Frequently Asked Questions
Check the following FAQs. If you have any questions, contact the IRB Chair.
The IRB is the acronym for the Institutional Review Board (IRB) for the Protection of Human Subjects of Research. The board consists of 10 members appointed by the University President. Institutions like the University of Richmond are required to have an IRB if they do research that involves human subjects. The IRB is established to protect the rights and welfare of human research subjects. The IRB was formerly administered by the School of Arts and Sciences. However, as more proposals began to come from investigators outside of the School of Arts and Sciences, the IRB was moved to the Office of the Provost, effective July 1, 2007. The responsibilities of the IRB are to protect human subjects of research and to ensure that research at the University of Richmond complies with federal and state regulations governing the conduct of human subjects research as spelled out in the HHS Regulations for the Protection of Human Subjects at title 45 Code of Federal Regulations Part 46, and in other applicable federal and state regulations.
Yes. Surveys involve interaction with living human beings for research purposes. Some surveys can be minimal risk and might be "exempted" or "expedited." Some surveys can collect sensitive information, however, that could be damaging to a subject if the results were linked to him or her. Often the principle risk is the disclosure of personally identifiable information. In some cases, the surveys themselves might touch on topics that can upset and therefore potentially harm subjects. IRB rules have been interpreted as having a very broad application. Any research involving intervention or interaction with persons and/or their personal records should be submitted to the University of Richmond IRB for review. Some research may be exempted, but this exemption must be granted by the IRB in writing. Also, an institution's IRB has the authority to adopt protections that exceed those of OHRP, whose regulations should be regarded as a "floor" and not a "ceiling." Some surveys may be determined to be "not reviewable research". For example, if the dining center surveys users and limits questions to favorite foods, the survey would not be reviewable. However, if the survey were to collect information about the respondents or ask questions about their weight and body image, then it would need to be reviewed by the IRB.
The principles of human subject research, briefly summarized, are respect for persons (informed consent, protecting privacy and maintaining confidentiality, safeguards to protect vulnerable populations), beneficence (an IRB assessment of risks and benefits of proposed research;minimization of risks to subjects, with risks justified by the benefits of the research), and justice (ensuring that selection of subjects is equitable). These principles are enumerated in the 1979 Belmont Report which is a concise statement of ethical principles and guidelines for research involving human subjects.
A consent form is the means by which a researcher documents the legally effective agreement of a person to participate in a research project. "Informed consent" refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of, among other things, the research's purposes, procedures, risks, benefits, and any other factors that may affect a person's decision to participate in the research project. It is important to remember that "informed consent" is a process as well as a form. The researcher should not just hand someone a form and ask them to sign it. Rather, the researcher should explain the research activity and the material covered on the form, ensure that the person understands their proposed participation, and then acquire the signature of the person when the researcher is confident that the subject understands his or her role in the research‚ Consent for online surveys does not require a signature but can be effected by using a consent button or click‚ See an example of an online consent form HERE.
It's almost impossible to get a signed consent form when one is conducting an online survey. However, the IRB will approve minimal risk projects involving online surveys provided that the basic elements of consent are covered and it is clear that a subject could reasonably be expected to understand their role in the research. Normally, an online survey would contain an introductory statement that describes the project and the role of the subject, provides information on the principal investigator, reviews the benefits and risks of the research, informs the subject that participation is voluntary, describes the uses of the data collected and the confidentiality/anonymity provided, provides IRB contact information, and informs the subject that he or she can stop at any time without penalty and skip any questions without penalty. The consent form would end with a statement similar to the following: "I understand my role as a research subject on this project and by continuing with the survey, I am providing my consent to participate. Further, I attest that I am 18 years of age or older. Online consent forms will be reviewed carefully by the IRB to assure that potential subjects are provided with needed information to provide informed consent. Online surveys will not be approved for subjects under 18 years of age. An example of an online consent form can be found HERE.
In-class research is generally covered by the University of Richmond's IRB rules and regulations. This is an area where the University of Richmond IRB has chosen to exceed the protections provided in OHRP regulations. OHRP regulations typically apply to research that contributes to "generalizable knowledge." The University of Richmond IRB considers classroom research to be reviewable by the IRB for many reasons. Going through the IRB review process promotes the protection of research subjects and contributes to the educational experience of students participating in research projects. There are exceptions to this policy. For example, if all of the research activities are confined entirely to the classroom, then the activity is considered a teaching activity and not a research activity. Were a class to develop a survey and then administer to non-class members the project would need to be reviewed by the IRB. If the class were to develop a survey and ONLY administer it to other members of the class, however, then the activity would be considered teaching and not research. Thus it would not be reviewable research and not under the jurisdiction of the UR IRB. Faculty using such research methods for teaching purposes should exercise their judgment when collecting information, even if for internal classroom use only. For example, when demonstrating surveys the collection of Social Security numbers would be inadvisable.
