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STUDENT RESEARCH
Student research is divided into two categories. Category 1 includes thesis projects (undergraduate and graduate), research designed to contribute to generalized knowledge, and any research not done as a part of a course. Category 2 includes research other than thesis projects that is done as part of a course, but in which the student's work is not specifically geared to contribute to generalized knowledge. In some instances, the subjects could be placed at risk. For this reason, proposed projects should be reviewed and approved prior to initiation of the course work to help ensure that the rights and welfare of human subjects are protected. Sometimes a faculty member can do this review and at other times the review must be conducted by the IRB.
Category 1 Student Projects:
All research that falls into Category 1 should be submitted directly to the IRB.
Category 2 Student Projects:
For research that falls into Category 2, the IRB requests that faculty members fill out a brief form and collect separate forms from students. These forms are to be evaluated by the course instructor and the instructor may either grant approval him or herself, ask for informal IRB assistance in evaluating the proposed research, or ask the student to submit a full application to the IRB.
Course instructors have primary responsibility for ensuring that the rights and welfare of human subjects are not violated. This responsibility includes communicating to students the ethical principles for the protection of human subjects. It also includes reviewing student research protocols and monitoring these activities and reporting of findings to ensure that human subjects are protected. Student projects that are not submitted to the IRB must fall within the parameters described below.
A. Ethical Principles for the Protection of Human Subjects
1. In a research study, every person has the right to determine what shall be done to him or her, what activities he or she shall engage in, and what risks he or she will take. Consequently, research on human subjects cannot be carried out without the subjects' or the subjects' legal guardians' competent, voluntary, and informed consent. There must be scientific justification for deception. Research involving deception must be conducted under carefully controlled conditions.
2. No person should be placed at risk as a subject unless the risks are reasonable in relation to the anticipated benefits of that activity. Any project involving greater than minimal risk must be submitted to the IRB for review and approval.
3. The benefits and burdens to subjects should not be unjustly distributed. The recruitment and selection of subjects should be reasonably related to the research. Subject's selection should not impose inequitable risks and burdens on any segment of society, nor should it unfairly benefit one group over others.
4. Special consideration and protection should be given to persons who may lack full capacity to secure their own rights and interests due to age, mental capacity, involuntary custody, language barriers, or other special circumstances. Projects that involve these subject populations must be submitted to the IRB for review and approval.
B. Definitions
1. "Course Directed Human Subjects Activity" means any observation or intervention by a student as part of a course that is designed to develop or contribute to student learning.
2. "Human Subject" means an individual about whom an investigator conducting research obtains either data through intervention or interaction with the person, or identifiable information.
3. "Student Researcher" means any student enrolled in a course at NGCSU, who conducts human subjects research as an assignment or project in the course, excluding thesis research that must be reviewed under established IRB procedures.
4. "Minimal risk" is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals.
C. Responsibility of Instructors
1. Instructors of courses in which students conduct activities involving human subjects are responsible for informing students of the ethical principles for the protection of the human subjects and applicable policies and procedures.
2. Instructors of courses in which students do conduct activities involving human subjects are responsible for prior review of those activities to ensure that they are within the specified parameters allowed for student research and that the activities are in accordance with IRB policies and procedures.
3. Students must complete, either individually or in small groups, the Applications to Engage in Course-Directed Human Subjects Activity. Instructors are responsible for reviewing and approving these student applications and are responsible for retaining the completed applications for a period of one academic year.
4. Course instructors must complete an Instructor Notification to the IRB of Course Directed Human Subjects Activity and forward it to the IRB.
D. Instructor Review of Student Research
1. The instructor is responsible for ensuring activity is minimal risk. Having students complete Applications to Engage in Course-Directed Human Subjects Activity should help instructors ensure that this criterion is met.
2. If the student project involves intervention but poses no more than minimal risk, the course instructor may review and approve the application. Informed consent of subjects is required or if the subjects are under the age of 18 then parental consent and child assent is required. If the research involves more than minimal risk, the IRB must review it.
3. The instructor is responsible for assessing whether risk is more than minimal. If there is any question or doubt about the degree of risk posed by the project and if there is any possibility of more than minimal risk, the protocol must be reviewed by the IRB.
4. The instructor must review and approve the procedures for obtaining informed consent from adult participants, and parental consent and child assent when the participants are minors.
5. The instructor must review and approve the instruments, methods, and procedures of the protocol in their final form prior to their use by student researchers.
6. The instructor must keep a record for at least one academic year of each project. These records must include the project titles, the student names, and the dates of the review and approval by the instructor. Special application forms are available for these course-directed activities.
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