Successful study recruitment involves development and implementation of a well-coordinated plan that may require the efforts of the entire research team. Once in place, subject recruitment efforts must be constantly assessed, with new strategies implemented as necessary. The study team may use only the recruitment strategies approved by the CPHS for the research study.
Based upon the specific inclusion/exclusion criteria for a study, the study team should establish a suitable recruitment plan. The plan may be as simple as identifying potential participants within the practices of the members of the research team or a multi-pronged comprehensive plan incorporating various methods of direct advertising. The plan should be outlined in the CPHS application. CPHS must approve the final copy of all advertisements including flyers that will be posted on bulletin boards or used as handouts, and broadcast on radio, television or through other venues (e.g., mass email).
Repeated attempts to contact a research subject may be necessary and appropriate. However, once a subject is contacted, a single informed refusal to participate concludes the investigator's efforts.
If an investigator plans to make repeated attempts to contact a subject, the subsequent methods should be described in the original protocol or in a request for change. Please contact the CPHS office for suggestions as to the methods for repeat contacting.
Cultural diversity in subject selection is strongly encouraged. Clinical studies should be inclusionary, designed in such a way that the subject pool is representative in gender, race, ethnicity, and age of the local population affected by the condition being studied. Exclusion of particular subgroups may be justified in the following cases:
- A specific scientific question is more appropriately addressed with a more targeted group,
- Specific known risks of intervention (or other participation) warrant exclusion of specific groups,
- Gender- or racial-neutrality has been previously demonstrated,
- Redress of gaps in medical knowledge about specific groups,
- Multicenter studies may achieve overall balance by choosing centers with complementary minority representation.
Subject enrollment need not be sufficient to provide high statistical power for calculating effects of gender and minority status on intervention effect in all cases. Investigators planning phase 3 clinical trials in which prior studies suggest a clinically “significant difference” in effect among subgroups or those in which differential effects are uncertain are encouraged to design the subject pool in sufficient numbers so as to provide a “valid analysis” in each subgroup.
Finders Fees or Bonuses: Accepting or paying a "finder's fee" for the referral of patients or subjects into a research study or bonus payments for enrolling a certain number of patients is not permitted. This does not mean that you cannot refer patients into an appropriate study. However, you may not offer to pay or agree to accept any payment for such referrals. This includes overt and covert payment as well as payment in kind such as bartered goods or services. If you are approached with such payments or if there is a question as to whether something constitutes an incentive or bonus payment, please contact the CPHS office at 713-500-7943.
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last modified October, 2013
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