This page has been updated to reflect the New Rule effective January 21, 2019.
Since incarceration may affect the ability to make a truly voluntary and un-coerced decision, specified safeguards are provided to prisoners who are considering participating in research.
A detailed description of considerations pertaining to prisoners is provided in federal guidelines (45 CFR 46, Subpart C).
Economically or Educationally Disadvantaged Persons
Unless clearly justified in the research protocol, the investigator must not recruit only this subject population.
The selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Other Subjects Needing Special Protections
Some types of studies may include procedures that could potentially harm an unborn child or pregnant woman. For this reason, federal guidelines identify pregnant women as a group that warrants special protection.
A more detailed description of considerations pertaining to pregnant women and fetuses is provided in federal guidelines (45 CFR 46, Subpart B).