Use of Human Subjects Policy
|Board of Trustees||10-10-2019|
|Executive Leadership Team||05-20-2019|
The purpose of the Stanly Community College (SCC) Use of Human Subjects Policy is to protect the rights and welfare of human subjects through the review of educational practices and potential research projects. SCC encourages and supports the scholarly endeavors of its students, faculty, and staff and is willing to participate in scholarly endeavors of third-parties when appropriate. When such scholarly work involves the use of human subjects for training and/or data collection and analysis, the proposed educational practices and research projects will be reviewed to ensure that:
- The rights and welfare of human subjects are protected
- Risks have been considered and minimized
- Potential for benefit has been identified and maximized
- All human subjects only volunteer to participate in research and/or training after being provided with legally effective informed consent
- Any research and educational practice is conducted in an ethical manner and in compliance with established standards, including handling all private information with confidentiality
Use of Human Subjects Procedures
|Executive Leadership Team||05-20-2019|
1. HUMAN SUBJECTS IN EDUCATION AND TRAINING
Laboratory hands-on training is an essential element in various SCC educational programs. Students must be proficient with live client and/or patient care techniques. Therefore, these skills must be practiced on volunteers under the supervision of program faculty, and practice is conducted at campus locations prior to or in conjunction with clinical placements. Volunteers must be 18 years or older who are fellow students or SCC employees. Members of the public may not participate in instructional skills training regardless of whether they volunteer. Safety and respect for each other are of vital importance. In order to protect the well-being of surrogates and to ensure that participating individuals are participating as a human subject on a voluntary basis, the following are required:
- Each educational program that requires the use of human subjects in the training curriculum will ensure that participating individuals are informed of the details and degree to which they are expected to participate as human subjects. Each program of this type will also require each participating individual to sign an informed consent or written authorization for use as a human subject prior to participation as a human subject.
- Students will not be allowed to apply modalities or procedures to human subjects until they have demonstrated proper operation of the equipment and are approved by an appropriate qualified instructor to work with human subjects. This approval will be documented in student or class records and kept by the program head or designee.
2. HUMAN SUBJECTS IN RESEARCH
- Definition – Research involving human subjects is defined as any systematic investigation designed to develop or contribute to generalizable knowledge that involves the investigation of one or more living individuals about whom the investigator (whether professional or student) conducts research and obtains:
- data through intervention or interaction with the individual, or
- identifiable private information
- Requesting investigators will complete, at least 45 days in advance of the proposed research start date, the Stanly Community College Research Approval Application, available from the Director of Institutional Effectiveness. The application includes (but is not limited to) sections pertaining to research design, requests for existing data from SCC Institutional Effectiveness personnel, and informed consent forms where applicable.
- SCC will not approve the research projects that are found to be “non-exempt” from the required review of an Institutional Review Board (IRB), as described in the Code of Federal Regulations - Title 45 (Public Welfare), Part 46 (Protection of Human Subjects) (45 CFR 46). SCC will consider the approval of research projects that either do not include human subject research or are considered “exempt” from the required review of an IRB. All research efforts that potentially include the use of SCC employee or student information will be reviewed to determine:
- whether the research involves human subjects;
- whether the research is considered “exempt” from the federal requirement for review by an Institutional Review Board (IRB);
- the level of involvement of SCC Institutional Effectiveness personnel in the project;
- approval of the project to proceed with or without modifications if the research project is determined to be “exempt” from IRB review requirements;
- disapproval of the project if the research is determined to be “non-exempt” from IRB review requirements.
D. Exempt Human Subject Research
Investigators cannot self-determine whether the proposed research is exempt from IRB review. This is to be determined by the Director of Institutional Effectiveness, who will follow the guidelines set forth in 45 CFR 46. If the complexity of the request or proposal requires additional expertise, a Research Review Committee will be formed by the Director. The Committee will review the proposal and make recommendations to the Director. Examples of exempt research (i.e. research that may be approved by SCC) include:
research conducted in established or commonly accepted educational settings involving normal educational practices;
research involving the use of educational tests if the information taken from these sources is recorded in such a manner that the subjects cannot be identified either directly or indirectly;
research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if these sources are publicly available and if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or indirectly;
research involving the observation of public behavior or research involving survey or interview procedures EXCEPT when:
- data are recorded in a manner enabling identification of subjects and the subject’s responses, if they were to become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing,
- the research deals with sensitive aspects of the subject’s behavior such as illegal conduct, drug or alcohol use, sexual behavior, or
- the research deals with study participants who are likely to be vulnerable to coercion or undue influence, such as minors under the age of 18 (45 CFR 46 Subpart D), prisoners (45 CFR 46 Subpart C), pregnant women (45 CFR 46 Subpart B), persons with mental disabilities, or person whose economic status would leave them susceptible to coercion.
E. Research Review Committee
The purpose of the Research Review Committee is to review research requests and proposals when the complexity of such projects requires a collaborative team of professionals with relevant expertise to determine whether research is considered exempt of the requirement of an IRB. The Committee will be comprised of the Director of Institutional Effectiveness and at least 2 research and subject matter professionals chosen at the discretion of the Director of Institutional Effectiveness, who will be briefed on the applicable federal guidelines.
F. Degree of SCC Involvement
When investigators request the use of existing data, which may only be accessible to specific SCC personnel, it becomes necessary for SCC personnel to assist in the retrieval of this data. It is important to note that the role of SCC personnel will be restricted to the extraction of such data for the investigator. Additional research-related tasks such as data analysis, statistical testing and graphic presentations will not be performed by SCC personnel. If the data request is unclear, the investigator may be required to work with his or her supervisor or educational advisor to better communicate the information requested.
G. Informed Consent
Each approved research project that requires intervention and/or interaction with the human subject will require that each subject sign an informed consent. The language of this form must indicate:
- that participation in the project is voluntary;
- that participation in the project is independent of course grades and/or other indicators of student success;
- a description of the purpose of the project and the details of participation;
- assurance that students, faculty, or staff involved in the research project will not be identified when the findings of that project are published;
- an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
- a list of possible risks and/or benefits of participating as a subject of research.
H. Approval of human research projects
Approval for human research projects is granted based on whether the project is determined to be “exempt” or “non-exempt” from IRB review requirements.
- Non-exempt research. When the proposed research is not applicable to the above described “exempt” categories, and consequently receives the “non-exempt” designation, the Director of Institutional Effectiveness will deny the project summarily. This includes research that falls under the exceptions listed in Section 2.D.d above. Investigators are welcomed to modify the project so that non-exempt human subject research is not included, and then reapply for SCC authorization.
- Exempt research. To minimize the distraction and burden of research activities that are a detriment to the mission of the College, all exempt research shall be subject to review and approval by the Director of Institutional Effectiveness, the Vice President of the area in which the research will be conducted, and the supervisor of primary individual(s) whose duties would be affected by the research. The Vice President and supervisor, at their discretion, may contact the employees in the area in which research will be conducted to determine feasibility of the study.
Revisions: 11/25/2013 (procedures), 4/10/2014 (policy)
References: 45 CFR Part 46, (Protection of Human Subjects)