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Protecting Human Subjects in Research

This section of the Handbook includes details about how to ensure the protection of human subjects when you are conducting research.

The Belmont Report identifies basic ethical principles and guidelines that address ethical issues arising from the conduct with human participants in research (access the report at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html). This report identifies three principles: respect for persons, beneficence, and justice. Each principle carries equal moral weight and, interestingly, they sometimes conflict with each other. Thus, the principles must be considered as an equal obligation with conflicts requiring careful consideration and "balancing." The principles and their corollary obligations are explained in the following table.

 

 PRINCIPLE OBLIGATION
Respect for persons: Respect for individual autonomy and allowance for the freedom of choice. This principle requires that individuals with reduced autonomy (also known as vulnerable) are protected.
  • Obtaining informed consent
  • Protecting privacy/maintaining confidentiality
  • Adding safeguards for those who may be vulnerable to coercion or undue influence
Beneficence: Maximize benefits to participants, science and society, while minimizing harm to participants and others.
  • IRB assessment of risk/benefit balance
  • Ensuring risks to participants are minimized
  • Confirming risk is justified by the benefits
Justice: When selecting participants, there is equitable distribution of both the burden and benefits of the study.
  •  Ensuring selection of participants is equitable in terms of benefits and burdens

For those conducting research with human subjects, USU’s IRB will review your IRB materials, considering these principles as well as questions such as:

  • Are there any concerns related to autonomy?
  • Has appropriate permission(s) been granted from collaborating institution(s) and/or organization(s)?
  • Are all public-facing materials understandable and free from spelling and grammar errors
  • Does the study use procedures consistent with sound research design/evidence-based practice
  • Is the study sound enough to reasonably expect results to answer the proposed question(s)?

Two concepts that receive much focus from an IRB in relation to the protection of human subjects in research are sensitive topics and vulnerable populations. These are covered in the next section.