IRB Application Instructions - Subject Population, Study Populations

Help Information

1. Purposeful Inclusion

2. Vulnerability to Coercion or Undue Influence

  • Additional safeguards are required if your project will involve subjects that likely will be vulnerable to coercion or undue influence

  • See HRPP Manual 6-8, Special Categories of Research Subjects for additional information

3. Prisoners

  • There are additional requirements if research involves prisoners (e.g. adequate assurance that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole)

  • Individuals who become prisoners during the study cannot be included in the research unless the project has been reviewed as a study involving prisoners

  • See “Definitions” on the website for the definition of prisoners

  • See HRPP Manual 6-8-B, Prisoners for requirements

4. Federal Bureau of Prisons

  • There are additional requirements if research will be conducted in the Federal Bureau of Prisons (e.g. research cannot involve medical experimentation, incentives may not be offered to help persuade inmate subjects to participate)

  • See HRPP Manual 2-2-C, U.S. Department of Justice for requirements

Helpful HRPP Manual Sections

Question Number

  • Initial Application (Exempt) - Question 9C

  • Initial Application (Expedited and Full Board) - Question 20C