246. Research Involving Economically or Educationally Disadvantaged Persons

Updated July 2, 2021

The participation in research by individuals from all socio-economic groups is essential to ensure that research findings can be of benefit to all persons at risk of a disease, disorder or condition under study. However, research involving people with economic or educational disadvantages (including illiteracy) may require special consideration to ensure recruitment and enrollment are equitable.

Safeguards to Minimize Coercion or Undue Influence

• Care must be taken to ensure participants' incentives for research participation are commensurate with the risks, discomforts and inconveniences involved in the research, and financial or other gains are not overly compelling.
• Recruitment materials may not promise "free" treatment or emphasize the medical care that participants may receive during the research.
• Recruitment processes occurring in institutional or other controlled settings must be carefully designed to ensure participation is truly voluntary.
• To ensure equity in enrollment, other factors bear consideration when planning research for persons who are economically disadvantaged (e.g., costs for childcare or transportation).

Additional Safeguards

• Safeguards must be in place during the consent process (and, indeed, the entire research relationship) to ensure open and free communication between the researcher and the prospective participant.
• Consent documents must be written in language that is easily understandable to participants.
• The possibility of illiteracy or limited reading skills, and the need for communicating in foreign languages must be considered and addressed.