IRB Handbook

What Principles Do I Need to Understand

The Belmont Report identifies basic ethical principles and guidelines that address ethical issues arising from the conduct with human participants in research. This report identifies three principles: respect for persons, beneficence, and justice. Each principle carries equal moral weight and 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 table below.

 

PRINCIPLE

OBLIGATION

 

Respect for persons: You respect individual autonomy and allow the freedom of choice. This principle requires that individuals with reduced autonomy (also known as vulnerable) are protected.

 

  • Obtaining informed consent
  • Protecting privacy and 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/project.

 

  • Ensuring selection of participants is equitable in terms of benefits and burdens

 

 

Aspen’s IRB will review your IRB application, considering these principles as well as questions such as:

 

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