Procedures for Research
All research involving human subjects conducted by students are to be supervised by a faculty member and be reviewed and approved by the Committee on Institution Research prior to initiation. Projects are initially reviewed regardless of the source of funding, and regardless of its federal status as an exempt, an expedited, or a full review project. Investigators may not solicit subject participation or begin data collection until they have received written approval from the CIR.
Generally, student research involving human subjects falls into one of two categories, only one of which requires CIR Review:
Independent Research — Projects which employ systematic data collection with the intent to contribute to generalizable knowledge. Thesis and dissertation projects involving human subjects are considered research as defined by 45 CFR 46 and always require review by the CIR. Study results are generalizable if they are expected to be submitted for publication in a journal or magazine, published in a newspaper or on the World Wide Web, published in bound volumes such as theses or dissertations, presented at a professional conference or otherwise widely distributed.
Methods Training-Research project where the overriding and primary purpose is a learning experience in the methods and procedures of research to acquire knowledge and skill is typically not subject to CIR review. An example of this is research that is carried out by students as part of an applied project for research methods training. The type of research is further characterized by minimal risk to human subjects and clearly falls within ethical guidelines for the protection of human subject participants in research. Important factors to consider are the potential risks to subjects posed by the research activity itself, in terms of:
- Potential harm from subject participation in the study;
- Possibility of disclosure of confidential information;
- Whether the individuals are either unable to give consent or are subject to significant coercion or pressure to participate.
Curriculum Projects — students conduct research involving human subjects need not be reviewed by the CIR if the following conditions are satisfied:
- The project(s) involve minimal risk to subjects; and
- They do not involve sensitive topics or vulnerable populations; and
- Results will never be distributed outside the classroom and/or institutional setting (including poster or showcase session or oral presentation to instructors and peers) or used for publication. If there is even a remote chance that the data or the report/manuscript will be used in the future for an off campus conference presentation, or submitted for publication, the research should go through CIR review. If the project is not subjected to CIR review before data collection begins the information will most likely not be permissible for inclusion in future presentations, publications, or research.
An example: consider a student who undertakes an individual or class project that does not involve a vulnerable population and involves no risk to the subjects of the study. The student delivers a presentation on campus (e.g., poster or showcase session or an oral presentation before faculty and peers.) This project would not require CIR review. However, if the results of this otherwise "no or low-risk" project may/might be disseminated at a professional conference, submitted for publication, or published on the World Wide Web, government regulations require prior review by CIR.
Although the CIR does not require review of classroom and curriculum projects, instructors are required to become fully familiar with each student's project(s), and to discuss it with the student. Experience has shown that time spent with students discussing matters such as courtesy, and avoidance of unnecessary discomfort or invasion of privacy, is time well spent. The recognition of the existence of Human Subjects Panels at all research institutions, and discussion of their goals and concerns, should be an integral part of introducing students to research methodologies. Similarly, faculty would do well to discourage inexperienced researchers’ enthusiasm to conduct practice research projects with vulnerable populations.
If in doubt, have the project reviewed or to ask for specific advice before the project begins. The CIR is unable to give post facto approval.
Faculty advisors of both undergraduate and graduate students must be certified to conduct research with human subjects, even if they are not currently conducting research with human subjects. One way of receiving certification is to complete the Computer-Based Training (CBT) program available on the office of Research website. Another method is to attend one of the Human Subjects Protection seminars presented by the Office of the Committee on Institutional Research.
Responsibility for Oversight of Student Projects / Activities
The faculty and the department have the responsibility for (1) making the decision whether student research activities involving human participants meet eligibility for exclusion from CIR review; (2) overseeing these activities; and (3) assuring that ethical principles are adhered to in the conduct of those activities. Specifically all participants must be invited to voluntarily participate and receive an explanation of what the activity is about and understand that their participation is voluntary , and the Principles of the Belmont Report regarding Respect for Persons, Beneficence and Justice should be adhered to when conducting the activity.