Minimizing Risk

It is the responsibility of IRB members to thoroughly review a research plan and decide whether to approve a protocol. When reviewing research Solutions IRB’s guidelines address three ethical principles that are fundamental to human subject protection, these being: respect for persons (respect for the right of self-government), beneficence (do no harm, maximize benefits, and minimize harms), justice (equal distribution of research burdens and benefits).

An IRB assures that adequate safeguards are incorporated into research design such as: frequent monitoring, the presence of trained personnel who can respond to emergencies, or coding of data to protect confidentiality are examples. For a study to be deemed minimal risk, the probability and magnitude of harm or discomfort in that study must be no greater than those ordinarily encountered in daily life.

Any study may contain diverse types of risk, such as: physical risks, psychological risks, social/economic risks, loss of confidentiality, and legal risks. Researchers are expected to take steps to minimize any potential risks. These include:

  • Using procedures that are consistent with sound research design
  • Not exposing subjects to unnecessary risk
  • Using procedures already being performed on the subjects for diagnostic or treatment purposes.
  • Prescreening to identify and eliminate high-risk participants,
  • Providing participants with as much information as possible during informed consent and debriefing.

Researchers must be sure that any risks involved in the research are reasonable in relation to the protocols anticipated benefits.

Authors: Ayn O’Reilly and Bridgette Moralez