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All research involving human subjects that is conducted by any employee, student, or agent of Metropolitan State University, or otherwise conducted at or sponsored by the University, irrespective of the risks, scope, funding, or location of the research, must comply with federal and campus policies for the protection of human subjects. The Human Subjects Review Board (HSRB) is responsible for ensuring that all Metropolitan State University research activities meet these requirements. Therefore, as stated in University Policy #2060 (.pdf), all research involving human subjects needs to be reviewed by the HSRB. We encourage all researchers to take advantage of Metropolitan State's membership in CITI and to complete the free training available on this web site: https://www.citiprogram.org/default.asp. Click on Register, then choose Metropolitan State University from the All Others dropdown menu.
Research Conducted by Students
- Capstones/Individual, Independent Research
Independent student research projects, including senior or capstone theses, undergraduate research projects, master's projects, and similar projects, must be submitted to the HSRB. However, because students conduct research as part of a course of study, a faculty member is ultimately responsible for the protection of human subjects and must be designated as the RPI, even if the student is the primary investigator.
As assurance that the University's guidelines will be followed, the faculty member is required to sign (as RPI) the student's application for HSRB approval. After approval, the RPI should take an active role in ensuring that projects are conducted in accordance with the HSRB's requirements. During the entire project, faculty members should instruct students on the ethical conduct of research and help them prepare applications for HSRB approval. In particular, students should:
- understand the elements of informed consent,
- develop a readable and understandable consent form and Student as Principal Investigator Worksheet (see samples),
- plan appropriate strategies for recruiting and informing subjects,
- establish and maintain strict guidelines for protecting anonymity and confidentiality, and
- allow sufficient time for HSRB review and completion of the project.
- Classroom Research Projects
Class assignments that involve gathering data systematically (e.g., survey, experiment, focus group, interview) from participants who are not class members, with the intent to analyze the data to come to conclusions, are considered to be research and therefore must be submitted for HSRB approval. The HSRB will review proposed research for evidence of appropriate risk assessment, participant recruitment, and provisions of informed consent.
If the overall objective of a course assignment is to learn about the design and conduct of research, and if the data will be collected and analyzed for classroom learning only, a Class Assignment Protocol form must be filed with the HSRB. If the same assignment will be used in several courses during an academic year, the HSRB may be able to approve all uses with a single application. The assignment must be reevaluated annually to ensure that the guidelines are maintained and to bring the research protocol up to date with any changes in federal guidelines.
In general, the class/research protocol should adhere to the following:
- the instructor will educate students in human subjects protection, including review of federal guidelines and University policy, such that students:
- understand the elements of informed consent and voluntary participation
- develop appropriate consent documents
- plan appropriate recruitment strategies
- identify and minimize potential risks to subjects
- assess the risk-benefit ratio for the project, and
- establish and maintain strict guidelines for protecting confidentiality.
- student projects will be reviewed by the instructor to ensure that the research protocol is in accordance with ethical standards and University policy,
- students will draw their research subjects from the student population (if extra credit points are awarded for subjects, a faculty member will determine whether the points awarded are appropriate in lights of the time spent by the subject)
- student projects will not involve any personal, sensitive, or incriminating topics or questions that could place subjects at risk,
- the projects will not manipulate the behavior of students in any way beyond the range of normal classroom activity or college life, and
- the projects will not involve physically invasive contact with the subjects.
An example of an acceptable class assignment protocol is a course in sociology that involves a cluster of independent research projects conducted by students. The students complete HSRB application forms and submit them to their instructor for review and approval. The instructor reviews each student's research protocol and makes recommendations to the students regarding any necessary changes in order to adhere to ethical standards and University policy. If the student's research conforms to ethical standards, the instructor approves the research. The approved forms are then filed with the HSRB office with the class assignment protocol form. Very ambitious projects and projects that involve sensitive topics and vulnerable populations are not suited to the class assignment protocol review process. These must be pursued as individual projects.
Pilot or Feasibility Studies
Pilot and feasibility studies, regardless of the number of subjects, require the same scrutiny as full-scale research projects and must be submitted for HSRB review and approval. Pilot and feasibility studies should be identified as such in the HSRB application. Subjects should be told that the study is a pilot.
Research Involving Secondary Use of Data
Projects that use previously gathered human subjects data, and that meet the definition of human subjects research, require HSRB review.
Research Conducted At Another Institution or Off-Campus Site
Irrespective of the research site, any human subject research conducted by any Metropolitan State University employee, student, or agent requires HSRB review and approval. Metropolitan State researchers who participate in off-campus research must receive approval from the HSRB and from the human subject research review committees at any outside institutions participating in or sponsoring the research. If no human subject research review committee exists at a given institution, researchers should consult with the HSRB on how to document the outside institution's approval. Researchers might be required to provide formal, written assurance that the research will be conducted according to ethical standards. The HSRB's approval of off-campus research is made contingent on outside institution's approvals and assurances. Off-campus research at sites that are not formally affiliated with an institution, government, or other agency must receive approval from the HSRB. The research must be approved by the local equivalent of a human subject research committee or, where there is no equivalent group, by local experts or community leaders. Appropriate permissions must be documented.
Projects for which the researcher is a consultant
When a Metropolitan State University researcher is a consultant, he or she is deemed to be conducting research and HSRB approval is required, unless all three of the following are true:
- The researcher consults or is hired on his or her own time,
- the researcher holds no rights in the work, and
- neither the researcher nor Metropolitan State University retains any data.