Recruitment Materials and Strategy

Successful recruitment of participants for clinical research studies involves the development and implementation of a well-planned strategy. The recruitment strategy and tools utilized must be frequently assessed relative to established goals, with new strategies implemented as necessary. Listed below are resources to assist with your recruitment efforts.

Special thanks to the Michael J. Fox Foundation for generously sharing many of the resources in the recruitment and retention toolkits.
Two people shaking hands

Planning and Feasability

  • Cohort Identification
  • Timeline for Recruitment Accrual
  • Budget
  • NCATS Initiatives
  • AccrualNet

  • Cohort Identification

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    Characterize your target population by defining your 1⁰ and 2⁰ audience

    Use this checklist to organize your criteria.

    I2B2 (CHCO only)

    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.

    Health Data COMPASS (CU Denver and CHCO)

    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 Chil​dren’s Hospital Colorado​.​

    Timeline for Recruitment Accrual

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    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.

    Budget

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    • What recruitment costs are you likely to incur?
    • Which recruitment resources do you plan to use? Different people will learn about your trial in different ways so consider implementing multiple recruitment tools. The more effective components there are in a recruitment plan, the more likely you will reach your recruitment goals.

      • Databases (i2b2, Health Data COMPASS)
      • Direct mailing: mass mailing, flyers, direct patient letters, postcards
      • Online Media: community sites, social media (Facebook, Google), Craigslist, YouTube
      • Newspapers: large circulation, local circulation, weekly circulation, neighborhood circulation, college newspapers
      • Campus emails
      • Tabletents
      • Radio, TV
      • Lunch-N-Learn, group orientation sessions
      • Community-based awareness programs
      • Health fairs

    NCATS Initiatives

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    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.

    • Technology platform has two major components:

      • Informatics for Integrating Biology and the Bedside (i2b2), a software package that converts raw records into de-identified and searchable participant information stored in a central database.

      • Shared Health Research Informatics Network (SHRINE), a search engine for i2b2. With appropriate agreements in place, an ACT investigator can use SHRINE to search de-identified records using a customized set of participant 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.

    • To improve research participant recruitment in the planning phase of clinical trials by rapidly providing investigators with estimates of the availability of candidate participants meeting the study’s entry criteria. Such estimates will be based on de-identified, aggregate data derived from the electronic health record (EHR) at individual sites and across the CTSA consortium.

    • In the implementation phase of a clinical trial, the RICs will support investigators through innovative strategies for enrolling research participants in a timely manner.

    AccrualNet

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    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

    Tools and Resources


    Marketing Strategies

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    ToolCostTime to ImplementTarget
    CraigslistFree~ 1 week or lessGeneral Public
    Campus emailsFree~ 1 week or lessFaculty, staff, patients
    Flyers$~ 1 week or lessGeneral Public
    Direct Patient letter$~ 1 - 2 monthsDiagnosis specific
    Clinic recruitment$~ 1 – 2 monthsDiagnosis specific
    Health Fairs$ - $$~ 1 – 2 monthsGeneral Public/Diagnosis Specific
    Foundations$ - $$~ 1 – 2 monthsGeneral Public/Diagnosis Specific
    Newspapers (neighborhood)$$~2 – 4 weeksGeneral Public
    Social Media (Facebook, Twitter, Google ads)$$~1 week or lessGeneral Public
    Newspapers (city)$$ - $$$~ 1 week or lessGeneral Public
    Mass Mailing Service$$$~ 1 – 2 monthsGeneral Public
    Radio ads$$$~2 – 4 weeksGeneral Public

    Templates

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    Letters

    Flyer with tab tear offs
    Small ad

    Media Contact Information

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    Paid Advertising Resources

    Media Buyer
    Erika Sabatos
    P: 720-234-5116
    Experienced media buyer who can help build a paid advertising plan and place advertising in market on behalf of a client.

    Denver Post
    Lauren Morrell
    P: 303-954-5217
    lmorrell@denverpost.com
    Advertising representative for print and digital advertising opportunities with the Denver Post.

