D. Research Population, Recruitment Methods, and Compensation

Research Plan Content

The purpose of the Research Plan is to describe the proposed research in sufficient detail so that the Institutional Review Board (IRB) can determine if approval criteria for human subjects research defined in federal regulations (45 CFR Part 46 and 21 CFR Parts 50, 56, 312 and 812) is met.

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every non-exempt project submitted for IRB review. It is also highly encouraged for exempt projects.

Print Research Plan Guidance

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.

  • When drafting the Research Plan, follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
  • For each section, this guidance includes a description of why the information is important for IRB review (in italics).

D. Research Population, Recruitment Methods, and Compensation

In order to approve research, the IRB must determine that the selection of participants is equitable and reasonably related to the purpose and aims of the research. The IRB must also consider whether adequate safeguards are in place to minimize any risks that are unique to vulnerable populations (e.g., pregnant women, fetuses, children, prisoners, cognitively impaired persons, etc.). To make this determination, the IRB must review all methods and materials used to contact and recruit potential participants, including letters, flyers, emails, etc.

1.  Participant Population

  • Describe the participant population:

    • Provide the rationale for including the participant population. When including any vulnerable populations in the study (e.g., children, prisoners, pregnant women, fetuses, etc.) explain why inclusion of this population is necessary to accomplish the research aims.

    • List the inclusion criteria such as age range, race or ethnicity, gender, language and literacy, etc.

    • List the exclusion criteria and rationale.

    • Address whether or not participants are fluent in English and/or if any of the study activities (i.e. recruitment, consent, assessments, etc.) will be carried out in a language other than English.

      • Describe how the research team member(s) are fluent in the language of the participants or if a translator will be used.

      • Describe how materials will be presented in the language understandable to participants (e.g. will translated materials be used?). If there is no written language, state this and explain translation.

  • Discuss the number of participants needed for the project including the following:

    • Provide the targeted number of individuals to be included in the research. If more than one group, provide numbers needed for each group and total number for the entire project. Ranges are acceptable (e.g. 20-25 individuals, survey distributed to 200 people and expected 65% response rate).

  • Provide rationale for targeted numbers.

2.  Recruitment Methods

  • Describe the process and/or method by which participants will be recruited for the research, including the following:

    • When and how will each step of recruitment occur (i.e., initial contact, introductions, follow-ups, etc.).

    • Describe how the participant population is accessed. Discuss relevant permissions (e.g., access to listservs, online databases, etc.).

    • State any recruitment materials that will be used, such as advertisements, flyers, or verbal scripts. If there are no written recruitment materials, explain.

    • Explain which research roles (e.g., PI, Research Assistant, etc.) will recruit participants and how they will be trained.

    • Describe any screening tests and/or procedures that will be used to ensure that potential participants are eligible to participate.

    • If any part of the recruitment procedures involves a language other than English describe any differences in the recruitment procedures for non-English speaking participants.

  • For research involving treatment (e.g. behavioral intervention, drug or device studies, etc.):

    • Describe how research treatment will be distinguished from regular treatment.

    • Indicate whether the individuals who will recruit participants have provided or will provide treatment or care to the prospective participants. If treatment providers also have a role in the research, describe measures to avoid or diminish undue influence.

3.  Compensation/Reimbursement

  • If there is the possibility that there will be costs to the participant or to a third party (e.g., an insurer), identify the specific expenses (e.g., drug tests, procedures, hospitalization, travel, etc.) and provide a justification for those costs.

  • If participants are to receive compensation for their time, please describe the following or simply state no compensation will be offered:

    • The amount and nature of the compensation (e.g., cash, gift card, course credit, etc.).

    • Explain how and when compensation will be provided, including payment schedules, whether or not compensation will be reduced if the participant does not complete all activities in the study, and how any proration will occur.

    • Explain how the method and amount of compensation is appropriate for the participant population and study activities (e.g., based on time commitment, number of study visits, travel expenses, age of participant population, etc.).