Research Involving Human Subjects
University Policy Number 4017
Standard Operating Procedures for research with humans (http://oria.gmu.edu/)
Related Law & Policy:
• Federal Regulations for research with humans:
Department of Agriculture, 7 CFR 1c
Department of Energy, 10 CFR 745
National Aeronautics and Space Administration, 14 CFR 1230
Department of Commerce, 15 CFR 27
Consumer Product Safety Commission, 16 CFR 1028
Agency for International Development (USAID), 22 CFR 225
Department of Housing and Urban Development, 24 CFR 60
Department of Justice, 28 CFR 46
Department of Defense, 32 CFR 219
Department of Education, 34 CFR 97
Department of Veterans Affairs, 38 CFR 16
Environmental Protection Agency, 40 CFR 26
Department of Health and Human Services, 45 CFR 46
National Science Foundation, 45 CFR 690
Department of Transportation, 49 CFR 11
Protection of Human Subjects, 21 CFR 50
Institutional Review Boards, 21 CFR 56
Investigational New Drug Application, 21 CFR 312
Investigational Device Exemptions, 21 CFR 812
• Commonwealth of Virginia:
Research – Human Research Review Committee 32.1-162.16-20
• Mason Policies:
University Policy Number 4001 – Financial Conflicts of Interests in University Contracts with Businesses under Virginia Law (adopted December 9, 2009)
University Policy Number 4007 - Misconduct in Research and Scholarship (adopted February 22, 2013)
University Policy Number 4010 – Financial Conflicts of Interest in Federally-Funded Research (adopted August 24, 2012)
George Mason University (the University) is committed to performing research with humans in an ethical manner that is compliant with regulatory requirements. This policy sets forth the principles and responsibilities for research projects involving human subjects.
This policy covers all faculty, staff, and students (both graduate and undergraduate) intending to conduct research using living individuals or pre-existing data containing identifiable private information about living people. This policy applies to research funded by any source as well as unfunded research.
II. Policy Statement
All work at the University must adhere to ethical principles. While no one document can address the wide range of research conducted by University employees and students, University researchers should identify the codes of ethics most relevant to their pursuits. These may include:
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1978.
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010
- Ethics codes adopted by national and international scholarly associations.
Individual researchers are responsible for evaluating if their work meets the federal definition of human subjects research, as defined by 45 CFR 46.102. If researchers incorrectly assume their work does not meet the federal definition of human subjects research, they bear the responsibility for noncompliance. They may consult ORIA staff, utilize the research determination form for an official finding by ORIA, or consult the guidance issued by the Working Group of the Human Subjects Research Subcommittee of the National Science and Technology Council and published in James D. Shelton, “How to Interpret the Federal Policy for the Protection of Human Subjects or “Common Rule” (Part A),” IRB: Ethics and Human Research 21 (November-December 1999): 6-9. Student researchers who are uncertain of the limits of the definition of human subjects research should consult their faculty advisors.
If a proposed project meets the federal definition of human subjects research, it must be reviewed by the IRB, ORIA staff, or others delegated by the Assistant Vice President for Research Integrity & Assurance to determine whether it is exempt from review under 45 CFR 46.101.
If a proposed project meets the federal definition of human subjects research and is not exempt, it must be reviewed by the IRB, either through an expedited or full board procedure, and researchers may not conduct the human subjects research without IRB approval.
“Human Subject” means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
“Interaction” includes communication or interpersonal contact between an investigator and a research subject.
“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.
“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. It also includes information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). 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) in order for the acquisition of 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.
See also: Glossary of Terms (http://oria.gmu.edu/research-with-humans-or-animals/institutional-review-board/human-subjects-policies-procedures-forms-and-instructions/glossary/)
A. Provost and Executive Vice President
In instances of an IRB finding of serious and/or continuing noncompliance the Provost and Executive Vice President (Provost) is the ultimate decision maker about University administrative actions.
B. Vice President for Research & Economic Development
The Vice President is the Institutional Signatory Official who has the authority to commit George Mason University to the terms and conditions of the University’s federalwide assurance. The Vice President appoints and removes IRB members, approves and rescinds authorization agreements for the IRB, and provides support for the IRB. In instances of an IRB finding of serious and/or continuing noncompliance, the Vice President for Research & Economic Development will provide recommendations for administrative actions to the Provost.
C. Assistant Vice President for Research Integrity & Assurance (AVP)
The Assistant Vice President for Research Integrity & Assurance directs the Office of Research Integrity & Assurance, establishes who may determine a human subjects research project to be exempt, and manages allegations of research being conducted contrary to this policy.
D. Institutional Review Board (IRB)
The Institutional Review Board reviews all covered research (through expedited and full board procedures specified in the Standard Operating Procedures). The IRB will approve covered research only if it meets the following requirements:
- risks to subjects are minimized
- risks are reasonable in relation to anticipated benefits
- selection of subjects is equitable
- informed consent is obtained or appropriately waived from all prospective subjects
- subjects’ privacy is protected and the confidentiality of data is maintained
- appropriate safeguards are incorporated for any vulnerable subjects.
The Institutional Review Board may approve protocols, require modification to secure approval, disapprove protocols, and suspend or terminate approval of research. Any suspension or termination of approval due to serious and/or continuing noncompliance shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, the Assistant Vice President for Research Integrity & Assurance, and—in the case of research sponsored by a Common Rule agency—the Common Rule department or agency head.
The board also conducts continuing reviews of approved research, reviews proposed amendments, adverse events, protocol deviations, and matters of non-compliance.
Neither the IRB nor ORIA has the authority to take disciplinary action against any individual relating to noncompliance. Findings of noncompliance that are neither serious nor continuing will be referred to appropriate administrative units, as described in the Noncompliance/Deviation SOP.
E. Faculty Advisory Board for Policy Development
The Faculty Advisory Board drafts and reviews new and updated policies and procedures that have the potential to impact researchers. The board also provides feedback on the effectiveness of the human subjects protection program. Though the board cannot overrule a decision by the IRB, it may hear concerns from researchers, consider their merits, and relay its judgment to the IRB and ORIA staff.
F. Office of Research Integrity & Assurance
The ORIA administratively manages the human subjects protection program. This involves serving as a resource for education and information, developing and distributing SOPs, maintaining communication mechanisms such as the website, providing guidance and feedback to investigators, providing administrative support to the IRB and Faculty Advisory Board, ensuring all requirements of the federalwide assurance are met, and conducting quality assurance activities.
G. Individuals Conducting Research
All individuals conducting research with human subjects have an obligation to follow protocols as described to ORIA and the IRB, ensure all subjects enrolled in research provide informed consent (unless altered or waived), and report protocol deviations and unanticipated problems to the ORIA. All projects must have a Principal Investigator (as defined in University policy 4012) ultimately responsible for the design, conduct, and reporting of the project and responsible for oversight of the research team.
In situations where the IRB find serious and/or continuing noncompliance with this policy, the Provost will determine what administrative actions the University takes against the respondent.
In addition to disciplinary administrative actions outlined in University policies and procedures, the Provost may apply the following administrative actions, including but not limited to:
- withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found,
- removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, initiation of steps leading to possible rank reduction or termination of employment consistent with university policy, and
- restitution of funds as appropriate.
A. Effective Date:
This policy will become effective upon the date of approval by the Senior Vice President for Administration and Finance and the Provost and Executive Vice President.
B. Date of Most Recent Review:
VII. Timetable for Review
This policy, and any related procedures, shall be reviewed every three years or more frequently as needed.
Jennifer (J.J.) Wagner Davis S. David Wu
Senior Vice President for Executive Vice President and Provost
Administration and Finance