IRB Policies and Resources
Note: The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017, and is scheduled for implementation on January 19, 2018. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The University of Richmond Policy Guide is currently under revision in response to these changes.
Comprehensive University of Richmond IRB policies were adopted by the Institutional Review Board at its December 8, 2009 meeting and subsequently revised, most recently at its April 26, 2016 meeting. The April 26, 2016 University of Richmond IRB Policy Guide is the current version of the UR IRB Policy Guide, but that policy and process is currently under revision to maintain consistent with new regulations required January 19, 2018. The University of Richmond IRB Policy Guide is subject to ongoing review and will be updated periodically. Please address any comments or suggestions about the IRB Policy Guide to the IRB Chair.
The University of Richmond has adopted a number of University-specific policies that exceed OHRP's base requirements. Many IRBs adopt policies beyond those contained in federal regulations in order to clarify the application of the regulations and to promote areas of interest specific to the institution.
Reporting Unanticipated Problems, including Adverse Events
Any problems involving risks to subjects should be reported as soon as possible, but no later than three working days after the occurence, to the IRB office. The board will convene, if necessary, to appropriately address serious unanticipated problems. If the safety of subjects is at risk, researchers can make appropriate changes as needed to protect subjects. Any changes made to protect subjects must be communicated immediately to the IRB and are subject to IRB review. NOTE: The provision for emergency action is contemplated principally for biomedical research. The use of such a procedure is not likely to occur at the University of Richmond.
Scope of Authority
The University of Richmond IRB is charged with regulating scientific studies involving human participants, as mandated by Title 45 Part 46 of the Department of Health and Human Services (DHHS) Code of Federal Regulations (CFR), Protection of Human Subjects, and therefore does not address other local, state, federal, or international requirements or restrictions, such as regulations pertaining to the use of data (e.g., the guidelines set forth by the Family Educational Rights and Privacy Act and the Health Insurance Portability and Accountability Act of 1996) and Title IX of the Civil Rights Act of 1964.
IRB Approval Does Not Guarantee Access to University Data
Please note, if your IRB research proposal requires access to University of Richmond data (such as e-mail addresses for surveys or student demographic data, etc.), the University may not provide you with that information even if your proposal is approved by the IRB. The IRB encourages you to contact Patty Murphy in the Office of Institutional Effectiveness to determine the feasibility of getting access to institutional information prior to submitting your proposal to the IRB for approval. Do not assume that because you have gotten access in the past or for other purposes, that the University will give you access for your current proposal.
The Office of Institutional Effectiveness regularly administers surveys on behalf of the University of Richmond, including surveys of students, alumni, faculty, and staff. Institutional Effectiveness also assists departments that want to participate in external surveys or create their own instrument. The results from these surveys are used for strategic planning, evaluation, and decision making. University of Richmond researchers wishing to access members of the University of Richmond community through surveys should contact the Office of Institutional Effectiveness.
External Research
The University of Richmond, as a rule, does not make information on its students, faculty, staff or alumni available to outside researchers. Even though student directory information is not FERPA-protected, the information is proprietary because it is housed and maintained in UR's information systems. So no outside researcher has the right to get access to that information. Also, most persons likely do not have the authority to disseminate student information, so they should not provide even directory information to an outside researcher. Outside researchers do conduct research on our students sometimes but they usually do so on their own, soliciting participants by putting ads in the student newspaper or using published directories to locate students on their own. If a survey firm contacts faculty, staff or students directly about participating in a research project, the decision to participate is the individual’s.
In some cases the University will make exceptions, but these are generally where there is a relevant University department or school that thinks that there will be a strong, direct benefit to the University of Richmond. That benefit often involves receiving information on the University of Richmond survey cohort that can be used to compare the University with other universities. Given the subject matter, it is possible that the Jepson School of Leadership Studies or the Robins School of Business might be interested in having their students participate in this outside survey. You could forward the message to those deans. They have the authority to determine if participation would benefit their school and to disseminate student contact information for that purpose
General Resources
The sites below are listed for reference purposes only and do not constitute an endorsement by the University of Richmond IRB.
The Principal Investigators Association offers a variety of resources of interest to principal investigators of research. The posting of this site does not constitute endorsement by the UR IRB.
Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 by Zachary M. Schrag makes the case that IRBs have greatly overstepped their original purposes.