Sometimes a slight change to a proposal can alter its review status. For example, a minimal risk survey involving only adults (those 18 and above) could likely be reviewed using the expedited process. The exact same survey involving minors (those under 18) would have to be reviewed by the convened IRB. The inclusion of detailed demographic questions (e.g. age, sex, major, etc.) could also change the review procedure because a combination of demographics might result in a confidential survey being potentially non-confidential. For example, there may only be one "female, Hispanic, second year, marketing major" at the University of Richmond. Consequently, a survey thought to be confidential might actually include personally identifiable information.
The process for class research can be streamlined. For example, a professor can submit an omnibus research proposal that lists him or herself as the principal investigator and all of the students as co-investigators. The professor could get the "template" proposal approved and then submit only the question sets of individuals or class groups. Faculty members are encouraged to contact the IRB Chair for examples of omnibus proposals. Some professors may require that each student submit a proposal to the IRB as part of their research training. In such cases the regular review process will be followed.
An internal staff assessment survey is generally "exempt research" or "not reviewable research". For example, a survey only collecting data for an internal administrative matter, such as a user feedback survey, is usually exempt. However, if the collector intends to use the data for research purposes or conference presentations, then the survey is no longer simply for internal assessment and may not be exempt from IRB review. Only the IRB can determine if an assessment survey is exempt, but this can usually be done on an expedited basis. Administrators should remember that informed consent cannot be achieved retroactively. Thus, if there is a possibility that a survey might be used in a presentation or posted on the web, the administrator should submit a proposal for IRB review. An exception would be a user survey where there is no personally identifiable information (such as a dining survey or a library user survey). No proposal review would be needed in such cases. If an administrator is unsure of whether or not an assessment activity is not reviewable, he or she should send the IRB Chair a brief summary of the activity via email. The IRB Chair will provide a written determination by email. NO IRB determinations are provided except in written form.
Yes. If a research subject is going to be interviewed or surveyed in a language other than English, the researcher needs to submit information on how the interviews will be conducted and copies of interviews and consent forms in the language(s) to be used. Generally, it is a good idea for the researcher to get an "approval with conditions" of the materials in English, then submit the translations. It is the responsibility of the researcher to certify to the IRB that the translation is a true representation of the content and spirit of the English versions of the proposal and consent forms submitted to the IRB. Investigators doing research abroad may need to acquire both UR IRB approval and a local IRB approval. The most common example of this is when students do research overseas as part of an SIT project. Both the SIT and UR IRBs need to approve the project.
"Engagement" in research requires UR IRB review and oversight. "Involvement" in research may not involve UR IRB review and oversight. This matter was clarified somewhat in an OHRP guidance document in October, 2008 when OHRP provided new guidance on the engagement of persons or institutions in research. Using this guidance, the UR IRB determined that simply forwarding emails that informed potential subjects about a study did not constitute "engagement" and therefore did not have to be reviewed by the UR IRB. However, were the person forwarding the emails to provide other assistance, such as the consenting of subjects, then the University would be engaged and IRB review would be required. Persons with questions about whether their "involvement" in a research project constitutes reviewable "engagement" should contact the IRB Chair.
Usually the risk level will be lower (no more than "minimal risk") for a proposal that can be reviewed using the expedited process. An expeditable proposal can be acted on by the IRB Chair and does not have to go before the convened IRB for approval. The information requested and the rigor of the reviews are almost identical. However, a proposal eligible for expedited review can often be reviewed on a more timely basis. As noted on the IRB website, the Chair is only authorized to review proposals that fall into certain categories specified by OHRP. The IRB chair can approve a proposal, return a proposal for more information, or approve with conditions using the expedited process. The Chair cannot disapprove a proposal using the expedited process.
No. Policies regarding the care and use of animals in research are set by the University's Institutional Animal Care and Use Committee or IACUC. However, the Chair of the IRB does administer the University's CITI training program, which also supplies online training regarding the care and use of animals in research. Registration information for CITI animal care and use training can be obtained under the "Researcher Training Requirements" section of this website.