Three Basic Ethical Principles Outlined in the Belmont Report
Respect for Persons (Treat individuals as autonomous human beings, capable of making their own decisions and choices, and do not use people as a means to an end)
Three Requirements Based on Respect for Persons
– obtain and document informed consent
– respect the privacy interests of research subjects
– consider additional protection when conducting research on individuals with limited autonomy
Beneficence (Minimize the risks of harm and maximize the potential benefits)
Five Requirements Based on Beneficence
– use procedures that present the least risk to subjects consistent with answering the scientific question
– gather data from procedures or activities that are already being performed for non-research reasons
– risks to subjects should be reasonable in relation to both the potential benefits to the subjects and the importance of the knowledge expected to result
– maintain promises of confidentiality
– monitor the data to ensure the safety of subjects
Justice (treat people fairly and design research so that its burdens and benefits are shared equitably)
Two Requirements Based on Justice
– select subjects equitably
– avoid exploitation of vulnerable populations or populations of convenience
Rationale for an Institutional Review Board (IRB)
The ethical principles and federal regulation generated by the Belmont Report provide a framework for IRBs to evaluate research involving human subjects. An objective review of research is necessary because
- some researchers focused on their goals may unintentionally overlook other implications or aspects of their work and
- no one can be totally objective about his or her own work.
The IRB review system is designed to provide an independent, objective review of research involving human subjects so that the privilege of conducting human subjects research may be maintained.
Research is a
- systematic investigation (this might range from applying scientific methodology involving independent and dependent variables to an ethnographic study of a community)
- including research development, testing, and evaluation (this also includes pilot studies, feasibility studies, and other preliminary studies)
- designed to develop or contribute to generalizable knowledge (An essential consideration is whether it is the intention of the investigator to contribute to generalizable knowledge.
Some activities that involve interactions with humans and data gathering many not fit the definition of research with human subjects. Always check with the IRB.
A human subject is a
“living individual" about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction (does not need to be face-to-face, could be via email or a participant observation) with the individual or
- Identifiable private information
(a) information about behaviors that occur in a context where the individual can reasonably expect that no observations or recording is taking place or
(b) information that is provided for a specific purpose and for which the individual can reasonably expect will not be made public.