    Aurora Sentinel
    Melanie Coker
    P: 720-449-9710
    mcoker@aurorasentinel.com

    Advertising representative for print and digital advertising opportunities with the Aurora Sentinel.

    Entercom Radio
    Roxanne Marati
    P: 303-967-2700
    rmarati@entercom.com
    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
    Jill Merriam
    Jill.merriam@kseradio.com
    Advertising representative for on-air and digital advertising opportunities on KOOL 105, The Wolf, and Mix 100 radio stations.

    ResearchMatch

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    ResearchMatch is a free recruitment tool and feasibility analysis resource to researchers at CU Denver. Follow 3 steps to register as a researcher.

    Health Literacy Articles

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    Report on the Health Literacy of America’s Adults: Results From the 2003 National Assessment of Adult Literacy

    Health literacy resources compiled by Paul D. Smith, MD.

    Health literacy from the Harvard School of Health

    Research Ethics Consult Service

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    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.

    Recruitment Oversight

    CU Denver Recruitment Guidelines

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    Acceptable Methods

    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.

    • Investigators maintain a separate database that asks research participants if they will agree ahead of time to be contacted for research in the future. Investigators contact patients about particular studies in accord with their signed consent.

    • Study investigators enter recruitment information on the School of Medicine list of University of Colorado Denver Clinical Trials web page or a similarly managed website. Subjects then contact the study investigators.

    • Advertisements, notices, and/or media are used to recruit subjects. The COMIRB must first approve the text of these. Subjects who respond to these will contact the study investigators. Note: No HIPAA-regulated Protected Health Information is used in this recruitment strategy.

    • Study investigators provide their colleagues with a "Dear Patient" letter describing the study. This letter can be signed by the study investigators and would inform the patients how to contact them.

    • Study investigators send a COMIRB-approved letter to colleagues asking for referrals of eligible patients interested in the study. The study investigators may provide the referring physicians a COMIRB-approved information sheet about the study to give to the patients. If interested, the patient will contact the PI.

    • Study investigators who are also clinicians providing direct care recruit their own patients directly. Nurses or staff working with the investigators also may approach the patients. This respects privacy but also raises ethical concerns because of the difficulty of saying no and the therapeutic misconception.

    • Study investigators recruit potential participants who are unknown to them. Examples include snowball sampling, use of social networks, direct approach to unknown people in public situations.

    • Study investigators request a Waiver of Consent/Authorization for recruitment purposes. In all cases, the waiver must be justified in the "Waiver of Consent/Authorization for Recruitment Purposes" section of the COMIRB application. Waivers are granted in three primary situations:

      • In minimal risk studies in which subjects will be not be contacted (e.g., many chart review studies) researchers request a complete waiver of consent/authorization. The application must explain why the study cannot be done without the waiver.

      • If the study requires researchers to review charts to identify prospective subjects who will then be contacted and asked to be in the study, the justification for the waiver to review charts must show why the study cannot be done without the waiver. The waiver covers collecting only the minimum amount of information needed to make contact; consent is obtained before additional information is gathered. The CHR’s usual policy is that patients identified through chart review should be approached by someone already involved in their care. "Already involved in their care" includes health care professionals directly involved in their care as well as administrative and research staff working with the health care professionals.

      • In some circumstances it may be necessary for members of the research team who are not involved in the patient’s care to make the approach, either in person or by phone or letter. The application should explain why the study cannot be done unless the researchers approach subjects directly. Direct approach by someone not involved in the patient’s care is an exception to the usual policy but may be approved in exceptional circumstances such as emergency care research.

       

    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:

    • A researcher’s name and phone number (for questions about the study) and
    • The phone number of the COMIRB (for questions about a research subject’s rights).

    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:

    • Health care professionals actually involved in the care or administrative or
    • Research staff working with the professionals involved in the care.

