4.03 – Research Policy
A.   Purpose
To establish research guidelines and standards that protect human subjects.
B.   Policy
The college will enforce research procedures and standards to advance learning through research studies while protecting members of the college community. These procedures and standards will be consistent with the United States Department of Health and Human Services’ Policy for the Protection of Human Research Subjects.
C.   Procedures
All research involving human subjects must be conducted in accordance with the United States Department of Health and Human Services’ Policy for the Protection of Human Research Subjects (45 CFR 46.101-124) standards for protection of subjects. To ensure compliance with these standards, research projects that are sponsored by the college, conducted by college employees, and/or involving the participation of college students must be reviewed and approved unless they fall into one of the following exempt categories:
- Research being conducted in commonly accepted educational settings that involve normal educational practices. This includes most operational research assessing topics such as instructional strategies, techniques, curricula, or classroom management methods.
- Research that only includes interactions such as educational tests, surveys, or observations of public behavior provided that the information collected is either not stored in a way that is personally identifiable or that it is personal information where disclosure would not place the subjects at risk of civil or criminal liability, or harm to their financial standing, employability, educational advancement, or reputation.
- Research involving benign behavioral interventions for adult subjects where the information is either not personally identifiable or where disclosure would not place the subjects at risk of civil or criminal liability, or harm to their financial standing, employability, educational advancement, or reputation. Benign behavioral interventions are those that are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and where the researcher has no reason to think the subjects will find the interventions offensive or embarrassing.
- Research involving the use of existing data that is either publicly available or used and maintained in a way that protects the confidentiality of subjects.
- Institutional research designed to improve services or benefits that protects the confidentiality of subjects.
Operational research conducted as a part of an employee’s job duties or instructional delivery commonly falls within one of the above exempt categories. If an individual has any doubt or questions about whether a research activity is exempt, they should contact the college’s institutional research office for guidance by emailing research@otc.edu.
While the collection of data using surveys may be exempt from review, all surveys conducted for operational research at the college should be developed and deployed by the college’s institutional research office. The institutional research office will maintain a survey software license that allows for the collection and storage of data consistent with privacy standards. Surveys may only be created independently with notification of and prior approval from the chief research and governmental affairs officer or their designee.
Research projects that do not fall in one of the exempt categories above must be reviewed and approved prior to beginning any data collection or soliciting participation. This review process begins with the submittal of an application using the college’s online form demonstrating how the research will meet federal standards including:
- Minimization of risk to participants and ensuring that any risks created for subjects are reasonable and justified by the anticipated benefits of the research.
- Assurance and documentation of informed consent for all participants including the use of consent forms with a clear explanation of the research being conducted, descriptions of any foreseeable risks, level of confidentiality provided to participants, and emphasis that participation is voluntary with no consequence for individuals who choose not to participate. Consent forms must also include contact information for those conducting the research in case of questions or issues that arise during participation, including the ability to withdraw from participation at any time. If participants are minors this informed consent must be provided to their parent or legal guardian with their consent being required prior to the minor’s participation.
- Equitable selection of subjects with an emphasis on avoiding undue harm to vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically disadvantaged persons.
- Appropriate monitoring, maintenance, and use of the data collected to protect the privacy and safety of all subjects.
This application will be reviewed by the chief research and governmental affairs officer and/or their designee(s) who will make the final determination on approval. To avoid conflicts of interest, the chief research and governmental affairs officer should refrain from conducting personal sponsored research at the college outside the scope of their institutional research employment functions. In the case of a conflict, designee(s) must be appointed to make a final determination on approval.
Approval of a research proposal does not obligate the use of college resources to promote participation in the research study. The use of college resources is focused on operational research that advances the college’s mission. Individuals conducting research projects for personal purposes are expected to provide necessary resources for their own projects.
Research being conducted for personal publications should de-identify the college unless specific permission has been obtained for use of the college’s name. Any published participant data must also be presented in aggregate form or otherwise de-identified to protect participant privacy unless specific permission has been provided by both the college and the identified participants.
D. Definitions
The college will use definitions of relevant terms from 45 CFR 46.102.
A participant is defined as a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. The use of individual student records can be considered participation requiring informed consent unless it falls within an exempt category defined above.
E. Authority
This policy is maintained under the authority of the chief research and governmental affairs officer.
F. Related Policies
G. Implementation
Policy approved and adopted by the Board of Trustees on 04/09/25.
Purpose, procedures, responsibilities, and definitions approved and adopted by the Cabinet on 03/24/25. Set for review in fiscal year 2026-2027.