Institutional Review Board (IRB) for Human Subjects Research
Welcome to the website for the Lynchburg College (LC) IRB. These pages have been designed to serve as an information and resource clearinghouse for researchers, potential and current research subjects, members of the LC community, and other interested individuals. The purpose of the LC IRB is to perform ethical review of proposals for human subjects research, and to provide leadership in the development of and education on policies and procedures for the responsible and ethical conduct of human subjects research.
Researchers are encouraged to consult this page first before submitting a research study proposal package. If you are ready to submit, then click here for our Submission Instructions and Forms page.
All human subjects research conducted by student, staff, faculty, and those otherwise affiliated with Lynchburg College must be reviewed by the IRB and approval must be obtained before the research may begin. Human subjects research falls into one of three categories:
- Exempt from continued oversight (exempt review status – less than minimal or no foreseeable risk or discomfort that is no more than what someone would experience in their daily lives if they were not participating in the study; no involvement of vulnerable populations),
- Expedited review (expedited review status – no more than minimal foreseeable risk or discomfort; may involve a vulnerable population but not one federally protected/requiring full board review), or
- Full formal review (full board review status – more than minimal foreseeable risk or discomfort; may or may not involve vulnerable populations).
See the Frequently Asked Questions (FAQ) section, below, for more information on determining type of review and submission procedures. Researchers are strongly encouraged to review the screening questions on the submission form to determine the type of review in which their research study likely falls.
The Federal Protection of Human Subjects Regulations, as set forth in 45 CFR part 46 (FAQ http://answers.hhs.gov/ohrp/categories/1562), is the guiding policy for policies and procedures used by the LC IRB. In addition to the federal regulation, the OHRP memos, documents, and other guidance materials have been used to establish the policies and procedures related to the responsible conduct of research at LC. It is the responsibility of the members of the IRB to review research study proposals to insure compliance with the federal regulation and the LC IRB policies for human subject research. Human subjects research may begin only after the IRB has approved it. Any reviewed project which will have a duration exceeding one year must reapply for approval each year. If the IRB decides that a shorter interval between reapplication is necessary, then this will be noted in the initial response to a request for review.
The Principal Investigator (PI) is the lead researcher for the study. Faculty Research Sponsors advising student research share in the responsibility for making certain that student research complies with policies and procedures. Undergraduate are not permitted to serve as the PI of a research study and must be listed under the research team as a student research; and graduate students may serve as Co-PI (not PI) or as members of a research team. In instances where the researcher is an LC employee and a student (graduate or undergraduate), the purpose of the research is used to determine the researcher’s primary role. This is consistent with the best practices for IRBs and with policies at our peer institutions. All researchers who will have access to the data that are being collected, including student researchers, must be listed on and sign (when applicable) the appropriate form(s). More information is found in the Student Research Policy and in the FAQ section, below.
Lynchburg College and the LC IRB are committed to integrity in scholarship and to ethics in research. Consistent with the nature of our educational community, faculty and staff reflect this commitment in their adherence to appropriate practices in conducting research in all its forms. In order to ensure support for this commitment, Lynchburg College is further committed to preventing misconduct in research through the wide dissemination of these guidelines and through its ongoing efforts to inform members of the community of appropriate research practices. In instances where allegations of misconduct are made, Lynchburg College also is committed to a vigorous investigation of the charges, support for individuals bringing such charges, and a prompt resolution of the case. The Research Integrity and Misconduct policy and instructions on reporting possible research misconduct are found via this link. This policy and the associated procedures apply to any person paid by, under the control of, or affiliated with the institution, such as faculty, trainees, technicians and other staff members, students, fellows, guest researchers, or collaborators at Lynchburg College.
The LC IRB is a registered as an official IRB with the federal government through the Office of Human Subjects Research Protection (OHRP), Department of Health and Human Services (HHS). Effective July 2013, the LC IRB holds a federal-wide assurance (FWA) with the OHRP. Institutions must have an FWA in order to receive support for research involving human subjects from HHS/OHRP. Also, the institution’s FWA provides the assurance required for researchers to conduct or support human subjects research with certain federal department and agencies. More information about FWA can be found online at http://www.hhs.gov/ohrp/assurances/assurances/index.html.