    SMC Oversight

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    The purposes of the CCTSI Study Monitoring Committee (SMC) include:

    • Oversee the safety of studies conducted within the Clinical and Translational Research Centers (CTRC).  The SMC is charged to prospectively review the Data and Safety Monitoring Plans (DSMP) of all studies conducted on a CTRC and review studies that are active. 
    • Oversee the recruitment and retention plan for all clinical research studies conducted at the University of Colorado Denver with COMIRB oversight.

    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:

    Safety

    • Provide independent monitoring to assure study safety and study integrity of active studies on a CTRC.
    • Educate and support investigators to develop detailed and effective data and safety monitoring plans for their study.
    • Ensure that there is appropriate oversight for significant risk studies (in conformity with NIH guidelines).
    • Provide SARC with updates on the progress of current studies on a CTRC as needed.
    • Ensure that new literature or research information is considered by on-going studies and revised appropriately.
    • Review safety reports from other safety bodies and ensure that recommendations have been appropriately addressed.
    • Oversee and liaise with safety officers.
    • Act as a resource for DSMBs, safety officers, investigators, SARC, COMIRB, and the CTRCs.

    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:

    • Risk
    • Investigator experience
    • Multicenter vs single site investigator initiated studies
    • Inclusion of normal, healthy subjects
    • Inclusion of special populations
    • Continued oversight of DSMB
    • Continued SAE and AE monitoring

    Recruitment

    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. 

    Ethical Concerns

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    The researcher and the study team members should consider the following ethical questions when evaluating a recruitment strategy:

    • Respect for privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? Will patients be upset when they learn researchers not involved in their care have read their medical records without permission?

    • Lack of pressure: Is the study introduced in a way that allows subjects ample time to consider, with no undue pressure because of timing of the request, who makes the request, how the request is made, or the offering of excessive inducements? Will patients be put in a situation where they may hesitate to say "no" to their own physician? How will pressure be minimized?

    • Unbiased presentation: Is all information accurate, balanced, and free of misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment?

    • The "Therapeutic Misconception": Patients tend to believe a clinical trial—or anything proposed by health care providers—will benefit them, even if they’re told there is no assured benefit. Does the recruitment strategy work to counteract this misconception?

    • Conflicting concerns

      • Subjects may prefer that someone involved in their care contact them about research, but they may find it hard to say "no" to a care provider.
      • Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their research.

       

     

    Principles

    • Use of medical records: Access to medical records and identifiable health information by people not directly involved in a patient’s care should be avoided.

    • Use of Protected Health Information: The amount of identifiable information gathered and the number of people who have access to identifiable information must be minimized.

    • Contact: Prospective research subjects should be contacted by people directly involved in their care, not by unknown researchers.

    COMIRB Recruitment Guidelines

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    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:

    • Existing Research Relationship
    • Clinical or Professional Relationship
    • Recruitment Database
    • HIPAA A Authorization
    • Advertisements
    • ResearchMatch

    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.

    Advertisements

    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:

    • The information contained in the advertisement
    • The mode of its communication
    • The final copy of printed advertisements
    • The final audio/video taped advertisements

    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:

    • Statements implying a certainty of favorable outcome or other benefits
    • Claims, either explicitly or implicitly, that the drug, biologic or device was safe or effective for the purposes under investigation
    • Claims, either explicitly or implicitly, that the test article was known to be equivalent or superior to any other drug, biologic or device
    • Using terms like "new treatment," "new medication", or "new drug" without explaining that the test article was investigational
    • Promising "free medical treatment" when the intent was only to say particpants will not be charged for taking part in the investigation"
    • Emphasis on payemnt or the amount to be paid, such as bold type or larger font on printed media
    • Does not include exculpatory language
    • Offers by the sponsor to include a coupon good for a discount on the purchase price for the product once it has been approved for marketing

    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.

    COMIRB Application

    You will need to indicate the methods of recruitment to be used in the study such as:

    • In-person or face-to-face
    • Direct mailings to potential subjects (Letters/Postcards, etc)
    • Electronic correspondence (E-mails)
    • Telephone
    • Advertisements
    • Other Methods

    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.