Human Research Protection
The Desert Research Institute (DRI) is committed to staying in compliance with Federal Policy (Common Rule) and Department of Health and Human Services Regulations for the Protection of Research Subjects for the very small number of research projects we conduct that involve human subjects. These federal regulations are intended to implement basic ethical principles governing the conduct of human subjects research. The ethical principles are set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"). No DRI faculty, staff, or students should be involved in human subjects research at any level without being familiar with these ethical principles.
- National Institutes of Health - Office of Human Subjects Research
- NIH - Human Subjects Research – Online Resources
- UNR Research Integrity Office
- The Belmont Report
Human Subjects Research - Ethical Principles
The information below summarizes in very general terms key points from the Belmont Report regarding human subject research.
I. Ethical principles:
- Respect for persons - (1) respect individual autonomy; (2) protect individuals with reduced autonomy
- Beneficence - maximize benefits and minimize harm
- Justice - ensure equitable distribution of research burdens and benefits
II. Application of general ethical principles to the conduct of human subjects research leads to the following requirements:
- Respect for persons - (1) informed consent; and (2) privacy and confidentiality
- Beneficence - (1) risk/benefit analysis; and (2) scientific merit
- Justice - review of subject selection.
- Research - a systematic investigation designed to develop and contribute to generalized knowledge
- Human subject - A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable information.
IV. Basic protections:
- Institutional assurances - federal departments and agencies will conduct or support research covered by regulations only if (1) the institution has an approved assurance; (2) the institution has certified to the department or agency head that the research has been approved by the Institutional Review Board (IRB); and (3) the research will be subject to continuing review by the IRB.
- Institutional Review Board (IRB) - the IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution. These officials may not approve research if it has been disapproved by the IRB, however.
- Informed consent - respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed to include three elements: information, comprehension, and voluntariness.