Overview of Ethical Research Involving Humans
- A human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about whom includes a subject’s opinion on a given topic. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information through coding) in order for obtaining the information to constitute research involving human subjects.
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of the federal policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
“A key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide variety of activities, including experiments, observational studies, surveys, tests, and recordings designed to contribute to generalizable knowledge. It generally does not include such operational activities as medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, “fact-finding” inquiries (such as criminal, civil, and congressional investigations, intelligence gathering), and simple data collection for other purposes. However, some of these activities may include or constitute research in the specific circumstance where there is clear advance intent to contribute to generalizable knowledge with a formal scientific protocol.”Shelton, J.D. 1999. How to interpret the federal policy for the protection of human subjects or “common rule” (part A). IRB: Ethics and Human Research. Vol. 21, No. 6, pp. 6-9.
ORIA is responsible for Mason’s program for promoting excellence in all aspects of research with humans. A fundamental principle of ORIA’s program is that all research with human subjects must be reviewed prior to a project’s initiation. Ethical review of projects will either be conducted by ORIA staff or members of the Institutional Review Board (IRB). The IRB is a committee composed of faculty, staff, and community members who are trained in issues related to protecting human participants in research. ORIA also collaborates with other institutional review units on campus such as the the Institutional Biosafety Committee and the Radiation Safety Committee to further achieve ORIA’s primary goal of assuring that the rights and welfare of human research subjects in activities conducted at and/or under the auspices of George Mason University are adequately protected.
Note: All researchers must receive written approval from ORIA prior to conducting a research project involving human subjects.
Specifically, ORIA is responsible for:
- Policy and procedure development
- Triage and review of GMU research projects involving human subjects
- Institutional Review Board (IRB) support
- Ethics training
Note: All human subjects related forms (including applications, continuing review forms, and amendment forms) must be submitted through our online protocol management system, IRBNet.
If you have any questions or to make an appointment with IRB staff for assistance, please e-mail irb@gmu.edu
Human Subjects Research Review Process
ORIA’s human subject research review process begins with the submission of the human subjects application. The application should be completed and submitted to ORIA prior to the applicable submission deadline listed on the IRB Meeting Schedule. Note that handwritten submissions will not be accepted. Please make sure to review the instructions for submitting an application as ORIA/the IRB will only review complete applications. Incomplete submissions may result in delays in the review process. ORIA staff will let you know upon submission if an application is complete.
Some research involving human subjects is exempt from review by the IRB. ORIA reviews all of the human subjects applications and determines whether the research is exempt or nonexempt. Mason faculty, staff, and students may not conduct research involving human subjects until the researcher receives either written documentation from ORIA that the research is exempt or written documentation that the research has been reviewed and approved by ORIA/the IRB. If ORIA finds that the research is exempt, ORIA will send a formal letter to the Principal Investigator and Co-investigator. Please visit the exempt research page for more information.
If ORIA staff finds that the research is nonexempt, ORIA will determine if the non-exempt research requires review by the full board or qualifies for expedited review. Under the expedited review process, at least one member of the IRB will review the research after receipt of a completed application. If the nonexempt research does not qualify for expedited review, ORIA staff will schedule the research for review by the full board which meets once a month. See the IRB Meeting Schedule for meeting and submission dates. Once a project has been approved by ORIA staff or the IRB as necessary, ORIA staff will send a formal letter to the Principal Investigator and Co-investigator (if one is designated on the application). No research may begin until written approval has been provided.
Some research involving human subjects is termed “exempt” based on the regulatory definition. This research is exempt from review by the IRB, however, ORIA conducts an initial review of the human subjects applications and determines whether the research is exempt or nonexempt. Investigators must submit the human subjects application for all research, including exempt research. Mason faculty, staff, and students may not conduct exempt research involving human subjects until the researcher receives exempt notification from ORIA.
The following list of exempt categories is identified in The Federal Policy for the Protection of Human Subjects, The Common Rule.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Note: If any term used on this page is unclear, please check the glossary page.