisements or the COMIRB Advertising Components Submission Form (CF-260); the final audio/video taped advertisements.
The COMIRB must approve any and all advertisements prior to posting and/or distribution. The COMIRB may review:
This informatiion should be submitted to the COMIRB with the initial application or as an addendum to the Protocol.
The COMIRB reviews the material to assure that the material is accurate and is not coercive or unduly optimistic, creating undue influence to the subject to participate which includes but is not limited to:
Any advertisement to recruit subjects should be limited to the infomration the prospective subjects need to determine their eligibility and interest.
Payments to Subjects
Payment to research subjects is a way to reimburse a subject for travel and other experiences incurred due to participation. However, payment for participation is not considered a research benefit. Regardless of the form of remuneration,
investigators must take care to avoid coercion of subjects. Payments should reflect the degree of risk, inconvenience, or discomfort associated with participation. The amount of compensation must be proportional to the risks and inconveniences
posed by participation in the study.
The panel must review both the amount of payment and the proposed method of disbursement to assure that neither entails problems of coercion or undue influence.
Credit for payment should accrue and not be contingent upon the participant completing the entire study. Any amount paid as bonus for completion of the entire study should not be so great that it becomes coercive.
You will need to indicate the methods of recruitment to be used in the study such as:
All recruitment materials must be approved by the COMIRB before use. All recruitment materials must include the COMIRB number and the PI's name. All advertisements must include the word "Research".
Selection of Subjects is Equitable
The COMIRB will review the recruitment methods and inclusion/exclusion criteria for the research to ensure equitable selection of subjects. In making this assessment the COMIRB takes into Account the purposes of the research and the setting in which the research will be conducted, and is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, fetuses, pregnant women, human in vitro fertililzation, persons who are decisionally challenged, or persons who are economically or educationally disadvantaged.