New River CTC Institutional Review Board for Human-Subjects Research
New River Community and Technical College encourages and supports the scholarly endeavors of its students, faculty, and staff. Pursuit of scholarly work and research may involve the use of human subjects for data collection and analysis. New River CTC’s Institutional Review Board (IRB) reviews human-subjects research proposals to ensure that:
- the rights and welfare of research participants are protected during research studies involving NRCTC students, faculty, and staff;
- risks have been considered and minimized;
- the potential for benefit has been identified and maximized;
- all volunteer research subjects agree to participate after being provided with legally effective informed consent;
- and any research is conducted in an ethical manner in compliance with established standards.
Any individual seeking to conduct human-subject research involving students, faculty, staff, or facilities of New River CTC must obtain approval from the New River CTC Institutional Review Board prior to soliciting subject participation or beginning data collection.
The definition of human-subjects research is taken from the Code of Federal Regulations Title 45 Public Welfare part 46 Protection of Human Subjects 46.102.
Research is defined in the federal code as 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 this 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 human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Therefore an institution becomes engaged in human-subjects research when its employees or agents: (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].
Institutional Review Board
The New River CTC Institutional Review Board (IRB) consists of at least five members and is composed of faculty and administrators of New River CTC as well as at least one member not associated with the College. The IRB reviews and evaluates projects and programs involving human-subjects research in accordance with the NRCTC IRB Handbook (PDF), applicable federal regulations, and sponsor policies and guidelines. Following the guidelines set forth in the Code of Federal Regulations (45 CFR 46), human subjects research can be classified into three review levels based on the type of research and the level of risk to the safety, health, welfare, or life of participants. These three review levels are:
- Exempt from review due to the minimal risk of certain types of research defined by the federal code;
- Expedited review for research where no more than minimal risk to human subjects is expected during research involving a specific list of research activities described in the federal code; and
- Full review for proposals involving elevated risk to the safety, health, welfare, or life of participants.
Submission of Proposals for IRB Review
The United States Office of Human Research Protections Decision Charts (link is external) can help you determine whether your research may qualify as Exempt, Expedited or require a Full Review of the New River CTC IRB. You may contact any member of the IRB for further guidance in determining the appropriate level of review to request. Only the IRB has authority to determine the level of review required.
Steps to approval of human-subject research include:
- Successful completion of human-subjects research training entitled “Protecting Human Research Participants” on the National Institutes of Health website by all researchers involved in the project who will be interacting with participants or handling the data generated by the project. Verification of training completion must accompany your application.
- Complete and submit to the chair of the IRB a Human Subject Research Application and any associated forms or sample surveys using either:
Applications for Exemption Status and Expedited Review require consideration from only a few members of the IRB and can be accomplished more quickly than a Full Review that requires a scheduled IRB meeting with a full quorum of members in attendance.